Generic Name: zoledronic acid (ZOE le DRON ik AS id)
Brand Names: Reclast, Zometa

What is Zometa?

Zometa (zoledronic acid) belongs to a group of medicines called bisphosphonates (bis FOS fo nayts). Zoledronic acid inhibits the release of calcium from bones.

Zometa is used to treat high blood levels of calcium caused by cancer (hypercalcemia of malignancy). Zometa 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 to treat Paget's disease, and to treat or prevent osteoporosis in postmenopausal women or people who take certain steroid medicines. Reclast is also used to increase bone mass in men with osteoporosis.

You should not be treated with Reclast if you are already receiving Zometa.

Zometa may also be used for purposes not listed in this medication guide.

Important information

Do not use Zometa if you are pregnant. It could harm the unborn baby.

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

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.

Slideshow: Flashback: FDA Drug Approvals 2013

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.

Zometa can harm your kidneys. This effect is increased when you also use other medicines harmful to the kidneys, such as: chemotherapy, antiviral medication, pain or arthritis medicine, injected antibiotics, or medicines to treat a bowel disorder or prevent organ transplant rejection.

Before taking this medicine

You should not use Zometa if you are allergic to zoledronic acid.

You also should not use Reclast if you have:

  • severe kidney disease; or

  • low levels of calcium in your blood.

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

  • kidney disease;

  • a history of thyroid or parathyroid surgery;

  • malabsorption syndrome (an inability to absorb food and nutrients properly);

  • a history of surgical removal of part of your intestine;

  • asthma caused by taking aspirin;

  • planned dental work or oral surgery;

  • if you are dehydrated;

  • if you take a diuretic ("water pill"); or

  • if you are using other bisphosphonates (alendronate, etidronate, ibandronate, pamidronate, risedronate, Actonel, Fosamax, Boniva, and others).

In rare cases, Zometa may cause bone loss (osteonecrosis) in the jaw. Symptoms include jaw pain or numbness, red or swollen gums, loose teeth, or slow healing after dental work. The longer you use Zometa, the more likely you are to develop this condition.

Osteonecrosis of the jaw may be more likely if you have cancer or received chemotherapy, radiation, or steroids. Other risk factors include blood clotting disorders, anemia (low red blood cells), and a pre-existing dental problem.

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.

FDA pregnancy category D. Do not use Zometa if you are pregnant. It could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment.

See also: Pregnancy and breastfeeding warnings (in more detail)

Zoledronic acid can pass into breast milk and may harm a nursing baby. Do not receive Zometa without telling your doctor if you are breast-feeding a baby.

How is Zometa given?

Zometa is injected into a vein through an IV. 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.

Your doctor may want you to take a calcium and/or vitamin D supplement while you are being treated with Zometa. Carefully follow your doctor's instructions about the type and strength of calcium to take.

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.

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

Zometa side effects

Get emergency medical help if you have any of these 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:

  • fever, chills, flu symptoms, flushing (warmth, redness, or tingly feeling);

  • severe joint, bone, or muscle pain;

  • new or unusual pain in your thigh or groin;

  • pale skin, feeling light-headed or short of breath;

  • hypocalcemia--numbness or tingly feeling in your fingers or toes or around your mouth, twitching, muscle spasms or cramps; or

  • signs of a kidney problem--little or no urinating; painful or difficult urination; swelling, rapid weight gain; feeling tired or short of breath.

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

Common Zometa side effects may include:

  • nausea, vomiting, stomach pain, loss of appetite;

  • diarrhea, constipation;

  • bone pain, back pain, muscle or joint pain;

  • swelling in your feet or ankles;

  • weight loss;

  • headache, tiredness, weakness, dizziness;

  • numbness or tingling;

  • cough, trouble breathing; or

  • sleep problems (insomnia).

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.

See also: Side effects (in more detail)

What other drugs will affect Zometa?

Zometa can harm your kidneys. This effect is increased when you also use certain other medicines, including: antivirals, chemotherapy, injected antibiotics, medicine for bowel disorders, medicine to prevent organ transplant rejection, injectable osteoporosis medication, and some pain or arthritis medicines (including aspirin, Tylenol, Advil, and Aleve).

Other drugs may interact with zoledronic acid, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Where can I get more information?

  • Your doctor or pharmacist can provide more information about Zometa.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Zometa only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2014 Cerner Multum, Inc. Version: 14.01. Revision Date: 2014-05-15, 10:23:06 AM.

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