Tretinoin - Oral

Pronunciation: TRET-i-noyn

Common Brand Name(s): Vesanoid

Important: How To Use This Information

This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

Warning

Tretinoin may cause serious (sometimes fatal) side effects. It must be used only under close medical supervision. Some patients may develop a life-threatening syndrome, usually during the first month of treatment with this medication. Tell your doctor right away if you experience any of the following symptoms: fever, trouble breathing, unusual tiredness, weight gain, swelling of the arms/legs/ankles/feet, dizziness, or fainting. You may be given other medications (including corticosteroids such as dexamethasone) to treat these side effects. Your doctor will also monitor your white blood cell count.

This medication can cause severe birth defects if used during pregnancy. This medication is not recommended for use during pregnancy. Also, it is important to prevent pregnancy while taking this drug. Pregnancy tests should be done one week before you start treatment with tretinoin. When possible, do not start tretinoin treatment until you have a negative pregnancy test result. As soon as treatment begins, you must immediately start using two effective forms of birth control together (or completely avoid sexual intercourse). However, do not use "mini-pills" (progesterone birth control pills that do not contain estrogen) because they may not work as well while you are taking tretinoin. You must also have monthly pregnancy testing and birth control counseling from your doctor while taking this medication. Continue using birth control as directed until one month after tretinoin use has been stopped.

Uses

Tretinoin is used to treat a certain type of cancer of the white blood cells (APL-acute promyelocytic leukemia). APL is a disease of too many white blood cells that do not mature or function properly. This medication is used to lessen the signs and severity of this disease (induce remission). Further treatment after remission will be determined by your doctor. Tretinoin works by promoting the growth of normal, mature cells in the bone marrow and blood. This medication helps to reverse symptoms of APL such as infections, tiredness, and bleeding. Tretinoin belongs to a class of drugs known as retinoids, which are related to vitamin A.

How To Use

Take this medication by mouth with or without food as directed by your doctor, usually twice a day.

Use this medication regularly in order to get the most benefit from it. Remember to use it at the same times each day. The dosage is based on your medical condition, body size, and response to therapy. Follow your doctor's directions for how long to take this medication.

Do not increase your dose or take this medication more often without your doctor's approval. Your condition will not improve any faster and the risk of serious side effects may be increased.

Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the capsules.

Side Effects

See also Warning section.

Headache, dizziness, fever, weakness, tiredness, dry mouth, dry skin, other skin changes, thinning hair, nausea, vomiting, itching, bone pain, mouth sores, increased sweating, and earache may occur. If any of these effects last or get worse, notify your doctor or pharmacist promptly.

Headache may occur several hours after taking a dose. Mild pain medications (such as acetaminophen) usually help relieve these headaches, which tend to go away as your body gets used to tretinoin. Talk with your doctor about which pain relievers are right for you.

To relieve dry mouth, suck on (sugarless) hard candy or ice chips, chew (sugarless) gum, drink water, or use a saliva substitute.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including:

  • stomach/abdominal pain
  • yellowing eyes/skin
  • dark urine
  • hearing problems (such as hearing loss)
  • signs of kidney problems (such as change in the amount of urine)
  • mental/mood changes (such as depression, anxiety, thoughts of suicide)
  • fast/slow/irregular heartbeat

Get medical help right away if you have any very serious side effects, including:

  • nausea/vomiting that doesn't stop
  • severe headache
  • vision changes
  • chest pain
  • jaw/left arm pain
  • trouble breathing
  • weakness on one side of the body
  • trouble speaking
  • confusion
  • pain/redness/swelling of arms/legs

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

  • rash
  • itching/swelling (especially of the face/tongue/throat)
  • severe dizziness
  • trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

Before taking tretinoin, tell your doctor or pharmacist if you are allergic to it; or to vitamin A-related drugs (other retinoids such as isotretinoin); or if you have any other allergies. This product may contain inactive ingredients (such as soybean, paraben preservatives), which can cause allergic reactions or other problems. Some people who are allergic to peanuts may also be allergic to soy. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

  • liver disease
  • high cholesterol/triglycerides (blood fats)
  • mental/mood problems (such as depression)

This drug may make you dizzy or cause severe headaches or vision changes. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness or clear vision until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

Children may be more sensitive to the effects of this drug, especially if they are also taking tetracycline medication. Tell your doctor right away if your child experiences severe headache, nausea/vomiting, or vision problems.

Do not donate blood while you are taking this medication and for at least 1 month after you stop taking it. This will prevent the possibility of your blood being given to a pregnant woman.

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using tretinoin. Tretinoin may harm an unborn baby. Ask about 2 reliable forms of birth control while using this medication and for 1 month after the last dose. If you become pregnant, talk to your doctor right away about the risks and benefits of this medication. (See also Warning section.)

Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the capsules.

It is not known if this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

Drug Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include:

  • drugs that prevent bleeding (anti-fibrinolytic drugs such as aminocaproic acid, aprotinin, tranexamic acid)
  • hydroxyurea
  • ketoconazole
  • "mini-pill" (progesterone birth control pills that do not contain estrogen)
  • tetracyclines
  • sulfisoxazole containing drugs
  • vitamin A

Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 9-1-1. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Notes

Do not share this medication with others.

Lab and/or medical tests (such as complete blood counts, liver function, blood cholesterol and triglyceride levels, pregnancy tests) should be done while you are taking this medication. Keep all medical and lab appointments. Consult your doctor for more details.

Missed Dose

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Storage

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.