Cinacalcet decreases levels of parathyroid hormone (PTH), calcium, and phosphorous in the body.

Cinacalcet is used to treat hyperparathyroidism (overactive functioning of the parathyroid glands) in people who are on long-term dialysis for kidney disease.

Cinacalcet is also used to treat hypercalcemia (high levels of calcium in the blood) in people with cancer of the parathyroid gland, and in people with overactive parathyroid glands that cannot be treated surgically.

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

You should not take cinacalcet if you have low levels of calcium in your blood (hypocalcemia).

Cinacalcet comes as a tablet to take by mouth. It is usually taken once a day with food or shortly after a meal. To help you remember to take cinacalcet, take it at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take cinacalcet exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Swallow the tablets whole; do not split, chew, or crush them.

Your doctor will probably start you on a low dose of cinacalcet and gradually increase your dose, not more than once every 2-4 weeks.

Cinacalcet may help control your condition but will not cure it. Continue to take cinacalcet even if you feel well. Do not stop taking cinacalcet without talking to your doctor.

Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not use cinacalcet in larger or smaller amounts or for longer than recommended.

Cinacalcet works best if you take it with food or shortly after eating a meal.

Do not crush or break a cinacalcet tablet. Swallow the pill whole.

To be sure your calcium and phosphorous levels do not get too low, your blood will need to be tested 1 week after you start taking cinacalcet or whenever your dose is changed. You may also need blood tests on a regular basis during treatment.

Store at room temperature away from moisture, light, and heat.

You should not use cinacalcet if you are allergic to it, or if you have:

• low levels of calcium in your blood (hypocalcemia).

To make sure cinacalcet is safe for you, tell your doctor if you have ever had:

• high or low blood pressure;

• heart disease, heart failure, heart rhythm disorder;

• personal or family history of long QT syndrome;

• a stomach ulcer or severe vomiting;

• liver disease;

• seizures; or

• if you have kidney disease and you are not on dialysis.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether cinacalcet passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are taking this medicine.

Cinacalcet is not approved for use by anyone younger than 18 years old.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

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

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Talk to your doctor about drinking grapefruit juice while taking this medication.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Cinacalcet may cause serious side effects. Call your doctor at once if you have:

• numbness or tingly feeling around your mouth;

• muscle pain, tightness, or contraction;

• a seizure (convulsions);

• shortness of breath (even with mild exertion), swelling, rapid weight gain;

• signs of stomach bleeding--bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds; or

• low levels of calcium in your blood--numbness or tingly feeling around your mouth, fast or slow heart rate, muscle tightness or contraction, overactive reflexes.

Common side effects of cinacalcet may include:

• nausea, vomiting; or

• diarrhea.

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.

Many drugs can interact with cinacalcet. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide. Tell your doctor about all your current medicines and any medicine you start or stop using.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to cinacalcet.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.