Soriatane is indicated for the treatment of severe psoriasis in adults. Because of significant adverse effects associated with its use, Soriatane should be prescribed only by those knowledgeable in the systemic use of retinoids. In females of reproductive potential, Soriatane should be reserved for non-pregnant patients who are unresponsive to other therapies or whose clinical condition contraindicates the use of other treatments (see boxed CONTRAINDICATIONS AND WARNINGS — Soriatane can cause severe birth defects).

Most patients experience relapse of psoriasis after discontinuing therapy. Subsequent courses, when clinically indicated, have produced efficacy results similar to the initial course of therapy.

There is intersubject variation in the pharmacokinetics, clinical efficacy and incidence of side effects with Soriatane. A number of the more common side effects are dose related. Individualization of dosage is required to achieve sufficient therapeutic response while minimizing side effects. Soriatane therapy should be initiated at 25 to 50 mg per day, given as a single dose with the main meal. Maintenance doses of 25 to 50 mg per day may be given dependent upon an individual patient's response to initial treatment. Relapses may be treated as outlined for initial therapy.

When Soriatane is used with phototherapy, the prescriber should decrease the phototherapy dose, dependent on the patient's individual response (see PRECAUTIONS: General).

Females who have taken Tegison (etretinate) must continue to follow the contraceptive recommendations for Tegison.

Information for Pharmacists: A Soriatane Medication Guide must be given to the patient each time Soriatane is dispensed, as required by law.

Brown and white capsules, 10 mg, imprinted SORIATANE 10 mg; bottles of 30 (NDC 63032-090-25).

Brown and yellow capsules, 25 mg, imprinted SORIATANE 25 mg; bottles of 30 (NDC 63032-091-25).

Store between 15° and 25°C (59° and 77°F). Protect from light. Avoid exposure to high temperatures and humidity after the bottle is opened.

PATIENT AGREEMENT/INFORMED CONSENT FOR FEMALE PATIENTS

To be completed by the patient* and signed by her prescriber

CAUSES BIRTH DEFECTS/DO NOT GET PREGNANT

*Must also be initialed by the parent or guardian of a minor patient (under age 18)

Read each item below and initial in the space provided to show that you understand each item. Do not sign this consent and do not take SORIATANE® (acitretin) if there is anything that you do not understand.

_____________________________________________________________

(Patient's name)

1. I understand that there is a very high risk that my unborn baby could have severe birth defects if I am pregnant or become pregnant while taking SORIATANE in any amount even for short periods of time. Birth defects have also happened in babies of women who became pregnant after stopping SORIATANE treatment. INITIAL: ___________
2. I understand that I must not become pregnant while taking SORIATANE and for at least 3 years after the end of my treatment with SORIATANE. INITIAL: ___________
3. I know that I must avoid all alcohol, including drinks, food, medicines, and over-the-counter products that contain alcohol. I understand that the risk of birth defects may last longer than 3 years if I swallow any form of alcohol during SORIATANE therapy, and for 2 months after I stop taking SORIATANE. INITIAL: ___________
4. I understand that I must not have sexual intercourse, or I must use 2 separate, effective forms of birth control at the same time. The only exceptions are if I have had surgery to remove the womb (a hysterectomy) or my prescriber has told me I have gone completely through menopause. INITIAL: ___________
5. I understand that I have to use 2 effective forms of birth control (contraception) at the same time for at least 1 month before starting SORIATANE, for the entire time of SORIATANE therapy, and for at least 3 years after SORIATANE treatment has stopped. INITIAL: ___________
6. I understand that any form of birth control can fail. Therefore, I must use 2 different methods at the same time, every time I have sexual intercourse. INITIAL: ___________
7. I understand that the following are considered effective forms of birth control: Primary: Tubal ligation (having my tubes tied), partner's vasectomy, birth control pills, injectable/implantable/insertable/topical (patch) hormonal birth control products, and IUDs (intrauterine devices). Secondary: Latex condoms (with or without spermicide, which is a special cream or jelly that kills sperm), diaphragms and cervical caps (which must be used with a spermicide). I understand that at least 1 of my 2 methods of birth control must be a primary method. INITIAL: ___________
8. I will talk with my prescriber about any medicines or dietary supplements I plan to take during my SORIATANE treatment because certain birth control methods may not work if I am taking certain medicines or herbal products (for example, Saint John's wort). INITIAL: ___________
9. Unless I have had a hysterectomy or my prescriber says I have gone completely through menopause, I understand that I must have 2 negative pregnancy test results before I can get a prescription to start SORIATANE. I will then have pregnancy tests on a monthly basis during my SORIATANE therapy as instructed by my prescriber. In addition, for at least 3 years after the end of my treatment with SORIATANE, I will have a pregnancy test every 3 months. INITIAL: ___________
10. I understand that I should not start taking SORIATANE until I am sure that I am not pregnant and have negative results from 2 pregnancy tests. INITIAL: ___________
11. I have received information on emergency contraception (birth control). INITIAL: ___________
12. I understand that my prescriber can give me a referral for a free contraceptive (birth control) counseling session and pregnancy testing. INITIAL: ___________
13. I understand that on a monthly basis during SORIATANE therapy and every 3 months for at least 3 years after stopping Soriatane treatment that I should receive counseling from my prescriber about contraception (birth control) and behaviors associated with an increased risk of pregnancy. INITIAL: ___________
14. I understand that I must stop taking SORIATANE right away and call my prescriber if I get pregnant, miss my menstrual period, stop using birth control, or have sexual intercourse without using my 2 birth control methods during and at least 3 years after stopping SORIATANE treatment. INITIAL: ___________
15. If I do become pregnant while on SORIATANE or at any time within 3 years of stopping SORIATANE, I understand that I should report my pregnancy to Stiefel at 1-888-500-DERM (3376) or to the Food and Drug Administration (FDA) MedWatch program at 1-800-FDA-1088. The information I share will be kept confidential (private) and will help the company and the FDA evaluate the pregnancy prevention program to prevent birth defects. INITIAL: ___________

I have received a copy of the Do Your P.A.R.T™ brochure. My prescriber has answered all my questions about SORIATANE. I understand that it is my responsibility to follow my doctor's instructions, and not to get pregnant during SORIATANE treatment or for at least 3 years after I stop taking SORIATANE.

I now authorize my prescriber, _____________________________________________, to begin my treatment with SORIATANE.

Patient signature: ________________________________________

Date: ___________________

Parent/guardian signature (if under age 18): ____________________

Date: ___________________

Please print: Patient name and address: _______________________________________ _______________________________________________________________

Telephone: _____________________________________________________________

I have fully explained to the patient, _________________________________________, the nature and purpose of the treatment described above and the risks to females of childbearing potential. I have asked the patient if she has any questions regarding her treatment with SORIATANE and have answered those questions to the best of my ability.

Prescriber signature: _____________________________ Date: __________________

Manufactured for Stiefel Laboratories, Inc., Coral Gables, FL 33134. October 2007. FDA rev date: 10/18/2007

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