In the U.S.—

• Antihyperparathyroid

Cinacalcet (sin-a-KAL-set) is a medicine used to treat hyperparathyroidism in patients with chronic kidney disease who are on dialysis. Hyperparathyroidism is a condition that is caused when the parathyroid glands located in the neck make too much parathyroid hormone (PTH). This hormone controls the concentrations of calcium and phosphorus in your blood. When there is too much PTH, it causes a condition where there is too much calcium in the blood called hypercalcemia. Cinacalcet helps lower the amount of PTH which makes the calcium concentration go back to normal. Cinacalcet is also used to treat hypercalcemia in patients with parathyroid cancer.

This medicine is available only with your doctor's prescription, in the following dosage forms:

Oral
• Tablets (U.S.)

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For cinacalcet, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to cinacalcet. Also tell your doctor and pharmacist if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Cinacalcet has not been studied in pregnant women. However, studies in animals have shown that cinacalcet can cause problems with weight gain in mother and pup. Before taking this medicine, make sure your doctor knows if you are pregnant or if you may become pregnant.

Breast-feeding—It is not known whether cinacalcet passes into breast milk. Because of the possibility of unwanted effects, it may be necessary for you to stop taking this medicine or stop breast-feeding during treatment. Be sure you have discussed the risks and benefits of this medicine with your doctor.

Children—Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of cinacalcet in children with use in other age groups.

Older adults—This medicine has been tested in a limited number of patients 65 years of age or older and has not been shown to cause different side effects or problems in older people than it does in younger adults.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking cinacalcet, it is especially important that your health care professional knows if you are taking any of the following:

• Amitriptyline (e.g., Elavil)—Use of these medicines with cinacalcet may increase the amount of amitriptyline in the body

• Erythromycin (e.g., Ery-Tab) or
• Itraconazole (e.g., Sporanox) or
• Ketoconazole (e.g., Nizoral)—When used together with cinacalcet, the dose of cinacalcet may need to be adjusted and calcium levels in the blood monitored by the doctor

• Flecainide (e.g., Tambocor) or
• Thioridazine (e.g., Mellaril) or
• Tricyclic antidepressants (most) (Amoxapine [e.g., Asendin], clomipramine [e.g., Anafranil], desipramine [e.g., Norpramin], doxepin [e.g., Sinequan], imipramine [e.g., Tofranil], nortriptyline [e.g., Aventyl, Pamelor], protriptyline [e.g., Vivactil], trimipramine [e.g., Surmontil]) or
• Vinblastine (e.g., Velban)—When used together with cinacalcet, the doses of these medicines may need to be adjusted

• Allergy to cinacalcet or any ingredient in the tablet—This medicine should not be used in these patients

• Liver disease—Higher blood levels of cinacalcet may result and your doctor may need to change your dose

• Seizure problems in the past—May increase risk of seizures while taking this medicine

Dosing—

The dose of cinacalcet will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of cinacalcet. If your dose is different, do not change it unless your doctor tells you to do so.

The number of tablets that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are taking cinacalcet

• For oral dosage form (tablets):
  • For hypercalcemia:
    • Adults—Oral, 30 mg twice a day. This medicine should be taken with food or shortly after a meal and the tablet should be taken whole, not crushed, divided, or chewed. Your doctor may adjust your dose every two to four weeks.
    • Children—This medicine has not been tested in children under the age of 18. Use and dose must be determined by your doctor.
  • For hyperparathyroidism:
    • Adults—Oral, 30 milligrams (mg) taken once a day. This medicine should be taken with food or shortly after a meal and the tablet should be taken whole, not crushed, divided, or chewed. Your doctor may change your dose every two to four weeks.
    • Children—This medicine has not been tested in children under the age of 18. Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

To store this medicine:

• Keep out of the reach of children.
• Store the medicine at room temperature.
• Do not store in the bathroom, near the kitchen sink, or in other damp places. heat or moisture may cause the medicine to break down.
• Do not keep outdated medicine or medicine no longer needed. Ask your health care professional how you should dispose of any medicine you do not use. Be sure that any discarded medicine is out of the reach of children.

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it.

Other medicines: Do not take other medicines unless they have been discussed with your doctor. Taking other medicines together with cinacalcet may require your doctor to change the dose of one of the medicines.

This medicine may cause some people to become hypocalcemic (not have enough calcium in their blood). The symptoms of hypocalcemia are abdominal cramps; confusion; convulsions; difficulty in breathing; irregular heartbeats; mood or mental changes; muscle cramps in hands, arms, feet, legs, or face; numbness and tingling around the mouth, fingertips, or feet; shortness of breath; and/or tremor. If you experience any of these symptoms, check with your doctor immediately.

This medicine may increase the risk of seizures in people who have had problems with seizures in the past. Your doctor may need to check your progress more often if you have experienced seizures in the past.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• More common
  • Blurred vision;  chest pain;  dizziness;  headache;  nervousness;  pounding in the ears;  slow or fast heartbeat 
  
  

• Less common
  • Convulsions;  cough or hoarseness;  fever or chills;  loss of bladder control ;  lower back or side pain;  muscle spasm or jerking of all extremities;  painful or difficult urination;  sudden loss of consciousness  
  
  

• Frequency not known
  • Abdominal cramps;  confusion;  difficulty in breathing;  irregular heartbeats ;  low bone turnover;  mood or mental changes;  muscle cramps in hands, arms, feet, legs, or face;  numbness and tingling around the mouth, fingertips, or feet;  shortness of breath ;  tremor 
  
  

Get emergency help immediately if any of the following symptoms of overdose occur:

• Symptoms of overdose
  • Abdominal cramps;  confusion;  difficulty in breathing;  irregular heartbeats ;  mood or mental changes;  muscle cramps in hands, arms, feet, legs, or face;  numbness and tingling around the mouth, fingertips, or feet;  shortness of breath;  tremor 
  
  

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome.

• More common
  • Diarrhea;  difficulty in moving;  joint pain;  lack or loss of strength ;  loss of appetite;  muscle aching or cramping;  muscle pains or stiffness;  nausea;  swollen joints;  vomiting;  weight loss 
  
  

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.