Usual Adult Dose for Psoriasis

Initial dose: 25 to 50 mg orally once a day, administered as a single dose with main meal
Maintenance dose: 25 to 50 mg orally once a day, administered upon an individual patient's response to initial treatment

Comments: When used with phototherapy, the healthcare provider should decrease the phototherapy dose, dependent on the patient's individual response.

Use: Treatment of severe psoriasis in adults

Renal Dose Adjustments

Severe renal impairment: Contraindicated

Liver Dose Adjustments

Severe liver impairment: Contraindicated

Precautions

US BOXED WARNINGS:

• Acitretin must not be used by females who are pregnant, or who intend to become pregnant during therapy or at any time for at least 3 years following discontinuation of therapy. Acitretin also must not be used by females who may not use reliable contraception while undergoing treatment and for at least 3 years following discontinuation of treatment. Acitretin is a metabolite of etretinate and major human fetal abnormalities have been reported with the administration of acitretin and etretinate. Potentially, any fetus exposed can be affected.
• Ethanol must not be ingested by female patients either during treatment with acitretin or for 2 months after cessation of therapy.
• Because of the teratogenicity of acitretin, a program called T.A.P.P., Take Action to Prevent Pregnancy, has been developed to educate women of childbearing potential and their healthcare providers about the serious risks associated with acitretin and to help prevent pregnancies from occurring with the use of this drug and for 3 years after its discontinuation. The T.A.P.P. program requirements are described below and program materials are available at http://www.tevagenerics.com/acitretin or may be requested by calling 1-855-850-2138 Important Information for Women of Childbearing Potential
• Acitretin should be considered only for women with 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 for acitretin until pregnancy is excluded. Acitretin is contraindicated in females of reproductive potential unless the patient meets ALL of the following conditions:
• Must have had 2 negative urine or serum pregnancy tests with a sensitivity of at least 25 mInternational Units(mIU)/mL before receiving the initial prescription for acitretin. The first test (a screening test) is obtained by the prescriber when the decision is made to pursue therapy with acitretin. The second pregnancy test (a confirmation test) should be done during the first 5 days of the menstrual period immediately preceding the beginning of therapy with acitretin. For patients with amenorrhea, the second test should be done at least 11 days after the last act of unprotected sexual intercourse (without using 2 effective forms of contraception [birth control] simultaneously).
• Must have a pregnancy test repeated every month during treatment with acitretin. The patient must have a negative result from a urine or serum pregnancy test before receiving a prescription for acitretin. To encourage compliance with this recommendation, a limited supply of the drug should be prescribed. For at least 3 years after discontinuing therapy with acitretin, a pregnancy test must be repeated every 3 months.
• Must have selected and have committed to use 2 effective forms of contraception (birth control) simultaneously, at least 1 of which must be a primary form, unless absolute abstinence is the chosen method, or the patient has undergone a hysterectomy or is clearly postmenopausal.
• Effective forms of contraception should be used for at least 1 month prior to initiation of therapy with acitretin, during therapy with acitretin, and for at least 3 years after discontinuing therapy with acitretin. An Acitretin Referral Form is available so that patients can receive an initial free contraceptive counseling session and pregnancy testing
• Effective forms of contraception include both primary and secondary forms of contraception. Primary forms of contraception include: tubal ligation, partner's vasectomy, intrauterine devices, birth control pills, and injectable/implantable/ insertable/topical hormonal birth control products. Secondary forms of contraception include latex condoms (with or without spermicide), diaphragms and cervical caps (which must be used with a spermicide).
• It has been established that acitretin interferes with the contraceptive effect of microdosed progestin preparations. 1 Microdosed "minipill" progestin preparations are not recommended for use with acitretin. It is not known whether other progestational contraceptives, such as implants and injectables, are adequate methods of contraception during acitretin therapy.
• Prescribers are advised to consult the package insert of any medication administered concomitantly with hormonal contraceptives, since some medications may decrease the effectiveness of these birth control products. Patients should be prospectively cautioned not to self-medicate with the herbal supplement St. John's wort because a possible interaction has been suggested with hormonal contraceptives based on reports of breakthrough bleeding on oral contraceptives shortly after starting St. John's wort. Pregnancies have been reported by users of combined hormonal contraceptives who also used some form of St. John's wort.
• Must have signed a Patient Agreement/Informed Consent for Female Patients that contains warnings about the risk of potential birth defects if the fetus is exposed to acitretin, about contraceptive failure, about the fact that they must not ingest beverages or products containing ethanol while taking acitretin and for 2 months after acitretin treatment has been discontinued, and about preventing pregnancy while taking acitretin and for at least 3 years after discontinuing acitretin.
• If pregnancy does occur during therapy with acitretin or at any time for at least 3 years following discontinuation of acitretin, the prescriber and patient should discuss the possible effects on the pregnancy.
• Acitretin, the active metabolite of etretinate, is teratogenic and is contraindicated during pregnancy. The risk of severe fetal malformations is well established when systemic retinoids are taken during pregnancy. Pregnancy must also be prevented after stopping acitretin therapy, while the drug is being eliminated to below a threshold blood concentration that would be associated with an increased incidence of birth defects.
• Severe birth defects have been reported where conception occurred during the time interval when the patient was being treated with acitretin and/or etretinate. In addition, severe birth defects have also been reported when conception occurred after the mother completed therapy.
• Females who have taken etretinate- must continue to follow the contraceptive recommendations for etrenitate. Etrenitate is no longer marketed in the U.S.; for information, call 1-888-838-2872.
• Patients should not donate blood during and for at least 3 years following the completion of therapy with acitretin because women of childbearing potential must not receive blood from patients being treated with acitretin.

Dialysis

Data not available

Other Comments

Administration advice:

• This drug should be administered with meals.

• Protect from light
• Exposure to high temperatures and humidity should be avoided after the bottle is opened.

• A medication guide must be given to the patient each time acitretin is dispensed, as required by law.

• Hepatic: Liver function (prior to and during therapy)
• Metabolic: Lipid levels (baseline and every 1 to 2 weeks)
• Neurologic: Signs and symptoms of pseudotumor cerebri
• Women of child-bearing potential: Pregnancy tests prior to starting therapy, during treatment, and every 1 to 3 months for 2 years after therapy discontinuation.