What is this medication?

ACITRETIN (a si TRE tin) treats psoriasis. It works by decreasing inflammation and slowing down the growth of skin cells. This reduces redness and swelling, as well as scaling of the skin. It belongs to a group of medications called retinoids.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Soriatane

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Alcoholism
• Depression
• Diabetes
• High cholesterol
• Heart disease
• Kidney disease
• Liver disease
• Taking St. John’s Wort
• Visual problems
• An unusual or allergic reaction to acitretin, etretinate, vitamin A, isotretinoin, tretinoin, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

Take this medication by mouth with a glass of water. Follow the directions on the prescription label. Take this medication with food. Take your medication at regular intervals. Do not take your medication more often than directed. Do not stop taking except on your care team’s advice.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your care team about the use of this medication in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, skip the missed dose and resume your normal schedule. Do not take double or extra doses.

What may interact with this medication?

Do not take this medication with any of the following:

• Alcohol, including alcohol that may be in drinks, food, or medications including over-the-counter medications
• Etretinate—tell your care team if you have ever taken this medication in the past
• Methotrexate
• Multivitamins or nutritional supplements that contain vitamin A
• Progestin-only contraceptives (mini pill)
• St. John’s Wort
• Tetracycline type antibiotics like tetracycline, doxycycline or minocycline
• Vitamin A type medications like isotretinoin, tretinoin

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. It may be some time before you see the benefit from this medication. Your psoriasis may get worse when you first start taking this medication. You may have to take it for 2 to 3 months before you see the full benefit.

Talk to your care team if you wish to become pregnant or think you might be pregnant. This medication can cause serious birth defects. If you were assigned female sex at birth, you will need 2 negative pregnancy tests before starting this medication and then once every month during treatment, even if you are not sexually active. Use 2 reliable forms of contraception together for 1 month before, during, and for at least 3 years after stopping this medication. Progestin hormones may not work as well while you are taking this medication. Talk to your care team about other forms of contraception. Stop taking this medication right away if you become pregnant, miss a menstrual cycle, or stop using contraception. Talk to your care team before breast-feeding. Changes to your treatment plan may be needed.

Before you receive your prescription, review the Do Your P.A.R.T. booklet, which includes the Do Your P.A.R.T. Patient Brochure, The Contraceptive Counseling Referral Form, the Patient Agreement/Informed Consent Form, and the Medication Guide. If you did not talk to your care team about this and sign the consent form, contact your care team.

Do not donate blood during and for 3 years after stopping treatment with this medication. Donated blood may contain enough of this medication to cause birth defects in a fetus if transfused to someone who is pregnant.

This medication may cause dry eyes. If you wear contact lenses, you may feel some discomfort. Lubricating eye drops may help. See you care team if the problem does not go away or is severe.

This medication can make you more sensitive to the sun. Keep out of the sun. If you cannot avoid being in the sun, wear protective clothing and use sunscreen. Do not use sun lamps or tanning beds/booths. If you are receiving light treatment (phototherapy), your care team may need to change your light dosages to avoid burns.

Your mouth may get dry. Chewing sugarless gum or sucking hard candy, and drinking plenty of water may help. Contact your care team if the problem does not go away or is severe.

This medication can increase bad cholesterol and fats (such as LDL, triglycerides) and decrease good cholesterol (HDL) in your blood. You may need blood tests to check your cholesterol. Ask your care team what you can do to lower your risk of high cholesterol while taking this medication.

This medication may affect your blood sugar levels. If you are diabetic, check with your care team if you notice any change in your blood sugar tests.

Avoid food, drinks, and medications that contain alcohol while taking this medication and for 2 months after treatment has stopped.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Blood clot—pain, swelling, or warmth in the leg, shortness of breath, chest pain
• Capillary leak syndrome—stomach or muscle pain, unusual weakness or fatigue, feeling faint or lightheaded, decrease in the amount of urine, swelling of the ankles, hands, or feet, trouble breathing
• Change in vision
• Heart attack—pain or tightness in the chest, shoulders, arms, or jaw, nausea, shortness of breath, cold or clammy skin, feeling faint or lightheaded
• Increased pressure around the brain—severe headache, blurry vision, change in vision, nausea, vomiting
• Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
• Pancreatitis—severe stomach pain that spreads to your back or gets worse after eating or when touched, fever, nausea, vomiting
• Redness, blistering, peeling, or loosening of the skin, including inside the mouth
• Stroke—sudden numbness or weakness of the face, arm, or leg, trouble speaking, confusion, trouble walking, loss of balance or coordination, dizziness, severe headache, change in vision
• Thoughts of suicide or self-harm, worsening mood, feelings of depression

Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):

• Change in taste
• Dry skin
• Dryness or irritation of the eyes, lips, mouth, or nose
• Hair loss
• Joint pain
• Nausea

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store at room temperature between 15 and 25 degrees C (59 and 77 degrees F). Protect from light. Avoid exposure to high temperatures and humidity after the bottle is opened. Throw away any unused medication after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.