What is bydureon pen?

Bydureon

SIDE EFFECTS

The following serious adverse reactions are described below or elsewhere in the prescribing information:

  • Risk of Thyroid C-cell Tumors
  • Acute Pancreatitis
  • Hypoglycemia
  • Acute Kidney Injury
  • Gastrointestinal Disease
  • Immunogenicity
  • Hypersensitivity
  • Injection-Site Reactions

Clinical Trial Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The safety data presented below are derived from six comparator-controlled trials of BYDUREON in patients who entered the studies not achieving adequate glycemic control on their current therapy . In a double-blind 26-week trial, patients on diet and exercise were treated with BYDUREON 2 mg once every 7 days (weekly), sitagliptin 100 mg daily, pioglitazone 45 mg daily, or metformin 2000 mg daily. In a double-blind 26-week trial, patients on metformin were treated with BYDUREON 2 mg once every 7 days (weekly), sitagliptin 100 mg daily, or pioglitazone 45 mg daily. In an open-label 26-week trial, patients on metformin or metformin plus sulfonylurea were treated with BYDUREON 2 mg once every 7 days (weekly) or optimized insulin glargine. In two open-label 24- to 30-week studies, patients on diet and exercise or metformin, a sulfonylurea, a thiazolidinedione, or combination of oral agents were treated with BYDUREON 2 mg once every 7 days (weekly) or BYETTA 10 mcg twice daily. In an open-label 26-week trial, patients on metformin, a sulfonylurea, metformin plus a sulfonylurea, or metformin plus pioglitazone were treated with BYDUREON 2 mg every 7 days (weekly) or liraglutide 1.8 mg once daily.

Common Adverse Reactions

Tables 1 and 2 summarize adverse reactions with an incidence ≥5% reported in the six comparatorcontrolled 24- to 30-week trials of BYDUREON used as monotherapy or as add-on to metformin, a sulfonylurea, a thiazolidinedione, or combination of these oral antidiabetic agents.

Table 1: Adverse Reactions Reported in ≥5% of BYDUREON-Treated Patients with Type 2 Diabetes Mellitus in Monotherapy Trial

Table 2: Adverse Reactions Reported in ≥5% of BYDUREON-Treated Patients with Type 2 Diabetes Mellitus in 24- to 30-Week Add-On Combination Therapy Trials

Nausea was a common adverse reaction associated with initiation of treatment with BYDUREON and usually decreased over time.

Adverse Reactions Leading To Study Withdrawal
Hypoglycemia

Table 3 summarizes the incidence of minor hypoglycemia in the six comparator-controlled 24- to 30week trials of BYDUREON used as monotherapy or as add-on to metformin, a sulfonylurea, a thiazolidinedione, or combination of these oral antidiabetic agents. In these trials, an event was classified as minor hypoglycemia if there were symptoms of hypoglycemia with a concomitant glucose <54 mg/dL and the patient was able to self-treat.

Table 3: Incidence (% of Subjects) of Minor* Hypoglycemia in Clinical Trials in Patients with Type 2 Diabetes Mellitus

Injection-Site Adverse Reactions

In five comparator-controlled 24- to 30-week trials, injection-site reactions were observed more frequently in patients treated with BYDUREON (17.1%) than in patients treated with BYETTA (12.7%), titrated insulin glargine (1.8%), or those patients who received placebo injections (sitagliptin (10.6%), pioglitazone (6.4%), and metformin (13.0%) treatment groups). These reactions for patients treated with BYDUREON were more commonly observed in antibody-positive patients (14.2%) compared with antibody-negative patients (3.1%), with a greater incidence in those with higher titer antibodies . Incidence of injection-site reactions for patients treated with BYETTA was similar for antibody-positive patients (5.8%) and antibody-negative patients (7.0%). One percent of patients treated with BYDUREON withdrew due to injection-site adverse reactions (injection-site mass, injection-site nodule, injection-site pruritus, and injection-site reaction).

Subcutaneous injection-site nodules may occur with the use of BYDUREON. In a separate 15-week study in which information on nodules were collected and analyzed, 24 out of 31 subjects (77%) experienced at least 1 injection-site nodule during treatment; 2 subjects (6.5%) reported accompanying localized symptoms. The mean duration of events was 27 days. The formation of subcutaneous nodules is consistent with the known properties of the microspheres used in BYDUREON.

Increase In Heart Rate

Increases in heart rate from baseline ranging from 1.5 to 4.5 beats per minute have been observed in comparator-controlled clinical trials.

Other Adverse Reactions

Immunogenicity

As with all therapeutic proteins, there is potential for immunogenicity. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, the incidence of antibodies to exenatide cannot be directly compared with the incidence of antibodies with other products.

Anti-exenatide antibodies were measured at prespecified intervals (4-14 weeks) in all BYDUREONtreated patients (N=918) in five of the comparator-controlled studies of BYDUREON. In these five trials, 452 BYDUREON-treated patients (49%) had low titer antibodies (≤125) to exenatide at any time during the trials and 405 BYDUREON-treated patients (45%) had low titer antibodies to exenatide at study endpoint (24-30 weeks). The level of glycemic control in these patients was generally comparable to that observed in the 379 BYDUREON-treated patients (43%) without antibody titers. An additional 107 BYDUREON-treated patients (12%) had higher titer antibodies at endpoint. Of these patients, 50 (6% overall) had an attenuated glycemic response to BYDUREON (<0.7% reduction in HbA1c); the remaining 57 (6% overall) had a glycemic response comparable to that of patients without antibodies . In the 30-week trial in which anti-exenatide antibody assessments were performed at baseline and at 4-week intervals from Week 6 to Week 30, the mean anti-exenatide antibody titer in the BYDUREON-treated patients peaked at Week 6 then declined by 56% from this peak by Week 30.

A total of 246 patients with antibodies to exenatide in the BYETTA and BYDUREON clinical trials were tested for the presence of cross-reactive antibodies to GLP-1 and/or glucagon. No treatment-emergent cross-reactive antibodies were observed across the range of titers.

Postmarketing Experience

The following additional adverse reactions have been reported during post-approval use of another formulation of exenatide. Because these events are reported voluntarily from a population of uncertain size, it is generally not possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Allergy/Hypersensitivity: injection-site reactions, generalized pruritus and/or urticaria, macular or papular rash, angioedema; anaphylactic reaction.

Drug Interactions: increased international normalized ratio (INR), sometimes associated with bleeding, with concomitant warfarin use .

Gastrointestinal: nausea, vomiting, and/or diarrhea resulting in dehydration; abdominal distension, abdominal pain, eructation, constipation, flatulence, acute pancreatitis, hemorrhagic and necrotizing pancreatitis sometimes resulting in death .

Neurologic: dysgeusia; somnolence

Renal and Urinary Disorders: altered renal function, including increased serum creatinine, renal impairment, worsened chronic renal failure or acute renal failure (sometimes requiring hemodialysis), kidney transplant and kidney transplant dysfunction.

Skin and Subcutaneous Tissue Disorders: alopecia

Read the entire FDA prescribing information for Bydureon (Exenatide)

Bydureon Pen

Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Byetta is injected under the skin. You may be shown how to use injections at home. Do not give yourself this medicine if you do not understand how to use the injection and properly dispose of used needles and syringes.

Byetta is usually injected twice a day, before the morning and evening meals. You must use Byetta within 60 minutes (1 hour) before eating. Your Byetta doses should be given at least 6 hours apart. Do not use Byetta after eating a meal.

Byetta comes in a prefilled injection pen with a “Pen User Manual” showing instructions for using the pen and injecting the medicine. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Never share an injection pen, cartridge, or syringe with another person, even if the needle has been changed. Sharing these devices can allow infections or disease to pass from one person to another.

Low blood sugar (hypoglycemia) can happen to everyone who has diabetes. Symptoms include headache, hunger, sweating, irritability, dizziness, nausea, fast heart rate, and feeling anxious or shaky. To quickly treat low blood sugar, always keep a fast-acting source of sugar with you such as fruit juice, hard candy, crackers, raisins, or non-diet soda.

