Sensipar (Cinacalcet)

BEFORE you use SENSIPAR talk to your doctor or pharmacist if:

1. You have or had seizures (convulsions). The risk of having a seizure is greater if you have had seizures before.
2. You have or had heart problems (low blood pressure or worsening heart failure).
3. You have or had liver problems.
4. You have lower blood calcium levels.
5. You are pregnant, breastfeeding, or plan to do so.

Low calcium levels can have an effect on your heart rhythm. Tell your doctor if you experience an unusually fast or pounding heart beat, if you have heart rhythm problems, or if you take medicines known to cause heart rhythm problems, while taking SENSIPAR.

SENSIPAR is not recommended for patients with CKD not receiving dialysis.

SENSIPAR should not be used in children. A death was reported in an adolescent clinical trial patient with very low calcium levels in the blood (hypocalcemia).

If you have any of the following side effects while taking SENSIPAR, you should tell your doctor right away.

• Nausea and vomiting. These are the most common side effects seen with SENSIPAR treatment. This may make it difficult to take your medicines.
• Diarrhea, muscle pain and back pain. These side effects also are commonly reported.
• Rash or hypersensitivity (allergic reactions). Cases of rash have been commonly reported, while cases of hypersensitivity (allergic reactions) have been uncommonly reported.
• Hives (urticaria) is very rarely reported.
• Swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing (angioedema) is also very rarely reported.

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, even those not prescribed.

Drugs that may interact with SENSIPAR include: ketoconazole, erythromycin, itraconazole, metoprolol, flecainide, vinblastine, thioridazine, rifampin, phenytoin, or medicines such as tricyclic antidepressants (desipramine, amitriptyline).

It is important to take SENSIPAR exactly as your doctor has instructed you. Your doctor will tell you how much SENSIPAR to take. Your doctor will order regular blood tests to measure how you are responding to SENSIPAR and may increase or decrease your dose based on your PTH, calcium, and phosphate levels.

Usual adult dose:

If you have secondary hyperparathyroidism the usual starting dose for SENSIPAR is one 30 mg tablet once daily.

If you have parathyroid cancer or primary hyperparathyroidism, the usual starting dose for SENSIPAR is one 30 mg tablet twice daily.

SENSIPAR is taken once a day with food or right after a meal. SENSIPAR tablets must be taken whole and are not to be divided. It's best to take SENSIPAR at the same time each day.

Overdose:

In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Tell your doctor or contact your regional Poison Control Centre immediately if you think you took more than the recommended dose of SENSIPAR.

Missed dose:

Do not take a double dose to make up for forgotten daily doses. If you have forgotten a dose of SENSIPAR, you should take your next daily dose as normal.