The Severity of Alopecia Tool (SALT) is used to measure scalp hair loss in alopecia areata1,2
The SALT measures scalp hair loss on a scale of 0 to 100
Image is for illustrative purposes only and is not representative of specific patients or efficacy data.
The SALT score, which ranges from 0-100, can be used to assess scalp hair loss. A SALT score of 100 indicates complete hair loss and a SALT score of 0 indicates no hair loss.
Interpretation of SALT scores:
SALT score of 100: Complete hair loss
SALT score of 50: 50% hair loss
SALT score of ≤20: 20% or less hair loss
SALT score of 0: No hair loss
Interpretation of SALT subscript scores:
SALT50: 50% hair regrowth from baseline
SALT90: 90% hair regrowth from baseline
Olumiant was studied as monotherapy in two phase 3 trials for adults with severe alopecia areata1,2
The primary endpoint was the proportion of patients achieving a SALT score of ≤20 at week 36
BRAVE-AA1 and BRAVE-AA2 Clinical Trial Design*
*BRAVE-AA1 was a phase 2/3 clinical trial and BRAVE-AA2 was a phase 3 clinical trial. Patient population shown for BRAVE-AA1 is for the phase 3 portion only.
Olumiant was studied in 2 clinical trials. BRAVE-AA1 enrolled 654 patients in the phase 3 portion. BRAVE-AA1 was a phase 2/3 trial and BRAVE-AA2 was a phase 3 clinical trial. BRAVE-AA2 enrolled 546 patients. Patients were randomized 2:2:3 to placebo, Olumiant 2 mg, or Olumiant 4 mg once daily. The primary endpoint was the proportion of patients achieving a SALT score of ≤20 at week 36.
Olumiant was studied in adults with a baseline SALT score of ≥50 and a current alopecia areata (AA) episode lasting >6 months and <8 years in duration.
Select inclusion criteria
- Males (18 to 60 years of age) and females (18 to 70 years of age)
- No spontaneous improvement over the past 6 months
- Patients with severe AA lasting ≥8 years were eligible only if episodes of regrowth were observed on affected areas over the past 8 years
SALT=Severity of Alopecia Tool.
Patients in the clinical trials had severe alopecia areata, with a mean scalp hair loss of 85% at baseline3
Patient Baseline Characteristics—Pooled Analysis From BRAVE-AA1 and BRAVE-AA2
Placebo (n=345)
|
Olumiant 2 mg/day (n=340)
|
Olumiant 4 mg/day (n=515)
| |
|---|---|---|---|
| Age (years), mean (SD) | Placebo (n=345): 37 (13) | Olumiant 2 mg/day (n=340): 38 (13) | Olumiant 4 mg/day (n=515): 37 (13) |
| Female | Placebo (n=345): 60% | Olumiant 2 mg/day (n=340): 62% | Olumiant 4 mg/day (n=515): 60% |
| Race | |||
| White | Placebo (n=345): 49% | Olumiant 2 mg/day (n=340): 55% | Olumiant 4 mg/day (n=515): 52% |
| Asian | Placebo (n=345): 38% | Olumiant 2 mg/day (n=340): 37% | Olumiant 4 mg/day (n=515): 35% |
| Black or African descent | Placebo (n=345): 10% | Olumiant 2 mg/day (n=340): 6% | Olumiant 4 mg/day (n=515): 9% |
| Duration since AA onset (years), mean (SD) | Placebo (n=345): 12 (11) | Olumiant 2 mg/day (n=340): 13 (11) | Olumiant 4 mg/day (n=515): 12 (11) |
| Duration of current AA episode (years), mean (SD) | Placebo (n=345): 4 (5) | Olumiant 2 mg/day (n=340): 4 (5) | Olumiant 4 mg/day (n=515): 4 (3) |
| <4 years | Placebo (n=345): 66% | Olumiant 2 mg/day (n=340): 68% | Olumiant 4 mg/day (n=515): 64% |
| ≥4 years | Placebo (n=345): 34% | Olumiant 2 mg/day (n=340): 32% | Olumiant 4 mg/day (n=515): 36% |
| Patients with universalis | Placebo (n=345): 41% | Olumiant 2 mg/day (n=340): 45% | Olumiant 4 mg/day (n=515): 46% |
| Patients with atopic background* | Placebo (n=345): 41% | Olumiant 2 mg/day (n=340): 38% | Olumiant 4 mg/day (n=515): 36% |
| SALT score, mean (SD) | Placebo (n=345): 85 (18) | Olumiant 2 mg/day (n=340): 86 (18) | Olumiant 4 mg/day (n=515): 85 (18) |
*Atopic background is defined as medical history of or ongoing atopic dermatitis, allergic rhinitis, allergic conjunctivitis, or allergic asthma.
