Calaspargase pegol
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From MedlinePlus, U.S. National Library of Medicine
Asparagine-specific Enzyme
Dosing in kidney impairment
This label has no separate kidney-impairment dosing section. Check warnings and clinical pharmacology in the full label.
Preparation and administration
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Preparation and Administration ASPARLAS is a clear and colorless solution. Visually inspect parenteral drug products for particulate matter, cloudiness, or discoloration prior to administration. If any of these are present, discard the vial. Do not administer if ASPARLAS has been shaken or vigorously agitated, frozen, or stored at room temperature for more than 48 hours.
Dilute ASPARLAS in 100 mL of 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP using sterile/aseptic technique. Discard any unused portion left in a vial. After dilution, administer immediately into a running infusion of either 0.9% sodium chloride or 5% dextrose, respectively. Administer the dose over a period of 1 hour.
Do not infuse other drugs through the same intravenous line during administration of ASPARLAS. The diluted solution may be stored for up to 4 hours at room temperature (15°C to 25°C [59°F to 77°F]) or refrigerated at 2°C to 8°C (36°F to 46°F) for up to 24 hours. Protect from light. Do not shake or freeze.
| Adverse Reaction | SeverityGrade 1 is mild, grade 2 is moderate, grade 3 is severe, and grade 4 is life-threatening. | Action |
|---|---|---|
| Infusion Reaction/ Hypersensitivity Reaction [see Warnings and Precautions (5.1)] | Grade 1 | Reduce the infusion rate by 50% |
| Grade 2 | Interrupt the infusion of ASPARLASTreat the symptomsWhen symptoms resolve, resume the infusion and reduce the infusion rate by 50% | |
| Grade 3 to 4 | Discontinue ASPARLAS permanently | |
| Pancreatitis [see Warnings and Precautions (5.2)] | Grades 3 to 4 | Hold ASPARLAS for elevations in lipase or amylase >3 × upper limit of normal (ULN) until enzyme levels stabilize or are decliningDiscontinue ASPARLAS permanently if clinical pancreatitis is confirmed |
| Thrombosis [see Warnings and Precautions (5.3)] | Uncomplicated deep vein thrombosis | Hold ASPARLASTreat with appropriate antithrombotic therapyUpon resolution of symptoms consider resuming ASPARLAS, while continuing antithrombotic therapy |
| Severe or life-threatening thrombosis | Discontinue ASPARLAS permanentlyTreat with appropriate antithrombotic therapy | |
| Hemorrhage [see Warnings and Precautions (5.4)] | Grade 3 to 4 | Hold ASPARLASEvaluate for coagulopathy and consider clotting factor replacement as neededResume ASPARLAS with the next scheduled dose if bleeding is controlled |
| Hepatotoxicity [see Warnings and Precautions (5.5)] | Total bilirubin more than 3 times to no more than 10 times the ULN | Hold ASPARLAS until total bilirubin is ≤1.5 times the ULN |
| Total bilirubin more than 10 times the ULN | Discontinue ASPARLAS and do not make up for missed doses |
Contraindications
4 CONTRAINDICATIONS ASPARLAS is contraindicated in patients with: History of serious hypersensitivity reactions, including anaphylaxis, to pegylated L-asparaginase therapy [see Warnings and Precautions (5.1) ] History of serious pancreatitis during previous L-asparaginase therapy [see Warnings and Precautions (5.2) ] History of serious thrombosis during previous L-asparaginase therapy [see Warnings and Precautions (5.3) ] History of serious hemorrhagic events during previous L-asparaginase therapy [see Warnings and Precautions (5.4) ] Severe hepatic impairment [see Warnings and Precautions (5.5) ] 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 )
Pregnancy and lactation
Pregnancy
8.1 Pregnancy Risk Summary Based on published literature studies with L-asparaginase in pregnant animals, ASPARLAS can cause fetal harm when administered to a pregnant woman. There are no available data on ASPARLAS use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. In animal reproduction studies, intravenous administration of calaspargase pegol-mknl to pregnant rats during organogenesis at doses 0.2 to 1 times the maximum recommended human doses did not result in adverse developmental outcomes.
Published literature studies in pregnant rabbits, however, suggest asparagine depletion may cause harm to the animal offspring (see Data ) . Advise pregnant women of the potential risk to a fetus. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies are 2 to 4% and 15 to 20%, respectively. Data Animal Data In an embryo-fetal development study, calaspargase pegol-mknl was administered intravenously at doses of 75, 150, and 300 U/kg (0.2, 0.6 and 1 times the maximum recommended human dose, respectively, based on AUC) to pregnant rats during the period of organogenesis.
Maternal toxicity of decreased body weight and food consumption was seen at all dose levels resulting in reductions in gravid uterine and placental weights, and slight reductions in fetal body weights. No evidence of structural abnormalities or embryo-fetal mortality were observed in this study at any of the doses tested. Published literature studies in which pregnant rabbits were administered L-asparaginase suggested harm to the animal offspring.
For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
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