(a si TRE tin)
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Soriatane: 10 mg, 17.5 mg, 25 mg [contains edetate calcium disodium]
Generic: 10 mg, 17.5 mg, 25 mg
Brand Names: U.S.
- Retinoid-Like Compound
Binds to and activates all nuclear subtypes (alpha, beta, and gamma) of retinoid X receptors (RXR) and retinoic acid receptors (RAR) to inhibit the expression of the proinflammatory cytokines interleukin-6 (IL-6), migration inhibitory factor-related protein-8 (MRP-8), and interferon-gamma (markers of hyperproliferation and abnormal keratinocyte differentiation). Resulting actions are anti-inflammatory and antiproliferative, and keratinocyte differentiation is normalized in the epithelium.
Oral: ~72% absorbed when given with food
Metabolized to cis-acitretin; both compounds are further metabolized. Concomitant ethanol use leads to the formation of etretinate (active).
Feces (34% to 54%); urine (16% to 53%)
Onset of Action
May take 2 to 3 months for full effect; improvement may be seen within 8 weeks
Time to Peak
Acitretin: 49 hours (range: 33 to 96); cis-acitretin: 63 hours (range: 28 to 157); etretinate: 120 days (range: Up to 168 days)
>99% bound, primarily to albumin
Special Populations: Renal Function Impairment
Plasma concentrations are lower in end-stage renal failure. Acitretin is not removed by dialysis.
Special Populations: Elderly
Higher plasma concentrations are seen; however, no changes occur in the half-life.
Use: Labeled Indications
Psoriasis: Treatment of severe psoriasis in adults.
Limitations of use: Not for the treatment of acne.
Canadian labeling: Additional uses (not in U.S. labeling): Other disorders of keratinization
Hypersensitivity (eg, angioedema, urticaria) to acitretin, other retinoids, or any component of the formulation; patients who are pregnant or intend on becoming pregnant during therapy or within 3 years after treatment discontinuation; severe hepatic or renal dysfunction; chronic abnormally elevated blood lipid levels; concomitant use with methotrexate or tetracyclines
Acitretin is contraindicated in females of childbearing potential unless all of the following conditions apply.
1) Patient has severe psoriasis unresponsive to other therapy or if clinical condition contraindicates other treatments.
2) Patient must have two negative urine or serum pregnancy tests prior to therapy.
3) Patient must have pregnancy test repeated monthly during therapy. After discontinuation of therapy, a pregnancy test must be repeated every 3 months for at least 3 years.
4) Patient must commit to using two effective forms of birth control starting 1 month prior to acitretin treatment and for 3 years after discontinuation. Prescriber must counsel patient about contraception every month during therapy and every 3 months following discontinuation for at least 3 years.
5) Patient is reliable in understanding and carrying out instructions.
6) Patient has received, and acknowledged, understanding of a careful oral and printed explanation of the hazards of fetal exposure to acitretin and the risk of possible contraception failure. Patient must sign an agreement/informed consent document stating that she understands these risks and that she should not consume ethanol during therapy or for 2 months after discontinuation.
Canadian labeling: Additional contraindications (not in U.S. labeling): Breastfeeding; concomitant use with Vitamin A or other retinoids
Psoriasis: Oral: Individualization of dosage is required to achieve maximum therapeutic response while minimizing side effects
Initial: 25 to 50 mg daily, given as a single dose with the main meal
Maintenance: 25 to 50 mg daily may be given after initial response to treatment; the maintenance dose should be based on clinical efficacy and tolerability
American Academy of Dermatology recommendations: 10 to 50 mg daily as a single dose; doses ≤25 mg daily are used to decrease side effects (Menter, 2009)
Initial: 25 mg daily, given as a single dose with the main meal. If response is inadequate after 4 weeks of therapy, the dose may be gradually increased (as tolerated) up to a maximum of 75 mg daily. Reduce dose if necessary to minimize side effects.
Maintenance: 25 to 50 mg daily may be given after initial response to treatment; the maintenance dose should be based on clinical efficacy and tolerability. Maximum: 75 mg daily
Other keratinization disorders: Adults: Oral: 10 to 50 mg daily; maximum: 50 mg daily
Refer to adult dosing.
Dosing: Renal Impairment
There are no dosage adjustments provided in manufacturer's labeling; use is contraindicated in patients with severely impaired renal function.
