- SIDE EFFECTS
- Clinical Trials Experience
- Pool Of Placebo-Controlled Trials
- Pool Of Placebo-And Active-Controlled Trials
- Other Adverse Reactions
- Postmarketing Experience
- SIDE EFFECTS
- What is Tanzeum?
- Important Information
- Before taking this medicine
- How should I use Tanzeum?
- Tanzeum dosing information
- What happens if I miss a dose?
- What happens if I overdose?
- What should I avoid while using Tanzeum?
- Tanzeum side effects
- What other drugs will affect Tanzeum?
- Further information
- More about Tanzeum (albiglutide)
- Help With the Cost of Tanzeum
- What is Tanzeum prescribed for?
- What are the potential side effects of Tanzeum?
- Help with the cost of Tanzeum
- General Information
- Clinical Results
- Side Effects
- Mechanism of Action
- Additional Information
- GSK receives US approval for once-weekly type 2 diabetes treatment, Tanzeum™ (albiglutide)
- Tanzeum Discontinued
- FDA Box Warning
- Uses of Albiglutide:
- What do I need to tell my doctor BEFORE I take Albiglutide?
- What are some things I need to know or do while I take Albiglutide?
- How is this medicine (Albiglutide) best taken?
- What are some side effects that I need to call my doctor about right away?
- What are some other side effects of Albiglutide?
- If OVERDOSE is suspected:
- How do I store and/or throw out Albiglutide?
- Consumer information use
- More about albiglutide
The following serious reactions are described below or elsewhere in the prescribing information:
- Risk of Thyroid C-Cell Tumors
- Acute Pancreatitis
- Hypoglycemia with Concomitant Use of Insulin Secretagogues or Insulin
- Hypersensitivity Reactions
- Renal Impairment
Clinical Trials 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 with rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Pool Of Placebo-Controlled Trials
The data in Table 1 are derived from 4 placebo-controlled trials. TANZEUM was used as monotherapy in 1 trial and as add-on therapy in 3 trials . These data reflect exposure of 923 patients to TANZEUM and a mean duration of exposure to TANZEUM of 93 weeks. The mean age of participants was 55 years, 1% of participants were 75 years or older and 53% of participants were male. The population in these studies was 48% white, 13% African/African American, 7% Asian, and 29% Hispanic/Latino. At baseline, the population had type 2 diabetes for an average of 7 years and had a mean HbA1c of 8.1%. At baseline, 17% of the population in these studies reported peripheral neuropathy and 4% reported retinopathy. Baseline estimated renal function was normal or mildly impaired (eGFR >60 mL/min/1.73 m²) in 91% of the study population and moderately impaired (eGFR 30 to 60 mL/min/1.73 m²) in 9%.
Table 1 shows common adverse reactions excluding hypoglycemia associated with the use of TANZEUM in the pool of placebo-controlled trials. These adverse reactions were not present at baseline, occurred more commonly on TANZEUM than on placebo, and occurred in at least 5% of patients treated with TANZEUM.
Table 1: Adverse Reactions in Placebo-Controlled Trials Reported in ≥5% of Patients Treated with TANZEUMa
(n = 468) %
(n = 923) %
|Upper respiratory tract infection||13.0||14.2|
|Injection site reactionb||2.1||10.5|
| a Adverse reactions reported include those occurring with the use of glycemic rescue medications which included metformin (17% for placebo and 10% for TANZEUM) and insulin (24% for placebo and 14% for TANZEUM).
b See below for other events of injection site reactions reported.
Gastrointestinal Adverse Reactions
In the pool of placebo-controlled trials, gastrointestinal complaints occurred more frequently among patients receiving TANZEUM (39%) than patients receiving placebo (33%). In addition to diarrhea and nausea (see Table 1), the following gastrointestinal adverse reactions also occurred more frequently in patients receiving TANZEUM: vomiting (2.6% versus 4.2% for placebo versus TANZEUM), gastroesophageal reflux disease (1.9% versus 3.5% for placebo versus TANZEUM), and dyspepsia (2.8% versus 3.4% for placebo versus TANZEUM). Constipation also contributed to the frequently reported reactions. In the group treated with TANZEUM, investigators graded the severity of GI reactions as “mild” in 56% of cases, “moderate” in 37% of cases, and “severe” in 7% of cases. Discontinuation due to GI adverse reactions occurred in 2% of individuals on TANZEUM or placebo.
Injection Site Reactions
In the pool of placebo-controlled trials, injection site reactions occurred more frequently on TANZEUM (18%) than on placebo (8%). In addition to the term “injection site reaction” (see Table 1), the following other types of injection site reactions also occurred more frequently on TANZEUM: injection site hematoma (1.9% versus 2.1% for placebo versus TANZEUM ), injection site erythema (0.4% versus 1.7% for placebo versus TANZEUM), injection site rash (0% versus 1.4% for placebo versus TANZEUM), injection site hypersensitivity (0% versus 0.8% for placebo versus TANZEUM), and injection site hemorrhage (0.6% versus 0.7% for placebo versus TANZEUM). Injection site pruritus also contributed to the frequently reported reactions. The majority of injection site reactions were judged as “mild” by investigators in both groups (73% for TANZEUM versus 94% for placebo). More patients on TANZEUM than on placebo: discontinued due to an injection site reaction (2% versus 0.2%), experienced more than 2 reactions (38% versus 20%), had a reaction judged by investigators to be “moderate” or “severe” (27% versus 6%), and required local or systemic treatment for the reactions (36% versus 11%).
