Olumiant ® (baricitinib) tabletter

För fullständig produktresumé för Olumiant se FASS.

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Olumiant®▼ (baricitinib): Användning hos patienter med nedsatt leverfunktion

Ingen dosjustering av baricitinib behövs till patienter med lätt eller måttligt nedsatt leverfunktion.

Clinical Studies Excluded Patients With History of Chronic Liver Disease

Patients were excluded from participating in BARI phase 3 clinical studies of rheumatoid arthritis if they had a history of

  • chronic liver disease with the most recent available AST or ALT >1.5 times the ULN or the most recent available total bilirubin ≥1.5 times the ULN

  • active hepatitis B virus, hepatitis C virus, or human immunodeficiency virus, or

  • chronic alcohol abuse, intravenous drug abuse, or other illicit drug abuse within the 2 years prior to study entry.1

Pharmacokinetic Analyses of Special Populations

Systemic Exposure to Baricitinib in Subjects With Moderate Hepatic Impairment

A phase 1 study (JAGC) evaluated the effect of hepatic impairment on the PK of a single 4 mg dose of BARI in subjects with moderate hepatic impairment (based on Child-Pugh B classification) compared with healthy subjects.1

Based on study results, there was no evidence to suggest any clinically relevant difference in systemic exposure in subjects with moderate hepatic impairment compared with subjects with normal hepatic function.1

Effect of Hepatic Transaminase and Bilirubin Covariates on the Pharmacokinetics of Baricitinib

Data from 4 phase 3 studies were pooled with 3 phase 2 studies in a combined population PK analysis. In the pooled analysis, potential covariates evaluated were

  • ALT, (mean=20.6 U/L; range=4 to 175 U/L),

  • AST, (mean=20.4 U/L; range=5 to 97 U/L), and

  • total bilirubin (mean=6.0 μM; range=2.0 to 35.9 μM).

Neither ALT nor AST, or bilirubin was found to have a significant effect on the PK of BARI.1

In summary, moderate hepatic dysfunction did not affect BARI PK, and no dose adjustment is recommended for patients with mild or moderate hepatic impairment.

Information From the Label

There was no clinically relevant effect on the PK of baricitinib in patients with mild or moderate hepatic impairment. The use of baricitinib has not been studied in patients with severe hepatic impairment.2

Dose dependent increases in blood alanine transaminase (ALT) and aspartate transaminase (AST) activity were reported in patients treated with baricitinib compared to placebo. Increases in ALT and AST to ≥ 5 and ≥ 10 x upper limit of normal (ULN) were reported in less than 1 % of patients in clinical trials. In rheumatoid arthritis clinical studies in treatment-naïve patients, combination with methotrexate resulted in increased frequency of hepatic transaminase elevations compared with baricitinib monotherapy.2

If increases in ALT or AST are observed during routine patient management and drug-induced liver injury is suspected, baricitinib should be temporarily interrupted until this diagnosis is excluded.2

In rheumatoid arthritis controlled studies, for up to 16 weeks, alanine transaminase (ALT) and aspartate transaminase (AST) elevations ≥ 3 x upper limit of normal (ULN) were observed in

  • 1.4 % and 0.8 % of patients treated with Baricitinib, compared to

  • 1.0 % and 0.8 % respectively of patients treated with placebo.2

Dose dependent increases in blood ALT and AST activity were also reported in studies extended over week 16. Most cases of hepatic transaminase elevations were asymptomatic and transient. The pattern and incidence of elevation in ALT/AST remained stable over time including in the long-term extension study.2

References

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

2. Olumiant [summary of product characteristics]. Eli Lilly Nederland B.V., The Netherlands.

Glossary

ALT = alanine aminotransferase

AST = aspartate aminotransferase

BARI = baricitinib

PK = pharmacokinetic

ULN = upper limit of normal

This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.

Datum fӧr senaste ӧversyn 2019 M01 14


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