Cinacalcet

WHY is this medicine prescribed?

Cinacalcet is used alone or with other medications to treat secondary hyperparathyroidism (a condition in which the body produces too much parathyroid hormone [a natural substance needed to control the amount of calcium in the blood] which can cause serious problems with the bones, heart, blood vessels, and lungs) in patients with chronic kidney disease (condition in which the kidneys stop working slowly and gradually) who are being treated with dialysis (medical treatment to clean the blood when the kidneys are not working properly). Cinacalcet is also used to treat high levels of calcium in the blood of patients who have parathyroid cancer (cancer of the glands in the neck that make parathyroid hormone). Cinacalcet is in a class of medications called calcimimetics. It works by signaling the body to produce less parathyroid hormone in order to decrease the amount of calcium in the blood.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

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.

What SPECIAL PRECAUTIONS should I follow?

Before taking cinacalcet,

• tell your doctor and pharmacist if you are allergic to cinacalcet or any other medications.

• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking. Be sure to mention any of the following: antidepressants (mood elevators) such as amitriptyline (Elavil), clomipramine (Anafranil), desipramine (Norpramin), fluoxetine (Prozac, Sarafem), imipramine (Tofranil), nefazodone, nortriptyline (Aventyl, Pamelor), paroxetine (Paxil), protriptyline (Vivactil) and trimipramine (Surmontil); antifungals such as fluconazole (Diflucan), itraconazole (Sporanox), and ketoconazole (Nizoral); cimetidine (Tagamet); cyclosporine (Neoral, Sandimmune); danazol (Danocrine); delavirdine (Rescriptor); diltiazem (Cardizem, Dilacor, Tiazac); erythromycin (E.E.S., E-Mycin, Erythrocin); flecainide (Tambocor); HIV protease inhibitors such as indinavir (Crixivan) and ritonavir (Norvir); isoniazid (INH, Nydrazid); metronidazole (Flagyl); oral contraceptives (birth control pills); thioridazine (Mellaril); troleandomycin (TAO); verapamil (Calan, Covera, Isoptin, Verelan); vinblastine (Velban); and zafirlukast (Accolate). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• tell your doctor if you have or have ever had seizures or liver disease.

• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking cinacalcet, call your doctor.

What SPECIAL DIETARY instructions should I follow?

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

What should I do IF I FORGET to take a dose?

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

Cinacalcet may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• upset stomach
• vomiting
• diarrhea
• dizziness
• weakness
• chest pain

Some side effects can be serious. The following symptoms are uncommon, but if you experience any of them, call your doctor immediately:

• burning, tingling, or unusual feelings of the lips, tongue, fingers, or feet
• muscle aches or cramps
• sudden tightening of the muscles in the hands, feet, face, or throat
• seizures
• infection of dialysis access (surgically created blood vessel where blood leaves and enters the body during dialysis)

Cinacalcet may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

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

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include:

• burning, tingling, or unusual feelings of the lips, tongue, fingers, or feet
• muscle aches or cramps
• sudden tightening of the muscles in the hands, feet, face, or throat
• seizures

What OTHER INFORMATION should I know?

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.