Vesanoid (Oral)

Tretinoin is part of a group of medicines called retinoids (RET-i-noyds). It is used to treat a type of leukemia known as acute promyelocytic leukemia (APL).

Tretinoin can cause very serious side effects. Make sure to talk with your doctor about the benefits of this medicine and the risks involved in taking it.

This medicine is available only with a prescription from your doctor.

Your doctor should check your progress at regular visits to ensure that the medicine is working correctly and to monitor for any unwanted effects.

Tretinoin causes fever, headache, tiredness, and weakness in most people who take it. It is very important that you continue taking the medicine even if it makes you feel unwell. Your health care professional may be able to suggest ways to relieve some of these effects. However, if you develop a very severe headache or a headache that happens with nausea, vomiting, or vision problems, check with your doctor immediately.

Tretinoin sometimes causes a severe reaction that starts in the lungs but can later spread to other parts of the body. Signs of this reaction include breathing problems, bone pain, chest pain, and fever. Check with your doctor right away if any of these effects occur during treatment.

In deciding to use a medicine, you and your doctor need to consider the risks of taking it against the benefits it may provide. Here are some important points to discuss:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, let your healthcare professional know if you have any other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

Studies involving a small number of children aged 1 to 16 years suggest that children may be more sensitive to the effects of this medicine. They may be more likely than adults to experience severe headaches and other side effects during treatment.

Geriatric

Many medicines have not been specifically studied in older adults. Therefore, it is unclear if they work the same way in older people as they do in younger adults, or if they cause different side effects or issues. There is no specific information comparing the use of tretinoin in older adults with other age groups.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication while breastfeeding. Consider the potential benefits and risks of taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if there might be an interaction. In such cases, your doctor may need to adjust the dose or take other precautions. It is especially important for your healthcare professional to know if you are taking any of the medicines listed below when using this medicine. The following interactions are significant, but this list may not include all possible interactions.

Using this medicine with any of the following medicines is generally not recommended, but may be necessary in some situations. If both medicines are prescribed together, your doctor may change the dose or how often you take one or both of the medicines.

• Aminocaproic Acid
• Aprotinin
• Chlortetracycline
• Demeclocycline
• Doxycycline
• Eravacycline
• Itraconazole
• Lymecycline
• Meclocycline
• Methacycline
• Minocycline
• Omadacycline
• Oxytetracycline
• Paclitaxel
• Paclitaxel Protein-Bound
• Palovarotene
• Rolitetracycline
• Sarecycline
• Tetracycline
• Tigecycline
• Tranexamic Acid

Using this medicine with any of the following medicines may increase the risk of certain side effects, but using both may be necessary for the best treatment. If both medicines are prescribed together, your doctor may change the dose or how often you take one or both of the medicines.

• Fluconazole
• Ketoconazole
• Voriconazole

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at the same time as eating food or specific types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also cause interactions. Discuss with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

• Black, tarry stools
• bleeding
• blistering
• bloody stools
• bone pain
• burning
• coldness
• difficulty in moving
• discomfort or pain in chest
• enlarged heart
• feeling of pressure
• fever
• hives
• infection
• inflammation
• joint pain
• lumps
• numbness
• paleness of skin
• rash
• redness
• scarring
• seizures
• shortness of breath, troubled breathing, tightness in chest, or wheezing
• soreness
• stinging
• increased sweating
• swelling
• swollen joints
• tenderness
• tingling
• ulceration
• unusual tiredness or weakness
• vomiting of blood or material that looks like coffee grounds
• warmth at site
• weight gain (occurring together with any of the other symptoms listed before)

Less common

• Blue lips and fingernails
• convulsions (seizures)
• difficulty in speaking, slow speech, or inability to speak
• faintness
• feeling of heaviness in chest
• severe headache
• inability to move arms, legs, or muscles of the face
• nausea and vomiting (occurring together with a headache)
• no blood pressure or pulse
• pain in back or left arm
• painful, red lumps under the skin, mostly on the legs
• prominent superficial veins over affected area
• stopping of heart
• unconsciousness
• vision problems (occurring together with a headache)
• warmth

Check with your doctor as soon as possible if any of the following side effects occur:

More common

• Any change in vision (not occurring with a headache)
• coughing, sneezing, sore throat, and stuffy or runny nose
• cracked lips
• crusting, redness, pain, or sores in mouth or nose
• decreased urination
• earache or feeling of fullness in the ear
• increase or decrease in blood pressure
• irregular heartbeat
• mental depression
• pain in stomach, side, abdomen or back
• pain and swelling in leg or foot
• skin rash
• swelling of abdomen (stomach area)
• swelling of face, fingers, hands, feet, or lower legs

Less common

• Bone swelling
• cramping or severe pain in stomach
• difficult or painful urination
• very severe and continuing drowsiness
• hallucinations (seeing, hearing, or feeling things that are not there)
• hearing loss
• severe and continuing heartburn, indigestion, or nausea
• mood, mental, or personality changes
• pain in lower back or side
• swollen area that feels sore and tender
• yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Acid or sour stomach
• agitation
• anxiety
• belching
• blurred vision
• bloating
• burning, crawling, or tingling feeling in the skin
• chills
• confusion
• constipation
• darkened urine
• diarrhea
• dizziness
• dryness of skin, mouth, or nose
• fast heartbeat
• flushing
• general feeling of discomfort or illness
• hair loss
• mild headache (not occurring together with other side effects)
• indigestion
• irritability
• itching of skin
• loss of appetite
• mood or mental changes
• muscle pain
• nausea and vomiting (not occurring together with a headache)
• shivering
• trouble sleeping
• weakness
• weight loss

Less common

• Anxiety and restlessness (occurring together)
• clumsiness or unsteadiness when walking
• difficulty sleeping
• disorientation
• forgetfulness
• frequent urination
• lethargy
• lightheadedness
• low body temperature
• redness, soreness or itching skin
• sores, welting or blisters
• sores on genitals
• swelling of feet or lower legs
• thirst
• trembling, sometimes with a flapping movement
• weak or feeble pulse
• weakness in legs

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Vesanoid

Available Dosage Forms:

• Capsule, Liquid Filled

Therapeutic Class: Antineoplastic Agent

Chemical Class: Retinoid

It is very important that you take tretinoin only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (capsules): For acute promyelocytic leukemia (APL): Adults—Dose is based on body size and must be determined by your doctor. The usual dose is 45 milligrams (mg) for each square meter of body surface area a day, given in two equally divided doses. Children—The dose will be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If it is almost time for your next dose, check with your health care professional to find out how much medicine to take for the next dose.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

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