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

In postmenopausal women with osteoporosis, BONIVA increases BMD and reduces the incidence of vertebral fractures (see CLINICAL PHARMACOLOGY: Clinical Studies). Osteoporosis may be confirmed by the presence or history of osteoporotic fracture or by a finding of low bone mass (BMD more than 2.0 standard deviations below the premenopausal mean [ie, T-score]).

The recommended dose of BONIVA Injection for the treatment of postmenopausal osteoporosis is 3 mg every 3 months (see INDICATIONS AND USAGE) administered over a period of 15 to 30 seconds.

No cases of acute renal failure were observed in controlled clinical trials in which intravenous BONIVA was administered as a 15- to 30-second bolus. The risk of serious renal toxicity with other intravenous bisphosphonates appears to be inversely related to the rate of drug administration (see PRECAUTIONS).

BONIVA Injection must be administered by a health care professional.

BONIVA Injection must only be administered intravenously (see WARNINGS). Care must be taken not to administer BONIVA Injection intra-arterially or paravenously as this could lead to tissue damage.

Do not administer BONIVA Injection by any other route of administration. The safety and efficacy of BONIVA Injection following non-intravenous routes of administration have not been established.

Administer BONIVA Injection using the enclosed needle. Prefilled syringes are for single use only. Discard unused portion.

BONIVA Injection must not be mixed with calcium-containing solutions or other intravenously administered drugs.

Parenteral drug products should be inspected visually for particulate matter and discoloration before administration, and not used if particulate matter is visible or product is discolored. Prefilled syringes with particulate matter or discoloration should not be used.

If the dose is missed, BONIVA Injection should be administered as soon as it can be rescheduled. Thereafter, injections should be scheduled every 3 months from the date of the last injection. Do not administer BONIVA Injection (3 mg) more frequently than once every 3 months.

Patients must receive supplemental calcium and vitamin D (see PRECAUTIONS: INFORMATION FOR PATIENTS).

Patients with Hepatic Impairment

No dose adjustment is necessary (see CLINICAL PHARMACOLOGY: Special Populations).

Patients with Renal Impairment

No dose adjustment is necessary for patients with mild or moderate renal impairment where creatinine clearance is equal to or greater than 30 mL/min.

BONIVA Injection should not be administered to patients with severe renal impairment, ie, patients with serum creatinine > 200 μmol/L (2.3 mg/dL) or creatinine clearance (measured or estimated) < 30 mL/min (see CLINICAL PHARMACOLOGY: Special Populations).

Geriatric Patients

No dosage adjustment is necessary in the elderly (see PRECAUTIONS: Geriatric Use).

One prefilled syringe of BONIVA Injection (ibandronate sodium), 3 mg/3 mL single-use, clear glass prefilled syringe, in a box with 1 needle and 2 alcohol swabs (NDC 0004-0188-09).

Each syringe is a 5 mL (5 cc) volume syringe supplied with a 23-gauge, ¾ inch needle with wings, needle-stick protection device, and 3-inch plastic tubing for attachment.

Storage

Store at 25°C USP Controlled Room Temperature].

BONIVA is a registered trademark of Roche Therapeutics Inc. Distributed by: Pharmaceuticals, Roche Laboratories Inc., 340 Kingsland Street, Nutley, New Jersey 07110-1199, Co-promoted by Roche Laboratories Inc. and GlaxoSmithKline. Research Triangle Park, NC 27709. Revised: February 2007. FDA rev date: 2/12/2007

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