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
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
Patients 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. For patients who do not achieve an optimal clinical response, increase to 3 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)
Administration Instructions (2.3):
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Infuse over at least 2 hours.
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Consider further prolonging the infusion time for the 3 mg/kg dose or if a hypersensitivity reaction occurs.
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Consider a 1-hour infusion for the 1 mg/kg dose in patients who tolerate the infusion.
DOSAGE FORMS AND STRENGTHS
Injection: 20 mg/10 mL (2 mg/mL) solution in single-use vials. (3)
CONTRAINDICATIONS
None. (4)
WARNINGS AND PRECAUTIONS
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Hypersensitivity Reactions including Anaphylaxis: Observe patients during and after the infusion. Consider interrupting the infusion or lowering the infusion rate, based on the severity of the reaction. If a severe hypersensitivity reaction occurs, immediately stop the infusion and initiate appropriate treatment. Pre-treatment with antipyretics and/or antihistamines may prevent subsequent reactions in those cases where symptomatic treatment is required. (5.1)
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Hypersensitivity to Eggs or Egg Products: Consider the risks and benefits of treatment in patients with known systemic hypersensitivity reactions to eggs or egg products. (5.2)
ADVERSE REACTIONS
The most common adverse reactions are:
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Patients with Rapidly Progressive Disease Presenting within the First 6 Months of Life (≥30%): diarrhea, vomiting, fever, rhinitis, anemia, cough, nasopharyngitis, and urticaria. (6.1)
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Pediatric and Adult Patients (≥8%): headache, fever, oropharyngeal pain, nasopharyngitis, asthenia, constipation, and nausea. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Alexion at 1-844-259-6783 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
See 17 for PATIENT COUNSELING INFORMATION.
Revised: 12/2015
