What are acitretin capsules used for?

Acitretin capsules are a medicine used to treat severe forms of psoriasis in adults. Psoriasis is a skin disease that causes cells in the outer layer of the skin to grow faster than normal and pile up on the skin's surface. Because acitretin capsules can have serious side effects, you should talk with your prescriber about whether possible benefits of acitretin capsules outweigh its possible risks.

Acitretin capsules may not work right away. You may have to wait 2 to 3 months before you get the full benefit of acitretin capsules. Psoriasis gets worse for some patients when they first start treatment with acitretin capsules.

CONTRAINDICATIONS AND WARNINGS: Acitretin Capsules must not be used by females who are pregnant or who may become pregnant during therapy or at any time for at least 3 years after discontinuation of treatment. Acitretin capsules also must not be used by females of reproductive potential who may not use 2 effective forms of contraception (birth control) simultaneously for at least 1 month before, during and for at least 3 years after treatment. Two effective forms of contraception (birth control) are to be used simultaneously, even when 1 form is a hormonal contraceptive. Patients should not selfmedicate with St. John's Wort because of a possible interaction with hormonal contraceptives. Prescribers must obtain negative results for 2 pregnancy tests before initiating treatment with acitretin capsules. The first test is a screening test; the second is a confirmation test done during the first 5 days of the menstrual period immediately preceding therapy with acitretin capsules. For patients with amenorrhea, the second test should be done at least 11 days after the last act of unprotected sexual intercourse. If the second pregnancy test is negative, initiation of treatment with acitretin capsules should begin within 7 days of the specimen collection.

Acitretin capsules should be limited to a monthly supply. Pregnancy testing throughout the treatment course should be monthly. Females must sign a Patient Agreement/Informed Consent for Female Patients form about the risks of birth defects. Acitretin is a metabolite of etretinate and major fetal abnormalities have been reported with both drugs. Acitretin can interact with ethanol to form etretinate. Therefore, females of reproductive potential must not ingest ethanol during treatment and for 2 months after cessation of treatment. Before prescribing, please see complete pregnancy warning in the accompanying complete prescribing information. Females who have undergone treatment with TEGISON® (etretinate) must continue to follow the contraception requirements for TEGISON.

Common side effects

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, dry mouth , joint pain, tight muscles, hair loss, dry eyes, rise in blood fats (lipids).

Serious side effects

• Severe birth defects
• Liver problems: signs and symptoms yellowing of skin or the whites of eyes, nausea and vomiting, loss of appetite, or dark urine
• Increased brain pressure: signs and symptoms Bad headaches, nausea, vomiting, blurred vision.
• Vision Problems: Decreased vision in the dark (night blindness).
• Depression
• Abnormal changes to bones or muscles: signs and symptoms include aches or pains in bones, joints, muscles, or back, trouble moving, or loss of feeling in hands or feet
• Affect blood sugar control: signs and symptoms include frequent urination, great thirst or hunger.
• Heart attack, blood clots, or stroke: signs and symptoms include shortness of breath, dizziness, nausea, chest pain, weakness, trouble speaking, or swelling of a leg
• Blood vessel problems: signs and symptoms sudden swelling in one part of body or all over body, weight gain, fever, light headedness or feeling faint, or muscle aches
• Serious allergic reactions: signs and symptoms include hives, itching, swelling of face, mouth, or tongue, or problems breathing
• Serious skin problems: signs and symptoms include have peeling of skin, or skin becomes itchy, and painful

Less frequent, but potentially serious, adverse events

Hepatotoxicity, pancreatitis, pseudotumor cerebri, hyperostosis, alterations in lipids, possible cardiovascular effects, ophthalmologic effects, capillary leak syndrome, and exfoliative dermatitis/erythroderma