More than 5000 patients have been treated with Olumiant in clinical trials^1,2

Patient Years of Exposure (PYE) for Olumiant

Clinical Trial Exposure — 1868 PYE in 1303 patients with severe alopecia areata, and 15,114 PYE in 3770 patients with moderate to severe rheumatoid arthritis.

^*As of November 2021, median exposure of 532 days and maximum exposure of 1128 days across two randomized AA clinical trials (N=1303).

^†As of November 2021, median exposure of 4.6 years and maximum exposure of 9.3 years across nine randomized RA clinical trials and one long-term extension trial (N=3770).

Alopecia Areata Safety

SELECT IMPORTANT SAFETY INFORMATION: WARNING RELATED TO SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS, AND THROMBOSIS

SERIOUS INFECTIONS: Olumiant-treated patients are at increased risk of serious bacterial, fungal, viral and opportunistic infections leading to hospitalization or death, including tuberculosis (TB). Interrupt treatment with Olumiant if a 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.

MORTALITY: Higher rate of all-cause mortality, including sudden cardiovascular death was observed with another Janus kinase (JAK) inhibitor vs. tumor necrosis factor (TNF) blockers in rheumatoid arthritis (RA) patients.

MALIGNANCIES: Malignancies have also occurred in patients treated with Olumiant. Higher rate of lymphomas and lung cancers was observed with another JAK inhibitor vs. TNF blockers in RA patients.

MAJOR ADVERSE CARDIOVASCULAR EVENTS (MACE): Higher rate of MACE (defined as cardiovascular death, myocardial infarction, and stroke) was observed with another JAK inhibitor vs. TNF blockers in RA patients.

THROMBOSIS: Thrombosis has occurred in patients treated with Olumiant. Increased incidence of pulmonary embolism, venous and arterial thrombosis was observed with another JAK inhibitor vs. TNF blockers.

In adult alopecia areata trials

Summary of TEAEs through week 36³

Most TEAEs were mild or moderate in severity

BRAVE-AA1 and BRAVE-AA2 (Pooled Results): Overview of Adverse Events

36-Week Placebo-Controlled Period

	Placebo (N=371)	Olumiant 2 mg/day (N=365)	Olumiant 4 mg/day (N=540)
Any TEAE	Placebo (N=371): 211 (56.9%)	Olumiant 2 mg/day (N=365): 221 (60.5%)	Olumiant 4 mg/day (N=540): 341 (63.1%)
TEAE severity
Mild	Placebo (N=371): 122 (32.9%)	Olumiant 2 mg/day (N=365): 136 (37.3%)	Olumiant 4 mg/day (N=540): 200 (37.0%)
Moderate	Placebo (N=371): 78 (21.0%)	Olumiant 2 mg/day (N=365): 79 (21.6%)	Olumiant 4 mg/day (N=540): 120 (22.2%)
Severe	Placebo (N=371): 11 (3.0%)	Olumiant 2 mg/day (N=365): 6 (1.6%)	Olumiant 4 mg/day (N=540): 21 (3.9%)
Serious AE	Placebo (N=371): 6 (1.6%)	Olumiant 2 mg/day (N=365): 8 (2.2%)	Olumiant 4 mg/day (N=540): 14 (2.6%)
Permanent discontinuation of study drug due to AE	Placebo (N=371): 6 (1.6%)	Olumiant 2 mg/day (N=365): 8 (2.2%)	Olumiant 4 mg/day (N=540): 12 (2.2%)

AE=adverse event; TEAE=treatment-emergent adverse event.

In adult alopecia areata trials

Adverse reactions (≥1%) through week 36⁴

BRAVE-AA1 and BRAVE-AA2 (Pooled Results): Adverse Reactions That Occurred in ≥1% of Patients on Olumiant and More Frequently Than Placebo

