Boniva Tablets® (ibandronate sodium)

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 is indicated for the treatment and prevention of osteoporosis in postmenopausal women. Boniva increases bone mineral density (BMD) and reduces the incidence of vertebral fractures.

Important Limitations of Use

The optimal duration of use has not been determined. The safety and effectiveness of Boniva for the treatment of osteoporosis are based on clinical data of three years duration. 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:

  • Abnormalities of the esophagus which delay esophageal emptying such as stricture or achalasia
  • Inability to stand or sit upright for at least 60 minutes
  • Hypocalcemia
  • Known hypersensitivity to Boniva Injection or to any of its excipients. Cases of anaphylaxis, including fatal events, have been reported.

Warnings and Precautions

  • Upper Gastrointestinal Adverse Reactions. Boniva may cause local irritation of the upper gastrointestinal mucosa. Physicians should therefore be alert to any signs or symptoms signaling a possible esophageal reaction and patients should be instructed to discontinue BONIVA and seek medical attention if they develop dysphagia, odynophagia, retrosternal pain or new or worsening heartburn.
  • Hypocalcemia and Mineral Metabolism. Treat hypocalcemia and other disturbances of bone and mineral metabolism before starting Boniva therapy. Instruct patients to take supplemental calcium and vitamin D if their dietary intake is inadequate.
  • Musculoskeletal Pain. Severe and occasionally incapacitating bone, joint, and/or muscle pain has been reported in patients taking Boniva. Consider discontinuing use if severe symptoms develop.
  • Jaw Osteonecrosis. Osteonecrosis of the jaw has been reported in patients treated with Boniva. Patients who develop osteonecrosis of the jaw while on bisphosphonate therapy should receive care by an oral surgeon.
  • 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.
  • Severe Renal Impairment. Boniva is not recommended for use in patients with severe renal impairment (creatinine clearance of less than 30 mL/min).

Additional Important Safety Information

The most frequently reported adverse reactions (>5%) are back pain, dyspepsia, pain in extremity, diarrhea, headache, and myalgia.

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.