ONCASPAR^Ò 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^Ò, like native L-asparaginase, is generally used in combination with other chemotherapeutic agents, such as vincristine, methotrexate, cytarabine, daunorubicin, and doxo-rubicin.^1,5 Use of ONCASPAR^Ò as a single agent should only be undertaken when multi-agent chemotherapy is judged to be inappropriate for the patient.

As a component of selected multiple agent regimens, the recommended dose of ONCASPAR^Ò is 2,500 IU/m² every 14 days by the intramuscular route or intravenous route of administration.

The preferred route of administration, however, is the intramuscular route because of the lower incidence of hepatotoxicity, coagulopathy, and gastrointestinal and renal disorders compared to the intravenous route of administration.

The safety and effectiveness of ONCASPAR^Ò 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 ONCASPARÒ for children with a body surface area ≥0.6 m2 is 2,500 IU/m2 administered every 14 days. Therecommended dose of ONCASPAR^Ò for children with a body surface area < 0.6 m² is 82.5 IU/kg administered every 14 days.

Do not administer ONCASPAR^Ò 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, the activity of ONCASPAR^Ò is destroyed after freezing.

When administering ONCASPAR^Ò 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.

When administered intravenously, ONCASPAR^Ò should be given over a period of 1 to 2 hours in 100 mL of sodium chloride or dextrose injection 5%, through an infusion that is already running.

Anaphylactic reactions require the immediate use of antihistamines, epinephrine, oxygen, and intravenous steroids.

Use of ONCASPAR^Ò 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, cytara-bine, daunorubicin, or doxorubicin, is inappropriate because of toxicity or other specific patient-related factors, or in patients refractory to other therapy. When ONCASPAR^Ò 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^Ò 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^Ò : 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^Ò in a clear, colorless, phosphate buffered saline solution, pH 7.3. Each vial contains 3,750 IU of ONCASPAR^Ò .

Handling and Storage

Avoid excessive agitation. DO NOT SHAKE.
Keep refrigerated at +2°C to +8°C (36°F to 46°F).
Do not use if cloudy or if precipitate is present.
Do not use if stored at room temperature (+15°C to +30°C; 59°F to 77°F) 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.

NDC 57665-002-02

REFERENCES

1. Capizzi, RL and Holcenberg, JS. Asparaginase. In: Holland and Frei (eds). Cancer Med third edition, Lea and Febiger, Phila. PA, 1993.

5. Clavell, LA, et al. Four-agent induction and intensive asparaginase therapy for treatment of childhood acute lymphoblastic leukemia. N Engl J Med 315 (11): 657-663, 1986.

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