Side effects of boniva

Contents

Boniva

SIDE EFFECTS

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 to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Treatment And Prevention Of Postmenopausal Osteoporosis

Daily Dosing

The safety of BONIVA 2.5 mg once daily in the treatment and prevention of postmenopausal osteoporosis was assessed in 3577 patients aged 41 – 82 years. The duration of the trials was 2 to 3 years, with 1134 patients exposed to placebo and 1140 exposed to BONIVA 2.5 mg. Patients with pre-existing gastrointestinal disease and concomitant use of non-steroidal anti-inflammatory drugs, proton pump inhibitors and H2 antagonists were included in these clinical trials. All patients received 500 mg calcium plus 400 international units vitamin D supplementation daily.

The incidence of all-cause mortality was 1% in the placebo group and 1.2% in the BONIVA 2.5 mg daily group. The incidence of serious adverse reactions was 20% in the placebo group and 23% in the BONIVA 2.5 mg daily group. The percentage of patients who withdrew from treatment due to adverse reactions was approximately 17% in both the BONIVA 2.5 mg daily group and the placebo group. Table 1 lists adverse reactions from the treatment and prevention studies reported in greater than or equal to 2% of patients and more frequently in patients treated daily with BONIVA than patients treated with placebo.

Table 1 Adverse Reactions Occurring at an Incidence Greater Than or Equal to 2% and in More Patients Treated with BONIVA Than in Patients Treated with Placebo Daily in the Osteoporosis Treatment and Prevention Studies

Body System Placebo
%
(n=1134)
BONIVA 2.5 mg
%
(n=1140)
Body as a Whole
Back Pain 12 14
Pain in Extremity 6 8
Asthenia 2 4
Allergic Reaction 2 3
Digestive System
Dyspepsia 10 12
Diarrhea 5 7
Tooth Disorder 2 4
Vomiting 2 3
Gastritis 2 2
Musculoskeletal System
Myalgia 5 6
Joint Disorder 3 4
Arthritis 3 3
Nervous System
Headache 6 7
Dizziness 3 4
Vertigo 3 3
Respiratory System
Upper Respiratory Infection 33 34
Bronchitis 7 10
Pneumonia 4 6
Pharyngitis 2 3
Urogenital System
Urinary Tract Infection 4 6

Gastrointestinal Adverse Reactions

Musculoskeletal Adverse Reactions

Ocular Adverse Events

Reports in the medical literature indicate that bisphosphonates may be associated with ocular inflammation such as iritis and scleritis. In some cases, these events did not resolve until the bisphosphonate was discontinued. There were no reports of ocular inflammation in studies with BONIVA 2.5 mg daily.

Monthly Dosing

The safety of BONIVA 150 mg once monthly in the treatment of postmenopausal osteoporosis was assessed in a two year trial which enrolled 1583 patients aged 54 – 81 years, with 395 patients exposed to BONIVA 2.5 mg daily and 396 exposed to BONIVA 150 mg monthly. Patients with active or significant pre-existing gastrointestinal disease were excluded from this trial. Patients with dyspepsia or concomitant use of non-steroidal anti-inflammatory drugs, proton pump inhibitors and H2 antagonists were included in this study. All patients received 500 mg calcium plus 400 international units vitamin D supplementation daily.

After one year, the incidence of all-cause mortality was 0.3% in both the BONIVA 2.5 mg daily group and the BONIVA 150 mg monthly group. The incidence of serious adverse events was 5% in the BONIVA 2.5 mg daily group and 7% in the BONIVA 150 mg monthly group. The percentage of patients who withdrew from treatment due to adverse events was 9% in the BONIVA 2.5 mg daily group and 8% in the BONIVA 150 mg monthly group. Table 2 lists the adverse events reported in greater than or equal to 2% of patients.

Table 2 Adverse Events with an Incidence of at Least 2% in Patients Treated with BONIVA 2.5 mg Daily or 150 mg Once-Monthly for Treatment of Postmenopausal Osteoporosis

Body System/Adverse Event BONIVA
2.5 mg Daily
%
(n=395)
BONIVA
150 mg Monthly
%
(n=396)
Vascular Disorders
Hypertension 7.3 6.3
Gastrointestinal Disorders
Dyspepsia 7.1 5.6
Nausea 4.8 5.1
Diarrhea 4.1 5.1
Constipation 2.5 4.0
Abdominal Paina 5.3 7.8
Musculoskeletal and Connective Tissue Disorders
Arthralgia 3.5 5.6
Back Pain 4.3 4.5
Pain in Extremity 1.3 4.0
Localized Osteoarthritis 1.3 3.0
Myalgia 0.8 2.0
Muscle Cramp 2.0 1.8
Infections and Infestations
Influenza 3.8 4.0
Nasopharyngitis 4.3 3.5
Bronchitis 3.5 2.5
Urinary Tract Infection 1.8 2.3
Upper Respiratory Tract Infection 2.0 2.0
Nervous System Disorders
Headache 4.1 3.3
Dizziness 1.0 2.3
General Disorders and Administration Site Conditions
Influenza-like Illnessb 0.8 3.3
Skin and Subcutaneous Tissue Disorders
Rashc 1.3 2.3
Psychiatric Disorders
Insomnia 0.8 2.0
a Combination of abdominal pain and abdominal pain upper
b Combination of influenza-like illness and acute phase reaction
c Combination of rash pruritic, rash macular, rash papular, rash generalized, rash erythematous, dermatitis, dermatitis allergic, dermatitis medicamentosa, erythema and exanthema

Gastrointestinal Adverse Events

Musculoskeletal Adverse Events

Acute Phase Reactions

Symptoms consistent with acute phase reactions have been reported with bisphosphonate use. Over the two years of the study, the overall incidence of acute phase reaction symptoms was 3% in the BONIVA 2.5 mg daily group and 9% in the BONIVA 150 mg monthly group. These incidence rates are based on the reporting of any of 33 acute-phase reaction like symptoms within 3 days of the monthly dosing and lasting 7 days or less. Influenza like illness was reported in no patients in the BONIVA 2.5 mg daily group and 2% in the BONIVA 150 mg monthly group.

Ocular Adverse Events

Two patients who received BONIVA 150 mg once-monthly experienced ocular inflammation, one was a case of uveitis and the other scleritis.

One hundred sixty (160) postmenopausal women without osteoporosis participated in a 1-year, double-blind, placebo-controlled study of BONIVA 150 mg once-monthly for prevention of bone loss. Seventy-seven subjects received BONIVA and 83 subjects received placebo. The overall pattern of adverse events was similar to that previously observed.

Postmarketing Experience

The following adverse reactions have been identified during postapproval use of BONIVA. 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.

Allergic reactions including anaphylactic reaction/shock with fatalities, angioedema, bronchospasm, asthma exacerbations, rash, Stevens-Johnson syndrome, erythema multiforme, and dermatitis bullous have been reported (see CONTRAINDICATIONS).

Hypocalcemia

Hypocalcemia has been reported in patients treated with BONIVA (see WARNINGS AND PRECAUTIONS).

Bone, joint, or muscle pain (musculoskeletal pain), described as severe or incapacitating, has been reported (see WARNINGS AND PRECAUTIONS).

Osteonecrosis of the jaw and other oro-facial sites, including the external auditory canal, have been reported in patients treated with BONIVA (see WARNINGS AND PRECAUTIONS).

Atypical Femoral Shaft Fracture

Atypical, low-energy, or low-trauma fractures of the femoral shaft (see WARNINGS AND PRECAUTIONS).

Read the entire FDA prescribing information for Boniva (Ibandronate Sodium)

Boniva Side Effects

Generic Name: ibandronate

Medically reviewed by Drugs.com. Last updated on Jan 9, 2019.

  • Overview
  • Side Effects
  • Dosage
  • Professional
  • Tips
  • Interactions
  • More

Note: This document contains side effect information about ibandronate. Some of the dosage forms listed on this page may not apply to the brand name Boniva.

In Summary

Common side effects of Boniva include: bronchitis and arthralgia. Other side effects include: myalgia. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to ibandronate: oral tablet

Other dosage forms:

  • intravenous solution

Along with its needed effects, ibandronate (the active ingredient contained in Boniva) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking ibandronate:

More common

  • Bladder pain
  • bloody or cloudy urine
  • chest pain
  • cough producing mucus
  • difficult, burning, or painful urination
  • difficulty with breathing
  • fever or chills
  • frequent urge to urinate
  • lower back or side pain
  • nervousness
  • pounding in the ears
  • shortness of breath
  • slow or fast heartbeat
  • sneezing
  • sore throat
  • tightness in the chest

Less common

  • Bloody or cloudy urine
  • body aches or pain
  • congestion
  • difficulty with swallowing
  • dizziness
  • dryness of the throat
  • fast heartbeat
  • frequent urge to urinate
  • hives
  • hoarseness
  • itching
  • numbness
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • runny nose
  • skin rash
  • tender, swollen glands in the neck
  • tingling
  • unusual tiredness or weakness
  • voice changes

Incidence not known

  • Abdominal or stomach cramps
  • blurred vision or other change in vision
  • bone, joint, or muscle pain, severe and occasionally incapacitating
  • confusion
  • convulsions
  • eye redness
  • eye tenderness
  • heavy jaw feeling
  • irregular heartbeats
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • loosening of a tooth
  • muscle cramps in the hands, arms, feet, legs, or face
  • noisy breathing
  • numbness and tingling around the mouth, fingertips, or feet
  • pain, swelling, or numbness in the mouth or jaw
  • sensitivity to light
  • severe eye pain
  • tearing
  • tremor
  • unusual pain in the thighs, groin, or hips

Get emergency help immediately if any of the following symptoms of overdose occur while taking ibandronate:

Symptoms of overdose

  • Acid or sour stomach
  • belching
  • bone pain
  • burning feeling in the chest or stomach
  • heartburn
  • indigestion
  • loss of appetite
  • pain or burning in the throat
  • sores or ulcers
  • stomach discomfort, upset, or pain
  • tenderness in the stomach area
  • vomiting
  • white spots on the lips or tongue or inside the mouth

Some side effects of ibandronate may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

  • Diarrhea
  • ear congestion
  • headache
  • loss of voice
  • pain in the extremity (arms and legs)

Less common

  • Cough
  • difficulty having a bowel movement (stool)
  • difficulty with moving
  • discouragement
  • feeling of constant movement of self or surroundings
  • feeling sad or empty
  • general feeling of discomfort or illness
  • irritability
  • joint pain
  • lack or loss of strength
  • lightheadedness
  • loss of interest or pleasure
  • muscle aches and pain
  • muscle stiffness
  • pain, swelling, or redness in the joints
  • sensation of spinning
  • shivering
  • stuffy nose
  • sweating
  • tooth disorder
  • trouble concentrating
  • trouble sleeping

For Healthcare Professionals

Applies to ibandronate: intravenous kit, intravenous solution, oral tablet

General

The most serious reported adverse reactions are anaphylactic reaction/shock, atypical fractures of the femur, osteonecrosis of the jaw, and ocular inflammation.

The most frequently reported adverse reactions are arthralgia and influenza-like symptoms, typically associated with the first dose, generally of short duration, mild, or moderate intensity.

Gastrointestinal

Very common (10% or more): Dyspepsia (up to 12%)

Uncommon (0.1% to 1%): Hemorrhage, duodenal ulcer, dysphagia, dry mouth

Respiratory

Very common (10% or more): Upper respiratory infection (up to 34%)

Common (1% to 10%): Bronchitis, pneumonia, pharyngitis, influenza, nasopharyngitis, asthma exacerbation

Uncommon (0.1% to 1%): Chest pain

Metabolic

Very common (10% or more): Hypocalcemia

Postmarketing reports: Hypocalcemia

Decreased renal calcium excretion may be accompanied by a fall in serum phosphate levels not requiring therapeutic measures. The serum calcium level may fall to hypocalcemic values.

Musculoskeletal

Very common (10% or more): Back pain (14%)

Postmarketing reports: Severe or incapacitating bone, join, or muscle pain (musculoskeletal pain); osteonecrosis of the jaw; atypical, low-energy, or low-trauma fractures of the femoral shaft; atypical subtrochanteric and diaphyseal femoral fractures

Cardiovascular

Common (1% to 10%): Hypertension

Uncommon (0.1% to 1%): Phlebitis, thrombophlebitis

Genitourinary

Common (1% to 10%): Urinary tract infection, cystitis

Hepatic

Common (1% to 10%): Increased gamma-glutamyl transpeptidase (GGT) levels

Hypersensitivity

Common (1% to 10%): Allergic reaction

Rare (less than 0.1%): Facial swelling/edema, urticaria

Postmarketing reports: Anaphylactic reaction/shock with fatalities, angioedema, bronchospasm, asthma exacerbations, rash, Stevens-Johnson syndrome, erythema multiforme, and dermatitis bullous

Local

Common (1% to 10%): Redness or swelling at the injection site

Nervous system

Common (1% to 10%): Headache, dizziness, paraesthesia, dysgeusia (taste perversion)

Other

Common (1% to 10%): Asthenia, vertigo, influenza-like illness, peripheral edema

Uncommon (0.1% to 1%): Malaise, pain

Combination of influenza-like illness and acute phase reaction has occurred. Influenza-like illness includes events reported as acute phase reaction or symptoms, including myalgia, arthralgia, fever, chills, fatigue, nausea, loss of appetite, and bone pain.

Psychiatric

Common (1% to 10%): Insomnia, depression

Renal

Common (1% to 10%): Increased creatinine

Uncommon (0.1% to 1%): Azotemia (uremia)

Postmarketing reports: Acute renal failure

Dermatologic

Rash occurred in combination of rash pruritic, rash macular, rash papular, rash generalized, rash erythematous, dermatitis, dermatitis allergic, dermatitis medicamentosa, erythema and exanthema.

Uncommon (0.1% to 1%): Pruritus, rash

Hematologic

Uncommon (0.1% to 1%): Anemia, increased blood parathyroid hormone

Ocular

Postmarketing reports: Ocular inflammation, iritis, uveitis, episcleritis (in some cases, these events resolve only after this drug was discontinued)

1. Cerner Multum, Inc. “Australian Product Information.” O 0

2. Cerner Multum, Inc. “UK Summary of Product Characteristics.” O 0

3. “Product Information. Boniva (ibandronate).” Roche Laboratories, Nutley, NJ.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

Related questions

  • What medications are available to treat osteoporosis?

Medical Disclaimer

More about Boniva (ibandronate)

  • During Pregnancy or Breastfeeding
  • Dosage Information
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  • Drug Interactions
  • Compare Alternatives
  • Support Group
  • Pricing & Coupons
  • En Español
  • 67 Reviews
  • Generic Availability
  • Drug class: bisphosphonates
  • FDA Alerts (4)
  • FDA Approval History

Consumer resources

  • Boniva
  • Boniva (Ibandronate Injection)
  • Boniva (Ibandronate Tablets)
  • Boniva (Advanced Reading)
  • Boniva Intravenous (Advanced Reading)

Professional resources

  • Boniva (AHFS Monograph)
  • … +1 more

Related treatment guides

  • Osteoporosis
  • Prevention of Osteoporosis

Boniva Injection®
(ibandronate sodium)

Contact Support & Other Resources

  • Report side effects for your Boniva prescription

    Report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch.

    You may also report side effects to Genentech at (888) 835-2555.

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What it Treats

BONIVA is a prescription medicine used to treat osteoporosis in women after menopause. BONIVA helps increase bone mass and helps reduce the chance of having a spinal fracture (break).

It is not known how long BONIVA works for the treatment of osteoporosis. You should see your doctor regularly to determine if BONIVA is still right for you.

It is not known if BONIVA is safe and effective in children.

Who should not take BONIVA?

Do not receive BONIVA if you:

  • Have low levels of calcium in your blood
  • Are allergic to ibandronate sodium or any of the ingredients in BONIVA

Important Safety Information

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

BONIVA Injection is given in your vein (intravenously) and only given by a healthcare provider. Do not give BONIVA Injection to yourself.