Your doctor can prescribe a glucagon emergency injection kit to use in case you have severe hypoglycemia and cannot eat or drink. Be sure your family and close friends know how to give you this injection in an emergency.

Also watch for signs of high blood sugar (hyperglycemia) such as increased thirst or urination, blurred vision, headache, and tiredness.

Blood sugar levels can be affected by stress, illness, surgery, exercise, alcohol use, or skipping meals. Ask your doctor before changing your dose or medication schedule.

Use a disposable needle and syringe only once. Follow any state or local laws about throwing away used needles and syringes. Use a puncture-proof “sharps” disposal container (ask your pharmacist where to get one and how to throw it away). Keep this container out of the reach of children and pets.

Byetta is only part of a complete treatment program that may also include diet, exercise, weight control, regular blood sugar testing, and special medical care. Follow your doctor’s instructions very closely.

Storing unopened (not in use) Byetta: Keep the medicine in its original container. Refrigerate and use until expiration date. Protect from light.

Do not freeze Byetta, and throw away the medicine if it has been frozen.

Storing opened (in use) Byetta: Store at room temperature and use within 30 days. Protect from heat and bright light. Do not store the injection pen with a needle attached.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose can cause severe nausea and vomiting, or signs of low blood sugar (headache, hunger, irritability, dizziness, feeling shaky).

Use the missed dose as soon as you remember, but only if you have not yet eaten a meal. Skip the missed dose if you have already eaten a meal, or if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

Copyright 1996-2020 Cerner Multum, Inc.

Latest Update: 11/9/2018, Version: 13.01

  • Bydureon injection is administered under the skin (subcutaneously) of the upper arm, abdomen or thigh ONCE WEEKLY. You should use the injection on the same day each week. Writing the day on a calendar will help you remember to use your injection. If you forget to take your injection on the planned day then take your injection as soon as possible after you notice. For your next injection you can return to your chosen injection day as long as the next injection is at least one day (24 hours) later. You can also change your chosen injection day. Do not take two injections on the same day.
  • Your weekly injection can be given at any time of day, either with or without meals.
  • Bydureon can be injected into the same area of the body each week; however a different area of the skin in the area should be used. This helps to prevent the skin thickening and pitting, which can occur if the injection is repeatedly given in the same site.
  • Warning!

    • Bydureon injections must not be injected into a vein (intravenously) or a muscle (intramuscularly).
    • Although it is not necessary for people using Bydureon to test their blood glucose levels daily, it may be necessary to carry out blood glucose tests regularly if you are also on other medicines for diabetes, for example gliclazide. If you are changing to Bydureon from twice daily Byetta injections your blood sugar may go up temporarily, but this should improve within the first two weeks of starting Bydureon.
    • Hypoglycaemia (low blood glucose) is a very common side effect when this medicine is used in combination with sulphonylurea medicines, such as gliclazide. Symptoms of hypoglycaemia usually occur suddenly and may include cold sweats, cool pale skin, tremor, anxious feeling, unusual tiredness or weakness, confusion, difficulty in concentration, excessive hunger, temporary vision changes, headache, nausea and palpitations. You should talk to your doctor about this and make sure you know what to do if you experience these symptoms.
    • Your ability to concentrate or react may be reduced if you have low blood sugar, and this can cause problems driving or operating machinery. You should take precautions to avoid low blood sugar when driving – discuss this with your doctor.
    • Rare cases of inflammation of the pancreas (pancreatitis) have been reported in people taking this medicine. For this reason, you should let your doctor know if you experience unexplained persistent severe abdominal pain while using this medicine, so this can be investigated.
    • If you stop using Bydureon injections the effects of Bydureon can last for up to ten weeks after your last injection.

    Use with caution in

    • People over 75 years of age.
    • People taking anticoagulant medicines such as warfarin.

    Not to be used in

    • Type 1 diabetes.
    • Diabetic ketoacidosis.
    • Pregnancy.
    • Breastfeeding.
    • This medicine is not recommended for people with moderate to severely decreased kidney function, or for people receiving dialysis or who have severe kidney failure.
    • This medicine is not recommended for people with any severe disease affecting the stomach or intestines.
    • This medicine is not recommended for children and adolescents under 18 years of age because it has not been studied in this age group.

    This medicine should not be used if you are allergic to any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.

    If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.

    Pregnancy and breastfeeding

    Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.

    • The safety of this medicine for use during pregnancy has not been established. It should not be used during pregnancy. Diabetes mellitus is usually controlled using insulin during pregnancy, because this provides a more stable control of blood sugar. If you get pregnant while taking this medicine, or are planning a pregnancy, you should seek medical advice from your doctor.
    • As it can take up to ten weeks after stopping Bydureon injections for the medicine to be fully removed from the body, women who could get pregnant should use an effective method of contraception to prevent pregnancy while using this medicine. If you want to plan a pregnancy, Bydureon injections should be stopped at least three months before you start trying for a baby.
    • It is not known if this medicine passes into breast milk. The manufacturer states that it should not be used by breastfeeding mothers. Seek medical advice from your doctor.

    Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Just because a side effect is stated here does not mean that all people using this medicine will experience that or any side effect.

    Very common (affect more than 1 in 10 people)

    • Low blood glucose level (hypoglycaemia) in people also taking a sulphonylurea medicine (see warning section above).
    • Feeling sick (this normally occurs when the Bydureon injections are started, but this usually improves over time).
    • Vomiting.
    • Diarrhoea or constipation.
    • Itching at the injection site.

    Common (affect between 1 in 10 and 1 in 100 people)

    • Reduced appetite.
    • Weight loss. If you are losing weight quickly (more than 1.5kg per week) you should talk to your doctor because rapid weight loss may not be good for you.
    • Headache.
    • Dizziness.
    • Feeling tired (fatigue).
    • Sleepiness.
    • Indigestion.
    • Acid reflux.
    • Excess gas in the stomach and intestines (flatulence).
    • Abdominal pain or bloating.
    • Increased sweating.
    • Feeling weak.
    • Redness or rash at the injection site.

    Uncommon (affect between 1 in 100 and 1 in 1000 people)

    • Unusual taste in the mouth.

    Rare (affect between 1 in 1000 and 1 in 10,000 people)

    • Dehydration.
    • Inflammation of the pancreas (pancreatitis) – see warning section above.
    • Rash, itching or hives.
    • Hair loss.
    • Reduced kidney function.
    • Severe swelling of the lips, face or tongue (angioedema). Get medical advice straight away if you experience this.

    The side effects listed above may not include all of the side effects reported by the medicine’s manufacturer.

    For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.

    How can this medicine affect other medicines?

    It is important to tell your doctor or pharmacist what medicines you are already taking, including those bought without a prescription and herbal medicines, before you start treatment with this medicine. Similarly, check with your doctor or pharmacist before taking any new medicines while using this one, to make sure that the combination is safe.

    Bydureon may increase the anti-blood-clotting effect of anticoagulant medicines such as warfarin, nicoumalone and phenindione. If you are taking any of these your blood clotting time (INR) may need to be monitored more frequently.

    Bydureon has not been studied in combination with the following medicines and is not currently recommended for use in combination with these medicines:

    • acarbose
    • Byetta (twice daily exenatide).
    • insulin
    • linagliptin
    • liraglutide
    • nateglinide
    • repaglinide
    • saxagliptin
    • sitagliptin
    • vildagliptin.

    How do I store Bydureon?

    • Before use, Bydureon kits should be stored in a refrigerator at 2-8°C. Do not freeze. Make sure the containers do not directly touch the freezer compartment.
    • A kit, which contains one vial of exenatide powder, one pre-filled syringe of solvent and two needles (one a spare), can be stored at room temperature (below 300C) for up to four weeks before use. Keep the kit in the original packaging to protect it from light.
    • After administering the injection, you should put the cap back on the needle and carefully dispose of the syringe with the needle still attached.
    • Make sure all medicines are kept out of the reach of children and avoid exposing them to excessive heat or direct sunlight.

