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|Cinacalcet

Cinacalcet

Cinacalcet is used for:

Treating an overactive parathyroid in dialysis patients with chronic kidney disease. It is also used to treat high blood calcium levels in patients with parathyroid cancer. It may also be used for other conditions as determined by your doctor.

Cinacalcet is a calcimimetic agent. It works by causing the parathyroid to produce less parathyroid hormone (PTH), which, in turn, helps to lower blood calcium levels.

Do NOT use Cinacalcet if:

• you are allergic to any ingredient in Cinacalcet

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

Before using Cinacalcet :

Some medical conditions may interact with Cinacalcet . 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 liver problems, low blood calcium levels, or seizures

Some MEDICINES MAY INTERACT with Cinacalcet .

• Azole antifungals (eg, ketoconazole, itraconazole) or erythromycin because side effects of Cinacalcet may be increased
• Flecainide, thioridazine, tricyclic antidepressants (eg, amitriptyline), or vinblastine because side effects ma y be increased by Cinacalcet

This may not be a complete list of all interactions that may occur. Ask your health care provider if Cinacalcet 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 Cinacalcet :

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

• Take Cinacalcet with food or shortly after a meal.
• Swallow Cinacalcet whole. Do not break, crush, or chew before swallowing.
• If you miss a dose of Cinacalcet , take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

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

Important safety information:

• Cinacalcet may cause dizziness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Cinacalcet . Using Cinacalcet alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.
• LAB TESTS, including calcium and phosphorous or parathyroid hormone blood levels, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.
• Cinacalcet is not recommended for use in CHILDREN. Safety and effectiveness have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, discuss with your doctor the benefits and risks of using Cinacalcet during pregnancy. It is unknown if Cinacalcet is excreted in breast milk. Do not breast-feed while taking Cinacalcet .

Possible side effects of Cinacalcet :

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:

Diarrhea; dizziness; loss of appetite; nausea; vomiting.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; cramping; muscle aches, pain, or weakness; muscle spasms; numbness; seizures; tingling; tremors; unusual weakness.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately. Symptoms may include burning, prickling, or itching of the skin; muscle aches, pain, or weakness; muscle spasms; seizures.

Store Cinacalcet at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Keep Cinacalcet out of the reach of children and away from pets.

General information:

• If you have any questions about Cinacalcet , please talk with your doctor, pharmacist, or other health care provider.
• Cinacalcet 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.

This information is a summary only. It does not contain all information about Cinacalcet . 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.