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zoledronic acid

Pronunciation

Generic Name: zoledronic acid (ZOE le DRON ik AS id)
Brand Name: 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.

Zometa and Reclast are two different brands of zoledronic acid.

The Reclast brand of zoledronic acid is used to treat Paget's disease, and to treat or prevent osteoporosis in postmenopausal women or people who take certain steroid medicines. Reclast is also used to increase bone mass in men with osteoporosis.

The Zometa brand of zoledronic acid is used to treat high blood levels of calcium caused by cancer (hypercalcemia of malignancy). Zometa also treats multiple myeloma (a type of bone marrow cancer) or bone cancer that has spread from elsewhere in the body.

You should not be treated with Reclast if you are already receiving Zometa.

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

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

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Slideshow: Flashback: FDA Drug Approvals 2013

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

You should not use zoledronic acid if you are allergic to it.

You also should not use Reclast if you have:

  • severe kidney disease; or

  • low levels of calcium in your blood.

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

  • kidney disease;

  • a history of thyroid or parathyroid surgery;

  • malabsorption syndrome (an inability to absorb food and nutrients properly);

  • a history of surgical removal of part of your intestine;

  • asthma caused by taking aspirin;

  • planned dental work or oral surgery;

  • if you are dehydrated;

  • if you take a diuretic ("water pill"); or

  • if you are using other bisphosphonates (alendronate, etidronate, ibandronate, pamidronate, risedronate, Actonel, Fosamax, Boniva, and others).

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.

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.

FDA pregnancy category D. Do not use zoledronic acid if you are pregnant. It could harm the unborn baby. Use effective 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 injected into a vein through an IV. A healthcare provider will give you this injection.

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.

You may need frequent medical tests to help your doctor determine how long to treat you with zoledronic acid. Your kidney function may also need to be checked.

You may not need to use zoledronic acid for longer than 3 to 5 years if you use it for osteoporosis. Visit your doctor regularly.

What happens if I miss a dose?

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

What happens if I overdose?

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

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; wheezing, chest tightness, trouble breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • fever, chills, flu symptoms, flushing (warmth, redness, or tingly feeling);

  • severe joint, bone, or muscle pain;

  • new or unusual pain in your thigh or groin;

  • pale skin, feeling light-headed or short of breath;

  • hypocalcemia--numbness or tingly feeling in your fingers or toes or around your mouth, twitching, muscle spasms or cramps; or

  • signs of a kidney problem--little or no urinating; painful or difficult urination; swelling, rapid weight gain; feeling tired or short of breath.

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

Common side effects may include:

  • nausea, vomiting, stomach pain, loss of appetite;

  • diarrhea, constipation;

  • bone pain, back pain, muscle or joint pain;

  • swelling in your feet or ankles;

  • weight loss;

  • headache, tiredness, weakness, dizziness;

  • numbness or tingling;

  • cough, trouble breathing; or

  • sleep problems (insomnia).

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.

See also: Side effects (in more detail)

Zoledronic acid dosing information

Usual Adult Dose for Osteolytic Bone Lesions of Multiple Myeloma:

Zometa(R):
4 mg IV over no less than 15 minutes, every 3 to 4 weeks

Comments: Oral calcium supplement of 500 mg and a multiple vitamin containing 400 international units of vitamin D daily are recommended.

Uses: Patients with multiple myeloma and patients with documented bone metastases from solid tumors, in conjunction with standard antineoplastic therapy

Usual Adult Dose for Osteolytic Bone Metastases of Solid Tumors:

Zometa(R):
4 mg IV over no less than 15 minutes, every 3 to 4 weeks

Comments: Oral calcium supplement of 500 mg and a multiple vitamin containing 400 international units of vitamin D daily are recommended.

Uses: Patients with multiple myeloma and patients with documented bone metastases from solid tumors, in conjunction with standard antineoplastic therapy

Usual Adult Dose for Hypercalcemia of Malignancy:

Zometa(R):
-Maximum dose: Single dose of 4 mg IV infusion over no less than 15 minutes

Comments: If serum calcium does not return to normal, retreatment should be considered after a minimum of 7 elapsed days.

Use: Treatment of hypercalcemia of malignancy (albumin-corrected calcium equal 12 mg/dL or grater)

Usual Adult Dose for Paget's Disease:

Reclast(R):
5 mg IV infusion, at a constant infusion rate, over no less than 15 minutes

Calcium and vitamin D supplementation:
-Calcium: 750 mg elemental calcium orally twice a day, or 500 mg orally three times a day
-Vitamin D: 800 international units orally daily, especially in the 2 weeks following drug administration

Comments: Retreatment may be considered in patients who have relapsed, based on increases in serum alkaline phosphatase or failure to achieve normalization of serum alkaline phosphatase.

Uses: Paget's disease of bone with elevations in serum alkaline phosphatase of two times or higher than upper limit of age- specific normal reference range

Usual Adult Dose for Osteoporosis:

Reclast(R):
5 mg IV infusion over no less than 15 minutes, once a year

Comments: An average of at least 1200 mg calcium and 800 to 1000 international units vitamin D daily is recommended.

Uses:
-Osteoporosis in postmenopausal women, diagnosed by bone mineral density or prevalent vertebral fracture (this drug reduces the incidence of fractures).
-To increase bone mass in men with osteoporosis.
-Treatment of glucocorticoid-induced osteoporosis in men and women who are either initiating or continuing systemic glucocorticoids in a daily dosage equivalent to 7.5 mg or greater of prednisone and are expected to remain on glucocorticoids for at least 12 months.

Usual Adult Dose for Prevention of Osteoporosis:

Reclast(R):
5 mg IV infusion over no less than 15 minutes, every 2 years

Uses:
-Prevention of osteoporosis in postmenopausal women.
-Prevention of glucocorticoid-induced osteoporosis in men and women who are either initiating or continuing systemic glucocorticoids in a daily dosage equivalent to 7.5 mg or greater of prednisone and are expected to remain on glucocorticoids for at least 12 months.

What other drugs will affect zoledronic acid?

Zoledronic acid can harm your kidneys. This effect is increased when you also use certain other medicines, including: antivirals, chemotherapy, injected antibiotics, medicine for bowel disorders, medicine to prevent organ transplant rejection, injectable osteoporosis medication, and some pain or arthritis medicines (including aspirin, Tylenol, Advil, and Aleve).

Other drugs may interact with zoledronic acid, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Where can I get more information?

  • Your doctor or pharmacist can provide more information about zoledronic acid.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Disclaimer: 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.

Copyright 1996-2012 Cerner Multum, Inc. Version: 14.01. Revision Date: 2014-05-15, 10:23:06 AM.

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