Zoledronic Acid

Zoledronic acid is a prescription medication used to treat high blood calcium caused by cancer, and to prevent or delay bone problems due to cancer. Zoledronic acid belongs to a group of drugs called biphosphonates, which slow the breakdown of bone. 

Zoledronic acid is given to treat and prevent osteoporosis in postmenopausal women and to treat osteoporosis in men.

Zoledronic acid is given for the treatment and prevention of glucocorticoid-induced osteoporosis and for the treatment of Paget's disease.

This medication comes in an injectable form to be given directly into a vein (IV) by a healthcare provider. How often you will receive zoledronic acid will depend on what you are being treated for.

For high blood calcium zoledronic acid is given once. For bone problems caused by cancer, it may given every 3 or 4 weeks for as long as 24 months.

Common side effects of zoledronic acid include fever, nausea, bone pain, and fatigue.

Zoledronic acid is a prescription medicine used:

• to treat high blood calcium caused by cancer (known medically as hypercalcemia of malignancy, HCM),
• with anti-cancer medicines to prevent or delay bone problems due to cancer (multiple myeloma and solid tumor cancers that have spread to the bone.)
• to treat and prevent osteoporosis in postmenopausal women
• to treat osteoporosis in men
• to treat and prevent glucocorticoid-induced osteoporosis
• to treat Paget's disease

​This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Zoledronic Acid may be found in some form under the following brand names:

• Reclast

• Zometa

Hypercalcemia of malignancy (HCM) patients may experience side effects including:

• flu-like symptoms (fever, chills, flushing, bone pain and/or joint or muscle pain)

Common side effects in HCM patients include:

• fever
• nausea
• constipation
• anemia
• shortness of breath
• diarrhea
• abdominal pain
• worsening of cancer
• insomnia
• vomiting
• anxiety
• urinary tract infection
• low phosphate levels
• confusion
• agitation
• a fungal infection called moniliasis
• low potassium levels
• coughing
• skeletal pain
• low blood pressure
• low magnesium levels
• redness and swelling injection site

Common side effects for patients with multiple myeloma and bone metastases due to solid tumors include:

• bone pain
• nausea
• fatigue
• anemia
• fever
• vomiting
• constipation
• shortness of breath
• diarrhea
• weakness
• muscle pain
• anorexia
• cough
• joint pain
• lower-limb swelling
• worsening of your cancer
• headache
• dizziness (excluding vertigo)
• insomnia
• decreased weight
• back pain
• numbness/tingling
• abdominal pain

Common side effects for patients being treated for osteoporosis or Paget’s disease:

• Fever
• Pain in your bones, joints or muscles
• Pain in your arms and legs
• Headache
• Flu-like illness (fever, chills, bone, joint, or muscle pain, fatigue)
• Nausea
• Vomiting
• Diarrhea

Eye-related side effects may occur with bisphosphonates, including zoledronic acid. Cases of swelling related to fluid build-up in the eye, as well as inflammation of the uvea, sclera, episclera, conjunctiva, and iris of the eye have been reported.

This is not a complete list of zoledronic acid side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• medicines which may be harmful to the kidney 
• medicines which are excreted by the kidney such as digoxin (Lanoxin)
• aminoglycosides such as amikacin (Amikin), gentamicin (Garamycin), kanamycin (Kantrex), neomycin (Neo-Fradin),  streptomycin, tobramycin
• certain diuretics ("water pills") such as bumetanide (Bumex), ethacrynic acid (Edecrin), and furosemide (Lasix).
• non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen (Advil, Motrin), naproxen (Aleve)
• vancomycin (Vancocin)

Ask your doctor or pharmacist for a list of these medicines, if you are not sure.

This is not a complete list of zoledronic acid drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with zoledronic acid including the following:

• Low calcium levels in your blood (hypocalcemia). Zoledronic acid may lower the calcium levels in your blood. If you have low blood calcium before you start taking zoledronic acid, it may get worse during treatment. Your low blood calcium must be treated before you take zoledronic acid. Most people with low blood calcium levels do not have symptoms, but some people may have symptoms. Call your doctor right away if you have symptoms of low blood calcium such as:
  • Spasms, twitches, or cramps in your muscles
  • Numbness or tingling in your fingers, toes, or around your mouth

• Severe kidney problems. Severe kidney problems may happen when you take zoledronic acid. Severe kidney problems may lead to hospitalization or kidney dialysis and can be life-threatening. Your risk of kidney problems is higher if you:
  • already have kidney problems
  • take a diuretic or “water pill"
  • do not have enough water in your body (dehydrated) before or after you receive zoledronic acid
  • are of advanced age since the risk increases as you get older
  • take any medicines known to harm your kidneys

• Severe jaw bone problems (osteonecrosis). Severe jaw bone problems may happen when you take zoledronic acid. Your doctor should examine your mouth before you start zoledronic acid. Your doctor may tell you to see your dentist before you start zoledronic acid. It is important for you to practice good mouth care during treatment with zoledronic acid.
• Possible harm to your unborn baby. Zoledronic acid should not be used if you are pregnant. Tell your doctor right away if you are
  
  pregnant or plan to become pregnant. Zoledronic acid may harm your unborn baby.
• Bone, joint, or muscle pain. Some people who take bisphosphonates, such as zoledronic acid, develop severe bone, joint, or muscle pain.
• Femoral fractures. These fractures may occur after minimal or no trauma. Tell your doctor if you have thigh or groin pain.

