Litfulo

Treatment should be initiated and supervised by a healthcare professional experienced in the diagnosis and treatment of alopecia areata. Posology The recommended dose is 50 mg once daily. The benefit-risk of treatment should be re-assessed at regular intervals on an individual basis.

Consideration should be given to discontinuing patients who show no evidence of therapeutic benefit after 36 weeks. 3 Laboratory monitoring Table 1. Laboratory measures and monitoring guidance Laboratory measures Monitoring guidance Action Platelet count Before treatment initiation, 4 weeks after initiation, and thereafter according to routine patient management.

Treatment should be discontinued if platelet count is < 50 × 103/mm3. 5 × 103/mm3 and may be restarted once ALC return above this value. 4). 4). Interruption or discontinuation of treatment may be needed for management of haematologic abnormalities as described in Table 1.

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. 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. 2). Ritlecitinib has not been studied in patients with end-stage renal disease (ESRD) or in patients with renal transplants and is therefore not recommended for use in these patients.

2). 3). Elderly No dose adjustment is required for patients ≥ 65 years of age. There are limited data in patients ≥ 65 years of age. Paediatric population 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. 4 Method of administration Oral use. Litfulo is to be taken once daily 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.

3%). Tabulated list of adverse reactions A total of 1630 patients were treated with ritlecitinib representing 3751 patient-years of exposure. Three placebo-controlled studies were integrated (130 participants on 50 mg daily and 213 participants on placebo) to evaluate the safety of ritlecitinib in comparison to placebo for up to 24 weeks after treatment initiation.

Table 2 lists all adverse reactions observed in alopecia areata placebo-controlled studies presented by system organ class and frequency, using the following categories: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1 000 to < 1/100); rare (≥ 1/10 000 to < 1/1 000); very rare (< 1/10 000).

Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. 8 Table 2. Adverse reactions System organ class Common Uncommon Infections and infestations Herpes zoster Folliculitis Upper respiratory tract infections Nervous system disorders Dizziness Gastrointestinal disorders Diarrhoea Skin and subcutaneous tissue disorders Acne Urticaria Rash Investigations Blood creatine phosphokinase increased Platelet count decreased Lymphocyte count decreased Alanine aminotransferase increased ˃ 3 × ULNa Aspartate aminotransferase increased ˃ 3 × ULNa a.

53 per 100 patient-years) treated with ritlecitinib 50 mg. 32 per 100 patient-years) treated with ritlecitinib 50 mg or higher. 3 per 100 patient-years) treated with ritlecitinib 50 mg or higher. Most infections were mild or moderate in severity.

5% in the ritlecitinib 50 mg group compared to 0 in placebo. All herpes zoster events were non-serious; 1 patient receiving ritlecitinib 200/50 mg (200 mg once daily for 4 weeks followed by 50 mg once daily) experienced an event of varicella zoster virus infection that met criteria as an opportunistic infection (multi-dermatomal herpes zoster).

Serious infections Serious infections have been reported in patients receiving ritlecitinib. The most frequent serious infections have been appendicitis, COVID-19 infection (including pneumonia), and sepsis. 3). The risks and benefits of treatment should be considered in patients:  with chronic or recurrent infection  who have been exposed to tuberculosis (TB)  with a history of serious or an opportunistic infection  who have resided or traveled in areas of endemic TB or mycoses, or  with underlying conditions that may predispose them to infection Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with ritlecitinib.

Treatment should be interrupted if a patient develops a serious or opportunistic infection. A patient who develops a new infection during treatment with ritlecitinib should undergo prompt and complete diagnostic testing appropriate for an immunocompromised patient, appropriate antimicrobial therapy should be initiated, and the patient should be closely monitored.

If interrupted, ritlecitinib may be resumed once the infection is controlled. As there is a higher incidence of infections in elderly and in the diabetic population in general, caution should be exercised when treating the elderly and patients with diabetes, and particular attention paid with respect to occurrence of infections.

Tuberculosis Patients should be screened for TB before starting therapy with ritlecitinib. 3). Anti-TB therapy should be started prior to initiating therapy with ritlecitinib in patients with a new diagnosis of latent TB or previously untreated latent TB.

In patients with a negative latent TB test, anti-TB therapy should still be considered before initiating treatment with ritlecitinib in those at high risk and screening for patients at high risk for TB during treatment with ritlecitinib should be considered.

1. 4). 2). 6).