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Boniva

"Sept. 9, 2011 -- Labels on bisphosphonates, a type of medication used to treat and prevent osteoporosis, should further clarify how long patients can take them, an FDA advisory panel voted today.

But the panel backed off giving any sp"...

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 (ibandronate sodium) 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 (ibandronate sodium) 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 IU vitamin D supplementation daily.

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

Table 1 : Adverse Events Occurring at a Frequency ≥ 2% and More Frequently in Patients Treated with BONIVA (ibandronate sodium) 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 12.2 13.5
  Pain in Extremity 6.4 7.8
  Infection 3.4 4.3
  Asthenia 2.3 3.5
  Allergic Reaction 1.9 2.5
Digestive System
  Dyspepsia 9.8 11.9
  Diarrhea 5.0 6.8
  Tooth Disorder 2.3 3.5
  Vomiting 2.1 2.7
  Gastritis 1.9 2.2
Metabolic and Nutritional Disorders
  Hypercholesterolemia 4.2 4.8
Musculoskeletal System
  Myalgia 5.1 5.7
  Joint Disorder 3.3 3.6
  Arthritis 2.7 3.2
Nervous System
  Headache 5.8 6.5
  Dizziness 2.6 3.7
  Vertigo 2.5 3.0
  Nerve Root Lesion 1.9 2.2
Respiratory System
  Upper Respiratory Infection 33.2 33.7
  Bronchitis 6.8 10.0
  Pneumonia 4.3 5.9
  Pharyngitis 1.5 2.5
Urogenital System
  Urinary Tract Infection 4.2 5.5

Gastrointestinal Adverse Events

The incidence of adverse events in the placebo and BONIVA (ibandronate sodium) 2.5 mg daily groups were: dyspepsia (10% vs. 12%), diarrhea (5% vs. 7%), and abdominal pain (5% vs. 6%).

Musculoskeletal Adverse Events

The incidence of adverse events in the placebo and BONIVA (ibandronate sodium) 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 (ibandronate sodium) 2.5 mg daily.

Monthly Dosing

The safety of BONIVA (ibandronate sodium) 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 (ibandronate sodium) 2.5 mg daily and 396 exposed to BONIVA (ibandronate sodium) 150 mg monthly. Patients with active or significant pre-existing gastrointestinal disease were excluded from this trial. Patients with dyspepsia or concomitant use of nonsteroidal anti-inflammatory drugs, proton pump inhibitors and H2 antagonists were included in this study. All patients received 500 mg calcium plus 400 IU 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 (ibandronate sodium) 150 mg monthly group. The incidence of serious adverse events was 5% in the BONIVA (ibandronate sodium) 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 (ibandronate sodium) 2.5 mg daily group and 8% in the BONIVA (ibandronate sodium) 150 mg monthly group. Table 2 lists the adverse events reported in ≥ 2% of patients.

Table 2 : Adverse Events with an Incidence of at Least 2% in Patients Treated with BONIVA (ibandronate sodium) 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 exanthem

Gastrointestinal Adverse Events

The incidence of adverse events in the BONIVA (ibandronate sodium) 2.5 mg daily and BONIVA (ibandronate sodium) 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 (ibandronate sodium) 2.5 mg daily and BONIVA (ibandronate sodium) 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 (ibandronate sodium) 2.5 mg daily group and 9% in the BONIVA (ibandronate sodium) 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 (ibandronate sodium) 150 mg monthly group.

Ocular Adverse Events

Two patients who received BONIVA (ibandronate sodium) 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 (ibandronate sodium) 150 mg once-monthly for prevention of bone loss. Seventy-seven subjects received BONIVA (ibandronate sodium) 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 anaphylaxis, angioedema, bronchospasm 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).

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. BONIVA (ibandronate sodium) should be taken 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 PATIENT INFORMATION).

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: 3/10/2011
This monograph has been modified to include the generic and brand name in many instances.

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