Drug Facts
Composition & Profile
Identifiers & Packaging
16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied: LEQSELVI tablets are packaged in white, high-density polyethylene (HDPE) bottles and closed with 24 mm white child-resistant caps with foil liner. Each bottle contains 1 g silica-gel canister. LEQSELVI is available as purple, round, immediate-release tablets debossed with “C” on one side and “8” on the other side: 8 mg: 60 tablets in a bottle; NDC: 47335-108-86 Storage and Handling: Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature]. Store in the original bottle to protect from moisture.; PRINCIPAL DISPLAY PANEL - NDC: 47335-108-06 - 60 Tablets - Carton Label 60 Tablets - Carton Label
- 16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied: LEQSELVI tablets are packaged in white, high-density polyethylene (HDPE) bottles and closed with 24 mm white child-resistant caps with foil liner. Each bottle contains 1 g silica-gel canister. LEQSELVI is available as purple, round, immediate-release tablets debossed with “C” on one side and “8” on the other side: 8 mg: 60 tablets in a bottle; NDC: 47335-108-86 Storage and Handling: Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature]. Store in the original bottle to protect from moisture.
- PRINCIPAL DISPLAY PANEL - NDC: 47335-108-06 - 60 Tablets - Carton Label 60 Tablets - Carton Label
Overview
LEQSELVI (deuruxolitinib) tablets contain the phosphate salt of deuruxolitinib, a Janus kinase (JAK) inhibitor, for oral administration. Deuruxolitinib phosphate is a white to off-white crystalline solid with the chemical name 1 H -Pyrazole-1-propanenitrile, β-(cyclopentyl-2,2,3,3,4,4,5,5- d 8 )-4-(7 H -pyrrolo[2,3- d ]pyrimidin-4-yl)-, (β R )-, phosphate (1:1). Deuruxolitinib has high aqueous solubility at low pH. Deuruxolitinib phosphate has a molecular weight of 412.42 g/mol and a molecular formula of C 17 H 13 D 8 N 6 O 4 P. The structural formula is: Each tablet contains 8 mg of deuruxolitinib (equivalent to 10.50 mg of deuruxolitinib phosphate) and the following excipients: colloidal silicon dioxide, lactose monohydrate, low-substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose and povidone. The tablet film coating contains the following excipients: carmine, FD&C blue #2 aluminum lake, glyceryl mono and dicaprylocaprate, polyvinyl alcohol, sodium lauryl sulfate, talc, and titanium dioxide. Chemical Structure
Indications & Usage
LEQSELVI™ is indicated for the treatment of adult patients with severe alopecia areata. Limitations of Use LEQSELVI is not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, cyclosporine, or other potent immunosuppressants. LEQSELVI is a Janus kinase (JAK) inhibitor indicated for the treatment of adults with severe alopecia areata. ( 1 ) Limitations of Use: LEQSELVI is not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, cyclosporine or other potent immunosuppressants. ( 1 )
Dosage & Administration
For recommended testing, evaluations, and procedures prior to and during LEQSELVI treatment, see Full Prescribing Information. ( 2.1 ) Recommended dosage is 8 mg twice daily. ( 2.2 ) For treatment interruption for certain adverse reactions, see Full Prescribing Information. ( 2.3 ) 2.1 Recommended Evaluations and Immunizations Prior to and During Treatment Perform the following prior to treatment with LEQSELVI: CYP2C9 genotype determination: Test patients for CYP2C9 variants to determine CYP2C9 genotype. LEQSELVI is contraindicated in patients who are CYP2C9 poor metabolizers (patients with decreased cytochrome P450 (CYP) 2C9 function) [see Contraindications ( 4 )] . An FDA-cleared or -approved test for the detection of CYP2C9 variants to direct the use of LEQSELVI is not currently available. Evaluation for use of concomitant CYP2C9 inhibitors: LEQSELVI is contraindicated in patients taking moderate or strong CYP2C9 inhibitors [see Warnings and Precautions ( 5.6 )] . Active and latent tuberculosis (TB) evaluation: LEQSELVI treatment is not recommended in patients with active TB. For patients with latent TB or