Important Safety Information For Acitretin

What is the most important information I should know about acitretin?

• Acitretin can cause severe birth defects. If you are a female who can get pregnant, you should use acitretin only if:
• • you are not pregnant now,
  • you can avoid becoming pregnant while taking acitretin and for at least 3 years after stopping acitretin, and
  • other medicines do not work for your severe psoriasis or you cannot use other psoriasis medicines.
• Acitretin can cause liver injury. Acitretin has been associated with abnormal liver function tests. Your prescriber should monitor how your liver is working with blood tests.

What are the important warnings and instructions about acitretin for women who can get pregnant?

• You must sign a Patient Agreement/Informed Consent for Female Patients form with your prescriber. This is to help you make sure you understand the risk of birth defects and how to avoid getting pregnant. If you did not talk to your prescriber about this and sign the form, contact your prescriber.
• You must not take acitretin if you are pregnant or might become pregnant during treatment or at any time for at least 3 years after you stop treatment because acitretin can cause severe birth defects.

• You must use 2 effective forms of birth control (contraception) at the same time while you are taking acitretin. You must use birth control for at least 1 month before you start treatment, during treatment, and for at least 3 years after you stop treatment.

  • Avoid progestin-only birth control pills (“minipills”). This type of birth control pill may not work while you take acitretin. Ask your prescriber if you are not sure what type of pills you are using.
  • Do not take St. John’s wort while taking acitretin. St. John’s wort may interfere with some types of birth control.
• During treatment and for 2 months after you stop acitretin, you must avoid drinks, foods, and all medicines that contain alcohol. This includes over-the-counter products that contain alcohol. Avoiding alcohol is very important because alcohol changes acitretin into a drug that may take longer than 3 years to leave your body.
• You and your prescriber must be sure you are not pregnant before you start acitretin. Do not start acitretin until you have negative results from 2 pregnancy tests.
• After you start acitretin, you must have a pregnancy test repeated each month that you are on treatment. You must have a pregnancy test repeated every 3 months for at least 3 years after you stop acitretin to make sure that you are not pregnant.
• Stop taking acitretin right away and contact your prescriber if you get pregnant while taking acitretin or at any time for at least 3 years after you have stopped treatment. You need to discuss the possible effects on the unborn baby with your prescriber.
• Do not take acitretin if you are breast feeding. Acitretin can pass into your milk and may harm your baby. You will need to choose either to breast feed or take acitretin, but not both.
• You should receive the EPPA™ Program Booklet from your prescriber. The booklet contains information about preventing pregnancy, birth control options, side effects, the importance of avoiding products containing alcohol, and information about completing the EPPA™ Program Patient Survey.

What are the important warnings and instructions about acitretin for male patients?

• Small amounts of acitretin are found in the semen of males taking acitretin. The amount of acitretin needed in semen to cause a birth defect is unknown.

What are the important warnings and instructions about acitretin for all patients?

• Do not donate blood while you are taking acitretin and for at least 3 years after stopping acitretin. Acitretin in your blood can harm an unborn baby if your blood is given to a pregnant woman. Acitretin does not affect your ability to receive a blood transfusion.

Who should not take acitretin?

• Do NOT take acitretin if you can get pregnant. Do not take acitretin if you are pregnant or might get pregnant during treatment with acitretin or at any time for at least 3 years after you stop treatment with acitretin (see “What are the important warnings and instructions for females taking acitretin?”).
• Do NOT take acitretin if you are breastfeeding. Acitretin can pass into your milk and may harm your baby. You will need to choose either to breastfeed or take acitretin, but not both.
• Do not take acitretin if you have severe liver or kidney disease.
• Do not take acitretin if you have repeated high blood lipids (fat in the blood).
• Do not take acitretin if you take methotrexate or tetracyclines. The use of these medicines with acitretin may cause serious side effects.
• Do not take acitretin if you have had an allergic reaction to acitretin or to any medicines that are like acitretin. Ask your prescriber or pharmacist if any medicines you are allergic to are like acitretin.

What are other possible side effects of acitretin?

