Soriatane

Pronunciation

Generic Name: acitretin (A-si-TRE-tin)
Brand Name: Soriatane

Soriatane causes severe birth defects. Do not take Soriatane if you are pregnant or if you may become pregnant during therapy or at any time within 3 years after you stop taking Soriatane. Women who are able to become pregnant should use Soriatane only if they are unable to use other medicines to treat psoriasis or if they have severe psoriasis that is not helped by other medicines.

The Do Your P.A.R.T. (Pregnancy Prevention Actively Required During and After Treatment) program provides information about the serious risks associated with Soriatane. It also provides information about preventing pregnancy while you use Soriatane and for at least 3 years after you stop. Ask your doctor or pharmacist any questions that you may have about the information, the program, or Soriatane. Do not take Soriatane if there is anything you do not understand.

You must have at least 2 negative pregnancy tests before you start Soriatane. You must also have monthly pregnancy tests while you take Soriatane. You must also have a pregnancy test every 3 months for at least 3 years after you stop taking Soriatane. Contact your doctor immediately if you think you may be pregnant.

The risk of birth defects lasts for at least 3 years after you stop Soriatane. Do not become pregnant while you take Soriatane and for at least 3 years after you stop taking it. You must use 2 effective forms of birth control for at least 1 month before you start Soriatane, while you take it, and for at least 3 years after you stop treatment.

Do not drink alcohol or take medicines that contain alcohol while you take Soriatane and for 2 months after you stop treatment. The risk of birth defects may last longer after you stop treatment if you drink alcohol or take any product that contains alcohol.

Women must sign a Patient Agreement/Informed Consent for Female Patients form before they start to take Soriatane. This form contains information on the risk of birth defects, birth control failure, and the need to avoid alcohol. Contact your doctor before you take Soriatane if you have any questions or if you have not signed this form.

Small amounts of Soriatane are found in semen. It is not known if this poses any risk to the fetus. Discuss any questions that you may have with your doctor.

Patients must not donate blood during treatment and for at least 3 years after treatment is stopped.

Serious liver problems have occurred in some patients taking Soriatane. Contact your doctor right away if you develop dark urine, pale stools, severe or persistent stomach pain, or yellowing of the skin or eyes.

Soriatane comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Soriatane refilled.


Soriatane is used for:

Treating severe psoriasis.

Soriatane is a vitamin A derivative (retinoid). Exactly how it works is not known.

Do NOT use Soriatane if:

  • you are allergic to any ingredient in Soriatane or to another retinoid (eg, tretinoin)
  • you are pregnant, planning to become pregnant, or are breast-feeding
  • you have severe liver or kidney problems
  • you have persistent high blood lipid levels
  • you are taking methotrexate, a tetracycline, or vitamin A

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

Slideshow: Psoriasis - Treatment Options to Manage Your Symptoms

Before using Soriatane:

Tell your health care provider if you have any medical conditions, especially if any of the following apply to you:

  • 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 diabetes or high blood lipid levels, are very overweight, or have a family member with any of these problems
  • if you have a history of liver or kidney problems, bone problems, pancreas problems (eg, pancreatitis), heart disease, or mental or mood problems (eg, depression, suicidal thoughts or actions)
  • if you receive phototherapy or drink alcohol
  • if you take St. John's wort; it may decrease the effectiveness of hormonal contraceptives (eg, birth control pills)
  • if you take a progestin-only birth control pill (mini-pill); your doctor may need to prescribe a different form of hormonal birth control

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

  • Certain medicines for diabetes (eg, glyburide) because the risk of low blood sugar may be increased
  • Methotrexate or tetracyclines (eg, doxycycline) because liver damage or increased pressure in the brain may occur
  • Vitamin A because it may increase the risk of Soriatane's side effects
  • Certain hormonal contraceptives (eg, low-dose progestin-only birth control pill, mini-pill) because their effectiveness may be decreased by Soriatane
  • Phenytoin because the risk of its side effects may be increased by Soriatane

This may not be a complete list of all interactions that may occur. Ask your health care provider if Soriatane 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 Soriatane:

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

  • Soriatane comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Soriatane refilled.
  • Take the capsule(s) by mouth with a meal at about the same time each day, or as directed by your doctor.
  • Continue to use Soriatane even if your condition does not improve right away. Your condition may become worse for a short time before it improves. It may take 2 to 3 months before you see the full benefits of Soriatane.
  • If you miss a dose of Soriatane, you may take it later the same day. If you do not remember until the next day, 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 Soriatane.

