SENSIPAR- cinacalcet hydrochloride tablet, coated

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

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

Disponible desde:

A-S Medication Solutions

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Sensipar is 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: Sensipar is 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 )] . Sensipar is indicated for the treatment of hypercalcemia in adult patients with Parathyroid Carcinoma [see Clinical Studies ( 14.2 )] . Sensipar is 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 )] . Sensipar 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 Sensipar use in pregnant women are insufficient to inform a drug associated

Resumen del producto:

Product: 50090-4470 NDC: 50090-4470-0 30 TABLET, COATED in a BOTTLE, PLASTIC

Estado de Autorización:

New Drug Application

Ficha técnica

SENSIPAR- CINACALCET HYDROCHLORIDE TABLET, COATED
A-S MEDICATION SOLUTIONS
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
SENSIPAR SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR SENSIPAR.
SENSIPAR (CINACALCET) TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2004
INDICATIONS AND USAGE
Sensipar is a calcium-sensing receptor agonist indicated for:
Secondary Hyperparathyroidism (HPT) in adult patients with chronic
kidney disease (CKD) on dialysis. (1.1)
Limitations of Use: Sensipar is 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
Sensipar 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
Sensipar treatment