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Tretinoin Dosage

Medically reviewed on December 21, 2017.

Applies to the following strengths: 10 mg

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.

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Precautions

US BOXED WARNING:
-EXPERIENCED PHYSICIAN: Patients with acute promyelocytic leukemia (APL) are at high risk in general and can have severe adverse reactions to this drug; administer this drug to these patients if the possible benefits outweigh the known risks and only under the strict supervision of a physician who is experienced with acute leukemia and in a facility with services sufficient to monitor drug tolerance and drug toxicity, including respiratory compromise.
-RETINOIC ACID-APL (RA-APL) SYNDROME: About 25% of patients with APL treated with this drug have experienced the RA-APL syndrome, some with fatal outcomes. This syndrome (characterized by fever; dyspnea; acute respiratory distress; weight gain; radiographic pulmonary infiltrates; pleural and pericardial effusions; edema; and hepatic, renal, and multi-organ failure) has occasionally been accompanied by impaired myocardial contractility and episodic hypotension. RA-APL syndrome generally occurs during the first month of treatment, with some cases reported following the first dose. If RA-APL syndrome is suspected (with or without concomitant leukocytosis), immediately administer dexamethasone 10 mg intravenously every 12 hours for 3 days or until symptom resolution irrespective of the leukocyte count; high-dose steroids given at the first suspicion of this syndrome appear to reduce morbidity and mortality. Although the majority of patients do not require discontinuation of this drug during treatment of RA-APL syndrome, consider temporarily withholding this drug in moderate and severe cases.
-LEUKOCYTOSIS: During treatment with this drug, about 40% of patients will develop rapidly evolving leukocytosis which is associated with a higher risk of life-threatening complications. Patients who present with high white blood cell (WBC) counts at diagnosis (greater than 5x10(9)/L) have an increased risk of a further rapid increase in WBC counts. When administering this drug, consider adding full-dose chemotherapy (including an anthracycline if not contraindicated) on day 1 or 2 for patients presenting with a WBC count of greater than 5x10(9)/L, OR administer the chemotherapy immediately in patients presenting with a WBC count of greater than 5x10(9)/L if the WBC count reaches 6x10(9)/L or greater by day 5, 10x10(9)/L or greater by day 10, or 15x10(9)/L or greater by day 28; data shows a lower reported incidence of RA-APL syndrome when chemotherapy is added in such cases.
-TERATOGENIC EFFECTS: There is a high risk that a severely deformed infant will result if this drug is administered during pregnancy. However, if this drug is the best available treatment for a pregnant woman or a woman of childbearing potential, counsel the patient of the risk to the fetus if pregnancy occurs during treatment and of the risk of possible contraception failure. Instruct patients to use 2 reliable forms of contraception simultaneously during treatment and for 1 month following discontinuation of treatment with this drug unless abstinence is the patient's chosen birth control method. Within 1 week prior to initiation of this drug, collect the patient's blood or urine for a serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL. Delay treatment with this drug until a negative test result is obtained, or place the patient on 2 reliable forms of contraception when a delay is not possible. Repeat pregnancy testing and contraception counseling monthly throughout treatment with this drug.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

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.

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.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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