Acitretin

Name: Acitretin

How should this medicine be used?

Acitretin comes as a capsule to take by mouth. It is usually taken once a day with the main meal. Take acitretin at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take acitretin exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Your doctor may start you on a low dose of acitretin and gradually increase your dose.

Acitretin controls psoriasis but does not cure it. It may take 2–3 months or longer before you feel the full benefit of acitretin. Your psoriasis may get worse during the first few months of treatment. This does not mean that acitretin will not work for you, but tell your doctor if this happens. Continue to take acitretin even if you feel well. Do not stop taking acitretin without talking to your doctor.

After you stop taking acitretin, your symptoms may come back. Tell your doctor if this happens. Do not use leftover acitretin to treat a new flare-up of psoriasis. A different medication or dose may be needed.

What special precautions should I follow?

Before taking acitretin,

  • tell your doctor and pharmacist if you have had a serious allergic reaction (difficulty breathing or swallowing, hives, itching, or swelling of the face, throat, tongue, lips, or eyes) to acitretin, other retinoids such as adapalene (Differen, in Epiduo), alitretinoin (Panretin), isotretinoin (Absorica, Accutane, Amnesteem, Claravis, Myorisan, Sotret, Zenatane), tazarotene (Avage, Fabior, Tazorac), tretinoin (Atralin, Avita, Renova, Retin-A), or any of the ingredients in acitretin capsules. Your doctor will probably tell you not to use acitretin. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
  • tell your doctor if you are taking any of the following medications: methotrexate (Trexall) or tetracycline antibiotics such as demeclocycline, doxycycline (Doryx, Monodox, Oracea, Periostat, Vibramycin), minocycline (Dynacin, Minocin, Solodyn), and tetracycline (Sumycin, in Helidac, in Pylera) while taking acitretin. Your doctor will probably tell you not to take acitretin if you are taking one or more of these medications.
  • tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking. Be sure to mention the medications and herbs listed in the IMPORTANT WARNING section and any of the following: glyburide (Diabeta, Glynase, in Glucovance), phenytoin (Dilantin, Phenytek), and vitamin A (in multivitamins). Also tell your doctor if you have ever taken etretinate (Tegison). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
  • tell your doctor if you have or have ever had the conditions mentioned in the IMPORTANT WARNING section and if you have high cholesterol or triglyceride levels, a family history of high cholesterol levels, or kidney disease. Your doctor may tell you that you should not take acitretin.
  • tell your doctor if you drink large amounts of alcohol; if you have diabetes or high blood sugar, spinal problems, depression, or stroke or mini-stroke; or if you have or have ever had joint, bone, or heart disease.
  • do not breast-feed while taking acitretin or if you have recently stopped taking acitretin.
  • you should know that acitretin may limit your ability to see at night. This problem may begin suddenly at any time during your treatment. Be very careful when driving at night.
  • plan to avoid unnecessary or prolonged exposure to sunlight and to wear protective clothing, sunglasses, and sunscreen. Do not use sunlamps while taking acitretin. Acitretin may make your skin sensitive to sunlight.
  • if you need to have phototherapy, tell your doctor that you are taking acitretin.
  • you should know that acitretin may dry your eyes and make wearing contact lenses uncomfortable during or after treatment. Remove your contact lenses and call your doctor if this happens.

What side effects can this medication cause?

Acitretin may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

  • peeling, dry, itchy, scaling, cracked, blistered, sticky or infected skin
  • brittle or weak fingernails and toenails
  • dandruff
  • sunburn
  • abnormal skin odor
  • excessive sweating
  • hair loss
  • changes in hair texture
  • dry eyes
  • loss of eyebrows or eyelashes
  • hot flashes or flushing
  • chapped or swollen lips
  • swollen or bleeding gums
  • excessive saliva
  • tongue pain, swelling, or blistering
  • mouth swelling or blisters
  • stomach pain
  • diarrhea
  • increased appetite
  • difficulty falling or staying asleep
  • sinus infection
  • runny nose
  • dry nose
  • nosebleed
  • joint pain
  • tight muscles
  • changes in taste

Some side effects can be serious. The following symptoms are uncommon, but if you experience any of them or those listed in the IMPORTANT WARNING section, call your doctor immediately:

  • rash
  • headache
  • extreme thirst, frequent urination, extreme hunger, blurred vision, or weakness
  • dry mouth, nausea and vomiting, shortness of breath, breath that smells fruity, and decreased consciousness
  • pain, swelling, or redness of eyes or eyelids
  • eye pain
  • eyes sensitive to light
  • swelling of hands, feet, ankles, or lower legs
  • redness or swelling in one leg only
  • depression
  • thoughts of hurting or killing yourself
  • bone, muscle, or back pain
  • difficulty moving any part of your body
  • loss of feeling in hands or feet
  • chest pain
  • slow or difficult speech
  • tingling in arms and legs
  • loss of muscle tone
  • weakness or heaviness in legs
  • cold, gray, or pale skin
  • slow or irregular heartbeat
  • dizziness
  • fast heartbeat
  • weakness
  • shortness of breath
  • ear pain or ringing

Acitretin may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about storage and disposal of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Brand names

  • Soriatane®

What should I avoid while taking acitretin?

Women taking acitretin must not drink alcohol during treatment and for at least 2 months after treatment ends. Alcohol can cause acitretin to convert to another substance in your body that can take 3 years or longer to clear from your body. Read the labels of all foods and medicines you consume to make sure they do not contain alcohol.

Do not donate blood while taking acitretin and for at least 3 years after you stop taking it. Donated blood may be given to a pregnant woman and could cause birth defects if the blood contains acitretin.

Avoid taking vitamin supplements that contain vitamin A. Acitretin is a form of vitamin A, and taking too much can cause side effects similar to overdose symptoms.

Avoid exposure to sunlight or tanning beds. Acitretin can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Acitretin may impair your vision, especially at night. Be careful if you drive or do anything that requires you to see clearly.

Uses for Acitretin

Psoriasis

Symptomatic management of severe psoriasis.1 23

Not indicated as a first-line antipsoriatic therapy in women of childbearing potential; should be used only in nonpregnant patients with severe psoriasis that is refractory to alternative therapies or in whom other therapies are contraindicated.1 23 (See Teratogenicity in Boxed Warning.)

Relapse may occur when acitretin is discontinued; if clinically indicated, repeat courses of the drug may be used since clinical efficacy in relapse has been similar to that of the initial course.1

Discoid Lupus Erythematosus

Has been used in a limited number of patients for the management of discoid lupus erythematosus†; efficacy was similar to that of hydroxychloroquine, but adverse effects were more severe and frequent with acitretin.20 21 Further study is needed to establish the role of acitretin in treating this condition.20

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

Acitretin

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Capsules

10 mg

Soriatane

Stiefel

17 mg

Soriatane

Stiefel

22.5 mg

Soriatane

Stiefel

25 mg

Soriatane

Stiefel

What do I need to tell my doctor BEFORE I take Acitretin?

  • If you have an allergy to acitretin or any other part of this medicine.
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If you have any of these health problems: High cholesterol, kidney disease, or liver disease.
  • If you are taking any of these drugs: Demeclocycline, doxycycline, minocycline, tetracycline, a product that has vitamin A in it, a product that is like vitamin A, or St. John's wort.
  • If you are taking methotrexate.
  • If you are breast-feeding. Do not breast-feed while you take acitretin. You will also need to avoid breast-feeding after you stop this medicine until there is no more of acitretin in your body. Talk with your doctor to see how long you need to avoid breast-feeding after you stop this drug.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take acitretin with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

How do I store and/or throw out Acitretin?

  • Store at room temperature.
  • Protect from light.
  • Protect from heat.
  • Store in a dry place. Do not store in a bathroom.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Check with your pharmacist about how to throw out unused drugs.

Pronunciation

(a si TRE tin)

Brand Names U.S.

  • Soriatane

Warnings/Precautions

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.

Disease-related concerns:

• 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.

Special populations:

• 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.

Other warnings/precautions:

• 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.

What should i avoid while taking acitretin (soriatane)?

Women taking acitretin must not drink alcohol during treatment and for at least 2 months after treatment ends. Alcohol can cause acitretin to convert to another substance in your body that can take 3 years or longer to clear from your body. Read the labels of all foods and medicines you consume to make sure they do not contain alcohol.

