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Vesanoid

Generic Name: tretinoin (TREH-tih-NO-in)
Brand Name: Generic only. No brands available.

Tretinoin can cause severe, even fatal, side effects. Therefore, it must be used only under close medical supervision. Notify your doctor immediately if you experience any of the following symptoms: fever, breathing trouble, weight gain, dizziness, chest pain, or unusual fatigue. It may be necessary for your doctor to use other medicines with tretinoin to reduce the chance of side effects. Vesanoid can cause severe birth defects when taken during pregnancy. Therefore, women who are pregnant must be informed of the risk to the fetus from tretinoin use. Women must avoid becoming pregnant while taking Vesanoid. Pregnancy tests should be performed 1 week before starting use of Vesanoid. Women should use 2 forms of contraception (birth control) at the same time, or avoid sexual intercourse, while taking Vesanoid and for 1 month after tretinoin use has been stopped. Women must also have monthly pregnancy testing and birth control counseling from their doctor while taking Vesanoid.


Vesanoid is used for:

Initiating remission for a certain type of acute promyelocytic leukemia (APL) that has failed to respond to other therapies. It may also be used for other conditions as determined by your doctor.

Vesanoid is a retinoid. How it works in APL is not completely understood. It is thought to decrease the growth of cells associated with APL.

Do NOT use Vesanoid if:

  • you are allergic to any ingredient in Vesanoid, including the preservative parabens

Contact your doctor or health care provider right away if any of these apply to you.

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Before using Vesanoid:

Some medical conditions may interact with Vesanoid. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have an abnormally high white blood cell count

Some MEDICINES MAY INTERACT with Vesanoid. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Aminocaproic acid, aprotinin, imidazoles (eg, ketoconazole), tetracyclines (eg, doxycycline), tranexamic acid, or vitamin A because the risk of serious side effects may be increased
  • Progesterone-only birth control pills because their effectiveness may be decreased by Vesanoid

This may not be a complete list of all interactions that may occur. Ask your health care provider if Vesanoid may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Vesanoid:

Use Vesanoid as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Take Vesanoid by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
  • If you miss a dose of Vesanoid, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Vesanoid.

Important safety information:

  • Vesanoid may cause dizziness or severe headache. These effects may be worse if you take it with alcohol or certain medicines. Use Vesanoid with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • If headache, nausea, vision changes, or vomiting occur, contact your doctor immediately. These could be the signs of increased pressure in the brain, a serious side effect.
  • Lab tests, including pregnancy tests, blood clotting factors, blood cholesterol and triglyceride levels, liver function, and white blood cell counts, may be performed while you use Vesanoid. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Vesanoid should not be used in CHILDREN younger than 1 year old; safety and effectiveness in these children have not been confirmed.
  • Caution is advised when using Vesanoid in CHILDREN; they may be more sensitive to its effects, especially increased pressure in the brain.
  • Women taking Vesanoid should use 2 methods of birth control during and for 1 month after using Vesanoid.
  • Progesterone-only birth control pills may not work as well while you are taking Vesanoid. Talk to your doctor about effective forms of birth control.
  • PREGNANCY and BREAST-FEEDING: Do not use Vesanoid if you are pregnant. It has been shown to cause harm to the fetus. Avoid becoming pregnant while you are taking it. If you think you may be pregnant, contact your doctor right away. It is not known if Vesanoid is found in breast milk. Do not breast-feed while taking Vesanoid.

Possible side effects of Vesanoid:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Bone pain; dry skin and mouth; fever; hair loss; headache; increased sweating; itching; nausea; rash; tiredness; vomiting; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); dizziness; hearing loss; heart attack; severe headache; shortness of breath; unusual bruising or bleeding; vision changes; weight gain.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include clumsiness; dizziness; flushing; headache; stomach pain.

Proper storage of Vesanoid:

Store Vesanoid at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store in a tightly closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Vesanoid out of the reach of children and away from pets.

General information:

  • If you have any questions about Vesanoid, please talk with your doctor, pharmacist, or other health care provider.
  • Vesanoid is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take Vesanoid or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Vesanoid. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Vesanoid. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Vesanoid.

This information should not be used to decide whether or not to take Vesanoid or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Vesanoid. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Vesanoid. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Vesanoid.

Issue Date: July 2, 2014
Database Edition 14.3.1.001
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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