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BaricitinibSnapshot

Indication and Dosage

NOTE: This information is based on international data. Refer to local guidance for specific approved regimens.

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

ADMINISTRATION: (3)

  • Oral once daily with or without food

Precautions

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

Adverse Reactions

  • 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

Drug Interactions

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