BONIVA may cause serious side effects including:

  1. Low calcium levels in your blood (hypocalcemia)
  2. Severe allergic reaction (anaphylactic reaction)
  3. Severe kidney problems
  4. Severe jaw bone problems (osteonecrosis)
  5. Bone, joint or muscle pain
  6. Unusual thigh bone fractures

1. Low calcium levels in your blood (hypocalcemia).

BONIVA may lower the calcium levels in your blood. If you have low blood calcium before you start taking BONIVA, it may get worse during treatment. Your low blood calcium must be treated before you receive BONIVA. Most people with low blood calcium levels do not have symptoms, but some people may have symptoms. Call your doctor right away if you have symptoms of low blood calcium such as:

  • Spasms, twitches, or cramps in your muscles
  • Numbness or tingling in your fingers, toes, or around your mouth

Your doctor may prescribe calcium and vitamin D to help prevent low calcium levels in your blood, while you receive BONIVA. Take calcium and vitamin D as your doctor tells you to.

2. Severe allergic reactions.

Some people who received BONIVA Injection had severe allergic reactions (anaphylactic reactions) that led to death. Get medical help right away if you have any of the symptoms of a serious allergic reaction such as:

  • Swelling of your face, lips, mouth or tongue
  • Trouble breathing
  • Wheezing
  • Severe itching
  • Skin rash, redness or swelling
  • Dizziness or fainting
  • Fast heartbeat or pounding in your chest
  • Sweating

3. Severe kidney problems.

Severe kidney problems, including kidney failure, may happen when you receive BONIVA. Your doctor should do blood tests to check your kidneys before you receive each dose of BONIVA.

4. Severe jaw bone problems (osteonecrosis).

Severe jaw bone problems may happen when you receive BONIVA. Your doctor may examine your mouth before you start BONIVA. Your doctor may tell you to see your dentist before you start BONIVA. It is important for you to practice good mouth care during treatment with BONIVA.

5. Bone, joint, or muscle pain.

Some people who receive BONIVA develop severe bone, joint, or muscle pain.

6. Unusual thigh bone fractures.

Some people have developed unusual fractures in their thigh bone. Symptoms of a fracture may include new or unusual pain in your hip, groin, or thigh.

Call your doctor right away if you have any of these side effects.

Who should not take BONIVA?

Do not take BONIVA if you:

  • Have low levels of calcium in your blood
  • Are allergic to ibandronate sodium or any of the ingredients in BONIVA.

What are the most common side effects of BONIVA?

  • Pain in your bones, joints or muscles
  • Back pain
  • Abdominal pain
  • Flu-like symptoms may happen within 3 days after you receive BONIVA. Symptoms include:
    • fever
    • chills
    • bone, joint, or muscle pain
    • fatigue

If you have flu-like symptoms, they should get better within 24 to 48 hours.

Some people have pain or a sore that will not heal in their mouth or jaw while they receive BONIVA. Tell your doctor or dentist if you have mouth or jaw problems.

If you have any questions about your condition or treatment, talk to your doctor.

You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at 1-888-835-2555.

Please see full Product Information for additional important safety information.

How long should you take a bisphosphonate for osteoporosis?

Published: March, 2016

Millions of postmenopausal women are taking a bisphosphonate like oral alendronate (Fosamax) or intravenous (IV) zoledronic acid (Reclast) to increase bone density. But because long-term use of these drugs has been associated with an increased risk of bone death in the jaw and unusual thighbone fractures, experts have debated how long women should stay on the drugs to minimize the risk of hip or vertebral fractures without raising their risk for these rare but serious complications.

After considering major randomized controlled clinical trials, a task force of the American Society for Bone and Mineral Research has released guidelines on the optimal duration of bisphosphonate therapy for osteoporosis. The guidelines, published in the January 2016 issue of the Journal of Bone and Mineral Research, recommend reassessing a woman’s fracture risk after five years of oral bisphosphonates or three years of IV therapy. They advise that women whose risk is still high should continue to take oral bisphosphonates for up to 10 years or IV therapy for up to six years. However, fracture risk should be reassessed every two to three years during extended therapy.

For women determined to be at low risk after five years of oral therapy or three years of IV therapy, treatment may be discontinued, but fracture risk should be reassessed periodically.

Guidelines are only advice, not mandates. If you are at high risk for a fracture of the hip or spine, the decision to take—or to continue taking—a bisphosphonate is one to make with your doctor after considering your general health, the potential risks and benefits of the medication, and your preferences.

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WARNINGS

Included as part of the “PRECAUTIONS” Section

PRECAUTIONS

Upper Gastrointestinal Adverse Reactions

BONIVA, like other bisphosphonates administered orally, may cause local irritation of the upper gastrointestinal mucosa. Because of these possible irritant effects and a potential for worsening of the underlying disease, caution should be used when BONIVA is given to patients with active upper gastrointestinal problems (such as known Barrett’s esophagus, dysphagia, other esophageal diseases, gastritis, duodenitis or ulcers).

Esophageal adverse experiences, such as esophagitis, esophageal ulcers and esophageal erosions, occasionally with bleeding and rarely followed by esophageal stricture or perforation, have been reported in patients receiving treatment with oral bisphosphonates. In some cases, these have been severe and required hospitalization. Physicians should therefore be alert to any signs or symptoms signaling a possible esophageal reaction and patients should be instructed to discontinue BONIVA and seek medical attention if they develop dysphagia, odynophagia, retrosternal pain or new or worsening heartburn.

The risk of severe esophageal adverse experiences appears to be greater in patients who lie down after taking oral bisphosphonates and/or who fail to swallow it with the recommended full glass (6-8 oz) of water, and/or who continue to take oral bisphosphonates after developing symptoms suggestive of esophageal irritation. Therefore, it is very important that the full dosing instructions are provided to, and understood by, the patient (see DOSAGE AND ADMINISTRATION). In patients who cannot comply with dosing instructions due to mental disability, therapy with BONIVA should be used under appropriate supervision.

There have been post-marketing reports of gastric and duodenal ulcers with oral bisphosphonate use, some severe and with complications, although no increased risk was observed in controlled clinical trials.

Hypocalcemia And Mineral Metabolism

Hypocalcemia has been reported in patients taking BONIVA. Treat hypocalcemia and other disturbances of bone and mineral metabolism before starting BONIVA therapy. Instruct patients to take supplemental calcium and vitamin D if their dietary intake is inadequate (see DOSAGE AND ADMINISTRATION).

Musculoskeletal Pain

Severe and occasionally incapacitating bone, joint, and/or muscle pain has been reported in patients taking BONIVA and other bisphosphonates (see ADVERSE REACTIONS). The time to onset of symptoms varied from one day to several months after starting the drug. Most patients had relief of symptoms after stopping. A subset had recurrence of symptoms when rechallenged with the same drug or another bisphosphonate. Consider discontinuing use if severe symptoms develop.

Jaw Osteonecrosis

Osteonecrosis of the jaw (ONJ), which can occur spontaneously, is generally associated with tooth extraction and/or local infection with delayed healing, and has been reported in patients taking bisphosphonates, including BONIVA. Known risk factors for osteonecrosis of the jaw include invasive dental procedures (e.g., tooth extraction, dental implants, boney surgery), diagnosis of cancer, concomitant therapies (e.g., chemotherapy, corticosteroids, angiogenesis inhibitors), poor oral hygiene, and co-morbid disorders (e.g., periodontal and/or other pre-existing dental disease, anemia, coagulopathy, infection, ill-fitting dentures). The risk of ONJ may increase with duration of exposure to bisphosphonates.

For patients requiring invasive dental procedures, discontinuation of bisphosphonate treatment may reduce the risk for ONJ. Clinical judgment of the treating physician and/or oral surgeon should guide the management plan of each patient based on individual benefit/risk assessment.

Patients who develop osteonecrosis of the jaw while on bisphosphonate therapy should receive care by an oral surgeon. In these patients, extensive dental surgery to treat ONJ may exacerbate the condition. Discontinuation of bisphosphonate therapy should be considered based on individual benefit/risk assessment.

Atypical Subtrochanteric And Diaphyseal Femoral Fractures

Atypical, low-energy, or low-trauma fractures of the femoral shaft have been reported in bisphosphonate-treated patients. These fractures can occur anywhere in the femoral shaft from just below the lesser trochanter to above the supracondylar flare and are transverse or short oblique in orientation without evidence of comminution. Causality has not been established as these fractures also occur in osteoporotic patients who have not been treated with bisphosphonates.

Atypical femur fractures most commonly occur with minimal or no trauma to the affected area. They may be bilateral and many patients report prodromal pain in the affected area, usually presenting as dull, aching thigh pain, weeks to months before a complete fracture occurs. A number of reports note that patients were also receiving treatment with glucocorticoids (e.g., prednisone) at the time of fracture.