those with a negative latent TB test who are at high risk of TB, start preventive therapy for TB prior to LEQSELVI treatment [ see Warnings and Precautions ( 5.1 ) ]. Viral hepatitis screening in accordance with clinical guidelines: LEQSELVI treatment is not recommended in patients with active hepatitis B or hepatitis C. Hepatitis B infection screening: If hepatitis B infection is discovered, follow hepatitis B clinical guidelines, or refer to a liver specialist. Monitor patients for reactivation in accordance with clinical guidelines during treatment [ see Warnings and Precautions ( 5.1 ) ]. Complete blood count (CBC): LEQSELVI treatment is not recommended in patients with an absolute lymphocyte count (ALC) <500 cells/mm 3 absolute neutrophil count (ANC) <1,000 cells/mm 3 , or hemoglobin level <8 g/dl. Monitor complete blood counts periodically during treatment and modify dosage as recommended [see Dosage and Administration ( 2.3 ) and Warnings and Precautions ( 5.8 )] . Complete any necessary immunizations, including herpes zoster vaccinations, according to current immunization guidelines prior to LEQSELVI treatment [see Warnings and Precautions ( 5.9 )] . 2.2 Recommended Dosage The recommended dosage of LEQSELVI for the treatment of severe alopecia areata is 8 mg orally twice daily, with or without food [see Clinical Pharmacology ( 12.3 )] . If a dose is missed, skip the missed dose and resume dosing at the next scheduled dose. 2.3 Treatment Interruption and Resumption Serious or Opportunistic Infections If a patient develops a serious or opportunistic infection, interrupt LEQSELVI treatment until the infection is controlled [see Warnings and Precautions ( 5.1 )] . Hematological Abnormalities Recommendations for LEQSELVI treatment interruption for hematologic abnormalities are described in Table 1 [see Warnings and Precautions ( 5.8 )] . Table 1: Recommendations for LEQSELVI Treatment Interruption for Hematologic Abnormalities and Resumption Laboratory Measure Interruption Criterion Resumption Criterion Absolute Lymphocyte Count (ALC) <500 cells/mm 3 ≥500 cells/mm 3 Absolute Neutrophil Count (ANC) <1000 cells/mm 3 ≥1000 cells/mm 3 Hemoglobin <8 g/dL ≥8 g/dL
Warnings & Precautions
Increased Risk of LEQSELVI-Associated Serious Adverse Reactions in CYP2C9 Poor Metabolizers or with Concomitant Use of Moderate or Strong CYP2C9 Inhibitors : LEQSELVI is contraindicated in patients who are CYP2C9 poor metabolizers or patients taking a moderate or strong CYP2C9 inhibitor. ( 5.6 ) Gastrointestinal Perforations: Monitor patients who may be at increased risk for gastrointestinal perforation. Evaluate promptly patients presenting with new onset abdominal symptoms. ( 5.7 ) Lipid Elevations, Anemia, Neutropenia, and Lymphopenia: Monitor for changes in lipids, hemoglobin, neutrophils, and lymphocytes. ( 5.8 ) Immunizations: Avoid use of live vaccines during or immediately prior to LEQSELVI treatment. ( 5.9 ) 5.1 Serious Infections Serious infections have been reported in subjects with alopecia areata receiving LEQSELVI [see Adverse Reactions ( 6.1 )] . Avoid use of LEQSELVI in patients with an active, serious infection including localized infections. Prior to LEQSELVI treatment, consider the risks and benefits in patients: with chronic or recurrent infection who have been exposed to tuberculosis with a history of a serious or opportunistic infection who have resided or traveled in areas of endemic tuberculosis or endemic 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 LEQSELVI. If the patient develops a serious infection, interrupt treatment with LEQSELVI until the infection resolves or is adequately treated. If a patient develops a new infection during treatment with LEQSELVI, initiate complete diagnostic testing appropriate for an immunocompromised patient and appropriate antimicrobial therapy. Tuberculosis Evaluate patients for latent and active tuberculosis (TB) infection prior to LEQSELVI treatment. LEQSELVI is not recommended for use in patients with active TB. Treat patients with latent TB before LEQSELVI