36-Week Placebo-Controlled Period^*

	Placebo (N=371)	Olumiant 2 mg/day (N=365)	Olumiant 4 mg/day (N=540)
Upper respiratory tract infections^†	Placebo (N=371): 19.9%	Olumiant 2 mg/day (N=365): 18.4%	Olumiant 4 mg/day (N=540): 21.3%
Headache	Placebo (N=371): 5.4%	Olumiant 2 mg/day (N=365): 5.5%	Olumiant 4 mg/day (N=540): 6.6%
Acne^‡	Placebo (N=371): 2.2%	Olumiant 2 mg/day (N=365): 5.8%	Olumiant 4 mg/day (N=540): 5.9%
Hyperlipidemia^§	Placebo (N=371): 3.0%	Olumiant 2 mg/day (N=365): 3.6%	Olumiant 4 mg/day (N=540): 5.9%
Blood creatine phosphokinase increased	Placebo (N=371): 1.3%	Olumiant 2 mg/day (N=365): 0.8%	Olumiant 4 mg/day (N=540): 4.3%
Urinary tract infections^‖	Placebo (N=371): 2.2%	Olumiant 2 mg/day (N=365): 3.8%	Olumiant 4 mg/day (N=540): 3.7%
Liver enzyme elevations^¶	Placebo (N=371): 2.4%	Olumiant 2 mg/day (N=365): 1.1%	Olumiant 4 mg/day (N=540): 3.0%
Folliculitis^#	Placebo (N=371): 0.8%	Olumiant 2 mg/day (N=365): 1.4%	Olumiant 4 mg/day (N=540): 2.2%
Fatigue	Placebo (N=371): 1.1%	Olumiant 2 mg/day (N=365): 0.8%	Olumiant 4 mg/day (N=540): 2.2%
Lower respiratory tract infections^**	Placebo (N=371): 0.8%	Olumiant 2 mg/day (N=365): 2.2%	Olumiant 4 mg/day (N=540): 2.0%
Nausea	Placebo (N=371): 1.6%	Olumiant 2 mg/day (N=365): 2.7%	Olumiant 4 mg/day (N=540): 2.0%
Genital Candida infections^††	Placebo (N=371): 0.3%	Olumiant 2 mg/day (N=365): 2.2%	Olumiant 4 mg/day (N=540): 1.3%
Anemia	Placebo (N=371): 0.3%	Olumiant 2 mg/day (N=365): 0.3%	Olumiant 4 mg/day (N=540): 1.3%
Neutropenia^‡‡	Placebo (N=371): 0.8%	Olumiant 2 mg/day (N=365): 0.3%	Olumiant 4 mg/day (N=540): 1.3%
Abdominal pain^§§	Placebo (N=371): 2.2%	Olumiant 2 mg/day (N=365): 3.8%	Olumiant 4 mg/day (N=540): 0.9%
Herpes zoster	Placebo (N=371): 0.5%	Olumiant 2 mg/day (N=365): 1.4%	Olumiant 4 mg/day (N=540): 0.9%
Weight increased	Placebo (N=371): 0.3%	Olumiant 2 mg/day (N=365): 1.6%	Olumiant 4 mg/day (N=540): 0.9%

^*%-study size adjusted percentages.

^†Includes acute sinusitis, influenza, laryngitis, nasopharyngitis, oropharyngeal pain, pharyngitis, pharyngotonsillitis, rhinitis, sinusitis, tonsillitis, upper respiratory tract infection, viral upper respiratory tract infection, viral sinusitis, viral pharyngitis, respiratory tract infection viral, rhinovirus infection, and adenoiditis.

^‡Includes acne and dermatitis acneiform.

^§Includes hyperlipidemia, hypercholesterolemia, hypertriglyceridemia, dyslipidemia, lipids increased, low density lipoprotein increased, blood cholesterol increased, and blood triglycerides increased.

^‖Includes cystitis, urinary tract infection, white blood cells urine positive, urinary tract infection bacterial, and pyelonephritis.

^¶Includes transaminases increased, aspartate aminotransferase increased, alanine aminotransferase increased, hepatic enzyme increased, gamma-glutamyl transferase increased, and hepatic function abnormal.

^#Was most commonly localized in the scalp region associated with hair regrowth.

^**Includes bronchitis, bronchiolitis, lower respiratory tract infection, pneumonia, COVID-19 pneumonia, and respiratory tract infection.

^††Includes vulvovaginal candidiasis, vulvovaginal mycotic infection, and genital infection fungal.

^‡‡Includes neutropenia and neutrophil count decreased.

^§§Includes abdominal pain, abdominal pain lower, abdominal pain upper, and abdominal discomfort.

