(ritlecitinib)

Prescribing Information
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Highlights

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use LITFULO safely and effectively. See full prescribing information for LITFULO.

LITFULO™ (ritlecitinib) capsules, for oral use
Initial U.S. Approval: 2023

WARNING: SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS (MACE), and THROMBOSIS

See full prescribing information for complete boxed warning.

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Increased risk of serious bacterial, fungal, viral, and opportunistic infections that may lead to hospitalization or death, including tuberculosis (TB). Interrupt treatment if serious infection occurs until the infection is controlled. LITFULO should not be given to patients with active tuberculosis. Test for latent TB before and during therapy; start treating latent TB prior to use. Monitor all patients for active TB during treatment, even patients with initial negative, latent TB test. (5.1). Monitor all patients for signs and symptoms of infection during and after treatment with LITFULO. (5.1)
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Higher rate of all-cause mortality, including sudden cardiovascular death with another Janus kinase inhibitor (JAK) vs. TNF blockers in rheumatoid arthritis (RA) patients. LITFULO is not approved for use in RA patients. (5.2)
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Malignancies were reported in patients treated with LITFULO (5.3). Higher rate of lymphomas and lung cancers with another JAK inhibitor vs. TNF blockers in RA patients.
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Higher rate of MACE (defined as cardiovascular death, myocardial infarction, and stroke) with another JAK inhibitor vs. TNF blockers in RA patients. (5.4).
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Thrombosis has occurred in patients treated with LITFULO. Increased incidence of pulmonary embolism, venous and arterial thrombosis with another JAK inhibitor vs. TNF blockers. (5.5)

INDICATIONS AND USAGE

LITFULO is a kinase inhibitor indicated for the treatment of severe alopecia areata in adults and adolescents 12 years and older. (1)

Limitations of Use: Not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, cyclosporine or other potent immunosuppressants (1).

DOSAGE AND ADMINISTRATION

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For recommended testing, evaluations and immunizations prior to LITFULO initiation, see Full Prescribing Information. (2.1)
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Recommended dosage is 50 mg orally once daily. (2.2)
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For dosage interruption for certain adverse reactions, see Full Prescribing Information. (2.4)

DOSAGE FORMS AND STRENGTHS

Capsules: 50 mg of ritlecitinib (3)

CONTRAINDICATIONS

LITFULO is contraindicated in patients with known hypersensitivity to ritlecitinib or any of its excipients. (4)

WARNINGS AND PRECAUTIONS

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Hypersensitivity: Discontinue LITFULO if a clinically significant hypersensitivity reaction occurs. (5.6)
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Laboratory Abnormalities: Perform ALC and platelet counts prior to LITFULO initiation. Treatment interruption or discontinuation are recommended based on ALC and platelet count abnormalities. (5.7)
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Vaccinations: Avoid use of live vaccines during or shortly prior to LITFULO treatment. (5.8)

ADVERSE REACTIONS

Most common adverse reactions (incidence ≥1%) are headache, diarrhea, acne, rash, urticaria, folliculitis, pyrexia, atopic dermatitis, dizziness, blood creatine phosphokinase increased, herpes zoster, red blood cell count decreased, and stomatitis. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

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Certain CYP3A substrates: Additional monitoring and dose adjustment of CYP3A substrate should be considered. (7.1)
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Certain CYP1A2 substrates: Additional monitoring and dose adjustment of CYP1A2 substrate should be considered. (7.1)
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Certain CYP3A inducers: Coadministration with strong inducers of CYP3A is not recommended. (7.2)

USE IN SPECIFIC POPULATIONS

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Lactation: Breastfeeding not recommended. (8.2)
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Severe Hepatic Impairment: Not recommended. (8.6)

See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.

Revised: 6/2023

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