Kanuma Generic Name & Formulations
Legal Class
Rx
General Description
Sebelipase alfa 20mg/10mL; soln for IV infusion after dilution; preservative-free.
Pharmacological Class
Hydrolytic lysosomal cholesteryl ester and triacylglycerol-specific enzyme.
How Supplied
Single-use vial—1
Manufacturer
Generic Availability
NO
Kanuma Indications
Indications
Lysosomal acid lipase (LAL) deficiency.
Kanuma Dosage and Administration
Adults and Children
<1 month: not established. Give as IV infusion over ≥2hrs; consider further prolonging infusion time for doses >1mg/kg or if hypersensitivity reactions occur. May consider a 1hr infusion for the 1mg/kg dose in those who tolerate the infusion. ≥1 month: 1mg/kg once every other week; increase to 3mg/kg once every other week if suboptimal response. Infants with rapidly progressive deficiency within first 6 months of life: initially 1mg/kg once weekly; increase to 3mg/kg once weekly if suboptimal response; may further increase to 5mg/kg once weekly if continued suboptimal response. May pre-treat with antipyretics and/or antihistamines.
Kanuma Contraindications
Not Applicable
Kanuma Boxed Warnings
Not Applicable
Kanuma Warnings/Precautions
Warnings/Precautions
Monitor for hypersensitivity reactions during and after infusion; interrupt or lower infusion rate based on severity. Discontinue immediately and treat if severe hypersensitivity including anaphylaxis occurs. Eggs or egg products allergy. Pregnancy. Nursing mothers.
Kanuma Pharmacokinetics
See Literature
Kanuma Interactions
Not Applicable
Kanuma Adverse Reactions
Adverse Reactions
Diarrhea, vomiting, fever, rhinitis, anemia, cough, nasopharyngitis, urticaria, headache, oropharyngeal pain, asthenia, constipation, nausea.
Kanuma Clinical Trials
See Literature
Kanuma Note
Not Applicable
Kanuma Patient Counseling
See Literature
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