Patient Medication Information: uses, side effects, how to take - Vesanoid
What is Vesanoid used for?
Vesanoid is used to treat adults and children (13 years and older) with a type of blood cancer called acute promyelocytic leukemia (APL).
Vesanoid can be used in patients with APL:
- who have never been treated for APL before, or
- where other current cancer treatments do not work, or
- where the APL has come back even after previous cancer treatment.
Serious Warnings and Precautions
Female Patients: Pregnancy
Differentiation Syndrome and Hyperleukocytosis:
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How does Vesanoid work?
Vesanoid helps stop the growth of abnormal blood cells which occur in APL.
What are the ingredients in Vesanoid?
Medicinal ingredients: Tretinoin (all-trans retinoic acid)
Non-medicinal ingredients: Gelatin, glycerol, hydrogenated hydrolyzed starch, hydrogenated soybean oil, iron oxide red, iron oxide yellow, mannitol, partially hydrogenated soybean oil, sorbitol, soybean oil, titanium dioxide, yellow beeswax
Vesanoid comes in the following dosage forms:
Capsules, 10 mg
Do not use Vesanoid if:
- you are allergic to tretinoin or to any ingredient in this medicine or container
you are pregnant or breastfeeding
- you are taking Vitamin A, tetracyclines or other retinoids
- you are 0 - 12 years old.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Vesanoid. Talk about any health conditions or problems you may have, including if you:
- have liver or kidney problems
- have ever had any mental health problems like depression
- have skin problems
- are pregnant, plan on getting pregnant, or are breastfeeding
- have an increased body mass index (BMI)
Other warnings you should know about:
Blood clots: Vesanoid may cause thrombosis (blood clots) during the first month of treatment.
Brain problems: Vesanoid may cause intracranial hypertension or pseudotumor cerebri (build of pressure around the brain). This is more common in children.
Heart problems: Vesanoid may cause heart problems, including myocarditis (inflammation of the heart muscle and lining around the heart). This can cause a heart attack which may lead to death. Your healthcare professional will decide the best treatment options for you.
Mental health problems: Vesanoid may cause depression, aggression, anxiety and mood changes. You may not notice these problems. It is important to tell your friends and family that Vesanoid can cause these mental problems. They could tell you if they notice these problems. Your healthcare professional will also monitor you for signs of these mental health problems.
Skin problems: Vesanoid may cause skin problems like Sweet’s syndrome, which is a type of rash.
See the “Serious side effects and what to do about them” table, below, for more information on these and other serious side effects.
Check-ups and testing: You will have regular visits with your healthcare professional, before, during and at the end of your treatment. They might do blood tests to check:
- Your calcium levels
- Blood health
- Blood fat levels
- Liver and kidney health
- Lung health
Driving and using machines: Vesanoid can cause dizziness or serious headache. Before you drive or do tasks that require special attention, wait until you know how you respond to Vesanoid.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
Serious Drug Interactions Taking the following medicines with Vesanoid cause serious problems:
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The following may also interact with Vesanoid:
- Medicines used to treat bacterial infections (antibiotics), like rifampin, erythromycin
- Medicines typically used to treat epilepsy (seizures) and insomnia like phenobarbital, pentobarbital
- Medicines used to treat stomach ulcers like cimetidine
- Medicines used to treat high blood pressure like verapamil, diltiazem
- Medicines used to treat arthritis like ciclosporin
- Medicines containing progestogen, like some types of birth control pills (minipill)
- Glucocorticoids (steroid hormones) used to treat inflammation and autoimmune diseases
How to take Vesanoid:
- Take exactly as your healthcare professional has told you. Check with your healthcare professional if you are not sure.
- Do not change your dose or stop taking it unless your healthcare professional tells you to.
- Swallow capsules whole with water. Do not chew the tablets.
Take with a meal or shortly after a meal.
Usual dose:
- Your healthcare professional will decide on the best dosage for you based on your size and condition.
- Your healthcare professional may have you do other treatments if you respond to Vesanoid.
Your healthcare professional may lower your dose, stop your treatment for a period of time or recommend that you stop treatment completely. This may happen if you:
- experience serious side effects, or
- your disease gets worse.
Overdose:
| If you think you, or a person you are caring for, have taken too much Vesanoid, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms. |
Missed Dose:
If you miss a dose of Vesanoid:
- Take the missed dose as soon as possible if it has been within 6 hours of your missed dose.
- Skip the missed dose if it has been 6 hours or more since your missed dose. Take your next dose at the usual time.
- Continue taking your capsules according to your usual schedule.
What are possible side effects from using Vesanoid?
These are not all the possible side effects you may have when taking Vesanoid. If you experience any side effects not listed here, tell your healthcare professional.
- dry skin
- dry mouth and lips
- swelling of the mouth and lips
- rash
- swelling
- nausea, vomiting
- headache
- shivering
- tiredness
- back, chest, bone or stomach pain
- coughing
Vesanoid can cause abnormal blood test results. Your healthcare professional will do blood tests during your treatment.
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| VERY COMMON | |||
| Differentiation Syndrome: fever, difficulty breathing, shortness of breath, lightheadedness, dizziness or a faint feeling, unusual swelling, weight gain, difficulty in urination, yellowing of the skin or eyes | X | ||
| Flushing: severe flushing may include general swelling, rash, itchiness | X | ||
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help |
|---|
| Only if severe | In all cases | ||
|---|---|---|---|
| Heart problems (disorders affecting your heart muscle, heart lining, valves or rhythm): Chest pain, or chest discomfort, high blood pressure, irregular heart rhythm, shortness of breath, fainting, swelling of the legs, ankles and feet, weakness, tiredness | X | ||
| Hypervitaminosis A (too much vitamin A in the body): dry skin, lip and mouth dryness, lip inflammation, rash, swelling, nausea, vomiting, bone pain, headache, fever, shivering, tiredness, back pain, chest pain, shortness of breath, coughing, stomach pain, bleeding into the skin, hair loss, vision changes | X | ||
| Infections (blood, fungal, respiratory): fever and chills, nausea, vomiting, diarrhea, generally feeling unwell, itching, burning, soreness, irritation, whitish-grey cottage cheese-like discharge from vagina, thick white patches in the mouth, tongue or on the throat, chest pain when you breath or cough, confusion, cough which may produce phlegm, fatigue, sweating, shortness of breath, runny or stuffy nose, body aches, headache, sneezing | X | ||
| Intercranial hypertension / pseudotumor cerebri (pressure around the brain): headache, nausea, ear buzzing, dizziness | X | ||
| Mental health problems: depression (feelings of sadness, irritability, unusual tiredness, trouble concentrating, change in normal sleep patterns and loss of appetite with possible weight loss), agitation, anxiety, mood changes, forgetfulness, feeling of weakness | X | ||
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help |
|---|
| Only if severe | In all cases | ||
|---|---|---|---|
| Skin problems, including Sweet’s syndrome: rash, itchy, red skin when exposed to sunlight | X | ||
| Thrombosis (clot in a blood vessel): swelling and pain in one part of the body | X | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice. |
Storage:
- Store at room temperature (15-30°C).
- Keep bottle tightly closed. Protect from light.
- Keep out of reach and sight of children.
- Wear rubber gloves when touching and throwing away broken capsules.
If you want more information about Vesanoid:
- Talk to your healthcare professional.
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html; the importer's website: https://xediton.com; or by calling 1-888-XEDITON (933-4866).
Date of Revision: November 18, 2022