Any patient with a history of bisphosphonate exposure who presents with thigh or groin pain should be suspected of having an atypical fracture and should be evaluated to rule out an incomplete femur fracture. Patients presenting with an atypical fracture should also be assessed for symptoms and signs of fracture in the contralateral limb. Interruption of bisphosphonate therapy should be considered, pending a risk/benefit assessment, on an individual basis.

Severe Renal Impairment

BONIVA is not recommended for use in patients with severe renal impairment (creatinine clearance of less than 30 mL/min).

Patient Counseling Information

“See FDA-approved patient labeling (PATIENT INFORMATION)”

Information For Patients

Instruct patients to read the Medication Guide carefully before taking BONIVA and to re-read it each time the prescription is renewed because it contains important information the patient should know about BONIVA. The Medication Guide also includes the dosing instructions in order to maximize absorption and clinical benefit.

  • BONIVA should be taken at least 60 minutes before the first food or drink (other than water) of the day and before taking any oral medication or supplementation including calcium, antacids or vitamins (see DRUG INTERACTIONS).
  • To facilitate delivery to the stomach, and thus reduce the potential for esophageal irritation, BONIVA tablets should be swallowed whole with a full glass of plain water (6 to 8 oz) while the patient is standing or sitting in an upright position. Patients should not lie down for 60 minutes after taking BONIVA.
  • Patients should not eat, drink anything except for water, or take other medications for 60 minutes after taking BONIVA.
  • Plain water is the only drink that should be taken with BONIVA. Note that some mineral waters may have a higher concentration of calcium and therefore should not be used.
  • Patients should not chew or suck the tablet because of a potential for oropharyngeal ulceration.
  • The BONIVA 150 mg tablet should be taken on the same date each month (i.e., the patient’s BONIVA day).
  • The patient must not take two 150 mg tablets within the same week.
  • If the once-monthly dose is missed, and the patient’s next scheduled BONIVA day is more than 7 days away, the patient should be instructed to take one BONIVA 150 mg tablet in the morning following the date that it is remembered (see DOSAGE AND ADMINISTRATION). The patient should then return to taking one BONIVA 150 mg tablet every month in the morning of their chosen day, according to their original schedule.
  • If the once-monthly dose is missed, and the patient’s next scheduled BONIVA day is only 1 to 7 days away, the patient must wait until the subsequent month’s scheduled BONIVA day to take their tablet. The patient should then return to taking one BONIVA 150 mg tablet every month in the morning of their chosen day, according to their original schedule.

Patients should receive supplemental calcium and vitamin D if dietary intake is inadequate. Intake of supplemental calcium and vitamin D should be delayed for at least 60 minutes following oral administration of BONIVA in order to maximize absorption of BONIVA.

Physicians should be alert to signs or symptoms signaling a possible esophageal reaction during therapy, and patients should be instructed to discontinue BONIVA and seek medical attention if they develop symptoms of esophageal irritation such as new or worsening dysphagia, pain on swallowing, retrosternal pain, or heartburn.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment Of Fertility

Carcinogenesis

In a 104-week carcinogenicity study, doses of 3, 7, or 15 mg/kg/day were administered by oral gavage to male and female Wistar rats (systemic exposures up to 12 and 7 times, respectively, human exposure at the recommended daily oral dose of 2.5 mg, and cumulative exposures up to 3.5 and 2 times, respectively, human exposure at the recommended once-monthly oral dose of 150 mg, based on AUC comparison). There were no significant drug-related tumor findings in male or female rats. In a 78-week carcinogenicity study, doses of 5, 20, or 40 mg/kg/day were administered by oral gavage to male and female NMRI mice (exposures up to 475 and 70 times, respectively, human exposure at the recommended daily oral dose of 2.5 mg and cumulative exposures up to 135 and 20 times, respectively, human exposure at the recommended once-monthly oral dose of 150 mg, based on AUC comparison). There were no significant drug-related tumor findings in male or female mice. In a 90-week carcinogenicity study, doses of 5, 20, or 80 mg/kg/day were administered in the drinking water to NMRI mice (cumulative monthly exposures in males and females up to 70 and 115 times, respectively, human exposure at the recommended dose of 150 mg, based on AUC comparison). A dose-related increased incidence of adrenal subcapsular adenoma/carcinoma was observed in female mice, which was statistically significant at 80 mg/kg/day (220 to 400 times human exposure at the recommended daily oral dose of 2.5 mg and 115 times human exposure at the recommended once-monthly oral dose of 150 mg, based on AUC comparison). The relevance of these findings to humans is unknown.

Mutagenesis

There was no evidence for a mutagenic or clastogenic potential of ibandronate in the following assays: in vitro bacterial mutagenesis assay in Salmonella typhimurium and Escherichia coli (Ames test), mammalian cell mutagenesis assay in Chinese hamster V79 cells, and chromosomal aberration test in human peripheral lymphocytes, each with and without metabolic activation. Ibandronate was not genotoxic in the in vivo mouse micronucleus tests for chromosomal damage.

Impairment Of Fertility

In female rats treated from 14 days prior to mating through gestation, decreases in fertility, corpora lutea, and implantation sites were observed at an oral dose of 16 mg/kg/day (45 times human exposure at the recommended daily oral dose of 2.5 mg and 13 times human exposure at the recommended once-monthly oral dose of 150 mg, based on AUC comparison).

Use In Specific Populations

Pregnancy

Risk Summary

BONIVA is not indicated for use in women of reproductive potential. There are no data with BONIVA use in pregnant women to inform any drug-associated risks.

In reproductive toxicity studies in the rat, BONIVA caused post-implantation loss and obstruction of labor with maternal and fetal periparturient mortality at greater than or equal to 3 times human exposure at the recommended 2.5 mg daily oral dose, or at greater than or equal to 1 times human exposure at the recommended 150 mg once-monthly oral dose. In pregnant rats, kidney developmental toxicity occurred in offspring at greater than or equal to 30 times the daily 2.5 mg human dose or at greater than or equal to 9 times the once-monthly 150 mg human dose. In rat reproductive studies, impaired pup neuromuscular development was observed at 45 times the daily 2.5 mg dose and 13 times the once-monthly 150 mg dose. In reproductive studies in the rabbit, BONIVA caused maternal mortality at greater than or equal to 8 times the daily 2.5 mg dose and greater than or equal to 4 times the once-monthly 150 mg dose (see Data).

Data

Animal Data

In female rats given ibandronate at oral doses greater than or equal to 3 times human exposure at the recommended daily oral dose of 2.5 mg or greater than or equal to 1 times human exposure at the recommended once-monthly oral dose of 150 mg beginning 14 days before mating and continuing through lactation, maternal deaths were observed at the time of delivery in all dose groups. Perinatal pup loss in dams given doses producing 45 times human exposure at the recommended daily dose and 13 times human exposure at the recommended once-monthly dose was likely related to maternal dystocia. Calcium supplementation did not completely prevent dystocia and periparturient mortality in any of the treated groups at greater than or equal to 16 times the recommended daily dose and greater than or equal to 4.6 times the recommended once-monthly dose. A low incidence of postimplantation loss was observed in rats treated from 14 days before mating throughout lactation or during gestation, only at doses causing maternal dystocia and periparturient mortality. In pregnant rats dosed orally from gestation day 17 through lactation day 21 (following closure of the hard palate through weaning), maternal toxicity, including dystocia and mortality, fetal perinatal and postnatal mortality, were observed at doses equivalent to human exposure at the recommended daily dose and greater than or equal to 4 times the recommended once-monthly dose. Periparturient mortality has also been observed with other bisphosphonates and appears to be a class effect related to inhibition of skeletal calcium mobilization resulting in hypocalcemia and dystocia.

Exposure of pregnant rats during the period of organogenesis resulted in an increased fetal incidence of RPU (renal pelvis ureter) syndrome at oral doses producing 30 times human exposure at the recommended daily oral dose of 2.5 mg and greater than or equal to 9 times human exposure at the recommended once-monthly oral dose of 150 mg. Impaired pup neuromuscular development (cliff avoidance test) was observed at 45 times human exposure at the daily dose and 13 times the once-monthly dose.

In pregnant rabbits treated orally with ibandronate during gestation at doses greater than or equal to 8 times the recommended human daily oral dose of 2.5 mg and greater than or equal to 4 times the recommended human once-monthly oral dose of 150 mg, dose-related maternal mortality was observed in all treatment groups. The deaths occurred prior to parturition and were associated with lung edema and hemorrhage. No significant fetal anomalies were observed.

