"A US Food and Drug Administration (FDA) advisory panel has backed a new biologic for psoriasis, though the panelists recommended strong warnings about the potential for suicide and self-injurious behavior (SIB) with the drug.
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.
DOSAGE AND ADMINISTRATION
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. Therapy with SORIATANE 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.
Females who have taken TEGISON (etretinate) must continue to follow the contraceptive recommendations for TEGISON. TEGISON is no longer marketed in the US; for information, call Stiefel at 1-888-784-3335 (1-888-STIEFEL).
Information For Pharmacists
SORIATANE must only be dispensed in no more than a monthly supply. 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 “A-10 mg”; bottles of 30 (NDC 0145-0090-25).
Rich yellow capsules, 17.5 mg, imprinted “A-17.5 mg”; bottles of 30 (NDC 0145-3817-03).
Brown and yellow capsules, 25 mg, imprinted “A-25 mg”; bottles of 30 (NDC 0145-009125).
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.
Manufactured for : Stiefel Laboratories, Inc. Research Triangle Park, NC 27709. Revised: May 2015This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 9/11/2015
Additional Soriatane Information
Soriatane - User Reviews
Soriatane User Reviews
Now you can gain knowledge and insight about a drug treatment with Patient Discussions.
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Find out what women really need.