Black Box Warnings .
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
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
elevated LFTs and hepatitis reported; D/C tx if hepatotoxicity suspected
Adult Dosing .
Dosage forms: 10,17.5,25
- [25-50 mg PO qd]
- Info: give w/ food
- [see below]
- severe impairment: contraindicated
- [see below]
- severe impairment: contraindicated
Peds Dosing .
Peds dosing is currently unavailable or not applicable for this drug.
- hypersens. to drug/class/compon.
- renal impairment, severe
- hepatic impairment, severe
- elevated lipid levels, chronic
- blood donation during tx and for >3y after D/C
- avoid alcohol use during tx and x2mo after D/C (female pts of childbearing potential)
- caution if alcohol abuse
- caution if diabetes mellitus
- caution if diabetes mellitus family hx
- caution if defective lipid metabolism
- caution if defective lipid metabolism family hx
- caution if obesity
- caution if obesity family hx
- caution if depression
- caution if psychiatric disorder
- caution if phototherapy
Drug Interactions .
- photodynamic therapy
- desogestrel (contraceptive)
- dienogest (contraceptive)
- drospirenone (contraceptive)
- ethynodiol (contraceptive)
- etonogestrel (contraceptive)
- levonorgestrel (contraceptive)
- medroxyprogesterone (contraceptive)
- norelgestromin (contraceptive)
- norethindrone (contraceptive)
- norgestimate (contraceptive)
- norgestrel (contraceptive)
- vitamin A
- estradiol (contraceptive)
- ethinyl estradiol (contraceptive)
- mestranol (contraceptive)
- black cohosh
- methoxsalen topical
Adverse Reactions .
- hypersensitivity rxn
- exfoliative dermatitis
- capillary leak syndrome
- skeletal hyperostosis
- pseudotumor cerebri
- hypervitaminosis A syndrome
- acute MI
- aggressive behavior
- suicidal ideation
- severe birth defects
- triglycerides incr.
- HDL-C decr.
- cholesterol incr.
- nail changes
- spinal hyperostosis progression
- skin atrophy
- sticky skin
- ocular irritation
- night vision decr.
- others: see pkg insert
Lactation: Possibly Unsafe
use 2 forms effective contraception (avoid progestin-only forms) 1mo prior to tx start, during tx, and for >3y after D/C in women of childbearing potential
Cr at baseline; LFTs at baseline, then q1-2wk until stable, then as clinically indicated; fasting lipid panel at baseline, then q1-2wk until stable (usually x4-8wk), then cont. periodically if long-term tx or high risk pt; urine or serum pregnancy test x2 at baseline, see pkg insert for timing, qmo during tx, then q3mo for >3y after D/C; glucose if diabetes; radiography periodically if long-term tx
Metabolism: isomerization extensively; CYP450: unknown; Info: active metabolites
Excretion: feces 34-54%, urine 16-53%; Half-life: 49h (parent drug), 63h (active metabolite)
Subclass: Psoriasis, Systemic
Mechanism of Action
exact mechanism of action unknown; activates retinoid receptors, normalizing skin cell growth cycle (retinoid)
Approximate Retail Price
This information is currently not available for this drug.
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