HIGHLIGHTS OF PRESCRIBING INFORMATION

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

INDICATIONS AND USAGE

LuciRit is a kinase inhibitor indicated for the treatment of severe alopecia areata in adults and adolescents 12 years and older.

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

DOSAGE AND ADMINISTRATION

• For recommended testing, evaluations and immunizations prior to LuciRit initiation, see Full Prescribing Information.

• Recommended dosage is 50 mg orally once daily.

• For dosage interruption for certain adverse reactions, see Full Prescribing Information.

DOSAGE FORMS AND STRENGTHS

Capsules: 50 mg×28 capsules

CONTRAINDICATIONS

LuciRit is contraindicated in patients with known hypersensitivity to ritlecitinib or any of its excipients.

WARNINGS AND PRECAUTIONS

• Hypersensitivity: Discontinue LuciRit if a clinically significant hypersensitivity reaction occurs.  

• Laboratory Abnormalities: Perform ALC and platelet counts prior to LuciRit initiation. Treatment interruption or discontinuation are recommended based on ALC and platelet count abnormalities.  

• Vaccinations: Avoid use of live vaccines during or shortly prior to LuciRit treatment.

ADVERSE REACTIONS

Most common adverse reactions (incidence ≥1%) are headache, diarrhea, acne, rash, urticaria, folliculitis, pyrexia, atopic dermatitis, dizziness, blood creatine phosphokinase increased, herpes zoster, red blood cell count decreased, and stomatitis.

DRUG INTERACTIONS

• Certain CYP3A substrates: Additional monitoring and dose adjustment of CYP3A substrate should be considered.

• Certain CYP1A2 substrates: Additional monitoring and dose adjustment of CYP1A2 substrate should be considered.

• Certain CYP3A inducers: Coadministration with strong inducers of CYP3A is not recommended.

USE IN SPECIFIC POPULATIONS

• Lactation: Breastfeeding not recommended.

• Severe Hepatic Impairment: Not recommended.

Storage

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