Acitretin Capsules

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:

• Alcohol use disorder
• Depression
• Diabetes
• High cholesterol
• Heart disease
• Kidney disease
• Liver disease
• An unusual or allergic reaction to acitretin, vitamin A, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breastfeeding

How should I use this medication?

Take this medication by mouth with water. Take it as directed on the prescription label at the same time every day. Take it with food. Keep taking it unless your care team tells you to stop.

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 it. Take your next dose at the normal time. Do not take extra or 2 doses at the same time to make up for the missed dose.

What may interact with this medication?

Do not take this medication with any of the following:

• Alcohol or any product containing alcohol
• Certain antibiotics, such as doxycycline, minocycline, tetracycline
• Demeclocycline
• Etretinate
• Methotrexate
• Other retinoids
• St. John's wort
• Vitamin A supplements

This medication may also interact with the following:

• Glyburide
• Phenytoin
• Progestin hormones

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 symptoms may get worse when you first start treatment. It may take 2 to 3 months to see the full benefit of treatment.

You may need blood work done while you are taking this medication.

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 increase blood sugar. The risk may be higher in patients who already have diabetes. Ask your care team what you can do to lower your risk of diabetes while taking this medication.

This medication may cause dry eyes. If you wear contact lenses, you may feel some discomfort. Lubricating eye drops may help. See your care team if the problem does not go away or is severe. This medication may make it difficult to see at night or in low lit areas. Avoid driving at night until you know how it has affected your vision.

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 sunscreen. Do not use sun lamps, tanning beds, or tanning 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.

Before you receive your first prescription, review the Patient Agreement/Informed Consent with your care team. This is to help you understand the risk of birth defects and how to avoid pregnancy. If you did not talk to your care team about this and sign the consent form, contact your care team.

Talk to your care team if you or your partner may be pregnant. Serious birth defects can occur if you take this medication during pregnancy and for 3 years after the last dose. The risk of birth defects may last longer than 3 years if you swallow any form of alcohol while taking this medication and for 2 months after the last dose. You will need a negative pregnancy test before, during, and after taking this medication. Progestin hormones may not work as well while you are taking this medication. Two forms of contraception are recommended before starting this medication, during treatment, and for 3 years after the last dose. Your care team can help you find the option that works for you.

Do not breastfeed while taking this medication and for 3 years after the last dose.

Do not donate blood while you are taking this medication and for 3 years after the last dose. Donated blood may contain enough of this medication to cause birth defects if transfused to someone who is pregnant.

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 20 and 25 degrees C (68 and 77 degrees F). Protect from light and moisture. Keep the container tightly closed. Avoid exposure to extreme heat. Get rid of any unused medication after the expiration date.

To get rid of medications that are no longer needed or have expired:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put it in the trash, empty the medication out of the container. Mix the medication with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

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.