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LITFULO™ (ritlecitinib)

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Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.

LITFULO™ Quick Finder

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the...
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WARNING: SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS (MACE), and THROMBOSIS

Increased risk of serious bacterial,...
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1 INDICATIONS AND USAGE

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

Limitations of Use: Not...

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2 DOSAGE AND ADMINISTRATION

2.1 Recommended Evaluations and Immunizations Prior to Treatment Initiation

Perform the following evaluations prior to LITFULO initiation...

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3 DOSAGE FORMS AND STRENGTHS

Capsules: 50 mg of ritlecitinib, size 3, opaque capsules with yellow body and blue cap. The body is printed with “RCB 50” and the cap is printed with “Pfizer” in black.

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5 WARNINGS AND PRECAUTIONS

5.1 Serious Infections

Serious infections have been reported in patients receiving LITFULO. The most frequent serious infections have been...

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6 ADVERSE REACTIONS

The following clinically significant adverse reactions are described elsewhere in the labeling:

Serious Infections [see Warnings and Precautions...
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7 DRUG INTERACTIONS

     

7.1 Effects of LITFULO on Other Drugs

Table 3 includes clinically significant drug interactions affecting other drugs....

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8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

     

Pregnancy Exposure Registry...

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10 OVERDOSAGE

LITFULO was administered in clinical trials up to a single oral dose of 800 mg. Adverse reactions were comparable to those seen at lower doses and no specific toxicities were identified. Pharmacokinetics (PK)...

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11 DESCRIPTION

LITFULO (ritlecitinib) capsules are formulated with ritlecitinib tosylate, a kinase inhibitor.

Ritlecitinib tosylate is a white to off white to pale pink solid which is freely soluble in water. The...

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12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

LITFULO is a kinase inhibitor.

Ritlecitinib irreversibly inhibits Janus kinase 3 (JAK3) and the tyrosine...

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13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

In a 2-year rat carcinogenicity study, ritlecitinib increased the incidence of...

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14 CLINICAL STUDIES

The efficacy and safety of LITFULO were evaluated in one randomized, double-blind, placebo-controlled trial (Trial AA-I) in subjects 12 years of age and older with alopecia areata with ≥50% scalp hair...

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16 HOW SUPPLIED/STORAGE AND HANDLING

LITFULO capsules are packaged in child-resistant, white, high-density polyethylene (HDPE) bottles with polypropylene (PP) cap with a foil heat induction seal liner. The bottles contain 1g...

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This Medication Guide...

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