SALT=Severity of Alopecia Tool; SD=standard deviation.
DOSING INFORMATION
The recommended dosage is 2 mg/day. Increase to 4 mg/day if response is not adequate. For patients with nearly complete or complete scalp hair loss, with or without substantial eyelash or eyebrow hair loss, consider 4 mg/day. Decrease to 2 mg/day once patients achieve an adequate response with 4 mg/day.
For adults with severe alopecia areata
Olumiant provided sustained response rates of a SALT score of ≤20 at week 521-3,6,7
BRAVE-AA1 and BRAVE-AA2 (Pooled Results): Percentage of Patients Who Achieved a SALT Score of ≤20 at Week 52, NRI*
Study participants were treated with Olumiant 4 mg/day (N=515) or Olumiant 2 mg/day (N=340) from 0 to 52 weeks in the BRAVE clinical trial program. 39% of patients on Olumiant 4 mg/day and 23% of patients on Olumiant 2 mg/day achieved a SALT score of ≤20 at week 52. All analyses were NRI.
In patients receiving treatment with 4 mg/day, decrease the dosage to 2 mg/day once patients achieve an adequate response.
These prespecified analyses included pooled data from the BRAVE-AA1 and BRAVE-AA2 trials that were not adjusted for multiplicity.
*Data collected after permanent study drug discontinuation or data collected at remote visits due to COVID-19 pandemic were excluded.
In BRAVE-AA1 and BRAVE-AA2, the primary endpoint was the proportion of patients achieving SALT ≤20 at week 36. These analyses included patients randomized to Olumiant 4 mg/day at baseline who remained on this dose through week 52.
SELECT IMPORTANT SAFETY INFORMATION RELATED TO VIRAL REACTIVATION
Viral reactivation, including cases of herpes virus reactivation (e.g., herpes zoster), were reported in clinical trials 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 starting therapy with Olumiant.
NRI=nonresponder imputation; SALT=Severity of Alopecia Tool.
For adults with severe alopecia areata
With Olumiant 4 mg/day, an improvement in eyebrow and eyelash coverage was observed at week 361-3,8-10
Results shown for patients with substantial eyebrow and eyelash hair loss at baseline
Percentage of Patients Who Achieved EB ClinRO 0,1 or EL ClinRO 0,1 With ≥2-Point Improvement From Baseline at Week 36, NRI†
In BRAVE-AA1, 31% of patients on Olumiant 4 mg/day (N=188) achieved EB ClinRO 0,1 with ≥2-point improvement from baseline at week 36 vs 3% on placebo (N=124) (p≤0.05). In BRAVE-AA2, 35% of patients on Olumiant 4 mg/day (N=161) achieved EB ClinRO 0,1 with ≥2-point improvement from baseline at week 36 vs 4% on placebo (N=112) (p≤0.05).
