LuciRit

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.