Soriatane (acitretin)

Acitretin is an oral medication used to treat psoriasis.

• Acitretin is used for treating severe psoriasis in adults.
• Acitretin should be prescribed only by doctors who have experience in the systemic use of retinoids because it has serious side effects.

Is Soriatane (acitretin) available as a generic drug?

Yes

Do I need a prescription for Soriatane (acitretin)?

Yes

• Acitretin is harmful to the fetus. It must not be used while pregnant, or by women who intend to be pregnant during therapy or within 3 years following discontinuation of therapy. It should also not be used by women who do not use reliable contraception. Patients must use 2 effective forms of contraception (birth control) simultaneously for at least 1 month prior to starting acitretin therapy, during therapy, and for at least 3 years after stopping treatment.
• Alcohol increases conversion of acitretin to etretinate (Tegison), which remains in the body much longer and is also harmful to the fetus. Therefore, women should not consume alcohol during treatment with acitretin and for 2 months after stopping therapy.
• Acitretin may cause liver damage. Acitretin should be discontinued if liver damage is suspected during treatment.

Common side effects of Soriatane include:

• Inflammation of the lips (cheilitis)
• Hair loss
• Increased triglyceride levels
• Skin peeling
• Dry skin (25%-50%)
• Itching
• Cold symptoms
• Joint pain
• Dry mouth

Other side effects of Soriatane include:

• Increased levels of liver enzymes
• Changes in phosphorus, potassium, sodium, and magnesium levels
• Nosebleeds
• Rash
• Increased sun sensitivity

Other less common side effects of Soriatane include:

• Water retention
• Headache
• Nausea
• Vomiting
• Insomnia
• Diarrhea
• Flushing
• Depression
• Fatigue
• Gingivitis
• Increased appetite
• Possible serious side effects include:
• Birth defects (Please see the pregnancy and breastfeeding safety section.)
• Liver toxicity
• Dry eyes (xerophthalmia)
• Pancreatitis
• Pseudotumor cerebri (increased pressure of the fluid in the brain)
• Skeletal abnormalities

Since acitretin can cause liver damage, liver function tests should be performed before treatment at 1- to 2-week intervals until stable, and thereafter at intervals as clinically needed

• The recommended dose for acitretin is 25 to 50 mg daily given as a single dose with the main meal.

• Acitretin is harmful to the fetus, and it must not be used during pregnancy. Women must use 2 effective forms of contraception (birth control) simultaneously for at least 1 month prior to starting acitretin therapy, during therapy, and for at least 3 years after stopping treatment. Major human fetal abnormalities associated with acitretin and/or etretinate include:
  • Meningomyelocele
  • Meningoencephalocele
  • Multiple synostoses
  • Facial dysmorphia
  • Syndactyly
  • Absence of terminal phalanges
  • Malformations of hip, ankle, and forearm
  • Low-set ears
  • High palate
  • Decreased cranial volume
  • Cardiovascular malformation
  • And alterations of the skull and cervical vertebrae
• Acitretin should not be used by women who are breastfeeding because acitretin can pass into breast milk and harm the infant.

• Combining acitretin with alcohol increases the formation of etretinate. Etretinate remains in the body for a longer period than acitretin and it is very harmful to a fetus.
• Acitretin may increase the effects of glyburide (Micronase) on blood glucose and potentially cause hypoglycemia.
• Acitretin reduces the effect of the microdose progestin minipill. The two drugs should not be combined.
• Acitretin should not be combined with methotrexate (Rheumatrex, Trexall) due to the increased risk of liver failure.
• Combining tetracycline with acitretin increases intracranial pressure.
• Taking vitamin A supplements may increase side effects of acitretin because acitretin and vitamin A have similar chemical structures.
• If phototherapy also is being used as treatment, the doses of phototherapy should be reduced to avoid excessive burning of the skin.

What preparations of Soriatane (acitretin) are available?

• Capsule: 10 and 25 mg

How should I keep Soriatane (acitretin) stored?

• Acitretin should be stored between 15 C and 25 C (59 C and 77 F) and protected from light.
• Exposure to high temperatures and humidity should be avoided after the bottle is opened.

How does Soriatane (acitretin) work?

• The mechanism of action of acitretin is unknown. It is chemically related to retinoic acid and retinol (vitamin A), and it reduces skin cell production and shedding. It takes several weeks to see its effects, up to 6 months to see a full response, and psoriasis may worsen before improvement is seen.

When was Soriatane (acitretin) approved by the FDA?

• The FDA approved acitretin in October 1996.