Dosing and uses of Soriatane (acitretin)
Adult dosage forms and strengths
capsule
- 10mg
- 25mg
Psoriasis
25-50 mg PO qDay
Other Indications & Uses
Off-label: Darier's disease, palmoplantar pustulosis, lichen planus, Sjogren-Larsson syndrome
Pediatric dosage forms and strengths
Safety and efficacy not established
Soriatane (acitretin) adverse (side) effects
>10%
Cheilitis (>75%)
Alopecia (50-75%)
Hypertriglyceridemia (50-75%)
Skin peeling (50-75%)
Dry skin (25-50%)
Dysglycemia (25-50%)
Increased LFT (25-50%)
Nail disorder (25-50%)
Pruritus (25-50%)
Rhinitis (25-50%)
arthralgia (10-25%)
changes in phosphorus, potassium, sodium, & magnesium levels (10-25%)
Dry mouth (10-25%)
Epistaxis (10-25%)
Erythematous rash (10-25%)
Hepatotoxicity (10-25%)
Hyperesthesia (10-25%)
Paresthesia (10-25%)
Paronychia (10-25%)
Rigors (10-25%)
Skin atrophy (10-25%)
Spinal hyperostosis (10-25%)
Sticky skin (10-25%)
Xerophthalmia (10-25%)
1-10%
Edema
Flushing
Depression
Fatigue
Headache
Insomnia
Somnolence
Abdominal pain
Anorexia
Diarrhea
Gingivitis
Increased appetite
Nausea
Stomatitis
Vomiting
Hot flashes
Vision changes
Corneal epithelial abnormality
Sinusitis
Warnings
Black box warnings
Elevated liver enzymes and hepatitis-related deaths reported
Use only for severe psoriasis in women who are unresponsive or have contraindications to other therapy
Should be prescribed by those who understand risk of teratogenic effects and those who are competent in the diagnosis and treatment of severe psoriasis and use of systemic retinoids
Teratogenic agent; do not use in females who are pregnant, who intend to become pregnant during therapy or within 3 years after discontinuation of therapy, or who may not use reliable contraception during this time period
Alcohol is contraindicated during treatment with acitretin and for 2 months after stopping therapy as ethanol promotes the formation of etretinate, which has prolonged half-life and teratogenic risk
Females with childbearing potential must participate in Do Your P.A.R.T. program and have signed Patient Agreement/Informed Consent for Female Patients
Do not use St. John’s wort due to the effect of decreased birth control effectiveness and potential breakthrough bleeding
If pregnancy occurs during therapy or 3 yr after discontinuation, prescribers should discuss possible risks for the pregnancy
Patients should not donate blood during therapy and 3 yr after discontinuation because women with childbearing potential should not receive blood from treated patients
Males have shown residual amounts of acitretin in seminal fluid, which appears to pose little risk to the fetus, but data are limited
Requirements for use in women of childbearing potentiaL
- Use is contraindicated in females with childbearing potential unless patient meets ALL of the following conditions:
- 1) 2 negative urine or serum pregnancy test results (baseline and 1st 5 days of menses immediately before initiating therapy)
- 2) Repeated urine or serum pregnancy test monthly during therapy and q3mth during the 3 yr following discontinuation of therapy
- 3) Committed to use 2 (at least one should be primary) effective forms of contraception simultaneously unless the patient is abstinent, postmenopausal, or has undergone a hysterectomy
- 4) Use 2 effective forms of contraception simultaneously for at least 1 month prior to therapy, during therapy, and for 3 yr after discontinuing therapy
- 5) Microdosed “minipill” progestin preparations are not recommended because acitretin interferes with contraception effect and it is unknown whether other progestin contraceptives are adequate contraceptive methods during acitretin therapy
Contraindications
Hypersensitivity to retinoids (eg, angioedema, urticaria), parabens
Coadministration with methotrexate (increased risk for hepatitis)
Coadministration with tetracyclines (increases ICP, pseudotumor cerebri)
Alcohol (see Black box warnings)
Severely impairment of liver or kidney function and in patients with chronic abnormally elevated blood lipid values (see Black box warnings)
Pregnancy: teratogenic (see Black box warnings)
Cautions
Check LFTs 1 day before starting, pregnancy test 2 wk prior to starting therapy
Hyperostosis reported with long-term treatment
New or progression of preexisting vertebral/skeletal abnormalities (eg, degenerative spurs, anterior bridging of spinal vertebrae, diffuse idiopathic skeletal hyperostosis, ligament calcification, and narrowing and destruction of a cervical disc space)
Elevated triglycerides and cholesterol reported; monitor for resulting cardiovascular conditions and pancreatitis
Ophthalmic conditions, including dry eyes, irritation, and brow/lash loss reported
Pseudotumor cerebri reported
May cause capillary leak syndrome
Exfoliative dermatitis and erythroderma reported
Pregnancy and lactation
Pregnancy category: X
Major human fetal abnormalities have been reported including meningomyelocele, meningoencephalocele, multiple synostoses, facial dysmorphia, syndactyly, absence of terminal phalanges, malformations of bones (hip, ankle, forearm, skull, cerebral vertebrae), low-set ears, high palate, decreased cranial volume, and cardiovascular malformations
Lactation: enters breast milk/not recommended
Pregnancy categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
Pharmacology of Soriatane (acitretin)
Mechanism of action
Retinoic acid analog
Pharmacokinetics
Half-Life: 49 hr
Peak Plasma Time: 2-5 hr
Protein Bound: >99.9% (primarily albumin)
Excretion: 34-54% feces; 16-53% urine