Pool Of Placebo-And Active-Controlled Trials
The occurrence of adverse reactions was also evaluated in a larger pool of patients with type 2 diabetes participating in 7 placebo-and active-controlled trials. These trials evaluated the use of TANZEUM as monotherapy, as add-on therapy to oral antidiabetic agents, and as add-on therapy to basal insulin . In this pool, a total of 2,116 patients with type 2 diabetes were treated with TANZEUM for a mean duration of 75 weeks. The mean age of patients treated with TANZEUM was 55 years, 1.5% of the population in these studies was 75 years or older and 51% of participants were male. Forty-eight percent of patients were white, 15% African/African American, 9% Asian, and 26% were Hispanic/Latino. At baseline, the population had diabetes for an average of 8 years and had a mean HbA1c of 8.2%. At baseline, 21% of the population reported peripheral neuropathy and 5% reported retinopathy. Baseline estimated renal function was normal or mildly impaired (eGFR >60 mL/min/1.73 m²) in 92% of the population and moderately impaired (eGFR 30 to 60 mL/min/1.73 m²) in 8% of the population.
In the pool of placebo-and active-controlled trials, the types and frequencies of common adverse reactions excluding hypoglycemia were similar to those listed in Table 1.
Other Adverse Reactions
The proportion of patients experiencing at least one documented symptomatic hypoglycemic episode on TANZEUM and the proportion of patients experiencing at least one severe hypoglycemic episode on TANZEUM in clinical trials is shown in Table 2. Hypoglycemia was more frequent when TANZEUM was added to sulfonylurea or insulin .
Table 2: Incidence (%) of Hypoglycemia in Clinical Trials of TANZEUMa
|Monotherapyb (52 Weeks)||Placebo
n = 101
|TANZEUM 30 mg Weekly
n = 101
|In Combination with Metformin Trial (104 Weeks)e||Placebo
n = 101
n = 302
|In Combination with Pioglitazone ± Metformin (52 Weeks)||Placebo
n = 151
n = 150
|In Combination with Metformin and Sulfonylurea (52 Weeks)||Placebo
n = 115
n = 271
|In Combination with Insulin Glargine (26 Weeks)||Insulin Lispro
n = 281
|In Combination with Metformin ± Sulfonylurea (52 Weeks)||Insulin Glargine
n = 241
n = 504
|In Combination with OADs in Renal Impairment (26 Weeks)|| Sitagliptin
n = 246
n = 249
|OAD = Oral antidiabetic agents.
a Data presented are to the primary endpoint and include only events occurring on-therapy with randomized medications and excludes events occurring after use of glycemic rescue medications (i.e., primarily metformin or insulin).
b In this trial, no documented symptomatic or severe hypoglycemia was reported for TANZEUM 50 mg and these data are omitted from the table.
c Plasma glucose concentration ≤70 mg/dL and presence of hypoglycemic symptoms.
d Event requiring another person to administer a resuscitative action.
e Rate of documented symptomatic hypoglycemia for active controls 18% (glimepiride) and 2% (sitagliptin).
In the pool of 7 placebo-and active-controlled trials, the adverse reaction of pneumonia was reported more frequently in patients receiving TANZEUM (1.8%) than in patients in the all-comparators group (0.8%). More cases of pneumonia in the group receiving TANZEUM were serious (0.4% for TANZEUM versus 0.1% for all comparators).
In the pool of 7 placebo-and active-controlled trials, adverse reactions of atrial fibrillation (1.0%) and atrial flutter (0.2%) were reported more frequently for TANZEUM than for all comparators (0.5% and 0%, respectively). In both groups, patients with events were generally male, older, and had underlying renal impairment or cardiac disease (e.g., history of arrhythmia, palpitations, congestive heart failure, cardiomyopathy, etc.).
In the pool of placebo-and active-controlled trials, serious events of appendicitis occurred in 0.3% of patients treated with TANZEUM compared with 0% among all comparators.
Consistent with the high homology of albiglutide with human GLP-1, the majority of patients (approximately 79%) with anti-albiglutide antibodies also tested positive for anti-GLP-1 antibodies; none were neutralizing. A minority of patients (approximately 17%) who tested positive for anti-albiglutide antibodies also transiently tested positive for antibodies to human albumin.
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 albiglutide cannot be directly compared with the incidence of antibodies of other products.
Liver Enzyme Abnormalities
In the pool of placebo-and active-controlled trials, a similar proportion of patients experienced at least one event of alanine aminotransferase (ALT) increase of 3-fold or greater above the upper limit of normal (0.9% and 0.9% for all comparators versus TANZEUM). Three subjects on TANZEUM and one subject in the all-comparator group experienced at least one event of ALT increase of 10-fold or greater above the upper limit of normal. In one of the 3 cases an alternate etiology was identified to explain the rise in liver enzyme (acute viral hepatitis). In one case, insufficient information was obtained to establish or refute a drug-related causality. In the third case, elevation in ALT (10 times the upper limit of normal) was accompanied by an increase in total bilirubin (4 times the upper limit of normal) and occurred 8 days after the first dose of TANZEUM. The etiology of hepatocellular injury was possibly related to TANZEUM but direct attribution to TANZEUM was confounded by the presence of gallstone disease diagnosed on ultrasound 3 weeks after the event.
Gamma Glutamyltransferase (GGT) Increase
In the pool of placebo-controlled trials, the adverse event of increased GGT occurred more frequently in the group treated with TANZEUM (0.9% and 1.5% for placebo versus TANZEUM).
Heart Rate Increase
In the pool of placebo-controlled trials, mean heart rate in patients treated with TANZEUM was higher by an average of 1 to 2 bpm compared with mean heart rate in patients treated with placebo across study visits. The long-term clinical effects of the increase in heart rate have not been established .
Consistent with the potentially immunogenic properties of protein and peptide pharmaceuticals, patients treated with TANZEUM may develop anti-albiglutide antibodies. 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 albiglutide in the studies described below cannot be directly compared with the incidence of antibodies in other studies or to other products.
In the pool of 7 placebo-and active-controlled trials, 116 (5.5%) of 2,098 patients exposed to TANZEUM tested positive for anti-albiglutide antibodies at any time during the trials. None of these antibodies were shown to neutralize the activity of albiglutide in an in vitro bioassay.
