Cinacalcet

Sensipar is a positive modulator of the calcium sensing receptor indicated for: Secondary Hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on dialysis. Limitations of Use: Sensipar is not indicated for use in patients with CKD who are not on dialysis Hypercalcemia in adult patients with Parathyroid Carcinoma (PC). Hypercalcemia in adult patients with primary HPT for whom parathyroidectomy would be indicated on the basis of serum calcium levels, but who are unable to undergo parathyroidectomy.

The calcium-sensing receptor on the surface of the chief cell of the parathyroid gland is the principal regulator of PTH synthesis and secretion. Cinacalcet, the active ingredient in Sensipar, is a calcimimetic agent that directly lowers PTH levels by increasing the sensitivity of the calcium-sensing receptor to activation by extracellular calcium. The reduction in PTH is associated with a concomitant decrease in serum calcium levels.

Sensipar tablets should be taken with food or shortly after a meal. Tablets should always be taken whole and not divided. Secondary HPT in patients with CKD on dialysis: ○ Starting dose is 30 mg once daily. ○ Titrate dose no more frequently than every 2 to 4 weeks through sequential doses of 30, 60, 90, 120, and 180 mg once daily as necessary to achieve targeted intact parathyroid hormone (iPTH) levels. ○ iPTH levels should be measured no earlier than 12 hours after most recent dose. Hypercalcemia in patients with PC or hypercalcemia in patients with primary HPT: ○ Starting dose is 30 mg twice daily. ○ Titrate dose every 2 to 4 weeks through sequential doses of 30 mg twice daily, 60 mg twice daily, 90 mg twice daily, and 90 mg three or four times daily as necessary to normalize serum calcium levels.

Sensipar treatment initiation is contraindicated if serum calcium is less than the lower limit of the normal range.

Hypocalcemia: Life threatening events and fatal outcomes were reported. Hypocalcemia can prolong QT interval, lower the threshold for seizures, and cause hypotension, worsening heart failure, and/or arrhythmia. Monitor serum calcium carefully for the occurrence of hypocalcemia during treatment. Upper Gastrointestinal (GI) Bleeding: Patients with risk factors for upper GI bleeding may be at increased risk. Monitor patients and promptly evaluate and treat any suspected GI bleeding. Hypotension, Worsening Heart Failure and/or Arrhythmias: In postmarketing safety surveillance, isolated, idiosyncratic cases of hypotension, worsening heart failure, and/or arrhythmia have been reported in patients with impaired cardiac function. Adynamic B one D isease: May develop if iPTH levels are suppressed below 100 pg/mL.

The following adverse reactions are discussed in greater detail in other sections of labeling: Hypocalcemia Upper Gastrointestinal Bleeding Hypotension, Worsening Heart Failure and/or Arrhythmias Adynamic Bone Disease The most common adverse reactions (i.e., ≥ 25%) associated with Sensipar were nausea and vomiting.

Co-administration with a strong CYP3A4 inhibitor may increase serum levels of cinacalcet. Dose adjustment and monitoring of iPTH serum phosphorus and serum calcium may be required. Cinacalcet is a strong inhibitor of CYP2D6. Dose adjustments may be required for concomitant medications that are predominantly metabolized by CYP2D6.

Storage Store at 25°C (77°F), excursions permitted from 15°C to 30°C (59°F to 86°F).