CINACALCET HYDROCHLORIDE- cinacalcet tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Amneal Pharmaceuticals LLC

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 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 [see Clinical Studies (14.3)] . Cinacalcet HCl 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 HCl use in pregn

Product summary:

Cinacalcet tablets, 30 mg are formulated as green color, film-coated, oval-shaped tablets debossed with “155” on one side and plain on the other side. They are available as follows: Bottles of 30:                NDC 65162-155-03 Bottles of 100:              NDC 65162-155-10 Bottles of 250:              NDC 65162-155-25 Cinacalcet tablets, 60 mg are formulated as green color, film-coated, oval-shaped tablets debossed with “157” on one side and plain on the other side. They are available as follows: Bottles of 30:                NDC 65162-157-03 Bottles of 100:              NDC 65162-157-10 Bottles of 250:              NDC 65162-157-25 Cinacalcet tablets, 90 mg are formulated as green color, film-coated, oval-shaped tablets debossed with “213” on one side and plain on the other side. They are available as follows: Bottles of 30:                NDC 65162-213-03 Bottles of 100:              NDC 65162-213-10 Bottles of 250:              NDC 65162-213-25 Storage Store at 20º to 25ºC (68º to 77ºF); excursions permitted between 15° to 30ºC (59° to 86ºF) [see USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CINACALCET HYDROCHLORIDE- CINACALCET TABLET
AMNEAL PHARMACEUTICALS LLC
----------
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 tablets are a positive modulator of the calcium sensing
receptor indicated for:
Secondary Hyperparathyroidism (HPT) in adult patients with chronic
kidney disease (CKD) on dialysis.
(1.1)
Limitations of Use: Cinacalcet tablets are not indicated for use in
patients with CKD who are not on
dialysis.
Hypercalcemia in adult patients with Parathyroid Carcinoma (PC). (1.2)
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. (1.3)
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 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. (2.5)
DOSAGE FORMS AND STRENGTHS
Tablets: 30 mg, 60 mg, and 90 mg