Bonviva Adverse Reactions

Experience from Clinical Trials: Treatment of postmenopausal osteoporosis: Once-monthly dosing: In a two-year study in postmenopausal women with osteoporosis (BM 16549) the overall safety of Ibandronic acid 150 mg once monthly and Ibandronic acid 2.5 mg daily was similar. The overall proportion of patients who experienced an adverse drug reaction, i.e. adverse event with a possible or probable relationship to trial medication, was 22.7% and 25.0% for Ibandronic acid 150 mg once monthly and 21.5% and 22.5% for Ibandronic acid 2.5 mg daily after one and two years, respectively. The majority of adverse drug reactions were mild to moderate in intensity. Most cases did not lead to cessation of therapy.
Tables 2 and 3 list adverse drug reactions occurring in more than 1% of patients treated with Ibandronic acid 150 mg monthly or 2.5 mg daily in study BM 16549 and in patients treated with Ibandronic acid 2.5 mg daily in study MF 4411. The tables show the adverse drug reactions in the two studies that occurred with a higher incidence than in patients treated with placebo in study MF 4411. Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Data at one year from BM 16549 are represented in Table 2 and cumulative data for the two years from BM 16549 are represented in Table 3. (See Tables 2 and 3.)

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Adverse drug reactions occurring at a frequency of less than or equal to 1%: The following list provides information on adverse drug reactions (considered possibly or probably related to treatment by the investigator) reported in study MF 4411 occurring more frequently with Ibandronic acid 2.5 mg daily than with placebo and study BM 16549 occurring more frequently with Ibandronic acid 150 mg once monthly than with Ibandronic acid 2.5 mg daily. Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness: Uncommon (1/100 - 1/1,000): Gastrointestinal Disorders: gastritis, oesophagitis including Oesophageal ulcerations or strictures, vomiting, dysphagia.
Nervous System Disorders: dizziness.
Musculoskeletal and Connective Tissue Disorders: back pain.
Rare (1/1,000 - 1/10,000): Gastrointestinal Disorders: duodenitis.
Immune System Disorders: hypersensitivity reactions.
Skin and Subcutaneous Tissue Disorders: angioedema, face oedema, urticaria.
Patients with a previous history of gastrointestinal disease including patients with peptic ulcer without recent bleeding or hospitalisation, and patients with dyspepsia or reflux controlled by medication were included in the once monthly treatment study.
For these patients, there was no difference in the incidence of upper gastrointestinal adverse events with the 150 mg once monthly regimen compared to the 2.5 mg daily regimen.
Abnormal laboratory findings: In the pivotal three-year study with Ibandronic acid 2.5 mg daily (MF 4411) there was no difference compared with placebo for laboratory abnormalities indicative of hepatic or renal dysfunction, impaired hematologic system, hypocalcemia or hypophosphatemia. Similarly, no differences were noted between the groups in study BM 16549 after one and two years.
Osteonecrosis of jaw: Osteonecrosis of the jaw and other oro-facial sites, including the external auditory canal, has been reported very rarely in patients treated with ibandronic acid (see Precautions). The majority of the reports refer to cancer patients, but such cases have also been reported in patients treated for osteoporosis.
Osteonecrosis of the jaw is generally associated with tooth extraction and/or local infection (including osteomyelitis). Diagnosis of cancer, chemotherapy, radiotherapy, corticosteroids and poor oral hygiene are also deemed as risk factors (see Precautions).
Ocular inflammation: Ocular inflammation events such as uveitis, episcleritis and scleritis have been reported with ibandronic acid. In some cases, these events did not resolve until the ibandronic acid was discontinued.
Anaphylactic reaction/shock: Cases of anaphylactic reaction/shock, including fatal events, have been reported in patients treated with intravenous ibandronic acid.
Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions.
The patient must seek medical attention immediately at the first sign of any adverse drug reaction.
Post Marketing: Musculoskeletal and connective tissue disorders: Osteonecrosis of the jaw has been reported very rarely in patients treated with ibandronic acid (refer to Precautions).