(ritlecitinib)

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Dosage and Administration

2 DOSAGE AND ADMINISTRATION

2.1 Recommended Evaluations and Immunizations Prior to Treatment Initiation

Perform the following evaluations prior to LITFULO initiation:

•
Tuberculosis (TB) infection evaluation: LITFULO initiation is not recommended in patients with active TB. For patients with latent TB or those with a negative latent TB test who are at high risk for TB, start preventive therapy for latent TB prior to initiation of LITFULO [see Warnings and Precautions (5.1)].
•
Viral hepatitis screening in accordance with clinical guidelines: LITFULO initiation is not recommended in patients with hepatitis B or hepatitis C [see Warnings and Precautions (5.1)].
•
Treatment with LITFULO should not be initiated in patients with an absolute lymphocyte count (ALC) <500/mm3 or a platelet count <100,000/mm3[see Warnings and Precautions (5.7)].
•
Update immunizations according to current immunization guidelines [see Warnings and Precautions (5.8)].

2.2 Recommended Dosage

The recommended dosage of LITFULO is 50 mg orally once daily with or without food [see Clinical Pharmacology (12.3)].

Swallow capsules whole. Do not crush, split, or chew LITFULO capsules.

If a dose is missed, administer the dose as soon as possible unless it is less than 8 hours before the next dose, in which case, skip the missed dose. Thereafter, resume dosing at the regular scheduled time.

2.3 Patients with Severe Hepatic Impairment

LITFULO is not recommended in patients with severe (Child Pugh C) hepatic impairment [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].

2.4 Treatment Interruption or Discontinuation

If treatment interruption is indicated, a temporary treatment interruption for less than 6 weeks is not expected to result in significant loss of regrown scalp hair.

Hematologic Abnormalities

Recommendations for LITFULO treatment interruption or discontinuation for hematologic abnormalities are summarized in Table 1.

Table 1. Laboratory Monitoring Guidance
Laboratory MeasureRecommendation
ALC = absolute lymphocyte count.

Platelet Count

Treatment should be discontinued if platelet count is <50,000/mm3

Lymphocytes

Treatment should be interrupted if ALC is <500/mm3 and may be restarted once ALC return above this value.

ALC and platelet counts are recommended before treatment initiation and at 4 weeks after treatment initiation, and thereafter according to routine patient management [see Warnings and Precautions (5.7)].

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