Brand Name
Leqselvi
Generic Name
Deuruxolitinib
View Brand Information FDA approval date: June 25, 2025
Classification: Janus Kinase Inhibitor
Form: Tablet
What is Leqselvi (Deuruxolitinib)?
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 inhibitor indicated for the treatment of adults 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.
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Related Clinical Trials
A Double-Blind, Randomized, Placebo-Controlled Multicenter Study to Evaluate the Efficacy and Safety of Deuruxolitinib in Adolescent Patients With Severe Alopecia Areata With an Open-label Extension Period
Summary: This study evaluates the safety and effectiveness of deuruxolitinib in adolescents aged 12 to less than 18 years who have 50% or greater scalp hair loss.
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Brand Information
LEQSELVI (deuruxolitinib phosphate)
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. (
- 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. (
- 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. (
- 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. (
- 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. (
1INDICATIONS AND 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.
2DOSAGE FORMS AND STRENGTHS
Tablet: purple, round, debossed with “C” on one side and “8” on the other side
3CONTRAINDICATIONS
LEQSELVI is contraindicated in patients who:
- Are CYP2C9 poor metabolizers
- Are on concomitant moderate or strong CYP2C9 inhibitors
4ADVERSE REACTIONS
The following clinically significant adverse reactions are described elsewhere in the labeling:
- Serious Infections
- Malignancy and Lymphoproliferative Disorders
- Thrombosis
- Gastrointestinal perforations
- Lipid Elevations, Anemia, Neutropenia and Lymphopenia
4.1Clinical 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
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
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).
5DRUG 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
Moderate or strong CYP2C9 inhibitors:
LEQSELVI is contraindicated in patients taking moderate or strong CYP2C9 inhibitors
Deuruxolitinib is a CYP2C9 substrate. Concomitant use with a moderate or strong CYP2C9 inhibitor is estimated to increase deuruxolitinib exposure (C
6OVERDOSAGE
There is no experience regarding human overdose with LEQSELVI.
There is no specific antidote for overdose with LEQSELVI. Treatment should be symptomatic and supportive and monitor patients for signs and symptoms of adverse reactions
In case of overdose, consider contacting the Poison Center at 1-800-222-1222 for latest recommendations.
7DESCRIPTION
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
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
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.
8CLINICAL STUDIES
Two multicenter, randomized, double-blind, placebo-controlled phase 3 clinical trials (AA-1 [
Deuruxolitinib 12 mg is not approved.
The trial population ranged from 18 to 65 years of age. Among the subjects enrolled, 64% were female, 74% were White, 9% were Black or African American, and 6% were Asian; 8% identified as Hispanic or Latino. At baseline, subjects had average current episode of hair loss of approximately 4 years, with 59% of subjects having complete or near complete scalp hair loss (defined as ≥ 95% scalp hair loss). The mean pooled baseline SALT scores across treatment groups ranged from 85.9 to 88.6 with a mean duration of current episode of hair loss of ranging 3.7 to 3.9 years. Approximately 73% of subjects had eyebrow hair involvement and 70% of subjects had eyelash hair involvement.
The primary endpoint for both trials assessed the proportion of subjects who achieved at least 80% scalp hair coverage (SALT score of ≤ 20) at Week 24. Key secondary outcomes included the percentage of responders (defined as “satisfied” or “very satisfied”) at Week 24 on the Satisfaction of Hair Patient-Reported Outcome (SPRO) and the percentage of subjects achieving an absolute SALT score of ≤ 20 at Week 20, 16, 12, and 8.
Upon completion of the 24-week trials, subjects were eligible to enroll in a long-term extension trial.
Clinical Response
Assessment of scalp hair loss was based on the SALT score. At Week 24, a greater proportion of subjects had a SALT ≤ 20 response (80% or more scalp hair) and SALT ≤ 10 response (90% or more scalp hair) with LEQSELVI 8 mg twice daily compared to placebo (
Figure 1: Clinical Response over Time in Adult Subjects with Severe AA in Trials AA- 1 and AA-2
The efficacy of LEQSELVI was generally comparable across multiple subgroups including age, gender, and body weight among these subgroups. The results for SALT score ≤ 20 at Week 24 by baseline scalp hair loss severity are presented in
9HOW 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.
10PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (
Serious Infections
Advise patients that they are more likely to develop infections when taking LEQSELVI.
Advise patients that the risk of herpes zoster is increased in patients treated with LEQSELVI and some cases can be serious
Instruct patients to tell their healthcare provider if they develop any signs or symptoms of an infection
Malignancies and Lymphoproliferative Disorders
Inform patients that LEQSELVI may increase the risk of developing certain cancers, including skin cancers, and that periodic skin examinations should be performed while using LEQSELVI. Instruct patients to inform their healthcare provider if they have ever had any type of cancer
Major Adverse Cardiovascular Events
Inform patients that LEQSELVI may increase the risk of major adverse cardiovascular events (MACE) including myocardial infarction, stroke, and cardiovascular death. Instruct all patients, especially current or past smokers or patients with other cardiovascular risk factors, to be alert for the development of signs and symptoms of cardiovascular events
Thrombosis
Advise patients that events of DVT, PE and CVT have been reported in clinical trials with LEQSELVI. Instruct patients to seek immediate medical attention if they develop any signs or symptoms of a DVT, PE, or CVT
Increased Risk of LEQSELVI-Associated Serious Adverse Reactions in CYP2C9 Poor Metabolizers or with Concomitant Use of Moderate or Strong CYP2C9 Inhibitors
Advise patients to inform their healthcare providers of all medications they are taking, including prescription medicines, over-the-counter drugs, vitamins, and herbal products (e.g., St. John's wort)
Gastrointestinal Perforations
Inform patients that gastrointestinal perforations have been reported in clinical trials with LEQSELVI. Instruct patients to seek medical care immediately if they experience new onset of abdominal pain, fever, chills, nausea, or vomiting
Laboratory Abnormalities
Inform patients that LEQSELVI may affect certain lab tests, and that blood tests are required before and during LEQSELVI treatment
Immunizations
Advise patients that vaccination with live vaccines is not recommended during or immediately prior to LEQSELVI treatment. Instruct patients to inform their healthcare practitioner that they are taking LEQSELVI prior to a potential vaccination
Pregnancy
Advise pregnant patients and patients of reproductive potential of the potential risk to a fetus and to inform their healthcare provider if they are pregnant or plan to become pregnant during treatment with LEQSELVI. Inform patients to report their pregnancy to Sun Pharmaceutical Industries, Inc at
Lactation
Advise patients not to breastfeed during treatment with LEQSELVI and for one day after the last dose
Manufactured for Sun Pharmaceutical Industries, Inc by: Halo Pharmaceutical, Inc, Whippany, NJ, 07981, USA
U.S. Patent No. 10,561,659; 10,265,258; 11,298,570 and 11,919,907
LEQSELVI is a trademark of Sun Pharmaceutical Industries, Inc.
© 2024 Sun Pharmaceutical Industries, Inc. All rights reserved
Code# 2142-00
7/2024
11PRINCIPAL DISPLAY PANEL - NDC: 47335-108-06 - 60 Tablets - Carton Label
