Litfulo (Ritlecitinib) | Severe Alopecia Areata | DengYue Medicine

Ritlecitinib Application Scope

Approved for severe alopecia areata in adults and adolescents aged 12 years and older.

Characteristics

• Ingredients:

  • Active: Ritlecitinib, a selective JAK3 and TEC kinase inhibitor

  • Inactive: Capsule excipients (unspecified in sources)

• Properties:

  • Irreversibly inhibits JAK3 and the TEC kinase family → modulates immune pathways involved in alopecia areata

• Packaging Specification: Oral capsules, 50 mg each

• Storage: As per label; no special refrigeration noted. Safe at standard room temperatures.

• Expiry Date: Manufacturer’s standard shelf‑life (typically 24 months)

• Executive Standard: FDA-approved under standard NDA processes; meets USP/EMA standards

• Approval Number / Date: FDA NDA registered; approved June 23, 2023

• Manufacturer: Pfizer Inc.

Guidelines for the Use of Ritlecitinib

• Dosage and Administration:

  • 50 mg orally once daily, with or without food

  • Swallow capsules whole; do not crush or chew

• Adverse Reactions:

  • Common (≥1%): headache, diarrhea, acne, rash/urticaria, folliculitis, fever, atopic dermatitis, dizziness, elevated CPK, stomatitis, herpes zoster, decreased RBC count

• Contraindications:

  • Known hypersensitivity to ritlecitinib or any capsule components

• Precautions:

  • Boxed warning: serious infections (incl. TB), malignancy, MACE events, thrombosis

  • Monitor lymphocyte and platelet counts; interrupt if ALC < 500/mm³ or platelets < 50,000/mm³

  • Screen for TB, hepatitis; update immunizations before initiation

  • Avoid live vaccines during treatment

Interactions

• Drug Interactions:​

• Use caution with CYP3A and CYP1A2 substrates—may increase exposure; monitor and adjust dosage

• Strong CYP3A inducers (e.g., rifampin) may reduce ritlecitinib effectiveness—avoid concurrent use

• Potential reduction in live vaccine response—live vaccines should be avoided

Note:

• If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
• It is only for internal discussion among medical staff and does not serve as a basis for medication. For specific medication guidelines, please consult the attending physician.