ZEMPLAR- paricalcitol injection, solution

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

PARICALCITOL (UNII: 6702D36OG5) (PARICALCITOL - UNII:6702D36OG5)

Disponible des:

AbbVie Inc.

Designació comuna internacional (DCI):

PARICALCITOL

Composición:

PARICALCITOL 2 ug in 1 mL

Vía de administración:

INTRAVENOUS

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

ZEMPLAR is indicated for the prevention and treatment of secondary hyperparathyroidism in patients 5 years of age and older with chronic kidney disease (CKD) on dialysis. ZEMPLAR is contraindicated in patients with: - Hypercalcemia [see Warnings and Precautions ( 5.1 )] - Vitamin D toxicity [see Warnings and Precautions ( 5.1 )] - Known hypersensitivity to paricalcitol or any of the inactive ingredients in ZEMPLAR. Hypersensitivity adverse reactions have been reported [e.g., angioedema (including laryngeal edema) and urticaria] [see Adverse Reactions ( 6.2 )] . Risk Summary Limited data with ZEMPLAR in pregnant women are insufficient to inform a drug-associated risk for major birth defects and miscarriage. There are risks to the mother and fetus associated with chronic kidney disease in pregnancy (see Clinical Considerations ) . In animal reproduction studies, slightly increased embryofetal loss was observed in pregnant rats and rabbits administered paricalcitol intravenously during the period of organogenes

Resumen del producto:

ZEMPLAR injection is a clear, colorless solution available in cartons of 25 vials as follows: Store at 25°C (77°F). Excursions permitted between 15° to 30°C (59° to 86°F). Discard any unused portion of the single-dose vial after use. The contents of the multiple-dose vial remain stable up to seven days after initial use when stored at controlled room temperature.

Estat d'Autorització:

New Drug Application

Fitxa tècnica

ZEMPLAR- PARICALCITOL INJECTION, SOLUTION
ABBVIE INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ZEMPLAR SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ZEMPLAR.
ZEMPLAR (PARICALCITOL) INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1998
INDICATIONS AND USAGE
ZEMPLAR is a vitamin D analog indicated for the prevention and
treatment of secondary
hyperparathyroidism in patients 5 years of age and older with chronic
kidney disease on dialysis (1).
DOSAGE AND ADMINISTRATION
Ensure serum calcium is not above the upper limit of normal before
initiating (2.1)
Administer ZEMPLAR intravenously through a hemodialysis vascular
access at any time during dialysis
(2.1).
Adult Dose:
Initiate at 0.04 mcg/kg to 0.1 mcg/kg (2.8 mcg to 7 mcg) no more
frequently than every other day
(2.2).
Target maintenance dose to intact parathyroid hormone (PTH) levels
within the desired therapeutic
range and serum calcium within normal limits (2.2).
Monitor serum calcium frequently (e.g., twice weekly) and intact PTH
levels every 2 to 4 weeks after
dose initiation or adjustment (2.2).
See Table 1 in the full prescribing information for titration
recommendations based upon intact PTH
levels (2.2).
Suspend or decrease the dose for persistent abnormally low intact PTH
or serum calcium consistently
above the normal range (2.2).
Pediatric Dose:
Initiate ZEMPLAR as an intravenous bolus dose of:
○ 0.04 mcg/kg if baseline intact PTH is less than 500 pg/mL, or
○ 0.08 mcg/kg if baseline intact PTH is 500 pg/mL or greater (2.3)
Target maintenance dose to intact PTH levels within the desired
therapeutic range and serum calcium
within normal limits (2.3).
Monitor serum calcium frequently (e.g., twice weekly) and intact PTH
levels every 2 to 4 weeks after
dose initiation or adjustment (2.3).
See Table 2 in the full prescribing information for titration
recommendations based upon intact PTH
levels (2.3).
Suspend or decrease the dose for persistent abnormally low inta