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Tretinoin

(tret-uh-noyn)

Trade/other name(s): Vesanoid, ATRA, All-Trans-Retinoic Acid

Why would this drug be used?

Tretinoin is used to treat acute promyelocytic leukemia that has certain gene changes, in which the long arms of chromosomes 15 and 17 are switched (translocated). This is noted as t(15;17).

How does this drug work?

Tretinoin is a retinoid, which are compounds related to vitamin A. They help to regulate the gene functions that allow cells to grow and divide. Tretinoin seems cause the abnormal promyelocytic leukemic cells to mature, and allow normal white blood cells to grow in the bone marrow. The exact way it works is still unclear. Since the growth of normal body cells may also be affected by tretinoin, other effects can occur. Some effects may not occur for months or years after the drug is used.

Before taking this medicine

Tell your doctor…

  • If you are allergic to anything, including medicines, dyes, additives, or foods.
  • If you have any medical conditions such as kidney disease, liver disease (including hepatitis), heart disease, congestive heart failure, diabetes, gout, or infections. These conditions may require that your medicine dose, regimen, or timing be changed.
  • If you have high cholesterol or high triglycerides (fats in the blood). This drug can raise them even further.
  • If you have ever had blood clots or stroke. Rarely, this drug can cause blood clots in the leg or arm, the lungs, brain (stroke), or other organs.
  • If you are pregnant, trying to get pregnant, or if there is any chance of pregnancy. This drug may cause birth defects if either the male or female is taking it at the time of conception or during pregnancy. Check with your doctor about what kinds of birth control can be used with this medicine.
  • If you are breast-feeding. The drug may pass into breast milk and harm the baby. Breast feeding is not recommended while you are taking tretinoin.
  • About any other prescription or over-the-counter medicines you are taking, including vitamins and herbs. In fact, keeping a written list of each of these medicines (including the doses of each and when you take them) with you in case of emergency may help prevent complications if you get sick.

Interactions with other drugs

Ketoconazole may cause tretinoin to build up in the body, which may worsen the chance of serious side effects. Limited information on drug interactions with tretinoin is available, but drugs that have caused problems in similar situations include cimetidine, erythromycin, verapamil, diltiazem, cyclosporine, and others.

Other medicines that may affect the amount of tretinoin in the body include TB drugs such as rifampicin, glucocorticoids (steroids such as prednisone or dexamethisone), and the anti-seizure drugs phenobarbital, pentobarbital, and carbamazepine.

Vitamin A supplements from animal sources (such as fish liver oil) can cause toxic levels of Vitamin A in the body when taken during treatment with tretinoin. Vitamin A precursors from vegetable sources (such as beta carotene) are not a problem.

Any medicine that is taken to stop bleeding may increase your risk of serious blood clots.

Birth control pills with small doses of progesterone (the "mini-pill") may not work when you are taking tretinoin.

Any drugs or supplements that interfere with blood clotting can raise the risk of bleeding during treatment with tretinoin. These include:

  • vitamin E
  • non-steroidal anti-inflammatory drugs (NSAIDs) such as aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve, Naprosyn), and many others
  • warfarin (Coumadin)
  • ticlopidine (Ticlid)
  • clopidogrel (Plavix)

Note that many cold, flu, fever, and headache remedies contain aspirin or ibuprofen. Ask your pharmacist if you aren't sure what's in the medicines you take.

Tetracycline may have a higher risk of causing increased pressure inside the head (pressure on the brain) if it is taken with tretinoin.

Check with your doctor, nurse, or pharmacist about other medicines, vitamins, herbs, and supplements, and whether alcohol can cause problems with this medicine.

Interactions with foods

No serious interactions with food are known at this time. Talk with your doctor, nurse, or pharmacist about whether grapefruit may cause a problem while taking tretinoin.

Tell all the doctors, dentists, nurses, and pharmacists you visit that you are taking this drug.

How is this drug taken or given?

Tretinoin is a capsule taken by mouth, usually twice a day, or as directed by your doctor. The dose depends on your body size, side effects, and how you respond to the medicine.

Take this drug exactly as directed by your doctor. If you do not understand the instructions, ask your doctor or nurse to explain them to you.

Keep the medicine in a tightly closed container away from heat, light, and moisture and out of the reach of children and pets.

Precautions

This medicine may cause drowsiness and may affect activities such as driving. Wait until you find out how it affects you before driving or operating other dangerous machinery.

Your doctor will likely test your blood throughout your treatment, looking for possible effects of the drug on blood counts (described below) or on other body organs. Based on the test results, you may be given medicines to help treat any effects. Your doctor may also need to reduce or delay your next dose of this drug, or even stop it altogether. Keep all your appointments for lab tests and doctor visits.

This drug can increase your chance of getting an infection. Be sure to let your doctor or nurse know right away if you have any signs of infection, such as fever (100.5° or higher), shaking chills, pain when passing urine, a new cough, or bringing up sputum.

