Consumer Drug Information

zoledronic acid

Generic Name: zoledronic acid (zole DRO nik AS sid)
Brand names: Reclast, Zometa, Zometa Concentrate, Aclasta

What is zoledronic acid?

Zoledronic acid (sometimes called zoledronate) is in a group of medicines called bisphosphonates (bis FOS fo nayts). Zoledronic acid inhibits the release of calcium from bones.

Zoledronic acid is used to treat Paget's disease, and high blood levels of calcium caused by cancer (hypercalcemia of malignancy). Zoledronic acid also treats multiple myeloma (a type of bone marrow cancer) or bone cancer that has spread from elsewhere in the body.

Zoledronic acid is also used to treat or prevent osteoporosis in postmenopausal women, and to increase bone mass in men with osteoporosis. Zoledronic acid is used to treat or prevent osteoporosis in people who will be taking certain steroid medicines for 12 months or longer.

Zoledronic acid may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about zoledronic acid?

Do not receive zoledronic acid without telling your doctor if you have had an allergic reaction to zoledronic acid or similar medicine such as alendronate (Fosamax), etidronate (Didronel), ibandronate (Boniva), pamidronate (Aredia), risedronate (Actonel), or tiludronate (Skelid). Do not use this medication without telling your doctor if you are pregnant. It could cause harm to the unborn baby. Use an effective form of birth control, and tell your doctor if you become pregnant during treatment.

Your doctor may recommend you have a dental exam for preventive tooth and gum care before you start your treatment with zoledronic acid. 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 zoledronic acid 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 zoledronic acid. It may take longer than normal for you to recover.

What should I discuss with my healthcare provider before receiving zoledronic acid?

You should not receive this medication if you are allergic to zoledronic acid or similar medicine such as alendronate (Fosamax), etidronate (Didronel), ibandronate (Boniva), pamidronate (Aredia), risedronate (Actonel), or tiludronate (Skelid).

You should also not receive zoledronic acid if you have:

low levels of calcium in your blood; or
if you are pregnant or breast-feeding.

Zometa and Reclast are two different brands of zoledronic acid. You should not be treated with Reclast if you are already receiving Zometa. Before receiving a Reclast injection, tell your doctor if you are already being treated with Zometa.

Before receiving zoledronic acid, tell your doctor if you have:

aspirin-sensitive asthma;
a thyroid or parathyroid disorder;
malabsorption syndrome (an inability to absorb food and nutrients properly);
a history of surgical removal of part of your intestine;
bone cancer; or
kidney disease.

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 dental surgery or pre-existing dental problems.

FDA pregnancy category D. This medication can cause harm to an unborn baby. Do not receive zoledronic acid without telling your doctor if you are pregnant. Use an effective form of birth control, and tell your doctor if you become pregnant during treatment. Zoledronic acid can pass into breast milk and may harm a nursing baby. Do not receive this medication without telling your doctor if you are breast-feeding a baby.

How is zoledronic acid given?

Zoledronic acid is given as an injection through a needle placed into a vein. You will receive this injection in a clinic or hospital setting. The medicine must be given slowly through an IV infusion, and can take at least 15 minutes to complete.

Zoledronic acid is sometimes given only once per year. Follow your doctor's instructions.

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 zoledronic acid. Carefully follow your doctor's instructions about the type and strength of calcium to take.

To be sure this medication is helping your condition and not causing harmful side effects, your blood will need to be tested on a regular basis. Your kidney function may also need to be tested. It is important that you not miss any scheduled visits to your doctor.

What happens if I miss a dose?

Contact your doctor if you miss a dose of zoledronic acid.

What happens if I overdose?

Seek emergency medical attention if you think you have received too much of this medicine. Overdose symptoms may include numbness or tingling in your hands and feet, muscle stiffness, spasms in the muscles of your face, uneven heartbeats, and wheezing or trouble breathing.

What should I avoid while receiving zoledronic acid?

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

Zoledronic acid side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects:

urinating less than usual or not at all;
muscle spasms, numb or tingly feeling (especially around your mouth);
fever, chills, body aches, flu symptoms;
pale skin, easy bruising, unusual weakness;
severe joint, bone, or muscle pain; or
bronchospasm (wheezing, chest tightness, trouble breathing).

Less serious side effects may include:

cough;
loss of appetite, nausea, vomiting;
diarrhea, constipation;
headache, tired feeling;
mild joint or muscle pain; or
redness or swelling where the needle was placed.

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.

Zoledronic acid Dosing Information

Usual Adult Dose for Osteolytic Bone Lesions of Multiple Myeloma:

Zometa:
4 mg given as a 15 minute intravenous infusion every 3 to 4 weeks.

Usual Adult Dose for Osteolytic Bone Metastases of Solid Tumors:

Zometa:
4 mg given as a 15 minute intravenous infusion every 3 to 4 weeks.

Usual Adult Dose for Hypercalcemia of Malignancy:

Zometa:
4 mg given as a 15 minute intravenous infusion. It is recommended that a minimum of 7 days elapse before retreatment.

Usual Adult Dose for Paget's Disease:

Reclast:
5 mg zoledronic acid in 100 mL intravenous infusion given over a period of not less than 15 minutes.

Usual Adult Dose for Osteoporosis:

Men, postmenopausal women and patients with glucocorticoid-induced osteoporosis expected to be on glucocorticoids for at least 12 months (Reclast):
5 mg intravenous infusion once a year given over no less than 15 minutes.

Usual Adult Dose for Prevention of Osteoporosis:

Reclast
For the prevention of glucocorticoid-induced osteoporosis in patients expected to be on glucocorticoids for at least 12 months: 5 mg intravenous infusion once a year given over no less than 15 minutes.

For the prevention of osteoporosis in postmenopausal women:
5 mg intravenous infusion given once every 2 years intravenously over no less than 15 minutes. Patients must be adequately supplemented with calcium and vitamin D if dietary intake is not sufficient. Postmenopausal women require an average of 1200 mg calcium and 800 to 1000 International Units of vitamin D daily.

What other drugs will affect zoledronic acid?

Before receiving zoledronic acid, tell your doctor if you are using any of the following drugs:

a diuretic (water pill);
an antibiotic such as amikacin (Amikin), gentamicin (Garamycin), kanamycin (Kantrex), neomycin (Mycifradin, Neo-Fradin, Neo-Tab), streptomycin, tobramycin (Nebcin, Tobi);
other medicines that can harm your kidneys, such as pentamidine (Nebupent), tacrolimus (Prograf), amphotericin B (Fungizone, AmBisome, Amphotec, Abelcet), capreomycin (Capastat), rifampin (Rifadin, Rimactane, Rifater), vancomycin (Vancocin, Vancoled), acyclovir (Zovirax), adefovir (Hepsera), cidofovir (Vistide), or foscarnet (Foscavir);
cancer medicine such as aldesleukin (Proleukin), carmustine (BiCNU, Gliadel), cisplatin (Platinol), ifosfamide (Ifex), oxaliplatin (Eloxatin), streptozocin (Zanosar), thalidomide (Thalomid), or tretinoin (Vesanoid); or
a non-steroidal anti-inflammatory drug (NSAID) such as ibuprofen (Motrin, Advil), naproxen (Aleve, Naprosyn), diclofenac (Cataflam, Voltaren), etodolac (Lodine), indomethacin (Indocin), ketoprofen (Orudis), piroxicam (Feldene), and others.

This list is not complete and there may be other drugs that can interact with zoledronic acid. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

Your doctor or pharmacist can provide more information about zoledronic acid.

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.