Asparlas
(Calaspargase Pegol)Dosage & Administration
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Asparlas Prescribing Information
Warnings and Precautions: Hepatotoxicity (Hepatotoxicity, including severe, life-threatening, and potentially fatal cases of hepatic veno-occlusive disease (VOD), have been observed in patients treated with ASPARLAS in combination with standard chemotherapy, including during the induction phase of multiphase chemotherapy [see Adverse Reactions (6)] . Do not administer ASPARLAS to patients with severe hepatic impairment[see Contraindications (4)] .Evaluate bilirubin and transaminases prior to each dose of ASPARLAS and at least weekly, during cycles of treatment that include ASPARLAS, through 6 weeks after the last dose of ASPARLAS. Monitor frequently for signs and symptoms of hepatic VOD, which may include rapid weight gain, fluid retention with ascites, hepatomegaly (which may be painful), and rapid increase of bilirubin. For patients who develop abnormal liver tests after ASPARLAS, more frequent monitoring for liver test abnormalities and clinical signs and symptoms of VOD is recommended. In the event of serious liver toxicity, including VOD, discontinue treatment with ASPARLAS and provide supportive care [see Dosage and Administration (2.3)] . | 11/2023 |
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. (
ASPARLAS is 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.
- Recommended Dosage: 2,500 units/m2 intravenously no more frequently than every 21 days. ()
2.1 Recommended DosageThe recommended dose of ASPARLAS is 2,500 units/m2given intravenously no more frequently than every 21 days.
- See Full Prescribing Information for important details regarding dosing modifications and preparation and administration. (,
2.2 Recommended PremedicationPremedicate patients with acetaminophen, an H-1 receptor blocker (such as diphenhydramine), and an H-2 receptor blocker (such as famotidine) 30-60 minutes prior to administration of ASPARLAS to decrease the risk and severity of both infusion and hypersensitivity reactions
[see Warnings and Precautions (5.1)].,2.3 Recommended Monitoring and Dosage Modifications for Adverse ReactionsMonitor patients at least weekly with bilirubin, transaminases, glucose, and clinical examinations until recovery from the cycle of therapy. If an adverse reaction should occur, modify treatment according to Table 1.
Table 1: Dosage Modifications 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 ASPARLAS
- Treat the symptoms
- When 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 declining
- Discontinue ASPARLAS permanently if clinical pancreatitis is confirmed
Thrombosis [see Warnings and Precautions (5.3)]Uncomplicated deep vein thrombosis - Hold ASPARLAS
- Treat with appropriate antithrombotic therapy
- Upon resolution of symptoms consider resuming ASPARLAS, while continuing antithrombotic therapy
Severe or life-threatening thrombosis - Discontinue ASPARLAS permanently
- Treat with appropriate antithrombotic therapy
Hemorrhage [see Warnings and Precautions (5.4)]Grade 3 to 4 - Hold ASPARLAS
- Evaluate for coagulopathy and consider clotting factor replacement as needed
- Resume 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
)2.4 Preparation and AdministrationASPARLAS 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.
Injection: 3,750 units/5 mL (750 units/mL) clear, colorless solution in a single-dose vial.
There are no data on the presence of calaspargase pegol-mknl in human milk, the effects on the breastfed child, or the effects on milk production. Because of the potential for adverse reactions in the breastfed child, advise women not to breastfeed during treatment with ASPARLAS and for 3 months after the last dose.
ASPARLAS is contraindicated in patients with:
- History of serious hypersensitivity reactions, including anaphylaxis, to pegylated L-asparaginase therapy [see]
5.1 HypersensitivityGrade 3 and 4 hypersensitivity reactions, including anaphylaxis, have been reported in clinical trials with ASPARLAS with an incidence between 7 and 21%
[see Contraindications (4), Adverse Reactions (6.1)]. Hypersensitivity reactions observed with other asparaginases include angioedema, lip swelling, eye swelling, erythema, blood pressure decreased, bronchospasm, dyspnea, pruritus, and rash[see Adverse Reactions (6.1)].Premedicate patients 30-60 minutes prior to administration of ASPARLAS
[see Dosage and Administration (2.2)]. Because of the risk of serious allergic reactions (e.g., life-threatening anaphylaxis), administer ASPARLAS in a clinical setting with resuscitation equipment and other agents necessary to treat anaphylaxis (e.g., epinephrine, oxygen, intravenous steroids, antihistamines)[see Dosage and Administration (2.4)]and observe patients for 1 hour after administration. Discontinue ASPARLAS in patients with serious hypersensitivity reactions. - History of serious pancreatitis during previous L-asparaginase therapy [see]
5.2 PancreatitisCases of pancreatitis have been reported in clinical trials with ASPARLAS with an incidence between 12 and 16%
[see Adverse Reactions (6.1)]. Hemorrhagic or necrotizing pancreatitis have been reported with other asparaginases.Inform patients of the signs and symptoms of pancreatitis, which, if left untreated, could be fatal. Assess serum amylase and/or lipase levels to identify early signs of pancreatic inflammation. Discontinue ASPARLAS if pancreatitis is suspected; if pancreatitis is confirmed, do not resume ASPARLAS
[see Dosage and Administration (2.3)]. - History of serious thrombosis during previous L-asparaginase therapy [see]
5.3 ThrombosisSerious thrombotic events, including sagittal sinus thrombosis, have been reported in clinical trials with ASPARLAS with an incidence of 9 to 12%. Discontinue ASPARLAS in patients experiencing serious thrombotic events
[see Dosage and Administration (2.3), Adverse Reactions (6.1)]. - History of serious hemorrhagic events during previous L-asparaginase therapy [see]
5.4 HemorrhageHemorrhage associated with increased prothrombin time (PT), increased partial thromboplastin time (PTT), and hypofibrinogenemia have been reported in patients receiving ASPARLAS
[see Adverse Reactions (6.1)]. Evaluate patients with signs and symptoms of hemorrhage with coagulation parameters including PT, PTT, fibrinogen. Consider appropriate replacement therapy in patients with severe or symptomatic coagulopathy[see Dosage and Administration (2.3)]. - Severe hepatic impairment [see]
5.5 Hepatotoxicity, Including Hepatic Veno-Occlusive DiseaseHepatotoxicity, including severe, life-threatening, and potentially fatal cases of hepatic veno-occlusive disease (VOD), have been observed in patients treated with ASPARLAS in combination with standard chemotherapy, including during the induction phase of multiphase chemotherapy[see Adverse Reactions (6)]. Do not administer ASPARLAS to patients with severe hepatic impairment[see Contraindications (4)].Evaluate bilirubin and transaminases prior to each dose of ASPARLAS and at least weekly, during cycles of treatment that include ASPARLAS, through 6 weeks after the last dose of ASPARLAS. Monitor frequently for signs and symptoms of hepatic VOD, which may include rapid weight gain, fluid retention with ascites, hepatomegaly (which may be painful), and rapid increase of bilirubin. For patients who develop abnormal liver tests after ASPARLAS, more frequent monitoring for liver test abnormalities and clinical signs and symptoms of VOD is recommended. In the event of serious liver toxicity, including VOD, discontinue treatment with ASPARLAS and provide supportive care[see Dosage and Administration (2.3)].