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Patient-years refers to the number of years for which patients contribute data. For example, if 100 patients were followed for 1 year each, the total patient-years is 100. If 50 patients were followed for 2 years each, the total patient-years would also be 100.
Adverse events observed in clinical trials may not fully characterize the risks of LITFULO. Certain adverse events may require longer observation periods and longer-term patient exposure to ascertain risk.3
The most common serious infections were related to appendicitis, COVID-19 infection (including pneumonia), and sepsis2
Other thromboembolic events include 1 event each of retinal artery occlusion and acute myocardial infarction2,3
The median time to onset of urticaria was 8 weeks with a median duration of 7 days. Most cases were mild to moderate in severity2
Safety analyses were based on observed data with no imputation of missing data. All analyses were ad hoc and there was no adjustment for multiplicity.3Ritlecitinib was also tested in a trial for another indication.4LITFULO all doses: 50 mg with or without a 200 mg QD 4-week loading dose, 30 mg with or without a 200 mg QD 4-week loading dose, and 10 mg QD, combined.3LITFULO ≥50 mg: 50 mg, with no loading dose, and 50 mg with either a 100 mg or 200 mg loading dose, QD, for 4 weeks, combined.3LITFULO all doses: IR based on LITFULO 50 mg with a 200 mg QD 4-week loading dose.3NMSC=nonmelanoma skin cancer; QD=once daily.Limitations and biases3
Adverse reaction rates observed in clinical trials may not fully characterize the risks of LITFULO
Certain adverse events may require longer observation periods and longer-term patient exposure to ascertain risk
Safety analyses were based on observed data with no imputation of missing data. All analyses were ad hoc and there was no adjustment for multiplicity
See additional considerationsAdditional ConsiderationsLoadingReferences:1.Sinclair R, Lesiak A, Mehlis S, et al. Long-term safety and efficacy of ritlecitinib in adults and adolescents with alopecia areata: interim results from the ALLEGRO-LT phase 3, open-label study. Poster presented at: 31st Annual Meeting of the European Academy of Dermatology and Venereology (EADV); September 7-10, 2022; Milan, Italy.2.LITFULO. Prescribing Information. Pfizer Inc.; 2023.3.Data on file. Pfizer Inc.; New York, NY.4.A 52-week study of ritlecitinib oral capsules in adults and adolescents with nonsegmental vitiligo (active and stable) Tranquillo (Tranquillo). ClinicalTrials.gov identifier: NCT05583526. Updated June 5, 2023. Accessed June 20, 2023.https://clinicaltrials.gov/study/NCT055835265.Long-term PF-06651600 for the treatment of alopecia areata (ALLEGRO-LT). ClinicalTrials.gov identifier: NCT04006457. Updated February 14, 2023. Accessed May 22, 2023.https://clinicaltrials.gov/ct2/show/NCT04006457Safety
This site is intended only for U.S. healthcare professionals. The products discussed in this site may have different product labeling in different countries. The information provided is for educational purposes only.
INDICATIONLITFULO (ritlecitinib) is a kinase inhibitor indicated for the treatment of severe alopecia areata in adults and adolescents 12 years and older.
Limitations of Use: Not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, cyclosporine or other potent immunosuppressants.
Important Safety InformationWARNING: SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS (MACE), AND THROMBOSIS
SERIOUS INFECTIONS Patients treated with LITFULO are at increased risk of serious bacterial, fungal, viral and opportunistic infections that may lead to hospitalization or death, including tuberculosis (TB).The most frequent serious infections reported with LITFULO have been appendicitis, COVID-19 infection (including pneumonia), and sepsis. Among opportunistic infections, multi-dermatomal herpes zoster was reported with LITFULO.
Avoid use of LITFULO in patients with an active, serious infection. Consider the risks and benefits of treatment prior to initiating LITFULO in patients:
with chronic or recurrent infection
who have been exposed to tuberculosis (TB)
with a history of serious infection or an opportunistic infection
who have resided or traveled in areas of endemic TB or mycoses, or
with underlying conditions that may predispose them to infection
Closely monitor patients for the development of signs and symptoms of infection during and after treatment with LITFULO. Interrupt treatment if a patient develops a serious or opportunistic infection. A patient who develops a new infection during treatment with LITFULO should undergo prompt and complete diagnostic testing appropriate for an immunocompromised patient, appropriate antimicrobial therapy should be initiated, and the patient should be closely monitored. LITFULO may be resumed once the infection is controlled.
Tuberculosis LITFULO should not be given to patients with active TB. Screen patients for TB before starting and monitor during therapy. Anti-TB therapy should be started prior to initiating therapy with LITFULO in patients with a new diagnosis of latent TB or previously untreated latent TB.In patients with a negative latent TB test, consider anti-TB therapy before initiating treatment with LITFULO in those at high risk and consider screening patients at high risk for TB during treatment with LITFULO.
Viral Reactivation Viral reactivation, including cases of herpes virus reactivation (eg, herpes zoster), was reported in clinical trials. If a patient develops herpes zoster, consider interrupting treatment until the episode resolves. Screening for viral hepatitis should be performed in accordance with clinical guidelines before starting therapy with LITFULO. Patients with evidence of HIV infection or hepatitis B or C infection were excluded from clinical trials.
MORTALITY In a large, randomized, postmarketing safety study of another Janus kinase (JAK) inhibitor in rheumatoid arthritis (RA) patients 50 years of age and older with at least one cardiovascular risk factor, a higher rate of all-cause mortality, including sudden cardiovascular death, was observed in RA patients treated with the JAK inhibitor compared with tumor necrosis factor (TNF) blockers. Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with LITFULO.LITFULO is not approved for use in RA patients.
