BARICITINIB

Background and Date of Approval

Baricitinib received initial approval from the United States Food and Drug Administration (FDA) on 31 May 2018.

Uses

Baricitinib is primarily indicated for treating moderate to severe rheumatoid arthritis in adults who have not adequately responded to conventional disease-modifying antirheumatic drugs (DMARDs). It is employed to alleviate inflammation and manage autoimmune conditions. Additionally, its potential applications extend to other autoimmune disorders and inflammatory conditions.

How is it administered?

Baricitinib is typically administered orally, which means it is taken by mouth as tablets. It is available as an oral tablet for easy ingestion. Your healthcare provider will determine the specific dosage and frequency of administration based on your medical condition and individual needs.

Side Effects

Common side effects of Baricitinib include upper respiratory tract infections, headaches, increased liver enzymes, elevated blood pressure, alterations in blood cell counts, and increased cholesterol levels. Serious side effects include increased susceptibility to serious infections, blood clot risk, potential for malignancies, gastrointestinal perforations, liver abnormalities, and reactivation of hepatitis B. Additional concerns comprise cardiovascular risks, interstitial lung disease exacerbation, mental health changes, skin cancer risk, potential exacerbation of diabetes, and surgery.

Warnings

Baricitinib can increase the risk of serious infections, including tuberculosis, bacterial, fungal, and viral infections. There is a potential increased risk of blood clots, which could lead to deep vein thrombosis or pulmonary embolism. The use of this medication may be associated with an increased risk of certain cancers, including lymphoma. There is a risk of gastrointestinal perforations, particularly in individuals with diverticulitis or gastrointestinal issues. It can impact liver enzymes. It might be associated with mood changes and depression.

Precautions

Screen for TB before starting Baricitinib. Individuals with latent TB should be treated before initiating treatment. Individuals with active infections should avoid using Baricitinib. Individuals at higher risk of blood clots require close monitoring. Regular cancer screenings are recommended. Regular monitoring of liver function is advised. Avoid live vaccines while on Baricitinib due to the potential for reduced vaccine efficacy. Monitor mental health closely.

Word of Advice

Assess cardiovascular health with your doctor before initiating Baricitinib. Monitor blood glucose levels routinely; inform your doctor if diabetes management adjustments are required. Gastrointestinal perforation, liver abnormalities, and gastrointestinal complications warrant clinical attention. Regular monitoring of liver enzymes, lipid profile, and blood pressure is necessary. Hepatitis B screening should be performed prior to treatment commencement. Vaccination schedules may require modification. Pre-existing or planned abdominal surgery, stomach and intestinal disorders, cataracts, and drug allergies must be discussed with your doctor. Exercise caution in patients with a history of or risk factors for interstitial lung disease, as Baricitinib may worsen this condition. The risk of lymphoma and other malignancies may be increased with this medication. Minimise sun exposure and report any skin changes to your doctor. Periodic ophthalmological examination is recommended.

References

Eli Lilly and Company Limited, US Food and Drug Administration, [Revised on 5/2022] [Accessed on 29th Aug 2023], / https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/207924s006lbl.pdf Eli Lilly and Company Limited, Electronic Medicines Compendium (EMC), [Revised on 23rd Mar 2023] [Accessed on 29th Aug 2023], https://www.medicines.org.uk/emc/product/909/smpc#gref

Frequently Asked Questions

What infections should I be concerned about while taking Baricitinib?

Baricitinib may increase the risk of serious infections. Tuberculosis (TB) should be ruled out before starting treatment.

Does Baricitinib increase the risk of blood clots?

Yes, Baricitinib may increase the risk of blood clots, particularly in individuals at higher risk. Close monitoring is recommended.

When can I expect to see results from Baricitinib?

The onset of improvement can vary. Some individuals may experience symptom relief within weeks, while others might take longer to respond.

Should I stop Baricitinib if I feel better?

No, following your healthcare provider's instructions is important and not discontinuing Baricitinib without consulting them, even if your symptoms improve.

How do I safely discontinue Baricitinib if needed?

Stopping Baricitinib should be discussed with your healthcare provider to avoid potential flare-ups of your condition.

Are mental health changes possible with Baricitinib?

Yes, mood changes and depression have been reported with Baricitinib. Monitor mental health and seek help if needed.

Available Brands 5

Written By: Muskan Patel, M.Pharm

Reviewed By: Dr. Vishwa Patel, MBBS