treatment. Consider anti-TB therapy prior to LEQSELVI treatment in patients with previously untreated latent TB or active TB in whom an adequate course of treatment cannot be confirmed, and for patients with a negative test for latent TB but who have risk factors for TB infection. Consultation with a physician with expertise in the treatment of TB is recommended to aid in the decision about whether initiating anti-TB therapy is appropriate for an individual patient. Monitor patients receiving LEQSELVI for signs and symptoms of active TB during treatment, including patients who tested negative for latent TB infection prior to treatment. Viral Reactivation Viral reactivation, including cases of herpes virus reactivation (e.g., herpes zoster) were reported in clinical trials with LEQSELVI [see Adverse Reactions ( 6.1 )] . If a patient develops herpes zoster, consider interrupting LEQSELVI treatment until the episode resolves. The impact of LEQSELVI on chronic viral hepatitis reactivation is unknown. Subjects with positive results for hepatitis B surface antigens (HBsAg), antibodies to hepatitis B core antigens (anti-HBc), or hepatitis C virus (HCV) with detectable HCV RNA at screening were excluded from LEQSELVI clinical trials. Perform screening for viral hepatitis before treatment with LEQSELVI. LEQSELVI is not recommended for use in patients with active hepatitis B or hepatitis C (HCV RNA detected). If non-active hepatitis B infection is discovered, monitoring for reactivation or prophylactic treatment is recommended. Follow hepatitis B clinical guidelines or refer to a liver specialist. Hepatitis B viral load (HBV-DNA titer) increase, with or without associated elevations in alanine aminotransferase and aspartate aminotransferase, has been reported in subjects with chronic HBV infections receiving JAK inhibitors used to treat inflammatory conditions. The effect of LEQSELVI on viral replication in patients with chronic HBV infection is unknown. 5.2 Mortality In a large, randomized, postmarketing safety trial of another JAK inhibitor in rheumatoid arthritis (RA) subjects 50 years and older with at least one cardiovascular risk factor, a higher rate of all-cause mortality, including sudden cardiovascular death, was observed in subjects treated with the JAK inhibitor compared with TNF blockers. Consider the benefits and risks for the individual patient prior to and during treatment with LEQSELVI. 5.3 Malignancy and Lymphoproliferative Disorders Malignancies were observed in clinical trials of LEQSELVI [see Adverse Reactions 6.1 )] . In a large, randomized, postmarketing safety trial of another JAK inhibitor in subjects with RA, a higher rate of malignancies (excluding non-melanoma skin cancer (NMSC)) was observed in subjects treated with the JAK inhibitor compared to those treated with TNF blockers. A higher rate of lymphomas was observed in subjects 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 trial, current or past smokers had an additional increased risk of overall malignancies. Consider the benefits and risks for the individual patient prior to and during treatment with LEQSELVI, particularly in patients with a known malignancy (other than successfully treated NMSC), patients who develop a malignancy, and patients who are current or past smokers. Non-melanoma skin cancers Non-melanoma skin cancers (NMSCs) have been reported in patients treated with LEQSELVI. Periodic skin examination is recommended for patients who are at increased risk for skin cancer. 5.4 Major Adverse Cardiovascular Events (MACE) In a large, randomized, postmarketing safety trial of another JAK inhibitor in subjects with RA 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 and during treatment with LEQSELVI, particularly in patients who are current or past smokers and patients with other cardiovascular risk factors. Inform patients about the symptoms of serious cardiovascular events and the steps to take if they occur. Discontinue LEQSELVI in patients that have experienced a myocardial infarction or stroke. 