Side Effect Reporting

You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch.

You may also report side effects to Genentech at (888) 835-2555.

Indication

Boniva (ibandronate) Injection is indicated for the treatment of osteoporosis in postmenopausal women. In postmenopausal women with osteoporosis, BONIVA increases bone mineral density (BMD) and reduces the incidence of vertebral fractures.

Important Limitations of Use.

The safety and effectiveness of Boniva for the treatment of osteoporosis are based on clinical data of one year duration. The optimal duration of use has not been determined. All patients on bisphosphonate therapy should have the need for continued therapy re-evaluated on a periodic basis. Patients at low-risk for fracture should be considered for drug discontinuation after 3 to 5 years of use. Patients who discontinue therapy should have their risk for fracture re-evaluated periodically.

Important Safety Information

Contraindications

Boniva is contraindicated in patients with the following conditions:

  • Hypocalcemia
  • Known hypersensitivity to Boniva Injection or to any of its excipients. Cases of anaphylaxis, including fatal events, have been reported.

Warnings and Precautions

  • Hypocalcemia and Mineral Metabolism. Boniva Injection may cause a decrease in serum calcium values. Treat hypocalcemia, hypovitaminosis D, and other disturbances of bone and mineral metabolism before starting Boniva Injection therapy.
  • Anaphylactic Reaction. Cases of anaphylaxis, including fatal events, have been reported. If anaphylactic or other severe hypersensitivity/allergic reactions occur, immediately discontinue the injection and initiate appropriate treatment.
  • Renal Impairment. Do not administer Boniva Injection to patients with severe renal impairment (creatinine clearance less than 30 mL/min). BONIVA Injection should be withheld in patients with renal deterioration.
  • Tissue Damage Related to Inappropriate Drug Administration. Boniva Injection must only be administered intravenously. Do not administer Boniva Injection by any other route of administration.
  • Osteonecrosis of the Jaw. Osteonecrosis of the jaw has been reported in patients treated with Boniva Injection. While on treatment, patients with concomitant risk factors should avoid invasive dental procedures.
  • Musculoskeletal Pain. Severe and occasionally incapacitating bone, joint, and/or muscle pain has been reported in patients taking Boniva. Discontinue BONIVA if severe symptoms develop.
  • Atypical Subtrochanteric and Diaphyseal Femoral Fractures. Patients presenting with an atypical fracture should also be assessed for symptoms and signs of fracture in the contralateral limb. Interruption of bisphosphonate therapy should be considered, pending a risk/benefit assessment, on an individual basis

Additional Important Safety Information

The most frequently reported adverse reactions (>5%) are arthralgia, back pain, and abdominal pain.

Report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. Report side effects to Genentech at (888) 835-2555.

Please see additional Important Safety Information in full Prescribing Information.