Exposure multiples for the rat studies were calculated for the recommended daily oral dose of 2.5 mg or once-monthly dose of 150 mg based on area under the curve (AUC) comparison. Exposure multiples for the rabbit study were calculated for the recommended human daily oral dose of 2.5 mg or once-monthly dose of 150 mg based on dose/body surface area comparison. Doses used in pregnant animals were 1, 4, 5, 6, 16, 10, 20, 30, 60 or 100 mg/kg/day in rats, and 1, 4 or 20 mg/kg/day in rabbits.

Lactation

BONIVA is not indicated for use in women of reproductive potential. There is no information on the presence of ibandronate in human milk, the effects of ibandronate on the breastfed infant, or the effects of ibandronate on milk production. Ibandronate is present in rat milk (see Data).The clinical relevance of these data is unclear.

Animal Data

In lactating rats treated with intravenous doses of 0.08 mg/kg, ibandronate was present in breast milk from 2 to 24 hours after dose administration. Concentrations in milk averaged 1.5 times plasma concentrations.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Geriatric Use

Of the patients receiving BONIVA 2.5 mg daily in postmenopausal osteoporosis studies, 52% were over 65 years of age, and 10% were over 75 years of age. Of the patients receiving BONIVA 150 mg once-monthly in the postmenopausal osteoporosis 1-year study, 52% were over 65 years of age, and 9% were over 75 years of age. No overall differences in effectiveness or safety were observed between these patients and younger patients but greater sensitivity in some older individuals cannot be ruled out.

Renal Impairment

BONIVA is not recommended for use in patients with severe renal impairment (creatinine clearance less than 30 mL/min).

The How’s and Why’s of Osteoporosis Medications

Class and Drug Brand Name Form Frequency Gender

Antiresorptive Agents

Bisphosphonates

Alendronate Fosamax®, Fosamax Plus D™ Oral (tablet, solution) Daily/Weekly Women & Men
Alendronate Binosto® Oral (effervescent tablet) Weekly Women & Men
Ibandronate Boniva® Oral (tablet) Monthly Women
Ibandronate Boniva® Intravenous (IV) injection Every 3 months Women
Risedronate Actonel® Oral (tablet) Daily/Weekly/Twice Monthly/Monthly Women & Men
Risedronate Atelvia™ Oral (tablet) Weekly Women
Zoledronic Acid Reclast® Intravenous (IV) infusion One Time per Year/Once every two years Women & Men

RANK ligand (RANKL) inhibitor

Denosumab Prolia™ Injection Every 6 Months Women & Men

Calcitonin

Calcitonin Fortical®, Miacalcin® Nasal spray Daily Women
Calcitonin Miacalcin® Injection Varies Women

Estrogen* (Hormone Therapy)

Estrogen Multiple Brands Oral (tablet) Daily Women
Estrogen Multiple Brands Transdermal (skin patch) Twice Weekly/Weekly Women

Estrogen Agonists/Antagonists
also called selective estrogen receptor modulators (SERMs)

Raloxifene Evista® Oral (tablet) Daily Women

Tissue Specific Estrogen Complex (TSEC)

Estrogen/Bazodoxifene Duavee® Oral (tablet) Daily Women

Anabolic Agents

Sclerostin Inhibitor

Romosozumab-aqqg Evenity Injection 2 injections once monthly for 12 months Women

Parathyroid Hormone (PTH) Analog

Teriparatide Forteo® Injection Daily Women & Men

Parathyroid Hormone-Related Protein (PTHrp) Analog

Abaloparatide Tymlos Injection Daily Women
*Estrogen is also available in other preparations including a vaginal ring, cream, by injection and as an oral tablet taken sublingually (under the tongue). The vaginal preparations do not provide significant bone protection.

What Causes Fragile Bones in Older People?

Available therapies for osteoporosis are effective in preventing osteoporosis and can reduce fracture risk by more than 50%.

Your skeleton is an active vital organ. It keeps you healthy through a constant process of repair, renewal, and mineral release. This process is called remodeling.The bone remodeling cycle consists of two distinct stages: (1) bone resorption (breakdown and removal) and (2) bone formation (generation of new bone). During resorption, cells on the bone’s surface called osteoclasts dissolve bone tissue, releasing it into the bloodstream and leaving behind tiny pits, or cavities. Then, during formation, cells called osteoblasts fill these cavities with new bone tissue. In normal bone, resorption and formation are in lock step, with one matching the other.

As we age, the remodeling process can become unbalanced. More old bone gets removed than new bone gets created. Over time, this leaves bones weaker and more likely to break. A variety of circumstances can cause unbalanced bone remodeling including hormonal changes, certain medications, prolonged inactivity, as well as other diseases.

Bone can also be resorbed to replace essential minerals missing in the bloodstream. This happens when there is not enough calcium in the diet. The result in all of these scenarios is the same: slow but steady weakening of bones that can eventually lead to osteoporosis and broken bones (also called fractures).

How Can Osteoporosis Medicine Help?

The goal of osteoporosis therapy is to try to restore the balance of resorption and formation. It can be done by slowing resorption through use of antiresorptive medication or by promoting bone formation using anabolic medication. By doing so, these therapies lower the risk for fractures, which is the goal of treatment.

Special Note: Information provided here about FDA-approved osteoporosis medicines is intended solely for general information and should NOT be relied upon for any particular diagnosis or treatment. This information does not imply an endorsement by NOF of any medicine or manufacturer.For more detailed information on the actions, administration, and possible side effects for each of the medicines discussed here, please consult the package insert, available online and at pharmacies.

Medications to Prevent Fragility Fractures

There are many medications available to treat osteoporosis and reduce the risk of fracture. They fall into two basic categories: antiresorptives and anabolics. Antiresorptive drugs include bisphosphonates (alendronate, ibandronate, risedronate, zoledronic acid), denosumab, calcitonin, estrogen/estrogen-progestin, an estrogen agonist/antagonist (raloxifene), and a tissue specific estrogen complex (estrogen/bazedoxifene). Antiresorptive drugs work by slowing the resorption or breakdown part of the remodeling cycle. Anabolics work by stimulating the formation part of the remodeling process. More bone is formed than is taken away. The result is stronger bone that is less likely to break. Teriparatide, a parathyroid hormone analog, abaloparatide, a parathyroid hormone-related protein analog, and romosozumab-aqqg, a sclerostin inhibitor, are the FDA-approved anabolic medicines available at this time.

All of these drugs reduce the likelihood of having fragility fractures. They come in a range of formulations, from daily tablets to yearly intravenous infusions. There is no best medication for everyone. The one that works for you depends on many factors. Your health history and preferences are considerations. Discuss it with your health care provider.

  • Alendronate Sodium or Alendronate Sodium plus Vitamin D3 (Fosamax®, Fosamax Plus D and Binosto®)
  • Ibandronate Sodium (Boniva®)
  • Risedronate Sodium (Actonel®and Atelvia™)
  • Zoledronic Acid (Reclast®)
  • Denosumab (Prolia®)
  • Calcitonin-Salmon (Fortical®and Miacalcin®)
  • Menopausal Hormone Therapy (MHT) (Multiple brands available)
  • Raloxifene (Evista®)
  • Tissue-Selective Estrogen Complex: Conjugated Estrogens/Bazedoxifene (Duavee®)
  • Teriparatide (Parathyroid Hormone analog) (PTH) (1-34) (Forteo®)
  • Abaloparatide (Parathyroid Hormone Related-Protein analog, (PTHrP) (1-34) (Tymlos®)
  • Romosozumab-aqqg (Evenity®)

It Can’t Work If You Don’t Take It

Like any medication, osteoporosis drugs can only work if they are taken exactly as prescribed. With many health conditions, it is easy to remember to take your medicine because when you don’t, you feel bad. Your blood pressure goes up or some other obvious problem results. That doesn’t happen with osteoporosis. Without bone density testing, you can’t even tell you have osteoporosis until you break a bone. By the same token, when you take osteoporosis medicine, you can’t feel your bones getting stronger. Youmightnotice that you haven’t broken a bone; however, if you are like most people, you won’t notice something that doesn’thappen.

