Olumiant

• Increased risk of serious bacterial, fungal, viral and opportunistic infections leading to hospitalization or death, including tuberculosis (TB). Interrupt treatment with OLUMIANT if serious infection occurs until the infection is controlled. OLUMIANT should not be given to patients with active tuberculosis. Test for latent TB before and during therapy, except for COVID-19; treat latent TB prior to use. Monitor all patients for active TB during treatment, even patients with initial negative, latent TB test.
• Higher rate of all-cause mortality, including sudden cardiovascular death with another Janus kinase inhibitor (JAK) vs. TNF blockers in rheumatoid arthritis (RA) patients.
• Malignancies have occurred in patients treated with OLUMIANT. Higher rate of lymphomas and lung cancers with another JAK inhibitor vs. TNF blockers in RA patients.
• Higher rate of MACE (defined as cardiovascular death, myocardial infarction, and stroke) with another JAK inhibitor vs. TNF blockers in RA patients.
• Thrombosis has occurred in patients treated with OLUMIANT. Increased incidence of pulmonary embolism, venous and arterial thrombosis with another JAK inhibitor vs. TNF blockers.

OLUMIANT^® is a Janus kinase (JAK) inhibitor indicated for:

• the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more TNF blockers.

• the treatment of COVID-19 in hospitalized adults requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or ECMO.
• the treatment of adult patients with severe alopecia areata.

Administration Instructions:

• See the full prescribing information for recommended evaluations and immunizations prior to treatment.
• Rheumatoid Arthritis and Alopecia Areata:
  Avoid initiation or interrupt OLUMIANT in patients with anemia (hemoglobin <8 g/dL), lymphopenia (ALC <500 cells/mm³) or neutropenia (ANC <1000 cells/mm³).
• COVID-19:
  Avoid initiation or interrupt OLUMIANT in patients with lymphopenia (ALC <200 cells/mm³) or neutropenia (ANC <500 cells/mm³).

• 2 mg once daily.
• OLUMIANT may be used as monotherapy or in combination with methotrexate or other non-biologic DMARDs.

• 4 mg once daily for up to 14 days.

• 2 mg once daily. Increase to 4 mg once daily, if the response to treatment is not adequate.
• For patients with nearly complete or complete scalp hair loss, with or without substantial eyelash or eyebrow hair loss, consider treating with 4 mg once daily.
• Reduce the dose to 2 mg once daily when an adequate response has been achieved.

• See the full prescribing information for dosage modifications by indication.

OLUMIANT is available as debossed, film-coated tablets:

• 1 mg tablet contains a recessed area on each face of the tablet surface, is very light pink, round, debossed with “Lilly” on one side and “1” on the other.
• 2 mg tablet contains a recessed area on each face of the tablet surface, is light pink, oblong, debossed with “Lilly” on one side and “2” on the other.
• 4 mg tablet contains a recessed area on each face of the tablet surface, is medium pink, round, debossed with “Lilly” on one side and “4” on the other.

• Hepatic Impairment
  : Not recommended in patients with RA or AA and severe hepatic impairment. OLUMIANT has not been studied in patients with COVID-19 and severe hepatic impairment.
• Renal Impairment
  : Not recommended in COVID-19 patients with eGFR <15 mL/min/1.73m², who are on dialysis, have ESRD, or acute kidney injury. OLUMIANT is not recommend in patients with RA or AA with eGFR <30 mL/min/1.73m².
• Pregnancy
  : Based on animal data, may cause fetal harm.
• Lactation
  : Advise not to breastfeed.