HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use LuciBaric safely and effectively. See full prescribing information for LuciBaric.

INDICATIONS AND USAGE

LuciBaric 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.

 Limitations of Use: Not recommended for use in combination with other JAK inhibitors, biologic DMARDs, or with potent immunosuppressants such as azathioprine and cyclosporine.

• 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.

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

DOSAGE AND ADMINISTRATION

Administration Instructions:

• See the full prescribing information for recommended evaluations and immunizations prior to treatment.

• Rheumatoid Arthritis and Alopecia Areata: Avoid initiation or interrupt LuciBaric 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 LuciBaric in patients with lymphopenia (ALC <200 cells/mm3) or neutropenia (ANC <500 cells/mm3).

Recommended Dosage:

 Rheumatoid Arthritis:

• 2mg once daily.

• LuciBaric may be used as monotherapy or in combination with methotrexate or other non-biologic DMARDs.

 COVID-19:

 • 4 mg once daily for up to 14 days.

 Alopecia Areata:

 • 2mg 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.

 • Reducethe dose to 2 mg once daily when an adequate response has been achieved.

 Dosage Modifications in Patients with Renal or Hepatic Impairment,or Cytopenias

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

DOSAGE FORMS AND STRENGTHS

Tablets: 2 mg×30 tablets

CONTRAINDICATIONS

None

WARNINGS AND PRECAUTIONS

• Hypersensitivity: Serious reactions have been reported. Discontinue LuciBaric if a serious hypersensitivity reaction occurs.

• Gastrointestinal Perforations: Monitor patients who may be at increased risk and evaluate promptly new onset of abdominal symptoms.

• Laboratory Abnormalities: Monitor for changes in lymphocytes, neutrophils, hemoglobin, liver enzymes, and lipids.

• Vaccinations: Avoid use with live vaccines.

ADVERSE REACTIONS

Adverse reactions reported in clinical trials (≥1%) are:

 • Rheumatoid Arthritis: upper respiratory tract infections (URTIs), nausea, herpes simplex, and herpes zoster.

 • COVID-19: increases of liver enzymes, thrombocytosis, creatine phosphokinase increases, neutropenia, deep vein thrombosis, pulmonary embolism, and urinary tract infection (UTI) .

 • Alopecia Areata: URTIs, headache, acne, hyperlipidemia, creatine phosphokinase increase, UTI, liver enzyme elevations, folliculitis, fatigue, lower respiratory tract infections, nausea, genital Candida infections, anemia, neutropenia, abdominal pain, herpes zoster, and weight increase.

DRUG INTERACTIONS

In patients taking strong Organic Anion Transporter 3 (OAT3) inhibitors (e.g., probenecid) the recommended dosage should be reduced.

USE IN SPECIFIC POPULATIONS

•Hepatic Impairment: Not recommended in patients with RA or AA and severe hepatic impairment. LuciBaric 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. LuciBaric 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.

Storage

Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature]. Protect from moisture. 

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