In adult alopecia areata trials

Adverse events (AEs) of special interest^3,5-11

BRAVE-AA1 and BRAVE-AA2 (Pooled Results): AEs of Special Interest

Weeks 0-36 (Placebo-Controlled Period)
n (%)

	Placebo (N=371)	Olumiant 2 mg/day (N=365)	Olumiant 4 mg/day (N=540)
Serious infections	Placebo (N=371): 0	Olumiant 2 mg/day (N=365): 2 (0.5%)	Olumiant 4 mg/day (N=540): 1 (0.2%)
Opportunistic infections	Placebo (N=371): 0	Olumiant 2 mg/day (N=365): 0	Olumiant 4 mg/day (N=540): 0
Malignancies other than NMSC^†	Placebo (N=371): 1 (0.3%)	Olumiant 2 mg/day (N=365): 0	Olumiant 4 mg/day (N=540): 1 (0.2%)
NMSC	Placebo (N=371): 0	Olumiant 2 mg/day (N=365): 0	Olumiant 4 mg/day (N=540): 0
MACE (adjudicated)^*	Placebo (N=371): 0	Olumiant 2 mg/day (N=365): 1 (0.3%)	Olumiant 4 mg/day (N=540): 0
VTE (adjudicated)	Placebo (N=371): 0	Olumiant 2 mg/day (N=365): 0	Olumiant 4 mg/day (N=540): 0

Weeks 0-52
n [IR/100 PYE]

	Olumiant 2 mg/day (N=365; PYE=340.50)	Olumiant 4 mg/day (N=540; PYE=516.53)
Serious infections	Olumiant 2 mg/day (N=365; PYE=340.50): 2 [0.6]	Olumiant 4 mg/day (N=540; PYE=516.53): 3 [0.6]
Opportunistic infections	Olumiant 2 mg/day (N=365; PYE=340.50): 0	Olumiant 4 mg/day (N=540; PYE=516.53): 0
Malignancies other than NMSC^†	Olumiant 2 mg/day (N=365; PYE=340.50): 0	Olumiant 4 mg/day (N=540; PYE=516.53): 2 [0.4]
NMSC	Olumiant 2 mg/day (N=365; PYE=340.50): 0	Olumiant 4 mg/day (N=540; PYE=516.53): 0
MACE (adjudicated)^*	Olumiant 2 mg/day (N=365; PYE=340.50): 1 [0.3]	Olumiant 4 mg/day (N=540; PYE=516.53): 0
VTE (adjudicated)	Olumiant 2 mg/day (N=365; PYE=340.50): 0	Olumiant 4 mg/day (N=540; PYE=516.53): 0

Extended Safety Analysis^*
n [IR/100 PYE]

	Olumiant 2 mg/day (N=595; PYE=640.16)	Olumiant 4 mg/day (N=996; PYE=1217.76)
Serious infections	Olumiant 2 mg/day (N=595; PYE=640.16): 4 [0.6]	Olumiant 4 mg/day (N=996; PYE=1217.76): 12 [1.0]
Opportunistic infections	Olumiant 2 mg/day (N=595; PYE=640.16): 1 [0.1]	Olumiant 4 mg/day (N=996; PYE=1217.76): 0
Malignancies other than NMSC^†	Olumiant 2 mg/day (N=595; PYE=640.16): 1 [0.1]	Olumiant 4 mg/day (N=996; PYE=1217.76): 2 [0.2]
NMSC	Olumiant 2 mg/day (N=595; PYE=640.16): 2 [0.3]	Olumiant 4 mg/day (N=996; PYE=1217.76): 0
MACE (adjudicated)^*	Olumiant 2 mg/day (N=595; PYE=640.16): 1 [0.1]	Olumiant 4 mg/day (N=996; PYE=1217.76): 0
VTE (adjudicated)	Olumiant 2 mg/day (N=595; PYE=640.16): 1 [0.1]^§	Olumiant 4 mg/day (N=996; PYE=1217.76): 0

^*The extended safety analysis of Olumiant includes all patients with AA who received at least 1 dose of Olumiant 2 mg/day or 4 mg/day in BRAVE-AA1 and BRAVE-AA2, with a median exposure of 532 days.

^†Weeks 0-36 includes the event of prostate cancer (placebo) and event of B-cell lymphoma (Olumiant 4 mg/day). Weeks 0-52 includes the event of prostate cancer (placebo) and events of B-cell lymphoma and breast cancer (Olumiant 4 mg/day). Extended safety analysis includes the event of chronic lymphocytic leukemia (Olumiant 2 mg/day) and events of B-cell lymphoma and breast cancer (Olumiant 4 mg/day).

