Soriatane (Acitretin) to Treat Psoriasis

Soriatane (acitretin) is an oral medication used to treat severe psoriasis in people who are resistant to other forms of treatment. It has been around since the 1980s and works by slowing cellular growth in a disease characterized by the hyperproduction of skin cells.

Soriatane is associated with a wide range of side effects and is only used in people who have few treatment options. This is especially true for women in whom the drug may cause birth defects. Some of these harmful compounds may persist in the blood for up to three years.

Soriatane is a retinoid, a class of drug chemically similar to vitamin A. Its exact mechanism of action is unknown, but it is believed that Soriatane works by binding to nuclear receptors within cells that regulate mitosis (cell division).

Psoriasis is an inflammatory autoimmune disorder that causes skin cells to replicate faster than they normally would. By tempering this process at the cellular level, Soriatane can effectively prevent or reverse symptoms of the disease.

Soriatane is a second-generation retinoid developed from an earlier form of the drug known as etretinate. Etretinate has an extremely long drug half-life, meaning that it persists in the bloodstream for a very long time. This made dosing difficult and could often lead to a toxic accumulation of the drug over a relatively short period of time.

Soriatane is approved for use in adults with severe psoriasis. Because of the risk of side effects, it is only used in people who have failed to find relief with topical medications, methotrexate, cyclosporine, or other first- and second-line drugs.

Soriatane is sometimes used in combination with ultraviolet (UV) light therapy or newer-generation biologic drugs such as Enbrel (etanercept) and Humira (adalimumab).

Severe psoriasis is generally defined as having psoriasis on more than 30 percent of your body or large areas of your face, palms, or soles. It might also be considered serious if it significantly affects your quality of life and ability to function normally from day to day.

Soriatane is sometimes used off label to treat Darier's disease, palmoplantar pustulosis, lichen planus, or Sjogren-Larsson syndrome.

Soriatane is available as an oral capsule in 10-milligram (mg), 17.5-mg, and 25-mg strengths. It is generally prescribed in a once-daily dose of 25 mg to 50 mg and taken with food for optimal absorption.

Soriatane does not cure psoriasis. While effective, it may take two to three months before you feel the complete benefits of treatment. During this time, you may experience a worsening of symptoms as your body adapt to the drug. This is normal and is not an indication that treatment is failing.

If you miss a dose, do not double up doses to "catch up." Instead, take your next dose as prescribed and make every effort to adhere to treatment every day at the same time.

The side effects of Soriatane are significant. Pre-marketing research issued by the U.S. Food and Drug Administration (FDA) reported that 98 percent of users reported an adverse reaction with 22 percent withdrawing from treatment as a result of an intolerable side effect.

The most common side effects (affecting at least 10 percent of users) include:

• Lip inflammation
• Hair loss
• Skin peeling
• Sneezing
• Runny nose
• Nasal congestion
• Dry skin
• Nail pitting, lifting, or discoloration
• Itchiness
• Sudden severe chills and shaking
• Eye dryness
• Dry mouth
• Nose bleeds
• Joint pain
• Spinal calcification
• Worsening of psoriatic lesions
• Rash
• Skin hypersensitivity
• Abnormal skin sensations
• Nail infections
• Skin thinning
• Sticky skin

Soriatane is also known to affect other organs besides the skin, including the heart, brain, liver, and circulatory system. This can result in less common but potentially more serious side effects.

Call your doctor immediately if you experience any of the following:

• Depression
• Suicidal thoughts
• Confusion
• Difficulty speaking
• Ear ringing
• Extreme fatigue
• Yellowing of the eyes or skin
• Vomiting
• Blurred vision
• Chest pains
• Slowed or irregular heartbeat
• Increased thirst
• Difficulty moving any part of your body
• Loss of feeling in your hands or feet
• Swelling of the hands, feet, or ankles
• Redness or swelling of one leg only

Symptoms like these could be a sign of drug hypersensitivity, liver toxicity, an acute cardiovascular event (including thromboembolism and capillary leak syndrome), or other serious concerns.

These tend to be more common in people with pre-existing illnesses such as heart disease, liver disease, kidney failure, diabetes, or psychiatric disorders.

Soriatane is known to interact with certain medications, typically increasing or decreasing the blood concentration of one or both drugs. These include:

• Dilantin (phenytoin), decreasing the concentration of the epilepsy drug
• Glynase (glyburide), increasing the potency of the diabetes drug
• Progestin-based contraception, reducing the efficacy of birth control
• Vitamin A, which can lead to vitamin A toxicity

The U.S. Food and Drug Administration issued a black box warning to advise consumers and health professionals about the dangers of Soriatane in pregnancy. Black box warnings are only issued when there is reasonable evidence of a serious hazard.

Soriatane is classified as a Pregnancy Category X drug, meaning that the drug can cause fetal harm and should only be used when no other reasonable options are available. With Soriatane specifically, there have been incidences of major birth defects, including bone and facial malformations, meningomyelocele (known as a "split spine"), and various heart and vascular defects.

Breastfeeding would also need to be avoided. Additionally, men who have taken Soriatane should not donate blood for three years to prevent blood transfusion to a woman of reproductive potential.

Other contraindications for Soraiatine use include:

• Severe liver or kidney impairment
• Retinoid hypersensitivity
• Methotrexate (which increases the risk of hepatitis)
• Tetracycline antibiotics (which can cause abnormal intracranial pressure)

Soriatane should also be avoided in heavy drinkers and people with alcoholism.