5.5 Thrombosis Thrombosis, including pulmonary embolism (PE), deep vein thrombosis (DVT) and cerebral venous sinus thrombosis (CVT) have been reported in clinical trials of deuruxolitinib [see Adverse Reactions ( 6.1 )] . There was no clear relationship between platelet count elevations and thrombotic events. Thrombosis, including DVT, PE, and arterial thrombosis have been reported in subjects receiving JAK inhibitors used to treat inflammatory conditions. Many of these adverse reactions were serious and some resulted in death. In a large, randomized, postmarketing safety trial of another JAK inhibitor in subjects with RA 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 LEQSELVI in patients who may be at increased risk of thrombosis. If symptoms of thrombosis occur, discontinue LEQSELVI and evaluate and treat patients appropriately. 5.6 Increased Risk of LEQSELVI-Associated Serious Adverse Reactions in CYP2C9 Poor Metabolizers or with Concomitant Use of Moderate or Strong CYP2C9 Inhibitors Higher plasma concentrations of deuruxolitinib, which may increase the risk of LEQSELVI-associated serious adverse reactions such as thrombosis, may occur when LEQSELVI is used in patients who: Are CYP2C9 poor metabolizers [see Use in Specific Populations ( 8.8 ) and Clinical Pharmacology ( 12.5 )] . Are on a concomitant moderate or strong CYP2C9 inhibitor [see Drug Interactions ( 7 ) and Clinical Pharmacology ( 12.3 )] . Prior to LEQSELVI treatment, test patients for CYP2C9 variants to determine if they are poor metabolizers [see Dosage and Administration ( 2.1 )] . An FDA-cleared or -approved test for the detection of CYP2C9 variants to direct the use of LEQSELVI is not currently available. LEQSELVI is contraindicated in patients who are CYP2C9 poor metabolizers or patients who are on concomitant moderate or strong CYP2C9 inhibitors [see Contraindications ( 4 )] . 5.7 Gastrointestinal Perforations Gastrointestinal perforations have been reported in clinical trials with LEQSELVI. Monitor patients treated with LEQSELVI who may be at increased risk for gastrointestinal perforation (e.g., patients with a history of diverticulitis). Evaluate promptly patients presenting with new onset abdominal symptoms for early identification of gastrointestinal perforation. 5.8 Lipid Elevations, Anemia, Neutropenia, and Lymphopenia Perform a CBC prior to and periodically during treatment with LEQSELVI [see Dosage and Administration ( 2.1 )] . Lipid Elevations Treatment with LEQSELVI was associated with increases in triglycerides and total cholesterol, including HDL-C and LDL-C [see Adverse Reactions 6.1 )] . The effect of these lipid parameter elevations on cardiovascular morbidity and mortality has not been determined. Perform assessment of lipid parameters at baseline and periodically during treatment with LEQSELVI. Manage patients according to clinical guidelines for hyperlipidemia. Anemia Treatment with LEQSELVI was associated with an increased incidence of anemia (hemoglobin less than 8 g/dL) compared to placebo [see Adverse Reactions ( 6.1 )] . Avoid or interrupt LEQSELVI treatment in patients with hemoglobin less than 8 g/dL [see Dosage and Administration ( 2.3 )] . Neutropenia Treatment with LEQSELVI was associated with an increased incidence of neutropenia (ANC less than 1000 cells/mm 3 ) compared to placebo [see Adverse Reactions ( 6.1 )] . Avoid or interrupt LEQSELVI treatment in patients with an ANC less than 1,000 cells/mm 3 [see Dosage and Administration ( 2.3 )] . Lymphopenia Treatment with LEQSELVI was associated with an increased incidence of lymphopenia (ALC less than 500 cells/mm 3 ) compared to placebo [see Adverse Reactions ( 6.1 )] . Avoid or interrupt LEQSELVI treatment in patients with an ALC less than 500 cells/mm 3 [see Dosage and Administration ( 2.3 )] . 5.9 Immunizations Prior to LEQSELVI treatment, complete all necessary immunizations, including varicella zoster or prophylactic herpes zoster vaccinations, in accordance with current immunization guidelines. Avoid use of live vaccines during or immediately prior to LEQSELVI treatment.
Boxed Warning
SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS, AND THROMBOSIS Increased risk of serious bacterial, fungal, viral and opportunistic infections, including tuberculosis (TB), that may lead to hospitalization or death. Interrupt treatment with LEQSELVI if a serious infection occurs until the infection is controlled. LEQSELVI treatment is not recommended in patients with active tuberculosis. Test for latent TB before and during therapy; treat latent TB prior to use. Monitor all patients for active TB during treatment, even patients with initial negative, latent TB test. ( 5.1 ) Higher rate of all-cause mortality, including sudden cardiovascular death, was observed with another Janus kinase (JAK) inhibitor vs. TNF blockers in rheumatoid arthritis (RA) patients. LEQSELVI is not approved for use in RA patients. ( 5.2 ) Malignancies were reported in patients treated with LEQSELVI. Higher rate of lymphomas and lung cancers was observed with another JAK inhibitor vs. TNF blockers in RA patients. ( 5.3 ) Higher rate of major adverse cardiovascular events (MACE) (defined as cardiovascular death, myocardial infarction, and stroke) was observed with another JAK inhibitor vs. TNF blockers in RA patients. ( 5.4 ) Thrombosis, including cerebral venous sinus thrombosis (CVT), deep vein thrombosis (DVT) and pulmonary embolism (PE) have been reported in patients treated with LEQSELVI. Increased incidence of pulmonary embolism, venous and arterial thrombosis was observed with another JAK inhibitor vs. TNF blockers. ( 5.5 ) WARNING: SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS (MACE) and THROMBOSIS See full prescribing information for complete boxed warning. Increased risk of serious bacterial, fungal, viral and opportunistic infections including tuberculosis (TB), that may lead to hospitalization or death. Interrupt treatment with LEQSELVI if a serious infection occurs until the infection is controlled. Test for latent TB before and during therapy; treat latent TB prior to use. Monitor all patients for active TB during treatment, even patients with initial negative, latent TB test. ( 5.1 ) Higher rate of all-cause mortality, including sudden cardiovascular death with another Janus kinase inhibitor (JAK) vs. TNF blockers in rheumatoid arthritis (RA) patients. LEQSELVI is not approved for use in RA patients. ( 5.2 ) Malignancies have occurred in patients treated with LEQSELVI. Higher rate of lymphomas and lung cancers with another JAK inhibitor vs. TNF blockers in RA patients. ( 5.3 ) Higher rate of MACE (defined as cardiovascular death, myocardial infarction, and stroke) with another Janus kinase inhibitor (JAK) vs. TNF blockers in rheumatoid arthritis (RA) patients. ( 5.4 ) Thrombosis has occurred in patients treated with LEQSELVI. Increased incidence of pulmonary embolism, venous and arterial thrombosis with another JAK inhibitor vs. TNF blockers. ( 5.5 )
Contraindications
LEQSELVI is contraindicated in patients who: Are CYP2C9 poor metabolizers [see Warnings and Precautions ( 5.6 )] . Are on concomitant moderate or strong CYP2C9 inhibitors [see Warnings and Precautions ( 5.6 )] . LEQSELVI is contraindicated in patients: Who are CYP2C9 poor metabolizers. ( 4 ) Using moderate or strong CYP2C9 inhibitors. ( 4 )
Adverse Reactions
The following clinically significant adverse reactions are described elsewhere in the labeling: Serious Infections [see Warnings and Precautions ( 5.1 )] Malignancy and Lymphoproliferative Disorders [see Warnings and Precautions ( 5.3 )] Thrombosis [see Warnings and Precautions ( 5.5 )] Gastrointestinal perforations [see Warnings and Precautions ( 5.7 )] Lipid Elevations, Anemia, Neutropenia and Lymphopenia [see Warnings and Precautions ( 5.8 )] Most common adverse reactions (≥1%) are: headache, acne, nasopharyngitis, blood creatine phosphokinase increased, hyperlipidemia, fatigue, weight increased, lymphopenia, thrombocytosis, anemia, skin and soft tissue infections, neutropenia, and herpes. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Sun Pharmaceutical Industries, Inc. at 1-800-818-4555 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 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 LEQSELVI was evaluated in three randomized, placebo-controlled clinical trials (including a dose-ranging trial), two open-label trials, and two long-term extension trials in adult subjects with severe alopecia areata. These subjects had at least 50% scalp hair loss as measured by the Severity of Alopecia Tool (SALT) for more than six months. A total of 1,730 subjects with alopecia areata were treated across all trials, representing 1,962.9 patient-years of exposure. There were 974 subjects who were exposed to either LEQSELVI 8 mg or deuruxolitinib 12 mg for at least 1 year and 104 subjects who were exposed for at least 3 years. Deuruxolitinib 12 mg is not approved. Among 1,020 subjects enrolled in the placebo-controlled clinical trials, 640 subjects received LEQSELVI 8 mg twice daily, 380 subjects received deuruxolitinib 12 mg twice daily and 299 subjects received placebo twice daily for up to 24 weeks [see Clinical Studies ( 14 )] . Adverse Reactions occurring at ≥1% in the LEQSELVI 8 mg or deuruxolitinib 12 mg twice daily group and at a higher rate than in the placebo group are presented in Table 2 . A total of 20 (3.1%) of subjects treated with LEQSELVI 8 mg were discontinued from the trials due to adverse reactions. Table 2: Adverse Reactions Reported in ≥1% of Subjects with Alopecia Areata Treated with LEQSELVI 8 mg Twice Daily or Deuruxolitinib 12 mg Twice Daily (and More Frequently than Placebo) in Placebo-Controlled Trials Over 24-Weeks a. %-study size adjusted percentages. b. Acne includes: acne, dermatitis acneiform, and acne pustular. c. Hyperlipidemia includes: blood cholesterol increased, low density lipoprotein increased, blood triglycerides increased, hypercholesterolemia, hyperlipidemia, hypertriglyceridemia, and dyslipidaemia. d. Fatigue includes: fatigue, asthenia, hypersomnia, somnolence, and lethargy. e. Skin and soft issue infections includes: folliculitis, impetigo, skin infection, subcutaneous abscess, furuncle, paronychia, and pustule. f. Anemia includes: anemia, hematocrit decreased, hemoglobin decreased, iron deficiency anemia, and red blood cell count decreased. g. Neutropenia includes: neutropenia and neutrophil count decreased. h. Thrombocytosis includes: thrombocytosis and platelet count increased. i. Herpes includes: oral herpes, herpes simplex, genital herpes simplex, and nasal herpes. Placebo N = 299 n (%) a LEQSELVI 8 mg twice daily N = 640 n (%) a Deuruxolitinib 12 mg twice daily N = 380 n (%) a Acne b 13 (4.3) 66 (10.0) 52 (12.6) Headache 30 (9.4) 83 (12.4) 44 (10.5) Nasopharyngitis 21 (6.7) 54 (8.1) 33 (7.7) Blood creatine phosphokinase increased 7 (2.2) 35 (5.3) 27 (7.4) Hyperlipidemia c 10 (3.1) 30 (4.4) 19 (5.2) Fatigue d 12 (3.9) 26 (3.9) 20 (4.9) Skin and soft tissue infections e 2 (0.8) 11 (1.6) 15 (4.0) Anemia f 3 (1.0) 18 (2.6) 16 (3.4) Weight increased 4 (1.4) 19 (2.9) 10 (2.5) Neutropenia g 3 (0.7) 10 (1.4) 10 (2.8) Lymphopenia 2 (0.6) 2 (0.3) 7 (2.0) Thrombocytosis h 0 18 (2.7) 6 (1.6) Herpes i 2 (0.6) 8 (1.2) 6 (1.6) Additional adverse drug reactions occurring in fewer than 1% of subjects: herpes zoster, lipase increased, and candidiasis. A total of 868 subjects in the long-term extension trials received treatment with LEQSELVI 8 mg twice daily and 991 subjects received treatment with deuruxolitinib 12 mg twice daily for 52 weeks. In two open-label extension trials up to 3 years, 829 subjects received treatment with LEQSELVI 8 mg twice daily, and 1066 subjects received treatment with deuruxolitinib 12 mg twice daily. Specific Adverse Reactions (0-52 weeks) All Infections During the 24-week treatment period, infections were reported in 97 subjects (88.0 per 100 patient-years) treated with placebo, 222 subjects (101.5 per 100 patient-years) treated with LEQSELVI 8 mg twice daily and 153 subjects (117.0 per 100 patient years) treated with deuruxolitinib 12 mg twice daily. During the 0-52 week period, infections were reported in 435 subjects (95.5 per 100 patient-years) treated with LEQSELVI 8 mg twice daily and 408 subjects (74.1 per 100 patient-years) treated with deuruxolitinib 12 mg twice daily. Serious Infections During the 24-week treatment period, serious infections were reported in 1 subject (0.8 per 100 patient-years) treated with placebo, 5 subjects (1.8 per 100 patient-years) treated with LEQSELVI 8 mg twice daily and 2 subjects (1.2 per 100 patient-years) treated with deuruxolitinib 12 mg twice daily. During the 0-52 week period, serious infections were reported in 5 subjects (0.7 per 100 patient-years) treated with LEQSELVI 8 mg twice daily and 4 subjects (0.5 per 100 patient-years) treated with deuruxolitinib 12 mg twice daily. Herpes Zoster During the 24-week treatment period, opportunistic infections (herpes zoster) were reported in 0 subjects treated with placebo, 3 subjects (1.1 per 100 patient-years) treated with LEQSELVI 8 mg twice daily and 3 subjects (1.8 per 100 patient-years) treated with deuruxolitinib 12 mg twice daily. During the 0-52 week period, herpes zoster was reported in 10 subjects (1.5 per 100 patient-years) treated with LEQSELVI 8 mg twice daily and 15 subjects (1.9 per 100 patient-years) treated with deuruxolitinib 12 mg twice daily. Malignancies During the 0-52 week period, malignancy excluding NMSC was reported in 3 subjects (0.4 per 100 patient-years) treated with LEQSELVI 8 mg twice daily and 4 subjects (0.5 per 100 patient-years) treated with deuruxolitinib 12 mg twice daily. Thrombosis During the 0-52 week period, thrombosis was reported in 0 subjects treated with LEQSELVI 8 mg twice daily and 1 subject (0.1 per 100 patient-years) treated with deuruxolitinib 12 mg twice daily who developed bilateral pulmonary embolism. Laboratory Abnormalities Anemia During the 24-week treatment period, anemia was reported in 3 subjects (2.3 per 100 patient-years) treated with placebo, 19 subjects (6.9 per 100 patient-years) treated with LEQSELVI 8 mg twice daily and 16 subjects (9.6 per 100 patient-years) treated with deuruxolitinib 12 mg twice daily. During the 0-52 week period, anemia was reported in 17 subjects (2.6 per 100 patient-years) treated with LEQSELVI 8 mg twice daily and 38 subjects (5.0 per 100 patient-years) treated with deuruxolitinib 12 mg twice daily. Neutropenia During the 24-week treatment period, neutropenia was reported in 3 subjects (2.3 per 100 patient-years) treated with placebo, 10 subjects (3.6 per 100 patient-years) treated with LEQSELVI 8 mg twice daily and 10 subjects (6.0 per 100 patient-years) treated with deuruxolitinib 12 mg twice daily. During the 0-52 week period, neutropenia was reported in 11 subjects (1.6 per 100 patient-years) treated with LEQSELVI 8 mg twice daily and 15 subjects (1.9 per 100 patient-years) treated with deuruxolitinib 12 mg twice daily. Lymphopenia