Usual Adult Dose for Acute Myeloid Leukemia

Combination therapy:
The dose which will be tolerated and effective varies according to the stage and type of cancer being treated. Because the usual therapies involve the use of this drug with other agents in combination, physicians administering these therapies should be experienced in the use of cancer chemotherapy and in the institutional protocol.

Single agent therapy:
2 mg/kg orally daily; if, after 4 weeks there is no improvement and no leukocyte or platelet depression, the dose may be increased to 3 mg/kg orally daily; the total daily dose may be given at one time

Comments:

• The dosing provided here is manufacturer suggested. The exact dose and duration of administration will depend on the nature and dose of other cytotoxic drugs given in conjunction with this drug. Consult institutional protocol.

Use: For remission induction and remission consolidation treatment of acute myeloid leukemia; however, it is not recommended for use during maintenance therapy or similar long-term continuous treatments due to the high risk of liver toxicity

Usual Adult Dose for Acute Nonlymphocytic Leukemia

Combination therapy:
The dose which will be tolerated and effective varies according to the stage and type of cancer being treated. Because the usual therapies involve the use of this drug with other agents in combination, physicians administering these therapies should be experienced in the use of cancer chemotherapy and in the institutional protocol.

Single agent therapy:
2 mg/kg orally daily; if, after 4 weeks there is no improvement and no leukocyte or platelet depression, the dose may be increased to 3 mg/kg orally daily; the total daily dose may be given at one time

Comments:

• The dosing provided here is manufacturer suggested. The exact dose and duration of administration will depend on the nature and dose of other cytotoxic drugs given in conjunction with this drug. Consult institutional protocol.

Use: For remission induction and remission consolidation treatment of acute myeloid leukemia; however, it is not recommended for use during maintenance therapy or similar long-term continuous treatments due to the high risk of liver toxicity

Usual Pediatric Dose for Acute Myeloid Leukemia

Combination therapy:
The dose which will be tolerated and effective varies according to the stage and type of cancer being treated. Because the usual therapies involve the use of this drug with other agents in combination, physicians administering these therapies should be experienced in the use of cancer chemotherapy and in the institutional protocol.

Single agent therapy:
2 mg/kg orally daily; if, after 4 weeks there is no improvement and no leukocyte or platelet depression, the dose may be increased to 3 mg/kg orally daily; the total daily dose may be given at one time

Comments:

• The dosing provided here is manufacturer suggested. The exact dose and duration of administration will depend on the nature and dose of other cytotoxic drugs given in conjunction with this drug. Consult institutional protocol.

Use: For remission induction and remission consolidation treatment of acute myeloid leukemia; however, it is not recommended for use during maintenance therapy or similar long-term continuous treatments due to the high risk of liver toxicity

Usual Pediatric Dose for Acute Nonlymphocytic Leukemia

Combination therapy:
The dose which will be tolerated and effective varies according to the stage and type of cancer being treated. Because the usual therapies involve the use of this drug with other agents in combination, physicians administering these therapies should be experienced in the use of cancer chemotherapy and in the institutional protocol.

Single agent therapy:
2 mg/kg orally daily; if, after 4 weeks there is no improvement and no leukocyte or platelet depression, the dose may be increased to 3 mg/kg orally daily; the total daily dose may be given at one time

Comments:

• The dosing provided here is manufacturer suggested. The exact dose and duration of administration will depend on the nature and dose of other cytotoxic drugs given in conjunction with this drug. Consult institutional protocol.

Use: For remission induction and remission consolidation treatment of acute myeloid leukemia; however, it is not recommended for use during maintenance therapy or similar long-term continuous treatments due to the high risk of liver toxicity

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Caution recommended.

Dose Adjustments

Patients with homozygous deficiency of either TPMT or NUDT15 enzyme usually require 10% or less of the standard dose. Reduce initial dosage in patients who are known to have homozygous TPMT or NUDT15 deficiency. Most patients with heterozygous TPMT or NUDT15 deficiency tolerate recommended thioguanine doses, but some require dose reduction based on toxicities. Patients who are heterozygous for both TPMT and NUDT15 may require more substantial dosage reductions. Reduce the dosage based on tolerability.

Precautions

CONTRAINDICATIONS:

• This drug should not be used in patients whose disease has demonstrated prior resistance.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• The exact dose and duration of administration will depend on the nature and dosage of other cytotoxic drugs given in conjunction with this drug.
• This drug is variably absorbed following oral administration and plasma levels may be reduced following emesis or intake of food.
• This drug can be used at various stages of treatment in short term cycles; however, it is not recommended for use during maintenance therapy or similar long-term continuous treatments due to the high risk of liver toxicity.

Storage requirements:

• Store at 15C to 25C (59F to 77F) in a dry place.

General:

• This is a potent drug. It should not be used unless a diagnosis of acute nonlymphocytic leukemia has been adequately established and the responsible physician is knowledgeable in assessing response to chemotherapy.

Monitoring:

• Consider testing for TPMT and NUDT15 deficiency in patients who experience severe bone marrow toxicities or repeated episodes of myelosuppression.
• Monitor liver function tests (serum transaminases, alkaline phosphatase, bilirubin) at weekly intervals when first beginning therapy and at monthly intervals thereafter.
• It may be advisable to perform liver function tests more frequently in patients with known preexisting liver disease or in patients who are receiving this drug with other hepatotoxic drugs.

Patient advice:

• Discontinue this drug immediately if jaundice is detected.