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Zoledronic Acid 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.

Zoledronic acid is used to treat high levels of calcium in the blood that may be caused by certain types of cancer. Zoledronic acid is also used along with cancer chemotherapy to treat bone damage caused by multiple myeloma cancer that begins in the plasma cells (white blood cells that produce substances needed to fight infection) or by cancer that began in another part of the body but has spread to the bones. Zoledronic acid is not cancer chemotherapy, and it will not slow or stop the spread of cancer. However, it can be used to treat bone disease in patients who have cancer. Zoledronic acid is in a class of medications called bisphosphonates. It works by slowing bone breakdown and decreasing the amount of calcium released from the bones into the blood.

How should this medicine be used?

Zoledronic acid comes as a solution (liquid) to infuse (inject slowly) intravenously (into a vein) over at least 15 minutes. It is usually injected by a health care provider in a doctor's office, hospital, or clinic. When zoledronic acid is used to treat high blood levels of calcium caused by cancer it is usually given as a single dose. A second dose may be given at least 7 days after the first dose if blood calcium does not drop to normal levels or remain at normal levels. When zoledronic acid is used to treat bone damage caused by multiple myeloma or cancer that has spread to the bones, it is usually given once every 3-4 weeks.

Your doctor will prescribe a calcium supplement and a multivitamin containing vitamin D to take during your treatment. You should take these supplements every day.

Other uses for this medicine

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

What storage conditions are needed for this medicine?

Your doctor will store this medication in his or her office and give it to you as needed.

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.

Symptoms of overdose may include:

fever
tingling in hands or feet
weakness
muscle cramps
fast, pounding, or irregular heartbeat
dizziness
depression
difficulty walking
seizures
confusion
shortness of breath
sudden tightening of muscles
numbness, burning, or tingling in fingers or toes
muscle weakness
double vision
difficulty speaking

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 lab tests to check your body's response to zoledronic acid.

Brand names

Zometa®

Notes:

[Watch page ]

EditText of this page (last edited February 27, 2008)