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Olumiant

BARICITINIB

Manufacturer: Eli Lilly and Company

Score: 144.0

Quick Summary

Olumiant (Baricitinib) is a Janus kinase (JAK) inhibitor used to treat adult patients with moderately to severely active rheumatoid arthritis, COVID-19 in hospitalized adults, and severe alopecia areata. Key clinical findings indicate its efficacy in these conditions, but it also carries important safety information, including warnings about serious infections, mortality, malignancy, major adverse cardiovascular events, and thrombosis. The drug has specific dosing recommendations, including initial dosing and potential adjustments based on patient conditions. Special population considerations, such as use during pregnancy, in nursing mothers, pediatric use, and geriatric use, are also crucial for safe administration.

Key Clinical Findings and Indications

  • Treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more TNF blockers
  • Treatment of COVID-19 in hospitalized adults requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or ECMO
  • Treatment of adult patients with severe alopecia areata

Important Safety Information

Warning

Increased risk of serious bacterial, fungal, viral and opportunistic infections leading to hospitalization or death, including tuberculosis (TB)

Contraindications

  • None

Adverse Reactions

  • Upper respiratory tract infections
  • Nausea
  • Herpes simplex
  • Herpes zoster
  • Thrombosis
  • Neutropenia
  • Anemia
  • Liver enzyme elevations

Dosing Recommendations

General Guidance

Dosage modifications are recommended for patients with renal or hepatic impairment, and for those taking strong OAT3 inhibitors

Rheumatoid Arthritis

Adult Dose

2 mg once daily

Pediatric Dose

Not established

COVID-19

Adult Dose

4 mg once daily for up to 14 days

Pediatric Dose

Not established

Alopecia Areata

Adult Dose

2 mg once daily, may increase to 4 mg once daily if response is not adequate

Pediatric Dose

Not established

Special Population Considerations

Pregnancy

  • Based on animal studies, may cause fetal harm
  • Insufficient data in humans to inform a drug-associated risk

Nursing Mothers

  • No data available

Pediatric Use

  • Safety and effectiveness not established

Geriatric Use

  • No overall differences in safety or effectiveness observed between geriatric and younger patients
  • Care should be taken in dose selection due to decreased renal function