Reclast

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

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

Pregnancy category: D

Lactation: Unknown whether drug crosses into breast milk; avoid using

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

GENERIC AVAILABLE: No

Tell your doctor about all prescription, non-prescription, illegal, recreational, herbal, nutritional, or dietary drugs you're taking, especially those mentioned in the Reclast Warnings section above, and any of the following:

• Aminoglycoside antibiotics, such as Amikin (amikacin), Garamycin (gentamicin), Kantrex (kanamycin), Neo-Rx or Neo-Fradin (neomycin), Humatin (paromomycin), streptomycin, or Tobi or Nebcin (tobramycin)
• Aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs), such as Advil or Motrin (ibuprofen) or Aleve (naproxen)
• Chemotherapy drugs for cancer
• Lanoxin or Digitek (digoxin)
• Diuretics (water pills), such as Bumex (bumetanide), Edecrin (ethacrynic acid), or Lasix (furosemide)
• Oral steroids, such as Decadron or Dexone (dexamethasone), Medrol (methylprednisolone), or Deltasone (prednisone)

Reclast and Other Interactions

Reclast may make you dizzy.

Don't drive or perform any activity that requires alertness until you know how this medicine affects you.

Reclast and Alcohol

Alcohol may worsen certain side effects of Reclast.

Talk to your doctor about how much alcohol is safe to drink while receiving this drug.

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 purposes not listed in this medication guide.

Call your doctor for instructions if you miss an appointment for your zoledronic acid injection.

Serious side effects have been reported with Reclast including the following:

• Low calcium levels in your blood (hypocalcemia). Reclast may lower the calcium levels in your blood. If you have low blood calcium before you start taking Reclast, it may get worse during treatment. Your low blood calcium must be treated before you take Reclast. 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 Reclast. 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 Reclast
  • 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 Reclast. Your doctor should examine your mouth before you start Reclast. Your doctor may tell you to see your dentist before you start Reclast. It is important for you to practice good mouth care during treatment with Reclast.
• Possible harm to your unborn baby. Reclast should not be used if you are pregnant. Tell your doctor right away if you are
  pregnant or plan to become pregnant. Reclast may harm your unborn baby.
• Bone, joint, or muscle pain. Some people who take bisphosphonates, such as Reclast, develop severe bone, joint, or muscle pain.

Do not take Reclast if you:

• are allergic to Reclast or any components of Reclast. Severe allergic reactions have occurred with Reclast 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 is in a class of drugs called bisphosphonates, and contains the same active ingredient as that found in Reclast.
• 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 Reclast. 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 Reclast there are no specific foods that you must exclude from your diet when receiving Reclast.

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

• Are receiving another medication containing zoledronic acid. Zometa has the same active ingredient as found in Reclast.
• Are allergic to Reclast or any of its ingredients, or any other medication, especially bisphosphonates.
• Have low blood calcium.
• Have kidney 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. Reclast may harm your unborn baby. Reclast should not be used if you are pregnant.
• Are breastfeeding or plan to breastfeed. It is not known if Reclast 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.

This section provides information on the proper use of a number of products that contain zoledronic acid. It may not be specific to Reclast. Please read with care.

A nurse or other trained health professional will give you this medicine. This medicine is given through a needle placed in one of your veins. The medicine must be injected slowly, so your IV tube will need to stay in place for at least 15 minutes.

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.

Your doctor may also give you vitamins containing Vitamin D and calcium. Tell your doctor if you are unable to take these supplements.

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.

This medicine comes with a Medication Guide. It is very important that you read and understand this information. Be sure to ask your doctor about anything you do not understand.

• If you have an allergy to zoledronic acid or any other part of Reclast (zoledronic acid (bone health)).
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you have low calcium levels.
• If you have kidney disease.
• If you are taking or will be taking another drug like this one.
• If you are taking another drug that has the same drug in it.
• If you are pregnant or may be pregnant. Do not take this medicine if you are pregnant.
• If you are breast-feeding or plan to breast-feed.

This is not a list of all drugs or health problems that interact with Reclast.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

• If you need to store Reclast at home, talk with your doctor, nurse, or pharmacist about how to store it.