^‡MACE was defined as adjudicated events of cardiovascular death, myocardial infarction, or stroke. The reported event was myocardial infarction (also adjudicated as arterial thromboembolism) in a patient with pre-existing cardiovascular risk factors.

^§An additional patient on Olumiant 2 mg/day not included in the extended safety analysis experienced both DVT and PE.

Certain adverse events, such as MACE and malignancy, require longer observation periods and larger patient exposure to ascertain risk.

Data cut-off dates for BRAVE-AA1 and BRAVE-AA2 (weeks 0-36) were February 2021 and January 2021, respectively. Data cut-off date for BRAVE-AA1 and BRAVE-AA2 (weeks 0-52 and extended safety analysis) was November 2021.

Patients considered at high risk of VTE, with significant cardiac history, current or recent serious infection, or malignancy within 5 years were excluded from clinical trials.

AE=adverse event; BMI=body mass index; MACE=major adverse cardiovascular event; NMSC=nonmelanoma skin cancer; PY=patient years.

SELECT IMPORTANT SAFETY INFORMATION: WARNING RELATED TO SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS, AND THROMBOSIS

MALIGNANCIES: Malignancies have also occurred in patients treated with Olumiant. Higher rate of lymphomas and lung cancers was observed with another JAK inhibitor vs. TNF blockers in RA patients.

In adult alopecia areata trials

Select lab changes through week 36³

BRAVE-AA1 and BRAVE-AA2 (Pooled Results): Summary of Laboratory Changes

36-Week Placebo-Controlled Period

Lab Abnormality	Description	Placebo (N=371)	Olumiant 2 mg/day (N=365)	Olumiant 4 mg/day (N=540)
Lab Abnormality
Anemia^*	Description: Hemoglobin Grade 3+ (<8.0 g/dL)	Placebo (N=371): 0	Olumiant 2 mg/day (N=365): 0	Olumiant 4 mg/day (N=540): 2 (0.4%)
Neutropenia^*	Description: Neutrophils Grade 3+ (<1000/mm³)	Placebo (N=371): 0	Olumiant 2 mg/day (N=365): 2 (0.6%)	Olumiant 4 mg/day (N=540): 5 (0.9%)
Lymphopenia^*	Description: Lymphocytes Grade 3+ (<500/mm³)	Placebo (N=371): 0	Olumiant 2 mg/day (N=365): 0	Olumiant 4 mg/day (N=540): 2 (0.4%)
Liver enzymes^†	Description: ALT ≥3x ULN	Placebo (N=371): 10 (2.7%)	Olumiant 2 mg/day (N=365): 7 (1.9%)	Olumiant 4 mg/day (N=540): 7 (1.3%)
Liver enzymes^†	Description: AST ≥3x ULN	Placebo (N=371): 8 (2.2%)	Olumiant 2 mg/day (N=365): 4 (1.1%)	Olumiant 4 mg/day (N=540): 6 (1.1%)
Lipids	Description: LDL cholesterol NCEP borderline high+ (≥130 mg/dL)	Placebo (N=371): 47 (17.7%)	Olumiant 2 mg/day (N=365): 59 (22.3%)	Olumiant 4 mg/day (N=540): 114 (28.1%)
Lipids	Description: HDL cholesterol NCEP high (≥60 mg/dL)	Placebo (N=371): 24 (11.9%)	Olumiant 2 mg/day (N=365): 76 (38.8%)	Olumiant 4 mg/day (N=540): 129 (42.4%)
Lipids	Description: Triglycerides NCEP very high (≥500 mg/dL)	Placebo (N=371): 3 (0.9%)	Olumiant 2 mg/day (N=365): 1 (0.3%)	Olumiant 4 mg/day (N=540): 4 (0.8%)

^*Percentages based on number of patients that had less than Grade 3 events at baseline.

^†Percentages based on number of patients with a minimum of 1 baseline and 1 post-baseline measure.

ALT=alanine aminotransferase; AST=aspartate aminotransferase; HDL=high-density lipoprotein; LDL=low-density lipoprotein; NCEP=National Cholesterol Education Program; ULN=upper limit of normal.

