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acitretin Images

Generic Name: acitretin

Brand Names: Soriatane Ck, Soriatane

There is an FDA Alert for this drug. Click here to view it.

  • Known human teratogen; very high risk of severe birth defects, generally characterized by malformations involving craniofacial, cardiovascular, skeletal, and CNS structures, if administered during pregnancy. (See Fetal/Neonatal Morbidity and Mortality and also see Contraindications under Cautions.)
  • Contraindicated during pregnancy. Acitretin must not be used in female patients who are or may become pregnant during therapy or within at least 3 years following drug discontinuance or in females who may not use reliable contraception during and for at least 3 years following cessation of therapy.
  • Do Your PART program developed to educate females of childbearing potential and their clinicians about risks associated with acitretin and to aid in the prevention of pregnancies during and for 3 years following drug discontinuance. (See Do Your PART Program under Cautions.)
  • Counseling about contraception and behaviors associated with increased pregnancy risk must occur monthly during and at 3-month intervals following drug discontinuance for at least 3 years.
  • If pregnancy occurs during therapy or at any time within at least 3 years following drug discontinuance, the clinician and patient should discuss the possible effects on the pregnancy. (See Pregnancy under Cautions.)

  • Concomitant use of acitretin and alcohol results in formation of etretinate, a known human teratogen with a longer elimination half-life than acitretin, prolonging the duration of potential teratogenic effects of acitretin; alcohol must not be used in female patients of childbearing potential during acitretin treatment and for 2 months following drug discontinuance. (See Specific Drugs under Interactions.)

    Blood Donation
  • Both male and female patients receiving acitretin should not donate blood during therapy and for at least 3 years following drug discontinuance because women of childbearing potential must not receive blood from patients receiving acitretin.

  • Risk of developing potentially serious hepatic injury. (See Hepatic Effects under Cautions.)
  • Monitor hepatic enzyme levels prior to initiating therapy, at weekly or biweekly intervals until stable, and thereafter at intervals based on clinician's discretion.
  • If hepatotoxicity is suspected during acitretin therapy, discontinue the drug and investigate the cause of the abnormality.

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