The following adverse reactions have been identified during post-approval use of TANZEUM. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Read the entire FDA prescribing information for Tanzeum (Albiglutide Pen for Injection, for Subcutaneous Use)
Generic Name: albiglutide (AL bi GLOO tide)
Brand Names: Tanzeum
Medically reviewed by Philip Thornton, DipPharm Last updated on Jan 6, 2020.
- Side Effects
What is Tanzeum?
Tanzeum (albiglutide) is an injectable diabetes medicine that helps control blood sugar levels.
Tanzeum is used together with diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus.
Tanzeum is usually given after other diabetes medications have been tried without success. It is not for treating type 1 diabetes.
You should not use Tanzeum if you have multiple endocrine neoplasia type 2 (tumors in your glands), a personal or family history of medullary thyroid cancer, insulin-dependent diabetes, or diabetic ketoacidosis.
Call your doctor at once if you have signs of a thyroid tumor, such as swelling or a lump in your neck, trouble swallowing, a hoarse voice, or shortness of breath.
Before taking this medicine
You should not use Tanzeum you are allergic to albiglutide, or if you have:
multiple endocrine neoplasia type 2 (tumors in your glands);
a personal or family history of medullary thyroid carcinoma (a type of thyroid cancer); or
diabetic ketoacidosis (call your doctor for treatment with insulin).
To make sure Tanzeum is safe for you, tell your doctor if you have ever had:
a stomach or intestinal disorder;
liver or kidney disease.
In animal studies, albiglutide caused thyroid tumors or thyroid cancer. It is not known whether these effects would occur in people using regular doses. Ask your doctor about your risk.
Albiglutide may harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant. Tanzeum can have long-lasting effects on your body. Avoid getting pregnant for at least 1 month after you stop using this medicine.
You should not breastfeed while using Tanzeum.
Tanzeum is not approved for use by anyone younger than 18 years old.
How should I use Tanzeum?
Use Tanzeum exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.
Tanzeum is injected under the skin. A healthcare provider may teach you how to properly use the medication by yourself.
Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you don’t understand all instructions.
Prepare an injection only when you are ready to give it. Do not use if the medicine has particles in it. Call your pharmacist for new medicine.
The prefilled injection pen contains a powder and a liquid that must be mixed before using the pen. Each different pen strength has a certain “wait” time to allow the powder to completely dissolve after mixing: 15 minutes for a 30-mg pen and 30 minutes for a 50-mg pen.
Tanzeum is usually given once per week at any time of the day, with or without a meal. If you want to change your weekly injection day, wait at least 4 days after your most recent injection before giving another one.
Drink plenty of liquids to keep your kidneys working properly.
Your healthcare provider will show you where on your body to inject Tanzeum. Use a different place each time you give an injection. Do not inject into the same place two times in a row.
You may have low blood sugar (hypoglycemia) and feel very hungry, dizzy, irritable, confused, anxious, or shaky. To quickly treat hypoglycemia, eat or drink a fast-acting source of sugar (fruit juice, hard candy, crackers, raisins, or non-diet soda).
Your doctor may prescribe a glucagon injection kit in case you have severe hypoglycemia. Be sure your family or close friends know how to give you this injection in an emergency.
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.
Call your doctor if you have ongoing vomiting or diarrhea, or if you are sweating more than usual. You can easily become dehydrated while taking Tanzeum. This can lead to kidney failure.
Store injection pens in their original carton in a refrigerator. Do not freeze Tanzeum, and throw away the medication if it has become frozen. Throw away any pens not used before the expiration date.
You may also store the pens at room temperature for up to 4 weeks before use.
Use an injection pen only once and then place it in a puncture-proof “sharps” container. Follow state or local laws about how to dispose of this container. Keep it out of the reach of children and pets.
Tanzeum dosing information
Usual Adult Dose for Diabetes Type 2:
Initial dose: 30 mg subcutaneously once a week
-If glycemic response is inadequate, may increase to 50 mg subcutaneously once a week
Maintenance dose: 30 or 50 mg subcutaneously once a week
-This drug is not recommended as first-line therapy because of uncertain relevance of the rodent C-cell tumor findings to humans; prescribe only to patients for whom the potential benefits are considered to outweigh the potential risk.
-This drug has not been studied in patients with a history of pancreatitis; consider alternative therapies
-The dose of concomitantly administered insulin or insulin secretagogues may need to be reduced when starting therapy in order to decrease the risk of hypoglycemia.
-This drug has not been studied in combination with prandial insulin.
Use: As an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus.
What happens if I miss a dose?
Use the medicine as soon as you can, but skip the missed dose if you are more than 3 days late for the dose. Do not use two doses within 3 days of each other.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What should I avoid while using Tanzeum?
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.
Tanzeum side effects
Get emergency medical help if you have signs of an allergic reaction to Tanzeum: hives; fast heartbeats, feeling light-headed; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
symptoms of pancreatitis – severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate;
signs of a thyroid tumor – swelling or a lump in your neck, trouble swallowing, a hoarse voice, or if you feel short of breath;
low blood sugar – headache, hunger, weakness, sweating, confusion, irritability, dizziness, fast heart rate, or feeling jittery; or
kidney problems – little or no urination, swelling in your feet or ankles, feeling tired or short of breath.
Common Tanzeum side effects may include:
cough, cold or flu symptoms;
back pain, joint pain; or
pain, swelling, or irritation where medicine was injected.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What other drugs will affect Tanzeum?
Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.
Tell your doctor about all your other medicines, especially:
oral diabetes medications.
This list is not complete. Other drugs may interact with albiglutide, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Tanzeum only for the indication prescribed.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Copyright 1996-2020 Cerner Multum, Inc. Version: 4.02.
