Alitretinoin - Oral

Pronunciation: AL-i-TRET-i-noyn

Common Brand Name(s): Toctino

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

Women who are pregnant must not use alitretinoin. Women must avoid becoming pregnant while taking this medication and for one month after stopping treatment. It can cause serious (even fatal) birth defects, miscarriage, or premature birth of the baby. Talk with your doctor about the risks and benefits of taking this medication and your birth control options. Read and sign the Patient Informed Consent Form provided by your doctor.

Women who are able to have children must use two reliable forms of birth control for 1 month before starting alitretinoin, during use, and for at least 1 month after treatment has stopped. Do not use "minipills" (non-estrogen-containing pills) for birth control because they may not work as well with this drug.

Women who are able to have children must also meet the following requirements: test negative on 2 pregnancy tests before starting treatment; start treatment on the second or third day of the next normal menstrual period; have monthly pregnancy tests during treatment and for one month after stopping treatment.

Alitretinoin has been rarely linked to increased pressure in the brain (benign intracranial hypertension). Stop taking alitretinoin and tell your doctor right away if you develop persistent headache, nausea, vomiting, or vision changes (such as blurred vision).

Uses

This medication is used in adults to treat severe hand eczema that has not improved with other treatments (such as corticosteroids applied to the skin). Alitretinoin belongs to a class of drugs known as retinoids, which are related to vitamin A. It works by decreasing the production of certain substances that cause skin inflammation.

How To Use

Read the Patient Information Leaflet provided by your pharmacist before you start taking alitretinoin and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth as directed by your doctor, usually once daily with a meal.

The dosage is based on your medical condition and response to treatment.

Take this medication regularly in order to get the most benefit from it. To help you remember, take it at the same time each day.

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.

Tell your doctor if your condition persists or worsens. It may take up to 2 months to notice improvement.

Side Effects

Headache, flushing, dry eyes, or dry lips/skin may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

To relieve dry eyes, you may use a lubricating eye ointment or tear replacement eye drops. Ask your pharmacist for details. If you wear contact lenses and get dry eyes, you may need to wear glasses while using this medication.

Remember that your doctor has prescribed this medication because he or she 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 any of these serious side effects occur:

  • mental/mood changes (such as depression, anxiety, thoughts of suicide)
  • back/joint/muscle pain

Stop taking alitretinoin and tell your doctor right away if any of these serious side effects occur:

  • abdominal pain
  • bloody/severe diarrhea
  • bleeding from the rectum
  • persistent/severe headache
  • vision changes (such as blurred/double vision, decreased vision)
  • persistent nausea/vomiting

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)
  • 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 alitretinoin, 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 soy), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

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

  • diabetes
  • high cholesterol/triglycerides
  • high levels of vitamin A
  • kidney disease
  • liver disease
  • mental/mood problems (such as depression)
  • thyroid disease

Do not donate blood while taking this drug and for at least 1 month after stopping treatment. This will lessen the chance of your blood being given to a pregnant woman.

This medication may make you more sensitive to the sun. Limit your time in the sun. Avoid tanning booths and sunlamps. Use sunscreen and wear protective clothing when outdoors. Tell your doctor right away if you get sunburned or have skin blisters/redness.

Alitretinoin may cause vision changes, including decreased night vision. Do not drive, use machinery, or do any activity that requires clear vision (especially at night) until you are sure you can perform such activities safely.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

This drug must not be used during pregnancy. It may harm an unborn baby. Females must use two reliable forms of birth control for 1 month before starting alitretinoin, during use, and for at least 1 month after treatment has stopped. If you become pregnant or think you may be pregnant, tell your doctor right away. 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 unknown if this drug passes into breast milk. However, similar drugs pass into breast milk. Breast-feeding while using this medication 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:

  • tetracycline antibiotics
  • vitamin A

Do not use "minipills" (non-estrogen-containing pills) for birth control because they may not work as well with this drug. Also, some drugs may cause hormonal birth control to work less well by decreasing the amount of birth control hormones in your body. Examples include griseofulvin, modafinil, rifamycins (such as rifampin, rifabutin), St. John's wort, among others. See also Warning section.

Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. 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. Symptoms of overdose may include: severe headache, diarrhea, facial flushing.

Notes

Do not share this medication with others.

Laboratory and/or medical tests (such as pregnancy tests, cholesterol/triglyceride levels, liver function) must be performed before you start treatment, periodically to monitor your progress, or to check for side effects. 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 your 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.

Is it an emergency?

If you or someone in your care has chest pains, difficulty breathing, or severe bleeding, it could be a life-threatening emergency. Call 9-1-1 or the local emergency number immediately.
If you are concerned about a possible poisoning or exposure to a toxic substance, call Poison Control now at 1-800-567-8911.

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