Posology : מינונים

4.2    Posology and method of administration

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.



Laboratory monitoring

Table 1. Laboratory measures and monitoring guidance
Laboratory        Monitoring guidance                                   Action measures
Platelet count                                                          Treatment should be Before treatment initiation, 4 weeks after            discontinued if platelet count is initiation, and thereafter according to               < 50 × 103/mm3.
Lymphocytes       routine patient management.                           Treatment should be interrupted if ALC is < 0.5 × 103/mm3 and may be restarted once ALC return above this value.
Abbreviation: ALC = absolute lymphocyte count

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 (see section 4.4).

Treatment interruption or discontinuation
If a patient develops a serious infection or opportunistic infection, ritlecitinib should be interrupted until the infection is controlled (see section 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.

Special populations

Renal impairment
No dose adjustment is required in patients with mild, moderate, or severe renal impairment (see section 5.2).

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.

Hepatic impairment
No dose adjustment is required in patients with mild (Child Pugh A) or moderate (Child Pugh B) hepatic impairment (see section 5.2). Ritlecitinib is contraindicated in patients with severe (Child Pugh C) hepatic impairment (see section 4.3).

Elderly
No dose adjustment is required for patients ≥65 years of age.

A total of 28 patients enrolled in alopecia areata trials were 65 years of age and older, and none were 75 years of age and older. Clinical trials of LITFULO did not include sufficient numbers of patients 65 years of age and older to determine whether they respond differently from younger adult patients.

As there is a higher incidence of infections in the elderly population in general, caution should be used when treating the elderly.



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.

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.