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Litfulo is a brand name for Ritlecitinib. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: 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 recommended for use in combination with other JAK inhibitors, biologic immunomodulators, cyclosporine or other potent immunosuppressants.…
Verbatim from this product's FDA label. Tap a section to expand.
2 DOSAGE AND ADMINISTRATION • For recommended testing, evaluations and immunizations prior to LITFULO initiation, see Full Prescribing Information. 1 ) • Recommended dosage is 50 mg orally once daily. 2 ) • For dosage interruption for certain adverse reactions, see Full Prescribing Information.
1 Recommended Evaluations and Immunizations Prior to Treatment Initiation Perform the following evaluations prior to LITFULO initiation: • Tuberculosis (TB) infection evaluation: LITFULO initiation is not recommended in patients with active TB.
1) ] . 1) ] . 7) ] . 8) ] . 3) ] . Swallow capsules whole. Do not crush, split, or chew LITFULO capsules. If a dose is missed, administer the dose as soon as possible unless it is less than 8 hours before the next dose, in which case, skip the missed dose.
Thereafter, resume dosing at the regular scheduled time. 3) ] . 4 Treatment Interruption or Discontinuation If treatment interruption is indicated, a temporary treatment interruption for less than 6 weeks is not expected to result in significant loss of regrown scalp hair.
Hematologic Abnormalities Recommendations for LITFULO treatment interruption or discontinuation for hematologic abnormalities are summarized in Table 1. Table 1. Laboratory Monitoring Guidance Laboratory Measure Recommendation ALC = absolute lymphocyte count.
Platelet Count Treatment should be discontinued if platelet count is <50,000/mm 3 Lymphocytes Treatment should be interrupted if ALC is <500/mm 3 and may be restarted once ALC return above this value. 7) ] .
7) ] 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.
1 ) To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. gov/medwatch . 1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The safety of LITFULO was evaluated in three randomized, placebo-controlled clinical trials and one long-term trial in subjects with alopecia areata, including alopecia totalis and alopecia universalis, who were 12 years of age and older.
A total of 1628 subjects were treated with LITFULO representing 2085 subject-years of exposure. There were 1011 subjects with at least 1 year of exposure to LITFULO. In the placebo-controlled period of clinical trials in alopecia areata, a total of 668 subjects were exposed to LITFULO with 130 receiving 50 mg once daily for up to 24 weeks.
5%) subjects were 65 years of age or older. 6%). Adverse reactions occurring at ≥1% in the treated groups and at a higher rate than placebo are presented in Table 2. 5%) subjects treated with LITFULO 50 mg were discontinued from the trials due to adverse reactions.
Table 2. Adverse Reactions in Clinical Trials of LITFULO for the Treatment of Alopecia Areata Reported in ≥1% of subjects and at a higher rate than placebo for up to 24 weeks. LITFULO 50 mg N=130 n (%) Placebo N=213 n (%) Headache Headache includes headache and migraine.
5) Diarrhea Diarrhea includes diarrhea and frequent bowel movements. 8) Acne Acne includes acne and acne pustular. 7) Rash Rash includes rash and dermatitis allergic. 5) 0 Specific Adverse Reactions Exposure adjusted incidence rates were adjusted by clinical trial size for all adverse reactions reported in this section.
5 WARNINGS AND PRECAUTIONS • Hypersensitivity: Discontinue LITFULO if a clinically significant hypersensitivity reaction occurs. 6 ) • Laboratory Abnormalities: Perform ALC and platelet counts prior to LITFULO initiation. Treatment interruption or discontinuation are recommended based on ALC and platelet count abnormalities.
7 ) • Vaccinations: Avoid use of live vaccines during or shortly prior to LITFULO treatment. 1 Serious Infections Serious infections have been reported in patients receiving LITFULO. 1) ] . 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 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 LITFULO 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 Screen patients for tuberculosis (TB) before starting therapy. LITFULO should not be given to patients with active TB. 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. 1) ] . If a patient develops herpes zoster, consider interrupting treatment until the episode resolves.
6) ] . LITFULO is contraindicated in patients with known hypersensitivity to ritlecitinib or any of its excipients. ( 4 )
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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53 per 100 subject-years) treated with LITFULO 50 mg. 71 per 100 subject-years) treated with LITFULO 50 mg or higher. Serious Infections In the placebo-controlled trials, for up to 24 weeks, 3 subjects reported serious infections across all ritlecitinib doses studied.
66 per 100 subject-years) treated with LITFULO 50 mg or higher. The most common serious infections were related to appendicitis, COVID-19 infection (including pneumonia), and sepsis. Herpes Zoster In the placebo-controlled trials, for up to 24 weeks, herpes zoster was reported in 4 subjects across all ritlecitinib doses studied and 0 subjects treated with placebo.
17 per 100 subject-years) treated with LITFULO 50 mg or higher. 1 per 100 subject-years) treated with LITFULO 50 mg or higher in all clinical trials. 33 per 100 subject-years) treated with ritlecitinib higher dose and no malignancy was reported in subjects treated with placebo.
37 per 100 subject-years) treated with LITFULO 50 mg or higher. 06 per 100 subject-years) treated with LITFULO. There was 1 report of retinal artery occlusion and 1 report of acute myocardial infarction. Urticaria In the placebo-controlled trials, for up to 24 weeks, urticaria was reported in 28 subjects treated in all ritlecitinib doses studied and 3 subjects treated with placebo.
03 per 100 subject-years in subjects treated with placebo. Across clinical trials, including the long-term trial, urticaria was reported in 76 subjects treated with LITFULO 50 mg or higher. 10 per 100 subject-years. The median time to onset of an initial event was 8 weeks; median duration of urticaria was 7 days.
Most of the cases were mild to moderate in severity. 1%) treated with LITFULO 50 mg. Age appeared to be a risk factor for lower ALC in subjects ≥65 years of age. Decreased Platelet Count In the placebo-controlled trials, for up to 24 weeks, treatment with 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. 1%) had a confirmed platelet count <100,000/mm 3 . No subject had a confirmed platelet count <75,000/mm 3 .
5%) subjects treated with LITFULO 50 mg and 0 subjects treated with placebo. 7) ] .
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.
2 Mortality 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 all-cause mortality, including sudden cardiovascular death, was observed in patients treated with the JAK inhibitor compared with TNF blockers.
Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with LITFULO. 1) ] . In a large, randomized, postmarketing safety study of another JAK inhibitor in RA patients, a higher rate of malignancies (excluding non-melanoma skin cancer (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 a successfully treated NMSC or cervical cancer.
Periodic skin examination is recommended for patients who are at increased risk for skin cancer. 4 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 major adverse cardiovascular events (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 a myocardial infarction or stroke. 1) ] . 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, DVT, and PE were observed 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. 6 Hypersensitivity Serious reactions including anaphylactic reactions, urticaria and rash have been observed in patients receiving LITFULO in clinical trials.
1) ] . 1) ] . 1) ] . 4) ] . Liver Enzyme Elevations – Treatment with LITFULO was associated with increased incidence of liver enzyme elevation compared to placebo. Increases of ALT ≥5 times the upper limit of normal (ULN) and increases of AST ≥5 times the ULN were observed in patients in LITFULO clinical trials.
Evaluate at baseline and thereafter according to routine patient management. Prompt investigation of the cause of liver enzyme elevation is recommended to identify potential cases of drug-induced liver injury. 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. 8 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.