Vesanoid 10 mg soft capsules – tretinoin for acute promyelocytic leukaemia

Vesanoid is a soft capsule medicine containing 10 mg tretinoin – a substance from the retinoid group, related to vitamin A. Tretinoin slows the growth of certain diseased blood cells and promotes their maturation.

It is used to treat acute promyelocytic leukaemia (APL), a particular type of blood cancer, in combination with arsenic trioxide or chemotherapy. It is used only in hospital and, because of the high risk of birth defects, requires strict contraception.

What is Vesanoid used for and how should it be taken?

Key facts about the medicine

What is Vesanoid used for?

Vesanoid is indicated in combination with arsenic trioxide or chemotherapy for patients with acute promyelocytic leukaemia (APL) that is:

• newly diagnosed,
• relapsed, or
• refractory to chemotherapy.

Genetic confirmation of the diagnosis (t(15;17) translocation or PML/RARα fusion) is required. Because of the risk of early bleeding, tretinoin treatment starts as soon as possible, already on the basis of the morphological findings.

How is it taken and dosed?

• Adults and elderly: the total daily dose is 45 mg/m² body surface area, divided into two equal doses – about 8 capsules a day.
• Swallow the capsules whole with water, preferably with or just after a meal; do not chew them.
• Induction treatment continues until complete remission, for a maximum of 90 days; this is followed by consolidation cycles (with arsenic trioxide or anthracyclines) and possibly maintenance treatment with drug-free periods.
• Treatment may last 3 months or more.

The doctor sets the dose according to the disease, body weight and height and tolerability – do not change it yourself.

Special patient groups

• Children: daily dose 45 mg/m² in two doses; in severe headache a lower dose of 25 mg/m² is considered. Data on efficacy and safety in children are limited.
• Impaired kidney or liver function: as a precaution the dose is reduced to 25 mg/m² a day in two doses.
• Elderly patients: the same dose as in adults (45 mg/m²) is used.

Contraindications – when the medicine must not be used

Do not take Vesanoid if:

• you are allergic to tretinoin, the excipients or other retinoids (isotretinoin, acitretin, tazarotene);
• you are allergic to peanut or soya – the medicine contains soya oil;
• you are breast-feeding;
• you are taking vitamin A, tetracyclines or other retinoids.

Warnings and precautions

Tell your doctor before treatment if:

• you have other illnesses or allergies;
• you have ever had mental health problems – depression, aggressive tendencies or mood changes (Vesanoid may affect mood);
• you have an intolerance to some sugars – the medicine contains sorbitol (1.93–2.94 mg per capsule).

Vesanoid may cause severe headache, feeling generally unwell, difficulty breathing, fever, dizziness and chest or back pain (possible differentiation syndrome or raised pressure in the head) – the doctor then changes the dose or adds other medicines. Ask family and friends to point out changes in mood or behaviour that you may not notice yourself.

Interactions with other medicines, food and drink

During treatment you must not take:

• tetracyclines (antibiotics);
• vitamin A;
• low-dose progesterone contraceptives ("mini-pills") – your doctor will prescribe a different contraceptive.

Special care is needed with: rifampicin and erythromycin, glucocorticoids, phenobarbital and pentobarbital, azole antifungals (ketoconazole, fluconazole, itraconazole, posaconazole), protease inhibitors and macrolides, cimetidine, verapamil and diltiazem, ciclosporin, and medicines that stop bleeding (tranexamic acid, aminocaproic acid, aprotinin). Tell your doctor about all medicines, including herbal ones.

Pregnancy and breast-feeding

Vesanoid can cause severe birth defects. You must not become pregnant during treatment and for four weeks after it ends; you and your partner must use reliable, continuous contraception throughout this period. Women are tested for pregnancy every month during treatment. If you become pregnant, tell your doctor immediately. The medicine passes into breast milk – you must not breast-feed during treatment.

Driving and using machines

Vesanoid has a minor to moderate influence on the ability to drive and use machines, especially if you have dizziness or severe headaches – do not drive in that case.

Possible side effects

Almost all patients have some side effect during treatment. Very common (more than 1 in 10) are:

• dry skin, mouth and nose, swollen, dry or cracked lips; rash, itching, redness and peeling of the skin; hair loss; increased sweating;
• headache, dizziness, raised pressure in the head, visual and hearing disturbances, dry eyes or conjunctivitis (a problem for contact lens wearers);
• irregular heartbeat, difficulty breathing, pain in the bones, joints, chest or abdomen;
• nausea, vomiting, diarrhoea or constipation, loss of appetite, inflammation of the pancreas and lips;
• insomnia, confusion, anxiety, depression, tingling in the arms and legs, tiredness and feeling cold;
• raised transaminases, creatinine and blood fats (triglycerides, cholesterol).

Of unknown frequency are genital ulcers, severe bacterial skin infections (necrotising fasciitis), kidney infarction, vasculitis, erythema nodosum, raised blood calcium and increased platelet or basophil counts.

Report suspected side effects to your doctor, pharmacist or ALIMS.

Overdose, missed dose and stopping treatment

• Overdose: if you or someone else takes too much, contact a doctor, pharmacist or the nearest hospital immediately.
• Missed dose: take the capsule as soon as you remember and tell your doctor straight away. Do not take a double dose.
• Stopping treatment: the duration of treatment and breaks are decided by the doctor; in severe differentiation syndrome the medicine may be paused.

Related information

For questions about treatment, diet and skin care during therapy, contact the haematologist or pharmacist at the healthcare institution where you are treated.

Composition, pack and manufacturer

• Active substance: tretinoin – 10 mg per soft capsule.
• Capsule content: yellow beeswax; hydrogenated, partially hydrogenated and refined soya-bean oil.
• Capsule shell: gelatin; glycerol 85% (E 422); Karion 83 (sorbitol, mannitol, hydrogenated hydrolysed starch); titanium dioxide (E 171); yellow and red iron oxide (E 172).
• Pack: amber glass bottle with plastic closure, 100 capsules; carton with 1 bottle.
• Marketing authorisation holder: CLINRES FARMACIJA D.O.O. BEOGRAD, Beogradskog bataljona 4, Belgrade. Manufacturer: CHEPLAPHARM ARZNEIMITTEL GMBH, Bahnhofstr. 1a, Mesekenhagen, Germany. Leaflet approved September 2022.

Storage

• Store below 30 °C in the original package to protect from light.
• Shelf life: 3 years.
• Keep out of the sight and reach of children; return unused capsules to the healthcare facility or a pharmacy that collects medicines.

Frequently asked questions

How long must contraception be used with Vesanoid?

Throughout treatment and for four weeks (one month) after the last dose – for both you and your partner. Women are tested for pregnancy every month, and low-dose progesterone "mini-pills" are not sufficient.

Can I take vitamins with Vesanoid?

Vitamin A must not be taken with Vesanoid. For other vitamin and herbal products always ask your doctor, as some may change the effect of the medicine.

How many capsules are taken a day?

The dose is 45 mg/m² body surface area per day, divided into two equal doses – in adults about 8 capsules a day. In kidney or liver impairment, and in children with severe headaches, the dose may be 25 mg/m².

Why can't I use Vesanoid if I am allergic to peanuts?

The capsules contain soya oil, and allergy to peanut or soya is a contraindication to the medicine.

Sources

• ALIMS – Patient leaflet Vesanoid®, 10 mg, soft capsules (September 2022, Serbian)
• ALIMS – Summary of Product Characteristics Vesanoid®, 10 mg, soft capsules (Serbian)

Sources checked on: 25 October 2026.