Contraindication in Pregnancy

• Not to be used by females who intend to become pregnant during therapy or who may not be able to use reliable contraception during therapy or for at least 3 yrs following cessation of therapy.

Teratogenicity

• Acitretin is a metabolite of etretinate and major human fetal abnormalities have been reported with both drugs (see specific abnormalities in package insert). Acitretin has been shown to be teratogenic and embryotoxic in animals (e.g. rabbits, mice and rats)(See package insert for specific doses used and comparative daa to recommended therapeutic doses.)

Ethanol Ingestion

• Do not ingest ethanol as concurrent administration forms etretinate, which has a significantly longer elimination half-life and increases duration of teratogenecity potential. Ethanol must not be ingested by female patients either during therapy or for 2 months after cessation of therapy (see Full Black box warnings for more details) 

Experienced Personnel

• This drug should only be prescribed by those with special competence in the diagnosis and treatment of severe psoriasis, are experienced in the use of systemic retinoids, and understand the risk of teratogenicity.

Pregnancy Prevention Actively Required During and After Treatment (P.A.R.T. Program):

• This program has been developed to educate women of childbearing potential and their healthcare providers about the serious risks associated with the use of this drug and to help prevent pregnancies from occurring with the use of this drug and for three years after its discontinuation. Program requirements are extensive and described in the full package insert and in PRECAUTIONS section of the insert.

Acitretin administered under restricted guidelines/conditions (see package insert including:

• severe psoriasis unresponsive to other therapies or whose clinical condition contraindicates the use of other treatments.
• Females of reproductive potential must not be given a prescription until pregnancy is excluded.
• This drug is contraindicated in females of productive potential unless the patient meets ALL of the criteria
• SEE FULL PACKAGE INSERT PRIOR TO PRESCRIBING and CRITERIA

Important Information for Males Taking acitretin:

• Patients should not donate blood during and for at least 3 years following acitretin capsules therapy because women of childbearing potential must not receive blood from patients being treated with acitretin capsules.
• Samples of seminal fluid from 3 male patients treated with acitretin and 6 male patients treated with etretinate have been assayed for the presence of acitretin. The maximum concentration of aciretin observed in the seminal fluid of these men was 12.5 ng/mL.  Assuming an ejaculate volume of 10 mL, the amount of drug transferred in semen would be 125 ng, which is 1/200,000 of a single 25 mg capsule.  Thus, although it appears that residual acitretin in seminal fluid poses little, if any, risk to a fetus while a male patient is taking the drug or after it is discontinued, the no-effect limit for teragenicity is unknown and there is no registry for birth defects associated with acitretin.  The available data are as follows:

There have been 25 cases of reported conception when the male partner was taking acitretin. The pregnancy outcome is known in 13 of these 25 cases. Of these, 9 reports were retrospective and 4 were prospective (meaning the pregnancy was reported prior to knowledge of the outcome)3.

Patient Counseling Information

• SORIATANE

Medication Guides

Patient Medication Guide

Package Inserts

Acitretin