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Vesanoid
Tretinoin
$762.00
10mg · 100 capsules
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FDA boxed warningEmbryo-fetal toxicity and differentiation syndrome
Tretinoin capsules can cause embryo-fetal loss and malformations when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Females of reproductive potential must have a negative pregnancy test before initiating tretinoin capsules. Advise females of reproductive potential to use two effective methods of contraception during treatment with tretinoin capsules and for 1 month after the last dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with tretinoin capsules and for 1 week after the last dose.
Differentiation Syndrome, which can be life-threatening or fatal, occurred in about 26% of patients with APL who received tretinoin capsules. At first signs or symptoms of this syndrome, immediately initiate high-dose corticosteroid therapy and hemodynamic monitoring until resolution of signs and symptoms. Consider withholding tretinoin capsules for moderate and severe Differentiation Syndrome until resolution.
About Vesanoid
Overview
Vesanoid contains tretinoin, a retinoid medicine supplied as oral capsules. It is used to induce remission in adults and children aged 1 year and older with acute promyelocytic leukemia (APL) that has the t(15;17) chromosome change or PML/RARα gene expression. It is used when anthracycline chemotherapy has not worked, the leukemia has returned after that treatment, or that chemotherapy cannot be used. Tretinoin helps immature APL cells mature and reduces their multiplication, although its exact mechanism is unknown.
What it treats
- To induce remission in acute promyelocytic leukemia (APL) in adults and children aged 1 year and older whose leukemia has the t(15;17) translocation or PML/RARα gene expression, when anthracycline chemotherapy has not worked, the disease has returned after it, or that chemotherapy cannot be used for medical reasons.
Safety information
Side effects
Common side effects include headache, fever, dry skin or mucous membranes, bone pain, feeling unwell, chills, upper respiratory tract problems, shortness of breath, bleeding, infections, nausea, vomiting, rash, swelling of the hands or feet, increased white blood cell counts, pain, bleeding in the digestive tract, chest discomfort and abdominal pain. Contact a doctor immediately for: • Fever, difficulty breathing, weight gain or swelling. These may be signs of differentiation syndrome, which can be life-threatening or fatal and can cause organ failure. It usually occurs during the first month of treatment and can begin after the first dose. • Headache with nausea, vomiting or changes in vision. These may indicate increased pressure inside the skull, particularly in children. • Bleeding, including bleeding in the digestive tract, or chest discomfort. Other serious risks include a rapid, potentially life-threatening rise in white blood cells, liver toxicity, and blood clots in veins or arteries, including clots causing stroke, heart attack or damage to the kidneys. Blood clots may occur during the first month of treatment. Tretinoin can also increase cholesterol and triglyceride levels. Blood tests are needed to monitor these levels and liver function. Tretinoin can cause pregnancy loss and serious birth defects. Contact your doctor immediately if you become pregnant during treatment.
FDA boxed warning
Embryo-fetal toxicity and differentiation syndrome
Tretinoin capsules can cause embryo-fetal loss and malformations when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Females of reproductive potential must have a negative pregnancy test before initiating tretinoin capsules. Advise females of reproductive potential to use two effective methods of contraception during treatment with tretinoin capsules and for 1 month after the last dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with tretinoin capsules and for 1 week after the last dose.
Differentiation Syndrome, which can be life-threatening or fatal, occurred in about 26% of patients with APL who received tretinoin capsules. At first signs or symptoms of this syndrome, immediately initiate high-dose corticosteroid therapy and hemodynamic monitoring until resolution of signs and symptoms. Consider withholding tretinoin capsules for moderate and severe Differentiation Syndrome until resolution.
A boxed warning is the strongest warning the US Food and Drug Administration requires on a medicine label. Text is taken from the official label, with internal section references removed.
When to call your doctor
If symptoms are severe or getting worse quickly, seek emergency care rather than waiting.
Before taking this medicine
Do not take tretinoin capsules if you are allergic to tretinoin, any capsule ingredient or other retinoids. Tretinoin can cause pregnancy loss and serious birth defects. If you are pregnant, discuss these risks with your prescriber. Women who could become pregnant must use two effective methods of contraception during treatment and for one month after the last dose. Men with female partners who could become pregnant must use effective contraception during treatment and for one week after the last dose. Do not breastfeed during treatment. Tretinoin is not recommended for patients whose acute promyelocytic leukemia (APL) lacks the t(15;17) translocation or PML/RARα fusion. Testing is needed to confirm these genetic markers. Important risks requiring close medical monitoring include: • Differentiation syndrome, which can be fatal. Seek immediate medical attention for fever, breathing difficulty, weight gain or swelling, particularly during the first month of treatment. • A rapid increase in white blood cells, which can be life-threatening. • Increased pressure inside the skull, particularly in children. Headache, nausea, vomiting or vision changes need prompt medical assessment. • Raised cholesterol or triglycerides and liver problems. Blood fat levels and liver function need monitoring before and during treatment. • Blood clots in veins or arteries, including those causing stroke or heart attack, which may occur during the first month. Avoid taking tretinoin with medicines that can increase pressure inside the skull, such as tetracyclines, or with antifibrinolytic medicines such as tranexamic acid, aminocaproic acid or aprotinin.
Interactions
Tretinoin capsules can interact with: • Medicines that strongly block the enzyme CYP3A: these can raise tretinoin levels and increase the risk of side effects. Combined use should be avoided if possible. If unavoidable, more frequent monitoring is needed. Medicines that moderately block CYP3A also require more frequent monitoring for side effects. • Medicines that strongly increase CYP3A activity: these can lower tretinoin levels and may make treatment less effective. Combined use should be avoided if possible. • Products that can increase pressure inside the skull, such as tetracycline antibiotics: combined use may increase this risk and should be avoided. • Vitamin A, including supplements: combined use may cause vitamin A-related side effects and should be avoided. • Antifibrinolytic medicines, which reduce the breakdown of blood clots: combined use may increase the risk of blood-clot complications, including fatal events, and should be avoided. Discuss these medicines and supplements with your doctor before taking them with tretinoin.
Using Vesanoid
Dosing
Dosing is set by your prescriber. Each health care professional may prescribe medication differently according to a patient's medical history and condition, so follow the directions on your prescription label and speak to your doctor or pharmacist before changing anything.
Storage
Store below 25°C in a dry place, in the original pack, away from direct light and moisture. Do not keep it in a bathroom. Keep all medicines out of the sight and reach of children.
Clinical information on this page is summarised from the US FDA label TRETINOIN CAPSULE [PAR HEALTH USA, LLC] (DailyMed, retrieved 19 September 2026).
Patient information and references
Official and supporting information to read alongside advice from your prescriber or pharmacist.
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