pharmacopeia
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Boxed warning

AND WARNINGS: Pregnancy Acitretin must not be used by females who are pregnant, or who intend to become pregnant during therapy or at any time for at least 3 years following discontinuation of therapy. Acitretin also must not be used by females who may not use reliable contraception while undergoing treatment and for at least 3 years following discontinuation of treatment. Acitretin is a metabolite of etretinate (TEGISON), and major human fetal abnormalities have been reported with the administration of acitretin and etretinate. Potentially, any fetus exposed can be affected. Clinical evidence has shown that concurrent ingestion of acitretin and ethanol has been associated with the formation of etretinate, which has a significantly longer elimination half-life than acitretin. Because the longer elimination half-life of etretinate would increase the duration of teratogenic potential for female patients, ethanol must not be ingested by female patients of childbearing potential either during treatment with acitretin or for 2 months after cessation of therapy. This allows for elimination of acitretin, thus removing the substrate for transesterification to etretinate. The mechanism of the metabolic process for conversion of acitretin to etretinate has not been fully defined. It is not known whether substances other than ethanol are associated with transesterification.

Mechanism of action

Sourced from openFDA

Mechanism-of-action classes: Interleukin 6 Receptor Antagonists; Unknown Cellular or Molecular Interaction.

Interleukin 6 Receptor

Indications

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  • Acitretin Capsules, USP are indicated for the treatment of severe psoriasis in adults. Because of significant adverse effects associated with its use, Acitretin Capsules, USP should be prescribed only by those knowledgeable in the systemic use of retinoids.ICD-10: L40.9

Contraindications

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  • Pregnancy Category X: ( see boxed CONTRAINDICATIONS AND WARNINGS . ) Acitretin is contraindicated in patients with severely impaired liver or kidney function and in patients with chronic abnormally elevated blood lipid values (see boxed WARNINGS: Hepatotoxicity , WARNINGS: Lipids and Possible Cardiovascular Effects , and PRECAUTIONS ).contraindicated

Dosage & administration

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There is intersubject variation in the pharmacokinetics, clinical efficacy, and incidence of side effects with Acitretin Capsules, USP. A number of the more common side effects are dose-related. Individualization of dosage is required to achieve sufficient therapeutic response while minimizing side effects. Therapy with Acitretin Capsules, USP should be initiated at 25 to 50 mg per day, given as a single dose with the main meal. Maintenance doses of 25 to 50 mg per day may be given dependent upon an individual patient’s response to initial treatment. Relapses may be treated as outlined for initial therapy. When Acitretin Capsules, USP are used with phototherapy, the prescriber should decrease the phototherapy dose, dependent on the patient’s individual response (see PRECAUTIONS: General ). Females who have taken TEGISON (etretinate) must continue to follow the contraceptive recommendations for TEGISON. TEGISON is no longer marketed in the US; for information, call 1-855-273-0150. Information for Pharmacists: Acitretin Capsules, USP must only be dispensed in no more than a month supply. An Acitretin Capsules, USP Medication Guide must be given to the patient each time acitretin capsules are dispensed, as required by law.

Warnings & precautions

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( See also boxed CONTRAINDICATIONS AND WARNINGS .) Hepatotoxicity: Of the 525 subjects treated in US clinical trials, 2 had clinical jaundice with elevated serum bilirubin and transaminases considered related to treatment with acitretin. Liver function test results in these subjects returned to normal after acitretin was discontinued. Two of the 1,289 subjects treated in European clinical trials developed biopsy-confirmed toxic hepatitis. A second biopsy in one of these subjects revealed nodule formation suggestive of cirrhosis. One subject in a Canadian clinical trial of 63 subjects developed a 3-fold increase of transaminases. A liver biopsy of this subject showed mild lobular disarray, multifocal hepatocyte loss, and mild triaditis of the portal tracts compatible with acute reversible hepatic injury. The subject’s transaminase levels returned to normal 2 months after acitretin was discontinued. The potential of therapy with acitretin to induce hepatotoxicity was prospectively evaluated using liver biopsies in an open-label trial of 128 subjects. Pretreatment and posttreatment biopsies were available for 87 subjects. A comparison of liver biopsy findings before and after therapy revealed 49 (58%) subjects showed no change, 21 (25%) improved, and 14 (17%) subjects had a worsening of their liver biopsy status.

Adverse reactions

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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 acitretin 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 acitretin. 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 acitretin. 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 acitretin. Since other factors may have contributed to these events, it is not known if they are related to acitretin (see PRECAUTIONS ). Reproductive: Vulvo-vaginitis due to Candida albicans.

Use in specific populations

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Pregnancy:

Pharmacokinetics

Sourced from openFDA
Metabolism
Absorption: Oral absorption of acitretin is optimal when given with food. For this reason, acitretin was given with food in all of the following trials.

Overdosage

Sourced from openFDA

In the event of acute overdosage, acitretin must be withdrawn at once. Symptoms of overdose are identical to acute hypervitaminosis A (e.g., headache and vertigo). The acute oral toxicity (LD 50 ) of acitretin in both mice and rats was greater than 4,000 mg per kg. In one reported case of overdose, a 32-year-old male with Darier’s disease took 21 x 25-mg capsules (525-mg single dose). He vomited several hours later but experienced no other ill effects. All female patients of childbearing potential who have taken an overdose of acitretin must: Have a pregnancy test at the time of overdose; Be counseled as per the boxed CONTRAINDICATIONS AND WARNINGS and PRECAUTIONS sections regarding birth defects and contraceptive use for at least 3 years’ duration after the overdose.

Approval history

Sourced from openFDA
  • Apr 4, 2013ANDAANDA091455Barr Labs Inc
  • Apr 4, 2013ANDAANDA202897Teva Pharms Usa
  • May 22, 2015ANDAANDA204633Sigmapharm Labs Llc
  • Sep 10, 2015ANDAANDA202148Mylan
  • Dec 23, 2015ANDAANDA202552Impax Labs Inc
  • Aug 5, 2024ANDAANDA217774Alembic

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
4,791 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Psoriasis1,16924%
  2. 2Drug Ineffective1,15624%
  3. 3Pain47910.0%
  4. 4Fatigue4729.9%
  5. 5Off Label Use4639.7%
  6. 6Pruritus4419.2%
  7. 7Nausea4288.9%
  8. 8Headache3637.6%
  9. 9Skin Exfoliation3607.5%
  10. 10Pneumonia3477.2%
  11. 11Pyrexia3367.0%
  12. 12Malaise3347.0%
  13. 13Nasopharyngitis3076.4%
  14. 14Diarrhoea3056.4%
  15. 15Cough2996.2%

Literature

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Recent PubMed references pinned to Acitretin as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 41 ClinicalTrials.gov registrations naming Acitretin as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Acitretin work?
Mechanism-of-action classes: Interleukin 6 Receptor Antagonists; Unknown Cellular or Molecular Interaction.
What is Acitretin used for?
According to FDA labeling, Acitretin carries indications including: Acitretin Capsules, USP are indicated for the treatment of severe psoriasis in adults. Because of significant adverse effects associated with its use, Acitretin Capsules, USP should be prescribed only by those knowledgeable in the systemic use of retinoids.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Acitretin?
Acitretin is classified as Retinoids for treatment of psoriasis, Retinoid, Interleukin 6 Receptor Antagonists, Unknown Cellular or Molecular Interaction, Decreased Epithelial Proliferation, Decreased Immunologically Active Molecule Activity, Keratin Alteration.
What are the contraindications for Acitretin?
Acitretin labeling lists contraindications including: Pregnancy Category X: ( see boxed CONTRAINDICATIONS AND WARNINGS . ) Acitretin is contraindicated in patients with severely impaired liver or kidney function and in patients with chronic abnormally elevated blood lipid values (see boxed WARNINGS: Hepatotoxicity , WARNINGS: Lipids and Possible Cardiovascular Effects , and PRECAUTIONS ).. Always consult the full prescribing information and a clinician.
Note. Data for acitretin is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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