The important thing is to take your medicine and take it consistently. If you have any trouble following your treatment plan, or if you have concerns about side effects, talk to your health care provider. Don’t suffer in silence. It happens to many people. Your provider can help you find something that works for you. There are lots of different options, one is sure to fit your needs.

How Can You Tell If the Medicine Is Working?

So, how can you tell your medicine is working? With antiresorptive medicines, the goal of treatment is to prevent further bone loss and reduce the risk of fractures. You know the drug is working when your bone density stays the same or improves and you have no additional broken bones. With anabolic medicine, the goal of treatment is to rebuild bone, increase bone mass, repair microscopic defects in bone, and reduce the risk of fractures. You know it’s working when your bone mineral density improves and you have no additional broken bones.

Your healthcare provider will keep track of your progress by periodically testing your bone density and sometimes checking your blood and urine.

How Long to Take Osteoporosis Medications?

Romosozumab-aqqg, Teriparatide and Abaloparatide are the only drugs for osteoporosis that have a defined treatment length. The FDA recommends that treatment be limited to no more than 18 months or two years. There is a great deal of variability in terms of ideal treatment duration for other medications.

Some drugs, like raloxifene and denosumab, leave the body quickly. Their effects generally disappear after one stops taking them. Some drugs, like bisphosphonates, stay in your bones after you stop taking them — some longer (alendronate, zoledronic acid) than others (risedronate, ibandronate). They may continue to work and offer protection even after one stops taking them. The most effective regimen and duration depends on the individual drug, the individual patient, and her/his level of fracture risk.

What Is a Bisphosphonate Holiday?

When a patient responds well to bisphosphonate therapy, many healthcare providers will consider a “bisphosphonate drug holiday” during which the patient takes a break from treatment. It’s important to recognize this is temporary, like a vacation, not permanent, like retirement. Eventually, lingering bisphosphonate benefits wear off and fracture risk rises. Drug holidays must be closely monitored so that treatment can be restarted when needed to avoid fractures. Also, only bisphosphonate drugs stay in the body long enough for a drug holiday to work. Other osteoporosis drugs lose their effect rapidly and must be taken continuously to protect bone, or if they are stopped, a different drug should be started in their place. Many healthcare providers consider a bisphosphonate drug holiday after five years of treatment if bone density is stable and no fractures have occurred.

Weighing Risks and Benefits of Anti-Fracture Medications

You may have heard about sudden thigh bone fractures in people who are taking antiresorptive drugs, namely bisphosphonates and denosumab. This rareside effect is called an atypical femur fracture (AFF). An even less common side effect reported in people taking bisphosphonates and denosumab is a nonhealing area in the jawbone called osteonecrosis of the jaw (ONJ). Although it has been seen in people on lower doses for shorter periods, ONJ is almost always seen in people being treated with high doses of these medications for cancer, frequently following oral surgery. Good dental care is a reasonable precaution for anyone taking antiresorptive medication for osteoporosis.

At the doses used for osteoporosis, AFF and ONJ are very rare. On the other hand, fragility fractures from osteoporosis are very common. Out of 1,000 women, 500 will suffer a fracture during their lifetime unless they get treatment for osteoporosis.

Don’t Forget Your Calcium and Vitamin D

Whatever medication you are prescribed to protect your bones, it won’t work without enough calcium and vitamin D. Calcium tablets are good for filling in when you can’t get enough in your diet, but it is always better to get calcium from food. Because there are not as many food sources of vitamin D, supplements are generally recommended for most people.

When You Prevent Falls, You Prevent Fractures

Falls are the leading cause of broken bones in older people. If you prevent falls, you prevent fractures. Many factors contribute to falling. These include bad eyesight, balance problems, sedating drugs, weak legs, dizziness, and slow reflexes. A lot can be done to reduce the risk for falls. Some suggestions include the following: Safety proof your home. Install grab bars in bathrooms. Get rid of tripping hazards. Put in brighter light bulbs. Keep your glasses prescription up to date. Exercise for muscle strengthening and to improve balance. Let your healthcare provider know right away if you are feeling dizzy. The bottom line is that you should stay as active as possible to build endurance and agility.

Taking Medicines Safely

Many diseases and medical treatments can contribute to broken bones in older people, either by causing bone loss or by causing falls. When visiting your healthcare provider, go over all of the medicine prescribed to you. Ask if anything you take can cause you to lose bone or make you dizzy or light headed. Most of the time, simple changes in scheduling or medication type can eliminate problems that could easily lead to devastating falls and broken bones.

Older Adults and Medications

Older people as a group tend to have more long-term, chronic illnesses such as arthritis, diabetes, high blood pressure and heart disease, than any other age group. Because they may have a number of health problems or issues at the same time, it is common for older people to take many different drugs.

For more information about safe medication for older adults visit the National Institute of Aging.

Understanding Your Medication

Try to find out as much as you can about any medication you are prescribed. Ask the following questions and write down the answers before leaving your healthcare provider’s office.

  • What is the name of the medication and its active ingredient?
  • For what condition or problem am I taking this medication and how does it work?
  • Does it contain anything to which I am allergic? How long will it take to work?
  • How should I store the medication? Does it need to be refrigerated?
  • Are there any side effects? How will I know if a side effect is serious?
  • Can the pharmacist substitute a less expensive, generic form of the medicine?

Find Out How to Take the Medication

Ask your doctor, pharmacist, or nurse about the right way to take any medicine before you start using it. Ask questions when you don’t know the meaning of a word or when instructions aren’t clear. Here are some specific questions to ask.

  • Should I take it whenever I need it or on a specific schedule?
  • Should I take it at a certain time of day?
  • How much should I take each time?
  • Do I need to take it with food?
  • Should I lie down or remain upright after taking the medicine?
  • May I drink alcohol while on this medication?
  • How long will I have to take it?

Ask What to Expect

  • How will I feel once I start taking this medicine?
  • How will I know if this medicine is working?
  • If I forget to take it, what should I do?
  • What side effects might I expect? Should I report them?
  • Can this medicine interact with other prescription and over-the-counter medicines — including herbal and dietary supplements — that I am taking now?

Tips for Taking Medicines Properly

Taking different medicines is not always easy to do properly. It may be hard to remember what each medicine is for, and how and when you should take each one. Here are some helpful tips for taking medicines.

  • Check the label on your medicinebefore taking it to make sure that it is for the correct person — you.
  • Read and save any written informationthat comes with the medicine.
  • Take the medicine according tothe schedule on the label.
  • Don’t take more or lessthan the prescribed amount of any medicine.
  • If swallowing tablets is difficult,ask your health care provider or pharmacist whether there is a liquid form of the medicine or whether you could crush your tablets. However, do NOT break, crush, or chew tablets without asking a health professional first.
  • Get into the habit of checking the expiration dateson your medicine bottles and throw away medicine that has expired.
  • Try to set and follow a routine for taking your medicines.

Last Reviewed 09/07/2018

March 19, 2012 — Three generic drugmakers may now sell their own versions of the bone-loss drug Boniva, the FDA ruled today.

Boniva, known by the generic name ibandronate, is a once-a-month pill prescribed to prevent or to treat bone loss from osteoporosis.

The FDA officially approves Boniva only for treatment of postmenopausal women, as the clinical studies that led to approval mostly enrolled women. However, doctors often prescribe the drug to men.

Overall, some 40 million Americans either suffer osteoporosis or are at high risk of the condition, which can lead to devastating bone fractures.

“Men as well as women are affected by osteoporosis, a disease that can be prevented and treated,” Keith Webber, PhD, an FDA deputy director, says in a news release.

Boniva is a member of a class of drugs called bisphosphonates, which help build bone.

Webber said the newly approved generic versions of Boniva should make the medication more affordable.

Generic ibandronate will be made by three firms: Apotex Inc., Orchid Healthcare, and Mylan Pharmaceuticals Inc. They will make 150 milligram ibandronate tablets.

The FDA will require each firm to give patients a medication guide describing the drug’s risks. Ibandronate can cause serious side effects including esophagus problems; low calcium levels in the blood; bone, joint, or muscle pain; severe jawbone problems; and unusual thigh bone fractures.

In clinical trials for Boniva, the most commonly observed adverse reactions were back pain, indigestion, pain in the arms or legs, diarrhea, headache, and muscle pain.

