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ASPARLAS is a brand name for Calaspargase Pegol, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: ASPARLAS ® (calaspargase pegol for injection) is indicated as: • A component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukaemia (ALL) in pediatric and young adult patients age 1 to 21 years. 1.1 Pediatrics Pediatrics (1 to <18 years): The safety and efficacy of ASPARLAS were…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations • ASPARLAS is used as part of combination chemotherapy protocols with other antineoplastic agents. ASPARLAS is not a bioequivalent alternative to pegaspargase (see 10 CLINICAL PHARMACOLOGY). In a multi-agent chemotherapeutic regimen, ASPARLAS at the same dose and ASPARLAS® (calaspargase pegol) Page 5 of 35 frequency as pegaspargase may increase toxicities due to the longer half-life of calaspargase pegol (see 8 ADVERSE REACTIONS; 14 CLINICAL TRIALS).
4 Administration).
Premedication:
Premedicate 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.
Steroid administration may also be considered in the premedication regimen. 2 Recommended Dose and Dosage Adjustment The recommended dose of ASPARLAS is 2,500 units/m2 administered as intravenous infusion no more frequently than every 21 days.
Therapeutic drug monitoring may be considered to assess silent inactivation of asparaginase per institutional guidelines. If premedication is administered, therapeutic drug monitoring may be measured per institutional guidelines or based on trough asparaginase activity levels before the next administration of ASPARLAS.
If asparaginase activity values fail to reach target levels, the use of a different asparaginase preparation could be considered (see 7 WARNINGS AND PRECAUTIONS, Resistance/Silent Inactivation). , with bilirubin, transaminases, glucose and clinical examinations until recovery from the cycle of therapy (see 7 WARNINGS AND PRECAUTIONS, Monitoring and Laboratory Tests).
If an adverse reaction should occur, modify treatment according to Table 1. Table 1. Recommended Dosage Modifications for ASPARLAS Adverse Reaction Severity* Action Infusion Reaction or Hypersensitivity Reaction (see 7 WARNINGS AND PRECAUTIONS, Hypersensitivity) 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 Thrombosis (see 7 WARNINGS AND PRECAUTIONS, Thrombosis/Coagulopathy) Uncomplicated deep vein thrombosis • Hold ASPARLAS.
; 14 CLINICAL TRIALS). 4 Administration).
Premedication:
Premedicate 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.
Steroid administration may also be considered in the premedication regimen. 2 Recommended Dose and Dosage Adjustment The recommended dose of ASPARLAS is 2,500 units/m2 administered as intravenous infusion no more frequently than every 21 days.
Therapeutic drug monitoring may be considered to assess silent inactivation of asparaginase per institutional guidelines. If premedication is administered, therapeutic drug monitoring may be measured per institutional guidelines or based on trough asparaginase activity levels before the next administration of ASPARLAS.
If asparaginase activity values fail to reach target levels, the use of a different asparaginase preparation could be considered (see 7 WARNINGS AND PRECAUTIONS, Resistance/Silent Inactivation). , with bilirubin, transaminases, glucose and clinical examinations until recovery from the cycle of therapy (see 7 WARNINGS AND PRECAUTIONS, Monitoring and Laboratory Tests).
If an adverse reaction should occur, modify treatment according to Table 1. Table 1. Recommended Dosage Modifications for ASPARLAS Adverse Reaction Severity* Action Infusion Reaction or Hypersensitivity Reaction (see 7 WARNINGS AND PRECAUTIONS, Hypersensitivity) 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 Thrombosis (see 7 WARNINGS AND PRECAUTIONS, Thrombosis/Coagulopathy) Uncomplicated deep vein thrombosis • Hold ASPARLAS.
, Hypersensitivity); • History of serious thrombosis during previous L-asparaginase therapy (see 7 WARNINGS AND PRECAUTIONS, Thrombosis/Coagulopathy); • History of serious pancreatitis during previous L-asparaginase therapy (see 7 WARNINGS AND PRECAUTIONS, Pancreatitis); • History of serious hemorrhagic events during previous L-asparaginase therapy (see 7 WARNINGS AND PRECAUTIONS, Thrombosis/Coagulopathy); • Severe hepatic impairment (see 7 WARNINGS AND PRECAUTIONS, Hepatotoxicity).
1 Dosing Considerations • ASPARLAS is used as part of combination chemotherapy protocols with other antineoplastic agents. ASPARLAS is not a bioequivalent alternative to pegaspargase (see 10 CLINICAL PHARMACOLOGY). In a multi-agent chemotherapeutic regimen, ASPARLAS at the same dose and ASPARLAS® (calaspargase pegol) Page 5 of 35 frequency as pegaspargase may increase toxicities due to the longer half-life of calaspargase pegol (see
ASPARLAS is contraindicated in patients with: • Anaphylactic or severe hypersensitivity reactions to the active substance (including pegylated L- asparaginase) or to any of the excipients (see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING; 7 WARNINGS AND PRECAUTIONS, Hypersensitivity); • History of serious thrombosis during previous L-asparaginase therapy (see 7 WARNINGS AND PRECAUTIONS, Thrombosis/Coagulopathy); • History of serious pancreatitis during previous L-asparaginase therapy (see 7 WARNINGS AND PRECAUTIONS, Pancreatitis); • History of serious hemorrhagic events during previous L-asparaginase therapy (see 7 WARNINGS AND PRECAUTIONS, Thrombosis/Coagulopathy); • Severe hepatic impairment (see 7 WARNINGS AND PRECAUTIONS, Hepatotoxicity).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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• Treat with appropriate antithrombotic therapy • Upon resolution of symptoms consider resuming ASPARLAS, while continuing antithrombotic therapy. ASPARLAS® (calaspargase pegol) Page 6 of 35 Adverse Reaction Severity* Action Severe or life- threatening thrombosis • Discontinue ASPARLAS permanently.
