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Rx Item-ASPARLAS CALASPARGASE PEGOL-MKNL 750U/ML SDV PF VIAL 1X5 ML BY Servier P

RX72694-0515-01/CVisit 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-ASPARLAS CALASPARGASE PEGOL-MKNL 750U/ML SDV PF VIAL 1X5 ML BY Servier P

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NDC No. 72694-0515-01 72694-515-01 7269451501 72694051501 UPC/GTIN No. 3-72694-51501-7 372694-515017 372694515017 MPN No.51501 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. for: Acute Lymphoblastic Leukemia
Asparlas (calaspargase pegol-mknl) is an asparagine specific enzyme ind

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Acute Lymphoblastic Leukemia

Asparlas (calaspargase pegol-mknl) is an asparagine specific enzyme indicated as a component of a multi-agent chemotherapy regimen for the treatment of acute lymphoblastic leukemia. ASPARLAS injection is supplied as a clear, colorless, preservative-free sterile solution in single-dose vials containing 3,750 units of calaspargase pegol-mknl per 5 mL solution (NDC 72694-515-01).

Store ASPARLAS refrigerated at 2�C to 8�C (36�F to 46�F) in the original carton to protect from light. Do not shake or freeze product. Unopened vials may be stored at room temperature (15�C to 25�C [59�F to 77�F]) for no more than 48 hours. These highlights do not include all the information needed to use ASPARLAS safely and effectively. See full prescribing information for ASPARLAS.

ASPARLAS� (calaspargase pegol - mknl) injection, for intravenous use
Initial U.S. Approval: 2018
INDICATIONS AND USAGE

ASPARLAS is an asparagine specific enzyme indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia in pediatric and young adult patients age 1 month to 21 years. (1.1)
DOSAGE AND ADMINISTRATION

Recommended Dosage: 2,500 units/m2 intravenously no more frequently than every 21 days. (2.1)
See Full Prescribing Information for important details regarding dosing modifications and preparation and administration. (2.2, 2.3)

DOSAGE FORMS AND STRENGTHS

Injection: 3,750 units/5 mL (750 units/mL) in a single-dose vial. (3)
CONTRAINDICATIONS

History of serious hypersensitivity reactions to pegylated L-asparaginase. (4)
History of serious thrombosis during L-asparaginase therapy. (4)
History of serious pancreatitis related to previous L-asparaginase treatment. (4)
History of serious hemorrhagic events during previous L-asparaginase therapy. (4)
Severe hepatic impairment. (4)

WARNINGS AND PRECAUTIONS

Hypersensitivity: Observe patients for one hour after administration. Discontinue ASPARLAS in patients with serious hypersensitivity reactions. (5.1)
Pancreatitis: Discontinue ASPARLAS in patients with pancreatitis. Monitor blood glucose (5.2)
Thrombosis: Discontinue ASPARLAS for severe or life-threatening thrombosis. Provide anticoagulation therapy as indicated.
Hemorrhage: Discontinue ASPARLAS for severe or life-threatening hemorrhage. Evaluate for etiology and treat. (5.3, 5.4)
Hepatotoxicity: Monitor for toxicity through recovery from cycle (5.4)

ADVERSE REACTIONS

The most common (incidence?10%) grade ? 3 adverse reactions were elevated transaminase, bilirubin increased, pancreatitis and abnormal clotting studies. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Servier Pharmaceuticals LLC at 1-800-807-6124 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
USE IN SPECIFIC POPULATIONS

Lactation: Advise women not to breastfeed. (8.2)

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 12/2018

RX72694-0515-01/C
Rx Item-ASPARLAS CALASPARGASE PEGOL-MKNL
RX72694-0515-01/C

Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.
Rx Item-ASPARLAS CALASPARGASE PEGOL-MKNL
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
AmericanPharmaWholesale.com
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