Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium
Litfulo is indicated for the treatment of severe alopecia areata in adults and adolescents 12 years of age and older (see section 5.1).
Treatment should be initiated and supervised by a healthcare professional experienced in the diagnosis and treatment of alopecia areata.
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.
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. |
| 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 (see section 4.4).
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.
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.
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.
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).
No dose adjustment is required for patients ≥65 years of age. There are limited data in patients ≥65 years of age.
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.
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.
Ritlecitinib was administered in placebo-controlled studies up to a single oral dose of 800 mg and multiple oral doses of 400 mg daily for 14 days. No specific toxicities were identified. In case of overdose, it is recommended that the patient be monitored for signs and symptoms of adverse reactions (see section 4.8). There is no specific antidote for overdose with ritlecitinib. Treatment should be symptomatic and supportive.
Pharmacokinetics (PK) data up to and including a single oral dose of 800 mg in healthy adult volunteers indicate that more than 90% of the administered dose is expected to be eliminated within 48 hours.
30 months.
This medicinal product does not require any special temperature storage conditions. Store in the original package in order to protect from light.
High-density polyethylene (HDPE) bottle with a silica gel desiccant and polypropylene closure containing 28 hard capsules.
OPA/Al/PVC/Al blisters containing 10 hard capsules. Each pack contains 30 or 90 hard capsules.
Not all pack sizes may be marketed.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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