More about Tanzeum (albiglutide)
- Side Effects
- During Pregnancy
- Dosage Information
- Drug Interactions
- Pricing & Coupons
- En Español
- 11 Reviews
- Drug class: incretin mimetics
- FDA Approval History
- Tanzeum (Advanced Reading)
- Tanzeum (FDA)
Related treatment guides
- Diabetes, Type 2
Help With the Cost of Tanzeum
Do you need help with the cost of Tanzeum? Tanzeum (albiglutide) is an injectable diabetes medicine that helps control blood sugar levels. Tanzeum is used together with diet and exercise to treat type 2 diabetes. Tanzeum is usually given after other diabetes medications have been tried without success.
What is Tanzeum prescribed for?
Tanzeum is used with a proper diet and exercise program to control high blood sugar in people with type 2 diabetes (non-insulin-dependent diabetes). Controlling high blood sugar helps prevent kidney damage, blindness, nerve problems, loss of limbs, and sexual function problems. Proper control of diabetes may also lessen your risk of a heart attack or stroke. Albiglutide is similar to a natural hormone in your body (incretin). It works by causing insulin release in response to high sugar levels (such as after a meal) and decreasing the amount of sugar your liver makes.
Tanzeum is not a substitute for insulin if you need insulin treatment.
What are the potential side effects of Tanzeum?
Injection site pain, vomiting, and stomach upset may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor right away if you have any serious side effects, including: signs of kidney problems (such as change in the amount of urine).
Get medical help right away if you have any very serious side effects, including: signs of pancreatitis (such as persistent nausea/vomiting, severe stomach/abdominal pain).
Help with the cost of Tanzeum
Not many people know that a number of Pharmaceutical companies run programs called the Patient Assistance Programs or prescription assistance programs. These programs are designed to help people with low income and little to no prescription insurance coverage by providing the medications at little or no money.
The Rx Solution is an organization that was founded to help such people. Here at The Rx Solution, we help a number of patients without prescription drug coverage to get medications through the various prescription assistance programs.
We bring together our nation’s largest pharmaceutical companies along with other medical professionals to help patients qualify for such programs for very low monthly fees. Our mission is to spread awareness of such programs and help eligible people get into such programs easily and without hassle.
If you need help with the cost of Tanzeum, call us today at (888) 823-0042 to enroll in our widely successful program. Join us today and let us lend you a helping hand.
DOSAGE AND ADMINISTRATION:
The recommended dosage of TANZEUM is 30 mg once weekly given as a subcutaneous injection in the abdomen, thigh, or upper arm region. The dosage may be increased to 50 mg once weekly if the glycemic response is inadequate.
TANZEUM may be administered at any time of day without regard to meals. Instruct patients to administer TANZEUM once a week on the same day each week. The day of weekly administration may be changed if necessary as long as the last dose was administered 4 or more days before.
If a dose is missed, instruct patients to administer as soon as possible within 3 days after the missed dose. Thereafter, patients can resume dosing on their usual day of administration. If it is more than 3 days after the missed dose, instruct patients to wait until their next regularly scheduled weekly dose.
Concomitant Use with an Insulin Secretagogue (e.g., Sulfonylurea) or with Insulin
When initiating TANZEUM, consider reducing the dosage of concomitantly administered insulin secretagogues (e.g., sulfonylureas) or insulin to reduce the risk of hypoglycemia .
Dosage in Patients with Renal Impairment
No dose adjustment is needed in patients with mild, moderate, or severe renal impairment (eGFR 15 to 89 mL/min/1.73 m2). Use caution when initiating or escalating doses of TANZEUM in patients with renal impairment. Monitor renal function in patients with renal impairment reporting severe adverse gastrointestinal reactions .
Reconstitution of the Lyophilized Powder
The lyophilized powder contained within the Pen must be reconstituted prior to administration. See Patient Instructions for Use for complete administration instructions with illustrations. The instructions may also be found at www.TANZEUM.com. Instruct patients as follows:
1. Hold the Pen body with the clear cartridge pointing up to see the in the number window.
2. To reconstitute the lyophilized powder with the diluent in the Pen, twist the clear cartridge on the Pen in the direction of the arrow until the Pen is felt/heard to “click” into place and the is seen in the number window. This mixes the diluent with the lyophilized powder.
3. Slowly and gently rock the Pen side-to-side 5 times to mix the reconstituted solution of TANZEUM. Advise the patient to not shake the Pen hard to avoid foaming.
4. Wait 15 minutes for the 30-mg Pen and 30 minutes for the 50-mg Pen to ensure that the reconstituted solution is mixed.
Preparing Pen for Injection
1. Slowly and gently rock the Pen side-to-side 5 additional times to mix the reconstituted solution.
2. Visually inspect the reconstituted solution in the viewing window for particulate matter. The reconstituted solution will be yellow in color. After reconstitution, use TANZEUM within 8 hours.
3. Holding the Pen upright, attach the needle to the Pen. Gently tap the clear cartridge to bring large bubbles to the top.
See Dosage and Administration for important administration instructions, including the injection procedure.
Alternate Method of Reconstitution (Healthcare Professional Use Only)
The Patient Instructions for Use provide directions for the patient to wait 15 minutes for the 30-mg Pen and 30 minutes for the 50-mg Pen after the lyophilized powder and diluent are mixed to ensure reconstitution.
Healthcare professionals may utilize the following alternate method of reconstitution. Because this method relies on appropriate swirling and visual inspection of the solution, it should only be performed by healthcare professionals.
1. Follow Step A (Inspect Your Pen and Twist Pen to Mix Your Medication) in the Instructions for Use. Make sure you have:
a. Inspected the Pen for in number window and expiration date.
b. Twisted the clear cartridge until appears in the number window and a “click” is heard. This combines the medicine powder and liquid in the clear cartridge.
2. Hold the Pen with the clear cartridge pointing up and maintain this orientation throughout the reconstitution.
3. Gently swirl the Pen in small circular motions for at least one minute. Avoid shaking as this can result in foaming, which may affect the dose.
