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HomeAboutAboutAlopecia AreataLITFULO MOASALT EvaluationEfficacyEfficacyStudy OverviewScalp Hair ResponseBefore & After ImagesSafetySafetyBOXED WARNING SummaryPooled Safety DataSpecific Adverse ReactionsAdditional ConsiderationsGetting StartedGetting StartedDosingGetting StartedSupport for PatientsSupport for PatientsSavings & Support OptionsSpecialty Pharmacy NetworkDownloadable Copay Savings CardRequest a RepEventsMaterialsVideos
Full Prescribing Information, including BOXED WARNINGMedication GuideIndication Patient Site
Pooled Safety DataPooled Safety DataSummary of LITFULO pooled safety data1

Summary of LITFULO pooled safety data1

  • A total of 1628 adult and adolescent (12 to 17 years old) patients received LITFULO, representing 2085 patient-years of exposure.* 1011 of these patients had more than 1 year of treatment with LITFULO
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Study Study Arms Description
Phase 2a Study2† LITFULO (n=48) vs
placebo (n=47)		 Placebo-controlled to
Week 24
ALLEGRO-2a1,3,4‡ LITFULO (n=36) vs
placebo (n=35)		 Placebo-controlled to
Week 24§
ALLEGRO-2b/35|| LITFULO (n=584) vs
placebo (n=131)		 Placebo-controlled to
Week 24
ALLEGRO-LT6¶ LITFULO (N=1052) Long-term study; no placebo arm
Ritlecitinib was also tested in a trial for another indication.7The Phase 2a Study was a randomized, double-blind, placebo-controlled, parallel-group, multicenter study that evaluated the efficacy and safety of LITFULO in adults ≥18 years of age with 50% or more scalp hair loss due to alopecia areata.2The ALLEGRO-2a Study was a randomized, double-blind, placebo-controlled study that evaluated the safety and tolerability of LITFULO in adults 18 to ≤50 years of age with 25% or more scalp hair loss due to alopecia areata.3The ALLEGRO-2a Study lasted for 24 months, 9 months of which were placebo-controlled. The data set for the placebo-controlled pool for alopecia areata utilized Weeks 0-24.1,3The efficacy and safety of LITFULO were evaluated in a randomized, double-blind, placebo-controlled, phase 2b/3 pivotal study in patients 12 years and older with alopecia areata and 50% or more scalp hair loss. Patients were randomized to receive LITFULO or placebo. The primary endpoint was the proportion of patients with SALT score ≤20 at Week 24. Safety was monitored throughout the study.1,5The ALLEGRO-LT Study is a phase 3 study investigating the long-term safety and efficacy of LITFULO in adults and adolescents (12 years and older) with alopecia areata, including de novo patients defined as those who did not previously receive LITFULO, and patients who rolled over from LITFULO studies (ALLEGRO-2a and ALLEGRO-2b/3).3,5,6Limitations and biases4
  • 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
 Adverse reactions (≥1%) reported in 3 placebo-controlled studies for up to 24 weeks1*
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Adverse Reactions, n (%) LITFULO 50 mg
(n=130)		 Placebo
(n=213)
Headache 14 (10.8) 18 (8.5)
Diarrhea 13 (10) 8 (3.8)
Acne 8 (6.2) 10 (4.7)
Rash 7 (5.4) 2 (0.9)
Urticaria 6 (4.6) 3 (1.4)
Folliculitis 4 (3.1) 4 (1.9)
Pyrexia 4 (3.1) 0
Dermatitis atopic 3 (2.3) 1 (0.5)
Dizziness 3 (2.3) 3 (1.4)
Blood creatine phosphokinase increased 2 (1.5) 0
Herpes zoster 2 (1.5) 0
Red blood cell count decreased 2 (1.5) 0
Stomatitis 2 (1.5) 0
3 placebo-controlled clinical studies of LITFULO for the treatment of alopecia areata were integrated to evaluate the safety of LITFULO in comparison to placebo. In the placebo-controlled period of clinical trials in alopecia areata, a total of 668 patients were exposed to LITFULO with 130 patients receiving LITFULO 50 mg once daily for up to 24 weeks.Lab abnormalities observed in LITFULO clinical trials1Lab abnormalities observed in LITFULO clinical trials1
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Decreased lymphocyte count ALC <500/mm3 Across clinical trials, including the long-term trial:
  • Confirmed ALC <500/mm3 occurred in 1 (<0.1%) subject treated with LITFULO 50 mg
  • Age appeared to be a risk factor in patients ≥65 years of age
Decreased platelet count <100,000/mm3 In the placebo-controlled studies, for up to 24 weeks:
  • LITFULO was associated with a decrease in platelet count
  • Maximum effects on platelets were observed within 4 weeks, after which platelet count remained stable at a lower level with continued therapy
Across clinical trials, including the long-term trial:
  • 1 (<0.1%) subject had a confirmed platelet count <100,000/mm3
  • No subject had a confirmed platelet count <75,000/mm3
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Creatine phosphokinase
elevations		 In the placebo-controlled studies, for up to 24 weeks:
  • Reported in 2 (1.5%) subjects treated with 50 mg and 0 subjects treated with placebo
Increased liver enzymes ≥3 times the ULN In the placebo-controlled studies, for up to 24 weeks:
  • Events of increases in liver enzymes ≥3 times the upper limit of normal were observed in subjects treated with LITFULO
See specific adverse reactions
Specific Adverse Reactions
ALC=absolute lymphocyte count; NMSC=nonmelanoma skin cancer; ULN=upper limit of normal.References:1. LITFULO. Prescribing Information. Pfizer; 2023. 2. King B, Guttman-Yassky E, Peeva E, et al. A phase 2a randomized, placebo-controlled study to evaluate the efficacy and safety of the oral Janus kinase inhibitors ritlecitinib and brepocitinib in alopecia areata: 24-week results. J Am Acad Dermatol. 2021;85(2):379-387. doi:10.1016/j.jaad.2021.03.050 3. Placebo-controlled safety study of ritlecitinib (PF-06651600) in adults with alopecia areata. ClinicalTrials.gov identifier: NCT04517864. Updated December 28, 2022. Accessed May 22, 2023. https://clinicaltrials.gov/ct2/show/NCT04517864 4. Data on file. Pfizer, Inc; New York, NY. 5. King B, Zhang X, Harcha WG, et al. Efficacy and safety of ritlecitinib in adults and adolescents with alopecia areata: a randomised, double-blind, multicentre, phase 2b–3 trial. Lancet. 2023;401(10387):1518-1529. doi:10.1016/S0140-6736(23)00222-2. Erratum in: Lancet. 2023 Jun 10;401(10392):1928. 6. 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/NCT04006457 7. A 52-week study of ritlecitinib oral capsules in adults and adolescents with vitiligo (active and stable) (tranquillo). ClinicalTrials.gov identifier: NCT05583526. Updated June 5, 2023. Accessed June 20, 2023. https://clinicaltrials.gov/study/NCT05583526 Safety Get appropriate patients started on LITFULO today Getting Started Loading Samples are available Order Samples Loading

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PP-LGF-USA-0187
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.
Important Safety Information WARNING: 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 full Prescribing Information, including BOXED WARNING and Medication 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.