Do not take zoledronic acid if you:

• are allergic to zoledronic acid or any components of zoledronic acid. Severe allergic reactions have occurred with zoledronic acid use. These reactions, including rare cases of hives and swelling near the eyes and lips, and very rare cases of life-threatening allergic reactions, have been reported.
• are being treated with another medication containing zoledronic acid. Zometa and Reclast both belong in a class of drugs called bisphosphonates and they contain the same active ingredient.
• have low levels of calcium in your blood.
• have kidney problems, tell your doctor. The risk of adverse reactions (especially related to the kidney) may be greater for you. It is important to get your blood tests while you are receiving zoledronic acid. Your doctor will monitor your kidney function before each dose. Tell your doctor if you are on other drugs, including aminoglycosides, loop diuretics, and drugs which may be harmful to the kidney. See "Drug Interactions" section.

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of zoledronic acid there are no specific foods that you must exclude from your diet when receiving zoledronic acid.

Before you start zoledronic acid, be sure to talk to your doctor if you:

• Are receiving another medication containing zoledronic acid. Zometa and Reclast have the same active ingredient.
• Are allergic to zoledronic acid or any of its ingredients, or any other medication, especially bisphosphonates.
• Have low blood calcium.
• Have kidney problems.
• Have liver problems.
• Had parathyroid or thyroid surgery (glands in your neck).
• Have been told you have trouble absorbing minerals in your stomach or intestines (malabsorption syndrome) or have had parts of your intestine removed.
• Have asthma (wheezing) from taking aspirin.
• Plan to have dental surgery or teeth removed.
• Are pregnant, or plan to become pregnant. Zoledronic acid may harm your unborn baby. Zoledronic acid should not be used if you are pregnant.
• Are breastfeeding or plan to breastfeed. It is not known if zoledronic acid passes into your milk and may harm your baby.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant, or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Zoledronic acid falls into category D. There are no adequate and well-controlled studies of zoledronic acid in pregnant women. Zoledronic acid may harm your unborn baby. Zoledronic acid should not be used if you are pregnant.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if zoledronic acid passes into your milk and may harm your baby. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using zoledronic acid.

Zoledronic acid is injected into the vein (intravenous) (IV) by a healthcare provider in a hospital or other medical facility.

• The infusion takes at least 15 minutes.
• Your doctor will monitor your kidney function before each dose.
• Your doctor may advise you to take oral calcium supplements and vitamin D daily.
• Drink plenty of water before receiving zoledronic acid injection.
• Administration of acetaminophen following zoledronic acid treatment may reduce the incidence of certain reactions such as chills, fever, joint pain, and bone pain.

Zometa (zoledronic acid):

• Zoledronic acid is given as a single dose in people with high blood calcium due to cancer (known medically as hypercalcemia of malignancy), although, sometimes a second dose is required. The second dose must be given at least 7 days after the first dose.
• Zoledronic acid is given every 3 to 4 weeks when used to prevent bone problems in people with cancer. Your doctor will make the decision as to how long you should continue zoledronic acid. It has been given to patients in studies for up to 24 months.
• If you have HCM, you should drink plenty of clear fluids before using zoledronic acid.

Reclast (zoledronic acid):

• Zoledronic acid is given once a year given for treating osteoporosis in postmenopausal women and treating osteoporosis in men.
• Zoledronic acid is given once every 2 years for preventing osteoporosis in postmenopausal women.
• Zoledronic acid is given once a year for treatment and prevention of glucocorticoid-induced osteoporosis.

The recommended zoledronic acid dose for treating high blood calcium due to cancer (known medically as hypercalcemia of malignancy) is 4 mg, taken as a single dose.

Zoledronic acid is also used to prevent bone problems (such as broken bones) in people with cancer. For this use, the recommended dose is zoledronic acid 4 mg every three to four weeks.

Treatment of Osteoporosis in Postmenopausal Women: The recommended regimen is a 5 mg infusion injected into the vein (intravenously) once a year.

Zoledronic acid is usually administered by a healthcare provider in a medical setting making it unlikely for an overdose to occur. However, if overdose is suspected, seek emergency medical attention.

Keep all medical and laboratory appointments. If you miss an appointment to receive a zoledronic acid infusion, call your healthcare provider right away.