Oncaspar

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Oncaspar

Facts of Oncaspar 3750 IU ?

  • Medicine Name: Oncaspar 3750 IU
  • Generic Name: Pegaspargase (L-Asparaginase)
  • Company Name: Sigma Tau
  • Available as (Form & Strength): 3750 UI (750 UI/ml), 5 ml
Category:

Product Description

WHAT ARE THE INDICATIONS OF ONCASPAR 3750 IU?

ONCASPAR® is indicated for patients with acute lymphoblastic leukemia who require L-asparaginase in their treatment regimen, but have developed hypersensitivity to the native forms of L-asparaginase (SEE CLINICAL PHARMACOLOGY). ONCASPAR®, like native L-asparginase, is generally used in combination with other chemotherapeutic agents, such as vincristine, methotrexate, cytarabine, daunorubicin, and doxorubicin.1,5 Use of ONCASPAR® as a single agent should only be undertaken when multi-agent chemotherapy is judged to be inappropriate for the patient.

WHAT ARE THE DOSAGE AND ADMINISTRATION?

  • As a component of selected multiple agent regimens, the recommended dose of ONCASPAR® is 2,500 IU/m2 every 14 days by the intramuscular route of administration.
  • The safety and effectiveness of ONCASPAR® have been established in patients with known previous hypersensitivity to L-asparaginase whose ages ranged from 1 to 21 years old. The recommended dose of ONCASPAR® for children with a body surface area < 0.6 m2 is 82.5 IU/kg administered every 14 days.
  • Do not administer ONCASPAR® if there is any indication that the drug has been frozen. Although there may not be an apparent change in the appearance of the drug, ONCASPAR®’s activity is destroyed after freezing.
  • When administering ONCASPAR® intramuscularly, the volume at a single injection site should be limited to 2 mL. If the volume to be administered is greater than 2 mL, multiple injection sites should be used.
  • Anaphylactic reactions require the immediate use of antihistamines, epinephrine, oxygen, and intravenous steroids.
  • Use of ONCASPAR® as the sole induction agent should be undertaken only in an unusual situation when a combined regimen, which uses other chemotherapeutic agents such as vincristine, methotrexate, cytarabine, daunorubicin, or doxorubicin, is inappropriate because of toxicity or other specific patient-related factors, or in patients refractory to other therapy. When ONCASPAR® is to be used as the sole induction agent, the recommended dosage regimen is also 2,500 IU/m2 every 14 days.
  • When a remission is obtained, appropriate maintenance therapy may be instituted. ONCASPAR® may be used as part of a maintenance regimen.
  • Parenteral drug products should be inspected visually for particulate matter, cloudiness or discoloration prior to administration, whenever solution and container permit.

DOSAGE FORM

ONCASPAR®: Use only one dose per vial; do not re-enter the vial. Discard unused portions. Do not save unused drug for later administration.

Sterile solution for injection in ready to use single-use vials. Preservative free.

QUANTITY PER INDIVIDUAL CONTAINER

5 mL per vial containing 750 IU/mL ONCASPAR® in a clear, colorless, phosphate buffered saline solution, pH 7.3. Each vial contains 3,750 IU of ONCASPAR®.

HOW SUPPLIED/STORAGE AND HANDLING ?

Avoid excessive agitation. DO NOT SHAKE.

Keep refrigerated at + 2°C to + 8°C (36°F to 46°F).

Do not use if cloudy of if precipitate is present.

Do not use if stored at room temperature for more than 48 hours.

DO NOT FREEZE. Do not use product if it is known to have been frozen. Freezing destroys activity, which cannot be detected visually.

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