Hemodialysis: Not removed by hemodialysis
Dosing: Hepatic Impairment
There are no dosage adjustments provided in manufacturer’s labeling; use is contraindicated in patients with severely impaired liver function.
Administer with food, preferably with the main meal of the day.
Take with food. Avoid ingestion of additional sources of exogenous vitamin A (in excess of RDA); use of ethanol and ethanol-containing products is contraindicated.
Store between 15°C to 25°C (59°F to 77°F). Avoid high temperatures and humidity. Protect from light.
Alcohol (Ethyl): May enhance the teratogenic effect of Acitretin. Avoid combination
Aminolevulinic Acid: Photosensitizing Agents may enhance the photosensitizing effect of Aminolevulinic Acid. Monitor therapy
Contraceptives (Estrogens): Retinoic Acid Derivatives may diminish the therapeutic effect of Contraceptives (Estrogens). Two forms of contraception are recommended in females of child-bearing potential during retinoic acid derivative therapy. Monitor therapy
Contraceptives (Progestins): Acitretin may diminish the therapeutic effect of Contraceptives (Progestins). Contraceptive failure is possible. Management: Given the potential for progestin-only preparations to fail to prevent pregnancy during acitretin therapy, such products should not be relied upon. Alternative, nonhormonal forms of contraception must be employed during acitretin therapy. Consider therapy modification
Methotrexate: Acitretin may enhance the hepatotoxic effect of Methotrexate. Avoid combination
Multivitamins/Fluoride (with ADE): May enhance the adverse/toxic effect of Retinoic Acid Derivatives. Avoid combination
Multivitamins/Minerals (with ADEK, Folate, Iron): May enhance the adverse/toxic effect of Retinoic Acid Derivatives. Avoid combination
Multivitamins/Minerals (with AE, No Iron): May enhance the adverse/toxic effect of Retinoic Acid Derivatives. Avoid combination
Porfimer: Photosensitizing Agents may enhance the photosensitizing effect of Porfimer. Monitor therapy
Tetracycline Derivatives: May enhance the adverse/toxic effect of Retinoic Acid Derivatives. The development of pseudotumor cerebri is of particular concern. Avoid combination
Verteporfin: Photosensitizing Agents may enhance the photosensitizing effect of Verteporfin. Monitor therapy
Vitamin A: May enhance the adverse/toxic effect of Retinoic Acid Derivatives. Avoid combination
Central nervous system: Hyperesthesia (10% to 25%), paresthesia (10% to 25%), rigors (10% to 25%)
Dermatologic: Cheilitis (>75%), alopecia (50% to 75%), exfoliation of skin (50% to 75%), xeroderma (25% to 50%), nail disease (25% to 50%), pruritus (25% to 50%), erythematous rash (10% to 25%), paronychia (10% to 25%), skin atrophy (10% to 25%), acquired cutaneous adherence (10% to 25%)
Endocrine & metabolic: Hypertriglyceridemia (50% to 75%), increased serum glucose (fasting; 25% to 50%), decreased HDL cholesterol (25% to 50%), hypercholesterolemia (25% to 50%), acetonuria (10% to 25%), decreased serum glucose (fasting; 10% to 25%), decreased serum magnesium (10% to 25%), hypermagnesemia (10% to 25%), hyperphospheremia (10% to 25%), increased gamma-glutamyl transferase (10% to 25%), increased serum potassium (10% to 25%), increased serum sodium (10% to 25%), increased uric acid (10% to 25%)
Gastrointestinal: Xerostomia (10% to 25%)
Genitourinary: Erythrocyturia (10% to 25%), hematuria (10% to 25%)
Hematologic & oncologic: Leukocyturia (25% to 50%), reticulocytosis (25% to 50%), increased haptoglobin (10% to 25%), decreased hematocrit (10% to 25%), decreased hemoglobin (10% to 25%), increased neutrophils (10% to 25%), change in WBC count (10% to 25%)
Hepatic: Increased liver enzymes (25% to 50%), increased serum alkaline phosphatase (10% to 25%), increased direct serum bilirubin (10% to 25%)
Neuromuscular & skeletal: Increased creatine phosphokinase (25% to 50%), arthralgia (10% to 25%), spinal hyperostosis (progression; 10% to 25%)
Ophthalmic: Xerophthalmia (10% to 25%)
Respiratory: Rhinitis (25% to 50%), epistaxis (10% to 25%)
1% to 10%:
Cardiovascular: Edema, flushing
Central nervous system: Bell's palsy, depression, drowsiness, fatigue, headache, hypertonia, insomnia, pain
Dermatologic: Abnormal hair texture, abnormal skin odor, Bullous skin disease, cold and clammy skin, dermatitis, diaphoresis (increased), madarosis, psoriasiform eruption, pyogenic granuloma, seborrhea, skin fissure, skin rash, sunburn
Endocrine & metabolic: Decreased haptoglobins, decreased serum albumin, decreased serum calcium, decreased serum iron, decreased serum potassium, decreased serum sodium, diaphoresis (increased), glycosuria, hot flash, hyperchloremia, hypochloremia, hypophosphatemia, increased serum albumin, increased serum calcium, increased serum iron, increased thirst
Gastrointestinal: Abdominal pain, anorexia, aphthous stomatitis, diarrhea, dysgeusia, gingival hemorrhage, gingivitis, increased appetite, nausea, sialorrhea, stomatitis, tongue disease
Hematologic & oncologic: Change in RBC count, decreased neutrophils, increased hematocrit, increased hemoglobin, reticulocytopenia, purpura
Hepatic: Increased serum bilirubin
Neuromuscular & skeletal: Arthritis, back pain, myalgia, ostealgia, osteoarthritis, peripheral joint hyperostosis
Ophthalmic: Blepharitis, blurred vision, cataract, conjunctivitis, diplopia, epithelial keratopathy, eye pain, nocturnal amblyopia, photophobia
Otic: Otalgia, tinnitus
Renal: Increased blood urea nitrogen, increased serum creatinine
<1% (Limited to important or life-threatening): Abnormal gait, abnormal lacrimation, acne vulgaris, ageusia, aggressive behavior, alcohol intolerance, anal disease, bone disease, bursitis (olecranon), candidiasis, capillary leak syndrome, cerebrovascular accident, chalazion, conjunctival hemorrhage, constipation, corneal lesion, corneal ulcer, cutaneous nodule, cyanosis, cyst, deafness, decreased libido, dyspepsia, dysuria, ectropion, epidermal thinning, exfoliative dermatitis, flu-like symptoms, fungal infection, furunculosis, gastritis, gingival hyperplasia, glossitis, hair discoloration, hepatic cirrhosis, hepatic dysfunction, hepatitis, herpes simplex infection, hordeolum (recurrent), hyperkeratosis, hypersensitivity reaction, hypertrichosis, hypoesthesia, increased bronchial secretions, increased cerumen production, intermittent claudication, laryngitis, leukorrhea, mastalgia, melena, migraine, myasthenia, myocardial infarction, myopathy (with peripheral neuropathy), nail disease (fragility), neuritis, otitis media, pancreatitis, papilledema, peripheral ischemia, pharyngitis, prolonged bleeding time, pseudotumor cerebri, skin hypertrophy, skin photosensitivity, spinal hyperostosis (new lesion), suicidal ideation, tendonitis, tenesmus, thromboembolism, tongue ulcer, vaginitis, voice disorder, warts, weight gain, wound healing impairment
Concerns related to adverse effects:
• Capillary leak syndrome: Capillary leak syndrome, a potential manifestation of retinoic acid syndrome (differentiation syndrome) has been reported with acitretin use. Capillary leak syndrome features may include localized or generalized edema with secondary weight gain, fever, and hypotension; rhabdomyolysis and myalgias have also been reported. Laboratory tests may show neutrophilia, hypoalbuminemia, and an elevated hematocrit. Discontinue use if capillary leak syndrome develops during therapy.
• Depression: Depression, including aggressive behavior and thoughts of self-harm have been reported; use with caution in patients with a history of mental illness.
• Exfoliative dermatitis: Exfoliative dermatitis has been reported with acitretin use; discontinue use if exfoliative dermatitis occurs during therapy.
• Hepatotoxicity: [US Boxed Warnings]: Hepatitis has been reported (including fatalities); some patients received etretinate for ≤1 month before presenting with hepatic signs or symptoms. Changes in transaminases have occurred in up to 1/3 of patients, which generally returned to normal after discontinuation of treatment. Monitor for hepatotoxicity; discontinue if hepatotoxicity is suspected.