    Other medicines containing the same active ingredient

    • Byetta.

    Last updated 27.06.2012

    BYDUREON® Pen, a treatment option for adults with type 2 diabetes, now available in pharmacies

    Monday, 8 September 2014

    AstraZeneca (NYSE: AZN) today announced that once-weekly BYDUREON® (exenatide extended-release for injectable suspension) Pen 2 mg, a prescription medicine, is now available in pharmacies across the United States. BYDUREON is approved by the U.S. Food and Drug Administration as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. BYDUREON is not recommended as first-line therapy for patients who have inadequate glycemic control on diet and exercise and should not be used for treatment of patients with type 1 diabetes or diabetic ketoacidosis. BYDUREON is not a substitute for insulin. The concurrent use of BYDUREON with insulin has not been studied and is not recommended. BYDUREON and BYETTA® (exenatide) injection contain the same active ingredient and should not be used together.

    BYDUREON Pen is a pre-filled, single-use pen injector which contains the same formulation and dose as the original BYDUREON single-dose tray. BYDUREON Pen eliminates the need for the patient to transfer the medication between a vial and syringe. The original BYDUREON single-dose tray remains available for current and new patients.

    “BYDUREON is the first once-weekly treatment option for adults with type 2 diabetes, and BYDUREON Pen now offers the same continuous release of exenatide in a pre-filled device,” said John Yee, M.D., vice president, head of Medical Affairs, U.S. Diabetes, AstraZeneca. “BYDUREON has been shown to provide significant HbA1c reduction and, although not a weight loss medicine, the additional benefit of weight loss.”

    The Prescribing Information for BYDUREON includes a Boxed Warning regarding the risk of thyroid C-cell tumors. It is unknown whether BYDUREON causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as human relevance could not be determined by clinical or nonclinical studies. BYDUREON is contraindicated in patients with a personal or family history of MTC, in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2), or history of a serious hypersensitivity reaction to exenatide or any of the product components.

    Based on post-marketing data, exenatide has been associated with acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis. If pancreatitis is suspected, BYDUREON should be discontinued promptly and not restarted if pancreatitis is confirmed. Other antidiabetic therapies should be considered in patients with a history of pancreatitis.

    BYDUREON Pen delivers exenatide via microsphere technology in a once-weekly dose requiring no titration. It can be administered at any time of the day, with or without meals. Prior to initiation of BYDUREON Pen, patients should be trained by their healthcare professional.

    AstraZeneca is committed to supporting patient access to BYDUREON Pen and connecting patients with the support they need. To help patients get started on BYDUREON Pen, AstraZeneca offers the SteadySTART™ program, in which a clinical educator teaches office staff or patients how to prepare and administer BYDUREON Pen. The company also offers BYDUREON Steady Support™ program resources for patients, including a support line and a face-to-face training session, as well as motivational support by mail and email, dosing day reminders, and a savings card.

    INDICATION and IMPORTANT SAFETY INFORMATION for BYDUREON® (exenatide extended-release for injectable suspension)

    Indication and Important Limitations of Use for BYDUREON

    BYDUREON is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

    • Because of the uncertain relevance of the rat thyroid C-cell tumor findings to humans, prescribe only to patients for whom potential benefits are considered to outweigh potential risk.
    • Not recommended as first-line therapy for patients who have inadequate glycemic control on diet and exercise.
    • Not a substitute for insulin, should not be used in patients with type 1 diabetes or diabetic ketoacidosis, and cannot be recommended for use with insulin.
    • BYDUREON and BYETTA® (exenatide) injection both contain the same active ingredient, exenatide, and should not be used together.
    • Exenatide has been associated with acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis, based on postmarketing data. It is unknown whether patients with a history of pancreatitis are at increased risk for pancreatitis while using BYDUREON; consider other antidiabetic therapies for these patients.

    Important Safety Information for BYDUREON

    BOXED WARNING: RISK OF THYROID C-CELL TUMORS
    Exenatide extended-release causes an increased incidence in thyroid C-cell tumors at clinically relevant exposures in rats compared to controls. It is unknown whether BYDUREON causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as human relevance could not be determined by clinical or nonclinical studies. BYDUREON is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Routine serum calcitonin or thyroid ultrasound monitoring is of uncertain value in patients treated with BYDUREON. Patients should be counseled regarding the risk and symptoms of thyroid tumors.

    Contraindications

    • Patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
    • Patients with prior serious hypersensitivity reactions to exenatide or to any of the product components.

    Warnings and Precautions

    • Pancreatitis: Based on postmarketing data, exenatide has been associated with acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis. After initiation of BYDUREON, observe patients carefully for pancreatitis (persistent severe abdominal pain, sometimes radiating to the back, with or without vomiting). If pancreatitis is suspected, BYDUREON should be discontinued promptly and should not be restarted if pancreatitis is confirmed.
    • Hypoglycemia: Increased risk of hypoglycemia when used in combination with a sulfonylurea (SU). Clinicians may consider reducing the SU dose to minimize risk of hypoglycemia. It is possible that use of BYDUREON with other glucose-independent insulin secretagogues (eg, meglitinides) could increase the risk of hypoglycemia.
    • Renal Impairment: Should not be used in patients with severe renal impairment or end-stage renal disease. Use with caution in patients with renal transplantation or moderate renal failure. Postmarketing reports of altered renal function with exenatide, including increased serum creatinine, renal impairment, worsened chronic renal failure, and acute renal failure, sometimes requiring hemodialysis and kidney transplantation.
    • Gastrointestinal Disease: Because exenatide is commonly associated with gastrointestinal adverse reactions, BYDUREON is not recommended in patients with severe gastrointestinal disease (eg, gastroparesis).
    • Immunogenicity: Patients may develop antibodies to exenatide. In 5 registration trials, attenuated glycemic response was associated in 6% of BYDUREON-treated patients with antibody formation. If worsening of or failure to achieve adequate glycemic control occurs, consider alternative antidiabetic therapy.
    • Hypersensitivity: Postmarketing reports of serious hypersensitivity reactions (eg, anaphylaxis and angioedema). If this occurs, patients should discontinue BYDUREON and other suspect medications and promptly seek medical advice.
    • Injection-Site Reactions: Postmarketing reports of serious injection-site reactions (eg, abscess, cellulitis, and necrosis), with or without subcutaneous nodules, with the use of BYDUREON.
    • Macrovascular Outcomes: No clinical studies establishing conclusive evidence of macrovascular risk reduction with BYDUREON or any other antidiabetic drug.

    Withdrawals

    Most Common Adverse Reactions (≥5%)

    Drug Interactions

    • Oral Medications: BYDUREON slows gastric emptying and can reduce the rate of absorption of orally administered drugs. Use with caution with oral medications.
    • Warfarin: Postmarketing reports with exenatide of increased international normalized ratio (INR) sometimes associated with bleeding with concomitant use of warfarin. Monitor INR frequently until stable upon initiation or alteration of BYDUREON.

    Use in Specific Populations

    • Pregnant and Nursing Women: Based on animal data, BYDUREON may cause fetal harm and should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. To report drug exposure during pregnancy call 1-800-633-9081. When administered to a nursing woman, a decision should be made whether to discontinue nursing or to discontinue BYDUREON.
    • Pediatric Patients: Use in pediatric patients is not recommended as safety and effectiveness have not been established.

    Please see US Full Prescribing Information for BYDUREON (exenatide extended-release for injectable suspension) 2 mg, including Boxed WARNING regarding risk of thyroid C-cell tumors.

    Please see Medication Guide.

    About GLP-1 Receptor Agonists

    An agonist is a molecule, such as a drug or a hormone, which binds to a receptor of a cell and triggers a response by that cell. A glucagon-like peptide-1 (GLP-1) receptor agonist binds to and activates the GLP-1 receptor, which exhibits multiple anti-hyperglycemic actions.