References:

Data on file. Lilly USA, LLC. DOF-BA-US-0077.
Taylor PC, Takeuchi T, Burmester GR, et al. Safety of baricitinib for the treatment of rheumatoid arthritis over a median of 4.6 and up to 9.3 years of treatment: final results from long-term extension study and integrated database. Ann Rheum Dis. Published online October 27, 2021. doi:10.1136/annrheumdis-2021-221276.
Data on file. Lilly USA, LLC. DOF-BA-US-0075.
Olumiant. Prescribing Information. Lilly USA, LLC.
Data on file. Lilly USA, LLC. DOF-BA-US-0078.
Data on file. Lilly USA, LLC. DOF-BA-US-0087.
Data on file. Lilly USA, LLC. DOF-BA-US-0089.
Data on file. Lilly USA, LLC. DOF-BA-US-0090.
Data on file. Lilly USA, LLC. DOF-BA-US-0091.
Data on file. Lilly USA, LLC. DOF-BA-US-0093.
King B, Ohyama M, Kwon O, et al. Two phase 3 trials of baricitinib for alopecia areata. N Engl J Med. 2022;386(18):1687-1699.

IMPORTANT SAFETY INFORMATION

WARNING:

SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS, AND THROMBOSIS

SERIOUS INFECTIONS -

Patients treated with Olumiant are at risk for developing serious infections that may lead to hospitalization or death. Most patients with rheumatoid arthritis (RA) who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. If a serious infection develops, interrupt Olumiant until the infection is controlled. Reported infections include:

Active tuberculosis (TB), which may present with pulmonary or extrapulmonary disease. Olumiant should not be given to patients with active tuberculosis. Test patients, except those with COVID-19, for latent TB before initiating Olumiant and during therapy. If positive, start treatment for latent infection prior to Olumiant use.
Invasive fungal infections, including candidiasis and pneumocystosis. Patients with invasive fungal infections may present with disseminated, rather than localized, disease.
Bacterial, viral, and other infections due to opportunistic pathogens.

Carefully consider the risks and benefits of Olumiant prior to initiating therapy in patients with chronic or recurrent infection.

Closely monitor patients for the development of signs and symptoms of infection during and after treatment with Olumiant including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy.

The most common serious infections reported with Olumiant included pneumonia, herpes zoster, and urinary tract infection. Among opportunistic infections, tuberculosis, multidermatomal herpes zoster, esophageal candidiasis, pneumocystosis, acute histoplasmosis, cryptococcosis, cytomegalovirus, and BK virus were reported with Olumiant. Some patients have presented with disseminated rather than localized disease, and were often taking concomitant immunosuppressants such as methotrexate or corticosteroids.

Avoid use of Olumiant in patients with an active, serious infection, including localized infections. Consider the risks and benefits of treatment prior to initiating Olumiant in patients: with chronic or recurrent infection; who have been exposed to TB; with a history of a serious or an opportunistic infection; who have resided or traveled in areas of endemic tuberculosis or endemic mycoses; or with underlying conditions that may predispose them to infection.

The risks and benefits of treatment with Olumiant in COVID-19 patients with other concurrent infections should be considered.

Consider anti-TB therapy prior to initiation of Olumiant in patients with a history of latent or active TB in whom an adequate course of treatment cannot be confirmed, and for patients with a negative test for latent TB but who have risk factors for TB infection.

Viral reactivation, including cases of herpes virus reactivation (e.g., herpes zoster), were reported in clinical studies with Olumiant. If a patient develops herpes zoster, interrupt Olumiant treatment until the episode resolves. The impact of Olumiant on chronic viral hepatitis reactivation is unknown. Screen for viral hepatitis in accordance with clinical guidelines before initiating Olumiant.

MORTALITY

In a large, randomized, postmarketing safety study in RA patients 50 years of age and older with at least one cardiovascular risk factor comparing another Janus kinase (JAK) inhibitor to tumor necrosis factor (TNF) blockers, a higher rate of all-cause mortality, including sudden cardiovascular death, was observed with the JAK inhibitor.

Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with Olumiant.