• Lipid effects: Lipid changes, including increased triglycerides, increased cholesterol, and decreased HDL, are common (up to 66%), which were reversible upon discontinuation of treatment; increased triglycerides may lead to pancreatitis. Fatal fulminant pancreatitis has been reported. Use with caution in patients at risk of hypertriglyceridemia (eg, patients with lipid metabolism disturbances, diabetes mellitus, obesity, increased alcohol intake, or a familial history of these conditions). Consider discontinuation if hypertriglyceridemia and decreased HDL persist. Use is contraindicated in patients with chronic abnormally elevated blood lipid values.
• Otic effects: Tinnitus and impaired hearing have been reported with use; consider therapy discontinuation and further evaluation if clinically indicated.
• Photosensitivity: May be photosensitizing; minimize sun or other UV exposure to treated areas. The risk of burning is increased with phototherapy; decreased doses are required.
• Pseudotumor cerebri: Retinoids, including acitretin, have been associated with pseudotumor cerebri (benign intracranial hypertension). Concurrent use of other drugs associated with this effect (eg, tetracyclines) may increase risk. Early signs and symptoms include papilledema, headache, nausea, vomiting, and visual disturbances. Discontinue use in patients experiencing papilledema.
• Skeletal abnormalities: Patients receiving long-term treatment should be periodically examined for bony abnormalities; risk vs benefit of therapy should be considered if abnormalities occur.
• Visual disturbances: May cause adverse effects to the eyes and vision, including a decrease in night vision or decreased tolerance to contact lenses. Use caution when operating vehicles at night; discontinue if visual changes occur.
• Diabetes: Impaired glucose control has been reported with retinoid use. Use with caution in patients with diabetes mellitus; new cases of diabetes have been diagnosed.
Concurrent drug therapy issues:
• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.
• Ethanol use: [US Boxed Warning]: Female patients should abstain from ethanol or ethanol-containing products during therapy and for 2 months after discontinuation.
• Females: [US Boxed Warning]: Females of childbearing potential must be able to fulfill all conditions for use prior to initiating therapy, including a Patient Agreement/Informed Consent (consult manufacturer's labeling for further detail). Prescriptions should be written for a monthly supply. The Do Your P.A.R.T. (Pregnancy Prevention Actively Required During and After Treatment) program explains teratogenic risks and requirements expected of females of childbearing potential to prevent pregnancies from occurring during use and 3 years following discontinuation; this should be used to educate patients and healthcare providers. Information for the Do Your P.A.R.T. program is available at www.soriatane.com/doyour-part-Program.html or by calling 1-888-784-3335.
• Pediatric: Growth potential may be affected. Long-term use of high-dose oral retinoids within this population has been associated with decreased bone mineral density, skeletal hyperostosis, and ossification of interosseous tendons and ligaments of the extremities (Menter, 2009).
• Pregnancy: [US Boxed Warning]: Acitretin is a known teratogen and contraindicated in females who are or may become pregnant. Birth defects (including facial, ear, central nervous system, cardiovascular, limb, bone, and joint) have been noted following acitretin exposure during pregnancy. Use only in women with severe psoriasis that is unresponsive to other therapies or with contraindications to the use of alternative treatments. Pregnancy must be avoided for at least 3 years after treatment discontinuation. Two reliable forms of contraception must be used simultaneously for 1 month prior to initiating therapy, during therapy, and for 3 years after discontinuation. Two negative pregnancy tests (sensitivity at least 25 milliunits/mL) are required prior to initiating therapy; pregnancy tests must be repeated every month during treatment. In addition, because ethanol forms a teratogenic metabolite and would increase the duration of teratogenic potential, ethanol should not be consumed during treatment or for 2 months after discontinuation. Any pregnancy which occurs during treatment, or within 3 years after treatment is discontinued, should be reported to the manufacturer at 1-888-784-3335 or to the FDA at 1-800-FDA-1088.
• Blood donation: [US Boxed Warning]: All patients should be advised not to donate blood during therapy or for 3 years following completion of therapy.
• Experienced physician: [US Boxed Warning]: Only physicians experienced with the diagnosis and treatment of severe psoriasis, including the use of retinoid treatment, and physicians who understand the risk of teratogenicity should prescribe acitretin.
• Medication guide: [US Boxed Warning]: All patients must be provided with a medication guide each time acitretin is dispensed. Female patients must also sign an informed consent prior to therapy.
• Subsequent use: Most patients experience relapse of psoriasis after discontinuing therapy. Subsequent courses, when clinically indicated, have produced results similar to the initial course of therapy.
• Worsening of disease: Transient worsening of psoriasis may initially occur; patients should be advised that it may take 2-3 months to achieve the full benefits of treatment.