Important safety information:

  • Soriatane may cause drowsiness or vision changes. These effects may be worse if you take it with alcohol or certain medicines. Use Soriatane with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Soriatane may cause decreased night vision. Use caution or avoid driving at night if you experience this effect.
  • Do not drink alcohol while you are taking Soriatane without first checking with your doctor.
  • Your condition may return after you stop treatment with Soriatane. Check with your doctor if this occurs. Do not use any leftover medicine to treat your skin condition.
  • Soriatane is similar to vitamin A. Before you start any new medicine, check the label to see if it has vitamin A in it too. Do not take other medicines that contain vitamin A without checking with your doctor.
  • Soriatane may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Soriatane. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.
  • Dental problems (eg, mouth sores, gum bleeding) may occur while you take Soriatane. Contact your doctor or dentist if these problems persist or become bothersome.
  • If you wear contact lenses, you may notice increased irritation with them while you are taking Soriatane. If these effects continue, check with your doctor.
  • A severe and sometimes fatal health problem called capillary leak syndrome (CLS) has happened with Soriatane. CLS may lead to low blood pressure and harm to the organs. It may also lead to a heartbeat that is not normal, chest pain or pressure, heart attack, lung or breathing problems, bleeding or lower blood flow in the stomach or bowel, kidney problems, swelling, or confusion. Discuss any questions or concerns with your doctor.
  • Serious skin problems have happened with Soriatane. These skin problems can start in a small area and spread over large areas of your body. Call your doctor right away if you have red, blistered, or swollen skin; your skin is peeling; or your skin gets itchy or painful.
  • Women who are able to become pregnant must use 2 effective forms of birth control for at least 1 month before they start Soriatane, while they take it, and for at least 3 years after they stop treatment.
  • Diabetes patients - Soriatane may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
  • Lab tests, including monthly pregnancy tests, liver function tests, x-rays, and lipid tests, may be performed while you use Soriatane. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Use Soriatane with caution in the ELDERLY; they may be more sensitive to its effects.
  • Soriatane is not recommended for use in CHILDREN; safety and effectiveness in children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: Do not use Soriatane if you are pregnant. If you think that you may be pregnant, contact your doctor right away. Women of childbearing age should either abstain from sexual intercourse or use 2 effective methods of birth control for at least 1 month before, while taking, and for 3 years after taking Soriatane. Do not breast-feed while you are using Soriatane and for at least 3 years after stopping treatment.

Possible side effects of Soriatane:

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:

Dry mouth, lips, or nose; dry or irritated eyes; hair loss; runny nose; thinning of the eyebrows or eyelashes; thinning, peeling, or scaling of the skin; weak nails.

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); back or joint pain or stiffness; blurred vision or other vision changes; bone pain; calf or leg pain or swelling; chest pain; dark urine; eye pain; fainting; fever; loss of appetite; mental or mood changes (eg, aggressiveness, depression); muscle pain, stiffness, or weakness; numbness or tingling of the hands or feet; one-sided weakness; pale stools; severe dizziness; severe or persistent headache; severe or persistent stomach pain, nausea, or vomiting; shortness of breath; signs of high blood sugar (eg, frequent hunger, thirst, or urination); slurred speech; suicidal thoughts or actions; swelling; vaginal itching, odor, or discharge; weight gain; yellowing of the skin or eyes.

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.

Proper storage of Soriatane:

Store Soriatane at room temperature, between 59 and 77 degrees F (15 and 25 degrees C) in a tightly closed container. Avoid temperatures above 120 degrees F (40 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Soriatane out of the reach of children and away from pets.

General information:

  • If you have any questions about Soriatane, please talk with your doctor, pharmacist, or other health care provider.
  • Soriatane 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 Soriatane 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 Soriatane. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Soriatane. 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 Soriatane.

Issue Date: September 3, 2014
Database Edition 14.3.1.003
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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