Zometa

Generic name: zoledronic acid (ZOE le DRON ik AS id)
Brand name: Zometa
Drug class: Bisphosphonates

Zometa (zoledronic acid - sometimes called zoledronate) is a bisphosphonate medicine that alters bone formation and breakdown in the body. This can slow bone loss and may help prevent bone fractures.

Zometa is used to treat high blood levels of calcium caused by cancer (also called hypercalcemia of malignancy). This medicine also treats multiple myeloma (a type of bone marrow cancer) or bone cancer that has spread from elsewhere in the body.

The Reclast brand of zoledronic acid is used in men and women to treat or prevent osteoporosis caused by menopause or by taking steroids. Reclast is also used to increase bone mass in men who have osteoporosis, and to treat Paget's disease of bone in men and women. You should not use Reclast and Zometa at the same time.

Warnings

Zoledronic acid may harm an unborn baby. Do not use Zometa if you are pregnant. Use effective birth control, and ask your doctor how long to prevent pregnancy after you stop this medicine.

Zometa can cause serious kidney problems, especially if you are dehydrated, if you take diuretic medicine, or if you already have kidney disease. Call your doctor if you urinate less than usual, if you have swelling in your feet or ankles, or if you feel tired or short of breath.

Also call your doctor if you have muscle spasms, numbness or tingling (in hands and feet or around the mouth), new or unusual hip pain, or severe pain in your joints, bones, or muscles.

Your doctor may recommend you have a dental exam for preventive tooth and gum care before you start your treatment with Zometa. This is especially important if you have cancer, if you are undergoing chemotherapy or using steroids, or if you have poor dental health.

Some people using medicines similar to Zometa have developed bone loss in the jaw, also called osteonecrosis of the jaw. Symptoms of this condition may include jaw pain, swelling, numbness, loose teeth, gum infection, or slow healing after injury or surgery involving the gums. You may be more likely to develop osteonecrosis of the jaw if you have cancer or have been treated with chemotherapy, radiation, or steroids. Other conditions associated with osteonecrosis of the jaw include blood clotting disorders, anemia (low red blood cells), and pre-existing dental problems.

Avoid having any type of dental surgery while you are being treated with Zometa. It may take longer than normal for you to recover.

Before taking this medicine

You should not be treated with Zometa if you are allergic to zoledronic acid.

You also should not receive Reclast if you have:

• low levels of calcium in your blood (hypocalcemia); or
• severe kidney disease.

You should not be treated with Zometa if are currently using any other bisphosphonate (such as alendronate, etidronate, ibandronate, pamidronate, risedronate, or tiludronate).

To make sure Zometa is safe for you, tell your doctor if you have ever had:

• kidney disease;
• hypocalcemia;
• thyroid or parathyroid surgery;
• surgery to remove part of your intestine;
• asthma caused by taking aspirin;
• any condition that makes it hard for your body to absorb nutrients from food (malabsorption);
• a dental problem (you may need a dental exam before you receive Zometa);
• if you are dehydrated; or
• if you take a diuretic or "water pill".

Zoledronic acid can cause serious kidney problems, especially if you are dehydrated, if you take diuretic medicine, or if you already have kidney disease.

This medicine may cause jaw bone problems (osteonecrosis). The risk is highest in people with cancer, blood cell disorders, pre-existing dental problems, or people treated with steroids, chemotherapy, or radiation. Ask your doctor about your own risk.

You may need to have a negative pregnancy test before starting treatment with Zometa.

Do not use Zometa if you are pregnant. Zoledronic acid may harm an unborn baby or cause birth defects. Zoledronic acid can remain in your body for weeks or years after your last dose. Use effective birth control to prevent pregnancy while using this medicine. Talk with your doctor about the need to prevent pregnancy after you stop using Zometa.

Zoledronic acid may affect fertility (ability to have children) in women. However, it is important to use birth control to prevent pregnancy because zoledronic acid can harm an unborn baby.

You should not breastfeed while using Zometa.

How is Zometa given?

Zometa is given as an infusion into a vein. A healthcare provider will give you this injection.

Drink at least 2 glasses of water within a few hours before your injection to keep from getting dehydrated.

You may need frequent medical tests to help your doctor determine how long to treat you with Zometa. Your kidney function may also need to be checked.

Pay special attention to your dental hygiene while using Zometa. Brush and floss your teeth regularly. If you need to have any dental work (especially surgery), tell the dentist ahead of time that you are using Zometa.

Zometa is only part of a complete program of treatment that may also include diet changes and taking calcium and vitamin supplements. Follow your doctor's instructions very closely.

Your doctor will determine how long to treat you with this medicine.

Dosing information

Usual Adult Dose for Osteolytic Bone Lesions of Multiple Myeloma:

Zometa: 4 mg IV over no less than 15 minutes, every 3 to 4 weeks.
Comments: Oral calcium supplement of 500 mg and a multiple vitamin containing 400 international units of vitamin D daily are recommended.
Uses: Patients with multiple myeloma and patients with documented bone metastases from solid tumors, in conjunction with standard antineoplastic therapy.

Usual Adult Dose for Osteolytic Bone Metastases of Solid Tumors:

Zometa: 4 mg IV over no less than 15 minutes, every 3 to 4 weeks.
Comments: Oral calcium supplement of 500 mg and a multiple vitamin containing 400 international units of vitamin D daily are recommended.
Uses: Patients with multiple myeloma and patients with documented bone metastases from solid tumors, in conjunction with standard antineoplastic therapy.

Usual Adult Dose for Hypercalcemia of Malignancy:

Zometa: Maximum dose: Single dose of 4 mg IV infusion over no less than 15 minutes.
Comments: If serum calcium does not return to normal, retreatment should be considered after a minimum of 7 elapsed days.
Use: Treatment of hypercalcemia of malignancy (albumin-corrected calcium equal 12 mg/dL or greater).

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your Zometa injection.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while receiving Zometa?

Avoid smoking, or try to quit. Smoking can reduce your bone mineral density, making fractures more likely.

Avoid drinking large amounts of alcohol. Heavy drinking can also cause bone loss.

Zometa side effects

Get emergency medical help if you have signs of an allergic reaction to Zometa: hives; wheezing, chest tightness, trouble breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• new or unusual pain in your thigh or hip;
• jaw pain or numbness, red or swollen gums, loose teeth, or slow healing after dental work;
• severe joint, bone, or muscle pain;
• kidney problems - little or no urination, swelling in your feet or ankles, feeling tired;
• low red blood cells (anemia) - pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet; or
• low calcium levels - muscle spasms or contractions, numbness or tingly feeling (around your mouth, or in your fingers and toes).

Serious side effects on the kidneys may be more likely in older adults.

Common Zometa side effects may include:

• trouble breathing;
• nausea, vomiting, diarrhea, constipation;
• bone pain, muscle or joint pain;
• fever or other flu symptoms;
• tiredness;
• eye pain or swelling;
• pain in your arms or legs;
• headache; or
• anemia.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Zometa?

Zoledronic acid can harm your kidneys, especially if you also use certain medicines for infections, cancer, osteoporosis, organ transplant rejection, bowel disorders, high blood pressure, or pain or arthritis (including Advil, Motrin, and Aleve).

Other drugs may interact with zoledronic acid, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.