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SORIATANE is a prescription medicine for the treatment of severe psoriasis in adults. If you can get pregnant, you should only use SORIATANE if other medicines do not work for your severe psoriasis or you cannot use other psoriasis medicines.

Most patients will have their psoriasis return if they stop treatment.

IMPORTANT SAFETY INFORMATION

SORIATANE can cause severe birth defects. If you are a female who can get pregnant, you should use SORIATANE only if you are not pregnant now, and you can avoid becoming pregnant while taking SORIATANE and for at least 3 years after stopping SORIATANE. Females who can get pregnant should take SORIATANE only if other medicines do not work for their severe psoriasis or they cannot use other psoriasis medicines.

SORIATANE can cause liver injury. SORIATANE has been associated with abnormal liver function tests. Your prescriber should monitor how your liver is working with blood tests. (See Bolded Warnings)
See full Important Safety Information below

INDICATION

SORIATANE is a prescription medicine for the treatment of severe psoriasis in adults. If you can get pregnant, you should only use SORIATANE if other medicines do not work for your severe psoriasis or you cannot use other psoriasis medicines.


Most patients will have their psoriasis return if they stop treatment.

DOSING

The approved dose of SORIATANE is 25 to 50 mg per day, taken as a single dose with a main meal.

About the Do Your P.A.R.T Program

(Pregnancy Prevention Actively Required During and After Treatment) The purpose of this program is to educate women who can get pregnant and their doctors about the serious risks associated with SORIATANE. It is also designed to help prevent pregnancies during treatment with SORIATANE and for at least 3 years after stopping treatment. Some components of the Do Your P.A.R.T. Program are:

  • Do Your P.A.R.T. Patient Brochure, which contains information on side effects associated with SORIATANE and different types of birth control. Patients should receive this brochure from their doctor before starting treatment.
  • A Patient Agreement/Informed Consent form that must be signed by women who can get pregnant, before starting SORIATANE
  • Medication Guide for SORIATANE, which provides important safety information
  • A voluntary patient survey for women who can get pregnant

If you think you've become pregnant while taking SORIATANE or within 3 years of stopping:

  • Stop taking SORIATANE (if you have not done so already)
  • Call your doctor to tell him/her you might be pregnant
  • Call Stiefel at 1-888-784-3335 (1-888-STIEFEL)
  • Or call FDA MedWatch at 1-800-FDA-1088 (1-800-332-1088)

While taking SORIATANE and for 3 years after stopping, if you think you have had unprotected sex (did not use 2 effective forms of birth control at the same time) or you feel that your birth control has failed, stop taking SORIATANE. Then call your physician and the emergency contraception hotline 1-888-NOT-2-LATE (1-888-668-2528) immediately.