    About Type 2 Diabetes

    Diabetes is estimated to affect 29.1 million people in the U.S. and more than 382 million people worldwide. The prevalence of diabetes is projected to reach more than 592 million people worldwide by 2035. Type 2 diabetes accounts for approximately 90-95 percent of all cases of diagnosed diabetes. Type 2 diabetes is a chronic disease characterized by pathophysiologic defects leading to elevated glucose levels. Significant unmet needs still exist, as many patients remain inadequately controlled on their current glucose-lowering regimen.

    About AstraZeneca

    AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialization of prescription medicines, primarily for the treatment of cardiovascular, metabolic, respiratory, inflammation, autoimmune, oncology, infection and neuroscience diseases. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information please visit: www.astrazeneca.com.

    Contacts

    PATIENT INFORMATION

    BYDUREON®
    (by-DUR-ee-on)
    (exenatide extended-release) for injectable suspension, for subcutaneous use

    What is the most important information I should know about BYDUREON?

    BYDUREON may cause serious side effects, including:

    • Possible thyroid tumors, including cancer. Tell your healthcare provider if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid cancer. In studies with rats or mice, BYDUREON and medicines that work like BYDUREON caused thyroid tumors, including thyroid cancer. It is not known if BYDUREON will cause thyroid tumors or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in people.
    • Do not use BYDUREON if you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC), or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).

    What is BYDUREON?

    • BYDUREON is an injectable prescription medicine that may improve blood sugar (glucose) in adults with type 2 diabetes mellitus and should be used along with diet and exercise.
    • BYDUREON is not recommended as the first choice of medicine for treating diabetes.
    • BYDUREON is not a substitute for insulin and is not for use in people with type 1 diabetes or people with diabetic ketoacidosis.
    • It is not known if BYDUREON can be used with mealtime insulin.
    • BYDUREON and BYDUREON BCise are long-acting forms of the medicine in BYETTA (exenatide). BYDUREON should not be used at the same time as BYETTA or BYDUREON BCise.
    • It is not known if BYDUREON can be used in people who have had pancreatitis.
    • It is not known if BYDUREON is safe and effective for use in children.

    Who should not use BYDUREON?

    Do not use BYDUREON if:

    • you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC) or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
    • you are allergic to exenatide or any of the ingredients in BYDUREON. See the end of this Medication Guide for a complete list of ingredients in BYDUREON.

    What should I tell my healthcare provider before using BYDUREON?

    Before using BYDUREON, tell your healthcare provider about all of your medical conditions, including if you:

    • have or have had problems with your pancreas or kidneys.
    • have severe problems with your stomach, such as slowed emptying of your stomach (gastroparesis) or problems with digesting food.
    • are pregnant or plan to become pregnant. BYDUREON may harm your unborn baby. Tell your healthcare provider if you become pregnant while using BYDUREON. Talk to your healthcare provider about the best way to control your blood sugar if you plan to become pregnant or while you are pregnant.
    • are breastfeeding or plan to breastfeed. It is not known if BYDUREON passes into your breast milk. You should talk with your healthcare provider about the best way to feed your baby while using BYDUREON.

    Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. BYDUREON may affect the way some medicines work and some medicines may affect the way BYDUREON works.

    Before using BYDUREON, talk to your healthcare provider about low blood sugar and how to manage it. Tell your healthcare provider if you are taking other medicines to treat diabetes including insulin or sulfonylureas.

    Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

    How should I use BYDUREON?

    • Read the Instructions for Use that comes with BYDUREON.
    • Use BYDUREON exactly as your healthcare provider tells you to.
    • BYDUREON should be injected right away after you prepare your dose.
    • Your healthcare provider should show you how to use BYDUREON before you use it for the first time.
    • BYDUREON is injected under the skin (subcutaneously) of your stomach (abdomen), thigh, or upper arm. Do not inject BYDUREON into a muscle (intramuscularly) or vein (intravenously).
    • Use BYDUREON 1 time each week on the same day each week at any time of the day.
    • BYDUREON may be taken with or without food.
    • If you miss a dose of BYDUREON, take the missed dose as soon as possible if there are at least 3 days (72 hours) until your next scheduled dose. If there are less than 3 days remaining, skip the missed dose and take your next dose on the regularly scheduled day. Do not take 2 doses of BYDUREON within 3 days of each other.
    • You may change the day of the week as long as your last dose was given 3 or more days before.
    • Do not mix insulin and BYDUREON together in the same injection.
    • You may give an injection of BYDUREON and insulin in the same body area (such as, your stomach area), but not right next to each other.
    • Change (rotate) your injection site with each weekly injection. Do not use the same site for each injection.
    • Do not share your BYDUREON pen, prefilled syringe, or needles with another person. You may give another person an infection or get an infection from them.
    • Your dose of BYDUREON and other diabetes medicines may need to change because of: change in level of physical activity or exercise, weight gain or loss, increased stress, illness, change in diet, or because of other medicines you take.

    What are the possible side effects of BYDUREON?

    BYDUREON may cause serious side effects, including:

    • See “What is the most important information I should know about BYDUREON?”
    • inflammation of your pancreas (pancreatitis). Stop using BYDUREON and call your healthcare provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without vomiting. You may feel the pain from your abdomen to your back.
    • low blood sugar (hypoglycemia). Your risk for getting low blood sugar may be higher if you use BYDUREON with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin. Signs and symptoms of low blood sugar may include:
      • dizziness or lightheadedness
      • sweating
      • confusion or drowsiness
      • headache
      • blurred vision
      • slurred speech
      • shakiness
      • fast heartbeat
      • anxiety, irritability, or mood changes
      • hunger
      • weakness
      • feeling jittery
    • kidney problems. In people who have kidney problems, diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration) which may cause kidney problems to get worse or kidney failure.
    • stomach problems. Other medicines like BYDUREON may cause severe stomach problems. It is not known if BYDUREON causes or worsens stomach problems.
    • serious allergic reactions. Stop using BYDUREON and get medical help right away if you have any symptoms of a serious allergic reaction, including itching, rash, or difficulty breathing.
    • injection-site reactions. Serious injection-site reactions, with or without bumps (nodules), have happened in some people who use BYDUREON. Some of these injectionsite reactions have required surgery. Call your healthcare provider if you have any symptoms of an injection-site reaction, including severe pain, swelling, blisters, an open wound, a dark scab.
    • gallbladder problems. Gallbladder problems have happened in some people who take BYDUREON or other medicines like BYDUREON. Tell your healthcare provider right away if you get symptoms of gallbladder problems which may include: pain in the right or middle upper stomach area, nausea and vomiting, fever, or your skin or the white part of your eyes turns yellow.

    The most common side effects of BYDUREON may include nausea, diarrhea, headache, vomiting, constipation, itching at the injection site, a small bump (nodule) at the injection site, indigestion.

    Nausea is most common when you first start using BYDUREON but decreases over time in most people as their body gets used to the medicine.

    Talk to your healthcare provider about any side effect that bothers you or does not go away.

    These are not all the possible side effects of BYDUREON. For more information, ask your healthcare provider or pharmacist.

    Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

    Keep BYDUREON and all medicines out of the reach of children.

    General information about the safe and effective use of BYDUREON.

    Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use BYDUREON for a condition for which it was not prescribed. Do not give your BYDUREON to other people, even if they have the same symptoms you have. It may harm them.

    You can ask your pharmacist or healthcare provider for information about BYDUREON that is written for health professionals.

    What are the ingredients in BYDUREON?

    Contents of the powder:

    Active Ingredient: exenatide

    Inactive Ingredients: polylactide-co-glycolide and sucrose

    Contents of liquid (diluent):

    Inactive Ingredients: carboxymethylcellulose sodium, polysorbate 20, sodium phosphate monobasic monohydrate, sodium phosphate dibasic heptahydrate, sodium chloride, water for injection. Sodium hydroxide may be added during manufacture of BYDUREON Pen for pH adjustment.

    This Medication Guide has been approved by the U.S. Food and Drug Administration.

