What is Zometa?

Zometa (zoledronic acid) is used to treat hypercalcemia (excess calcium in the blood) that may occur with some types of cancer. It is also used to treat multiple myeloma (tumors formed by the cells of the bone marrow), as well as to treat bone metastasis (spread of cancer).

Zometa is an intravenous bisphosphonate drug made by Novartis Pharmaceuticals Corporation, and was approved by the U.S. Food and Drug Administration (FDA) in 2001 for treating hypercalcemia, and in 2002 for treatment of bone metastasis.

Zometa and Osteonecrosis of the Jaw

In September 2004, Novartis Pharmaceuticals and the FDA notified dental healthcare professionals of revisions to prescribing information to describe the occurrence of osteonecrosis of the jaw (ONJ) observed in cancer patients receiving treatment with intravenous bisphosphonates (such as Zometa). ONJ is a medical condition in which the jawbone partially crumbles and dies. ONJ may cause severe pain, loose teeth, exposed bone, loss of function, and disfigurement.

The revised prescribing information recommends that cancer patients receive a dental examination prior to starting bisphosphonate treatment, and that they avoid invasive dental procedures while on these medications.

Taking Zometa

Because Zometa is administered intravenously, it should only be administered by or under the supervision of your doctor or healthcare professional. Follow your healthcare professional's orders regarding Zometa dosing.

It is important that your healthcare professional check your progress at regular visits after you start taking Zometa, even if your condition improves. Tell your healthcare professional right away if you experience any of the following symptoms while taking Zometa:

• agitation
• blood in urine
• coma
• confusion
• decreased urine output
• depression
• dizziness
• headache
• irritability
• lethargy
• muscle twitching
• nausea
• rapid weight gain
• seizures
• stupor
• swelling of face, ankles, or hands
• unusual tiredness or weakness

These could be signs of serious kidney problems.

Zometa Health Risks and Side Effects

Zometa may cause side effects. Tell your healthcare professional if any of these symptoms are severe and/or persistent:

• redness or swelling in the place where you received your injection
• red, swollen, or teary eyes
• constipation
• upset stomach
• vomiting
• diarrhea
• stomach pain
• loss of appetite
• weight loss
• heartburn
• difficulty swallowing
• mouth sores
• pain anywhere in the body
• excessive worry
• agitation
• difficulty falling asleep or staying asleep
• white patches in the mouth
• swelling, redness, irritation, burning, or itching of the vagina
• white vaginal discharge
• hair loss

Some side effects can be serious. The following symptoms are uncommon, but if you experience any of them, call your healthcare professional immediately:

• fever, chills, and other signs of infection
• bone, joint, or muscle pain, and other flu-like symptoms
• rash
• itching
• chest pain
• coughing
• weakness
• muscle cramps
• fast, pounding, or irregular heartbeat
• dizziness
• depression
• difficulty walking
• seizures
• confusion
• leg swelling
• shortness of breath
• sudden tightening of muscles
• numbness, burning, or tingling in fingers or toes
• dry mouth
• decreased urination
• sunken eyes
• sluggishness
• headache
• pale skin
• unusual bruising or bleeding
• frequent urination, especially at night
• excessive thirst
• hallucinations (seeing things or hearing voices that do not exist)
• muscle weakness
• double vision
• difficulty speaking
• jaw or mouth pain

What Should I Tell My Healthcare Professional?

You should tell your healthcare professional if you:

• have or had any unusual allergic reaction to Zometa or other medications used to treat high blood calcium or osteoporosis; or if you are allergic to any other substances (foods, preservatives, or dyes)

• are or may be pregnant, are planning to become pregnant, or are breast-feeding. Animal studies have shown that Zometa causes birth defects. Studies have not been done in pregnant women, and it is unknown if Zometa passes into breast milk. However, Zometa is not recommended during breast-feeding, because it can cause bone problems in nursing babies.

• have asthma

• have heart disease

• have kidney disease

• have cancer or are undergoing cancer treatment

• are planning to have dental procedures or surgery while receiving Zometa treatment - jaw tightness, swelling, numbing, or pain or loose tooth could all be signs of serious jaw disease

• have poor dental hygiene

• experience dehydration (not having enough water or fluids in your body can increase the risk of severe kidney problems while take Zometa)

• have liver problems