"March 7, 2013 -- An FDA panel voted to stop recommending calcitonin salmon for the treatment of osteoporosis in women who are at least five years past menopause.
The committee voted 12-9 against continued marketing of the drug, citing"...
Treatment of Postmenopausal Osteoporosis
BONIVA Injection is indicated for the treatment of osteoporosis in postmenopausal women. In postmenopausal women with osteoporosis, BONIVA increases bone mineral density (BMD) and reduces the incidence of vertebral fractures [see Clinical Studies].
Important Limitations of Use
The safety and effectiveness of BONIVA for the treatment of osteoporosis are based on clinical data of one year duration. The optimal duration of use has not been determined. 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.
DOSAGE AND ADMINISTRATION
Important Administration Instructions
BONIVA Injection must be administered intravenously only by a health care professional. Care must be taken not to administer intra-arterially or paravenously as this could lead to tissue damage [see WARNINGS AND PRECAUTIONS].
- Appropriate medical support and monitoring measures should be readily available when BONIVA Injection is administered. If anaphylactic or other severe hypersensitivity/allergic reactions occur, immediately discontinue the injection and initiate appropriate treatment [see WARNINGS AND PRECAUTIONS].
- Visually inspect the liquid in the prefilled syringe for particulate matter and discoloration before administration. Do not use prefilled syringes with particulate matter or discoloration.
- Administer only with the enclosed needle.
- Discard any unused portion.
- Do not mix with calcium-containing solutions or other intravenously administered drugs.
- Prefilled syringes are for single use only.
The recommended dose of BONIVA Injection for the treatment of postmenopausal osteoporosis is 3 mg every 3 months administered intravenously over a period of 15 to 30 seconds. Do not administer more frequently than once every 3 months.
Laboratory Testing and Oral Examination Prior to Administration
Prior to administration of each dose obtain a serum creatinine [see WARNINGS AND PRECAUTIONS]. Given that bisphosphonates have been associated with osteonecrosis of the jaw (ONJ), perform a routine oral examination prior to administration of BONIVA Injection.
Calcium and Vitamin D Supplementation
Dosing After Missed Dose
If the dose is missed, administer as soon as it can be re-scheduled. Thereafter, BONIVA Injection should be scheduled every 3 months from the date of the last injection.
Dosage Modifications in Patients with Renal Impairment
Do not administer to patients with severe renal impairment (creatinine clearance less than 30 mL/minute) [see WARNINGS AND PRECAUTIONS and CLINICAL PHARMACOLOGY]. No dose adjustment is necessary for patients with mild or moderate renal impairment (creatinine clearance greater than or equal to 30 mL/min) [see CLINICAL PHARMACOLOGY].
Dosage Forms And Strengths
BONIVA Injection is supplied as a kit containing:
- a 3 mg/3 mL single-use prefilled syringe.
- a 25-gauge, 3/4 inch needle with wings, needle-stick protection device, and a 9 cm plastic tubing for attachment
BONIVA Injection (ibandronate sodium) is supplied as a kit containing a 3 mg/3 mL single-use, clear glass, 5 mL (5 cc) prefilled syringe, a 25-gauge, 3/4 inch needle with wings, needle-stick protection device, and a 9 cm plastic tubing for attachment (NDC 0004 0191 09).
Storage and Handling
Store at 25°C (77°F); excursions permitted between 15° and 30°C (59° and 86°F) [see USP Controlled Room Temperature].
Distributed by Genentech USA Inc., a member of the Roche Group, 1 DNA Way, South San Francisco CA 94080-4990. Revised: April 2013
Last reviewed on RxList: 5/6/2013
This monograph has been modified to include the generic and brand name in many instances.
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