Table 2.
Recommendations for reducing the risk of drug-induced liver injury before initiation of treatment with cladribine tablets for people with multiple sclerosis
| EU SmPC | NICE |
|---|---|
|
• Take comprehensive patient history of previous liver injury with other drugs or underlying liver disorders • Assess serum aminotransferase, alkaline phosphatase and total bilirubin before initiation of therapy in year 1 and 2 • Monitor liver enzyme and bilirubin during treatment based on clinical signs and symptoms • Measure serum transaminases and total bilirubin promptly If a patient develops clinical signs, unexplained liver enzyme elevations or symptoms of hepatic dysfunction • Interrupt or discontinue treatment with CladT as appropriate |
• Check the patient’s history for liver disorders • Monitor liver function tests (including total bilirubin) before each treatment course in years 1 and 2, and during treatment if clinically indicated • Urgently check liver function tests (including bilirubin) in patients with signs or symptoms of liver injury • Discontinue or interrupt treatment in patients with hepatic dysfunction or unexplained increases in liver enzymes |