During the 24-week treatment period, lymphopenia was reported in 2 subjects (1.5 per 100 patient-years) treated with placebo, 2 subjects (0.7 per 100 patient-years) treated with LEQSELVI 8 mg twice daily and 7 subjects (4.2 per 100 patient-years) treated with deuruxolitinib 12 mg twice daily. During the 0-52 week period, lymphopenia was reported in 4 subjects (0.6 per 100 patient-years) treated with LEQSELVI 8 mg twice daily and 10 subjects (1.3 per 100 patient-years) treated with deuruxolitinib 12 mg twice daily. Lipid Elevations During the 24-week treatment period, lipid elevations were reported in 10 subjects (7.7 per 100 patient-years) treated with placebo, 30 subjects (11.0 per 100 patient-years) treated with LEQSELVI 8 mg twice daily and 18 subjects (10.9 per 100 patient-years) treated with deuruxolitinib 12 mg twice daily. During the 0-52 week period, lipid elevations were reported in 47 subjects (7.2 per 100 patient-years) treated with LEQSELVI 8 mg twice daily and 66 subjects (8.7 per 100 patient-years) treated with deuruxolitinib 12 mg twice daily. Creatine Phosphokinase (CPK) Elevations During the 24-week treatment period, CPK elevations were reported in 7 subjects (5.4 per 100 patient-years) treated with placebo, 35 subjects (12.9 per 100 patient-years) treated with LEQSELVI 8 mg twice daily and 27 subjects (16.6 per 100 patient-years) treated with deuruxolitinib 12 mg twice daily. During the 0-52 week period, CPK elevations were reported in 49 subjects (7.6 per 100 patient-years) treated with LEQSELVI 8 mg twice daily and 46 subjects (6.1 per 100 patient-years) treated with deuruxolitinib 12 mg twice daily. Thrombocytosis During the 24-week treatment period, an increase in platelet count was reported in 0 subjects treated with placebo, 18 subjects (6.6 per 100 patient-years) treated with LEQSELVI 8 mg twice daily and 6 subjects (3.6 per 100 patient-years) treated with deuruxolitinib 12 mg twice daily. During the 0-52 week period, an increase in platelet count was reported in 20 subjects (3.0 per 100 patient-years) treated with LEQSELVI 8 mg twice daily and 26 subjects (3.4 per 100 patient-years) treated with deuruxolitinib 12 mg twice daily. Adverse Reactions Observed after 52 weeks Thrombosis Venous thromboembolic events were reported in 4 subjects treated with deuruxolitinib 12 mg twice daily between Week 52 and Week 98. These 4 subjects experienced 7 thrombotic events (0.2 per 100 patient-years), including deep vein thrombosis (DVT), bilateral pulmonary embolism (PE), pulmonary embolism, and cerebral venous sinus thrombosis (CVT).
Drug Interactions
Effect of Other Drugs on LEQSELVI Strong CYP3A and moderate or strong CYP2C9 inducers: Avoid concomitant use of LEQSELVI with strong CYP3A and moderate or strong CYP2C9 inducers. Deuruxolitinib is a CYP2C9 and CYP3A substrate. Concomitant use with a strong CYP3A and moderate or strong CYP2C9 inducer decreases deuruxolitinib exposure (C max and AUC), which may reduce LEQSELVI efficacy [see Clinical Pharmacology ( 12.3 )] . Moderate or strong CYP2C9 inhibitors: LEQSELVI is contraindicated in patients taking moderate or strong CYP2C9 inhibitors [see Contraindications ( 4 )] . Deuruxolitinib is a CYP2C9 substrate. Concomitant use with a moderate or strong CYP2C9 inhibitor is estimated to increase deuruxolitinib exposure (C max and AUC), which may increase the risk of LEQSELVI serious adverse reactions such as thrombosis [see Clinical Pharmacology ( 12.3 )] . Strong CYP3A4 and moderate or strong CYP2C9 inducers: Avoid concomitant use. ( 7 ) Moderate or strong CYP2C9 inhibitors: Contraindicated. ( 7 )
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