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If you wish to report an adverse event (side effect) or product complaint with a Lilly product, please call Lilly UK on 01256 315 000 (UK) or 016640446 (Ireland). Additionally reporting forms for adverse events and further information can be found at yellowcard.mhra.gov.uk or search for MHRA Yellow Card in the Google Play or Apple App Store (UK) or www.hpra.ie (Ireland).

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Safety and Monitoring

Olumiant was clinically tested in more than 3400 patients3

Olumiant® (baricitinib) is the first JAK inhibitor approved for rheumatoid arthritis (RA) in the EU.4


Olumiant was studied in a robust Phase III clinical trial programme in adult patients with moderate to severe active RA with an inadequate response to MTX and other CDMARDS, and who were biologically naïve.2


Olumiant was clinically tested in more than 3400 patients overall, representing more than 4,000 patient-years of exposure.3

Over 90% of patients completing an Olumiant clinical study continued into the RA-BEYOND study; an ongoing, 5-year follow-up safety trial.5


The adverse events reported most commonly (≥2%) with Olumiant monotherapy or in combination with conventional synthetic DMARDs comprised of increased LDL cholesterol (33.6%), upper respiratory tract infections (14.7%), and nausea (2.8%).1 Infections reported with Olumiant treatment included Herpes zoster. However, these infections ocurred in fewer than one in ten patients.1


Adverse Events Profile1

Watch Professor Peter Taylor discuss the saftey profile of baricitinib

Special warnings and precautions for use1


This section summarises the special warnings and precautions associated with Olumiant use for rheumatoid arthritis patients. For further information and full detail, please refer to the Summary of Product Characteristics which can be found on the right-hand side of this page.


Infections1

Olumiant is associated with an increased rate of infections compared to placebo. The risks and benefits of treatment with Olumiant should be carefully considered prior to initiating therapy in patients with active, chronic or recurrent infections. If an infection develops, the patient should be monitored carefully and Olumiant therapy should be temporarily interrupted if the patient is not responding to standard therapy. Olumiant treatment should not be resumed until the infection resolves.
Patients should be screened for tuberculosis (TB) before starting Olumiant therapy. Olumiant should not be given to patients with active TB.

Viral reactivation1

Viral reactivation, including cases of herpes virus reactivation (e.g.herpes zoster, herpes simplex) were reported in clinical studies. If a patient develops herpes zoster, Olumiant treatment should be temporarily interrupted until the episode resolves. Screening for viral hepatitis should be performed in accordance with clinical guidelines before starting therapy with Olumiant.

Vaccination1

No data is available on the response to vaccination with live vaccines in patients receiving Olumiant. Use with live, attenuated vaccines during, or immediately prior to, Olumiant therapy is not recommended. Prior to initiating Olumiant, it is recommended that all patients be brought up to date with all immunisations in agreement with current immunisation guidelines.

Malignancy1

The risk of malignancies including lymphoma is increased in patients with rheumatoid arthritis. Immunomodulatory medicinal products may increase the risk of malignancies including lymphoma. The clinical data is insufficient to assess the potential incidence of malignancies following exposure to Olumiant. Long-term safety evaluations are ongoing.

Contraindications with Olumiant1

Please refer to the SPC for further confirmation.

Watch Professor Peter Taylor talk through the contraindications and precautions for baricitinib

Monitoring1


Lipid parameters should be assessed approximately 12 weeks following initiation of Olumiant therapy and thereafter patients should be managed according to international clinical guidelines for hyperlipidaemia.


Laboratory measures for ANC, ALC, haemoglobin and liver transaminases should be recorded before treatment initiation and thereafter according to routine patient management.

*ANC - Absolute neutrophil
**ALC - Absolute lymphocyte count

Hear Professor Peter Taylor's monitoring guidance for baricitinib

References

  1. Olumiant (baricitinib) tablets. Summary of Product Characteristics. Eli Lilly and Company Limited, 2018
  2. Taylor PC, et al. N Engl J Med 2017;376(7):652-62.
  3. Smolen JS, et al. Ann Rheum Dis 2016;75:243-4
  4. European Medicines Agency. Available at ema.europa.eu [Accessed August 2018].
  5. Lilly DoF Patient Disposition 2016

©2018 Eli Lilly and Company. All rights reserved. The Olumiant mark and Olumiant design are the trademarks of Eli Lilly and Company.


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