Acute promyelocytic leukaemia (APL)

Active Ingredient: Tretinoin

Indication for Tretinoin

Population group: only adults (18 - 65 years old)

Tretinoin is indicated in combination with arsenic trioxide or chemotherapy for the treatment of patients with acute promyelocytic leukaemia (APL) which is newly diagnosed, relapsed or refractory to chemotherapy.

Combination of tretinoin with chemotherapy or arsenic trioxide is known to be effective and to induce very high rates of haematologic remission in patients with genetically confirmed APL, i.e. patients whose blasts harbor the t(15;17) by karyotyping or FISH or the PML-RARa fusion as detected by PCR. Thus, genetic confirmation of diagnosis is mandatory. Combination treatment with arsenic trioxide has been shown an effective treatment option in patients with newly diagnosed low-to-intermediate risk APL. However, because APL is characterized by high risk of early haemorrhagic death, current recommendations dictate that early treatment with tretinoin is started as soon as possible upon morphologic suspicion only.

For the selection of treatment strategy the relapse risk – indicated by pre-therapeutic white blood cell count (WBC) and platelet count (Sanz score) with high-risk (WBC>10 × 10^9^/L), intermediate risk (WBC≤10 × 109/L, platelet count ≤40 × 109/L), and low risk (WBC≤10x109/L, platelet count >40 × 109/L) - should be taken into consideration.

For this indication, competent medicine agencies globally authorize below treatments:

45 mg/m² in 2 divided doses daily

Route of admnistration


Defined daily dose

45 - 45 mg per m² of body surface area (BSA)

Dosage regimen

From 22.5 To 22.5 mg per m² of body surface area (BSA) 2 time(s) per day every day

Detailed description

For all therapy phases a total daily dose of 45 mg/m² body surface divided in two equal doses is recommended for oral administration to adult and elderly APL patients. This is approximately 8 capsules per adult dose.

Dosage considerations

It is recommended to take the capsules with a meal or shortly thereafter.

Active ingredient


Tretinoin decreases cohesiveness of follicular epithelial cells resulting in decreased microcomedone formation. Additionally, tretinoin stimulates mitotic activity and increased turnover of follicular epithelial cells, causing extrusion of the comedones.

Read more about Tretinoin

Related medicines

Develop a tailored medication plan for your case, considering factors such as age, gender, and health history

Ask the Reasoner

Liability Disclaimer : RxReasoner has utilized reasonable care in providing content and services that are accurate, complete and up to date. However, RxReasoner does not accept any responsibility or liability about it. The content and services of RxReasoner are for informational purposes only and they are not intended to be a substitute for the knowledge, expertise, skill, and judgment of physicians, pharmacists, nurses, or other healthcare professionals involved in patient care. RxReasoner offers no medical advice. Users are responsible for the use of the provided content. A shown indication or treatment should not be construed to indicate that the medication is safe, appropriate, or effective in any given patient or under any particular circumstances. The absence of an indication or treatment should not roule out the existence of other appropriate medications. Always seek the advice of a physician or other qualified health provider with any questions you may have regarding a medical condition or medicament. RxReasoner is not liable for any damages allegedly sustained arising out of the use of its content and services.