MALIGNANCIES

Lymphoma and other malignancies have been observed in patients treated with Olumiant. In RA patients treated with another JAK inhibitor, a higher rate of malignancies (excluding non-melanoma skin cancer [NMSC]) was observed when compared with TNF blockers. Patients who are current or past smokers are at additional increased risk. A higher rate of lymphomas was observed in patients treated with the JAK inhibitor compared to those treated with TNF blockers. A higher rate of lung cancers and an additional increased risk of overall malignancies were observed in current or past smokers treated with the JAK inhibitor compared to those treated with TNF blockers.

Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with Olumiant, particularly in patients with a known malignancy (other than successfully treated NMSC), patients who develop a malignancy, and patients who are current or past smokers.

NMSCs have been reported in patients treated with Olumiant. Periodic skin examination is recommended for patients who are at increased risk for skin cancer.

MAJOR ADVERSE CARDIOVASCULAR EVENTS

In RA patients 50 years of age and older with at least one cardiovascular risk factor treated with another JAK inhibitor, a higher rate of major adverse cardiovascular events (MACE) (defined as cardiovascular death, myocardial infarction [MI], and stroke) was observed when compared with TNF blockers. Patients who are current or past smokers are at additional increased risk. Discontinue Olumiant in patients that have experienced a myocardial infarction or stroke.

Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with Olumiant, particularly in patients who are current or past smokers and patients with other cardiovascular risk factors. Inform patients about the symptoms of serious cardiovascular events and the steps to take if they occur.

THROMBOSIS

Thrombosis, including deep venous thrombosis (DVT) and pulmonary embolism (PE), has been observed at an increased incidence in patients treated with Olumiant compared to placebo. In addition, there were cases of arterial thrombosis. Many of these adverse events were serious and some resulted in death. In RA patients 50 years of age and older with at least one cardiovascular risk factor treated with another JAK inhibitor, a higher rate of thrombosis was observed when compared with TNF blockers. Avoid Olumiant in patients at risk. Discontinue Olumiant and promptly evaluate patients with symptoms of thrombosis.

HYPERSENSITIVITY

Reactions such as angioedema, urticaria, and rash that may reflect drug hypersensitivity have been observed in patients receiving Olumiant, including serious reactions. If a serious hypersensitivity reaction occurs, promptly discontinue Olumiant while evaluating the potential causes of the reaction.

GASTROINTESTINAL PERFORATIONS

Gastrointestinal perforations have been reported in Olumiant clinical studies. Monitor Olumiant-treated patients who may be at increased risk for gastrointestinal perforation (e.g., patients with a history of diverticulitis). Promptly evaluate patients who present with new onset abdominal symptoms for early identification of gastrointestinal perforation.

LABORATORY ABNORMALITIES

Neutropenia - Olumiant treatment was associated with an increased incidence of neutropenia (absolute neutrophil count [ANC] <1000 cells/mm³) compared to placebo. Evaluate at baseline and thereafter according to routine patient management.

In patients with RA or alopecia areata (AA), avoid initiation or interrupt Olumiant treatment in patients with an ANC <1000 cells/mm³. In patients with COVID-19, avoid initiation or interrupt Olumiant treatment in patients with an ANC <500 cells/mm³.

Lymphopenia - Absolute lymphocyte count (ALC) <500 cells/mm³ were reported in Olumiant clinical trials. Lymphocyte counts less than the lower limit of normal were associated with infection in patients treated with Olumiant, but not placebo. Evaluate at baseline and thereafter according to routine patient management.

In patients with RA or AA, avoid initiation or interrupt Olumiant treatment in patients with an ALC <500 cells/mm³. In patients with COVID-19, avoid initiation or interrupt Olumiant treatment in patients with an ALC <200 cells/mm³.

Anemia - Decreases in hemoglobin levels to <8 g/dL were reported in Olumiant clinical trials. Evaluate at baseline and thereafter according to routine patient management.

In patients with RA or AA, avoid initiation or interrupt Olumiant treatment in patients with hemoglobin <8 g/dL. In patients with COVID-19, there is limited information regarding use of Olumiant in patients with hemoglobin less than 8 g/dL.

Liver Enzyme Elevations - Olumiant treatment was associated with increased incidence of liver enzyme elevation compared to placebo. Increases of alanine transaminase (ALT) ≥5x upper limit of normal (ULN) and increases of aspartate transaminase (AST) ≥10x ULN were observed in patients in Olumiant clinical trials.

Evaluate at baseline and thereafter according to routine patient management. Promptly investigate the cause of liver enzyme elevation to identify potential cases of drug-induced liver injury. If increases in ALT or AST are observed and drug-induced liver injury is suspected, interrupt Olumiant until this diagnosis is excluded.

