KANUMA- sebelipase alfa injection, solution, concentrate

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Sebelipase alfa (UNII: K4YTU42T8G) (Sebelipase alfa - UNII:K4YTU42T8G)

Available from:

Alexion Pharmaceuticals, Inc.

INN (International Name):

Sebelipase alfa

Composition:

Sebelipase alfa 2 mg in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

KANUMA® is indicated for the treatment of patients with a diagnosis of Lysosomal Acid Lipase (LAL) deficiency. None. Risk Summary Available data with KANUMA use in pregnant women are insufficient to identify a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. Animal reproductive studies conducted with sebelipase alfa showed no evidence of embryolethality, fetotoxicity, teratogenicity, or abnormal early embryonic development at dosages up to 164 and 526 times the human dosage of 1 mg/kg every other week (based on AUC) in rats and rabbits, respectively. The background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Animal Data Sebelipase alfa administered during the period of organogenesis to rats (on gestation days 6, 9, 12, 15 and 17) and rabbits

Product summary:

KANUMA (sebelipase alfa) injection is a preservative-free, clear to slightly opalescent, colorless to slightly colored, nonpyrogenic solution supplied as 20 mg/10 mL (2 mg/mL) in single-dose, glass vials. NDC 25682-007-01: 20 mg/10 mL vial Store KANUMA refrigerated at 2°C to 8°C (36°F to 46°F) in original carton to protect from light. Do not shake or freeze the vials.

Authorization status:

Biologic Licensing Application

Summary of Product characteristics

KANUMA- SEBELIPASE ALFA INJECTION, SOLUTION, CONCENTRATE
ALEXION PHARMACEUTICALS, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
KANUMA SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR KANUMA.
KANUMA (SEBELIPASE ALFA) INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 2015
RECENT MAJOR CHANGES
Dosage and Administration (2.1, 2.2)
11/2021
Warnings and Precautions (5.1)
11/2021
INDICATIONS AND USAGE
KANUMA is a hydrolytic lysosomal cholesteryl ester and
triacylglycerol-specific enzyme indicated for the
treatment of patients with a diagnosis of Lysosomal Acid Lipase (LAL)
deficiency. (1)
DOSAGE AND ADMINISTRATION
Infants with Rapidly Progressive LAL Deficiency Presenting within the
First 6 Months of Life:
The recommended starting dosage is 1 mg/kg as an intravenous infusion
once weekly. (2.1)
For patients with a suboptimal clinical response, increase the dosage
to 3 mg/kg once weekly. (2.1)
For patients with continued suboptimal clinical response, further
increase the dosage to 5 mg/kg once
weekly. (2.1)
Pediatric and Adult Patients with LAL Deficiency:
The recommended dosage is 1 mg/kg as an intravenous infusion once
every other week. (2.1)
For patients with a suboptimal clinical response, increase the dosage
to 3 mg/kg once every other
week. (2.1)
See Full Prescribing Information for complete Dosage and
Administration Information.
Administration Instructions
Infuse over at least 2 hours. (2.3)
Consider further prolonging the infusion time for patients receiving
dosages greater than 1 mg/kg or for
those who have experienced a hypersensitivity reaction. (2.3)
Consider a 1-hour infusion for the 1 mg/kg dose in patients who
tolerate the infusion. (2.3)
DOSAGE FORMS AND STRENGTHS
Injection: 20 mg/10 mL (2 mg/mL) solution in single-dose vials. (3)
CONTRAINDICATIONS
None. (4)
WARNINGS AND PRECAUTIONS
Hypersensitivity Reactions including Anaphylaxis: Observe patients
during and after the infusion.
Consider interrupting the infusion or