Usual Adult Dose for Rheumatoid Arthritis

2 mg orally once a day

Comments:

• Limitations of Use: Not recommended for use in combination with other Janus kinase (JAK) inhibitors, biologic DMARDs, or with potent immunosuppressants (e.g., azathioprine, cyclosporine).
• This drug may be used as monotherapy or in combination with methotrexate or other nonbiologic DMARDs.

Use: For the treatment of patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to at least 1 tumor necrosis factor (TNF) blocker

Usual Adult Dose for COVID-19

4 mg orally once a day
Duration of therapy: 14 days or until hospital discharge, whichever occurs first

Use: For the treatment of coronavirus disease 2019 (COVID-19) in hospitalized patients requiring supplemental oxygen, noninvasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO)

Usual Adult Dose for Alopecia

2 mg orally once a day

• If response to therapy is not adequate: 4 mg orally once a day

For patients with nearly complete or complete scalp hair loss, with or without substantial eyelash or eyebrow hair loss: 4 mg orally once a day should be considered

Once response to therapy with 4 mg is adequate: 2 mg orally once a day

Comments:

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

Use: For the treatment of patients with severe alopecia areata

Usual Pediatric Dose for COVID-19

For investigational use only

2 to less than 9 years: 2 mg orally once a day
9 years and older: 4 mg orally once a day

Duration of therapy: 14 days or until hospital discharge, whichever is first

Comments:

• The US FDA issued an Emergency Use Authorization (EUA) to allow the emergency use of this drug for treatment of COVID-19 in hospitalized pediatric patients (2 to less than 18 years) requiring supplemental oxygen, noninvasive or invasive mechanical ventilation, or ECMO; this drug is not approved by the US FDA for use.
• The optimal duration of therapy is unknown.
• This drug is not authorized for patients younger than 2 years.
• This drug should be used during pregnancy only if the benefit justifies the risk.
• For additional information: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization#coviddrugs.

Use: For the treatment of COVID-19 in hospitalized patients requiring supplemental oxygen, noninvasive or invasive mechanical ventilation, or ECMO

Renal Dose Adjustments

ADULT PATIENTS:
Alopecia Areata:

• Mild renal dysfunction (estimated glomerular filtration rate [eGFR] 60 to less than 90 mL/min/1.73 m2): Dosage should be maintained.
• Moderate renal dysfunction (eGFR 30 to less than 60 mL/min/1.73 m2):
• If the recommended dosage is 2 mg orally once a day: Dosage should be reduced to 1 mg orally once a day.
• If the recommended dosage is 4 mg orally once a day: Dosage should be reduced to 2 mg orally once a day.
• Severe renal dysfunction (eGFR less than 30 mL/min/1.73 m2): Not recommended

COVID-19:

• Mild renal dysfunction (eGFR 60 to less than 90 mL/min/1.73 m2): 4 mg orally once a day
• Moderate renal dysfunction (eGFR 30 to less than 60 mL/min/1.73 m2): 2 mg orally once a day
• Severe renal dysfunction (eGFR 15 to less than 30 mL/min/1.73 m2): 1 mg orally once a day
• ESRD or acute kidney injury (eGFR less than 15 mL/min/1.73 m2): Not recommended

Rheumatoid Arthritis:

• Mild renal dysfunction (eGFR 60 to less than 90 mL/min/1.73 m2): 2 mg orally once a day
• Moderate renal dysfunction (eGFR 30 to less than 60 mL/min/1.73 m2): 1 mg orally once a day
• Severe renal dysfunction (eGFR less than 30 mL/min/1.73 m2): Not recommended

EUA RECOMMENDATIONS FOR PEDIATRIC PATIENTS:
2 to less than 9 years:

• Estimated GFR 60 to less than 90 mL/min/1.73 m2: 2 mg orally once a day
• Estimated GFR 30 to less than 60 mL/min/1.73 m2: 1 mg orally once a day
• Estimated GFR less than 30 mL/min/1.73 m2, ESRD, or acute kidney injury: Not recommended

9 years and older:

• Estimated GFR 60 to less than 90 mL/min/1.73 m2: 4 mg orally once a day
• Estimated GFR 30 to less than 60 mL/min/1.73 m2: 2 mg orally once a day
• Estimated GFR 15 to less than 30 mL/min/1.73 m2: 1 mg orally once a day, if the benefit outweighs the risk
• Estimated GFR less than 15 mL/min/1.73 m2, ESRD, or acute kidney injury: Not recommended

Liver Dose Adjustments

ADULT PATIENTS:
Alopecia Areata or Rheumatoid Arthritis:

• Mild to moderate liver dysfunction: No adjustment recommended
• Severe liver dysfunction: Not recommended

COVID-19:

• Mild to moderate liver dysfunction: No adjustment recommended
• Severe liver dysfunction: Data not available

Comments (for adult [approved] and pediatric patients [EUA]):

• If increases in ALT or AST are observed and drug-induced liver injury (DILI) is suspected, this drug should be interrupted until the diagnosis of DILI is excluded.
• It is not known if dose adjustment is needed in patients with COVID-19 and severe liver dysfunction; this drug should only be used in such patients if the benefit outweighs the risk.

Dose Adjustments

ADULT PATIENTS:
ALOPECIA AREATA OR RHEUMATOID ARTHRITIS:
Infections:

• Use should be avoided in patients with active serious or opportunistic infection (including localized infections).
• If a patient develops a serious infection, therapy should be held until the infection is controlled.

Cytopenias and Anemia:

• Absolute lymphocyte count (ALC) at least 500 cells/mcL: Dosage should be maintained.
• ALC less than 500 cells/mcL: This drug should be interrupted until ALC at least 500 cells/mcL.
• Absolute neutrophil count (ANC) at least 1000 cells/mcL: Dosage should be maintained.
• ANC less than 1000 cells/mcL: This drug should be interrupted until ANC at least 1000 cells/mcL.
• Hemoglobin at least 8 g/dL: Dosage should be maintained.
• Hemoglobin less than 8 g/dL: This drug should be interrupted until hemoglobin at least 8 g/dL.

COVID-19:
Infections:

• Patients should be monitored for signs/symptoms of new infections during therapy.
• The risks and benefits of treatment with this drug in COVID-19 patients with other concurrent infections should be considered.

Cytopenias:

• ALC at least 200 cells/mcL: Dosage should be maintained.
• ALC less than 200 cells/mcL: This drug should be interrupted until ALC at least 200 cells/mcL.
• ANC at least 500 cells/mcL: Dosage should be maintained.
• ANC less than 500 cells/mcL: This drug should be interrupted until ANC at least 500 cells/mcL.

ALOPECIA AREATA, COVID-19, OR RHEUMATOID ARTHRITIS:
Drug Interactions:

• Coadministration with strong organic anion transporter 3 (OAT3) inhibitors (e.g., probenecid):
• If the recommended dosage is 4 mg orally once a day: Dosage should be reduced to 2 mg orally once a day.
• If the recommended dosage is 2 mg orally once a day: Dosage should be reduced to 1 mg orally once a day.
• If the recommended dosage is 1 mg orally once a day: Discontinuation of probenecid should be considered.

EUA RECOMMENDATIONS FOR PEDIATRIC PATIENTS:
Abnormal Laboratory Values:
If a laboratory abnormality is likely due to the underlying disease state, the risks and benefits of continuing this drug at the same or a reduced dose should be considered.

• ALC at least 200 cells/mcL: Dose should be maintained.
• ALC less than 200 cells/mcL: Interruption should be considered until ALC is at least 200 cells/mcL.
• ANC at least 500 cells/mcL: Dose should be maintained.
• ANC less than 500 cells/mcL: Interruption should be considered until ANC is at least 500 cells/mcL.

