Tretinoin Capsules are a type of retinoid drug used for inducing remission in acute promyelocytic leukemia (APL).

How to Use Tretinoin Capsules

Dosage and Administration Regimen

Recommended dosage: 22.5 mg/m², taken orally twice daily, until complete remission (CR) is achieved. Treatment should start immediately after a confirmed diagnosis of APL (with t(15;17) translocation or PML/RARα fusion gene).

Course duration limit: After achieving CR, continue medication for 30 days, or the total treatment course should not exceed 90 days (whichever comes first).

Administration Precautions

Administration after meals: It is recommended to take the medication with food to improve absorption.

Swallow whole: Do not chew, crush, or open the capsules, as this may damage the sustained-release structure of the drug.

Management of missed doses: If the time since the missed dose is more than 10 hours before the next scheduled dose, the missed dose can be taken; otherwise, skip it. Do not take an additional dose after vomiting; continue with the next scheduled dose as planned.

Dosage Adjustment of Tretinoin Capsules

Situations Not Requiring Dosage Adjustment

Hepatic or renal impairment: Patients with mild to severe hepatic or renal impairment should use the conventional dosage.

Elderly patients: Patients aged 65 years and above do not require dosage adjustment, but close monitoring of cardiac function is necessary.

Absolute Contraindications

Contraindicated in patients with a known hypersensitivity to tretinoin or other retinoid drugs.

Concomitant use with strong CYP3A inducers (such as rifampicin, carbamazepine) is prohibited, as this can significantly reduce the plasma drug concentration and lead to treatment failure.

Drugs Requiring Cautious Concomitant Use

Strong CYP3A inhibitors (such as ketoconazole): May increase the toxicity of tretinoin; close monitoring for adverse reactions is required.

Antifibrinolytic drugs (such as tranexamic acid): Increase the risk of thrombosis; concomitant use should be avoided.

Use of Tretinoin Capsules in Special Populations

Pregnancy and Lactation

Pregnancy: Tretinoin has confirmed teratogenicity. Before medication, female patients must have a negative pregnancy test. During treatment and within 1 month after discontinuing the drug, two effective contraceptive measures should be adopted. Male patients should use contraception during treatment and within 1 week after discontinuing the drug.

Lactation: Breastfeeding is prohibited during treatment and within 1 week after the last dose.

Pediatric Patients

Children aged ≥ 1 year: Administer at the same dosage (22.5 mg/m²), but be alert to severe headaches and increased intracranial pressure; dosage reduction may be necessary if required.

Infants aged < 1 year: Efficacy has not been established, and use is not recommended.

Patients with Concurrent Diseases

Hyperlipidemia: 60% of patients may develop hypercholesterolemia/hypertriglyceridemia; baseline and regular monitoring of blood lipids is required.

HBV/HCV coinfection: Liver function should be monitored, and interruption of anti-hepatitis B drugs should be avoided to prevent virus reactivation.