4. Inspect the solution, and if needed, continue to gently swirl the Pen until all the powder is dissolved and you see a clear yellow solution that is free of particles. A small amount of foam, on top of the solution at the end of reconstitution, is normal.
a. For 30-mg Pen: Complete dissolution usually occurs within 2 minutes but may take up to 5 minutes, as confirmed by visual inspection for a clear yellow solution free of particles.
b. For 50-mg Pen: Complete dissolution usually occurs within 7 minutes but may take up to 10 minutes.
5. After reconstitution, continue to follow the steps in the Instructions for Use, starting at Step B: Attach the Needle.
Important Administration Instructions
Instruct patients as follows:
•The pen should be used within 8 hours of reconstitution prior to attaching the needle.
•After attaching the supplied needle, remove air bubbles by slowly twisting the Pen until you see the in the number window. At the same time, the injection button will be automatically released from the bottom of the Pen.
•Use immediately after the needle is attached and primed. The product can clog the needle if allowed to dry in the primed needle.
•After subcutaneously inserting the needle into the skin in the abdomen, thigh, or upper arm region, press the injection button. Hold the injection button until you hear a ‘click’ and then hold the button for 5 additional seconds to deliver the full dose.
When using TANZEUM with insulin, instruct patients to administer as separate injections and to never mix the products. It is acceptable to inject TANZEUM and insulin in the same body region but the injections should not be adjacent to each other.
When injecting in the same body region, advise patients to use a different injection site each week. TANZEUM must not be administered intravenously or intramuscularly.
Tanzeum (albiglutide) is an agonist of the albumin-based glucagon-like peptide (GLP)-1 fusion protein. It augments glucose-dependent insulin secretion and slows gastric emptying.
Tanzeum is specifically indicated as an adjunct to diet and exercise to improve glycemic control in adults with type II diabetes mellitus.
Tanzeum is supplied as a solution for subcutaneous injection. The recommended dose is 30 mg once weekly given as a subcutaneous injection in the abdomen, thigh, or upper arm region. The dosage may be increased to 50 mg once weekly if the glycemic response is inadequate. Tanzeum may be administered at any time of day without regard to meals. It should be administered once a week on the same day each week. The day of weekly administration may be changed if necessary as long as the last dose was administered 4 or more days before. If a dose is missed, Tanzeum should be administered as soon as possible within 3 days after the missed dose. Thereafter, dosing can resume on the usual day of administration. If it is more than 3 days after the missed dose, dosing should wait until the next regularly scheduled weekly dose.
The FDA approval of Tanzeum was based on a 52-week, randomized, double-blind, placebo-controlled, multicenter trial. A total of 296 subjects with type 2II diabetes inadequately controlled on diet and exercise were randomized Tanzeum 30 mg SC once weekly, Tanzeum 30 mg SC once weekly uptitrated to 50 mg once weekly at Week 12, or placebo. Compared with placebo, treatment with Tanzeum 30 mg or 50 mg resulted in statistically significant reductions in HbA1c from baseline at Week 52. The adjusted mean change in weight from baseline did not differ significantly between Tanzeum (-0.4 to -0.9 kg) and placebo (-0.7 kg) at Week 52.
Adverse effects associated with the use of Tanzeum may include, but are not limited to, the following:
- upper respiratory tract infection
- injection site reaction
Mechanism of Action
Tanzeum (albiglutide) is a GLP-1 receptor agonist, a recombinant fusion protein comprised of 2 tandem copies of modified human GLP-1 genetically fused in tandem to human albumin. The human GLP-1 fragment sequence 7 36 has been modified with a glycine substituted for the naturally-occurring alanine at position 8 in order to confer resistance to dipeptidylpeptidase IV (DPP-IV) mediated proteolysis. The human albumin moiety of the recombinant fusion protein, together with the DPP-IV resistance, extends the half-life allowing once-weekly dosing.
For additional information regarding Tanzeum or type II diabetes, please visit the Tanzeum web page.
GSK receives US approval for once-weekly type 2 diabetes treatment, Tanzeum™ (albiglutide)
April 15, 2014 — GlaxoSmithKline plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has approved TanzeumTM (albiglutide) for injection, for subcutaneous use, as a once-weekly treatment for type 2 diabetes. Tanzeum has been approved as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Albiglutide, a glucagon-like peptide-1 receptor agonist (GLP-1), is a biological product for the treatment of type 2 diabetes, administered once-weekly using an injector pen supplied with a 5mm 29-gauge thin-walled needle. Glucagon-like peptide-1 is an important incretin hormone that helps reduce blood glucose levels but, in people with type 2 diabetes, its production is often reduced or absent.
Vlad Hogenhuis, Senior Vice-President and Head, GSK Global Cardiovascular, Metabolic and Neurosciences Franchise, said: “Many type 2 diabetes patients struggle to keep their blood sugar within the recommended levels. We are pleased that the approval of Tanzeum provides an effective new weekly GLP-1 treatment option for appropriate patients in the US.”
The FDA approval of albiglutide is based on the results of GSK’s comprehensive Phase III Harmony programme, consisting of eight trials and involving over 5,000 patients, over 2,000 of whom were treated with Tanzeum. The Harmony studies evaluated albiglutide against commonly-used classes of type 2 diabetes treatment, including insulin, metformin, glimepiride and pioglitazone, in patients at different stages of the disease, as well as those with renal impairment.
Following this approval by the FDA, GSK anticipates the US launch of Tanzeum in the third quarter of 2014.
Albiglutide was licensed by the European Medicines Agency in March 2014, under the brand name Eperzan®, for use in adult patients with type 2 diabetes.
Diabetes is a global epidemic, affecting 382 million individuals globally, over 20 million of whom are in the US.1 Up to 95% of these patients have type 2 diabetes.1 Type 2 diabetes is a life-long, progressive and, in some cases, preventable condition characterized by high blood sugar levels, known as hyperglycemia. A lack of physical activity, obesity, increasing age, high blood pressure and genetics are known risk factors that can contribute to the development of type 2 diabetes.2,3 Treatment options include lifestyle changes such as increased physical activity and diet but, as the condition progresses, patients may require the addition of oral and injectable medications to control blood sugar levels and, ultimately, the use of insulin, either daily or with meals.
