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.

Important Safety Information

What is the most important information I should know about SORIATANE?

  • 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,
    • you can avoid becoming pregnant while taking SORIATANE and for at least 3 years after stopping SORIATANE, and
    • other medicines do not work for your severe psoriasis or you 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.

What are the important warnings and instructions about SORIATANE for women who can get pregnant?

  • You must not take SORIATANE if you are pregnant or might become pregnant during treatment or at any time for at least 3 years after you stop treatment because SORIATANE can cause severe birth defects.
  • You must use 2 effective forms of birth control (contraception) at the same time while you are taking SORIATANE. You must use birth control for at least 1 month before you start treatment, during treatment, and for at least 3 years after you stop treatment.
    • Avoid progestin-only birth control pills ("minipills"). This type of birth control pill may not work while you take SORIATANE. Ask your prescriber if you are not sure what type of pills you are using.
    • Do not take St. John's Wort while taking SORIATANE. St. John's Wort may interfere with some types of birth control.
  • During treatment and for 2 months after you stop SORIATANE, you must avoid drinks, foods, and all medicines that contain alcohol. This includes over-the-counter products that contain alcohol. Avoiding alcohol is very important because alcohol changes SORIATANE into a drug that may take longer than 3 years to leave your body.
  • You and your prescriber must be sure you are not pregnant before you start SORIATANE. Do not start SORIATANE until you have negative results from 2 pregnancy tests.
  • After you start SORIATANE, you must have a pregnancy test repeated each month that you are on treatment. You must have a pregnancy test repeated every 3 months for at least 3 years after you stop SORIATANE to make sure that you are not pregnant.
  • Stop taking SORIATANE right away and contact your prescriber if you get pregnant while taking SORIATANE or at any time for at least 3 years after you have stopped treatment. You need to discuss the possible effects on the unborn baby with your prescriber.
  • Do not take SORIATANE if you are breast feeding. SORIATANE can pass into your milk and may harm your baby. You will need to choose either to breast feed or take SORIATANE, but not both.
  • You should receive the Do Your P.A.R.T. brochure from your prescriber. The brochure contains information about preventing pregnancy, birth control options, side effects, the importance of avoiding products containing alcohol, and information about completing the Do Your P.A.R.T. survey.

What are the important warnings and instructions about SORIATANE for male patients?

  • Small amounts of SORIATANE are found in the semen of males taking SORIATANE. The amount of SORIATANE needed in semen to cause a birth defect is unknown.

What are the important warnings and instructions about SORIATANE for all patients?

  • Do not donate blood while you are taking SORIATANE and for at least 3 years after stopping SORIATANE. SORIATANE in your blood can harm an unborn baby if your blood is given to a pregnant woman. SORIATANE does not affect your ability to receive a blood transfusion.

Who should not take SORIATANE?

  • Do not take SORIATANE if you have severe liver or kidney disease.
  • Do not take SORIATANE if you have repeated high blood lipids (fat in the blood).
  • Do not take SORIATANE if you take methotrexate or tetracyclines. The use of these medicines with SORIATANE may cause serious side effects.
  • Do not take SORIATANE if you have had an allergic reaction to SORIATANE or other medicines like SORIATANE.

What are other possible side effects of SORIATANE?