    Instructions for Use

    BYDUREON®
    (by-DUR-ee-on)
    Single-Dose Tray
    (exenatide extended-release) for injectable suspension

    Before using Bydureon, your healthcare provider should show you how to use it the right way.

    Read these Instructions for Use before you start using BYDUREON Single-Dose Tray and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.

    Getting ready

    Never share your BYDUREON vials or needles with anyone else. You may give an infection to them or get an infection from them.

    BYDUREON Single-Dose Tray is not for self-injection by people who are blind or cannot see well.

    Supplies needed to give your BYDUREON Single-Dose Tray injection (not all supplies are included):

    • 1 BYDUREON Single-Dose Tray that contains:
      • 1 BYDUREON vial
      • 1 Syringe
      • 2 Needles
      • 1 Vial connector
    • alcohol swab
    • a clean flat surface
    • sharps container for throwing away used needles, vials, and syringes. See Step 4h “Disposing of used Needles and Syringes.”

    Your guide to your BYDUREON Single-Dose Tray

    • Single-dose tray

    Keep this flap open so you can refer to it as you go through the steps.


    Your guide to the parts

    • Single-dose tray


    What is Inside

    To take the correct dose, read each page so that you do every step in order.

    This step-by-step guide is divided into 4 sections:

    • Getting Started
    • Connecting the Parts
    • Mixing the Medicine and Filling the Syringe
    • Injecting the Medicine

    For Common Questions and Answers, see page X.

    How to store your Single-Dose Trays of BYDUREON

    • Store your BYDUREON trays in the refrigerator at 36°F to 46°F (2°C to 8°C).
    • If needed, you can keep your BYDUREON tray out of the refrigerator at 68°F to 77°F (20°C to 25°C) for up to 4 weeks.
    • Protect BYDUREON from light until you are ready to prepare and use your dose.
    • Do not freeze BYDUREON trays.
    • Do not use BYDUREON past the expiration date. The expiration date is labeled EXP and can be found on the paper cover of each tray.
    • Keep BYDUREON, and all medicines, out of the reach of children.
    1. Getting Started
    2. 1a) Take a Single-Dose Tray from the refrigerator.

      1b) Wash your hands. Prepare to clean your injection site with soap and water or an alcohol swab prior to injecting your medicine.

      Peel back the paper cover to open.
      Remove the syringe. The liquid in the syringe should be clear with no particles in it. It is okay if there are bubbles. Place the needle, vial connector package, vial, and syringe on a clean, flat surface.


      Pick up the needle, and twist off the blue cap.
      Set the covered needle aside. You will use it later. There is a spare needle in the tray if you need it.


      Pick up the vial.
      Tap the vial several times against a hard surface to loosen the powder.


      Use your thumb to remove the green cap.
      Put the vial aside.


    3. Connecting the Parts
    4. Pick up the vial connector package and peel off the paper cover. Do not touch the orange connector inside.


      Hold the vial connector package.
      In your other hand, hold the vial.


      Press the top of the vial firmly into the orange connector.


      Then lift the vial with the orange connector now attached out of the clear package.


      This is what the vial should now look like.
      Put it aside for later.


      Pick up the syringe.
      With your other hand, firmly grasp the 2 gray squares on the white cap.


      Break off the cap. Be careful not to push in the plunger.


      Just like you might break a stick, you are breaking off the cap.


      This is what the broken-off cap looks like.
      You will not be using the cap and can throw it away.


      This is what the syringe should now look like.


      Now, pick up the vial with the orange connector attached.


      Twist the orange connector onto the syringe until snug. While twisting, be sure to grasp the orange connector. Do not over tighten.

      This is how the parts should now look when they are connected.



    5. Mixing the Medicine and Filling the Syringe
    6. Important:

      During these next steps, you will be mixing the medicine and filling the syringe. After you mix the medicine, you must inject it. You cannot save the mixed medicine to inject at a later time.

      With your thumb, push down the plunger until it stops.


      The plunger may feel like it is springing back a little. For steps 3a to 3f, keep pushing down on the plunger with your thumb.


      Hold the plunger down and shake hard. Keep shaking until the liquid and powder are mixed well.
      The vial will not come off. The orange connector will keep it attached to the syringe.


      Shake hard like you would shake a bottle of oil-and-vinegar salad dressing.


      When the medicine is mixed well, it should look cloudy.

      If you see clumps of dry powder on the sides or bottom of the vial, the medicine is not mixed well.
      Shake hard again until well mixed.
      Keep pushing down on the plunger while shaking.



      If you have any questions or are not sure if your BYDUREON is mixed well, call 1-877-700-7365 for help.
      Now, hold the vial upside down so the syringe is pointing up. Continue to hold the plunger in place with your thumb. Gently tap the vial with the other hand. Continue to hold the plunger in place.
      The tapping helps the medicine drip down. It is okay if there are bubbles.



      Pull the plunger down beyond the black dashed Dose Line.
      This draws the medicine from the vial into the syringe. You may see air bubbles. This is normal.
      A little bit of liquid may cling to the sides of the vial.


      With 1 hand, hold the plunger in place so it does not move.


      With the other hand, twist the orange connector to remove it from the syringe.
      Be careful not to push in the plunger.


      This is what the syringe should now look like.


    7. Injecting the Medicine
    8. Pick up the needle. Twist the needle onto the syringe until snug. Do not remove the needle cover yet.


    Important:

    Read the next steps carefully and look closely at the pictures. This helps you get the correct dose of medicine.

    Slowly push in the plunger so the top of the plunger lines up with the black dashed Dose Line.


    Then, take your thumb off the plunger.


    The top of the plunger must stay lined up with the black dashed Dose Line as you go through the next steps. This will help you get the correct dose of medicine.


    Put aside the syringe with the needle attached.

    Important:

    It is normal to see a few bubbles in the mixture. The bubbles will not harm you or affect your dose.

    You can inject the medicine in your stomach area (abdomen), your thigh, or the back of your upper arm.
    Each week you can use the same area of your body but choose a different injection site in that area.
    Gently clean the site you choose with soap and water or an alcohol swab.


    Now, pick up the syringe and hold it near the black dashed Dose Line.


    Pull the needle cover straight off. Do not twist.
    Be careful not to push in the plunger.
    When you remove the cover, you may see 1 or 2 drops of liquid. This is normal.


    Insert the needle into your skin (subcutaneously). To inject your full dose, push down on the plunger with your thumb until it stops.
    Withdraw the needle.
    Be sure to use the injection technique recommended by your healthcare provider.


    Disposing of used Needles and Syringes:


    • Put your used needles and syringes in a FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) loose needles and syringes in your household trash.
    • If you do not have a FDA-cleared sharps disposal container, you may use a household container that is:
      • made of a heavy-duty plastic,
      • can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,
      • upright and stable during use,
      • leak-resistant, and
      • properly labeled to warn of hazardous waste inside the container.
    • When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and pens. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA’s website at: http://www.fda.gov/safesharpsdisposal.

    Please keep these Instructions for Use for your next dose.

    Common Questions and Answers

    If your question is about: See question number:
    How soon to inject after mixing 1
    Mixing the medicine 2
    Air bubbles in syringe 3
    Attaching the needle 4
    Removing the needle cover 5
    Plunger not lining up with black dashed Dose Line 6
    Being unable to push the plunger down when injecting 7

    1. After I mix the medicine, how long can I wait before taking the injection?
    2. You must take your injection of BYDUREON right after mixing it. If you do not inject BYDUREON right away, the medicine will start to form small clumps in the syringe. These clumps can clog the needle when you take the injection (see question 7).

    3. How do I know that the medicine is mixed well?
    4. When the medicine is mixed well, it should look cloudy. There should not be any dry powder on the sides or bottom of the vial. If you do see any dry powder, shake hard while continuing to push down on the plunger with your thumb. (This question relates to the steps shown on pages X through X.)