About Tanzeum TM (albiglutide)
Tanzeum is a GLP-1 receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
LIMITATIONS OF USE
Tanzeum is not recommended as first-line therapy for patients inadequately controlled on diet and exercise. Tanzeum has not been studied in patients with a history of pancreatitis. Tanzeum is not for treatment of type 1 diabetes mellitus or diabetic ketoacidosis. Tanzeum has not been studied in patients with pre-existing severe gastrointestinal disease. Tanzeum has not been studied in combination with prandial insulin.
Full US Prescribing Information, including BOXED WARNING, Medication Guide and Instructions for Use will soon be available at us.gsk.com. Prior to the label being posted online, a copy of the label may be requested from the GSK Media or Investor Relations contacts listed in the “GlaxoSmithKline Inquiries” section at the end of this document.
Tanzeum has been approved with a Risk Evaluation and Mitigation Strategy (REMS), required by the FDA to ensure that the benefits of Tanzeum outweigh the potential risk of medullary thyroid carcinoma and the risk of acute pancreatitis. A non-promotional factsheet, reviewed by the FDA, with more detailed safety information is available at www.TANZEUMREMS.com.
Important Safety information for Tanzeum (albiglutide)
The following information is taken from the highlights section of the US Prescribing Information. Please see full Prescribing Information including boxed warning.
BOXED WARNING: RISK OF THYROID C-CELL TUMORS
Thyroid C-cell tumors have been observed in rodent studies with glucagon-like peptide-1 (GLP-1) receptor agonists at clinically relevant exposures. It is unknown whether Tanzeum causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans. Tanzeum is contraindicated in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
Do not use in patients with a personal or family history of medullary thyroid carcinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Do not use in patients with a prior serious hypersensitivity reaction to albiglutide or to any of the product components.
WARNINGS AND PRECAUTIONS
Pancreatitis: Discontinue promptly if suspected. Do not restart if confirmed. Consider other antidiabetic therapies in patients with a history of pancreatitis.
Hypoglycemia: Can occur when used in combination with insulin secretagogues (e.g. sulfonylureas) or insulin. Consider lowering sulfonylurea or insulin dosage when starting Tanzeum.
Hypersensitivity Reactions: Discontinue Tanzeum if suspected. Monitor and treat promptly per standard of care until signs and symptoms resolve.
Renal Impairment: Monitor renal function in patients with renal impairment reporting severe adverse gastrointestinal reactions.
Macrovascular Outcomes: There have been no clinical trials establishing conclusive evidence of macrovascular risk reduction with Tanzeum or any other antidiabetic drug.
Adverse reactions, reported in ≥10% of patients treated with Tanzeum and more frequently than in patients on placebo, were upper respiratory tract infection, diarrhea, nausea, and injection site reaction.
TanzeumTM and Eperzan® are trademarks of the GlaxoSmithKline group of companies.
GSK – one of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For further information please visit www.gsk.com.
1. IDF. Diabetes Atlas. Sixth Edition. 2013. Available at: . Last accessed April 2014
2. Elbein SC. Genetics Factors Contributing to Type 2 Diabetes across Ethnicities. Diabetes Sci Technol. 2009 July; 3(4): 685-689.
3. IDF. Types of diabetes. 2013. available at: http://www.idf.org/types-diabetes. Last accessed April 2014.
Tanzeum is the brand name of the drug albiglutide, an injection drug that’s used along with diet and exercise to control blood sugar levels in people with type 2 diabetes.
About 24 million Americans have type 2 diabetes, which causes high blood sugar levels that can increase the risk of serious complications such as blindness, heart disease, nerve damage, and kidney damage.
Tanzeum belongs to a class of drugs known as incretin mimetics. It works by helping the pancreas release the optimal amount of insulin when blood sugar levels are high and by slowing the movement of food through the stomach.
The drug may help patients reduce the risk of serious complications associated with type 2 diabetes because it keeps blood sugar levels closer to normal.
The Food and Drug Administration (FDA) approved Tanzeum in 2014. The drug is manufactured by GlaxoSmithKline, LLC.
Tanzeum’s safety and effectiveness was evaluated in eight clinical trials that involved more than 2,000 people with type 2 diabetes.
Patients who took the medication in these studies had an improvement in their hemoglobin A1C levels (a measure of blood sugar control).
Tanzeum may increase the risk of thyroid gland tumors and thyroid cancer.
Tell your doctor if you have a family history of thyroid cancer, medullary thyroid carcinoma (a specific type of thyroid cancer), or multiple endocrine neoplasia syndrome type 2 (a condition that causes tumors in more than one gland in the body).
You should alert your physician immediately if you experience any of the following symptoms while taking Tanzeum:
- Swelling or a lump in the neck
- Difficulty swallowing
- Shortness of breath
Tanzeum should not be used to treat type 1 diabetes (a disease in which the body does not produce insulin) or diabetic ketoacidosis (a condition that may develop if high blood sugar levels are not treated).
Before taking this medication, you should tell your doctor if have:
- An intestinal disorder
- Liver disease
- Kidney disease
- Any stomach disorder
You should also tell your physician if you use insulin or any other diabetes medications.
Tanzeum comes with patient instructions for safe use. Follow these directions carefully and ask your doctor or pharmacist if you have any questions.
Tanzeum is not recommended as the first medication to treat diabetes. This drug helps control type 2 diabetes, but it does not cure the condition. You should continue to use the injection even if you feel well.
Pregnancy and Tanzeum
Tanzeum might harm an unborn baby.
It’s also unknown whether Tanzeum passes into breast milk and could harm a breastfeeding baby.
Before taking Tanzeum, talk with your doctor if you’re pregnant, might become pregnant, or are breastfeeding.
Tanzeum (albiglutide) is an injectable diabetes medication that was approved by the U.S. Food and Drug Administration (FDA) in 2014. A glucagon-like peptide (GLP-1) receptor agonist, Tanzeum is used, along with diet and exercise, to help control blood sugar levels in those with type 2 diabetes, and is typically prescribed after other diabetes medications have been unsuccessful.
On August 1st, the FDA added the risk of anaphylactic reaction to the medication’s label.
An anaphylactic reaction is a severe, potentially life-threatening allergic reaction that requires a medical diagnosis. According to the Merck Manual, Anaphylactic reactions
- Often begin with a feeling of uneasiness, followed by tingling sensations and dizziness.
- People then rapidly develop severe symptoms, including generalize itching and hives, swelling, wheezing and difficulty breathing, fainting and/or other allergy symptoms.
- These reactions can quickly become life threatening.
In addition to the change in label for Tanzeum for Anaphylactic reaction, another Glucagon-like Peptide-1 (GLP-1) Agonist class drug, Trulicity, was recently updated with similar anaphylactic risks. All other drugs in the GLP-1 agonist class had anaphylactic reaction warnings on their label prior to these two alerts.
On July 26, 2017, GlaxoSmithKline announced that the company is discontinuing the manufacturing and sale of Tanzeum due to limited prescribing of the drug and declining sales, despite the fact that it was priced lower than its rivals, Eli Lilly’s Trulicity and Novo’s Victoza.
According to a GSK press release, they will continue to invest in a small marketing effort, but due to a decline in sales, “it has been harder and harder to make the type of impact we would want for patients.”
The drug maker is suggesting that medical professionals transition patients currently on Tanzeum to an alternative therapy before July 2018, when the medication will no longer be commercially available, and not to start Tanzeum on any new patients.
FDA Box Warning
In March 2015, the FDA announced that it would be requiring Tanzeum to carry a boxed warning that thyroid C-cell tumors have been observed in rodents using GLP-1 receptor agonists at clinically relevant exposures; however, it is unknown whether Tanzeum causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans. This medication is not recommended for use in patients with a personal or family history of MTC, in patients with multiple endocrine neoplasia syndrome type 2, or for patients with a history of serious hypersensitivity to the medication or any of its components.
The FDA’s initial approval of Tanzeum carries with it several limitations, including:
- The medication is not recommended as first-line therapy for patients inadequately controlled on diet and exercise.
- It has not been studied in patients with a history of pancreatitis.
- It is not for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis.
- It is not recommended for patients with pre-existing gastrointestinal disease.
Other labeled serious risks associated with Tanzeum use include pancreatitis, acute kidney injury, renal impairment, and pneumonia.
Despite the boxed warning and label changes, TruLaw is still monitoring Tanzeum for some serious adverse events that have been reported to the FDA but are not currently listed in the drug’s current prescribing information, including Meniere’s disease.
Generic Name: Albiglutide (al bi GLOO tide)
Brand Name: Tanzeum
Medically reviewed by Drugs.com. Last updated on Jun 29, 2019.
- Side Effects
- Drugs like this one have been shown to cause thyroid cancer in some animals. It is not known if albiglutide may cause thyroid cancer in humans. Call your doctor right away if you have a neck mass, trouble breathing, trouble swallowing, or hoarseness that will not go away.
- Do not use albiglutide if you have a health problem called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2), or if you or a family member have had thyroid cancer.
Uses of Albiglutide:
- It is used to lower blood sugar in patients with high blood sugar (diabetes).
What do I need to tell my doctor BEFORE I take Albiglutide?
- If you have an allergy to albiglutide or any other part of albiglutide.
- If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
- If you have any of these health problems: Acidic blood problem, type 1 diabetes, pancreatitis, or stomach or bowel problems.
- If you are pregnant or plan to get pregnant.
- If you are breast-feeding or plan to breast-feed.
This is not a list of all drugs or health problems that interact with albiglutide.
Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take albiglutide with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.
What are some things I need to know or do while I take Albiglutide?
- Tell all of your health care providers that you take albiglutide. This includes your doctors, nurses, pharmacists, and dentists.
- Follow the diet and workout plan that your doctor told you about.
- Wear disease medical alert ID (identification).
- Check your blood sugar as you have been told by your doctor.
- Have blood work checked as you have been told by the doctor. Talk with the doctor.
- It may be harder to control blood sugar during times of stress such as fever, infection, injury, or surgery. A change in physical activity, exercise, or diet may also affect blood sugar.
- Talk with your doctor before you drink alcohol.
- Do not share pen or cartridge devices with another person even if the needle has been changed. Sharing these devices may pass infections from one person to another. This includes infections you may not know you have.
- Kidney problems have happened with drugs like this one. Sometimes, kidney problems have needed to be treated in the hospital. Dialysis has also been needed. Talk with your doctor.
- If you cannot drink liquids by mouth or if you have upset stomach, throwing up, or diarrhea that does not go away; you need to avoid getting dehydrated. Contact your doctor to find out what to do. Dehydration may lead to new or worse kidney problems.
How is this medicine (Albiglutide) best taken?
Use albiglutide as ordered by your doctor. Read all information given to you. Follow all instructions closely.
- It is given as a shot into the fatty part of the skin on the top of the thigh, belly area, or upper arm.
- If you will be giving yourself the shot, your doctor or nurse will teach you how to give the shot.
- Take with or without food.
- Take the same day each week.
- This medicine needs to be mixed before use. Follow how to mix as you were told by the doctor.
- Do not shake.
- Use the dose within 8 hours after mixing.
- Use your dose right away after you put the needle on the pen.
- Do not use if the solution is cloudy, leaking, or has particles.
- This medicine is yellow after mixing. Do not use if the solution changes color.
- Wash your hands before and after use.
- Move site where you give the shot each time.
- Do not mix albiglutide in the same syringe with insulin.
