CINACALCET tablet, film coated

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

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

Beszerezhető a:

NorthStar RxLLC

Az alkalmazás módja:

ORAL

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

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 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 use in pregnant women are insuf

Termék összefoglaló:

Cinacalcet tablets are supplied as follows: 30 mg light-green, film-coated, oval-shaped tablets, debossed with “379” on one side and plain on other side. Bottles of 30 with Child-resistant cap……………….…..NDC 16714-078-01 60 mg light-green, film-coated, oval-shaped tablets, debossed with “380” on one side and plain on other side. Bottles of 30 with Child-resistant cap……………….…..NDC 16714-079-01 90 mg light-green, film-coated, oval-shaped tablets, debossed with “600” on one side and plain on other side. Bottles of 30 with Child-resistant cap……………….…..NDC 16714-080-01 Storage Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F) [see USP Controlled Room Temperature.] Dispense in tight, light-resistant container as per USP.

Engedélyezési státusz:

Abbreviated New Drug Application

Termékjellemzők

CINACALCET - CINACALCET TABLET, FILM COATED
NORTHSTAR RXLLC
----------
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)
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)
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, 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 (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, 60, and 90 mg tablets (3)
CONTRAINDICATIONS
Cinacalcet t