zoledronic acid 4 mg/5 mL intravenous solution

Generic name:
Zoledronic acid - injection

Pronunciation
(ZOLE-eh-dron-ick)

Brand name(s)
Zometa

This medication is used to treat high blood calcium levels (hypercalcemia) that may occur with cancer. Zoledronic acid is also used with cancer chemotherapy to treat bone problems that may occur with multiple myeloma and other types of cancer (such as breast, lung) that have spread to the bones. Zoledronic acid belongs to a class of drugs known as bisphosphonates. It lowers high blood calcium levels by reducing the amount of calcium released from your bones into your blood. It also works by slowing the breakdown of your bones by cancer to prevent bone fractures.

Read the Patient Information Leaflet if available from your pharmacist before you start receiving zoledronic acid and each time you get a treatment. If you have any questions, ask your doctor or pharmacist.

This medication is given by injection into a vein as directed by your doctor, usually over at least 15 minutes. The dosage is based on your medical condition and response to treatment.

If you are giving this medication to yourself at home, learn all preparation and usage instructions from your health care professional. Before using, check this product for particles or discoloration. If either is present, do not use the liquid. Learn how to store and discard medical supplies safely.

Avoid mixing zoledronic acid with IV fluids that have calcium in them (such as Ringer's solution, Hartmann's solution, parenteral nutrition-TPN/PPN). Talk to your pharmacist for more details.

For the treatment of high blood calcium levels, fluids are usually given through a vein before you receive this medication. To decrease the chance of kidney problems, drink plenty of fluids during treatment unless otherwise directed by your doctor. It takes at least 7 days after a dose to get the full benefit of this drug. The dose may need to be repeated depending on your blood calcium levels.

For the treatment of multiple myeloma and bone problems caused by the spread of cancer, this medication is given as directed by your doctor, usually every 3 to 4 weeks. You may also be instructed to take calcium and vitamin D supplements each day.

Dizziness, headache, tiredness, or flu-like symptoms (such as fever, chills, muscle/joint aches) may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including:

• increased or severe bone/joint/muscle pain
• new or unusual hip/thigh/groin pain
• jaw/ear pain
• eye/vision problems
• numbness/tingling
• muscle spasms
• irregular heartbeat

Get medical help right away if you have any serious side effects, including:

• signs of kidney problems (such as change in the amount of urine)
• seizures

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before using zoledronic acid, tell your doctor or pharmacist if you are allergic to it; or to other bisphosphonates (such as alendronate, risedronate); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• kidney problems
• dehydration
• aspirin-sensitive asthma

Some people using zoledronic acid may have serious jawbone problems. Your doctor should check your mouth before you start this medication. Tell your dentist that you are using this medication before you have any dental work done. To help prevent jawbone problems, have regular dental exams and learn how to keep your teeth and gums healthy. If you have jaw pain, tell your doctor and dentist right away.

Before having any surgery (especially dental procedures), tell your doctor and dentist about this medication and all other products you use (including prescription drugs, nonprescription drugs, and herbal products).

This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

Older adults may be at greater risk for kidney problems while using this drug.

Tell your doctor if you are pregnant or plan to become pregnant. Zoledronic acid may stay in your body for many years. You should not become pregnant while using zoledronic acid. Zoledronic acid may harm an unborn baby. Ask about reliable forms of birth control while using this medication and after the last dose. If you become pregnant, talk to your doctor right away about the risks and benefits of this medication.

It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breastfeeding is not recommended while using this drug and after stopping treatment. This medication may stay in your body for many years. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include:

• calcium-containing IV fluids

There is another zoledronic acid product that is used to prevent or treat bone loss (osteoporosis). That product should not be used together with this medication.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669. Symptoms of overdose may include: change in the amount of urine, muscle spasms, muscle weakness, mental/mood changes, irregular heartbeat, seizures.

Lab and/or medical tests (such as calcium and other blood mineral levels, kidney function) will be done before you start using this medication and while you are using it. Keep all medical and lab appointments. Consult your doctor for more details.

It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule. Do not double the dose to catch up.

Consult the product instructions and your pharmacist for storage details. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.