Cyramza ® (ramucirumab)

För fullständig produktresumé för Cyramza® se FASS.

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Cyramza® (ramucirumab): Patienter med nedsatt leverfunktion

Kliniska data tyder på att inga dosjusteringar krävs hos patienter med mild eller måttligt nedsatt leverfunktion.

Use in Patients With Hepatic Impairment

There have been no formal studies with ramucirumab in patients with hepatic impairment. Clinical data suggest that no dose adjustments are required in patients with mild or moderate hepatic impairment. There are no data regarding ramucirumab administration in patients with severe hepatic impairment. No dose reductions are recommended.1

Based on the results of the PopPK analysis, ramucirumab exposure was similar in patients with mild hepatic impairment (total bilirubin >1.0-1.5 times ULN and any AST, or total bilirubin ≤1.0 ULN and AST >ULN) or moderate hepatic impairment (total bilirubin >1.5-3.0 times ULN and any AST) compared to patients with normal hepatic function (total bilirubin and AST ≤ULN). No PK data were available from patients with severe hepatic impairment (total bilirubin >3 times ULN and any AST).1

Use in Patients With Severe Liver Cirrhosis

Ramucirumab should be used with caution in patients with severe liver cirrhosis (Child-Pugh B or C), cirrhosis with hepatic encephalopathy, clinically significant ascites due to cirrhosis, or hepatorenal syndrome. There are very limited efficacy and safety data available in these patients. Ramucirumab should only be used in these patients if the potential benefits of treatment are judged to outweigh the potential risk of progressive hepatic failure.1

In HCC patients with liver cirrhosis, hepatic encephalopathy was reported at a higher rate in the ramucirumab-treated patients compared to the placebo-treated patients.2

References

1. Cyramza [summary of product characteristics]. Eli Lilly Nederland B.V., The Netherlands.

2. Data on file, Eli Lilly and Company and/or one of its subsidiaries.

Glossary

AST = aspartate aminotransferase

HCC = hepatocellular carcinoma

PK = pharmacokinetic(s)

PopPK = population pharmacokinetic 

ULN = upper limit of normal

Datum fӧr senaste ӧversyn 2019 M08 15

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