Zoledronic Acid Injection

pronounced as (zoe' le dron ik)

Brand Name(s): Reclast®, Zometa®

Why is this medicine prescribed?

Zoledronic acid is used to prevent or treat osteoporosis (condition in which the bones become thin and weak and break easily) and treat Paget's disease of bone (a condition in which the bones are soft and weak and may be deformed, painful, or easily broken). Zoledronic acid is also used to treat high levels of calcium in the blood that may be caused by certain types of cancer and to treat bone damage caused by multiple myeloma [cancer that begins in the plasma cells (white blood cells that produce substances needed to fight infection)] or by cancer that began in another part of the body but has spread to the bones. Zoledronic acid is in a class of medications called bisphosphonates. It works by slowing bone breakdown, increasing bone density (thickness), and decreasing the amount of calcium released from the bones into the blood.

Are there other uses for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

How should this medicine be used?

Zoledronic acid comes as a solution (liquid) to inject into a vein over at least 15 minutes. It is injected by a healthcare provider in a doctor's office, hospital, or clinic. How frequently it is given depends on the condition being treated:

  • to treat high calcium levels, it is given as a single dose that may be repeated in 7 days if needed
  • to treat bone damage, it is given once every 3 to 4 weeks
  • to prevent or treat osteoporosis, it is given once every 1 to 2 years
  • to treat Paget's disease, it is given as a single dose. Your doctor may decide a repeat dose is needed in the future

Be sure to drink at least 2 glasses of water or another liquid within a few hours before you receive zoledronic acid.

You may experience a reaction during the first few days after you receive a dose of zoledronic acid injection. Symptoms of this reaction may include flu-like symptoms, fever, headache, chills, and bone, joint or muscle pain. These symptoms may begin during the first 3 days after you receive a dose of zoledronic acid injection and may last 3 to 14 days.

If you are receiving zoledronic acid injection to prevent or treat osteoporosis, you must continue to receive the medication as scheduled even if you are feeling well. You should talk to your doctor from time to time about whether you still need to be treated with this medication.

You will be given the Medication Guide. Read the information carefully and ask your doctor or pharmacist if you have any questions.

What special precautions should I follow?

Before receiving zoledronic acid injection,

  • tell your doctor or pharmacist if you are allergic to this drug, any part of this drug, or any other drugs, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.
  • tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take while receiving zoledronic acid injection. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
  • the following nonprescription products may interact with zoledronic acid: aspirin and other nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen and naproxen. Be sure to let your doctor and pharmacist know that you are taking these medications before you start using zoledronic acid. Do not start any of these medications while receiving zoledronic acid without discussing with your healthcare provider.
  • tell your doctor if you have or have ever had kidney disease or if you have a dry mouth, dark urine, decreased sweating, dry skin, and other signs of dehydration or recently have had diarrhea, vomiting, fever, infection, excessive sweating, or have been unable to drink enough fluids. Your doctor will wait until you are no longer dehydrated before giving you zoledronic acid injection or if you have certain types of kidney disease may not prescribe this treatment for you. Also tell your doctor if you have ever had a low level of calcium in your blood. Your doctor will probably check the level of calcium in your blood before you begin treatment and may not prescribe this medication if the level is too low.
  • tell your doctor if you have been treated with zoledronic acid or other bisphosphonates in the past; if you have ever had surgery on your parathyroid gland (small gland in the neck) or thyroid gland or surgery to remove sections of your small intestine; and if you have or have ever had heart failure (condition in which the heart cannot pump enough blood to other parts of the body); anemia (condition in which red blood cells cannot bring enough oxygen to other parts of the body); any condition that stops your blood from clotting normally; low levels of calcium, magnesium, or potassium in your blood; any condition that prevents your body from absorbing nutrients from food; or problems with your mouth, teeth, or gums; an infection, especially in your mouth; asthma or wheezing, especially if it is made worse by taking aspirin; or parathyroid or liver disease.
  • tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. You should use a reliable method of birth control to prevent pregnancy while you are receiving zoledronic acid. If you become pregnant while receiving zoledronic acid, call your doctor immediately. Zoledronic acid may harm the fetus. Talk to your doctor if you plan to become pregnant at any time in the future because zoledronic acid may remain in your body for years after you stop receiving it.
  • you should know that zoledronic acid injection may cause severe bone, muscle, or joint pain. You may begin to feel this pain within days or months after you first receive zoledronic acid injection. Call your doctor right away if you experience severe pain at any time during your treatment with zoledronic acid injection.
  • you should know that zoledronic acid may cause osteonecrosis of the jaw (ONJ, a serious condition of the jaw bone), especially if you have dental surgery or treatment while you are using the medication. A dentist should examine your teeth and perform any needed treatments before you start to use zoledronic acid. Be sure to brush your teeth and clean your mouth properly while you are using zoledronic acid. Talk to your doctor before having any dental treatments while you are using this medication.

What special dietary instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do if I forget to take a dose?

If you miss an appointment to receive a zoledronic acid infusion, call your doctor as soon as possible.

What side effects can this medicine cause?

Zoledronic acid may cause side effects. Tell your doctor if any of these symptoms, or those listed in the HOW or PRECAUTIONS sections, are severe or do not go away:

  • itching, redness, pain, or swelling in the place where you received your injection
  • red, swollen, itchy, or teary eyes or swelling around the eyes
  • constipation,nausea, vomiting ,diarrhea, stomach pain, heartburn
  • loss of appetite, weight loss
  • excessive worry
  • agitation
  • depression
  • difficulty falling asleep or staying asleep
  • fever, chills, cough, and other signs of infection
  • mouth sores, white patches in the mouth
  • swelling, redness, irritation, burning, or itching of the vagina
  • white vaginal discharge
  • numbness or tingling around the mouth or in fingers or toes
  • hair loss

Some side effects can be serious. If you experience any of the following symptoms, call your doctor immediately:

  • rash, itching, hives, hoarseness, difficulty breathing or swallowing, or swelling of the eyes, face, lips, tongue, throat, hands, arms, feet, ankles, or lower legs
  • upper chest pain, irregular heartbeat
  • muscle spasms, twitches, or cramps
  • unusual bruising or bleeding
  • painful or swollen gums, loosening of the teeth, numbness or heavy feeling in the jaw, sore in the mouth or the jaw that does not heal
  • dull, aching pain in the hips, groin, or thighs

Zoledronic acid may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

Being treated with a bisphosphonate medication such as zoledronic acid injection for osteoporosis may increase the risk that you will break your thigh bone(s). You may find that one or both of your thigh bones have broken even though you have not fallen or experienced other trauma. Talk to your doctor about the risks of receiving zoledronic acid injection.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online ( https://www.fda.gov/Safety/MedWatch ) or by phone ( 1-800-332-1088).

What should I know about storage and disposal of this medication?

Your doctor will store this medication in his or her office and give it to you as needed.

What other information should I know?

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to zoledronic acid.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.

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