Vesanoid (Tretinoin / ATRA)

What it is and what it treats

Vesanoid contains tretinoin, also known as all-trans retinoic acid (ATRA), an oral retinoid indicated for induction of remission in acute promyelocytic leukaemia (APL), a subtype of acute myeloid leukaemia characterised by the t(15;17) chromosomal translocation and the resulting PML-RARα fusion protein. Unlike cytotoxic chemotherapy, tretinoin acts through a differentiation mechanism, prompting immature leukaemic promyelocytes to mature into functional granulocytes rather than killing them outright.

Regulatory approval covers tretinoin for induction therapy in newly diagnosed APL and in relapsed disease, typically as part of a combination regimen with arsenic trioxide or anthracycline-based chemotherapy according to risk stratification and national treatment protocols. It is administered under the supervision of a haematologist experienced in managing APL, given the need for close monitoring during induction.

Tretinoin is not indicated as topical therapy for dermatological conditions; Vesanoid is an oral capsule intended specifically for the treatment of a haematological malignancy, and is pharmaceutically and clinically distinct from topical tretinoin preparations used for skin conditions, despite sharing the same active molecule.

Presentations and dosage forms

• 10 mg soft gelatin capsules for oral administration
• Capsules are typically opaque and light-protective owing to the photosensitivity of the active substance
• Supplied in blister packaging for oral use only

How it is administered

The approved product information describes tretinoin as given orally in divided daily doses during induction of remission in APL, calculated according to body surface area, continued until complete remission is documented or for a defined maximum induction period as set out in the label and applicable treatment protocol. Dosing and duration are determined by the treating haematologist based on the specific regimen used (for example combined with arsenic trioxide or chemotherapy) and are not a matter for self-adjustment.

Close clinical and laboratory monitoring is required throughout induction, including full blood counts, coagulation studies, liver function tests and assessment for signs of differentiation syndrome. The label describes concurrent use with corticosteroids as prophylaxis against differentiation syndrome in certain protocols, at the discretion of the treating physician.

Because tretinoin is teratogenic, the product information mandates pregnancy exclusion before starting treatment and the use of effective contraception during and for a defined period after treatment in patients of childbearing potential. This is a labelled contraindication in pregnancy and is not a general dosing consideration for the wider patient population.

Storage and handling

• Store below 25°C
• Protect from light and moisture
• Keep capsules in the original blister until immediately before use
• No refrigeration or cold-chain handling is required
• Keep out of reach of children

Side effects

The following reflects the adverse reaction profile described in the approved product information for tretinoin (ATRA) when used for induction of APL. Adverse effects are common during induction and require active clinical monitoring.

Commonly reported

Serious effects requiring medical attention

Differentiation syndrome can be life-threatening and requires immediate clinical assessment and treatment, typically with corticosteroids, without necessarily discontinuing tretinoin unless directed by the treating haematologist. Any new respiratory, cardiac or neurological symptom during induction should be reported to the clinical team without delay.

Availability and supply route

Registration of tretinoin (Vesanoid) for APL varies by country, and its supply is tightly controlled given both its narrow indication and its teratogenic risk. Haematology units and procurement teams should confirm current registration status and any risk-management requirements with the relevant national medicines authority.

Because APL requires urgent induction therapy and the medicine may not be registered or immediately stocked in every market, named-patient supply frameworks allow a physician to request the medicine for a specific, identified patient under documented clinical justification, subject to national import and pharmacovigilance controls. This route requires a valid prescription and is distinct from routine retail supply.

Pharmacy Remedy is a licensed Turkish pharmaceutical wholesaler operating in the B2B channel, supplying hospitals, haematology units and other licensed healthcare entities against valid prescriptions and appropriate import documentation. It does not sell medicines to members of the public, and all supply is subject to verification of licensure and compliance with destination-country requirements.

Frequently asked questions

Primary sources

• EMA — Vesanoid (tretinoin) product information
• FDA — Vesanoid (tretinoin) prescribing information

Further reading and regulatory routes

• How to verify a medicine is genuine
• Why medicines cost less in Türkiye
• WHO falsified medicine alerts
• Named patient supply
• UAE import guide
• For healthcare professionals
• All medicine monographs

Related medicines

• Tasigna (nilotinib)
• Xospata (gilteritinib)
• Calquence (acalabrutinib)