In BRAVE-AA1, 34% of patients on Olumiant 4 mg/day (N=167) achieved EL ClinRO 0,1 with ≥2-point improvement from baseline at week 36 vs 3% on placebo (N=96) (p≤0.05). In BRAVE-AA2, 34% of patients on Olumiant 4 mg/day (N=140) achieved EL ClinRO 0,1 with ≥2-point improvement from baseline at week 36 vs 6% on placebo (N=90) (p≤0.05).
All analyses were NRI.
*The EB ClinRO and EL ClinRO are 4-point scales measuring eyebrow and eyelash hair loss, respectively, ranging from 0 (EB ClinRO: Full eyebrow coverage and no areas of eyebrow hair loss; EL ClinRO: Continuous eyelash line along both eyelids) to 3 (EB ClinRO: No notable eyebrow; EL ClinRO: No notable eyelashes). The ClinRO measures were developed following psychometric validation techniques but with limited data on content validity and interrater reliability. Both eyebrows and both eyelashes were evaluated together, not individually. This information should be taken into consideration when evaluating these data.
‡Data collected after permanent study drug discontinuation or data collected at remote visits due to the COVID-19 pandemic were excluded.
†p≤0.05 vs placebo.
SELECT IMPORTANT SAFETY INFORMATION RELATED TO MORTALITY
In a large, randomized, postmarketing safety study 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 all-cause mortality, including sudden cardiovascular death, was observed with the JAK inhibitor compared with TNF blockers. Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with Olumiant.
ClinRO Measure for Eyebrow Hair Loss™ and ClinRO Measure for Eyelash Hair Loss™ are trademarks owned or licensed by Eli Lilly and Company, its subsidiaries or affiliates.
EB ClinRO=Clinician-Reported Outcome Measure for Eyebrow Hair Loss™; EL ClinRO=Clinician-Reported Outcome Measure for Eyelash Hair Loss™; NRI=nonresponder imputation.
For adults with severe alopecia areata
Visible results with Olumiant through week 361,11-13
See the difference Olumiant can make
Scalp Hair Results
Patient 1
Clinical trial patient treated with Olumiant 2 mg/day for 36 weeks. Individual results may vary.*
Patient 2
Clinical trial patient treated with Olumiant 4 mg/day for 36 weeks. Individual results may vary.*
Patient 3
Clinical trial patient treated with Olumiant 2 mg/day for 36 weeks. Individual results may vary.*
Patient 4
Clinical trial patient treated with Olumiant 4 mg/day for 36 weeks. Individual results may vary.*
Patient hairstyles may influence appearance of SALT scores depicted.
*Based on the pooled post-hoc, placebo-controlled analysis of patients who achieved the primary endpoint (SALT score of ≤20 at week 36) in BRAVE-AA1 and BRAVE-AA2, the observed mean SALT score at week 36 was 8.6 (SD: 6.7) among patients treated with Olumiant 2 mg/day (N=67) and the observed mean SALT score at week 36 was 6.4 (SD: 6.5) among patients treated with Olumiant 4 mg/day (N=175).12
Eyebrow and Eyelash Results
Clinical trial patients treated with Olumiant 4 mg/day for 36 weeks. Individual results may vary.*
The ClinRO measures were developed following psychometric validation techniques but with limited data on content validity and interrater reliability. Both eyebrows and both eyelashes were evaluated together, not individually. This information should be taken into consideration when evaluating these data.8
SELECT IMPORTANT SAFETY INFORMATION RELATED TO MALIGNANCY AND LYMPHOPROLIFERATIVE DISORDERS
Malignancies were observed in clinical studies with Olumiant. In RA patients treated with another JAK inhibitor, a higher rate of malignancies (excluding non-melanoma skin cancer [NMSC]) and a higher rate of lymphomas were observed in patients treated with the JAK inhibitor compared 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 in patients 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. Periodic skin examination is recommended for patients who are at increased risk for skin cancer.
