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FDA approves updated Soriatane label

First posted May 23, 2003

Soriatane, also known as acitretin, recently received approval for an enhanced product label from the U.S. Food and Drug Administration (FDA). The oral retinoid (vitamin A derivative) was initially approved six years ago for treating severe psoriasis.

Retinoids affect how cells regulate their behavior, including how fast skin cells will grow and be shed from the skin's surface. Many physicians believe Soriatane works better when used with ultraviolet light B or PUVA (the use of a light-sensitizing drug with ultraviolet light A), rather than by itself.

Roche Pharmaceuticals, manufacturer of the drug, hopes the updated label will encourage patients with severe psoriasis to use Soriatane as an alternative to other systemic treatments.

"The goal is to make sure that patients know that Soriatane is an option, and that it isn't cytotoxic (harmful to cells) or immune suppressive like other systemics," says Gail Safian of the Roche public affairs department.

With the updated label, Roche is also looking for more doctors to use Soriatane with phototherapy or for more types of psoriasis. The label was approved on May 8 with updated information on dosage, warnings and side effects, including the following:

Psoriasis types: The label includes data supporting the use of Soriatane as a maintenance therapy and for the treatment of five different types of psoriasis: plaque, guttate, pustular, erythrodermic and palmoplantar. Previously, the label only indicated the use of Soriatane for plaque, erythrodermic and pustular types. Now, the label indicates for "severe psoriasis in adults."

Combination therapy: The new label includes updated instructions for using phototherapy with Soriatane. Many doctors treat plaque psoriasis with this combination. The label clarifies that "significantly lower doses of phototherapy are required" when used with Soriatane, because Soriatane makes the skin more sensitive to light.

Dosage: The capsules are available in 10 milligrams (mg) and 25 mg. The label clarifies that dosage information is 25 mg to 50 mg per day, instead of the previous instructions of 25 mg or 50 mg. The dosage range helps doctors using Soriatane for the first time understand the dosing flexibility, according to Safian. Maintenance therapy continues with 25 mg to 50 mg, depending on the patient's response to initial treatment.

Pregnancy: The label emphasizes the warnings for women of child-bearing age. Women of child-bearing age must be tested twice for pregnancy before beginning the drug, and use two forms of birth control while on Soriatane. They also must sign a consent form acknowledging they are aware that they must not be pregnant when they start Soriatane or become pregnant for three years after stopping Soriatane.

Depression: Because it is a vitamin A derivative like Accutane, which has a questionable association with depression, Soriatane's label also includes a warning of depression as a possible side effect. According to Roche, depression was reported by a small number of patients, but it is not known if Soriatane is directly responsible.