BaricitinibSnapshot

Indication (1)

Restricted emergency use in combination with remdesivir for treatment of suspected or laboratory confirmed COVID-19 in hospitalized adults requiring supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO)

Dosage

• 2 mg and 4 mg doses approved for emergency use (duration unspecified) (1)

• Dosing regimens in clinical trials include: (2)

  • 4 mg PO daily (either orally or via nasogastric tube) for 14 days or until hospital discharge

  • 2 mg PO daily for patients with eGFR < 60 mL/min for 14 days or until hospital discharge

ADMINISTRATION: (3)

• Oral once daily with or without food

Infection:

• Consider the risks and benefits in patients with active or chronic infection that is not due to SARS-CoV-2

• Treatment has been associated with an increased rate of infection, with respiratory tract infections being the most common

• Screen for tuberculosis before starting treatment and do not give to patients with active tuberculosis; consider anti-tuberculosis therapy in patients with previously untreated latent tuberculosis

Thrombosis:

• Use caution in patients with risk factors for deep vein thrombosis/pulmonary embolism (DVT/PE) (e.g., elderly, obesity, surgery, immobilization, prior history of clots)

• Stop treatment and give appropriate medical care if signs of DVT or PE develop

Malignancy:

• Use caution in patients with a known cancer

• Increases risk of malignancies, including lymphoma

Neutropenia:

• Avoid in patients with absolute neutrophil count (ANC) < 1 x 109 cells/L

Lymphopenia:

• Avoid in patients with absolute lymphocyte count (ALC) < 0.5 x 109 cells/L

Anemia:

• Avoid in patients with hemoglobin < 8 gram/dL

Renal impairment:

• CrCl 30 to 60 mL/min: reduce dose to 2 mg daily

• CrCl < 30 mL/min: avoid use

Hepatic impairment:

• Not recommended for use in patients with severe hepatic impairment Interrupt therapy if drug-induced hepatic injury is suspected

Elderly (75 years or older):

• Reduce dose to 2 mg daily

Pregnancy:

• Contraindicated for use during pregnancy

• No adequate data regarding treatment of pregnant women

• Infections: upper respiratory tract infections, Herpes zoster and simplex, gastroenteritis, urinary tract infections, pneumonia

• Hematologic: neutropenia, lymphopenia, anemia, thrombocytosis, DVT, PE

• Hepatic: elevated hepatic enzymes

• Metabolic: hypercholesterolemia, hypertriglyceridemia

• Gastrointestinal: nausea

• Dermatologic: rash, acne, urticaria, face swelling

• Others: weight increase, increased CPK

Vaccinations:

• Avoid live, attenuated vaccines during or immediately prior to use

Strong OATP3 inhibitors (e.g., probenecid):

• Reduce dose to 2 mg daily

References:

1. Eli Lilly News Release. Lilly accelerating baricitinib's availability in India following receipt of permission for restricted emergency use as a COVID-19 therapy via donations and licensing agreements. Retrieved May 7, 2021. Available at on the World Wide Web at: https://investor.lilly.com/news-releases/news-release-details/lilly-accelerating-baricitinibs-availability-india-following

2. Kalil AC, Patterson TF, Mehta AK, et al. Baricitinib plus remdesivir for hospitalized adults with COVID-19. N Engl J Med 2021; 384(9):795-807.

3. Olumiant (baricitinib tablets) prescribing information. Haryana, India: Eli Lilly Company (India) Pvt. Ltd.; 2019 Dec. Available on the World Wide Web at: https://www.lillyindia.co.in/our-medicines/current-medicines