Usual Adult Dose for Acute Lymphoblastic Leukemia

1500 mg/m2 IV over 2 hours on days 1, 3, and 5 repeated every 21 days

Comments:

• Measures should be taken to prevent hyperuricemia such as hydration, urine alkalinization, and prophylaxis with allopurinol.
• The recommended duration of therapy has not been clearly established. In clinical trials, therapy was usually continued until there was evidence of disease progression, unacceptable toxicity, loss of benefit, or the patient became a candidate for bone marrow transplant.

Uses: For the treatment of patients with T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma whose disease has not responded to or has relapsed following treatment with at least 2 chemotherapy regimens. This use is based on the induction of complete responses.

Usual Adult Dose for Lymphoma

1500 mg/m2 IV over 2 hours on days 1, 3, and 5 repeated every 21 days

Comments:

• Measures should be taken to prevent hyperuricemia such as hydration, urine alkalinization, and prophylaxis with allopurinol.
• The recommended duration of therapy has not been clearly established. In clinical trials, therapy was usually continued until there was evidence of disease progression, unacceptable toxicity, loss of benefit, or the patient became a candidate for bone marrow transplant.

Uses: For the treatment of patients with T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma whose disease has not responded to or has relapsed following treatment with at least 2 chemotherapy regimens. This use is based on the induction of complete responses.

Usual Pediatric Dose for Acute Lymphoblastic Leukemia

650 mg/m2 IV over 1 hour daily for 5 consecutive days repeated every 21 days

Comments:

• Measures should be taken to prevent hyperuricemia such as hydration, urine alkalinization, and prophylaxis with allopurinol.
• The recommended duration of therapy has not been clearly established. In clinical trials, therapy was usually continued until there was evidence of disease progression, unacceptable toxicity, loss of benefit, or the patient became a candidate for bone marrow transplant.

Uses: For the treatment of patients with T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma whose disease has not responded to or has relapsed following treatment with at least 2 chemotherapy regimens. This use is based on the induction of complete responses.

Usual Pediatric Dose for Lymphoma

650 mg/m2 IV over 1 hour daily for 5 consecutive days repeated every 21 days

Comments:

• Measures should be taken to prevent hyperuricemia such as hydration, urine alkalinization, and prophylaxis with allopurinol.
• The recommended duration of therapy has not been clearly established. In clinical trials, therapy was usually continued until there was evidence of disease progression, unacceptable toxicity, loss of benefit, or the patient became a candidate for bone marrow transplant.

Uses: For the treatment of patients with T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma whose disease has not responded to or has relapsed following treatment with at least 2 chemotherapy regimens. This use is based on the induction of complete responses.

Renal Dose Adjustments

CrCl less than 50 mL/min: Data not available
CrCl 50 mL/min or greater: No adjustment recommended.

Liver Dose Adjustments

Severe hepatic impairment (total bilirubin greater than 3 times upper limit of normal): Monitor closely.

Precautions

US BOXED WARNINGS:
NEUROLOGICAL ADVERSE REACTIONS:

• Severe neurologic adverse reactions have been reported (e.g.., altered mental states including severe somnolence, central nervous system effects including convulsions, peripheral neuropathy ranging from numbness and paresthesias to motor weakness and paralysis). There have also been reports of adverse reactions associated with demyelination, and ascending peripheral neuropathies similar in appearance to Guillain-Barre syndrome.
• Full recovery from these adverse reactions has not always occurred with cessation of therapy. Patients should be monitored for neurologic adverse reactions, and therapy should be discontinued for neurologic adverse reactions of NCI Common Toxicity Criteria for Adverse Events (CTCAE) Grade 2 or greater.

CONTRAINDICATIONS:

• None

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• This drug should be administered under the supervision of a physician experienced in the use of cancer chemotherapeutic agents.
• Prior to administration, inspect the drug product visually for particulate matter and discoloration.
• Administer this drug as a 2-hour infusion in adult patients and as a 1-hour infusion in pediatric patients.

Storage requirements:

• This drug should be stored at 25C (77F). Excursions are permitted to 15C to 30C (59F to 86F).

Reconstitution/preparation techniques:

• This drug is a cytotoxic agent. Caution should be used during handling and preparation. Use of gloves and other protective clothing to prevent skin contact is recommended. Proper aseptic technique should be used.
• Do not dilute this drug product prior to administration.
• The appropriate dose should be transferred into polyvinylchloride (PVC) infusion bags or glass containers.

General:

• This drug is stable in polyvinylchloride (PVC) infusion bags and glass containers for up to 8 hours at up to 30 degrees Celsius.

Monitoring:

• Monitor complete blood counts (including platelets).

Patient advice:

• Do not breastfeed during therapy with this drug.
• Do not receive live vaccines during therapy with this drug.
• This drug causes somnolence. Do not drive or engage in hazardous occupations or activities until somnolence has resolved.