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Rx Item-KANUMA SEBELIPASE ALFA 2MG/ML SINGLEDOSE PRESRV FREE VIAL 1X10 ML BY Ale

RX25682-0007-01Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop

Rx Item-KANUMA SEBELIPASE ALFA 2MG/ML SINGLEDOSE PRESRV FREE VIAL 1X10 ML BY Ale

$12252.00$11499.00

KANUMA SEBELIPASE ALFA 2MG/ML SINGLEDOSE PRESRV FREE VIAL 1X10 ML BY Alexion Pharma NDC No.25682-0007-01 25682-007-01 2568200701 25682000701 UPC/GTIN No.3-24167-55302-5 324167-553025 324167553025 MPN No.000701 Only Lic.-Physician, Pharmacy, Dentist, Drug Mfg, Dist., Gov, Hospital, Lic.Lab, Naturalist, Naturopath, NP, Optometrist, & Pharmacist, PA, Physical Therapist, Podiatrist, Research Co., Uni., VA, Vet & Wholesalers In Scope Of their Practice Can Order Rx Item.

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For: Lysosomal Acid Lipase Deficiency

Kanuma (sebelipase alfa) is an enzyme replacement therapy for the treatment of lysosomal acid lipase deficiency (LAL-D). 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

KANUMAŽ 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):

Infuse over at least 2 hours.
Consider further prolonging the infusion time for the 3 mg/kg dose or if a hypersensitivity reaction occurs.
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

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)
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:

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)
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

RX25682-0007-01
Rx Item-KANUMA SEBELIPASE ALFA 2MG/ML SI
RX25682-0007-01

Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.
Rx Item-KANUMA SEBELIPASE ALFA 2MG/ML SI
Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.

Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop
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Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop