Boniva® (ibandronate sodium) Tablets
Full Prescribing Information (221K/PDF)
Important Patient Information (67K/PDF)
May 26, 2005 Boniva 2.5 mg Customer Letter (46K/PDF)

06-30-2009 Boniva® (ibandronate sodium) 2.5mg Tablets Product On Back Order (652K/PDF)

02-27-2009 Boniva® (ibandronate sodium) 2.5mg Tablets Short-Dated Supply Situation (393K/PDF)

Boniva is a prescription medication used for osteoporosis treatment in women after menopause. Boniva helps reverse bone loss in most women who take it, even though they won't be able to see or feel a difference. Boniva may help lower the chances of breaking bones (fractures).

For Boniva to treat osteoporosis, patients have to take it as prescribed. Boniva will not work if patients stop taking it.

Important Safety Information for Boniva Tablets People should not take Boniva if they have certain problems with their esophagus (the tube that connects the mouth and stomach), low blood calcium, cannot sit or stand for at least 60 minutes, have severe kidney disease, or are allergic to Boniva. Patients should stop taking Boniva and tell their doctor right away if they experience difficult or painful swallowing, chest pain, or severe or continuing heartburn, as these may be signs of serious upper digestive problems. Patients must follow the dosing instructions for once-monthly Boniva carefully to lower the chance of these events occurring. Side effects may include diarrhea, pain in the arms or legs, or upset stomach. Patients should tell their doctor and dentist about all the medicines they take. Patients should tell their doctor and dentist if they develop jaw problems (especially following a dental procedure) or severe bone, joint, and/or muscle pain. Their doctor may also recommend a calcium and vitamin D supplement.

For additional important safety information, including the full prescribing information, please visit www.boniva.com.

 

Boniva® (ibandronate sodium) Injection
Full Prescribing Information (245K/PDF)
Important Patient Information (84K/PDF)

06-13-2008 Packaging Change: Boniva® (ibandronate sodium) Single-Use Pre-Filled Syringe (3mg/ml) (210K/PDF)

03-01-2006 New Product Announcement Boniva® (ibandronate sodium) Injection (345K/PDF)

Boniva Injection is indicated for the treatment of osteoporosis in postmenopausal women.

Important Safety Information for Boniva Injection Boniva Injection is contraindicated in patients with uncorrected hypocalcemia or known hypersensitivity to Boniva Injection or any of its excipients. Boniva Injection, like other bisphosphonates administered intravenously, may cause a transient decrease in serum calcium values. Hypocalcemia, hypovitaminosis D, and other disturbances of bone and mineral metabolism must be effectively treated before starting therapy. Patients must receive supplemental calcium and vitamin D. Boniva Injection must be administered intravenously only by a healthcare professional. Patients who receive Boniva Injection should have serum creatinine measured prior to each dose. Boniva Injection should not be administered to patients with severe renal impairment (serum creatinine >2.3mg/dL or creatinine clearance <30 mL/min). Rarely, patients have reported severe bone, joint, and/or muscle pain after taking bisphosphonate therapy for osteoporosis. Osteonecrosis of the jaw has been reported in patients treated with bisphosphonates; most cases have been in cancer patients undergoing dental procedures who received intravenous bisphosphonates.

In a one-year study comparing Boniva Injection 3 mg quarterly and Boniva Tablets 2.5mg daily, the overall safety and tolerability profiles of the two dosing regimens were similar. The most commonly reported adverse events (≥5.0%), regardless of causality, were arthralgia (9.6% Boniva Injection vs 8.6% Boniva Tablets 2.5 mg), back pain (7.0% vs 7.5%), hypertension (5.3% vs 7.1%), abdominal pain (5.1% vs 5.6%), influenza (4.7% vs 8.0%) and nasopharyngitis (3.4% vs 6.0%). In some patients acute phase reaction-like events (10% Boniva Injection vs 4% Boniva Tablets) have been reported within 3 days of an IV dose and lasting for 7 days or less, most commonly after the first injection. In most cases, no specific treatment was required and symptoms subsided within 24-48 hours.

View full prescribing information for additional safety information.