Lipid Elevations - Treatment with Olumiant was associated with increases in lipid parameters, including total cholesterol, low-density lipoprotein cholesterol, and high-density lipoprotein cholesterol. Assess lipid parameters approximately 12 weeks following Olumiant initiation in patients with RA or AA. Manage patients according to clinical guidelines for the management of hyperlipidemia.

VACCINATIONS

Avoid use of live vaccines with Olumiant. Update immunizations in patients with RA or AA prior to initiating Olumiant therapy in agreement with current immunization guidelines.

ADVERSE REACTIONS

In RA trials, the most common adverse reactions (≥1%) reported with Olumiant were: upper respiratory tract infections, nausea, herpes simplex, and herpes zoster.

In COVID-19 trials, the most common adverse reactions (≥1%) reported with Olumiant were: ALT ≥3x ULN, AST ≥3x ULN, thrombocytosis (platelets >600,000 cells/mm³), creatine phosphokinase >5x ULN, neutropenia (ANC <1000 cells/mm³), DVT, PE, and urinary tract infection.

In AA trials, the most common adverse reactions (≥1%) reported with Olumiant were: upper respiratory tract infections, headache, acne, hyperlipidemia, creatine phosphokinase increase, urinary tract infections, liver enzyme elevations, folliculitis, fatigue, lower respiratory tract infections, nausea, genital Candida infections, anemia, neutropenia, abdominal pain, herpes zoster, and weight increase.

PREGNANCY AND LACTATION

Based on animal studies, Olumiant may cause fetal harm when administered during pregnancy. Advise pregnant women and women of reproductive potential of the potential risk to a fetus. Consider pregnancy planning and prevention for women of reproductive potential. Advise women not to breastfeed during treatment with Olumiant and for 4 days after the last dose.

HEPATIC AND RENAL IMPAIRMENT

Olumiant is not recommended in patients with RA or AA and severe hepatic impairment or severe renal impairment (estimated glomerular filtration rate [eGFR] <30 mL/min/1.73m²).

Olumiant should only be used in patients with COVID-19 and severe hepatic impairment if the potential benefit outweighs the potential risk. Olumiant is not recommended in patients with COVID-19 who are on dialysis, have end-stage renal disease, or with eGFR <15 mL/min/1.73m².

BA HCP ISI ALL 14SEP2022

Please click to access full Prescribing Information, including Boxed Warning about Serious Infections, Mortality, Malignancy, Major Adverse Cardiovascular Events, and Thrombosis, and Medication Guide.

INDICATIONS

Alopecia Areata

Olumiant is indicated for the treatment of adult patients with severe alopecia areata.

Limitations of Use: Not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, cyclosporine or other potent immunosuppressants.

Rheumatoid Arthritis

Olumiant is a Janus kinase (JAK) inhibitor indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more tumor necrosis factor (TNF) blockers.

Limitations of Use: Not recommended for use in combination with other JAK inhibitors, biologic disease-modifying antirheumatic drugs (DMARDs), or with potent immunosuppressants, such as azathioprine and cyclosporine.

COVID-19

Olumiant is a Janus kinase (JAK) inhibitor indicated for the treatment of coronavirus disease 2019 (COVID-19) in hospitalized adults requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).

More than 5000 patients have been treated with Olumiant in clinical trials1,2

Alopecia Areata Safety

Adverse reactions (≥1%) through week 364

Adverse events (AEs) of special interest3,5-11

Select lab changes through week 363

IMPORTANT SAFETY INFORMATION

WARNING:

SERIOUS INFECTIONS -

MORTALITY

MALIGNANCIES

MAJOR ADVERSE CARDIOVASCULAR EVENTS

THROMBOSIS

HYPERSENSITIVITY

GASTROINTESTINAL PERFORATIONS

LABORATORY ABNORMALITIES

VACCINATIONS

ADVERSE REACTIONS

PREGNANCY AND LACTATION

HEPATIC AND RENAL IMPAIRMENT

INDICATIONS

More than 5000 patients have been treated with Olumiant in clinical trials^1,2

Adverse reactions (≥1%) through week 36⁴

Adverse events (AEs) of special interest^3,5-11

Select lab changes through week 36³