Asparlas

ASPARLAS- calaspargase pegol injection, solution
Servier Pharmaceuticals LLC

1 INDICATIONS AND USAGE

1.1 Acute Lymphoblastic Leukemia

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.

2 DOSAGE AND ADMINISTRATION

2.1 Recommended Dosage

The recommended dose of ASPARLAS is 2,500 units/m2 given intravenously no more frequently than every 21 days.

2.2 Dose Modifications

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.

Table 1. Dose Modifications
Adverse Reaction Severity * Action
*
Grade 1 is mild, grade 2 is moderate, grade 3 is severe, and grade 4 is life-threatening
Infusion Reaction or Hypersensitivity Reaction 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
Hemorrhage 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.
Pancreatitis Grades 3 to 4
  • Hold ASPARLAS for elevations in lipase or amylase >3 times the ULN until enzyme levels stabilize or are declining
  • Discontinue ASPARLAS permanently if clinical pancreatitis is confirmed.
Thromboembolism 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
Hepatotoxicity Total bilirubin more than 3 times to no more than 10 times the upper limit of normal
  • Hold ASPARLAS until Total bilirubin levels go down to ≤ 1.5 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

2.3 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.

3 DOSAGE FORMS AND STRENGTHS

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

4 CONTRAINDICATIONS

ASPARLAS is contraindicated in patients with:

5 WARNINGS AND PRECAUTIONS

5.1 Hypersensitivity

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.

5.2 Pancreatitis

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)].

5.3 Thrombosis

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)].

5.4 Hemorrhage

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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