Generic Boniva Availability

Boniva is a brand name of ibandronate, approved by the FDA in the following formulation(s):

BONIVA (ibandronate sodium – injectable;intravenous)

  • Manufacturer: ROCHE
    Approval date: January 6, 2006
    Strength(s): EQ 3MG BASE/3ML

BONIVA (ibandronate sodium – tablet;oral)

Has a generic version of Boniva been approved?

A generic version of Boniva has been approved by the FDA. However, this does not mean that the product will necessarily be commercially available – possibly because of drug patents and/or drug exclusivity. The following products are equivalent to Boniva and have been approved by the FDA:

ibandronate sodium injectable;intravenous

ibandronate sodium tablet;oral

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Boniva. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.

See also: Generic Drug FAQs.

Related Patents

Patents are granted by the U.S. Patent and Trademark Office at any time during a drug’s development and may include a wide range of claims.

  • Pharmaceutical composition containing diphosphonic acid or salt thereof
    Patent 6,294,196
    Issued: September 25, 2001
    Inventor(s): Gabel; Rolf-Dieter & Preis; Walter & Woog; Heinrich
    Assignee(s): Hoffmann-La Roche Inc.

    The invention relates to a solid pharmaceutical form of administration containing a diphosphonic acid or a physiologically compatible salt thereof as the active substance, wherein the active substance is present in granulate form, optionally together with pharmaceutical adjuvants in the inner phase, and the outer phase contains a lubricant in the form of less than 5% by weight of stearic acid relative to the total weight of the form of administration.

    Patent expiration dates:

    • October 7, 2019
      ✓ Drug product
  • Method of treatment using bisphosphonic acid
    Patent 7,192,938
    Issued: March 20, 2007
    Inventor(s): Bauss; Frieder & Pichler; Bernhard & Turley; Stephen
    Assignee(s): Hoffmann-La Roche Inc.

    The present invention refers to a pharmaceutical composition of a bisphosphonic acid or salt thereof, and an excipient thereof, and a method of treating disorder characterized by pathologically increased bone resorption comprising orally administering at least 150% of the expected efficious daily dose of a bisphosphonic acid or a pharmaceutically acceptable salt thereof and one or more pharmaceutically acceptable excipients thereof and administering the dose at a period of one two or three consecutive days per month.

    Patent expiration dates:

    • May 6, 2023
      ✓ Patent use: TREATMENT AND PREVENTION OF OSTEOPOROSIS IN POSTMENOPAUSAL WOMEN BY ONCE-MONTHLY ORAL ADMINISTRATION OF IBANDRONATE SODIUM MONOHYDRATE EQUIVALENT TO 150MG OF IBANDRONIC ACID
  • Method of treatment using bisphosphonic acid
    Patent 7,410,957
    Issued: August 12, 2008
    Inventor(s): Bauss; Frieder & Pichler; Bernhard & Turley; Stephen
    Assignee(s): Hoffmann-La Roche Inc.

    The present invention refers to a pharmaceutical composition of a bisphosphonic acid or salt thereof, and an excipient thereof, and a method of treating disorder characterized by pathologically increased bone resorption comprising orally administering at least 150% of the expected efficious daily dose of a bisphosphonic acid or a pharmaceutically acceptable salt thereof and one or more pharmaceutically acceptable excipients thereof and administering the dose at a period of one two or three consecutive days per month.

    Patent expiration dates:

    • May 6, 2023
      ✓ Patent use: TREATMENT AND PREVENTION OF OSTEOPOROSIS
  • Method of treatment using bisphosphonic acid
    Patent 7,718,634
    Issued: May 18, 2010
    Inventor(s): Bauss; Frieder & Pichler; Bernhard & Turley; Stephen
    Assignee(s): Hoffman-La Roche Inc.

    The present invention refers to a pharmaceutical composition of a bisphosphonic acid or salt thereof, and an excipient thereof, and a method of treating disorder characterized by pathologically increased bone resorption comprising orally administering at least 150% of the expected efficious daily dose of a bisphosphonic acid or a pharmaceutically acceptable salt thereof and one or more pharmaceutically acceptable excipients thereof and administering the dose at a period of one two or three consecutive days per month.

    Patent expiration dates:

    • May 6, 2023
      ✓ Patent use: TREATMENT AND PREVENTION OF OSTEOPOROSIS

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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Glossary

Term Definition
Drug Patent A drug patent is assigned by the U.S. Patent and Trademark Office and assigns exclusive legal right to the patent holder to protect the proprietary chemical formulation. The patent assigns exclusive legal right to the inventor or patent holder, and may include entities such as the drug brand name, trademark, product dosage form, ingredient formulation, or manufacturing process A patent usually expires 20 years from the date of filing, but can be variable based on many factors, including development of new formulations of the original chemical, and patent infringement litigation.
Drug Exclusivity Exclusivity is the sole marketing rights granted by the FDA to a manufacturer upon the approval of a drug and may run simultaneously with a patent. Exclusivity periods can run from 180 days to seven years depending upon the circumstance of the exclusivity grant.
RLD A Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart.
AB Products meeting necessary bioequivalence requirements. Multisource drug products listed under the same heading (i.e., identical active ingredients(s), dosage form, and route(s) of administration) and having the same strength (see Therapeutic Equivalence-Related Terms, Pharmaceutical Equivalents) generally will be coded AB if a study is submitted demonstrating bioequivalence. In certain instances, a number is added to the end of the AB code to make a three character code (i.e., AB1, AB2, AB3, etc.). Three-character codes are assigned only in situations when more than one reference listed drug of the same strength has been designated under the same heading. Two or more reference listed drugs are generally selected only when there are at least two potential reference drug products which are not bioequivalent to each other. If a study is submitted that demonstrates bioequivalence to a specific listed drug product, the generic product will be given the same three-character code as the reference listed drug it was compared against.
AP Injectable aqueous solutions and, in certain instances, intravenous non-aqueous solutions. It should be noted that even though injectable (parenteral) products under a specific listing may be evaluated as therapeutically equivalent, there may be important differences among the products in the general category, Injectable; Injection. For example, some injectable products that are rated therapeutically equivalent are labeled for different routes of administration. In addition, some products evaluated as therapeutically equivalent may have different preservatives or no preservatives at all. Injectable products available as dry powders for reconstitution, concentrated sterile solutions for dilution, or sterile solutions ready for injection are pharmaceutical alternative drug products. They are not rated as therapeutically equivalent (AP) to each other even if these pharmaceutical alternative drug products are designed to produce the same concentration prior to injection and are similarly labeled. Consistent with accepted professional practice, it is the responsibility of the prescriber, dispenser, or individual administering the product to be familiar with a product’s labeling to assure that it is given only by the route(s) of administration stated in the labeling.

Boniva vs Fosamax: Main Differences and Similarities

If you or someone you know suffers from osteoporosis, Boniva (ibandronate) and Fosamax (alendronate) are two options that can help treat bone loss. Both medications are classified as bisphosphonates which work by preventing the breakdown of bone and increasing bone mass. While they are similar in how they work, they have some important differences to know.

Boniva is the brand name for ibandronate sodium. It is FDA approved to treat and prevent osteoporosis in postmenopausal women. It can also reduce the incidence of vertebral fractures, or fractures that occur in the spine.

Boniva is administered as a 150 mg oral tablet taken once per month. It can also be administered as an IV injection every 3 months. Although it is considered a long-term medication, it is recommended to stop taking Boniva after 3 to 5 years in those with low risk of osteoporosis.

Fosamax

Fosamax also goes by its generic name, alendronate sodium. It is a bisphosphonate medication approved to treat postmenopausal osteoporosis in women and increase bone mass in men with osteoporosis. Fosamax can also reduce the risk of fractures in the hip or spine.

Fosamax is available as a 10 mg oral tablet taken daily or a 70 mg oral tablet taken weekly. Like other bisphosphonates, it is only recommended for up to 3 to 5 years in those with low risk of osteoporosis.

Boniva vs Fosamax Side by Side Comparison

Boniva and Fosamax are similar medications with identical uses. However, they also differ in some ways. Their features can be explored in the table below.

