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acitretin
generic
Black Box Warnings .
Appropriate Use
use only by physicians experienced in severe psoriasis diagnosis/tx, systemic retinoid use, and retinoid teratogenicity risk; give Medication Guide w/ every prescription dispensed and ensure women of child-bearing potential meet all requirements of Take Action Against Pregnancy (T.A.P.P.) program
Pregnancy Contraindicated
do not use in female pts who are or may become pregnant during tx or for at least 3y after D/C; exposure may lead to major fetal abnormalities incl. meningomyelocele, meningoencephalocele, mult. synostoses, facial dysmorhpia, syndactyly, absent terminal phalanges, malformations of hip, ankle, and forearm, low-set ears, high palate, decr. cranial volume, cardiovascular malformation, and skull/cervical vertebrae alterations
Women of Child-Bearing Potential
only consider tx in women w/ severe psoriasis unresponsive or not candidate for other tx; prescribe only if pregnancy excluded and pt meets set criteria: 2 initial negative pregnancy tests then negative pregnancy tests qmo during tx and q3mo for >3y after D/C, use of 2 effective forms of contraception (avoid progestin-only forms) 1mo prior to tx start, during tx, and for >3y after D/C, and signed Patient Agreement/Informed Consent for Female Pts; prescriber must counsel pt qmo during tx and q3mo x3y after D/C about contraception and behaviors assoc. w/ incr. pregnancy risk
Avoid Alcohol in Female Pts
avoid alcohol during tx and x2mo after D/C due to formation of etretinate, a teratogen w/ significantly longer half-life than acitretin
Acitretin in Body Fluids
avoid blood donation during tx and >3y after tx to prevent transfusion to women of child-bearing potential; small amt acitretin in seminal fluid poses little if any fetal risk but no-effect limit for teratogenicity unknown
Hepatotoxicity
elevated LFTs and hepatitis reported; D/C tx if hepatotoxicity suspected
Adult Dosing .
Dosage forms: CAP: 10 mg, 17.5 mg, 25 mg
psoriasis, severe
- [25-50 mg PO qd]
- Info: give w/ food
renal dosing
- [see below]
- severe impairment: contraindicated
- HD/PD: not defined
hepatic dosing
- [see below]
- severe impairment: contraindicated
Peds Dosing .
Peds dosing is currently unavailable or not applicable for this drug.