SORIATANE - Do Your P.A.R.T.

SORIATANE is indicated for the treatment of severe psoriasis in adults. Due to the risk of severe birth defects, in females of reproductive potential SORIATANE should be reserved for nonpregnant patients with severe psoriasis who are unresponsive to other therapies or whose clinical condition contraindicates the use of other treatments.

Important Safety Information including Boxed Warning

CONTRAINDICATIONS AND WARNINGS: SORIATANE

(acitretin) 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. SORIATANE 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 one month before, during, and for at least three years after treatment. Two effective forms of contraception (birth control) are to be used simultaneously, even when one is a hormonal contraceptive. Patients should not self-medicate with St. John's Wort because of possible interaction with hormonal contraceptives. Prescribers must obtain negative results for 2 pregnancy tests before initiating treatment with SORIATANE. 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 SORIATANE therapy. For patients with amenorrhea, the second test should be done at least 11 days after the last act of unprotected sexual intercourse. Timing of pregnancy testing throughout the treatment course should be monthly or individualized based on the prescriber's clinical judgement. Females must sign a Patient Information/Consent 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 product information. Females who have undergone treatment with Tegison

(etretinate) must continue to follow the contraception requirements for Tegison.

CAUSES BIRTH DEFECTS. DO NOT GET PREGNANT

Common side effects include: cheilitis, rhinitis, dry mouth, arthralgia, spinal hyperostosis, alopecia, skin peeling, dry skin, nail disorder, pruritus, erythematous rash, hyperesthesia, paresthesia, paronychia, skin atrophy, sticky skin, and alteration in lipids.

Less frequent, but potentially serious, adverse events include hepatotoxicity, pancreatitis, and pseudotumor cerebri, as well as hyperostosis, alteration in lipids with possible cardiovascular effects, and ophthalmologic effects.

Common side effects can include: chapped lips; peeling fingertips, palms, and soles; itching; scaly skin all over; weak nails; sticky or fragile (weak) skin; runny or dry nose; nosebleeds; dry mouth; joint pain; tight muscles; hair loss; dry eyes; and rise in blood fats (lipids).

Less frequent, but potentially serious side effects include: bad headaches, nausea, vomiting, blurred vision; decreased vision in the dark; depression; yellowing of your skin or the whites of your eyes, loss of appetite or dark urine; aches or pains in your bones, joints, muscles or back, trouble moving; loss of feeling in your hands or feet; frequent urination, great thirst or hunger. Shortness of breath, dizziness, chest pain, weakness, trouble speaking, or swelling of a leg may be signs of a heart attack, blood clots, or stroke.

You are encouraged to report the side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. For more information, ask your doctor or call 1-888-500-3376.

For more information about SORIATANE®, please see Medication Guide.
For further information on SORIATANE®, please see full Prescribing Information.

SORIATANE is a registered trademark and Do Your P.A.R.T is a trademark of Stiefel Laboratories, Inc.