  • Serious side effects – These can lead to permanent harm, or rarely, to death. Stop taking SORIATANE and call your prescriber right away if you get the following signs or symptoms:
    • yellowing of your skin or the whites of your eyes, nausea and vomiting, loss of appetite, or dark urine. These can be signs of serious liver damage.
    • aches or pains in your bones, joints, muscles, or back; trouble moving; loss of feeling in your hands or feet. These can be signs of abnormal changes to your bones or muscles.
    • shortness of breath, dizziness, nausea, chest pain, weakness, trouble speaking, or swelling of a leg. These may be signs of a heart attack, blood clots, or stroke. SORIATANE can cause serious changes in blood fats (lipids). It is possible for these changes to cause blood vessel blockages that lead to heart attacks, strokes, or blood clots.
    • decreased vision in the dark or "night blindness." Since this can start suddenly, you should be very careful when driving at night. If you develop any vision problems or eye pain, stop taking SORIATANE and call your prescriber.
    • abdominal pain, nausea, vomiting. These may be signs of pancreatitis (inflammation of the pancreas).
    • bad headaches, nausea, vomiting, blurred vision. These can be signs of increased brain pressure that can lead to blindness or even death.
    • depression and other mental health problems. There have been some reports of patients developing mental problems including a depressed mood, aggressive feelings, or thoughts of ending their own life (suicide). It is very important to stop taking SORIATANE and call your prescriber right away if you develop such problems.
    • visual changes, frequent urination, great thirst, or hunger. These can be signs of high blood sugar.
  • Psoriasis may get worse for some patients when they first start treatment with SORIATANE. Some patients may have more redness and itching. If this happens, tell your prescriber.
  • Common side effects – If you develop any of these side effects or any unusual reaction, contact your prescriber to see if you need to change the amount of SORIATANE you take:
    • 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. Your prescriber or pharmacist can recommend a lotion or cream to help treat drying or chapping.
    • dry mouth
    • joint pain
    • tight muscles
    • hair loss. Most patients have some hair loss, but this condition varies among patients. No one can tell if you will lose hair, how much hair you may lose, or if and when it may grow back.
    • dry eyes. SORIATANE may dry your eyes. Wearing contact lenses may be uncomfortable during and after treatment with SORIATANE because of the dry feeling in your eyes. If this happens, remove your contact lenses and call your prescriber.
    • rise in blood fats (lipids). SORIATANE can cause your blood fats (lipids) to rise. Most of the time this is not serious. But sometimes the increase can become a serious problem (see information under "Serious side effects"). You should have blood tests as directed by your prescriber.

These are not all the possible side effects of SORIATANE. For more information, ask your prescriber or pharmacist.


What else should I avoid while taking SORIATANE?

  • Avoid non-medical ultraviolet (UV) light. SORIATANE can make your skin more sensitive to UV light. Do not use sunlamps, and avoid sunlight as much as possible. If you are taking light treatment (phototherapy), your prescriber may need to change your light dosages to avoid burns.
  • Avoid dietary supplements containing vitamin A. SORIATANE is related to vitamin A. Therefore, do not take supplements containing vitamin A because they may add to the unwanted effects of SORIATANE. Check with your prescriber or pharmacist if you have any questions about vitamin supplements.
  • DO NOT SHARE SORIATANE with anyone else, even if they have the same symptoms. Your medicine may harm them or their unborn child.

What should I tell my doctor before taking SORIATANE?

Tell your prescriber if you have or ever had:

  • liver problems
  • alcoholism
  • kidney problems
  • high cholesterol or high triglycerides
    (fat in the blood)
  • heart disease
  • depression
  • diabetes or high blood sugar
  • an allergic reaction to a medication



Your prescriber needs this information to decide if SORIATANE is right for you and to know what dose is best for you.



Tell your prescriber about all the medicines you take, including prescription and non-prescription medicines, alcohol-containing medicines, vitamins, and herbal supplements. Some medicines can cause serious side effects if taken while you also take SORIATANE. Some medicines may affect how SORIATANE works, or SORIATANE may affect how your other medicines work. Be especially sure to tell your prescriber if you are taking the following medicines:

  • methotrexate
  • tetracyclines
  • glibenclamide
  • phenytoin
  • vitamin A supplements
  • progestin-only oral contraceptives ("minipills")
  • St. John's Wort herbal supplement


Tell your prescriber if you are getting phototherapy treatment. Your doses of phototherapy may need to be changed to prevent a burn.



For more information about SORIATANE, please see the full Prescribing Information, including Boxed Warning, and Medication Guide.