The link you clicked on will take you to a site maintained by a third party, which is solely responsible for its content. Eli Lilly and Company does not control, influence, or endorse this site, and the opinions, claims or comments expressed on this site should not be attributed to Eli Lilly and Company. Eli Lilly and Company is not responsible for the privacy policy of any third party websites. We encourage you to read the privacy policy of every website you visit.
Tips for searching:
• You have to select a product and type at least 2 words to activate the search
• Use only words that are specific to the information you are looking for
• Avoid typing questions or sentences
Please do not use this field to report adverse events or product complaints. Adverse events and product complaints should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search for MHRA Yellow card in the Google play or Apple app store. Adverse events and product complaints should also be reported to Lilly: please call Lilly UK on 01256 315 000.
This information is intended for UK registered healthcare professionals only in response to your search for information. For current information for all Lilly products, including Summaries of Product Characteristics, Patient Information Leaflets and Instructions for Use, please visit: www.medicines.org.uk
How to manage the risk of venous thromboembolism?
Clinical trial criteria related to birth control
Efficacy and safety of baricitinib in patients with concomitant oral contraceptives
Is there a potential for drug-drug interactions between baricitinib and oral contraceptives?
In patients with known venous thromboembolism (VTE) risk factors other than cardiovascular or malignancy risk factors, baricitinib should be used with caution. VTE risk factors other than cardiovascular or malignancy risk factors include use of combined hormonal contraceptives. 1
Please refer to the following sections of the Baricitinib Lilly Summary of Product Characteristics (SmPC) for information on how to manage the risk of VTE with baricitinib use:
4.3 Contraindications
4.4 Special warnings and precautions for use
4.6 Fertility, pregnancy and lactation
4.8 Undesirable effects
Baricitinib should only be used if no suitable treatment alternatives are available in patients:
Patients were excluded from participating in baricitinib 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.2
For full information on baricitinib clinical trials in rheumatoid arthritis, please refer to the section 5.1 of the summary of product characteristics (SmPC).1
Thorough subgroup analyses of the efficacy and safety of concomitant use of baricitinib and oral contraceptives have not been conducted.
Summary of Concomitant Hormone Modulators Used in Each Baricitinib Rheumatoid Arthritis Clinical Trials presents the percentages of patients with concomitant use of hormone modulators including contraceptives in the 4 pivotal phase 3 clinical trials in adults with RA.
Treatment Arm |
Treatment Arm |
Treatment Arm |
|
RA-BEGIN (N=584) |
MTX |
Baricitinib 4 mg |
Baricitinib 4 mg plus MTX |
Total, n (%) |
15 (7.1) |
18 (11.3) |
20 (9.3) |
Eugynon®c |
3 (1.4) |
3 (1.9) |
4 (1.9) |
Estradiol |
0 |
1 (0.6) |
3 (1.4) |
Drospirenone |
0 |
4 (2.5) |
2 (0.9) |
Drospirenone w/ ethinylestradiol |
2 (1.0) |
3 (1.9) |
2 (0.9) |
Ethinylestradiol |
0 |
5 (3.1) |
1 (0.5) |
Diane®d |
2 (1.0) |
1 (0.6) |
0 |
RA-BEAM (N=1305) |
Placebo |
Baricitinib 4 mg |
Adalimumab |
Total, n (%) |
38 (7.8) |
44 (9.0) |
19 (5.8) |
Drospirenone w/ ethinylestradiol |
5 (1.0) |
10 (2.1) |
2 (0.6) |
Eugynonc |
8 (1.6) |
6 (1.2) |
3 (0.9) |
Ethinylestradiol |
3 (0.6) |
4 (0.8) |
0 |
RA-BUILD (N=684) |
Placebo |
Baricitinib 2 mg |
Baricitinib 4 mg |
Total, n (%) |
19 (8.3) |
21 (9.2) |
19 (8.4) |
Eugynonc |
6 (2.6) |
5 (2.2) |
4 (1.8) |
Drospirenone w/ethinylestradiol |
2 (0.9) |
0 |
2 (0.9) |
Estradiol |
1 (0.4) |
4 (1.7) |
1 (0.4) |
RA-BEACON (N=527) |
Placebo |
Baricitinib 2 mg |
Baricitinib 4 mg |
Total, n (%) |
15 (8.5) |
9 (5.2) |
16 (9.0) |
Estradiol |
4 (2.3) |
3 (1.7) |
5 (2.8) |
Eugynonc |
2 (1.1) |
4 (2.3) |
3 (1.7) |
Medroxyprogesterone |
1 (0.6) |
0 |
2 (1.1) |
Abbreviations: ATC = Anatomical Therapeutic Chemical; MTX = methotrexate.
aCategorized by Anatomical Therapeutic Chemical classification
bPresenting only preferred name medications totaling ≥0.5% across all the treatment arms.
cContains ethinylestradiol and norgestrel.
dContains cyproterone acetate and ethinylestradiol.
Based on clinical pharmacology studies, baricitinib had no effect on the pharmacokinetics of the components of Microgynon®, Bayer, United Kingdom (ethinyl estradiol and levonorgestrel), a cytochrome P450 (CYP) 3A substrate.5
In addition, no clinically relevant effects on baricitinib pharmacokinetics occurred with the co-administration of baricitinib and
In clinical pharmacology studies, coadministration of baricitinib with the CYP3A substrates simvastatin, ethinyl oestradiol, or levonorgestrel resulted in no clinically meaningful changes in the PK of these medicinal products.1
For full information on interactions of baricitinib with other medicinal products please refer to the summary of product characteristics, section 4.5 and 5.2.
The treating physician may use the information provided, the patient’s prior medical history and other concomitant medications, and other individual factors, in formulating an assessment and approach. The treating physician should consider potential risks and benefits of treatment options and monitor appropriately.
1Baricitinib Lilly [summary of product characteristics]. Eli Lilly Nederland B.V., The Netherlands (UK).
2Data on file, Eli Lilly and Company and/or one of its subsidiaries.
3Micromedex Solutions® Pharmaceutical Knowledge: Diane®. In: IBM Micromedex, Armonk, New York: IBM, Inc. http://www.Micromedex.com. Accessed February 8, 2024.
4Micromedex Solutions® Pharmaceutical Knowledge: Eugynon®. In: IBM Micromedex, Armonk, New York: IBM, Inc. http://www.Micromedex.com. Accessed February 8, 2024.
5Payne 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
Links to references and third-party websites are provided solely for your convenience and to facilitate easy access to the sources cited.
Date of Last Review: 23 January 2024