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LITFULO™ (ritlecitinib)
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LITFULO™ Quick Finder
Highlights
Boxed Warning
WARNING: SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS (MACE), and THROMBOSIS
- •
- Increased risk of serious bacterial,...
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Indications and Usage
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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Dosage and Administration
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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Dosage Forms and Strengths
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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Contraindications
4 CONTRAINDICATIONS
LITFULO is contraindicated in patients with known hypersensitivity to ritlecitinib or any of its excipients [see Warnings and Precautions (5.6)].
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Warnings and Precautions
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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Adverse Reactions
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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Drug Interactions
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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Use in Specific Populations
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Pregnancy Exposure Registry...
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Overdosage
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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Description
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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Clinical Pharmacology
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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Nonclinical Toxicology
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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Clinical Studies
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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How Supplied/Storage and Handling
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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Other
For Medical Information about LITFULO, please visit www.pfizermedinfo.com or call 1-800-438-1985.
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Contact Pfizer Medical Information to speak with a professional regarding your medical question on a Pfizer prescription product: (800) 438-1985
Report Adverse Event
To report an adverse event related to a Pfizer product and you are not part of a clinical trial* for this product, click the link below to submit your information: Pfizer Safety Reporting Site
*If you are involved in a clinical trial for either product, adverse events should be reported to your coordinating study site.
If you cannot use the above website to report an adverse event related to a Pfizer product, please call Pfizer Medical Information at (800) 438-1985.
You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatchor by calling
(800)-332-1088.
(800)-332-1088.