Olumiant ® (baricitinib) tabletter

För fullständig produktresumé för Olumiant se FASS.

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Olumiant® ▼ (baricitinib): Samtidig användning med orala preventivmedel

Vid kliniska studier av reumatoid artrit (RA) fick vissa patienter som behandlades med baricitinib samtidigt orala preventivmedel.

Clinical Trial Criteria Related to Birth Control

Patients were excluded from participating in BARI RA clinical studies if they were women of childbearing potential who did not agree to use 2 forms of highly effective birth control when engaging in sexual intercourse while enrolled in the study and for at least 28 days following the last dose of study treatment.1

Potential for Drug-Drug Interactions

Based on clinical pharmacology studies, BARI had no effect on the pharmacokinetics of the components of Microgynon® (Bayer, United Kingdom), a CYP 3A substrate.2

In addition, no clinically relevant effects on BARI pharmacokinetics occurred with the co-administration of BARI and

  • a CYP 3A inhibitor

  • a CYP2C19/CYP2C9/CYP 3A inhibitor

  • a CYP 3A inducer, or

  • a Pgp inhibitor.2

Thrombosis Risk

DVT and PE are listed as uncommon in the table of adverse reactions in the summary of product characteristics. 3

Events of deep venous thrombosis (DVT) and pulmonary embolism (PE) have been reported in patients receiving baricitinib. Baricitinib should be used with caution in patients with risk factors for DVT/PE, such as older age, obesity, a medical history of DVT/PE, or patients undergoing surgery and immobilisation. If clinical features of DVT/PE occur, baricitinib treatment should be discontinued and patients should be evaluated promptly, followed by appropriate treatment.3

Baseline Use of Oral Contraceptives and Association of VTE

In all BARI-treated patients with rheumatoid arthritis, risk factors possibly associated with VTE events were evaluated in a single- and multi-variable analysis comparing the risks between patients with (n=42) and without events (n=3450) using data through April 1, 2017.4

Concomitant use of BARI and oral contraceptive pills or selective estrogen receptor modulators was observed in

  • 3 (7.1%) of the 42 patients with VTE, and

  • 214 (6.2%) of the 3450 patients without VTE.1

Based on the analysis, no association was observed between concomitant use of oral contraceptive pills or selective estrogen receptor modulators and incidence of VTE.1

References

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

2. Payne C, Zhang X, Shahri N, et al. Evaluation of potential drug-drug interactions with baricitinib [abstract]. Ann Rheum Dis. 2015;74(suppl 2):1063. http://dx.doi.org/10.1136/annrheumdis-2015-eular.1627

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

4. Eli Lilly and Company. Lilly FDA Advisory Committee Meeting NDA 207924 Briefing Document. https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/ArthritisAdvisoryCommittee/UCM605062.pdf. Accessed July 23, 2018. https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/ArthritisAdvisoryCommittee/UCM605062.pdf

Glossary

BARI = baricitinib

CYP = cytochrome P450

DVT = deep vein thrombosis

Microgynon® = ethinyl estradiol and levonorgestrel

PE = pulmonary embolism

Pgp = P-glycoprotein

RA = rheumatoid arthritis

VTE = venous thromboembolism

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 2018 M07 26


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