Do not donate blood while taking acitretin and for at least 3 years after you stop taking it. Donated blood may be given to a pregnant woman and could cause birth defects if the blood contains acitretin.

Avoid taking vitamin supplements that contain vitamin A. Acitretin is a form of vitamin A, and taking too much can cause side effects similar to overdose symptoms.

Avoid exposure to sunlight or tanning beds. Acitretin can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Acitretin may impair your vision, especially at night. Be careful if you drive or do anything that requires you to see clearly.

Side effects

Hypervitaminosis A produces a wide spectrum of signs and symptoms primarily of the mucocutaneous, musculoskeletal, hepatic, neuropsychiatric, and central nervous systems. Many of the clinical adverse reactions reported to date with administration of SORIATANE resemble those of the hypervitaminosis A syndrome.

Adverse Events/Postmarketing Reports

In addition to the events listed in the tables for the clinical trials, the following adverse events have been identified during postapproval use of SORIATANE. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Cardiovascular

Acute myocardial infarction, thromboembolism (see WARNINGS), stroke.

Immune System Disorders

Hypersensitivity, including angioedema and urticaria (see CONTRAINDICATIONS).

Nervous System

Myopathy with peripheral neuropathy has been reported during therapy with SORIATANE. Both conditions improved with discontinuation of the drug.

Psychiatric

Aggressive feelings and/or suicidal thoughts have been reported. These events, including self-injurious behavior, have been reported in patients taking other systemically administered retinoids, as well as in patients taking SORIATANE. Since other factors may have contributed to these events, it is not known if they are related to SORIATANE (see PRECAUTIONS).

Reproductive

Vulvo-vaginitis due to Candida albicans.

Skin and Appendages

Thinning of the skin, skin fragility, and scaling may occur all over the body, particularly on the palms and soles; nail fragility is frequently observed. Madarosis and exfoliative dermatitis/erythroderma have been reported (see WARNINGS).

Vascular Disorders

Capillary leak syndrome (see WARNINGS).

Clinical Trials

During clinical trials with SORIATANE, 513 of 525 (98%) subjects reported a total of 3,545 adverse events. One-hundred sixteen subjects (22%) left trials prematurely, primarily because of adverse experiences involving the mucous membranes and skin. Three subjects died. Two of the deaths were not drug-related (pancreatic adenocarcinoma and lung cancer); the other subject died of an acute myocardial infarction, considered remotely related to drug therapy. In clinical trials, SORIATANE was associated with elevations in liver function test results or triglyceride levels and hepatitis.

The tables below list by body system and frequency the adverse events reported during clinical trials of 525 subjects with psoriasis.

Table 3: Adverse Events Frequently Reported during Clinical Trials Percent of Subjects Reporting (N = 525)

Body System > 75% 50% to 75% 25% to 50% 10% to 25%
CNS       Rigors
Eye Disorders       Xerophthalmia
Mucous Membranes Cheilitis   Rhinitis Dry mouth Epistaxis
Musculoskeletal       Arthralgia Spinal hyperostosis (progression of existing lesions)
Skin and Appendages   Alopecia Skin peeling Dry skin Nail disorder Pruritus Erythematous rash Hyperesthesia Paresthesia Paronychia Skin atrophy Sticky skin

Table 4: Adverse Events Less Frequently Reported during Clinical Trials (Some of Which May Bear No Relationship to Therapy) Percent of Subjects Reporting (N = 525)

Body System 1% to 10%   < 1%
Body as a Whole Anorexia Edema Fatigue Hot flashes Increased appetite   Alcohol intolerance Dizziness Fever Influenza-like symptoms Malaise Moniliasis Muscle weakness Weight increase
Cardiovascular Flushing   Chest pain Cyanosis Increased bleeding time Intermittent claudication Peripheral ischemia
CNS (also see Psychiatric) Headache Pain   Abnormal gait Migraine Neuritis Pseudotumor cerebri (intracranial hypertension)
Eye Disorders Abnormal/ blurred vision Blepharitis Conjunctivitis/ irritation Corneal epithelial abnormality Decreased night vision/night blindness Eye abnormality Eye pain Photophobia Abnormal lacrimation Chalazion Conjunctival hemorrhage Corneal ulceration Diplopia Ectropion Itchy eyes and lids Papilledema Recurrent sties Subepithelial corneal lesions
Gastrointestinal Abdominal pain Diarrhea Nausea Tongue disorder   Constipation Dyspepsia Esophagitis Gastritis Gastroenteritis Glossitis Hemorrhoids Melena Tenesmus Tongue ulceration
Liver and Biliary     Hepatic function abnormal Hepatitis Jaundice  
Mucous Membranes Gingival bleeding Gingivitis Increased saliva Stomatitis Thirst Ulcerative stomatitis Altered saliva Anal disorder Gum hyperplasia Hemorrhage Pharyngitis
Musculoskeletal Arthritis Arthrosis Back pain Hypertonia Myalgia Osteodynia Peripheral joint hyperostosis (progression of existing lesions) Bone disorder Olecranon bursitis Spinal hyperostosis (new lesions) Tendonitis  
Psychiatric Depression Insomnia Somnolence   Anxiety Dysphonia Libido decreased Nervousness  
Reproductive     Atrophic vaginitis Leukorrhea  
Respiratory Sinusitis   Coughing Increased sputum Laryngitis  
Skin and Appendages Abnormal skin odor Abnormal hair texture Bullous eruption Cold/clammy skin Dermatitis Increased sweating Infection Psoriasiform rash Purpura Pyogenic granuloma Rash Seborrhea Skin fissures Skin ulceration Sunburn Acne Breast pain Cyst Eczema Fungal infection Furunculosis Hair discoloration Herpes simplex Hyperkeratosis Hypertrichosis Hypoesthesia Impaired healing Otitis media Otitis externa Photosensitivity reaction Psoriasis aggravated Scleroderma Skin nodule Skin hypertrophy Skin disorder Skin irritation Sweat gland disorder Urticaria Verrucae
Special Senses/ Other Earache Taste perversion Tinnitus   Ceruminosis Deafness Taste loss  
Urinary     Abnormal urine Dysuria Penis disorder  

Laboratory

Therapy with SORIATANE induces changes in liver function tests in a significant number of patients. Elevations of AST (SGOT), ALT (SGPT) or LDH were experienced by approximately 1 in 3 subjects treated with SORIATANE. In most subjects, elevations were slight to moderate and returned to normal either during continuation of therapy or after cessation of treatment. In subjects receiving SORIATANE during clinical trials, 66% and 33% experienced elevation in triglycerides and cholesterol, respectively. Decreased high density lipoproteins (HDL) occurred in 40% (see WARNINGS). Transient, usually reversible elevations of alkaline phosphatase have been observed.

Table 5 lists the laboratory abnormalities reported during clinical trials.

Table 5: Abnormal Laboratory Test Results Reported during Clinical Trials Percent of Subjects Reporting

Body System 50% to 75% 25% to 50% 10% to 25% 1% to 10%
Electrolytes     Increased: -Phosphorus -Potassium -Sodium Increased and decreased: -Magnesium Decreased: -Phosphorus -Potassium -Sodium Increased and decreased: -Calcium -Chloride
Hematologic   Increased: -Reticulocytes Decreased: -Hematocrit -Hemoglobin -WBC Increased: -Haptoglobin -Neutrophils -WBC Increased: -Bands -Basophils -Eosinophils -Hematocrit -Hemoglobin -Lymphocytes -Monocytes Decreased: -Haptoglobin -Lymphocytes -Neutrophils -Reticulocytes Increased or decreased: -Platelets -RBC
Hepatic   Increased: -Cholesterol -LDH -SGOT -SGPT Decreased: -HDL cholesterol Increased: -Alkaline phosphatase -Direct bilirubin -GGTP Increased: -Globulin -Total bilirubin -Total protein Increased and decreased: -Serum albumin
Miscellaneous Increased: -Triglycerides Increased: -CPK -Fasting blood sugar Decreased: -Fasting blood sugar -High occult blood Increased and decreased: -Iron
1
Renal     Increased: -Uric acid Increased: -BUN -Creatinine
Urinary   WBC in urine Acetonuria Hematuria RBC in urine Glycosuria Proteinuria

Read the entire FDA prescribing information for Soriatane (Acitretin)

Read More »
  • Psoriasis

For Healthcare Professionals

Applies to acitretin: oral capsule, oral and topical kit

General

The most commonly reported side effects were hypervitaminosis A, skin peeling, alopecia, dry mucous membranes of mouth and nose, chelitis, increased triglycerides, and rhinitis.[Ref]

Hepatic

Very common (10% or more): Increased SGOT (up to 50%), increased SGPT (up to 50%), increased alkaline phosphatase (up to 25%), increased direct bilirubin (up to 25%), increased GGTP (up to 25%)
Common (1% to 10%): Increased globulin, increased total bilirubin, increased total protein, increased and decreased serum albumin
Uncommon (0.1% to 1%): Abnormal hepatic function, hepatitis, jaundice[Ref]

Metabolic

Very common (10% or more): Increased/decreased LDH (up to 50%), increased/decreased cholesterol (up to 50%), increased fasting blood sugar (up to 50%), decreased fasting blood sugar (up to 25%)
Common (1% to 10%): Increased appetite, anorexia, thirst
Uncommon (0.1% to 1%): Alcohol intolerance, weight increase[Ref]

Hypersensitivity

Postmarketing reports: Hypersensitivity, including angioedema and urticaria[Ref]

Cardiovascular

Common (1% to 10%): Hot flashes, flushing
Uncommon (0.1% to 1%): Chest pain, cyanosis, intermittent claudication, peripheral ischemia
Postmarketing reports: Acute myocardial infarction, thromboembolism, capillary leak syndrome, stroke[Ref]

Dermatologic

Very common (10% or more): Hypervitaminosis A (over 80%), skin peeling (up to 80%), alopecia (up to 75%), dry skin ( up to 50%), nail disorder (up to 50%), pruritus (up to 50%), scaling and thinning of healthy skin with increased sensitivity (up to 40%), erythema (up to 40%), sensation of "burning skin" (up to 40%), sensation of "sticky skin" (up to 40%), dermatitis (up to 40%), hair loss (up to 40%), inflammation of the nail wall (up to 40%), nail fragility (up to 40%), erythematous rash (up to 25%), paronychia (up to 25%), skin atrophy (up to 25%), skin fragility
Common (1% to 10%): Abnormal skin odor, abnormal hair texture, bullous eruption, cold/clammy skin, increased sweating, psoriasiform rash, purpura, pyogenic granuloma, rash, seborrhea, skin fissures, skin ulceration, sunburn, rhagades, blistering of the skin, change in pigmentation of the skin and hair, change in growth rate of hair, change in hair structure
Uncommon (0.1% to 1%): Acne, cyst, eczema, furunculosis, hyperkeratosis, hypertrichosis, hypoesthesia, otitis media, otitis externa, photosensitivity reactions, aggravated psoriasis, skin nodule, skin hypertrophy, skin disorder, skin irritation, sweat gland disorder, urticaria, verrucae
Rare (less than 0.1%): Retinoid dermatitis (occasionally provoking psoriatic lesion)
Postmarketing reports: Madarosis, exfoliative dermatitis/erythroderma[Ref]

Gastrointestinal

Very common (10% or more): Dry mucous membranes of mouth and nose (up to 80%), chelitis (more than 75%), high occult blood (up to 25%),
Common (1% to 10%): Abdominal pain, diarrhea, nausea, tongue disorder, gingival bleeding, gingivitis, increased saliva, stomatitis, ulcerative stomatitis, inflammation of oral mucosa and gingiva
Uncommon (0.1% to 1%): Constipation, dyspepsia, esophagitis, gastritis, gastroenteritis, glossitis, hemorrhoids, melena, tenesmus, tongue ulceration, altered saliva, anal disorder, gum hyperplasia, hemorrhage, pharyngitis, heartburn, inflammatory bowel disorders
Rare (less than 0.1%): Pancreatitis, icterus
Frequency not reported: Rectal hemorrhage[Ref]

Genitourinary

Very common (10% or more): WBC in urine (up to 50%), acetonuria, hematuria, RBC in urine
Common (1% to 10%): Glycosuria, proteinuria
Uncommon (0.1% to 1%): Atrophic vaginitis, abnormal urine, dysuria. penis disorder, leukorrhea, breast pain
Rare (less than 0.1%): Metrorrhagia
Postmarketing reports: Vulvo-vaginitis due to Candida albicans.[Ref]

Musculoskeletal

Very common (10% or more): Arthralgia (up to 25%), spinal hyperostosis
Common (1% to 10%): Arthritis, arthrosis, back pain, hypertonia, myalgia, osteodynia, peripheral joint hyperostosis (progression of existing lesions), demineralization and rarefaction of bone, cortical hyperostosis, periosteal calcification, premature epiphyseal closure, calcification of spinal ligaments resulting in spinal cord compression
Uncommon (0.1% to 1%): Muscle weakness, bone disorder, olecranon bursitis, tendonitis, scleroderma[Ref]

Nervous system

Very common (10% or more): Hyperesthesia (up to 25%), paresthesia (up to 25%)
Common (1% to 10%): Headache, taste perversion
Uncommon (0.1% to 1%): Dizziness, abnormal gait, migraine, neuritis, pseudotumor cerebri (intracranial hypertension), taste loss, dysgeusia, lassitude, disturbance of consciousness
Rare (less than 0.1%): Lightheadedness, visual disturbance
Postmarketing reports: Myopathy with peripheral neuropathy[Ref]

Ocular

Very common (10% or more): Conjunctivitis (up to 40%), xerophthalmia (up to 25%), dry eyes, eye irritation, intolerance of contact lenses
Common (1% to 10%): Abnormal/ blurred vision,
blepharitis, irritation, corneal epithelial abnormality, decreased night vision/night blindness, eye abnormality, eye pain, photophobia
Uncommon (0.1% to 1%): Abnormal lacrimation, chalazion, conjunctival hemorrhage, corneal ulceration, diplopia, ectropion, itchy eyes and lids,
papilledema, recurrent sties, subepithelial corneal lesions
Rare (less than 0.1%): Keratitis, abrasion and irregularities leading to corneal opacities[Ref]

Other

Very common (10% or more): Increased triglycerides (up to 75%), increased creatinine phosphokinase (up to 50%), feeling of cold (up to 40%), rigors (up to 25%), increased phosphorus (up to 25%), increased potassium (up to 25%), increased sodium (up to 25%), increased and decreased magnesium (up to 25%)
Common (1% to 10%): Edema, fatigue, pain, earache, tinnitus, decreased phosphorus, decreased potassium, decreased sodium, increased and decreased calcium, increased and decreased chloride, increased and decreased iron
Uncommon (0.1% to 1%): Fever, influenza-like symptoms, malaise, impaired healing, ceruminosis, deafness. peripheral edema, sensation of heat
Frequency not reported: Elevation in lactate dehydrogenase[Ref]

Respiratory

Very common (10% or more): Rhinitis (up 80%), epistaxis (up to 40%)
Common (1% to 10%): Sinusitis
Uncommon (0.1% to 1%): Coughing, increased sputum, laryngitis, dysphonia[Ref]

Endocrine

Rare (less than 0.1%): Gynecomastia[Ref]

Hematologic

Very common (10% or more): Increased reticulocytes (up to 50%), decreased hematocrit (up to 25%), decreased hemoglobin (up to 25%), decreased WBC (up to 25%), increased haptoglobin (up to 25%), increased neutrophils (up to 25%), increased WBC (up to 25%)
Common (1% to 10%): Increased bands, increased basophils, increased eosinophils, increased hematocrit, increased hemoglobin, increased lymphocytes, increased monocytes, decreased haptoglobin, decreased lymphocytes , decreased neutrophils, decreased reticulocytes, increased or decreased platelets, increased or decreased RBC
Uncommon (0.1% to 1%): Increased bleeding time[Ref]

Immunologic

Uncommon (0.1% to 1%): Moniliasis, fungal infection, herpes simplex[Ref]

Oncologic

Frequency not reported: Pyogenic granuloma[Ref]

Psychiatric

Common (1% to 10%): Depression, insomnia, somnolence
Uncommon (0.1% to 1%): Anxiety, decreased libido, nervousness, abnormal thinking, emotional lability, aggressive feelings
Postmarketing reports: Suicidal thoughts[Ref]

Renal

Very common (10% or more): Increased uric acid (up to 25%)
Common (1% to 10%): Increased BUN, increased creatinine[Ref]

Some side effects of acitretin may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Acitretin Identification

Substance Name

Acitretin

CAS Registry Number

55079-83-9

Drug Class

Keratolytic Agents

Retinoids

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