BONIVA Injection—Quarterly Injectable Bisphosphonate

BONIVA Injection: Proven experience your patients can count on

Established safety and tolerability profile

Demonstrated tolerability
Two years of experience with patients with PMO

Proven efficacy

Provides fracture protection with significant increases in BMD
Provides an alternative for women with PMO, including those who have difficulty with oral dosing requirements
Extends your ability to treat more patients with BONIVA

Effective patient management on a quarterly basis

Quarterly visits allow

More frequent patient monitoring
Regular patient feedback

Office administration assures compliance

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

Administered intravenously over 15 to 30 seconds
Eliminates the need for pre- and post-dose fasting
Everything you need is included

Prefilled syringe, butterfly needle, and alcohol swabs
No reconstitution or refrigeration is necessary (store kit at 77°F; excursions permitted between 59°F and 86°F)

Image: Janice, Age: 68, Intolerant to oral bisphosphonates

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.

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