This drug may increase your risk of bleeding. Speak with your doctor before taking any drugs or supplements that might affect your body's ability to stop bleeding, such as aspirin or aspirin-containing medicines, warfarin (Coumadin), or vitamin E. Tell your doctor right away if you have unusual bruising, or bleeding such as nosebleeds, bleeding gums when you brush your teeth, or black, tarry stools.

This drug may cause blood clots. They may form in the leg or arm (deep vein thrombosis), and cause stroke, or a blockage in the lungs or other organs. Call your doctor or nurse right away if you develop pain in your lower leg (calf), redness or swelling of your arm or leg, shortness of breath, chest pain, or trouble speaking or moving.

Tretinoin may cause sores in the mouth or on the lips, which often occur within the first few weeks after starting treatment. This can cause mouth pain, bleeding, or even trouble eating. Your doctor or nurse can suggest ways to reduce this, such as changing the way you eat or how you brush your teeth. If needed, your doctor can prescribe medicine to help with the pain.

Tretinoin can cause severe liver damage in a few people. Your doctor will likely check your blood so that if this happens, it can be found early. Call your doctor right away if you notice nausea, vomiting, fatigue, poor appetite, dark urine, yellowing skin or eyes, or tenderness under the right side of the rib cage.

Do not get any immunizations (vaccines), either during or after treatment with this drug, without your doctor's OK. Tretinoin may affect your immune system. Thjs could make vaccinations ineffective, or could even lead to serious infections if you get a live virus vaccine during or soon after treatment. Try to avoid contact with people who have recently received a live virus vaccine, such as the oral polio vaccine or smallpox vaccine. Check with your doctor about this.

Tell your doctor or nurse right away if you develop fever, trouble breathing, wheezing, cough, rapid weight gain, swelling, or irregular heart beat. This can be a serious complication and must be treated right away. This problem happens to about 1 in 4 people who take the drug, and it can cause organs to fail. It most often happens during the first month of treatment, sometimes after the first dose.

Vitamin A toxicity may occur (from getting too much Vitamin A). The symptoms include headache, usually starting the first week of treatment and then fading, along with fever, dry mouth and skin, bone pain, nausea, vomiting, rash, sores in the mouth, hair loss, and changes in vision. Report any of these to your doctor or nurse right away. Tell your doctor if you are taking any vitamin A products (see "Interactions with other drugs", above).

It is important to keep taking this drug, even if you feel well. If you have side effects, talk to your doctor or nurse find out whether the problems are serious and how you can lessen them.

If you have hallucinations (seeing, hearing, or feeling things that aren't there) confusion, or seizures, get help right away.

Avoid pregnancy during treatment and for at least a month after taking this drug. Tretinoin can harm the fetus and cause birth defects. Your doctor may tell you to use 2 types of birth control, and require pregnancy tests each month during treatment.

Possible side effects

You will probably not have most of the following side effects, but if you have any talk to your doctor or nurse. They can help you understand the side effects and cope with them.

Common

  • headache
  • fever*
  • weakness
  • fatigue (tiredness)
  • shivering
  • bleeding*
  • infection
  • shortness of breath*
  • dry mouth
  • bone pain
  • nausea*
  • vomiting
  • rash
  • poor appetite
  • abnormal blood tests which suggest that the drug is affecting the liver (Your doctor will discuss the importance of this finding, if any.)

Less common

  • dizziness*
  • feeling of pins and needles in hands and feet
  • earache
  • anxiety
  • depression
  • trouble sleeping
  • heartburn
  • swollen belly*
  • weight gain*
  • weight loss
  • pneumonia
  • diarrhea
  • constipation
  • syndrome of fever, trouble breathing, weight gain, changes in chest x-ray, and fluid outside the lungs or heart*
  • sores in mouth or on lips*
  • itching
  • sweating
  • changes in vision
  • skin changes
  • loss of or thinning hair (including face and body hair)
  • irregular heartbeat*
  • changes in blood pressure
  • flushing

Rare

  • heart failure
  • heart attack
  • other heart damage
  • ulcer
  • decreased hearing
  • agitation
  • hallucinations*
  • seizures*
  • sleepiness*
  • slow speech
  • trouble passing urine
  • high triglyceride and cholesterol levels (lipids) in the blood
  • blood clots, including stroke, lung blockage, or heart attack*
  • birth defects if taken during pregnancy, or if pregnancy occurs within a month after taking the drug
  • death due to lung failure, multiple organ failure, or other cause

*See the "Precautions" section for more detailed information.

There are other side effects not listed above that can also occur in some patients. Tell your doctor or nurse if you develop these or any other problems.

FDA approval

Yes – first approved in 1995.

Disclaimer: This information does not cover all possible uses, actions, precautions, side effects, or interactions. It is not intended as medical advice, and should not be relied upon as a substitute for talking with your doctor, who is familiar with your medical needs.

Last Medical Review: 02/22/2010
Last Revised: 02/22/2010