Boniva Fosamax
Prescribed For
  • Postmenopausal osteoporosis (treatment and prevention)
  • Reduce the incidence of vertebral fractures
  • Postmenopausal osteoporosis (treatment and prevention)
  • Osteoporosis in men
  • Glucocorticoid-induced osteoporosis
  • Paget’s disease
  • Reduce the incidence of vertebral and nonvertebral fractures
Drug Classification
  • Bisphosphonate
  • Bisphosphonate
Manufacturer
  • Genentech
  • Merck & Co.
Common Side Effects
  • Indigestion
  • Pain in arms and legs
  • Muscle pain
  • Diarrhea
  • Headache
  • Back pain
  • Indigestion
  • Pain in arms and legs
  • Muscle pain
  • Diarrhea
  • Stomach ache
  • Acid reflux
  • Constipation
  • Nausea
Is there a generic?
  • Yes, ibandronate sodium
  • Yes, alendronate sodium
Is it covered by insurance?
  • Varies according to your provider
  • Varies according to your provider
Dosage Forms
  • Oral tablet
  • Solution for injection
  • Oral tablet
Average Cash Price
  • $258 per 1, 150 mg tablet.
  • $207 per 4, 70 mg tablets
SingleCare Discount Price
  • Boniva Price
  • Fosamax Price
Drug Interactions
  • Calcium supplements
  • Antacids (aluminum hydroxide, calcium carbonate, etc.)
  • NSAIDs (ibuprofen, ketorolac, diclofenac, etc.)
  • Aspirin
  • Calcium supplements
  • Antacids (aluminum hydroxide, calcium carbonate, etc.)
  • NSAIDs (ibuprofen, ketorolac, diclofenac, etc.)
  • Aspirin
Can I use while planning pregnancy, pregnant, or breastfeeding?
  • Boniva is Pregnancy Category C. Animal studies have shown adverse effects to the fetus. Adequate studies have not been performed in humans. Boniva is not expected to harm breastfed infants. Consult a doctor regarding steps to take while pregnant and breastfeeding
  • Fosamax is Pregnancy Category C. Animal studies have shown adverse effects to the fetus. Adequate studies have not been performed in humans. Fosamax is not expected to harm breastfed infants. Consult a doctor regarding steps to take while pregnant and breastfeeding

Summary

Boniva (ibandronate) and Fosamax (alendronate) are bisphosphonate medications that can treat and prevent osteoporosis. They both work in similar ways to increase bone mass and prevent the incidence of fractures.

Boniva is approved to prevent spine fractures while Fosamax is approved to prevent spine and hip fractures. Unlike Boniva, Fosamax can also treat osteoporosis in men, Paget’s disease, and glucocorticoid-induced osteoporosis.

Both Boniva and Fosamax can be given as oral tablets. However, Boniva is taken on a monthly basis while Fosamax is taken on a daily or weekly basis. Both medications are only recommended for up to 5 years in those with a low risk of fractures.

It is important not to eat, drink, or take other medications while taking these bisphosphonates. Boniva can be taken up to 1 hour before or after food, drink, and medications while Fosamax can be taken up to 30 minutes before or after food, drink, and medications.

Depending on your overall condition, your doctor may prescribe one bisphosphonate over the other. For those who are more prone to hip and vertebral fractures, Fosamax may be a better option. However, Boniva may be preferred for its once a month dosing. Consult your doctor to talk more about these medications.

Boniva and Weight gain – from FDA reports

Summary:

Weight gain is found among people who take Boniva, especially for people who are female, 60+ old , have been taking the drug for 2 – 5 years, also take medication Fosamax, and have Gastroesophageal reflux disease. This study is created by eHealthMe based on reports of 25,722 people who have side effects when taking Boniva from Food and Drug Administration (FDA), and is updated regularly.

eHealthMe has been monitoring drugs since 2008. Our original studies have been referenced on 600+ peer-reviewed medical publications. On eHealthMe, patients can manage drugs and prevent side effects with real-world data, qualified professionals and financial protection. Join now, it’s free.

On Jan, 04, 2020

25,722 people reported to have side effects when taking Boniva.
Among them, 357 people (1.39%) have Weight gain

Number of reports submitted per year:

Time on Boniva when people have Weight gain *:

  • < 1 month: 2.63 %
  • 1 – 6 months: 15.79 %
  • 6 – 12 months: 13.82 %
  • 1 – 2 years: 21.05 %
  • 2 – 5 years: 39.47 %
  • 5 – 10 years: 3.95 %
  • 10+ years: 3.29 %

Gender of people who have Weight gain when taking Boniva *:

  • female: 95.72 %
  • male: 4.28 %

Age of people who have Weight gain when taking Boniva *:

  • 0-1: 0.0 %
  • 2-9: 0.0 %
  • 10-19: 0.83 %
  • 20-29: 0.41 %
  • 30-39: 1.24 %
  • 40-49: 8.68 %
  • 50-59: 43.39 %
  • 60+: 45.45 %

Conditions people have *:

  1. Gastroesophageal Reflux Disease (a condition in which stomach contents leak backward from the stomach into the oesophagus): 22 people, 6.16%
  2. Hormone Replacement Therapy: 21 people, 5.88%
  3. Pain: 18 people, 5.04%
  4. High Blood Cholesterol: 17 people, 4.76%
  5. Hypothyroidism (abnormally low activity of the thyroid gland, resulting in retardation of growth and mental development): 14 people, 3.92%

Other drugs people take besides Boniva *:

  1. Fosamax: 172 people, 48.18%
  2. Actonel: 41 people, 11.48%
  3. Synthroid: 37 people, 10.36%
  4. Nexium: 25 people, 7.00%
  5. Omeprazole: 23 people, 6.44%

Other side effects people have besides Weight gain *:

* Approximation only. Some reports may have incomplete information.

Do you take multiple drugs?

Monitor your drugs and prevent drug interactions with real-world data and on-demand qualified professionals. It’s free. Join eHealthMe now.

Related publications that referenced our studies:

  • Eslami Shahrbabaki M, Nasirian M, Eslami Shahrbabaki P, “Extreme Weight Gain due to Short-term Use of Low-dose Propranolol”, Journal of Mazandaran University of Medical Sciences, 2015 Jan .

How the study uses the data?

The study is based on ibandronate sodium (the active ingredients of Boniva) and Boniva (the brand name). Other drugs that have the same active ingredients (e.g. generic drugs) are not considered. Dosage of drugs is not considered in the study.

To check all the drugs that have ingredients of ibandronate sodium and Weight gain:

  • Weight gain and drugs with ingredients of ibandronate sodium (414 reports)

How severe was Weight gain and when was it recovered:

  • Weight gain in Boniva

What’s eHealthMe?

eHealthMe is a health data analysis company based in Mountain View, California. We monitor and analyze the outcomes of drugs and supplements that are currently on the market since 2008. Original studies of eHealthMe have been referenced on 600+ peer-reviewed medical publications. On eHealthMe, health care professionals and consumers can study drugs with our free tools. Reports generated by our tools are personalized to gender and age. Choose a tool now.

What is Boniva?

Boniva has active ingredients of ibandronate sodium. It is often used in osteoporosis. Check the latest outcomes from 26,081 Boniva users, or browse all drugs.

What is Weight gain?

Weight gain has been reported by people with depression, rheumatoid arthritis, high blood pressure, birth control, pain. Check the latest reports from 166,164 Weight gain patients, or browse all conditions.

Browse side effects by gender and age:

Female: 0-1 2-9 10-19 20-29 30-39 40-49 50-59 60+

Male: 0-1 2-9 10-19 20-29 30-39 40-49 50-59 60+

How to use the study?

Patients can bring a copy of the report to their healthcare provider to ensure that all drug risks and benefits are fully discussed and understood. It is recommended that patients use the information presented as a part of a broader decision-making process.

Please DO NOT STOP MEDICATIONS without first consulting a physician since doing so could be hazardous to your health.

Ibandronate

How to take it

If you’re taking it in tablet form

Ibandronate should be taken on an empty stomach so it can be absorbed properly.

Take it first thing, and wait at least one hour before having any food, drink and any other medication, although you can have water if you wish.

It’s also best to wait at least four hours after taking ibandronate before taking a calcium supplement. Calcium can affect how the medication is absorbed.

If you’re taking it as an injection

This is given by a healthcare professional once every three months. In most cases, this is at a hospital or clinic, but you may be invited to your local GP practice.

How long to take it

Ibandronate is generally prescribed long term, so you need to be happy it is the right option for you.

To get the full benefits, ibandronate should be taken regularly as instructed by your doctor or pharmacist.

It is recommended that your treatment is formally reviewed by your doctor after five years. The review checks that your benefits from taking ibandronate continue to outweigh any risks.

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