What are the monitoring requirements for Acitretin (Soriatane) therapy?

From the Guidelines

Acitretin monitoring should include regular assessments of liver enzymes, lipid levels, and blood sugar levels, as well as monitoring for clinical signs of hypervitaminosis A and other adverse effects, with the most recent guidelines recommending monitoring of liver enzymes and lipid levels monthly for the first 3 months, then every 3 months thereafter 1.

Key Monitoring Parameters

• Liver enzymes: every 2-4 weeks for the first 2 months, then every 3 months, with discontinuation of acitretin if transaminases are elevated to three times their upper normal limit 1
• Lipid levels: every 2-4 weeks for the first 2 months, then every 3 months, with referral to a lipidologist if triglycerides are > 5 mmol L-1 1
• Blood sugar levels: regular monitoring in diabetic patients, with more frequent checks during the first few weeks of treatment 1

Additional Considerations

• Women of childbearing potential: monthly pregnancy tests, effective contraception for at least 3 years after stopping treatment, and avoidance of pregnancy for at least 3 years after discontinuation of therapy 1
• Patients with significant hepatic or renal impairment: avoidance of acitretin therapy 1
• Patients with hypertriglyceridemia: monitoring and management of lipid levels to prevent acute pancreatitis 1

Clinical Signs to Monitor

• Hypervitaminosis A: dry lips, skin peeling, headache, depression, decreased night vision, and bone abnormalities with long-term use 1
• Other adverse effects: cheilitis, alopecia, xerosis, pruritus, xerophthalmia, night blindness, dry mouth, paronychia, paresthesia, headache, pseudotumor cerebri, nausea, abdominal pain, joint pain, myalgia, and hypertriglyceridemia 1

From the FDA Drug Label

Acitretin capsules should be limited to a monthly supply.

• Must have a pregnancy test with a sensitivity of at least 25 mIU per mL repeated every month during treatment with acitretin capsules.

For at least 3 years after discontinuing therapy with acitretin capsules, a pregnancy test must be repeated every 3 months

Counseling about contraception and behaviors associated with an increased risk of pregnancy must be repeated on a monthly basis by the prescriber during therapy with acitretin capsules and every 3 months for at least 3 years following discontinuation of acitretin capsules.

Monitoring Requirements for Acitretin:

• Monthly pregnancy tests during treatment
• Monthly supply of the drug
• Counseling about contraception and pregnancy risk on a monthly basis during therapy and every 3 months for at least 3 years after discontinuation
• Pregnancy tests every 3 months for at least 3 years after discontinuing therapy with acitretin capsules 2

From the Research

Acitretin Monitoring

• Acitretin is a systemic retinoid that requires monitoring for potential adverse events, including hepatotoxicity and osteoarticular changes 3, 4, 5.
• Liver function tests, including transaminases, should be monitored regularly, as acitretin can cause elevated transaminases, indicating acute hepatocyte damage 4.
• Cholestatic enzymes, such as γ-glutamyltransferase (GGT) and alkaline phosphatase (ALP), should also be considered in patients with transaminase abnormalities, as acitretin-induced hepatitis can present with a mixed pattern of hepatocyte injury and cholestasis 4.
• The concurrent use of methotrexate and acitretin may not be an absolute contraindication, but patients should be closely monitored for hepatotoxicity 6.
• Liver biopsies may not be necessary with acitretin treatment, as a prospective 2-year study found no biopsy-proven hepatotoxicity in patients treated with oral acitretin 5.
• The predictive value of liver function tests for hepatotoxicity is limited, and monitoring recommendations are often poorly followed 7.

Laboratory Tests

• Transaminases (e.g., ALT, AST) should be monitored regularly 4.
• Cholestatic enzymes (e.g., GGT, ALP) should be considered in patients with transaminase abnormalities 4.
• Lipid profiles should be monitored, as acitretin can affect lipid metabolism 3.
• Complete blood counts (CBC) should be monitored regularly, especially in patients receiving concurrent methotrexate therapy 6.

Patient Monitoring

• Patients should be closely monitored for signs and symptoms of hepatotoxicity, such as jaundice, dark urine, and abdominal pain 4, 5.
• Patients should be advised to report any changes in their medical condition, including the development of osteoarticular symptoms, such as disc space narrowing 3.