Tretinoin Dosage

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Usual Adult Dose for:

Usual Pediatric Dose for:

Additional dosage information:

Usual Adult Dose for Acute Promyelocytic Leukemia

45 mg/m2/day administered as two evenly divided doses until complete remission is documented. Therapy should be discontinued 30 days after achievement of complete remission or after 90 days of treatment, whichever comes first.

Usual Pediatric Dose for Acute Promyelocytic Leukemia

There are limited clinical data on the pediatric use of tretinoin. The safety and efficacy of tretinoin in patients < 1 year has not been established. Of 15 pediatric patients (1 to 16 years) treated with tretinoin the incidence of complete remission was 67%. Dose reduction may be considered for pediatric patients experiencing serious and/or intolerable toxicity, however, the safety and efficacy of doses less than 45 mg/m2/day have not been evaluated in the pediatric population.

45 mg/m2/day administered as two evenly divided doses until complete remission is documented. Therapy should be discontinued 30 days after achievement of complete remission or after 90 days of treatment, whichever comes first.

Precautions

Tretinoin is indicated for the induction of remission only. All patients should receive a standard consolidation and/or maintenance chemotherapy regimen for APL after induction therapy unless otherwise contraindicated.

There is high risk that a severely deformed infant will result if tretinoin is administered during pregnancy. It should be assured that women of childbearing potential have received full information and warnings regarding risks to the fetus should pregnancy occur.

Tretinoin has potentially significant toxic side effects in APL patients. Tretinoin should be administered under the supervision of a physician experienced with APL patients and in a facility with laboratory and supportive services sufficient to monitor drug tolerance and maintain a patient compromised by drug toxicity, including respiratory compromise.

Other Comments

Tretinoin is indicated for the induction of remission in patients with acute promyelocytic leukemia (APL), French-American-British (FAB) classification M3, characterized by the presence of the t(15;17) translocation and/or the presence of the PML/RARalpha gene who are refractory to, or who have relapsed from, anthracycline-based chemotherapy, or for whom anthracycline-based chemotherapy is contraindicated.

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