Does Quilipta (Opicapone) affect Liver Function Tests (LFTs)?

Quilipta (Opicapone) and Liver Function Tests

Quilipta (Opicapone) can cause liver enzyme elevations, but severe liver injury is rare and typically resolves after discontinuation. Based on the FDA drug label, transaminase elevations over 3 times the upper limit of normal have been observed in clinical trials, though at a similar rate to placebo (0.9% vs 1.2%) 1.

Effects on Liver Function Tests

• Transaminase elevations: The FDA label indicates that cases of transaminase elevations >3x upper limit of normal have been temporally associated with Quilipta treatment 1
• Resolution pattern: These elevations were asymptomatic and resolved within 8 weeks of discontinuation 1
• Severity: No cases of severe liver injury or jaundice were reported in clinical trials 1

Risk Factors and Pharmacokinetics

Research on opicapone shows that patients with moderate liver impairment experience significantly higher exposure to the drug:

• Exposure to opicapone increased by approximately 84% in patients with moderate hepatic impairment 2
• The maximum concentration (Cmax) increased by about 89% in these patients 2
• The apparent total clearance was decreased by approximately 35% 2

Monitoring Recommendations

While the FDA label doesn't mandate specific LFT monitoring protocols for Quilipta, prudent clinical practice suggests:

• Baseline testing: Obtain liver function tests before initiating therapy
• Follow-up monitoring: Consider periodic monitoring, especially in patients with:
  • Pre-existing liver disease
  • Concomitant use of other hepatotoxic medications
  • Symptoms suggestive of liver dysfunction

Clinical Management of LFT Abnormalities

If LFT elevations occur:

1. Evaluate for alternative causes of liver enzyme elevations
2. Consider discontinuation if significant elevations occur
3. Monitor LFTs after discontinuation to confirm improvement
4. Consider alternative medications if needed

Comparison to Other Medications

The hepatotoxicity profile of Quilipta appears more favorable than some other medications:

• Unlike lomitapide, which carries a black box warning for liver toxicity 3, Quilipta has no such warning
• The incidence of LFT abnormalities with Quilipta is lower than that seen with some atypical antipsychotics, which can cause asymptomatic increases in liver enzymes in up to 27.2% of patients 4

Conclusion

Quilipta can affect liver function tests, but severe hepatotoxicity appears rare. Monitoring should be considered based on individual risk factors, with particular attention to patients with pre-existing liver disease or those taking other hepatotoxic medications.