    5. I’m ready to take the injection. What should I do if I see air bubbles in the syringe?
    6. It is normal for air bubbles to be in the syringe. The air bubbles will not harm you or affect your dose. BYDUREON is injected into your skin (subcutaneously). Air bubbles are not a problem with this type of injection. (This question relates to step 3f shown on page X and step 4c shown on page X.)

    7. What should I do if I have trouble attaching the needle?
    8. First, be sure you have removed the blue cap. Then, twist the needle onto the syringe until snug. To prevent losing medicine, do not push in the plunger while attaching the needle. (This question relates to step 4a on page X.)

    9. What should I do if I have trouble removing the needle cover?
    10. With one hand, hold the syringe near the black dashed Dose Line. With your other hand, hold the needle cover. Pull the needle cover straight off. Do not twist it. (This question relates to step 4f on page X.)

    11. I am at step 4c. What should I do if the top of the plunger has been pushed past the black dashed Dose Line?
    12. The black dashed Dose Line shows the correct dose. If the top of the plunger has been pushed past the line, you should continue from step 4d and take the injection. Before your next injection in 1 week, carefully review the instructions on pages X through X.

    13. When I inject, what should I do if I cannot push the plunger all the way down?
    14. This means the needle has become clogged. Remove the needle from your skin and replace it with the spare needle from your tray. Then choose a different injection site and finish taking the injection.

      To review how to:

    • Remove the blue cap of the needle, see page X
    • Attach the needle, see page X
    • Remove the needle cover and give the injection, see pages X and X

    If you still cannot push the plunger all the way down, remove the needle from your skin. Use a puncture-resistant container to throw away the syringe with the needle still attached. It is important that you then call 1-877-7007365.

    To help prevent a clogged needle, always mix the medicine very well and inject right after mixing.

    Where to learn more about BYDUREON

    • Talk with your healthcare provider
    • Read the Medication Guide that came with your BYDUREON. The Medication Guide can help answer your questions about BYDUREON, such as what it is used for, possible side effects, and when to take BYDUREON.
    • Enroll in BYDUREON Support for FREE ongoing help managing your diabetes. Visit www.bydureon.com or call 1-877-700-7365.

    Instructions for Use

    BYDUREON®
    (by-DUR-ee-on) Pen
    (exenatide extended-release) for injectable suspension

    Figure A

    Before using Bydureon Pen, your healthcare provider should show you how to use it the right way.

    Read the Instructions for Use before you start using Bydureon Pen and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.

    Getting ready

    Never share your Bydureon Pen or needles with anyone else. You may give an infection to them or get an infection from them.

    Bydureon Pen is not for self-injection by people who are blind or cannot see well.

    Supplies needed to give your Bydureon Pen injection (not all supplies are included):

    • 1 Bydureon single-use “Pen” tray that contains:
      • 1 Bydureon Pen
      • 1 custom needle
    • a clean flat surface
    • alcohol swab
    • sharps container for throwing away used needles and Pens. See “Properly dispose of your Pen” at the end of these instructions.





    How should I store Bydureon?

    • Store your Bydureon Pens in the refrigerator at 36°F to 46°F (2°C to 8°C).
    • Protect pens from light until you are ready to prepare and use your dose.
    • Do not use pens past the expiration date.
    • Do not freeze Bydureon. Do not use Bydureon if it has been frozen.
    • Keep Bydureon in its sealed tray until ready for use.
    • If needed, you can keep your Bydureon Pen out of the refrigerator at 68°F to 77°F (20°C to 25°C) for up to 4 weeks.

    Keep Bydureon Pen, and all medicines, out of the reach of children.

    Step 1: Prepare your Bydureon Pen
    Let your Pen come to room temperature.

    • Remove 1 Pen from the refrigerator and let it stand at room temperature for at least 15 minutes.
    • Do not use a pen past its expiration date.

    Wash your hands.
    Open the tray.

    • Pull up on the corner tab.
    • Remove the Pen and needle.
      • Do not use your Pen or needle if any parts are broken or missing.


    Check the liquid in your Pen.

    • Check the liquid inside the inspection window. It should be clear and free of particles. Do not use the Pen if the liquid is colored, has particles, or is not clear. Throw it away and get a new one.
      • You may see bubbles in the liquid, this is normal.


    Peel off the paper tab from the needle cover.


    Attach the needle to the Pen.

    • Screw the needle onto the Pen by pushing and twisting clockwise until it is tight. Do not remove the needle cover yet.

    Step 2: Mix your dose
    Combine the medicine.

    • While holding the pen straight up, slowly turn the knob. Stop when you hear the click and the green label disappears.

    Firmly tap your Pen to mix.

    • Hold your Pen by the end with the orange label and tap the Pen firmly against the palm of your hand.
      • DO NOT twist the white knob.
      • ROTATE your Pen every 10 taps.
      • You may need to tap your Pen 80 times or more.


    Check the Bydureon mix.

    • Hold your Pen up to the light and look through both sides of the mixing window. The solution should have no clumps and be uniformly cloudy (see Figure B).


    Figure B

    • To get your full dose, Bydureon must be mixed well.
    • If Bydureon is not mixed well, keep tapping your Pen longer and more firmly until it is mixed well.
    • Do not give your Bydureon injection unless your Bydureon is mixed well.

    Stop. Do Not proceed unless your medicine is mixed well.

    To get your full dose the medicine must be mixed well. If it’s not mixed well, tap longer and more firmly.

    Check the Bydureon mix again.

    • Compare both sides of the mixing window to the photos below by holding your Pen against the page. Pay attention to the bottom surface. If you do not see clumps you are ready to inject (see Figure C).


    Figure C

    If you have any questions or are not sure if your Bydureon is mixed well, call 1-877-700-7365 for help.

    Step 3: Inject your dose

    Important: After the medicine is mixed well, you must inject your dose right away. You cannot save it for later use.

    Choose your injection site.

    • The recommended injection sites for Bydureon are your stomach (abdomen), thigh, or back of the arm.
      • Each week you can use the same area of your body but choose a different injection site in that area.
      • Gently wipe the site you choose with an alcohol swab (not included).

    Twist knob to release injection button.

    • Hold your Pen with the needle pointing straight up and turn the white knob until the orange label disappears and the injection button is released. Do not push the injection button yet.

    Remove the needle cover.

    • Pull the needle cover straight off. Do not twist the needle cover.
      • You may see a few drops of liquid on the needle or in the cover.


    Inject your Bydureon.

    • Insert the needle into your skin.
    • Press the injection button with your thumb until you hear a “click.” Keep holding the button down and slowly count to 10 to get your full dose.

    Properly dispose of your used Pen.

    • Put your used needles and Pens in an FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) loose needles and Pens in your household trash. See Common Questions and Answers for additional disposal information.

    Common Questions and Answers:

    1. How do I know that the Bydureon is mixed well?
    2. The Bydureon is mixed well when the liquid looks cloudy from both sides of the window. You should not see any clumps in the liquid. It may help to hold your Pen up to the light to see in the window. If you see clumps of any size keep tapping your Pen firmly against the palm of your hand until mixed.

    3. I am having trouble mixing my dose. What should I do?
    4. Remember, before preparing your dose, leave your Pen out of the refrigerator for at least 15 minutes. This will let your Pen warm up to room temperature. It will be easier to mix Bydureon if your Pen is at room temperature.

      Be sure you are holding your Pen at the end with the knob and the orange label. This will help you grip your Pen better and tap it more firmly against your palm.

      It may also help to tap the mixing window on both sides against your palm. If you see any clumps, keep tapping.

    5. After I mix Bydureon, how long can I wait before taking the injection?
    6. You must inject your dose of Bydureon right after mixing it. If you do not inject your Bydureon right away, small clumps of medicine may form in your Pen and you may not get your full dose.

    7. I am ready to inject my dose. What should I do if I see air bubbles in the Pen?
    8. It is normal for air bubbles to be in your Pen. Bydureon is injected into your skin (subcutaneously). Air bubbles will not harm you or affect your dose with this type of injection.

    9. What should I do if I cannot push the injection button all the way in when trying to inject my dose?
    10. Check that you have fully screwed on the pen needle. Also be sure you twisted the knob until it stopped, the orange label disappeared, and the injection button appears.