Clinical experience with acute overdosage of zoledronic acid (Reclast) solution for intravenous infusion is limited. Patients who have received doses higher than those recommended should be carefully monitored. Overdosage may cause clinically significant renal impairment, hypocalcemia, hypophosphatemia, and hypomagnesemia. Clinically relevant reductions in serum levels of calcium, phosphorus, and magnesium should be corrected by intravenous administration of calcium gluconate, potassium or sodium phosphate, and magnesium sulfate, respectively.

Single doses of Reclast should not exceed 5 mg and the duration of the intravenous infusion should be no less than 15 minutes [see Dosage and Administration (2)]. 

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Summary of Use during Lactation

Because no information is available on the use of zoledronic acid during breastfeeding, an alternate drug may be preferred, especially while nursing a newborn or preterm infant. However, absorption of zoledronic acid by a breastfed infant is unlikely.

Drug Levels

Zoledronic acid has a serum half-life of about 1.7 hours and is poorly absorbed orally, so absorption of zoledronic acid by a breastfed infant is unlikely.

Maternal Levels. Relevant published information was not found as of the revision date.

Infant Levels. Relevant published information was not found as of the revision date.

Effects in Breastfed Infants

Relevant published information was not found as of the revision date.

Effects on Lactation and Breastmilk

Relevant published information was not found as of the revision date.

Alternate Drugs to Consider

Pamidronate

References

Zoledronic acid may harm an unborn baby. Avoid getting pregnant while using this medicine and tell your doctor if you become pregnant.

Zoledronic acid can cause serious kidney problems, especially if you are dehydrated, if you take diuretic medicine, or if you already have kidney disease. Call your doctor if you urinate less than usual, if you have swelling in your feet or ankles, or if you feel tired or short of breath.

Also call your doctor if you have muscle spasms, numbness or tingling (in hands and feet or around the mouth), new or unusual hip pain, or severe pain in your joints, bones, or muscles.

You should not be treated with zoledronic acid if you are allergic to it.

You also should not receive Reclast if you have:

• low levels of calcium in your blood (hypocalcemia); or

• severe kidney disease.

You should not be treated with zoledronic acid if are currently using any other bisphosphonate (such as alendronate, etidronate, ibandronate, pamidronate, risedronate, or tiludronate).

To make sure zoledronic acid is safe for you, tell your doctor if you have ever had:

• kidney disease;

• hypocalcemia;

• thyroid or parathyroid surgery;

• surgery to remove part of your intestine;

• asthma caused by taking aspirin;

• any condition that makes it hard for your body to absorb nutrients from food (malabsorption); or

• a dental problem (you may need a dental exam before you receive zoledronic acid).

Zoledronic acid can cause serious kidney problems, especially if you are dehydrated, if you take diuretic medicine, or if you already have kidney disease.

In rare cases, this medicine 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 zoledronic acid, 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.

Zoledronic acid may harm an unborn baby. Use effective birth control to prevent pregnancy while you are using this medicine. Tell your doctor if you become pregnant. You may also need to use birth control for several weeks after you last received zoledronic acid. This medicine can have long-lasting effects on your body.

Zoledronic acid can pass into breast milk and may harm a nursing baby. You should not breast-feed while using this medicine.

Call your doctor for instructions if you miss an appointment for your zoledronic acid injection.

Get emergency medical help if you have signs of an allergic reaction: hives; wheezing, chest tightness, trouble breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• new or unusual pain in your thigh or hip;

• jaw pain, numbness, or swelling;

• kidney problems--little or no urination, swelling in your feet or ankles, feeling tired or short of breath;

• severe joint, bone, or muscle pain; or

• low calcium levels--muscle spasms or contractions, numbness or tingly feeling (around your mouth, or in your fingers and toes).

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

Common side effects may include:

• nausea, vomiting, diarrhea, constipation;

• bone pain, muscle or joint pain;

• fever or other flu symptoms;

• pain in your arms or legs;

• red or puffy eyes;

• headache, tiredness; or

• trouble breathing.

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.