Tretinoin Dosage

Medically reviewed by Drugs.com. Last updated on Jun 13, 2024.

Applies to the following strengths: 10 mg

Usual Adult Dose for Acute Promyelocytic Leukemia

45 mg/m2/day administered as 2 evenly divided doses until complete remission

Duration of therapy: Discontinue therapy 30 days after complete remission or after 90 days of therapy, whichever comes first.

Comments:

If after initiation of therapy the presence of the t(15;17) translocation is not confirmed by cytogenetics and/or polymerase chain reaction studies and the patient has not responded to therapy, alternative treatment should be considered.
This drug is for the induction of remission only. Optimal consolidation or maintenance regimens have not been determined. All patients should receive a standard consolidation and/or maintenance chemotherapy regimen for APL after induction therapy, unless contraindicated.

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

Usual Pediatric Dose for Acute Promyelocytic Leukemia

1 year and older:
45 mg/m2/day administered as 2 evenly divided doses until complete remission

Duration of therapy: Discontinue therapy 30 days after complete remission or after 90 days of therapy, whichever comes first.

Comments:

There are limited clinical data on the pediatric use of this drug.
Out of 15 pediatric patients (1 to 16 years) treated with this drug 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.

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Precautions

US BOXED WARNINGS:
EXPERIENCED PHYSICIAN AND INSTITUTION:

Patients with acute promyelocytic leukemia (APL) can have severe adverse reactions to this drug; therefore, it should only be administered to these patients under the supervision of a physician experienced in the management of acute leukemia and in a facility equipped to monitor drug tolerance and protect/maintain a patient compromised by drug toxicity, including respiratory compromise.
The benefit should outweigh the risk of using this drug.

RETINOIC ACID-APL SYNDROME:

About 25% of patients with APL treated with this drug experience a syndrome called retinoic acid-APL (RA-APL) 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.
This syndrome is occasionally accompanied by impaired myocardial contractility and episodic hypotension.
It has been observed with or without concomitant leukocytosis.
Endotracheal intubation and mechanical ventilation may be required due to hypoxemia and some patients have died from multi-organ failure.
The syndrome generally occurs during the first month of therapy, with some cases reported following the first dose.
High-dose steroids (dexamethasone 10 mg IV every 12 hours for 3 days or until resolution of symptoms) should be immediately initiated irrespective of the leukocyte count.
Most patients do not require termination of therapy during treatment of the RA-APL syndrome; however, in cases of moderate and severe RA-APL syndrome, temporary interruption of therapy should be considered.

LEUKOCYTOSIS AT PRESENTATION AND RAPIDLY EVOLVING LEUKOCYTOSIS DURING THERAPY:

About 40% of patients develop rapidly evolving leukocytosis.
Patients who present with high WBC at diagnosis [greater than 5 x 10(9)/L] have an increased risk of a further rapid increase in WBC counts.
Rapidly evolving leukocytosis is associated with a higher risk of life-threatening complications.
If RA-APL syndrome is present with leukocytosis, treatment with high-dose steroids should be initiated immediately. Some experts routinely add chemotherapy to this drug in the case of patients presenting with a WBC count of greater than 5 x 10(9)/L or in the case of a rapid increase in WBC count for patients leukopenic at start of therapy and have reported a lower incidence of the RA-APL syndrome.
Consideration should be given to adding full-dose chemotherapy (including an anthracycline if not contraindicated) to this drug on Day 1 or 2 for patients presenting with a WBC count of greater than 5 x 10(9)/L, or immediately, for patients presenting with a WBC count of less than 5 x 10(9), if the WBC count reaches 6 x 10(9)/L or greater by day 5, or 10 x 10(9)/L or greater by day 10, or 15 x 10(9)/L or greater by day 28.

TERATOGENIC EFFECTS:

There is a high risk that a severely deformed infant will result if this drug is administered during pregnancy.
If this drug is given to a pregnant woman or a woman of childbearing potential, the patient should be advised of the risk to the fetus.
Women of childbearing potential should be instructed to use 2 reliable forms of contraception simultaneously during therapy and for 1 month after.
Within 1 week prior to starting this drug, the patient should have blood or urine collected for a serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL.
When possible, therapy should be delayed until a negative result from a pregnancy test is obtained. When a delay is not possible, the patient should be placed on 2 reliable forms of contraception.
Pregnancy testing and contraception counseling should be repeated monthly.

CONTRAINDICATIONS:

Hypersensitivity to the active component or any of the ingredients
Hypersensitivity to other retinoids
In patients who are sensitive to parabens which are used as preservatives in the gelatin capsule

Safety and efficacy have not been established in patients younger than 1 year.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

Swallow capsules whole with water; do not chew.
This drug should be administered with a meal or shortly thereafter.
This drug 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 contraindicated.

Storage requirements: