acitretin
Regulatory sources consulted
Approved indications
- Severe psoriasis in adults; reserve for nonpregnant women of reproductive potential who do not respond to or cannot receive other therapies.
Contraindications
Absolute
- Pregnancy or pregnancy potential without strict prevention; breastfeeding; severe hepatic or renal impairment; chronic hyperlipidemia; hypersensitivity to retinoids.
- Concomitant methotrexate, tetracyclines, vitamin A, or other retinoids.
Clinical warnings
- Major warning · Potent human teratogen. Women of reproductive potential must use two effective forms of contraception simultaneously from 1 month before, during, and for 3 years after treatment; obtain two negative pregnancy tests before starting, repeat monthly during treatment, and every 3 months for 3 years afterward. Do not donate blood during treatment or for 3 years after completion. Avoid alcohol during treatment and for 2 months afterward. Monitor liver function and lipids; watch for intracranial hypertension, visual changes, and bone effects. — DailyMed acitretin capsules set ID a6546625-acb8-460e-b34e-f795bfb3680a
Drug interactions
- ModerateAlcohol
Mechanism: It promotes formation of etretinate, which has a much longer half-life and is highly teratogenic.
Recommendation: Women of reproductive potential must avoid it during treatment and for 2 months afterward.
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a6546625-acb8-460e-b34e-f795bfb3680a
- HighProgestin-only minipill
Mechanism: Acitretin may reduce its contraceptive effect.
Recommendation: Do not use it as the contraceptive method during treatment.
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a6546625-acb8-460e-b34e-f795bfb3680a
- ModeratePhenytoin
Mechanism: Acitretin may partially reduce phenytoin protein binding and increase its free fraction.
Recommendation: Monitor response and signs of phenytoin toxicity; adjust only under clinical supervision.
https://cima.aemps.es/cima/dochtml/ft/74727/FT_74727.html
- ModerateGlyburide and other antidiabetic medicines
Mechanism: In 3 of 7 volunteers, acitretin enhanced the glucose-lowering effect of glyburide; without glyburide, no effect on glucose tolerance was detected.
Recommendation: Closely monitor blood glucose in people with diabetes.
https://api.fda.gov/drug/label.json?search=openfda.spl_set_id:08ce9fdd-1e84-4043-b085-91053f975b64
Adverse events
Common (≥1%)
Cheilitis and mucosal dryness · Scaling, dry skin, itching, or alopecia · Lipid and liver-test abnormalities · Arthralgia
Rare but serious
Hepatitis or jaundice · Intracranial hypertension · Night blindness or ulcerative keratitis
Pregnancy and lactation
Contraindicated during pregnancy and breastfeeding. Avoid pregnancy during treatment and for at least 3 years after stopping.
Recent literature (PubMed)
Plaque psoriasis is a chronic, immune-mediated inflammatory skin disease that has considerable effects on patients' physical, psychological and social well-being. It is strongly influenced by genetic predisposition, with HLA-C*06:02 showing the strongest association, particularly in those with early-onset disease. Additional susceptibility loci, including IL23A, IL12B and IL17RA, are linked to dysregulation of the IL-23-T helper 17 axis, which contributes to chronic inflammation and keratinocyte hyperproliferation. Plaque psoriasis is frequently associated with psoriatic arthritis and other comorbidities, such as cardiovascular disease, metabolic syndrome and psychiatric disorders, all of which contribute to increased morbidity and mortality. Management strategies are tailored to disease severity and the presence of comorbidities. For mild disease, topical therapies remain the first-line treatment, including corticosteroids, vitamin D analogues and topical calcineurin inhibitors. New non-steroidal agents, such as topical PDE4 and aryl hydrocarbon receptor agonists, offer additional options. In moderate-to-severe disease, oral systemic therapies, such as methotrexate, ciclosporin, acitretin, apremilast and deucravacitinib, provide a range of immunomodulatory effects. Biologic therapies targeting TNF, IL-17, IL-23 and IL-12/23 have demonstrated high efficacy in improving both cutaneous and systemic inflammation. Current research on systemic therapies is focused on the development of additional inhibitors of the Tyk2 pathway and inhibitors to IL-23 receptor, IL-17, and TNF. Early screening for psoriatic arthritis, proactive cardiovascular risk reduction and multidisciplinary care are crucial to optimizing long-term outcomes. Ongoing research continues to advance precision medicine approaches, with the goal of enhancing treatment durability and improving quality of life for individuals living with psoriasis.
Oral psoriasis therapies include both older traditional immunosuppressants, such as methotrexate, cyclosporine, and acitretin, as well as newer, more targeted agents, such as apremilast, deucravacitinib, and oral interleukin-23 receptor antagonists. Patients may prefer oral therapies to injectable therapies based on the route of administration. Both older and newer oral psoriasis therapies can be utilized effectively in the treatment of psoriasis. Here, we will review oral agents used in the treatment of psoriasis as well as provide commentary on their role in our current, evolving psoriasis treatment paradigm. A maternal acitretin dose of 0.65 mg/kg daily produced low levels in milk in one woman. Because there is no published experience with the safe use of acitretin during breastfeeding, current expert opinion recommends avoiding acitretin during breastfeeding.[1] Various topical agents that are less likely to be absorbed by the mother may be preferred during breastfeeding, especially while nursing a newborn or preterm infant. Only water-miscible cream or gel products should be applied to the breast because ointments may expose the infant to high levels of mineral paraffins via licking.[2]
For psoriatic patients who need to receive nonlive or live vaccines, evidence-based recommendations are needed regarding whether to pause or continue systemic therapies for psoriasis and/or psoriatic arthritis. To evaluate literature regarding vaccine efficacy and safety and to generate consensus-based recommendations for adults receiving systemic therapies for psoriasis and/or psoriatic arthritis receiving nonlive or live vaccines. Using a modified Delphi process, 22 consensus statements were developed by the National Psoriasis Foundation Medical Board and COVID-19 Task Force, and infectious disease experts. Key recommendations include continuing most oral and biologic therapies without modification for patients receiving nonlive vaccines; consider interruption of methotrexate for nonlive vaccines. For patients receiving live vaccines, discontinue most oral and biologic medications before and after administration of live vaccine. Specific recommendations include discontinuing most biologic therapies, except for abatacept, for 2-3 half-lives before live vaccine administration and deferring next dose 2-4 weeks after live vaccination. Studies regarding infection rates after vaccination are lacking. Interruption of antipsoriatic oral and biologic therapies is generally not necessary for patients receiving nonlive vaccines. Temporary interruption of oral and biologic therapies before and after administration of live vaccines is recommended in most cases.