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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 pts of child-bearing potential meet all requirements of manufacturer's acitretin program (see pkg insert for details)
Pregnancy Contraindicated
contraindicated in 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
Pts of Childbearing Potential
only consider tx in pts pf childbearing potential w/ severe psoriasis unresponsive or not candidate for other tx; prescribe only if pregnancy excluded and pt meets set criteria: negative pregnancy tests x2 before tx start, then qmo during tx, and then q3mo for at least 3y after D/C, abstinence or use of 2 effective forms of contraception for at least 1mo before tx start, during tx, and for at least 3y after D/C, and signed Patient Agreement/Informed Consent for Female Pts; 2 forms of effective contraception should incl. at least 1 primary form (tubal ligation, IUD, hormonal, or vasectomy); prescriber must counsel pt qmo during tx and q3mo for at least 3y after D/C about contraception and behaviors assoc. w/ incr. pregnancy risk
Avoid Alcohol in Pts of Childbearing Potential
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 for at least 3y after D/C to prevent transfusion to pts of childbearing potential; minimal acitretin transferred in seminal fluid and likely poses little, if any, fetal risk but no-effect limit for teratogenicity is 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.