Zoledronic acid (Injection)

Introduction

Zoledronic Acid (zoe-le-DRON-ik AS-id)

Treats high blood calcium levels (hypercalcemia) that sometimes occur in patients with cancer. Also treats bone damage caused by Paget's disease, multiple myeloma, and cancers that spread to the bone. Also treats osteoporosis (thinning of the bones) in men and in women who have gone through menopause. Reduces the risk of having more fractures in patients who had a recent hip fracture. This medicine is a bisphosphonate.

Brand Name(s)

Reclast, Zometa

There may be other brand names for this medicine.

When This Medicine Should Not Be Used

You should not receive this medicine if you have had an allergic reaction to zoledronic acid or to similar medicines such as alendronate (Fosamax®), etidronate (Didronel®), pamidronate (Aredia®), risedronate (Actonel®), or tiludronate (Skelid®). You should not receive this medicine if you are pregnant or breastfeeding, or if you have low calcium in the blood (hypocalcemia) or severe kidney disease (such as kidney failure). Do not use other medicines that also contain zoledronic acid, such as Reclast® or Zometa®. Using these medicines together may increase your chance for more serious side effects.

How to Use This Medicine

Injectable

• A nurse or other trained health professional will give you this medicine.
• Your doctor will prescribe your exact dose and tell you how often it should be given. This medicine is given through a needle placed in one of your veins. It will take at least 15 minutes for you to receive one dose of this medicine.
• For hypercalcemia, this medicine is usually given only once. If your doctor decides that you need additional doses, you will receive the medicine again after at least 7 days have passed. This treatment will continue until your body responds to the medicine.
• For bone cancer and multiple myeloma, this medicine is usually given every 3 to 4 weeks. This treatment will continue until your body responds to the medicine.
• For osteoporosis, this medicine is usually given once a year and will continue until your body responds to the medicine.
• You may also receive other medicines to help keep your body from losing too much fluid.
• Drink extra fluids so you will pass more urine while you are using this medicine. This will keep your kidneys working well and help prevent kidney problems. However, it is very important to not drink too much liquid. Talk to your doctor about the right amount of liquids for you.
• Your doctor may also give you vitamin D and calcium supplements. Tell your doctor if you are unable to take these medicines.
• This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions. Ask your pharmacist for the Medication Guide if you do not have one.

If a dose is missed:

• This medicine needs to be given on a fixed schedule. If you miss a dose or forget to use your medicine, call your doctor or pharmacist for instructions.

Drugs and Foods to Avoid

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Make sure your doctor knows if you are also using digoxin (Lanoxin®), medicine to treat an infection (such as amikacin, gentamicin, streptomycin, tobramycin, Amikin®, or Garamycin®) or certain diuretics or "water pills" (such as furosemide, torsemide, Demadex®, or Lasix®). Tell your doctor if you are also using a pain or arthritis medicine, sometimes called "NSAIDs", such as aspirin, celecoxib, ibuprofen, naproxen, rofecoxib, valdecoxib, Advil®, Aleve®, Bextra®, Celebrex®, Motrin®, Vioxx®, or Voltaren®.

Warnings While Using This Medicine

• Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.
• Make sure your doctor knows if you have kidney disease, congestive heart failure, aspirin-sensitive asthma (asthma that is brought on by aspirin sensitivity), parathyroid problems, or stomach absorption problems. Also tell your doctor if you have had surgery on your parathyroid or thyroid gland, or if you have had portions of your bowel removed.
• Tell your doctor if you have anemia, bleeding problems, cancer, dehydration, infection of any kind, any type of mineral imbalance, poor oral hygiene, or dental problems.
• This medicine may rarely cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash; itching; hoarseness; trouble breathing; trouble swallowing; or any swelling of your hands, face, or mouth after receiving the medicine.
• Your doctor will need to know if you have a history of problems with your mouth or teeth (such as gum disease). Make sure your doctor knows if you have been treated with a bisphosphonate medicine, such as alendronate (Fosamax®), etidronate (Didronel®), pamidronate (Aredia®), risedronate (Actonel®), or tiludronate (Skelid®) in the past.
• You may need to have a dental exam before you start using this medicine.
• Make sure any doctor or dentist who treats you knows that you are using this medicine, especially if you are having dental surgery. You should avoid having major dental work done while you are being treated with this medicine.
• Make sure you tell your doctor about any new medical problems, especially with your teeth or jaws. Tell your doctor if you have severe bone, joint, or muscle pain while using this medicine.
• This medicine may increase your risk of developing fractures of the thigh bone. This may be more common if you use it for a long time. Check with your doctor right away if you have a dull or aching pain in the thighs, groin, or hips.
• Your doctor will need to check your blood or urine at regular visits while you are using this medicine. Be sure to keep all appointments.

Possible Side Effects While Using This Medicine

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blood in the urine, lower back pain, side pain, or sharp back pain just below the ribs.
• Chest pain.
• Decrease in how much or how often you urinate, or have burning or painful urination.
• Dry mouth, increased thirst, or muscle cramps.
• Fast, slow, pounding, or uneven heartbeat.
• Fever, chills, cough, sore throat, and body aches.
• Lightheadedness, dizziness, or fainting.
• Loss of appetite, nausea, vomiting, sleepiness, or changes in personality.
• Muscle weakness, spasm, or tremor.
• Numbness and tingling around the mouth.
• Pain or other problems with your teeth or jaw.
• Pale skin.
• Rapid weight gain.
• Redness, irritation, or pain in your eyes.
• Severe muscle, bone, or joint pain.
• Shortness of breath or troubled breathing.
• Swelling in your hands, ankles, or feet.
• Unusual bleeding or bruising.
• Unusual tiredness or weakness.

If you notice these less serious side effects, talk with your doctor:

• Feeling agitated, confused, or depressed.
• Hair loss.
• Headache or trouble sleeping.
• Mild nausea, diarrhea, constipation, stomach pain, or upset stomach.
• Mild skin rash or itching.
• Numbness, tingling, or burning pain in your hands, arms, legs, or feet.
• Redness, pain, or swelling of your skin where the needle is placed.
• Sores or white patches on your lips, mouth, or throat.
• Weakness.

If you notice other side effects that you think are caused by this medicine, tell your doctor

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