No, oral terbinafine should NOT be prescribed to this patient due to significantly elevated liver transaminases
This 34-year-old woman with ALT 261 U/L (approximately 6.5× upper limit of normal) and AST 113 U/L (approximately 2.8× upper limit of normal) has a clear contraindication to terbinafine therapy, as systemic terbinafine is not recommended in patients with active or chronic liver disease. 1
Why Terbinafine is Contraindicated
Pre-existing Liver Disease Exclusion
- The British Association of Dermatologists explicitly states that systemic terbinafine is not recommended in patients with active or chronic liver disease 1
- Baseline liver function tests are recommended before initiating terbinafine specifically to identify patients like this one who should not receive the drug 1
- Although terbinafine is associated with only minimal hepatic toxicity in healthy patients, rare reports of serious hepatotoxicity have occurred, usually in patients with pre-existing liver disease 1
Severity of Transaminase Elevation
- This patient's ALT of 261 U/L represents a >3× upper limit of normal elevation, which is the threshold used to define clinically significant hepatotoxicity 1
- Her transaminase pattern (ALT >> AST) suggests active hepatocellular injury, not just chronic stable liver disease 1
- Even in patients already on terbinafine, the drug should be held when ALT rises to ≥3× ULN 1
Renal Function is NOT the Issue
- Her GFR of 116 mL/min/1.73 m² is normal to high-normal and poses no contraindication 1
- Terbinafine clearance is decreased only in patients with severe kidney disease, not at this GFR level 1
- More than 99% of terbinafine is cleared by the kidney, but dose adjustment is not needed until severe renal impairment is present 1
Clinical Reasoning Algorithm
Step 1: Check baseline liver function → This patient has ALT >6× ULN
Step 2: Determine if liver disease is active → Yes, significantly elevated transaminases indicate active hepatocellular injury
Step 3: Apply contraindication → Do not prescribe terbinafine 1
What Should Be Done Instead
Immediate Actions
- Investigate the cause of her elevated transaminases before treating any fungal infection 1
- Evaluate for viral hepatitis, autoimmune hepatitis, medication-induced liver injury, alcohol use, non-alcoholic fatty liver disease, and other hepatobiliary pathology
- Repeat liver function tests in 48-72 hours to assess trajectory 1
Alternative Antifungal Options (Once Liver Status Clarified)
- Topical antifungals (ciclopirox, amorolfine) can be used for onychomycosis without systemic absorption concerns 1
- Griseofulvin may be considered if oral therapy is absolutely necessary, though it also requires baseline liver monitoring and is less effective than terbinafine 1
- Itraconazole is an alternative oral agent but also carries hepatotoxicity risk and would require the same caution in this patient 1
Common Pitfalls to Avoid
- Do not assume normal renal function makes terbinafine safe — the contraindication here is hepatic, not renal 1
- Do not start terbinafine with a plan to "monitor closely" — the drug should not be initiated in the presence of active liver disease 1
- Do not overlook that onychomycosis is not life-threatening — delaying treatment until liver function normalizes is appropriate 1
- Do not forget that terbinafine-induced hepatotoxicity can be severe — cases of cholestatic hepatitis requiring 11-15 months for resolution have been reported 2
Risk Context from the Literature
- Post-marketing surveillance shows serious adverse events occur in only 0.04% of terbinafine users 1
- However, when hepatotoxicity does occur, it can be severe and prolonged, with peak bilirubin reaching 718 μmol/L and recovery taking over a year 2
- Most hepatotoxicity occurs in patients with pre-existing liver disease, making this patient particularly high-risk 1