Olumiant ® (baricitinib) tabletter

För fullständig produktresumé för Olumiant se FASS.

Denna information är endast avsedd för sjukvårdspersonal verksam i Sverige och som svar på din fråga. Informationen nedan är på engelska

Hur ska Olumiant® (baricitinib) användas hos patienter med atopisk dermatit med nedsatt leverfunktion?

Ingen dosjustering krävs hos patienter med lätt eller måttligt nedsatt leverfunktion. Användningen av baricitinib har inte studerats hos patienter med allvarligt nedsatt leverfunktion och rekommenderas därför inte.

SE_cFAQ_BAR050B_HEPATIC_IMPAIRMENT_AD
SE_cFAQ_BAR050B_HEPATIC_IMPAIRMENT_AD
en-GB

Baricitinib Label Information Related to Hepatic Impairment

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.1

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.1

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.1

Please refer to section 4.8 of the Olumiant Summary of Product Characteristics for further information on this topic.

Clinical Studies Excluded Patients With History of Chronic Liver Disease

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

  • a hepatic disorder that could constitute an unacceptable risk when taking investigational product or interfere with the interpretation of data
  • laboratory abnormalities at screening of AST, ALT, or ALP >2 times the ULN or 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.2

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.3

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.3

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

Data from 4 RA phase 3 studies were pooled with 3 RA 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.2

In summary, moderate hepatic dysfunction did not affect BARI PK, and no dose adjustment is recommended for patients with mild or moderate hepatic impairment.2

References

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

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

3A pharmacokinetic study of baricitinib in participants with liver disease. ClinicalTrials.gov website. https://clinicaltrials.gov/ct2/show/results/NCT01870388 . Updated June 6, 2017. Accessed February 25, 2020.

Glossary

ALP = alkaline phosphate

ALT = alanine aminotransferase

AST = aspartate aminotransferase

BARI = baricitinib

PK = pharmacokinetic

RA = rheumatoid arthritis

ULN = upper limit of normal

Datum fӧr senaste ӧversyn 2020 M02 10


Kontakta Medicinsk Information på Lilly

Kontakta oss på telefon

Kontorstid vardagar 9.00-17.00

Eller så kan du

Klicka för att chatta är tillgänglig

Klicka för att chatta är offline

Skriv din fråga till oss