Medical Editor: John P. Cunha, DO, FACOEP
What Is Boniva?
Boniva (ibandronate) is a bisphosphonate drug that alters the cycle of bone formation and breakdown in the body used to treat or prevent osteoporosis in women after menopause. Boniva slows bone loss while increasing bone mass, which may prevent bone fractures.
What Are Side Effects of Boniva?
Side effects of Boniva include:
- back pain,
- headache,
- redness or swelling of your eyes,
- diarrhea,
- flu-like symptoms,
- nausea or stomach upset,
- pain in your arms or legs,
- redness or swelling where Boniva was injected,
- weakness,
- allergic reaction,
- indigestion,
- vomiting,
- joint pain,
- dizziness,
- spinning sensation (vertigo),
- upper respiratory infection,
- pneumonia, or
- urinary tract infection.
Dosage for Boniva
The dose of Boniva is one 150 mg tablet taken once monthly on the same date each month.
What Drugs, Substances, or Supplements Interact with Boniva?
Boniva may interact with products containing calcium, aluminum, magnesium, or iron (such as antacids, supplements or vitamins); aspirin or NSAIDs. Tell your doctor all medications and supplements you use.
Boniva During Pregnancy and Breastfeeding
There are no adequate and well-controlled studies of this drug in pregnant women. It is not known whether ibandronate is excreted in human milk. Boniva is typically given to women after menopause.
Additional Information
Our Boniva Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
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.
QUESTION
What is another medical term for osteoporosis? See AnswerGet emergency medical help if you have signs of an allergic reaction: hives; wheezing, difficult breathing; swelling of your face, lips, tongue, or throat.
Stop using ibandronate and call your doctor at once if you have:
- chest pain, new or worsening heartburn;
- difficulty or pain when swallowing;
- pain or burning under the ribs or in the back;
- severe heartburn, burning pain in your upper stomach, or coughing up blood;
- new or unusual pain in your thigh or hip;
- jaw pain, numbness, or swelling;
- severe joint, bone, or muscle pain; or
- low calcium levels--muscle spasms or contractions, numbness or tingly feeling (around your mouth, or in your fingers and toes).
Common side effects may include:
- heartburn, stomach pain, diarrhea;
- back pain, bone pain, muscle or joint pain;
- pain in your arms or legs;
- headache; or
- fever, chills, tiredness, flu-like symptoms.
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.
SLIDESHOW
Osteoporosis Super-Foods for Strong Bones With Pictures See SlideshowSIDE EFFECTS
Adverse reactions that appear in other sections of the labeling include:
- Hypocalcemia and Mineral Metabolism [see WARNINGS AND PRECAUTIONS]
- Anaphylactic Reaction [see WARNINGS AND PRECAUTIONS]
- Renal Impairment [see WARNINGS AND PRECAUTIONS]
- Tissue Damage Related to Inappropriate Drug Administration [see WARNINGS AND PRECAUTIONS]
- Osteonecrosis of the Jaw [see WARNINGS AND PRECAUTIONS]
- Musculoskeletal Pain [see WARNINGS AND PRECAUTIONS]
- Atypical Subtrochanteric and Diaphyseal Femoral Fractures [see WARNINGS AND PRECAUTIONS]
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.
Quarterly Intravenous Injection
In a 1-year, double-blind, multicenter study comparing BONIVA Injection administered intravenously as 3 mg every 3 months to BONIVA 2.5 mg daily oral tablet in women with postmenopausal osteoporosis, the overall safety and tolerability profiles of the two dosing regimens were similar. The incidence of serious adverse reactions was 8.0% in the BONIVA 2.5 mg daily group and 7.5% in the BONIVA Injection 3 mg once every 3 months group. The percentage of patients who withdrew from treatment due to adverse reactions was approximately 6.7% in the BONIVA 2.5 mg daily group and 8.5% in the BONIVA Injection 3 mg every 3 months group. Table 1 lists the adverse reactions reported in greater than 2% of patients.
Table 1 : Adverse Reactions With an Incidence of at Least 2% in Patients Treated with BONIVA Injection (3 mg once every 3 months) or BONIVA Daily Oral Tablet (2.5 mg)
| Body System/Adverse Reaction | BONIVA 2.5 mg Daily (Oral) % (n=465) |
BONIVA 3 mg every 3 months (Intravenous) % (n=469) |
| Infections and Infestations | ||
| Influenza | 8 | 5 |
| Nasopharyngitis | 6 | 3 |
| Cystitis | 3 | 2 |
| Gastroenteritis | 3 | 2 |
| Urinary Tract Infection | 3 | 3 |
| Bronchitis | 3 | 2 |
| Upper Respiratory Tract Infection | 3 | 1 |
| Gastrointestinal Disorders | ||
| Abdominal Pain* | 6 | 5 |
| Dyspepsia | 4 | 4 |
| Nausea | 4 | 2 |
| Constipation | 4 | 3 |
| Diarrhea | 2 | 3 |
| Gastritis | 2 | 2 |
| Musculoskeletal and Connective Tissue Disorders | ||
| Arthralgia | 9 | 10 |
| Back Pain | 8 | 7 |
| Localized Osteoarthritis | 2 | 2 |
| Pain in Extremity | 2 | 3 |
| Myalgia | 1 | 3 |
| Nervous System Disorders | ||
| Dizziness | 3 | 2 |
| Headache | 3 | 4 |
| Psychiatric Disorders | ||
| Insomnia | 3 | 1 |
| Depression | 2 | 1 |
| General Disorders and Administration Site Conditions | ||
| Influenza-like Illness† | 1 | 5 |
| Fatigue | 1 | 3 |
| Skin and Subcutaneous Tissue Disorders | ||
| Rash‡ | 3 | 2 |
| * Combination of abdominal pain and abdominal pain upper † Combination of influenza-like illness and acute phase reaction ‡ Combination of rash, rash pruritic, rash macular, dermatitis, dermatitis allergic, exanthema, erythema, rash papular, rash generalized, dermatitis medicamentosa, rash erythematous |
||
Acute Phase Reaction-like Events
Symptoms consistent with acute phase reaction (APR) have been reported with intravenous bisphosphonate use. The overall incidence of patients with APR-like events was higher in the intravenous treatment group (4% in the BONIVA 2.5 mg daily oral tablet group vs. 10% in the BONIVA Injection 3 mg once every 3 months group).
