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Adverse event reporting can be found at the bottom of the page

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About

AboutAlopecia AreataBurden of Alopecia AreataMOA
EfficacySafety ProfileOverviewSALT score ≤10SALT score ≤20PGI-CEyebrow and Eyelash ResponsesBefore and After Patient ImagesSafety ProfileSafety ProfileContraindications, Special Warnings and PrecautionsAdverse ReactionsPatient ProfilesGetting Started
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Click here for LITFULO (ritlecitinib) Prescribing Information

Dosing

Monitoring

Posology and method of administration

Treatment should be initiated and supervised by a healthcare professional experienced in the diagnosis and treatment of alopecia areata.1

The recommended dose is 50mg once daily, to be taken orally with or without food. Capsules should be swallowed whole and should not be crushed, split or chewed, because these methods of administration have not been studied in clinical trials.1

The benefit-risk of treatment should be re-assessed at regular intervals on an individual basis. Consideration should be given to discontinuing Litfulo in patients who show no evidence of therapeutic benefit after 36 weeks.1

   

Treatment initiation

Treatment with ritlecitinib should not be initiated in patients with
an absolute lymphocyte count
(ALC) < 0.5 × 103/mm3
or a
platelet count < 100 × 103/mm3

Treatment interruption or discontinuation
If a patient develops a serious infection or opportunistic infection, Litfulo should be interrupted until the infection is controlled.
Interruption or discontinuation of treatment may be needed for management of haematologic abnormalities.
If treatment interruption is needed, the risk of significant loss of regrown scalp hair after a temporary treatment interruption for less than 6 weeks is low. If the duration of treatment interruption is more than 6 weeks, the risk of significant hair loss increases and is greater the longer the duration of treatment interruption.
Missed doses

If a dose is missed, patients should be advised to take the dose as soon as possible unless it is less than 8 hours before the next dose, in which case the patient should not take the missed dose. Thereafter, dosing should be resumed at the regular scheduled time.

Dosing in special populations1

Renal impairment1

No dose adjustment is required in patients with mild renal impairment (estimated glomerular filtration rate, (eGFR), of 60 to <90 mL/min); moderate renal impairment (eGFR 30 to <60 mL/min) or severe renal impairment (eGFR <30 mL/min). Ritlecitinib has not been studied in patients with end-stage renal disease or in patients with renal transplants, and is therefore not recommended for use in these patients.1


Hepatic impairment1

No dose adjustment is required in patients with mild (Child Pugh A) or moderate (Child Pugh B) hepatic impairment. Litfulo is contraindicated in patients with severe (Child Pugh C) hepatic impairment.1


Elderly population1

No dose adjustment is required for patients ≥65 years of age. Data are limited in patients ≥65 years of age.


Paediatric population1

No dose adjustment is required for adolescents 12 to <18 years of age. The safety and efficacy of Litfulo in children under 12 years of age have not yet been established. No data are available.

Monitoring
Litfulo (ritlecitinib) Summary of Product Characteristics
PP-LGF-GBR-0271. June 2025

Adverse events should be reported. Reporting forms and information can be found at https://yellowcard.mhra.gov.uk or search 

for MHRA Yellow Card in Google Play or Apple App Store

 

Adverse events should also be reported to Pfizer Medical Information on 01304 616161

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