Ország: Egyesült Államok
Nyelv: angol
Forrás: NLM (National Library of Medicine)
CINACALCET HYDROCHLORIDE (UNII: 1K860WSG25) (CINACALCET - UNII:UAZ6V7728S)
Strides Pharma Inc.
ORAL
PRESCRIPTION DRUG
Cinacalcet tablets are indicated for the treatment of secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on dialysis [see Clinical Studies (14.1)]. Limitations of Use: Cinacalcet tablets are not indicated for use in patients with CKD who are not on dialysis because of an increased risk of hypocalcemia [see Warnings and Precautions (5.1)] Cinacalcet tablets are indicated for the treatment of hypercalcemia in adult patients with Parathyroid Carcinoma [see Clinical Studies (14.2)]. Cinacalcet tablets are indicated for the treatment of severe hypercalcemia in adult patients with primary HPT who are unable to undergo parathyroidectomy [see Clinical Studies (14.3)]. Cinacalcet tablets treatment initiation is contraindicated if serum calcium is less than the lower limit of the normal range [see Warnings and Precautions (5.1)]. Risk Summary Limited case reports of cinacalcet tablets use in pregnant women are insufficient to inform a drug associated risk of adverse developmenta
Cinacalcet 30 mg tablets are formulated as light-green, film-coated, oval-shaped tablets marked with "SCT" on one side and "30" on the opposite side, packaged in bottles of 30 tablets. (NDC 42543-961-04) Cinacalcet 60 mg tablets are formulated as light-green, film-coated, oval-shaped tablets marked with "SCT" on one side and "60" on the opposite side, packaged in bottles of 30 tablets. (NDC 42543-962-04) Cinacalcet 90 mg tablets are formulated as light-green, film-coated, oval-shaped tablets marked with "SCT" on one side and "90" on the opposite side, packaged in bottles of 30 tablets. (NDC 42543-963-04) Storage Store at 25o C (77o F); excursions permitted between 15°C to 30o C (59°F to 86o F). [See USP Controlled Room Temperature].
Abbreviated New Drug Application
CINACALCET - CINACALCET TABLET, FILM COATED STRIDES PHARMA INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE CINACALCET TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR CINACALCET TABLETS. CINACALCET TABLETS, FOR ORAL USE INITIAL U.S. APPROVAL: 2004 INDICATIONS AND USAGE Cinacalcet is a positive modulator of the calcium sensing receptor indicated for: (1) • Secondary Hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on dialysis. (1.1) (1) Limitations of Use: Cinacalcet is not indicated for use in patients with CKD who are not on dialysis (1) • Hypercalcemia in adult patients with Parathyroid Carcinoma (PC). (1.2) (1) • Severe hypercalcemia in adult patients with primary HPT who are unable to parathyroidectomy. (1.3) (1) DOSAGE AND ADMINISTRATION Cinacalcet tablets should be taken with food or shortly after a meal (2.1) Tablets should always be taken whole and not divided (2.1) Secondary HPT in patients with CKD on dialysis (2.2): Starting dose is 30 mg once daily. Titrate dose no more frequently than every 2 to 4 weeks through sequential doses of 30 mg, 60 mg, 90 mg, 120 mg, 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 severe hypercalcemia in patients with primary HPT (2.3): 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. Once the maintenance dose has been established, monitor serum calcium approximately monthly for patients with secondary HPT and every 2 months for patients with PC or primary HPT (2.4) DOSAGE FORMS AND STRENGTHS Tablets: 30 mg,60 mg, and 90 mg tablets (3) (3) CONTRAINDICATIONS Cinacalcet tablets treatment initiation is con Olvassa el a teljes dokumentumot