ZEMPLAR- paricalcitol capsule, liquid filled

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

AbbVie Inc.

INN (International Name):

PARICALCITOL

Composition:

PARICALCITOL 2 ug

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

ZEMPLAR capsules are indicated in adults and pediatric patients 10 years of age and older for the prevention and treatment of secondary hyperparathyroidism associated with Chronic Kidney Disease (CKD) Stages 3 and 4. ZEMPLAR capsules are indicated in adults and pediatric patients 10 years of age and older for the prevention and treatment of secondary hyperparathyroidism associated with CKD Stage 5 in patients on hemodialysis (HD) or peritoneal dialysis (PD). ZEMPLAR capsules should not be given to patients with evidence of - hypercalcemia or - vitamin D toxicity [see Warnings and Precautions ( 5.1 )] .   Risk Summary Limited data with ZEMPLAR capsules 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 paricalc

Product summary:

ZEMPLAR capsules are available as 1 mcg and 2 mcg capsules. The 1 mcg capsule is an oval, gray, soft gelatin capsule supplied and imprinted as follows: Bottles of 30 – NDC 0074-9036-30 (imprinted with “ZA”) Bottles of 30 – NDC 0074-4317-30 (imprinted with the “a” logo and “ZA”) The 2 mcg capsule is an oval, orange-brown, soft gelatin capsule supplied and imprinted as follows: Bottles of 30 – NDC 0074-9037-30 (imprinted with “ZF”) Bottles of 30 – NDC 0074-4314-30 (imprinted with the “a” logo and “ZF”) Storage Store ZEMPLAR capsules at 25°C (77°F). Excursions permitted between 15°- 30°C (59°- 86°F). See USP Controlled Room Temperature.

Authorization status:

New Drug Application

Summary of Product characteristics

ZEMPLAR- PARICALCITOL CAPSULE, LIQUID FILLED
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) CAPSULES, FOR ORAL USE
INITIAL U.S. APPROVAL: 1998
INDICATIONS AND USAGE
ZEMPLAR is a vitamin D analog indicated in adults and pediatric
patients 10 years and older for the
prevention and treatment of secondary hyperparathyroidism associated
with:
Chronic kidney disease (CKD) Stages 3 and 4 (1.1).
CKD Stage 5 in patients on hemodialysis or peritoneal dialysis (1.2).
DOSAGE AND ADMINISTRATION
Initial Dosage: CKD Stages 3 and 4 (2.1, 2.3)
Adult: Baseline iPTH ≤ 500
pg/mL
1 mcg orally daily or 2 mcg three times a week*
Adult: Baseline iPTH > 500
pg/mL
2 mcg orally daily or 4 mcg three times a week*
Pediatric: Ages 10 to 16
years
1 mcg orally three times a week*
Dose Titration: CKD Stages 3 and 4 (2.1, 2.3)
Adult: iPTH same, increased
or decreased by < 30%
relative to baseline
Increase dose by 1 mcg daily or 2 mcg three times a week*
Adult: iPTH decreased by ≥
30% and ≤ 60% relative to
baseline
Maintain dose
Adult: iPTH decreased by >
60% or iPTH < 60 pg/mL
relative to baseline
Decrease dose by 1 mcg daily or 2 mcg three times a week*
Pediatric: Ages 10 to 16
years
Increase each dose by 1 mcg three times a week every 4 weeks or
decrease
each dose by 1 mcg three times a week at any time based on iPTH, serum
calcium and phosphorus levels.*
* Not more frequently than every other day when dosing three times a
week.
Initial Dosage: CKD Stage 5 (2.2, 2.3)
Adult
Dose (micrograms) = baseline iPTH (pg/mL) divided by 80. Administer
dose orally three
times a week.*
Pediatric:
Ages 10 to 16
years
Dose (micrograms) = baseline iPTH (pg/mL) divided by 120. Administer
dose orally three
times a week.*
Dose Titration: CKD Stage 5 (2.2, 2.3)
Adult
Dose in micrograms is based on most recent iPTH (pg/mL) divided by 80
with adjustments
based on serum calcium and ph