General MedicinePrescription OnlyPregnancy Cat. Not classifiedFDA Yes
Leqselvi
DEURUXOLITINIB PHOSPHATE
1 INDICATIONS 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. 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, ...
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Brand names:LEQSELVI
Quick Reference
Medicine ClassGeneral Medicine
FDA ApprovedYes
PregnancyCategory Not classified
Quick Facts
- Active ingredient
- DEURUXOLITINIB PHOSPHATE
- Medicine class
- General Medicine
- Brand names
- LEQSELVI
- Availability
- Prescription only (Rx)
- Pregnancy category
- Not classified
- Half-life
- half-life is approximately 4 hrs
- FDA approved
- Yes
What Is Leqselvi?
1 INDICATIONS 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. 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, ...
Leqselvi (DEURUXOLITINIB PHOSPHATE) belongs to the General Medicine class of medications. It was first approved by the FDA in Yes. This medication requires a prescription from a licensed healthcare provider.
Key Safety Information
- •Always follow the dose recommended by your healthcare professional. Taking more than prescribed increases the risk of side effects including serious complications.
- •Seek emergency care if you experience signs of an allergic reaction — hives, swelling, difficulty breathing, or rash. Stop the medication and call your doctor immediately.
- •Some medications can increase the risk of cardiovascular events. Tell your doctor if you have high blood pressure, a history of heart attack or stroke, or any pre-existing health condition.
- •Avoid or limit alcohol while taking Leqselvi. Do not drink alcohol without first discussing it with your healthcare provider as it may increase adverse effects.
- •Take Leqselvi with food or a full glass of water if stomach upset occurs. Stop use and talk to your doctor if you experience persistent stomach pain or GI symptoms.
- •Tell your doctor about all medications, supplements, and vitamins you take. Some combinations significantly increase the risk of harm.
This is a summary only. Always read the full prescribing information and consult your healthcare provider for personalized medical advice.
Uses & Indications
Leqselvi is prescribed for the following conditions. Some uses are FDA-approved indications; others may be evidence-based off-label uses. Consult your healthcare provider for personalized guidance.
1 INDICATIONS 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.
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.
Dosage Guide
The following are general dosing guidelines only. Your actual dose should be determined by your healthcare provider based on your condition, renal/hepatic function, and other medications.
AD
Adult Dosage
2 DOSAGE AND 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 (
Available Forms
Available Strengths
Side Effects
Common
- 6 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.
Serious
- 5 WARNINGS AND 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.
Rare
Medicine Interactions
Always inform your healthcare provider and pharmacist about ALL medications you take, including prescriptions, OTC medicines, vitamins, and supplements.
MajorModerateMinor
Warnings & Contraindications
5 WARNINGS AND 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
How Leqselvi Works
12.1 Mechanism of Action Deuruxolitinib is a Janus kinase (JAK) inhibitor. JAKs mediate the signaling of a number of cytokines and growth factors that are important for hematopoiesis and immune function. JAK signaling involves recruitment of STATs (signal transducers and activators of transcription) to cytokine receptors, activation and subsequent localization of STATs to the nucleus leading to modulation of gene expression. In an in vitro kinase activity assay, deuruxolitinib had greater inhibitory potency for JAK1, JAK2 and TYK2 relative to JAK3. The relevance of inhibition of JAK enzymes to therapeutic effectiveness is not currently known.
Pharmacokinetics
Absorption
Absorption Deuruxolitinib bioavailability is 90%, with peak plasma concentrations reached within 1
Half-Life
half-life is approximately 4 hrs
Metabolism
Metabolism Deuruxolitinib is primarily metabolized by CYP2C9 (76%) and CYP3A4 (21%) and to a lesser extent by CYP1A2 (3%)
Excretion
Excretion After a single dose of radiolabeled deuruxolitinib, there was no unchanged dose recovered in either urine or feces
Pregnancy & Breastfeeding Safety
Not classified
Breastfeeding
Many medications pass into breast milk in varying amounts. Before using Leqselviwhile breastfeeding, discuss the benefits and risks with your healthcare provider or pharmacist — they can weigh your dose, your infant's age, and available lactation safety data to find the safest option for you and your baby.
Storage & Handling
Store at room temperature. Keep away from moisture and heat. Keep out of reach of children.
Frequently Asked Questions
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Leqselvi side effects
Complete adverse effect profile including common, serious, and rare reactions
Sources & References
- • FDA Prescribing Information — Official labeling and package insert for Leqselvi
- • U.S. National Library of Medicine — MedlinePlus drug information
- • American Hospital Formulary Service (AHFS) — Clinical pharmacology monograph
- • PubMed / MEDLINE — View clinical studies
Last reviewed by MedCentralHub Medical Review Board · MedCentralHub Editorial Policy
Medical Disclaimer
The information on this page is for educational purposes only and is not intended as medical advice, diagnosis, or treatment. Always consult your doctor, pharmacist, or qualified healthcare provider before starting, stopping, or changing any medication.