EB ClinRO=Clinician-Reported Outcome Measure for Eyebrow Hair Loss™; EL ClinRO=Clinician-Reported Outcome Measure for Eyelash Hair Loss™; SALT=Severity of Alopecia Tool; SD=standard deviation.
For adults with severe alopecia areata
BRAVE-AA2: Most responders on Olumiant maintained a SALT score of ≤20 even after their dose was lowered1,14,15
75% of responders who were switched from Olumiant 4 mg/day to Olumiant 2 mg/day at week 52 maintained a SALT score of ≤20 at week 76
BRAVE-AA2 Dose-Titration Period (Weeks 52-76): Percentage of Patients Who Sustained a SALT Score of ≤20, NRI*
In BRAVE-AA2, during the dose-titration period from weeks 52-76, 75% of responders who were switched from Olumiant 4 mg/day to Olumiant 2 mg/day at week 52 maintained a SALT score of ≤20 at week 76. All analyses were NRI.
In patients receiving treatment with 4 mg/day, decrease the dosage to 2 mg/day once patients achieve an adequate response.
*Data collected after permanent study drug discontinuation or data collected at remote visits due to COVID-19 pandemic were excluded.
These prespecified subgroup analyses were not adjusted for multiplicity.
Eligible responders (SALT score of ≤20) in the Olumiant 4 mg/day treatment arm were rerandomized to continue Olumiant 4 mg/day or transition to Olumiant 2 mg/day at week 52. Patients rerandomized to Olumiant 2 mg/day at week 52 who experienced a loss of treatment response (>20-point worsening in SALT score) were retreated with Olumiant 4 mg/day.
SELECT IMPORTANT SAFETY INFORMATION RELATED TO 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 MACE (defined as cardiovascular death, nonfatal MI, and non-fatal stroke) was observed with the JAK inhibitor compared to those treated with TNF blockers. Patients who are current or past smokers are at additional increased risk. 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. Discontinue Olumiant in patients that have experienced a myocardial infarction or stroke.
References:
- Olumiant. Prescribing Information. Lilly USA, LLC.
- King B, Ohyama M, Kwon O, et al. Two phase 3 trials of baricitinib for alopecia areata. N Engl J Med. 2022;386:1687-1699. doi:10.1056/NEJMoa2110343.
- King B, Ohyama M, Kwon O, et al. Two phase 3 trials of baricitinib for alopecia areata. N Engl J Med. 2022;386(suppl):1-76.
- Data on file. Lilly USA, LLC. DOF-BA-US-0075.
- Data on file. Lilly USA, LLC. DOF-BA-US-0070.
- Data on file. Lilly USA, LLC. DOF-BA-US-0076.
- Data on file. Lilly USA, LLC. DOF-BA-US-0074.
- Wyrwich K, Kitchen H, Knight S, et al. Development of clinician-reported outcome (ClinRO) and patient-reported outcome (PRO) measures for eyebrow, eyelash and nail assessment in alopecia areata. Am J Clin Dermatol. 2020;21(5):725-732.
- Data on file. Lilly USA, LLC. DOF-BA-US-0063.
- Data on file. Lilly USA, LLC. DOF-BA-US-0064.
- Data on file. Lilly USA, LLC. DOF-BA-US-0084.
- Data on file. Lilly USA, LLC. DOF-BA-US-0086.
- Data on file. Lilly USA, LLC. DOF-BA-US-0092.
- Data on file. Lilly USA, LLC. DOF-BA-US-0078.
- Data on file. Lilly USA, LLC. DOF-BA-US-0079.
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).
IMPORTANT SAFETY INFORMATION FOR OLUMIANT (baricitinib) tablets
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, lower respiratory tract infections, nausea, anemia, neutropenia, vulvovaginal candidiasis, 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.
Please click to access full Prescribing Information, including Boxed Warning about Serious Infections, Mortality, Malignancy, Major Adverse Cardiovascular Events, and Thrombosis, and Medication Guide.
BA HCP ISI ALL 13JUN2022