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Ibandronate Injection

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IMPORTANT WARNING:

Posted 10/01/2007 FDA issued an early communication about the ongoing review of new safety data regarding the association of atrial fibrillation with the use of bisphosphonates. Bisphosphonates are a class of drugs used primarily to increase bone mass and reduce the risk for fracture in patients with osteoporosis, slow bone turnover in patients with Paget's disease of the bone, treat bone metastases, and lower elevated levels of blood calcium in patients with cancer.

FDA reviewed spontaneous postmarketing reports of atrial fibrillation reported in association with oral and intravenous bisphosphonates and did not identify a population of bisphosphonate users at increased risk of atrial fibrillation. In addition, as part of the data review for the recent approval of once-yearly Reclast for the treatment of postmenopausal osteoporosis, FDA evaluated the possible association between atrial fibrillation and the use of Reclast (zoledronic acid). Most cases of atrial fibrillation occurred more than a month after drug infusion. Also, in a subset of patients monitored by electrocardiogram up to the 11th day following infusion, there was no significant difference in the prevalence of atrial fibrillation between patients who received Reclast and patients who received placebo.

Upon initial review, it is unclear how these data on serious atrial fibrillation should be interpreted. Therefore, FDA does not believe that healthcare providers or patients should change either their prescribing practices or their use of bisphosphonates at this time. For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2007/safety07.htm#Bisphosphonates and http://www.fda.gov/cder/drug/early_comm/bisphosphonates.htm.

Why is this medication prescribed?

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Ibandronate injection is used to treat osteoporosis (a condition in which the bones become thin and weak and break easily) in women who have undergone menopause ('change of life,' end of menstrual periods). Ibandronate is in a class of medications called bisphosphonates. It works by preventing bone breakdown and increasing bone density (thickness).

How should this medicine be used?

Ibandronate injection comes as a solution (liquid) to be injected into a vein. Ibandronate injection is given only by a health care provider usually once every 3 months. Do not give an ibandronate injection to yourself.

Ibandronate injection controls osteoporosis but does not cure it. Ibandronate injection helps to treat osteoporosis only as long as you receive regular injections. It is important that you receive your ibandronate injection once every 3 months for as long as your health care provider prescribes it.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

Other uses for this medicine

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

In case of emergency/overdose

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

What other information should I know?

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain tests to check your body's response to ibandronate injection.

Before having any bone imaging study, tell your doctor and health care personnel that you are receiving ibandronate injection

Brand names

Boniva® Injection

Notes:

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EditText of this page (last edited March 11, 2008)