Metoprolol, carvediol, flecainide, vinblastine, thioridazine

TCADs Ketoconazole, itrakonazole, rifampicin, erthromycin,

Desipramine, Phenytoin St.Johns Wort

FDA approved label August 1, 2011

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use Sensipar safely and effectively. See full prescribing information for Sensipar. Sensipar® (cinacalcet) Tablets

Initial US Approval: 2004

Hypercalcemia in patients with parathyroid carcinoma

Secondary hyperparathyroidism in patients with chronic kidney disease on dialysis

Nausea, anorexia, dizziness, parathesthesia, rash, myalgia, chest pain

Asthnenia, hypocalcemia,

Reduced testosterone levels

Seizures

Hypotension

Worsensing cardiac failure

Angioedema

Hypercalcemia Lactation

Special precautions

Moderate to severe hepatic impairment Impaired cardiac function

Epilepsy In hyperparathyroidism monitor parathyroid levels 1- 4 weeks after initiation or dose adjustment and regulary during maintenance

Suspend therapy if serum calcium < 7.5mg/dL Changes in smoking habits

Pregnancy

History of seizures

Indication-

Hypercalcemia in patients with parathyroid carcinoma

Secondary hyperparathyroidism in patients with chronic kidney disease on dialysis Parathyroid carcinoma and primary hyperparathyroidism

Dosage-

initially 30mg twice daily

Titrate every 2- 4 weeks to 60mg twice daily, then 90mg twice daily then 90mg three or four times daily as necessary to reduce serum calcium to below ULN

Maximum - 90mg four times daily

secondary hyperparathyroidism - Initially 30mg once daily

Titrate evey 2-4 weeks acording to target parathyoid level

Maximum 180mg once daily

Patients below 18 years - not recommended

 PATIENT COUNSELING INFORMATION

• Take with food: Patients should be advised to take Sensipar with food or shortly after a meal. Tablets should be taken whole and should not be divided.

• Laboratory monitoring: Patients should be informed of the importance of regular blood tests, in order to monitor the safety and efficacy of Sensipar therapy. 

• Side-Effects of Treatment: Patients should be advised to report nausea, vomiting, and potential symptoms of hypocalcemia, including tingling/numbness of the skin, muscle pain, and muscle cramping.

• Seizures: Patients should be queried if they are taking medication to prevent seizures or have had seizures in the past and be advised to report any seizure episodes while on Sensipar therapy.

Sensipar® (cinacalcet) Tablets Manufactured by: Amgen Inc. One Amgen Center Drive Thousand Oaks, California 91320-1799 This product, or its use, may be covered by one or more US Patents including US Patent Nos. 6,313,146; 6,211,244; 6,031,003; 6,011,068, and 7,829,595

Take with food or shortly after food.
Swallow whole. Do no divide

Contraindicated during pregnancy and lactation