      If you still cannot push the button in, this may mean that the needle is clogged. Remove the needle from your skin and replace it with the spare needle from the carton. Review how to attach the needle. Then choose a different injection site and finish taking the injection.

      If you still cannot push the button all the way in, remove the needle from your skin. Use a puncture-resistant container to throw away the pen with the needle still attached.

      If you have problems giving your Bydureon Pen injection or have any questions call 1-877-700-7365 for more instructions.

    11. How do I know if I injected my full dose?
    12. To be sure you get your full dose, press the injection button with your thumb until you hear a “click.” After the “click,” continue to hold the needle in your skin for 10 seconds. This will allow enough time for you to get your full dose.

    13. What if I do not have an FDA-cleared sharps disposal container?
      Do not throw away (dispose of) loose needles and Pens in your household trash.
      • If you do not have an FDA-cleared sharps disposal container, you may use a household container that is:
        • made of a heavy-duty plastic,
        • can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,
        • upright and stable during use,
        • leak-resistant, and
        • properly labeled to warn of hazardous waste inside the container.

      When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and Pens. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA’s website at: http://www.fda.gov/safesharpsdisposal

    This Instructions for Use has been approved by the U.S. Food and Drug Administration.

    BYDUREON PFill Pen 2MG/0.65ml 4X1

    Bydureon®

    exenatide

    Consumer Medicine Information

    What is in this leaflet

    This leaflet answers some common questions about BYDUREON.

    It does not contain all the available information.

    It does not take the place of talking to your doctor or pharmacist.

    The information in this leaflet was last updated on the date shown on the final page. More recent information on this medicine may be available. Make sure you speak to your pharmacist, nurse or doctor to obtain the most up to date information on this medicine.

    All medicines have risks and benefits. Your doctor has weighed the risks of you taking BYDUREON against the benefits they expect it will have for you.

    If you have any concerns about taking this medicine, consult your doctor or pharmacist.

    Keep this leaflet with the medicine. You may need to read it again.

    What BYDUREON is used for

    BYDUREON is an injectable medicine used to improve blood sugar control in adults with type 2 diabetes mellitus.

    It is used with metformin or sulfonylureas. It may also be used with a combination of metformin and sulfonylureas.

    Ask your doctor or healthcare professional if you are not sure whether your antidiabetic medicine contains sulfonylurea.

    Diabetes mellitus is a condition in which your pancreas does not produce enough insulin to control your blood sugar level. BYDUREON helps your body to increase production of insulin when your blood sugar is high.

    BYDUREON is not a substitute for insulin in patients who require insulin treatments for their diabetes.

    This medicine has not been studied in children.

    This medicine is only available with a doctor’s prescription.

    Ask your doctor if you have any questions about why this medicine has been prescribed for you.

    Before you use BYDUREON

    When you must not use it

    Do not use BYDUREON if:

    • you have type 1 diabetes or diabetic ketoacidosis (often caused by very high blood glucose levels)
    • you are allergic to exenatide or any of the ingredients listed at the end of this leaflet
    • you have severe kidney problems or you are on dialysis

    Do not use BYDUREON after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering.

    Return the product to your pharmacist if it has expired or is damaged.

    Talk to your doctor if you are not sure whether you should start using BYDUREON.

    Before you start to use it

    Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.

    Tell your doctor if you have or have had any of the following medical conditions:

    • kidney problems
    • high blood pressure or other heart problems
    • high cholesterol and triglycerides (a lipid disorder involving too many fatty acids in the blood stream)
    • pancreatitis
    • gall stones
    • inflammation of the gall bladder (cholecystitis)
    • alcohol abuse

    Tell your doctor if you have severe problems with your stomach or food digestion. BYDUREON slows stomach emptying so food passes more slowly through your stomach.

    Tell your doctor if you are pregnant or plan to become pregnant. Use of this medicine in pregnancy is limited. Your doctor can discuss with you the risks and benefits involved.

    Tell your doctor if you are breast-feeding or plan to breast-feed. It is not known if this medicine passes into your breast milk. Your doctor can discuss with you the risks and benefits involved.

    If you have not told your doctor about any of the above, tell them before you start using this medicine.

    Taking other medicines

    Tell your doctor if you are taking any other medicines, including any that you get without a prescription from your pharmacy, supermarket or health food shop.

    Some medicines may be affected by BYDUREON or may affect how it works. You may need different amounts of your medicines or you may need to take different medicines.

    These include:

    • warfarin, a medicine used to prevent blood clots. Taking BYDUREON while you are taking warfarin may cause you to bleed more easily
    • angiotensin converting enzyme inhibitors, medicines used to treat high blood pressure and other heart conditions
    • nonsteroidal anti-inflammatory medicines
    • diuretics, medicines used to treat fluid retention and high blood pressure. Taking BYDUREON while you are taking these medicines may affect your kidneys
    • orlistat, a weight loss medicine
    • opioids, a narcotic commonly used as a pain killer
    • anticholinergics, a type of medicine used to relieve stomach cramps or spasms, to treat travel sickness and to treat Parkinson’s disease
    • when using BYDUREON in combination with sulfonylureas, you may need to adjust the dose of the sulfonylurea to avoid hypoglycaemia
    • use of BYDUREON with insulins or other GLP-1 agonists (e.g. BYETTA) is not recommended

    Your doctor and pharmacist have more information on medicines to be careful with or avoid while using this medicine.

    How to use BYDUREON

    Carefully follow all the directions given to you by your doctor or health care professional. They may differ from the information contained in this leaflet.

    How to use it

    BYDUREON is a powder that must be mixed with a diluent (solvent) before use. Only mix BYDUREON with the diluent if the diluent is clear and free of particles. Once you have mixed BYDUREON with the diluent, the mixture should be white to off white and cloudy.

    BYDUREON must be injected immediately after mixing with the diluent.

    BYDUREON comes as either a kit containing a vial and syringe or a dual-chamber pen. Your health care professional should teach you how to use the BYDUREON kit or pen.

    Read the User Manual for information on how to use the BYDUREON kit or pen before beginning therapy.

    Read the User Manual each time you get a new kit or pen, in case something has changed.

    Refer to the User Manual each time you inject this medicine.

    Use a new injection needle for each injection and dispose of it after each use.

    This medicine is for you; never share BYDUREON with others.

    If you do not understand the User Manual, ask your doctor or health care professional for help.

    How much to use

    Each BYDUREON kit or pen contains a single 2 mg dose. The whole dose should be mixed with the diluent for each injection. BYDUREON needs to be injected only once per week.

    Use BYDUREON exactly as prescribed by your doctor.

    When to use it

    Inject BYDUREON once a week, at any time of the day, with or without meals.

    You may wish to choose a specific day of the week that will be your BYDUREON injection day.

    How long to use it

    Do not stop using BYDUREON unless your doctor tells you to.

    If you forget to use it

    If you miss a dose of BYDUREON, you should take it as soon as you notice.

    The next weekly dose can be taken on the preferred day of the week as long as it is at least one day after the last dose taken.

    Do not take an extra dose or increase the amount of your next dose to make up for the one you missed.

    If you are not sure if you have taken your entire dose, do not inject another dose of BYDUREON. Wait until your next weekly dose is due.

    Ask your healthcare professional if you are not sure what to do.

    If you have trouble remembering to use your medicine, ask your doctor or healthcare professional for some hints.

    If you take too much (overdose)

    If you take too much BYDUREON, immediately call your doctor or the Poisons Information Centre (telephone AU: 13 11 26, NZ: 0800 764 766) for advice, or go to Accident and Emergency at the nearest hospital.

    Symptoms of an overdose may include nausea, vomiting, dizziness, or symptoms of low blood sugar. You may need urgent medical attention.

    While you are using BYDUREON

    Things you must do

    If you are about to be started on any new medicine, remind your doctor and pharmacist that you are using BYDUREON.