These incidence rates are based upon reporting of any of 33 potential APR-like symptoms within 3 days of an intravenous dose and lasting 7 days or less. In most cases, no specific treatment was required and the symptoms subsided within 24 to 48 hours.
Injection Site Reactions
Local reactions at the injection site, such as redness or swelling, were observed at a higher incidence in patients treated with BONIVA Injection 3 mg every 3 months (1.7%; 8/469) than in patients treated with placebo injections (0.2%; 1/465). In most cases, the reaction was of mild to moderate severity.
Daily Oral Tablet
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 oral tablet group. The percentage of patients who withdrew from treatment due to adverse reactions was approximately 17% in both the placebo group and the BONIVA 2.5 mg daily oral tablet group. Table 2 lists adverse reactions from the Treatment and Prevention Studies reported in greater than or equal to 2% of patients and in more patients treated with BONIVA 2.5 mg daily oral tablet than patients treated with placebo.
Table 2 : Adverse Reactions Occurring at an Incidence greater than or equal to 2% and in More Patients Treated with BONIVA 2.5 mg Daily Oral Tablet than in Patients Treated with Placebo in the Osteoporosis Treatment and Prevention Studies
| Body System | Placebo % (n=1134) |
BONIVA 2.5 mg daily % (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 | 33 | 34 |
| Infection | ||
| Bronchitis | 7 | 10 |
| Pneumonia | 4 | 6 |
| Pharyngitis | 2 | 3 |
| Urogenital System | ||
| Urinary Tract Infection | 4 | 6 |
Gastrointestinal Adverse Reactions
The incidence of selected gastrointestinal adverse reactions in the placebo and BONIVA 2.5 mg daily groups were: dyspepsia (10% vs. 12%), diarrhea (5% vs. 7%), and abdominal pain (5% vs. 6%).
Musculoskeletal Adverse Reactions
The incidence of selected musculoskeletal adverse reactions in the placebo and BONIVA 2.5 mg daily groups were: back pain (12% vs. 14%), arthralgia (14% vs. 14%) and myalgia (5% vs. 6%).
Postmarketing Experience
The following adverse reactions have been identified during post-approval use of BONIVA Injection. 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.
Hypersensitivity: Allergic reactions including anaphylaxis with fatalities, angioedema, asthma exacerbation, bronchospasm, rash, Stevens-Johnson syndrome, erythema multiforme, and dermatitis bullous [see CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS].
Hypocalcemia: Hypocalcemia [see WARNINGS AND PRECAUTIONS].
Renal Toxicity: Acute renal failure [see WARNINGS AND PRECAUTIONS].
Osteonecrosis of the Jaw: Osteonecrosis of the jaw and other oro-facial sites, including the external auditory canal [see WARNINGS AND PRECAUTIONS].
Musculoskeletal Pain: Bone, joint, or muscle pain (musculoskeletal pain), described as severe or incapacitating [see WARNINGS AND PRECAUTIONS].
Atypical Femoral Shaft Fracture: Atypical, low-energy, or low-trauma fractures of the femoral shaft [see WARNINGS AND PRECAUTIONS].
Eye Inflammation: Iritis and uveitis. In some cases with other bisphosphonates, these events did not resolve until the bisphosphonate was discontinued.
DRUG INTERACTIONS
Melphalan/Prednisolone
Intravenous ibandronate (6 mg) did not interact with intravenous melphalan (10 mg/m²) or oral prednisolone (60 mg/m²). [See CLINICAL PHARMACOLOGY]
Tamoxifen
There was no interaction between oral 30 mg tamoxifen and intravenous 2 mg ibandronate. [See CLINICAL PHARMACOLOGY]
Bone Imaging Agents
Bisphosphonates are known to interfere with the use of bone-imaging agents. Specific studies with BONIVA have not been performed.
Read the entire FDA prescribing information for Boniva (Ibandronate Sodium)
© Boniva Patient Information is supplied by Cerner Multum, Inc. and Boniva Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.
Health Solutions From Our Sponsors