Lipid profile (baseline and at 1- to 2-week intervals for 4 to 8 weeks, then as clinically indicated); liver function tests (baseline, and at 1- to 2-week intervals until stable, then as clinically indicated); blood glucose in patients with diabetes; evaluate for bone abnormalities (with long-term use); pregnancy tests (2 negative tests prior to therapy initiation, monthly during treatment, and every 3 months for ≥3 years after discontinuation of therapy)
The American Academy of Dermatology recommends: CBC and renal function tests (baseline and then every 12 weeks); liver function tests (every 2 weeks for the first 8 weeks, then every 6 to 12 weeks thereafter) (Menter, 2009)
Pregnancy Risk Factor
[US Boxed Warning]: Acitretin is a known teratogen and use is contraindicated in females who are or may become pregnant. Birth defects (including facial, ear, central nervous system, cardiovascular, limb, bone, and joint) have been noted following acitretin exposure during pregnancy. Use only in women with severe psoriasis that is unresponsive to other therapies or with contraindications to the use of alternative treatments. Pregnancy must be avoided for at least 3 years after treatment discontinuation. Two reliable forms of contraception must be used simultaneously for 1 month prior to initiating therapy, during therapy, and for 3 years after discontinuation. Two negative pregnancy tests (sensitivity at least 25 milliunits/mL) are required prior to initiating therapy; pregnancy tests must be repeated every month during treatment. In addition, because ethanol forms a teratogenic metabolite and would increase the duration of teratogenic potential, ethanol should not be consumed during treatment or for 2 months after discontinuation.
Only physicians experienced with the diagnosis and treatment of severe psoriasis, including the use of retinoid treatment, and physicians who understand the risk of teratogenicity should prescribe acitretin. Females of childbearing potential must be able to fulfill all conditions for use prior to initiating therapy, including a Patient Agreement/Informed Consent (consult manufacturer's labeling for further detail). Prescriptions should be written for a monthly supply. The Do Your P.A.R.T. (Pregnancy Prevention Actively Required During and After Treatment) program explains teratogenic risks and requirements expected of females of childbearing potential to prevent pregnancies from occurring during use and 3 years following discontinuation; this should be used to educate patients and healthcare providers. Information for the Do Your P.A.R.T. program is available at www.soriatane.com/doyour-part-Program.html or by calling 1-888-784-3335.
Limited amounts of acitretin are found in seminal fluid; although it appears this poses little risk to a fetus, the actual risk of teratogenicity is not known.
Any pregnancy which occurs during treatment, or within 3 years after treatment is discontinued, should be reported to the manufacturer at 1-888-784-3335 or to the FDA at 1-800-FDA-1088.
• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)
• Patient may experience rhinorrhea, nail changes, dry mouth, dry lips, dry eyes, itching, or hair loss. Have patient report immediately to prescriber signs of liver problems (dark urine, fatigue, lack of appetite, nausea, abdominal pain, light-colored stools, vomiting, or jaundice), signs of capillary leak syndrome (abnormal heartbeat; angina; shortness of breath; weight gain; vomiting blood or vomit that looks like coffee grounds; black, tarry, or bloody stools; urinary retention or change in amount of urine passed; or hematuria), signs of depression (suicidal ideation, anxiety, emotional instability, or confusion), signs of high blood sugar (confusion, fatigue, increased thirst, hunger, polyuria, flushing, fast breathing, or breath that smells like fruit), signs of severe cerebrovascular disease (change in strength on one side is greater than the other, trouble speaking or thinking, change in balance, or change in eyesight), signs of DVT (edema, warmth, numbness, change in color, or pain in the extremities), signs of pancreatitis (severe abdominal pain, severe back pain, severe nausea, or vomiting), anger, behavioral changes, angina, severe dizziness, passing out, severe headache, nausea, vomiting, seizures, burning or numbness feeling, severe muscle pain, severe muscle weakness, bone pain, joint pain, vision changes, eye pain, severe eye irritation, contact lens discomfort, hearing impairment, tinnitus, edema, weight gain, severe diarrhea, rectal bleeding, rectal pain, poor night vision, or signs of Stevens-Johnson syndrome/toxic epidermal necrolysis (red, swollen, blistered, or peeling skin [with or without fever]; red or irritated eyes; or sores in mouth, throat, nose, or eyes) (HCAHPS).
• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.
Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.
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Other brands: Soriatane