Ibanox Adverse Reactions

Summary of the safety profile: The most serious reported adverse reactions are anaphylactic reaction/shock, atypical fractures of the femur, osteonecrosis of the jaw, gastrointestinal irritation, ocular inflammation (see paragraph "Description of selected adverse reactions" as follows and Precautions). The most frequently reported adverse reactions are arthralgia and influenza-like symptoms. These symptoms are typically in association with the first dose, generally of short duration, mild or moderate in intensity, and usually resolve during continuing treatment without requiring remedial measures (see paragraph "Influenza-like illness" as follows).
Tabulated list of adverse reactions: In Table 4, a complete list of known adverse reactions is presented. The safety of oral treatment with ibandronic acid 2.5 mg daily was evaluated in 1,251 patients treated in 4 placebo-controlled clinical studies, with the large majority of patients coming from the pivotal three-year fracture study (MF4411).
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 reaction, was 22.7% and 25.0% for ibandronic acid 150 mg once monthly after one and two years, respectively. Most cases did not lead to cessation of therapy.
Adverse reactions are listed according to MedDRA system organ class and frequency category.
Frequency categories are defined using the following convention: very common (>1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. (See Table 4.)

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Description of selected adverse reactions: Gastrointestinal adverse reactions: 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.
Influenza-like illness: Influenza-like illness includes events reported as acute phase reaction or symptoms including myalgia, arthralgia, fever, chills, fatigue, nausea, loss of appetite, or bone pain.
Osteonecrosis of jaw: Cases of osteonecrosis of the jaw have been reported, predominantly in cancer patients treated with medicinal products that inhibit bone resorption, such as ibandronic acid (see Precautions). Cases of ONJ have been reported in the post-marketing setting for ibandronic acid.
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.
ADR Reporting: The patient is advised to seek IMMEDIATE medical attention at the first sign of adverse drug reaction.