Generic Name: acitretin
Brand Names:
Soriatane CK, Soriatane
Teratogenicity
- 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.)
Alcohol
- 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.
Hepatotoxicity
- 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.
 | SORIATANE 25 ROCHE SORIATANE 25 ROCHE 25 mg
bottle, 30 each Acitretin 25mg, Oral capsule, brown, yellow, oblong-shaped, side 1:SORIATANE 25 ROCHE SORIATANE 25 ROCHE |
 | SORIATANE 10 ROCHE SORIATANE 10 ROCHE 10 mg
bottle, 30 each Acitretin 10mg, Oral capsule, brown, white, oblong-shaped, side 1:SORIATANE 10 ROCHE SORIATANE 10 ROCHE |
 | SORIATANE 25mg SORIATANE 25mg 25 mg
bottle, 30 each Acitretin 25mg, Oral capsule, brown, yellow, oblong-shaped, side 1:SORIATANE 25mg SORIATANE 25mg |
 | SORIATANE 10mg SORIATANE 10mg 10 mg
bottle, 30 each Acitretin 10mg, Oral capsule, brown, white, oblong-shaped, side 1:SORIATANE 10mg SORIATANE 10mg |
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