AREDIA

Do NOT use Aredia if:

• you are allergic to any ingredient in Aredia or to other bisphosphonates (eg, alendronate)

Contact your doctor or health care provider right away if any of these apply to you.

Before using Aredia:

Some medical conditions may interact with Aredia. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have stomach or bowel problems, low calcium blood levels, blood problems (eg, anemia, low blood platelet levels, low white blood cell counts), kidney problems, or dental problems
• if you have had thyroid surgery or have low parathyroid hormone levels
• if you are using chemotherapy or radiation

Some MEDICINES MAY INTERACT with Aredia. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Corticosteroids (eg, prednisone) because the risk of jaw bone problems may be increased
• Thalidomide or medicines that may harm the kidney (eg, aminoglycosides [eg, amikacin, gentamicin], amphotericin B, cyclosporine, nonsteroidal anti-inflammatory drugs [NSAIDs] [eg, ibuprofen], tacrolimus, vancomycin) because the risk of kidney side effects may be increased. Ask your doctor if you are unsure if any of your medicines might harm the kidney

This may not be a complete list of all interactions that may occur. Ask your health care provider if Aredia may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Aredia:

Use Aredia as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Aredia is usually given as an injection at your doctor’s office, hospital, or clinic. If you will be using Aredia at home, a health care provider will teach you how to use it. Be sure you understand how to use Aredia. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
• Do not use Aredia if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
• Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
• If you miss a dose of Aredia, contact your doctor right away.

Ask your health care provider any questions you may have about how to use Aredia.

Important safety information:

• Aredia may cause dizziness or drowsiness. These effects may be worse if you take it with alcohol or certain medicines. Use Aredia with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Talk with your doctor about whether you should take a calcium and vitamin D supplement while you use Aredia. Do not start a calcium and vitamin D supplement without first checking with your doctor. Do not take a calcium and vitamin D supplement if you have high blood calcium levels.
• Aredia may cause jaw bone problems in some patients, especially those who have cancer, are using certain medicines (such as chemotherapy or corticosteroids), or have poor dental hygiene. These problems have been often associated with dental procedures. Talk to your doctor about an appropriate dental examination before you begin treatment with Aredia.
• Certain dental procedures should be avoided if possible while you are using Aredia.
• Proper dental care is important while you are taking Aredia. Brush and floss your teeth and visit the dentist regularly.
• Lab tests, including kidney function tests, complete blood cell counts, and calcium, phosphate, magnesium, and potassium blood levels, may be performed while you use Aredia. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Use Aredia with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: Do not use Aredia if you are pregnant. It may cause harm to the fetus. Avoid becoming pregnant while you are taking it. If you think you may be pregnant, contact your doctor right away. You will need to discuss the benefits and risks of using Aredia while you are pregnant. It is not known if Aredia is found in breast milk. If you are or will be breast-feeding while you use Aredia, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Aredia:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Back pain; constipation; coughing; dizziness; drowsiness; headache; increased sweating; indigestion; loss of appetite; mild bone, joint, or muscle pain; mild fever for 24 to 48 hours; nausea; stomach pain; stuffy or runny nose; trouble sleeping; unusual tiredness; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); confusion; decreased urination; fainting; fast or irregular heartbeat; frequent or painful urination; hallucinations; jaw pain or swelling; mental or mood changes; muscle cramps or spasms; numbness or tingling of the skin; pain, swelling, or redness at injection site; persistent or high fever; seizures; severe or persistent stomach pain, headache, or dizziness; severe or persistent tiredness or weakness; severe or prolonged bone, joint, or muscle pain; shortness of breath; vision changes; white patches in the mouth.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects.

If OVERDOSE is suspected:

Contact your local Poison Control or emergency room immediately.Symptoms may include high fever; lightheadedness; muscle cramps or spasms; taste changes.

Proper storage of Aredia:

Aredia is usually handled and stored by a health care provider. If you are using Aredia at home, store Aredia as directed by your pharmacist or health care provider. Keep Aredia out of the reach of children and away from pets.

General information:

• If you have any questions about Aredia, please talk with your doctor, pharmacist, or other health care provider.
• Aredia is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.
• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Aredia. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.