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 Recommended 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 [see Warnings and Precautions (5.1)].

2.3 Recommended Monitoring and Dosage Modifications for Adverse Reactions

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. Dosage 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/ 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
Thrombosis [see Warnings and Precautions (5.2)] 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.
Pancreatitis [see Warnings and Precautions (5.3)] Grades 3 to 4
  • Hold ASPARLAS for elevations in lipase or amylase >3 × ULN until enzyme levels stabilize or are declining
  • Discontinue ASPARLAS permanently if clinical pancreatitis is confirmed.
Hemorrhage [see Warnings and Precautions (5.5)] 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 (5.6)] Total bilirubin more than 3 times to no more than 10 times the upper limit of normal
  • Hold ASPARLAS until total bilirubin is ≤ 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

2.4 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 [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.

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