PARICALCITOL capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Golden State Medical Supply, Inc.

INN (International Name):

PARICALCITOL

Composition:

PARICALCITOL 1 ug

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Paricalcitol capsules are indicated in adults for the prevention and treatment of secondary hyperparathyroidism associated with Chronic Kidney Disease (CKD) Stages 3 and 4. Pediatric use information for patients 10 to 16 years of age is approved for AbbVie Inc.’s Zemplar (paricalcitol) capsules. However, due to AbbVie Inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. Paricalcitol capsules are indicated in adults for the prevention and treatment of secondary hyperparathyroidism associated with CKD Stage 5 in patients on hemodialysis (HD) or peritoneal dialysis (PD). Pediatric use information for patients 10 to 16 years of age is approved for AbbVie Inc.’s Zemplar (paricalcitol) capsules. However, due to AbbVie Inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. Paricalcitol capsules should not be given to patients with evidence of - hypercalcemia or hypercalcemia or - vitamin D toxicity [see

Product summary:

Paricalcitol capsules are available as 1 mcg, 2 mcg, and 4 mcg capsules. The 1 mcg capsule is an oval, gray, soft gelatin capsule imprinted with "PA1", and is available in the following package size: Bottles of 30 (NDC 60429-836-30) The 2 mcg capsule is an oval, orange-brown, soft gelatin capsule imprinted with "PA2", and is available in the following package size: Bottles of 30 (NDC 60429-837-30) Storage Store paricalcitol capsules at 25°C (77°F). Excursions permitted between 15°- 30°C (59°- 86°F). See USP Controlled Room Temperature.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

PARICALCITOL- PARICALCITOL CAPSULE
GOLDEN STATE MEDICAL SUPPLY, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
PARICALCITOL
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PARICALCITOL CAPSULES SAFELY AND
EFFECTIVELY.
SEE FULL PRESCRIBING INFORMATION FOR PARICALCITOL CAPSULES.
PARICALCITOL CAPSULES, FOR ORAL USE
INITIAL U.S. APPROVAL: 1998
RECENT MAJOR CHANGES
Dosage and Administration, Pediatric Patients 10/2016
INDICATIONS AND USAGE
Paricalcitol is a vitamin D analog indicated in adults 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)
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*
DOSE TITRATION: CKD STAGES 3 AND 4 ( 2.1)
Adult: iPTH same, increased or decreased by < 30% relative to
base line
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
base line
Decrease dose by 1 mcg daily or 2 mcg three times a
week*
* Not more frequently than every other day when dosing three times a
week.
INITIAL DOSAGE: CKD STAGE 5 ( 2.2)
AdultDose (micrograms) = baseline iPTH (pg/mL) divided by 80.
Administer dose orally three times a week.*
DOSE TITRATION: CKD STAGE 5 ( 2.2)
AdultDose in micrograms is based on most recent iPTH (pg/mL) divided
by 80 with adjustments based on serum calcium
and phosphorous levels. Dose three times a week.*
* Not more frequently than every other day.
CKD Stage 5: To avoid hypercalcemia only treat patients after their
baseline serum calcium has been reduced to 9.5
mg/dL or lower (2.2).
DOSAGE FORMS AND STRENGTHS
Capsules: 1 mcg, 2 mcg, and 4 mcg ( 3).
CONTRAINDICATIONS
• Evidence of hypercalcem