CINACALCET HYDROCHLORIDE

Electrolyte / Mineral

Brand names: Sensipar

Oral

Mechanism of Action

12.1 Mechanism of Action 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.

Indications

but who are unable to undergo parathyroidectomy [see Clinical Studies ( 14.3 )] .

Contraindications

• 5.1 )

FDA Warnings

5 WARNINGS AND PRECAUTIONS Hypocalcemia : Life threatening events and fatal outcomes were reported
1 ) Upper Gastrointestinal (GI) Bleeding: Patients with risk factors for upper GI bleeding may be at increased risk
Life threatening events and fatal outcomes associated with hypocalcemia have been reported in patients treated with Sensipar, including in pediatric patients
Clinical studies indicate that Sensipar-treated patients with CKD not on dialysis have an increased risk for hypocalcemia compared with Sensipar-treated patients with CKD on dialysis, which may be due to lower baseline calcium levels

Known Side Effects

7 documented side effects by frequency

Nausea

1-10%

Vomiting

0.1-1%

General Unwellness

0.1-1%

Diarrhea

0.1-1%

Decreased Appetite

0.1-1%

Drug Not Working

0.1-1%

Low Blood Pressure

0.1-1%

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Formulations

Dosage Forms

Tablet

Route

Oral