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Boniva

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Boniva

Side Effects
Interactions

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

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%).

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
aCombination of abdominal pain and abdominal pain upper
bCombination of influenza-like illness and acute phase reaction
cCombination of rash pruritic, rash macular, rash papular, rash generalized, rash erythematous, dermatitis, dermatitis allergic, dermatitis medicamentosa, erythema and exanthema

Gastrointestinal Adverse Events

The incidence of adverse events in the BONIVA 2.5 mg daily and BONIVA 150 mg monthly groups were: dyspepsia (7% vs. 6%), diarrhea (4% vs. 5%), and abdominal pain (5% vs. 8%).

Musculoskeletal Adverse Events

The incidence of adverse events in the BONIVA 2.5 mg daily and BONIVA 150 mg monthly groups were: back pain (4% vs. 5%), arthralgia (4% vs. 6%) and myalgia (1% vs. 2%).

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.

Hypersensitivity

Allergic reactions including anaphylactic reaction/shock; in some cases fatal, angioedema, bronchospasm, asthma exacerbations, and rash have been reported (see CONTRAINDICATIONS).

Hypocalcemia

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

Musculoskeletal Pain

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

Jaw Osteonecrosis

Osteonecrosis of the jaw has 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 Boniva (ibandronate sodium) Side Effects Center for a complete guide to possible side effects

DRUG INTERACTIONS

Calcium Supplements/Antacids

Products containing calcium and other multivalent cations (such as aluminum, magnesium, iron) are likely to interfere with absorption of BONIVA. Therefore, instruct patients to take BONIVA at least 60 minutes before any oral medications, including medications containing multivalent cations (such as antacids, supplements or vitamins). Also, patients should wait at least 60 minutes after dosing before taking any other oral medications (see DOSAGE AND ADMINISTRATION).

Aspirin/Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)

Because aspirin, NSAIDs, and bisphosphonates are all associated with gastrointestinal irritation, caution should be exercised in the concomitant use of aspirin or NSAIDs with BONIVA.

H2 Blockers

In healthy volunteers, co-administration with ranitidine resulted in a 20% increased bioavailability of ibandronate, which was not considered to be clinically relevant (see CLINICAL PHARMACOLOGY).

Drug/Laboratory Test Interactions

Bisphosphonates are known to interfere with the use of bone-imaging agents. Specific studies with ibandronate have not been performed.

Last reviewed on RxList: 1/5/2015
This monograph has been modified to include the generic and brand name in many instances.

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