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Dosage of Ritlecitinib

1.Recommended Evaluations and Immunizations Prior to Treatment Initiation

Perform the following evaluations prior to ritlecitinib initiation: 

Tuberculosis (TB) infection evaluation: ritlecitinib initiation is not recommended in patients with activeTB. 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 ritlecitinib.

Viral hepatitis screening in accordance with clinical guidelines: ritlecitinib initiation is not recommended in patients with hepatitis B or hepatitis C.

Treatment with ritlecitinib should not be initiated in patients with an absolute lymphocyte count (ALC)<500/mm3 or a platelet count <100,000/mm3.Update immunizations according to current immunization guidelines.

2.Recommended Dosage

The recommended dosage of ritlecitinib is 50 mg orally once daily with or without food.Swallow capsules whole. Do not crush, split, or chew ritlecitinib capsules.If a dose is missed, administer the dose as soon as possible unless it is less than 8 hours before the next dose, inwhich case, skip the missed dose. Thereafter, resume dosing at the regular scheduled time.

3.Patients with Severe Hepatic Impairment

ritlecitinib is not recommended in patients with severe (Child Pugh C) hepatic impairment.

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.

from FDA,2023.06

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