CINACALCET tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CINACALCET HYDROCHLORIDE (UNII: 1K860WSG25) (CINACALCET - UNII:UAZ6V7728S)

Available from:

Golden State Medical Supply, Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

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 51407-295-30) 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 51407-296-30) 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 51407-297-30) Storage Store at 25 o C (77 o F); excursions permitted between 15°C to 30 o C (59°F to 86 o F). [See USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CINACALCET- CINACALCET TABLET, FILM COATED
GOLDEN STATE MEDICAL SUPPLY, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
CINACALCET TABLETS. 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 ta