PARICALCITOL injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Hospira, Inc.

INN (International Name):

PARICALCITOL

Composition:

PARICALCITOL 5 ug in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Paricalcitol Injection 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. Paricalcitol Injection is contraindicated in patients with: - Hypercalcemia [see Warnings and Precautions (5.1)] - Vitamin D toxicity [see Warnings and Precautions (5.1)] or - Known hypersensitivity to paricalcitol or any inactive ingredient in Paricalcitol Injection. Hypersensitivity adverse reactions have been reported [e.g., angioedema (including laryngeal edema) and urticaria] [see Adverse Reactions (6.2)] Risk Summary Limited data with Paricalcitol Injection 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 another pa

Product summary:

Paricalcitol Injection is a clear, colorless solution available in trays of 25 vials as follows: Store under normal lighting conditions at 20° – 25°C (68° – 77°F) [see USP controlled room temperature]. Do not freeze. After breakage of the seal for first use the multi-dose vials are stable for up to 28 days when stored between 20° – 25°C (68° – 77°F).

Authorization status:

New Drug Application

Summary of Product characteristics

PARICALCITOL- PARICALCITOL INJECTION, SOLUTION
HOSPIRA, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PARICALCITOL INJECTION SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR PARICALCITOL
INJECTION.
PARICALCITOL INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1998
RECENT MAJOR CHANGES
Indications and Usage (1)
12/2019
Dosage and Administration (2)
12/2019
Contraindications (4)
12/2019
Warnings and Precautions (5)
12/2019
INDICATIONS AND USAGE
Paricalcitol Injection 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 Paricalcitol Injection intravenously through a hemodialysis
vascular access at any time during dialysis (2.1).
Do not inject Paricalcitol Injection directly into a vein.
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 phosphorus
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 Paricalcitol Injection 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 ca