Olumiant ® ▼ (baricitinib)

Can I give Olumiant®▼ (baricitinib) and oral contraceptives concomitantly in patients with rheumatoid arthritis?

The concomitant use of baricitinib and oral contraceptives is not contraindicated. In rheumatoid arthritis clinical trials, some patients treated with baricitinib were taking concomitant oral contraceptives.

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Clinical trial exclusion criteria 

Women of childbearing potential were excluded from the study if they did not agree to use 2 forms of highly effective birth control when having sex during the study and for at least 28 days after the last dose.1

Pharmacokinetics considerations 

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

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 P-glycoprotein (Pgp) inhibitor.2

Safety considerations based on the use of oral contraceptives and association of venous thromboembolism

In all BARI-treated patients with RA, risk factors possibly associated with venous thromboembolism (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, 2017.3

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

No association was observed between concomitant use of oral contraceptive pills or selective estrogen receptor modulators and incidence of VTE.1

Safety considerations based on the SmPC

Deep venous thrombosis (DVT) and pulmonary embolism (PE) are listed as uncommon in the table of adverse reactions in the summary of product characteristics. 4

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.4

If clinical features of DVT/PE occur,

  • discontinue baricitinib
  • evaluate your patient promptly, and
  • treat it appropriately.4

References

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

2Payne C, Zhang X, Shahri N, et al. Evaluation of potential drug-drug interactions with baricitinib. Ann Rheum Dis. 2015;74(suppl 2):1063. European League Against Rheumatism abstract AB0492. http://dx.doi.org/10.1136/annrheumdis-2015-eular.1627

3Eli 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

4Olumiant [summary of product characteristics]. Eli Lilly Nederland B.V., The Netherlands.

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.

Date of Last Review: March 11, 2021


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