Alitretinoin (Systemic)

(a li TRET i noyn)

• 9-cis-Retinoic Acid
• 9-cis-Tretinoin

Use is contraindicated.

Consider dose reduction to 10 mg once daily for intolerable side effects.

Administer once daily with a main meal, preferably at the same time each day.

[Canadian Boxed Warning]: Alitretinoin is a known teratogen and is contraindicated in pregnancy. Females must avoid becoming pregnant while receiving alitretinoin and for at least 1 month after discontinuation of therapy. Discontinue immediately if pregnancy is discovered during treatment or within 1 month after discontinuation. Fetal abnormalities and spontaneous abortion may occur. The risk for severe birth defects is high, with any dose or even with short treatment duration. If treatment with alitretinoin is required in women of childbearing potential, two effective and reliable forms of birth control should be used simultaneously for at least 1 month prior to starting therapy, during therapy, and for at least 1 month after treatment. Two negative pregnancy tests (sensitivity at least 25 milliunits/mL) and onset of next menses for 2 or 3 days are required prior to initiating therapy. Patients should be advised of the potential harm to the fetus and the physician and patient should discuss the desire to maintain the pregnancy.

Only physicians familiar with systemic retinoid therapy should prescribe alitretinoin. Females of childbearing potential must be able to fulfill all conditions for use prior to initiating therapy (consult manufacturer labeling for further detail). Physicians are required to use the Toctino Pregnancy Prevention Program, which includes comprehensive information regarding conditions that must be met prior to initiating therapy, birth control options, potential risks of therapy, informed consent, and monthly pregnancy reminders. Even women with amenorrhea, a history of infertility, or those who claim an absence of sexual activity must comply with these conditions.

Small amounts of alitretinoin have been detected in the semen of some healthy male volunteers, although accumulation in the semen is not anticipated. Systemic exposure of female partners or fetus is expected to be negligible. The manufacturer labeling suggests that there is no apparent fetal risk in pregnant females whose male partners are receiving alitretinoin.