• Treat with appropriate antithrombotic therapy. Pancreatitis (see 7 WARNINGS AND PRECAUTIONS, Pancreatitis) Grades 3 to 4 • Hold ASPARLAS for elevations in lipase or amylase >3 x ULN until enzyme levels stabilize or are declining • Discontinue ASPARLAS permanently if clinical pancreatitis is confirmed.
Hemorrhage (see 7 WARNINGS AND PRECAUTIONS, Thrombosis/Coagulopathy) 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.
5 times the upper limit of normal Total bilirubin more than 10 times the upper limit of normal • Discontinue ASPARLAS and do not make up for missed doses *NCI – CTCAE grading system used for grading the ADRs. 4 Administration • ASPARLAS is a preservative-free, 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 (see 11 STORAGE, STABILITY AND DISPOSAL).
9% sodium chloride or 5% dextrose solution prior to administering as an intravenous infusion over a period of 1 to 2 hours, through an infusion that is already running. 9% sodium chloride or 5% dextrose. ASPARLAS® (calaspargase pegol) Page 7 of 35 • Administer the dose intravenously over a period of 1-2 hours.
• 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) or refrigerated at 2°C to 8°C for up to 24 hours • Protect from light • Do not shake or freeze.
• Treat with appropriate antithrombotic therapy • Upon resolution of symptoms consider resuming ASPARLAS, while continuing antithrombotic therapy. ASPARLAS® (calaspargase pegol) Page 6 of 35 Adverse Reaction Severity* Action Severe or life- threatening thrombosis • Discontinue ASPARLAS permanently.
• Treat with appropriate antithrombotic therapy. Pancreatitis (see 7 WARNINGS AND PRECAUTIONS, Pancreatitis) Grades 3 to 4 • Hold ASPARLAS for elevations in lipase or amylase >3 x ULN until enzyme levels stabilize or are declining • Discontinue ASPARLAS permanently if clinical pancreatitis is confirmed.
Hemorrhage (see 7 WARNINGS AND PRECAUTIONS, Thrombosis/Coagulopathy) 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.
5 times the upper limit of normal Total bilirubin more than 10 times the upper limit of normal • Discontinue ASPARLAS and do not make up for missed doses *NCI – CTCAE grading system used for grading the ADRs. 4 Administration • ASPARLAS is a preservative-free, 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 (see 11 STORAGE, STABILITY AND DISPOSAL).
9% sodium chloride or 5% dextrose solution prior to administering as an intravenous infusion over a period of 1 to 2 hours, through an infusion that is already running. 9% sodium chloride or 5% dextrose. ASPARLAS® (calaspargase pegol) Page 7 of 35 • Administer the dose intravenously over a period of 1-2 hours.
• 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) or refrigerated at 2°C to 8°C for up to 24 hours • Protect from light • Do not shake or freeze.
5 OVERDOSAGE In case of overdose, patients must be carefully monitored for signs and symptoms of adverse reactions, and appropriately managed with symptomatic and supportive treatment. For management of a suspected drug overdose, contact your regional poison control centre.
6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING Table 2 – Dosage Forms, Strengths, Composition and Packaging 7 WARNINGS AND PRECAUTIONS General ASPARLAS should be prescribed and administered by physicians and health care personnel experienced in the use of antineoplastic products.
It should only be given in a hospital setting where appropriate resuscitation equipment is available. Patients should be closely monitored and carefully observed for any adverse reactions throughout the infusion period. ASPARLAS is not a bioequivalent alternative to pegaspargase (see 10 CLINICAL PHARMACOLOGY).
In a multi-agent chemotherapeutic regimen, ASPARLAS at the same dose and frequency as pegaspargase may increase toxicities due to the longer half-life of calaspargase pegol (see 8 ADVERSE REACTIONS; 14 CLINICAL TRIALS). Carcinogenesis and Mutagenesis Carcinogenicity and mutagenicity studies have not been conducted with ASPARLAS.
Driving and Operating Machinery Route of Administration Dosage Form / Strength/Composition Non-medicinal Ingredients Intravenous infusion Concentrate for solution for infusion / 3 750 units/5 mL (750 units/mL) Monobasic Sodium Phosphate, Dibasic Sodium Phosphate Heptahydrate, Sodium Chloride, Water for Injection ASPARLAS® […]