ASPARLAS- calaspargase pegol injection, solution
Servier Pharmaceuticals LLC
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.
The recommended dose of ASPARLAS is 2,500 units/m2 given intravenously no more frequently than every 21 days.
Monitor 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.
|Adverse Reaction||Severity *||Action|
|Infusion Reaction or Hypersensitivity Reaction||Grade 1|| |
|Grade 2|| |
|Grade 3 to 4|| |
|Hemorrhage||Grade 3 to 4|| |
|Pancreatitis||Grades 3 to 4|| |
|Thromboembolism||Uncomplicated deep vein thrombosis|| |
|Severe or life-threatening thrombosis|| |
|Hepatotoxicity||Total bilirubin more than 3 times to no more than 10 times the upper limit of normal|| |
|Total bilirubin more than 10 times the upper limit of normal|| |
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.
Injection: 3,750 units/5 mL (750 units/mL) clear, colorless solution in a single-dose vial.
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 thrombosis during previous L-asparaginase therapy [see Warnings and Precautions (5.3)] ;
- History of serious pancreatitis during previous L-asparaginase therapy [see Warnings and Precautions (5.2)] ;
- 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)].
Grade 3 and 4 hypersensitivity reactions including anaphylaxis have been reported in clinical trials with ASPARLAS with an incidence between 7 to 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.
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)] and observe patients for 1 hour after administration. Discontinue ASPARLAS in patients with serious hypersensitivity reactions.
Cases of pancreatitis have been reported in clinical trials with ASPARLAS with an incidence between 12 to 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 (2.2)].
Serious 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 (2.2), Adverse Reactions (6.1)].
Hemorrhage 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 (2.2)].
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