Acitretin

For female patients:

Do not take acitretin if you are pregnant or plan to become pregnant within the next 3 years. Acitretin may harm the fetus. You should not begin taking acitretin until you have taken two pregnancy tests with negative results. You must use two acceptable forms of birth control for 1 month before you begin taking acitretin, during your treatment with acitretin, and for 3 years after treatment. Your doctor will tell you which methods of birth control are acceptable. You do not need to use two methods of birth control if you have had a hysterectomy (surgery to remove the womb), if your doctor tells you that you have finished menopause (change of life), or if you practice total sexual abstinence.

If you plan to use oral contraceptives (birth control pills) while taking acitretin, tell your doctor the name of the pill you will use. Acitretin interferes with the action of microdosed progestin ('minipill') oral contraceptives. Do not use this type of birth control while taking acitretin. If you plan to use hormonal contraceptives (birth control pills, patches, implants, injections, and intrauterine devices), be sure to tell your doctor about all the medications, vitamins, and herbal supplements you are taking. Many medications interfere with the action of hormonal contraceptives. Do not take St. John's wort if you are using any type of hormonal contraceptive.

You will need to take pregnancy tests regularly during your treatment with acitretin and for at least 3 years after taking acitretin. Stop taking acitretin and call your doctor immediately if you become pregnant, miss a menstrual period, or have sex without using two forms of birth control. In some cases, your doctor can prescribe emergency contraception ('the morning after pill') to prevent pregnancy.

Do not consume foods, drinks, or prescription or nonprescription medications that contain alcohol while taking acitretin and for 2 months after treatment. Alcohol and acitretin combine to form a substance that remains in the blood for a long time and can harm the fetus. Read medication and food labels carefully and ask your doctor or pharmacist if you are not sure whether a medication contains alcohol.

Your doctor will give you a Patient Agreement/Informed Consent to read and sign before you begin treatment. Be sure to read this carefully and ask your doctor if you have any questions.

For male patients:

A small amount of acitretin is present in the semen of male patients who take this medication. It is not known whether this small amount of medication can harm the fetus. Talk to your doctor about the risks of taking this medication if your partner is pregnant or plans to become pregnant.

For male and female patients:

Do not donate blood while taking acitretin and for 3 years after treatment.

Acitretin may cause liver damage. Tell your doctor if you have or have ever had liver disease. If you experience any of the following symptoms, call your doctor immediately: nausea, vomiting, loss of appetite, pain in the upper right part of the stomach, yellowing of the skin or eyes, or dark urine.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with acitretin and each time you fill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (https://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm388814.htm) or the manufacturer's website to obtain the Medication Guide.

Acitretin is used to treat severe psoriasis (abnormal growth of skin cells that causes red, thickened, or scaly skin). Acitretin is in a class of medications called retinoids. The way acitretin works is not known.

Acitretin comes as a capsule to take by mouth. It is usually taken once a day with the main meal. Take acitretin at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take acitretin exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Your doctor may start you on a low dose of acitretin and gradually increase your dose.

Acitretin controls psoriasis but does not cure it. It may take 2–3 months or longer before you feel the full benefit of acitretin. Your psoriasis may get worse during the first few months of treatment. This does not mean that acitretin will not work for you, but tell your doctor if this happens. Continue to take acitretin even if you feel well. Do not stop taking acitretin without talking to your doctor.

After you stop taking acitretin, your symptoms may come back. Tell your doctor if this happens. Do not use leftover acitretin to treat a new flare-up of psoriasis. A different medication or dose may be needed.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before taking acitretin,