- If you are also using insulin, you may inject albiglutide and the insulin in the same area of the body but not right next to each other.
- Keep taking albiglutide as you have been told by your doctor or other health care provider, even if you feel well.
- Throw away needles in a needle/sharp disposal box. Do not reuse needles or other items. When the box is full, follow all local rules for getting rid of it. Talk with a doctor or pharmacist if you have any questions.
- Attach new needle before each dose.
What do I do if I miss a dose?
- Take a missed dose as soon as you think about it.
- If you miss your dose by more than 3 days, skip the missed dose. Take your next dose on your normal day.
- Do not take 2 doses at the same time or extra doses.
What are some side effects that I need to call my doctor about right away?
WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
- Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
- Signs of a pancreas problem (pancreatitis) like very bad stomach pain, very bad back pain, or very bad upset stomach or throwing up.
- Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
- Dizziness or passing out.
- Low blood sugar can happen. The chance may be raised when albiglutide is used with other drugs for diabetes. Signs may be dizziness, headache, feeling sleepy or weak, shaking, fast heartbeat, confusion, hunger, or sweating. Call your doctor right away if you have any of these signs. Follow what you have been told to do for low blood sugar. This may include taking glucose tablets, liquid glucose, or some fruit juices.
What are some other side effects of Albiglutide?
All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
- Upset stomach.
- Irritation where the shot is given.
- Back pain.
- Joint pain.
- Signs of a common cold.
- Flu-like signs.
These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.
You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.
If OVERDOSE is suspected:
If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.
How do I store and/or throw out Albiglutide?
- Store in a refrigerator. Do not freeze.
- Store in original container.
- This medicine may be stored at room temperature for up to 4 weeks before use.
- Do not use if it has been frozen.
- Protect from light.
- Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
- Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
Consumer information use
- If your symptoms or health problems do not get better or if they become worse, call your doctor.
- Do not share your drugs with others and do not take anyone else’s drugs.
- Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
- Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
- This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time albiglutide is refilled. If you have any questions about albiglutide, please talk with the doctor, pharmacist, or other health care provider.
- If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
More about albiglutide
- Side Effects
- During Pregnancy
- Dosage Information
- Drug Interactions
- En Español
- 11 Reviews
- Drug class: incretin mimetics
- Albiglutide Subcutaneous (Advanced Reading)
Other brands: Tanzeum
- Albiglutide (Wolters Kluwer)
- Diabetes, Type 2
The FDA has approved GlaxoSmithKline’s Tanzeum (albiglutide) subcutaneous injection as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus (T2DM). The approval, however, carries with it several limitations: (1) the medication is not recommended as first-line therapy for patients inadequately controlled on diet and exercise; (2) it has not been studied in patients with a history of pancreatitis; (3) it is not for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis; (4) it is not for patients with preexisting severe gastrointestinal disease; and (5) it has not been studied in combination with prandial insulin.1 Approximately 24 million Americans and 382 million people worldwide are affected by diabetes, with up to 95% of these cases being T2DM.2,3
Pharmacology and Pharmacokinetics
Tanzeum is a glucagon-like peptide-1 (GLP-1) receptor agonist. GLP-1 is an incretin hormone that helps to reduce blood glucose levels; it is often reduced or absent in patients with T2DM.2 Tanzeum augments glucose-dependent insulin secretion and slows gastric emptying. 1 It has an elimination half-life of approximately 5 days. Age, gender, race, and body weight do not affect the pharmacokinetics of Tanzeum.1
Dosage and Administration
Tanzeum should be given subcutaneously in the abdomen, thigh, or upper arm as a 30-mg dose once weekly, and may be increased to 50 mg once weekly in patients needing additional glycemic control. The dose can be given at any time of day, without regard to meals. If a dose is missed, administer a dose within 3 days. Tanzeum is available as a 30-mg or 50-mg single-dose pen.1
The safety and efficacy of Tanzeum was evaluated in 8 clinical trials of more than 2000 patients with T2DM. It has been studied alone and in combination with metformin, metformin and a sulfonylurea, a thiazolidinedione (with and without metformin), and insulin glargine (with or without oral antidiabetic drugs).1,3 The efficacy of Tanzeum was compared with placebo, glimepiride, pioglitazone, liraglutide, sitagliptin, insulin lispro, and insulin glargine. In patients with T2DM, treatment with Tanzeum resulted in a clinically relevant reduction from baseline in glycated hemoglobin compared with placebo.1
Contraindications, Warnings, and Precautions
Tanzeum carries a boxed warning that thyroid C-cell tumors have been observed in rodents using GLP-1 receptor agonists at clinically relevant exposures. It is unknown if Tanzeum causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans. Its use is contraindicated in patients with a personal or family history of MTC or in patients with multiple endocrine neoplasia syndrome type 2. Tanzeum is also contraindicated in patients with a history of serious hypersensitivity to the medication or any of its components.
Treatment with Tanzeum should be discontinued immediately if pancreatitis or hypersensitivity is suspected. Hypoglycemia may occur during concomitant use with insulin or an insulin secretagogue. Patients with renal impairment who report severe adverse gastrointestinal reactions should have their renal function monitored. No clinical studies have established conclusive evidence that treatment with Tanzeum, or any other antidiabetic medication, will reduce the macrovascular risks of diabetes.
Tanzeum delays gastric emptying and may impact the absorption of concomitantly administered oral medications. Tanzeum is also Pregnancy Category C and should only be used during pregnancy if the potential benefit outweighs the potential fetal risk. Patients who are breast-feeding should not use the drug. The most commonly reported adverse reactions (≥10%) are upper respiratory tract infection, diarrhea, nausea, and injection site reaction.1
Dr. Holmberg earned her PharmD from the University of Connecticut and completed an ambulatory care residency at the Phoenix VA Healthcare System. Her practice has also included pediatrics and inpatient mental health. She resides in Phoenix, Arizona.