Drug Interactions:

• Coadministration with strong OAT3 inhibitors (e.g., probenecid):
• If the recommended dose is 4 mg orally once a day: Dose should be reduced to 2 mg orally once a day.
• If the recommended dose is 2 mg orally once a day: Dose should be reduced to 1 mg orally once a day.
• If the recommended dose is 1 mg orally once a day: Discontinuation of probenecid should be considered.
• Coadministration with other JAK inhibitors or biologic DMARDs (biologic treatments targeting cytokines, B-cells, or T-cells): Not recommended

Precautions

US BOXED WARNINGS:

• SERIOUS INFECTIONS: Patients treated with this drug are at risk for developing serious infections that may lead to hospitalization or death. Most patients with rheumatoid arthritis who developed these infections were taking concomitant immunosuppressants (e.g., methotrexate, corticosteroids). If a serious infection develops, therapy should be interrupted until the infection is controlled. Reported infections include: active tuberculosis (TB), which may present with pulmonary/extrapulmonary disease; invasive fungal infections (including candidiasis, pneumocystosis); and bacterial, viral, and other infections (due to opportunistic pathogens). Patients (except for those with COVID-19) should be tested for latent TB before starting this drug and during therapy; if positive, treatment for latent infection should be started prior to therapy. Patients with invasive fungal infections may present with disseminated, rather than localized, disease. The risks and benefits of this drug should be carefully considered before starting therapy in patients with chronic/recurrent infection. Patients should be closely monitored for signs/symptoms of infection during and after therapy including the possible development of TB in patients who tested negative for latent TB before starting therapy.
• MORTALITY: A large, randomized, postmarketing safety study in rheumatoid arthritis patients 50 years and older with at least 1 cardiovascular risk factor compared another JAK inhibitor to TNF blockers; a higher rate of all-cause mortality (including sudden cardiovascular death) was observed with the JAK inhibitor.
• MALIGNANCIES: Lymphoma and other malignancies have been reported with this drug. In rheumatoid arthritis patients treated with another JAK inhibitor, a higher rate of malignancies (excluding nonmelanoma skin cancer) was observed when compared with TNF blockers; patients who are current/past smokers are at additional increased risk.
• MAJOR ADVERSE CARDIOVASCULAR EVENTS (MACE): In rheumatoid arthritis patients 50 years and older with at least 1 cardiovascular risk factor treated with another JAK inhibitor, a higher rate of MACE (defined as cardiovascular death, myocardial infarction, and stroke) was observed when compared with TNF blockers; patients who are current/past smokers are at additional increased risk. This drug should be discontinued in patients who have had a myocardial infarction or stroke.
• THROMBOSIS: Thrombosis, including deep venous thrombosis and pulmonary embolism, has been reported at an increased incidence in patients treated with this drug compared to placebo; there were also cases of arterial thrombosis. Many of these adverse events were serious and some resulted in death. In rheumatoid arthritis patients 50 years and older with at least 1 cardiovascular risk factor treated with another JAK inhibitor, a higher rate of thrombosis was observed when compared with TNF blockers. This drug should be avoided in patients at risk. Patients with symptoms of thrombosis should discontinue therapy and be promptly evaluated.

US BOXED WARNINGS (ASSOCIATED WITH EUA):

• This EUA is for the unapproved use of this drug to treat COVID-19 in hospitalized pediatric patients (2 to less than 18 years) requiring supplemental oxygen, noninvasive or invasive mechanical ventilation, or ECMO.
• The prescribing health care provider and/or the provider's designee is/are responsible for mandatory reporting of all serious adverse events and medication errors potentially related to this drug within 7 calendar days from health care provider's awareness of the event; the Fact Sheet for Health Care Providers should be consulted for reporting requirements.
• ClinicalTrials.gov should be consulted for information on clinical trials testing this drug in COVID-19.

CONTRAINDICATIONS: None

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

ADULT PATIENTS:

• Alopecia areata or rheumatoid arthritis: Data not available
• COVID-19: Not recommended

EUA RECOMMENDATIONS FOR PEDIATRIC PATIENTS: Not recommended

Other Comments

Administration advice:

• Prior to initiating therapy, consider performing the following evaluations:
• Active and latent TB infection evaluation: Do not give this drug to patients with active TB; if positive for latent infection in patients with rheumatoid arthritis or alopecia areata, consider treatment for TB prior to using this drug.
• Viral hepatitis screening according to clinical guidelines
• CBC: Assess baseline values and verify if therapy can be started; monitor CBC during therapy and modify dosage as recommended.
• In patients with rheumatoid arthritis or alopecia areata: Do not start this drug in patients with ALC less than 500 cells/mcL, ANC less than 1000 cells/mcL, or hemoglobin level less than 8 g/dL.
• In patients with COVID-19: Do not start this drug in patients with ALC less than 200 cells/mcL or ANC less than 500 cells/mcL.
• Baseline liver and renal function: Assess baseline values and monitor patients for laboratory changes; modify dosage based on liver and renal dysfunction and laboratory abnormalities.
• Before starting therapy in patients with rheumatoid arthritis or alopecia areata, update immunizations according to current guidelines.
• Administer with or without food.
• For patients unable to swallow whole tablets, an alternative mode of administration may be considered:
• Oral dispersion: Disperse the tablet(s) in about 10 mL (5 mL minimum) of room temperature water and administer immediately; rinse the container with an additional 10 mL (5 mL minimum) of room temperature water and have the patient swallow the entire contents.
• Gastrostomy tube (G tube): Disperse the tablet(s) in about 15 mL (10 mL minimum) of room temperature water, withdraw the entire contents from the container into an appropriate syringe, and immediately administer through the gastric feeding tube; rinse the container with about 15 mL (10 mL minimum) of room temperature water, withdraw the contents into the syringe, and administer through the tube.
• Nasogastric tube (NG tube) or orogastric tube (OG tube): Disperse the tablet(s) in about 30 mL of room temperature water, withdraw the entire contents from the container into an appropriate syringe, and immediately administer through the enteral feeding tube (to avoid clogging small diameter tubes [smaller than 12 French], the syringe can be held horizontally and shaken during administration); rinse the container with a sufficient amount (at least 15 mL) of room temperature water, withdraw the contents into the syringe, and administer through the tube.
• Dispersed tablets are stable in water for up to 4 hours.

Reconstitution/preparation techniques for alternative administration:

• Tablets may be crushed to facilitate dispersion; if tablets are crushed, proper control measures (e.g., ventilated enclosure) or personal protective equipment (i.e., N95 respirator) should be used.
• The tablet(s) needed to achieve the desired dose (up to 4 mg) should be placed in a container with the specified amount of room temperature water and then swirled gently; for administration via G tube, NG tube, or OG tube, it should be ensured that the tablet(s) have been sufficiently dispersed to allow free passage through the tip of the syringe.

General:

• Intact tablets are not hazardous; it is not known if powder from the crushed tablets may constitute a reproductive hazard to the preparer.

EUA RECOMMENDATIONS FOR PEDIATRIC PATIENTS:

• Patient Selection:
• Baseline estimated GFR, liver enzymes, and CBC should be evaluated to determine treatment suitability and dose; patients with abnormal baseline and postbaseline values should be monitored closely. Dose Adjustments should be consulted for patients with laboratory abnormalities.
• This drug is not recommended for patients on dialysis, with ESRD (estimated GFR less than 15 mL/min/1.73 m2), with acute kidney injury, or with active TB.
• The Fact Sheet for Health Care Providers should be consulted regarding approved available alternatives.

Monitoring:

• Dermatologic: Skin examinations (periodically during therapy)
• Hematologic: CBC (at baseline and during therapy)
• Hepatic: Hepatic function (at baseline and during therapy); liver enzymes (at baseline and thereafter according to routine patient management)
• Infections/Infestations: For active/latent TB (before therapy); for viral hepatitis (according to clinical guidelines); for signs/symptoms of infection including TB (during and after therapy)
• Metabolic: Lipid parameters (about 12 weeks after starting therapy)
• Renal: Renal function (at baseline and during therapy)

Patient advice:

• Read the US FDA-approved patient labeling (Medication Guide).
• Notify health care provider if any signs/symptoms of an infection develop.
• Be alert for signs/symptoms of cardiovascular events, especially if you are a current/former smoker or have other cardiovascular risk factors.
• Seek immediate medical attention if any signs/symptoms of a DVT or pulmonary embolism develop.
• Stop this drug and seek immediate medical attention if any signs/symptoms of serious allergic reactions develop.
• Seek medical care at once if new onset of abdominal pain, fever, chills, nausea, or vomiting occurs.
• Do not breastfeed during therapy and for 4 days after the last dose.
• For pediatric patients: Read the Fact Sheet for Patients, Parents, and Caregivers.
• Inform health care provider if you are pregnant or intend to become pregnant during therapy. Report your pregnancy to Eli Lilly and Company at 1-800-545-5979.

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