What are the precautions when prescribing Acitretin (Soriatane)?

Precautions When Prescribing Acitretin (Soriatane)

Acitretin is absolutely contraindicated in pregnancy and women of childbearing potential unless strict contraception protocols are followed, as it is a potent teratogen requiring contraception for 3 years after discontinuation. 1, 2

Pregnancy-Related Precautions

For Women of Childbearing Potential:

• Must have two negative pregnancy tests (sensitivity ≥25 mIU/mL) before starting therapy 2
  • First test: screening test when considering therapy
  • Second test: confirmation test during first 5 days of menstrual period immediately preceding therapy
• Start therapy only on the second or third day of the next menstrual cycle 1
• Maintain effective contraception:
  • Two effective forms of contraception simultaneously for at least 1 month before, during, and for 3 years after discontinuation 2
  • Primary forms include: tubal ligation, partner's vasectomy, IUDs, birth control pills, injectable/implantable hormonal contraceptives
  • Secondary forms include: condoms, diaphragms with spermicide, cervical caps with spermicide
• Monthly pregnancy tests during treatment and every 3 months for 3 years after discontinuation 1, 2
• Complete abstinence from alcohol during and for 2 months after therapy (alcohol consumption can convert acitretin to etretinate, which has a much longer half-life) 1, 2

Hepatic Precautions

• Avoid in significant hepatic impairment (liver enzymes >2 times normal), hepatitis, and alcohol abuse 1
• Monitor liver function tests:
  • Every 2-4 weeks for first 2 months
  • Then every 3 months
  • If abnormal, check weekly and adjust dose accordingly
  • Discontinue if transaminases exceed 3 times normal 1

Renal Precautions

• Avoid in moderate to severe renal impairment 1
• Monitor renal function tests every 3 months 1

Lipid Abnormalities

• Check fasting lipid profile:
  • Before starting therapy
  • Monthly for first 3 months
  • Then every 3 months 1
• People with diabetes, obesity, or alcoholism need more frequent monitoring due to increased risk of hypertriglyceridemia 1

Drug Interactions

• Methotrexate: Increased risk of hepatotoxicity; avoid combination 1
• Tetracyclines: Risk of benign intracranial hypertension; avoid combination 1
• Mini-pill (progestin-only): Decreased contraceptive efficacy; avoid 1
• Phenytoin: Acitretin reduces protein binding; clinical significance unknown 1
• Antidiabetic agents: Increased risk of hypoglycemia; monitor glucose levels 1
• Corticosteroids: Increased risk of hyperlipidemia 1
• Vitamin A: Avoid supplements exceeding recommended daily allowance (2400-3000 IU daily) 1

Additional Precautions

• Blood donation: Patients should not donate blood during treatment or for at least 1 year after discontinuation 1
• UV radiation: Enhanced effects of UV radiation; patients should avoid excessive sun exposure and use of sun lamps 1
• Children: Not recommended due to risk of bone changes (premature epiphyseal closure, skeletal hyperostosis) 1
• Skin fragility: Advise against waxing for hair removal 1
• Glucose monitoring: Check fasting glucose before starting and monitor regularly, especially in diabetic patients 1

Baseline Investigations Before Starting Acitretin

1. Pregnancy test (for women of childbearing potential)
2. Liver function tests
3. Renal function tests
4. Fasting lipid profile
5. Fasting blood glucose
6. Complete blood count 1

Common Side Effects to Monitor

• Mucocutaneous effects: cheilitis, xerosis, pruritus, skin peeling, "sticky" skin
• Alopecia
• Dry eyes and mucous membranes
• Hypertriglyceridemia
• Elevated cholesterol
• Elevated liver enzymes
• Musculoskeletal pain 1, 3

Monitoring During Treatment

• Liver function tests: Monthly for first 3 months, then every 3 months
• Lipid profile: Monthly for first 3 months, then every 3 months
• CBC and renal function: Every 3 months
• Pregnancy tests: Monthly during treatment, then every 3 months for 3 years after discontinuation 1

Acitretin should only be prescribed by physicians experienced in systemic retinoid therapy who understand the teratogenic risks and can implement appropriate monitoring protocols 2.