    Tell any other doctors, dentists and health care professionals who treat you that you are using this medication.

    If you are going to have surgery, tell the surgeon or anaesthetist that you are using this medicine. It may affect other medicines used during surgery.

    If you become pregnant while using this medicine, tell your doctor immediately. Make sure all friends, relatives, workmates or carers know that you have diabetes.

    Tell your doctor if you experience hypoglycaemia (low blood sugar levels).

    When BYDUREON is used with a medicine that contains sulfonylurea, hypoglycaemia can occur. The dose of your sulfonylurea medicine may need to be reduced while you use BYDUREON.

    Some symptoms of hypoglycaemia are:

    • drowsiness
    • weakness
    • confusion
    • irritability
    • hunger
    • fast heartbeat
    • sweating

    If you are experiencing any of these symptoms of hypoglycaemia, immediately eat some sugary food or have a drink, e.g. lollies, biscuits or fruit juice.

    Tell your doctor if you have trouble recognising the symptoms of hypoglycaemia. Under certain conditions, the early warning signs of hypoglycaemia can be different or less obvious.

    Tell your doctor, diabetes education nurse or pharmacist if you are travelling. You may not be able to get BYDUREON in the country you are visiting.

    Ask your doctor for a letter explaining why you are taking injecting devices with you. Each country you visit will need to see this letter, so you should take several copies.

    Your doctor, diabetes education nurse or pharmacist can provide you with some helpful information.

    Things you must not do

    Do not stop using your medicine or change your dosage unless your doctor tells you to.

    Do not use the medicine if you think it has been frozen or exposed to excessive heat. It will not work as it should.

    Do not use this medicine to treat any other complaints unless your doctor tells you to.

    Do not give your medicine to anyone else, even if they have the same condition as you.

    Things to be careful of

    Tell your doctor if you drink alcohol. Alcohol may mask the symptoms of hypoglycaemia, or make it worse.

    Be careful driving or operating machinery.

    If you use BYDUREON in combination with sulfonylureas, hypoglycaemia can occur. Hypoglycaemia may reduce your ability to concentrate.

    Side effects

    Tell your doctor or healthcare professional as soon as possible if you do not feel well while you are using BYDUREON.

    BYDUREON helps most people with type 2 diabetes, but it may have unwanted side effects in some people. All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects.

    Ask your doctor or healthcare professional to answer any questions you may have.

    When BYDUREON is used with a medicine that contains sulfonylurea, hypoglycaemia can occur.

    Tell your doctor if you experience hypoglycaemia.

    Tell your doctor if you notice any of the following:

    • nausea
    • vomiting
    • diarrhoea
    • constipation
    • dizziness or light headedness
    • headache
    • feeling jittery
    • acid stomach
    • abdominal pain or distension
    • loss of energy and strength
    • redness, swelling or itching at the injection site (local allergy)
    • a lump or hardening under the skin at the injection site
    • indigestion (dyspepsia)
    • excessive sweating (hyperhidrosis)
    • mood changes
    • flu-like symptoms
    • bone or muscle pain

    These are the more common side effects of BYDUREON. Mostly these are mild and short-lived.

    BYDUREON may reduce your appetite. Nausea and vomiting were very commonly reported in patients using BYDUREON. Mostly these were mild to moderate and short-lived. In most patients who initially experienced nausea, the frequency and severity decreased with continued therapy.

    You may experience dehydration as a result of nausea, vomiting and/or diarrhoea. Some symptoms of mild to moderate dehydration are:

    • dry mouth
    • decreased frequency of urination and concentrated urine
    • headache
    • muscle weakness
    • dizziness or light headedness

    Drink plenty of fluids if you are experiencing any of these symptoms. Tell your doctor immediately or go to Accident and Emergency at your nearest hospital if you continue to experience these symptoms.

    Tell your doctor immediately if you notice any of the following:

    • passing little or no urine
    • taste disturbance or loss of taste
    • sleepiness or drowsiness
    • swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing
    • stomach discomfort relieved by belching or passing wind
    • constipation
    • itching
    • hives, pinkish, itchy swellings on the skin, itchy rash
    • red raised skin rash
    • bleeding more easily than normal, if you are taking warfarin

    These are rare or very rare side effects of BYDUREON. The above list includes serious side effects which may require medical attention.

    Tell your doctor immediately if you are experiencing any of the following:

    • severe abdominal pain and
    • vomiting and/or
    • diarrhoea and/or
    • nausea

    These can be symptoms of acute pancreatitis which has been reported rarely in patients taking BYDUREON.

    Do not be alarmed by this list of possible side effects. You may not experience any of them.

    Tell your doctor if you notice anything that is making you feel unwell.

    Other side effects not listed above may also occur in some people.

    After using BYDUREON

    Storage

    Keep BYDUREON in the refrigerator where the temperature stays between 2-8°C. Do not freeze. Do not use BYDUREON if it has been frozen.

    Keep this medicine where children cannot reach it.

    Each BYDUREON kit or pen contains one dose, you should use the full dose each time you inject.

    Use a new BYDUREON kit or pen for each injection.

    BYDUREON can be kept out of the refrigerator (below 30°C) for a total of 4 weeks.

    Discard the used BYDUREON components, including the needle, immediately after use.

    Ask your pharmacist how to discard BYDUREON.

    BYDUREON is for use in a single patient only.

    Disposal

    Dispose of your syringe or pen with the needle still attached into a yellow plastic sharps container or similar puncture proof container composed of hard plastic or glass.

    Ask your doctor, nurse or pharmacist where you can dispose of the container when it is full.

    If your doctor tells you to stop using this medicine or the expiry date has passed, ask your pharmacist what to do with any medicine that is left over.

    Product description

    What it looks like

    BYDUREON powder is white to off white. The diluent is a clear colourless to pale yellow to pale brown liquid. When mixed together, the solution is white to off white and cloudy.

    BYDUREON Kit
    BYDUREON is supplied in a kit containing a vial of exenatide powder, a syringe of diluent (solvent), an adapter and 2 needles (1 spare). Each kit contains dosing for 1 week of treatment as a single dose.

    BYDUREON Pen
    BYDUREON is supplied in a dual-chambered pen containing exenatide powder in one chamber and diluent (solvent) in the other chamber for suspension.

    Each pre-filled pen is provided with one custom needle. Each pack also contains one spare needle.

    Each pen contains dosing for 1 week of treatment as a single dose.

    BYDUREON is available in packs of 4 single dose kits, 4 single dose pens or 1 single dose pen.

    Ingredients

    BYDUREON powder contains 2 mg of exenatide as the active ingredient. It also contains lactic-glycolic copolymer and sucrose.

    The diluent contains:

    • carmellose sodium
    • sodium chloride
    • polysorbate 20
    • monobasic sodium phosphate monohydrate
    • dibasic sodium phosphate (as heptahydrate)
    • sodium hydroxide (pen only)
    • water for injection

    Suppliers

    Supplied in Australia by

    AstraZeneca Pty Ltd
    ABN 54 009 682 311
    66 Talavera Road
    Macquarie Park NSW 2113

    Supplied in New Zealand by

    AstraZeneca Limited
    Auckland

    For all enquiries contact AstraZeneca by calling 1800 805 342 (Australia) or 09 306 5650 (New Zealand)

    Australian Registration Number:

    The Australian Registration Numbers for BYDUREON 2 mg are:

    BYDUREON Kit – AUST R 175504

    BYDUREON Pen – AUST R 235962

    Further information

    Your food and exercise plan, along with your periodic blood sugar testing and scheduled A1C (also known as HbA1C) checks, will continue to be important in managing your diabetes while you are taking BYDUREON.

    You can get more information about diabetes from:

    Diabetes Australia

    • free call helpline 1300 136 588

    Diabetes New Zealand

    • toll free helpline 0800 342 238

    This leaflet was updated in March 2017.

    BYDUREON® is a registered trademark of the AstraZeneca group of companies.

    About the author

    Leave a Reply

    Your email address will not be published. Required fields are marked *