• Serious side effects – Stop taking acitretin and call your prescriber right away if you get the following signs or symptoms of possible serious side effects:

  • yellowing of your skin or the whites of your eyes, nausea and vomiting, loss of appetite, or dark urine. These can be signs of serious liver damage.
  • aches or pains in your bones, joints, muscles, or back, trouble moving, or loss of feeling in your hands or feet. These can be signs of abnormal changes to your bones or muscles.
  • shortness of breath, dizziness, nausea, chest pain, weakness, trouble speaking, or swelling of a leg. These may be signs of a heart attack, blood clots, or stroke. Acitretin can cause serious changes in blood fats (lipids). It is possible for these changes to cause blood vessel blockages that lead to heart attacks, strokes, or blood clots.
  • vision problems. Decreased vision in the dark (night blindness). Since this can start suddenly, you should be very careful when driving at night. Stop taking acitretin and call your prescriber if you develop any vision problems or eye pain.
  • abdominal pain, nausea, vomiting. These may be signs of pancreatitis (inflammation of the pancreas).
  • blood vessel problems. Acitretin can cause fluid to leak out of your blood vessels into your body tissues. Call your prescriber right away if you have any of the following symptoms: sudden swelling in one part of your body or all over your body, weight gain, fever, lightheadedness or feeling faint, or muscle aches. If this happens, your prescriber will tell you to stop taking acitretin.
  • serious allergic reactions. See “Who should not take acitretin?” Serious allergic reactions can happen during treatment with acitretin. Call your prescriber right away if you get any of the following symptoms of an allergic reaction: hives, itching, swelling of your face, mouth, or tongue, or problems breathing. If this happens, stop taking acitretin and do not take it again.
  • serious skin problems. Acitretin can cause skin problems that can begin in a small area and then spread over large areas of your body. Call your prescriber right away if your skin becomes red and swollen (inflamed), you have peeling of your skin, or your skin becomes itchy and painful. You should stop acitretin if this happens.

• Common side effects – If you develop any of these side effects or any unusual reaction, contact your prescriber to see if you need to change the amount of acitretin you take:

  • chapped lips, peeling fingertips, palms, and soles, itching, scaly skin all over, weak nails, sticky or fragile (weak) skin, runny or dry nose, or nosebleeds. Your prescriber or pharmacist can recommend a lotion or cream to help treat drying or chapping.
  • dry mouth
  • joint pain
  • tight muscles
  • hair loss. Most patients have some hair loss, but this condition varies among patients. No one can tell if you will lose hair, how much hair you may lose, or if and when it may grow back. You may also lose your eyelashes.
  • dry eyes. Acitretin may dry your eyes. Wearing contact lenses may be uncomfortable during and after treatment with acitretin because of the dry feeling in your eyes. If this happens, remove your contact lenses and call your prescriber.
  • rise in blood fats (lipids). Acitretin can cause your blood fats (lipids) to rise. Most of the time this is not serious. But sometimes the increase can become a serious problem (see information under “Serious side effects”). You should have blood tests as directed by your prescriber.

Psoriasis may get worse for some patients when they first start treatment with acitretin. Some patients may have more redness and itching. If this happens, tell your prescriber.

These are not all the possible side effects of acitretin. For more information, ask your prescriber or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What else should I avoid while taking acitretin?

• Avoid non-medical ultraviolet (UV) light. Acitretin can make your skin more sensitive to UV light. Do not use sunlamps, and avoid sunlight as much as possible. If you are taking light treatment (phototherapy), your prescriber may need to change your light dosages to avoid burns.
• Avoid dietary supplements containing vitamin A. Acitretin is related to vitamin A. Therefore, do not take supplements containing vitamin A because they may add to the unwanted effects of acitretin. Check with your prescriber or pharmacist if you have any questions about vitamin supplements.
• DO NOT SHARE acitretin with anyone else, even if they have the same symptoms. Your medicine may harm them or their unborn child.

What should I tell my doctor before taking acitretin?

Tell your prescriber if you have or ever had:

• liver problems
• alcoholism
• kidney problems
• high cholesterol or high triglycerides (fat in the blood)
• heart disease
• depression
• diabetes or high blood sugar
• an allergic reaction to a medication

Your prescriber needs this information to decide if acitretin is right for you and to know what dose is best for you.

Tell your prescriber about all the medicines you take, including prescription and non-prescription medicines, alcohol-containing medicines, vitamins, and herbal supplements. Some medicines can cause serious side effects if taken while you also take acitretin. Some medicines may affect how acitretin works, or acitretin may affect how your other medicines work. Be especially sure to tell your prescriber if you are taking the following medicines:

• methotrexate
• tetracyclines
• glyburide
• phenytoin
• vitamin A supplements
• progestin-only oral contraceptives (“minipills”)
• TEGISON or TIGASON (etretinate). Tell your prescriber if you have ever taken this medicine in the past.
• St. John’s wort herbal supplement

Tell your prescriber if you are getting phototherapy treatment. Your doses of phototherapy may need to be changed to prevent a burn.

For more information about acitretin, please see the full Prescribing Information, including Boxed Contraindications and Warnings, and Medication Guide.

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