• tell your doctor and pharmacist if you have had a serious allergic reaction (difficulty breathing or swallowing, hives, itching, or swelling of the face, throat, tongue, lips, or eyes) to acitretin, other retinoids such as adapalene (Differen, in Epiduo), alitretinoin (Panretin), isotretinoin (Absorica, Accutane, Amnesteem, Claravis, Myorisan, Sotret, Zenatane), tazarotene (Avage, Fabior, Tazorac), tretinoin (Atralin, Avita, Renova, Retin-A), or any of the ingredients in acitretin capsules. Your doctor will probably tell you not to use acitretin. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
• tell your doctor if you are taking any of the following medications: methotrexate (Trexall) or tetracycline antibiotics such as demeclocycline, doxycycline (Doryx, Monodox, Oracea, Periostat, Vibramycin), minocycline (Dynacin, Minocin, Solodyn), and tetracycline (Sumycin, in Helidac, in Pylera) while taking acitretin. Your doctor will probably tell you not to take acitretin if you are taking one or more of these medications.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking. Be sure to mention the medications and herbs listed in the IMPORTANT WARNING section and any of the following: glyburide (Diabeta, Glynase, in Glucovance), phenytoin (Dilantin, Phenytek), and vitamin A (in multivitamins). Also tell your doctor if you have ever taken etretinate (Tegison). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you have or have ever had the conditions mentioned in the IMPORTANT WARNING section and if you have high cholesterol or triglyceride levels, a family history of high cholesterol levels, or kidney disease. Your doctor may tell you that you should not take acitretin.
• tell your doctor if you drink large amounts of alcohol; if you have diabetes or high blood sugar, spinal problems, depression, or stroke or mini-stroke; or if you have or have ever had joint, bone, or heart disease.
• do not breast-feed while taking acitretin or if you have recently stopped taking acitretin.
• you should know that acitretin may limit your ability to see at night. This problem may begin suddenly at any time during your treatment. Be very careful when driving at night.
• plan to avoid unnecessary or prolonged exposure to sunlight and to wear protective clothing, sunglasses, and sunscreen. Do not use sunlamps while taking acitretin. Acitretin may make your skin sensitive to sunlight.
• if you need to have phototherapy, tell your doctor that you are taking acitretin.
• you should know that acitretin may dry your eyes and make wearing contact lenses uncomfortable during or after treatment. Remove your contact lenses and call your doctor if this happens.

Unless your doctor tells you otherwise, continue your normal diet.

Skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Acitretin may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• peeling, dry, itchy, scaling, cracked, blistered, sticky or infected skin
• brittle or weak fingernails and toenails
• dandruff
• sunburn
• abnormal skin odor
• excessive sweating
• hair loss
• changes in hair texture
• dry eyes
• loss of eyebrows or eyelashes
• hot flashes or flushing
• chapped or swollen lips
• swollen or bleeding gums
• excessive saliva
• tongue pain, swelling, or blistering
• mouth swelling or blisters
• stomach pain
• diarrhea
• increased appetite
• difficulty falling or staying asleep
• sinus infection
• runny nose
• dry nose
• nosebleed
• joint pain
• tight muscles
• changes in taste

Some side effects can be serious. The following symptoms are uncommon, but if you experience any of them or those listed in the IMPORTANT WARNING section, call your doctor immediately:

• rash
• headache
• extreme thirst, frequent urination, extreme hunger, blurred vision, or weakness
• dry mouth, nausea and vomiting, shortness of breath, breath that smells fruity, and decreased consciousness
• pain, swelling, or redness of eyes or eyelids
• eye pain
• eyes sensitive to light
• swelling of hands, feet, ankles, or lower legs
• redness or swelling in one leg only
• depression
• thoughts of hurting or killing yourself
• bone, muscle, or back pain
• difficulty moving any part of your body
• loss of feeling in hands or feet
• chest pain
• slow or difficult speech
• tingling in arms and legs
• loss of muscle tone
• weakness or heaviness in legs
• cold, gray, or pale skin
• slow or irregular heartbeat
• dizziness
• fast heartbeat
• weakness
• shortness of breath
• ear pain or ringing

Acitretin may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (https://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location — one that is up and away and out of their sight and reach. https://www.upandaway.org

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include:

• headache
• dizziness
• vomiting
• upset stomach
• dry, itchy skin
• loss of appetite
• bone or joint pain

If a female who could become pregnant takes an overdose of acitretin, she should take a pregnancy test after the overdose and use two forms of birth control for the next 3 years.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to acitretin.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

• Soriatane^®