Cinacalcet is used to treat patients with long-term kidney disease (chronic renal failure) who are on dialysis. It works by lowering the amount of a certain natural chemical (parathyroid hormone) and certain minerals (calcium, phosphorus) in your body. This medication helps to slow down the development of bone disease and prevents mineral imbalance caused by high levels of parathyroid hormone, calcium, and phosphorus. Cinacalcet is also used to reduce the high level of a certain mineral (calcium) in patients with cancer of the parathyroid gland.

Take this medication by mouth, with food or shortly after a meal, or as directed by your doctor. Swallow the tablet whole. Do not break the tablet unless instructed to do so by your doctor.

Your dosage of this medication and how often you take it are based on your medical condition and response to therapy. This drug may be used alone or in combination with other medications. Be sure to keep all medical appointments so your doctor can closely monitor your response to determine the dosage that is right for you. Follow your doctor's instructions exactly as directed. Consult your doctor or pharmacist if you have any questions about your therapy.

Take this medication regularly in order to get the most benefit from it. To help you remember, take it at the same time(s) each day.

Inform your doctor if your condition worsens or if you develop new symptoms.

Nausea, vomiting, loss of appetite, diarrhea, dizziness, or muscle pain may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she 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 immediately if any of these unlikely but serious side effects occur: fast/pounding heartbeat, headache, unusual weakness, signs of infection (e.g., fever), severe or worsened bone/joint pain, burning/tingling of hands/feet, severe muscle spasms, mental/mood changes, seizures.

This medication can infrequently cause chest pain that is usually not serious. However, you may not be able to tell it apart from chest pain due to heart problems (e.g., heart attack). Therefore, seek immediate medical attention if you develop chest pain.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: 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.

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 taking this medication, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, low calcium levels in the blood (hypocalcemia), seizures, high blood pressure.

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

This drug may pass into breast milk and could have undesirable effects on a nursing infant. Therefore, breast-feeding is not recommended while using this drug. Consult your doctor before breast-feeding.

Your healthcare professionals (e.g., doctor or pharmacist) may already be aware of any possible drug interactions and may be monitoring you for it. Do not start, stop or change the dosage of any medicine before checking with them first.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: drugs affecting liver enzymes that remove cinacalcet from your body such as azole antifungals (e.g., itraconazole, ketoconazole), macrolide antibiotics (e.g., erythromycin), anti-seizure medications (e.g., carbamazepine, phenytoin).

This drug can slow down the removal of other drugs from your body by affecting certain liver enzymes. Examples of these affected drugs include: antiarrhythmics (e.g., flecainide, mexiletine), tricyclic antidepressants (e.g., amitriptyline, desipramine, nortriptyline), vinblastine.

Also report the use of drugs which might increase seizure risk (decrease seizure threshold) when combined with cinacalcet such as: isoniazid (INH), theophylline, phenothiazines (e.g., thioridazine) among others.

Consult your doctor or pharmacist for details.

This product can affect the results of certain lab tests. Make sure laboratory personnel and your doctors know you take this drug.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly. Symptoms of overdose may include: severe muscle spasms, seizures.

Do not share this medication with others.

Laboratory and/or medical tests (e.g., calcium, phosphorus, parathyroid hormone levels) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

Store at room temperature at 77 degrees F (25 degrees C) away from light and moisture. Brief storage between 59-86 degrees F (15-30 degrees C) is permitted. Do not store in the bathroom. Keep all medicines 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 for more details about how to safely discard your product.

Information last revised July 2009 Copyright(c) 2009 First DataBank, Inc.