Active Ingredient: Ritlecitinib
Ritlecitinib is indicated for the treatment of severe alopecia areata in adults and adolescents 12 years of age and older.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Oral, 50 milligrams ritlecitinib, once daily.
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 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. |
| Lymphocytes | 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 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.
If a patient develops a serious infection or opportunistic infection, ritlecitinib should be interrupted until the infection is controlled.
Interruption or discontinuation of treatment may be needed for management of haematologic abnormalities as described in the table above.
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 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.
Ritlecitinib is to be taken once daily with or without food.
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