Asparaginase Escherichia Coli Dosage

Usual Adult Dose for Acute Lymphocytic Leukemia

Intradermal Skin Test:

Because of the occurrence of allergic reactions, an intradermal skin test should be performed prior to the initial administration of asparaginase and when asparaginase is given after an interval of a week or more has elapsed between doses.

Use approximately two international units for the intradermal skin test. The skin test site should be observed for at least one hour for the appearance of a wheal or erythema either of which indicates a positive reaction. An allergic reaction even to the skin test dose in certain sensitized individuals may rarely occur. A negative skin test reaction does not preclude the possibility of the development of an allergic reaction.

Clinical data are insufficient for a recommendation concerning the use of combination regimens in adults. However, the use of asparaginase as the sole induction agent should be undertaken only in an unusual situation when a combined regimen is inappropriate because of toxicity or other specific patient-related factors, or in cases refractory to other therapy.

As a sole induction agent: 200 international units/kg/day intravenously for 28 days.

(When complete remissions were obtained with this regimen, they were of short duration, 1 to 3 months.)

Usual Pediatric Dose for Acute Lymphocytic Leukemia

Intradermal Skin Test:

Because of the occurrence of allergic reactions, an intradermal skin test should be performed prior to the initial administration of asparaginase and when asparaginase is given after an interval of a week or more has elapsed between doses.

Use approximately two international units for the intradermal skin test. The skin test site should be observed for at least one hour for the appearance of a wheal or erythema either of which indicates a positive reaction. An allergic reaction even to the skin test dose in certain sensitized individuals may rarely occur. A negative skin test reaction does not preclude the possibility of the development of an allergic reaction.

Recommended Induction Regimens:

Combination regimens recommended for acute lymphocytic leukemia:

Regimen I

Prednisone 40 mg/m2 per day orally in three divided doses for 15 days, followed by tapering of the dosage as follows: 20 mg/square meter for 2 days, 10 mg/square meter for 2 days, 5 mg/square meter for 2 days, 2.5 mg/square meter for 2 days and then discontinue.

Vincristine sulfate 2 mg/m2 intravenously once weekly on days 1, 8, and 15 of the treatment period. The maximum single dose should not exceed 2 mg.

Asparaginase 1,000 international units/kg/day intravenously for ten successive days beginning on day 22 of the treatment period.

Regimen II

Prednisone 40 mg/m2 per day orally in three divided doses for 28 days (the total daily dose should be to the nearest 2.5 mg), following which the dosage of prednisone should be discontinued gradually over a 14 day period.

Vincristine sulfate 1.5 mg/m2 intravenously weekly for four doses, on days 1, 8, 15, and 22 of the treatment period. The maximum single dose should not exceed 2 mg.

Asparaginase 6,000 international units/m2 intramuscularly on days 4, 7, 10, 13, 16, 19, 22, 25, and 28 of the treatment period. When a remission is obtained with either of the above regimens, appropriate maintenance therapy must be instituted. asparaginase should not be used as part of a maintenance regimen. The above regimens do not preclude a need for special therapy directed toward the prevention of central nervous system leukemia.

Use of asparaginase as the sole induction agent should be undertaken only in an unusual situation when a combined regimen is inappropriate because of toxicity or other specific patient-related factors, or in cases refractory to other therapy.

As a sole induction agent: 200 international units/kg/day intravenously for 28 days.

(When complete remissions were obtained with this regimen, they were of short duration, 1 to 3 months.)

Renal Dose Adjustments

Data not available.

Liver Dose Adjustments

Data not available.

Dose Adjustments

Desensitization:

Desensitization should be performed before administering the first dose of asparaginase on initiation of therapy in positive reactors, and on retreatment of any patient in whom such therapy is deemed necessary after carefully weighing the increased risk of hypersensitivity reactions. Rapid desensitization of the patient may be attempted with progressively increasing amounts of intravenously administered asparaginase provided adequate precautions are taken to treat an acute allergic reaction should it occur. One reported schedule begins with a total of 1 intl unit given intravenously and doubles the dose every 10 minutes, provided no reaction has occurred, until the accumulated total amount given equals the planned doses for that day.

Precautions

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

Dialysis

Data not available.

Other Comments

As a component of selected multiple agent induction regimens, asparaginase may be administered by either the intravenous or the intramuscular route. When administered intravenously this enzyme should be given over a period of not less than thirty minutes through the side arm of an already running infusion of Sodium Chloride Injection or Dextrose Injection 5% (D5W).

When administering asparaginase intramuscularly, the volume at a single injection site should be limited to 2 mL. If a volume greater than 2 mL is to be administered, two injection sites should be used.

Asparaginase toxicity is reported to be greater in adults than in pediatric patients.

Further information

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