MALIGNANCIES AND LYMPHOPROLIFERATIVE DISORDERS Malignancies, including non-melanoma skin cancer (NMSC), were observed in clinical trials of LITFULO.
In a large, randomized, postmarketing safety study of another JAK inhibitor in RA patients, a higher rate of malignancies (excluding NMSC) was observed in patients treated with the JAK inhibitor compared to those treated with TNF blockers. A higher rate of lymphomas was observed in patients treated with the JAK inhibitor compared to those treated with TNF blockers. A higher rate of lung cancers was observed in current or past smokers treated with the JAK inhibitor compared to those treated with TNF blockers.In this study, current or past smokers had an additional increased risk of overall malignancies.
The risks and benefits of ritlecitinib treatment should be considered prior to initiating or continuing therapy in patients with a known malignancy other than successfully treated NMSC or cervical cancer.
Periodic skin examination is recommended for patients who are at increased risk for skin cancer.
MAJOR ADVERSE CARDIOVASCULAR EVENTS (MACE) In a large, randomized, postmarketing safety study of another JAK inhibitor in RA patients 50 years of age and older with at least one cardiovascular risk factor, a higher rate of MACE (defined as cardiovascular death, non-fatal myocardial infarction [MI], and non-fatal stroke) was observed with the JAK inhibitor compared to those treated with TNF blockers.Patients who are current or past smokers are at additional increased risk.
Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with LITFULO, particularly in patients who are current or past smokers and patients with other cardiovascular risk factors. Patients should be informed about the symptoms of serious cardiovascular events and the steps to take if they occur. Discontinue LITFULO in patients that have experienced an MI or stroke.
THROMBOEMBOLIC EVENTS Thrombosis has occurred in patients treated with LITFULO.An event of pulmonary embolism (PE) was reported in a patient receiving LITFULO. In a ritlecitinib higher dosing group, 1 patient reported an event of retinal artery occlusion.
In a large, randomized, postmarketing safety study of another JAK inhibitor in RA patients 50 years of age and older with at least one cardiovascular risk factor, higher rates of overall thrombosis, deep vein thrombosis, arterial thrombosis and PE were observed with the JAK inhibitor compared to those treated with TNF blockers.
Avoid LITFULO in patients who may be at increased risk of thrombosis. If symptoms of thrombosis or embolism occur, patients should interrupt LITFULO and be evaluated promptly and treated appropriately.
CONTRAINDICATION LITFULO is contraindicated in patients with known hypersensitivity to ritlecitinib or any of its excipients.
HYPERSENSITIVITY Serious reactions, including anaphylactic reactions, urticaria, and rash have been observed in patients receiving LITFULO in clinical trials. If a clinically significant hypersensitivity reaction occurs, discontinue LITFULO and institute appropriate therapy.
LABORATORY ABNORMALITIES Treatment with LITFULO was associated with decreases in lymphocytes and platelets. Prior to LITFULO initiation, perform absolute lymphocyte count (ALC) and platelet count. After initiating treatment with LITFULO, treatment interruption or discontinuation is recommended based on ALC and platelet count abnormalities.
Liver Enzyme Elevations: Treatment with LITFULO was associated with increased incidence of liver enzyme elevation compared to placebo. Increases of alanine transaminase (ALT) and aspartate aminotransferase (AST) ≥5 times the upper limit of normal were observed in patients in LITFULO clinical trials. Evaluate at baseline and thereafter according to routine patient management. If increases in ALT or AST are observed and drug-induced liver injury is suspected, interrupt LITFULO until this diagnosis is excluded.
Creatine Phosphokinase (CPK) Elevations: Treatment with LITFULO was associated with increased incidence of CPK elevation compared to placebo.
VACCINATIONS No data are available on the response to vaccination in patients receiving LITFULO. Use of live attenuated vaccines should be avoided during or shortly prior to initiating treatment. Prior to initiating LITFULO, it is recommended that patients be brought up to date with all immunizations, including prophylactic herpes zoster vaccinations, in agreement with current immunization guidelines.
HEPATIC IMPAIRMENT LITFULO is not recommended in patients with severe hepatic impairment.
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.
DRUG INTERACTIONS LITFULO can increase plasma concentrations of CYP3A and CYP1A2 substrates. Consider additional monitoring and dose adjustment of CYP3A and CYP1A2 substrates where small concentration changes may lead to serious adverse reactions when used with LITFULO.
Coadministration with strong inducers of CYP3A is not recommended.
USE IN PREGNANCY Available clinical trial data on LITFULO use in pregnant women are insufficient to identify a drug-associated risk from major birth defects, miscarriage or other adverse maternal or fetal outcomes. Advise pregnant females and females of reproductive potential to inform their healthcare providers if they are pregnant or intend to become pregnant during treatment with LITFULO.
If a patient becomes pregnant while receiving LITFULO, healthcare providers should report LITFULO exposure by calling 1-877-390-2940.
LACTATION Advise women not to breastfeed during treatment with LITFULO and for 14 hours after the last dose.
Please see fullPrescribing Information, includingBOXED WARNINGandMedication Guide.IndicationLITFULO is a kinase inhibitor indicated for the treatment of severe alopecia areata in adults and adolescents 12 years and older.
Limitations of Use: Not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, cyclosporine or other potent immunosuppressants.