BONIVA Injection Dosing

BONIVA Injection—an effective dosing option

Administered over 15 to 30 seconds with an IV bolus injection
Intravenous administration eliminates the need for pre- and post-dose fasting and activity restrictions

Each BONIVA Injection kit contains a pre-filled syringe, butterfly needle, and two alcohol swabs
No reconstitution or refrigeration is necessary (store kit between 59°F and 86°F)

Patients with uncorrected hypocalcemia should not receive BONIVA Injection
Patients must receive supplemental calcium and vitamin D
Patients who receive BONIVA Injection should have serum creatinine measured prior to each dose
Patients with severe renal impairment (creatinine clearance <30 mL/min) should not receive BONIVA Injection

Reimbursement process similar to other injectables

Image: Quick 15- to 30-second administration with a 3-mg quarterly IV bolus injection

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 only be administered intravenously 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 (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 2.5 mg daily, the overall safety and tolerability profiles with the two dosing regimens were similar. The most commonly reported adverse events (>5%) regardless of causality were arthralgia (9.6% BONIVA Injection vs 8.6% BONIVA Tablet 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 in 24-48 hours.

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