What are the considerations for using Acitretin (Soriatane) in patients with impaired renal function or infection?

Acitretin Use in Renal Disease and Infection

Renal Disease Considerations

Acitretin is contraindicated in patients with severely impaired renal function according to FDA labeling and major dermatology guidelines. 1, 2 However, emerging evidence suggests cautious use may be possible in select patients with end-stage renal disease (ESRD) on hemodialysis with appropriate monitoring.

Contraindication Status and Rationale

• Severely impaired liver or kidney function is an absolute contraindication per FDA labeling and the 2020 American Academy of Dermatology/National Psoriasis Foundation guidelines 1, 2
• The British Association of Dermatologists (2010) similarly recommends avoiding acitretin therapy in moderate to severe renal impairment 1
• Baseline renal function tests are required before initiating therapy, with ongoing monitoring every 3 months 1

Pharmacokinetic Alterations in Renal Failure

• Plasma concentrations of acitretin are approximately 59% lower in patients with end-stage renal failure compared to age-matched controls 2
• In patients on hemodialysis, the area under the plasma concentration curve for both acitretin and its 13-cis metabolite are approximately 50% lower than in patients without renal failure 3
• Acitretin is not removed by hemodialysis, as no retinoids are detectable in dialysate 2, 3

Emerging Evidence for Use in Hemodialysis Patients

Despite the contraindication, a 2024 retrospective study provides preliminary safety data:

• 24 patients with ESRD on hemodialysis were treated with acitretin at Duke and Vanderbilt University Medical Centers 4
• While adverse effects were common, they were not a frequent cause of treatment discontinuation 4
• No association was found between acitretin treatment and hospital admissions or mortality 4
• Statistically significant increases in alkaline phosphatase (P = 0.03) and total bilirubin (P < 0.001) occurred during treatment, though without dose dependency or temporal association with acitretin initiation 4

Clinical Decision Algorithm for Renal Disease

If severe renal impairment or ESRD:

1. Consider acitretin contraindicated per standard guidelines 1, 2
2. Explore alternative therapies first (biologics, phototherapy, other systemics)
3. Only if benefits clearly outweigh risks and no alternatives exist, consider cautious use with:
   • Baseline alkaline phosphatase and total bilirubin measurement 4
   • More frequent monitoring of liver function tests (monthly initially) 4
   • Close monitoring of alkaline phosphatase and bilirubin throughout therapy 4
   • Standard monitoring of lipid profile, CBC, and renal function tests every 3 months 1
   • Recognition that lower plasma concentrations may require standard or potentially higher dosing 3

Common pitfall: Assuming hemodialysis will clear acitretin—it does not, as the drug is not removed by dialysis 2, 3

Infection Considerations

Candida Infections

• Increased incidence of vulvovaginitis due to Candida albicans has been noted during acitretin treatment 1
• This represents a direct effect of the medication on mucosal immunity and should be anticipated and treated symptomatically

No Direct Immunosuppression

Unlike many systemic psoriasis therapies, acitretin does not cause significant immunosuppression:

• Acitretin demonstrates immunomodulatory effects including inhibition of polymorphonuclear leukocyte accumulation and effects on lymphocytic function 5
• There is no contraindication to using acitretin in patients with active infections (unlike biologics or other immunosuppressants)
• The drug does not increase susceptibility to serious bacterial or viral infections

Surgical Considerations

• Acitretin does not significantly affect wound healing and does not need to be stopped for routine surgery such as orthopedic procedures 1
• A study of 44 complex wounds in transplant recipients showed no significant effects on wound infection, dehiscence, hypertrophic scarring, or hypergranulation 1

Drug Interaction with Tetracyclines

• Acitretin and tetracyclines are contraindicated together due to the risk of pseudotumor cerebri (benign intracranial hypertension) from additive increased intracranial pressure 1, 2
• If treating an infection in a patient on acitretin, avoid tetracyclines, doxycycline, or minocycline 6
• Consider alternative antibiotics such as macrolides, fluoroquinolones, or beta-lactams 6
• Patients with severe headache, nausea, vomiting, and visual disturbance should discontinue acitretin immediately and be referred for neurological evaluation 1

Monitoring During Concurrent Illness

• Standard monitoring protocols should continue during acute infections 1
• No dose adjustment is required for acitretin during acute illness unless hepatic or renal function deteriorates 1