Deuruxolitinib
Deuruxolitinib (Leqselvi) is a JAK inhibitor taken by mouth to treat severe alopecia areata in adults.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
Deuruxolitinib (Leqselvi) is a twice-daily tablet for adults with severe alopecia areata (autoimmune hair loss) that blocks JAK enzymes, which signal the immune system to attack hair follicles; it is a newer specialist medicine, on the U.S. market since about 2025. Day to day most people tolerate it reasonably well, and headache, acne and cold-like symptoms are what they usually notice. Its boxed warning covers serious infections including tuberculosis, higher death rates, cancer, major heart events and blood clots, so fever, sudden chest pain or leg swelling needs prompt care. You need a CYP2C9 genetic test first, because people who break the drug down slowly cannot take it.
Clinical pearls
- Fluconazole and other drugs that block the CYP2C9 enzyme are off-limits, because they push deuruxolitinib levels up and raise clot risk.
- Rifampin can drop deuruxolitinib levels so low it stops working, so any new antibiotic needs a quick interaction check.
- Expect regular blood tests for blood counts and cholesterol, plus periodic skin checks for new or changing growths.
- Live vaccines are off the table during treatment and just before starting, so sort out any due vaccines with your prescriber early.
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾
Leqselvi carries a serious boxed warning — the FDA's most prominent safety alert — covering five major risks.
- Serious infections: Leqselvi suppresses the immune system, raising the risk of life-threatening bacterial, fungal, viral, and opportunistic infections, including tuberculosis. Treatment must be stopped if a serious infection occurs. Screening for TB and hepatitis is required before starting.
- Increased mortality: A different JAK inhibitor used in rheumatoid arthritis patients was linked to a higher rate of death, including from sudden heart problems, compared to other treatments. Leqselvi is not approved for rheumatoid arthritis, but this risk is considered relevant.
- Cancer: Cancers, including lymphomas and lung cancers, have been reported. Risk may be higher in current or past smokers.
- Major cardiovascular events (MACE): Heart attack, stroke, and cardiovascular death have been associated with this class of drug. Current or past smokers face additional risk. Stop Leqselvi immediately if you have a heart attack or stroke.
- Blood clots (thrombosis): Serious and sometimes fatal clots in the legs, lungs, and brain have been reported with Leqselvi. Seek emergency care immediately if you develop sudden leg pain, chest pain, or a severe headache.
Patient information guide A plain-language walkthrough of Deuruxolitinib, written from its FDA label.
What Deuruxolitinib is used for
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Deuruxolitinib is an oral JAK inhibitor currently available as Leqselvi. Here is what it is approved for:
- Leqselvi is indicated for the treatment of severe alopecia areata in adults — an autoimmune condition that causes significant scalp hair loss (at least 50% of the scalp affected for more than six months)
- Leqselvi is not recommended for use alongside other JAK inhibitors, biologic immunomodulators, cyclosporine, or other potent immunosuppressants
- Leqselvi is not approved for rheumatoid arthritis or any other condition
How Deuruxolitinib works
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Deuruxolitinib blocks a family of enzymes called Janus kinases (JAKs) — specifically JAK1, JAK2, and TYK2. These enzymes normally help pass signals from inflammatory proteins (cytokines) into cells, activating gene changes that drive the immune response. In alopecia areata, that immune response mistakenly attacks hair follicles. By blocking JAK signaling, deuruxolitinib dials down this immune attack and creates an environment where hair can regrow.
Deuruxolitinib dosage
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Leqselvi is taken as an oral tablet twice daily. It can be taken with or without food — eating a high-fat meal does not meaningfully change how the drug is absorbed or works. Before starting, you will need a genetic test (CYP2C9 genotype), TB testing, hepatitis screening, and a blood count — these are required steps, not optional.
- Take at roughly the same times each day
- Do not take with moderate or strong CYP2C9-inhibiting medications (contraindicated)
- Follow your prescriber's instructions precisely — do not adjust your dose without guidance
Dosing details from the FDA-approved label
From the Deuruxolitinib prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.
- Recommended dosage (LEQSELVI)
- 8 mg twice daily
Read the label’s full dosing text
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 ( 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 )] .
Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →
Deuruxolitinib side effects
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The most commonly reported side effects with Leqselvi include:
Common side effects
- Headache
- Acne or acne-like skin reactions
- Nasopharyngitis (common cold symptoms)
- Elevated creatine phosphokinase (a muscle enzyme) in blood tests
- Increased cholesterol or triglycerides (hyperlipidemia)
- Fatigue
- Weight gain
- Herpes virus reactivation (cold sores, genital herpes)
- Low blood cell counts: anemia, neutropenia, lymphopenia
- Elevated platelet count (thrombocytosis)
When to get medical help
- Get medical help right away if you develop signs of a serious infection: fever, chills, sweats, muscle aches, cough, shortness of breath, or painful skin sores
- Seek emergency care immediately for symptoms of a blood clot: leg pain or swelling, sudden chest pain, difficulty breathing, or sudden severe headache
- Call your doctor right away if you have symptoms of a heart attack or stroke: chest pain, sudden numbness or weakness on one side, or trouble speaking
- Tell your doctor if you notice any new or changing skin growths — periodic skin checks are recommended
- Contact your doctor if you are a person with diabetes and experience signs of low blood sugar (hypoglycemia): shakiness, sweating, confusion, or rapid heartbeat
- Tell your doctor immediately if you develop new or worsening abdominal pain, which could signal a gastrointestinal perforation (a tear in the stomach or intestine)
More serious reactions — including blood clots, serious infections, gastrointestinal perforation, and cancer — have also occurred. Contact your doctor or seek emergency care right away if you notice warning signs for any of these.
Deuruxolitinib warnings and precautions
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- Serious infections: Leqselvi suppresses the immune system. Bacterial, fungal, viral, and opportunistic infections — including tuberculosis and herpes zoster (shingles) — have occurred. Screening is required before starting, and treatment must be paused if a serious infection develops.
- Blood clots (thrombosis): Deep vein thrombosis (leg clots), pulmonary embolism (lung clots), and cerebral venous sinus thrombosis (brain vein clots) have been reported. Seek emergency help immediately for sudden leg pain/swelling, chest pain, or severe headache.
- Cancer risk: Malignancies have been observed in clinical trials. Smokers face higher risk. Periodic skin exams are recommended for those at increased skin cancer risk.
- Major cardiovascular events: Heart attack and stroke risk is elevated with this drug class. Leqselvi must be stopped if you experience a heart attack or stroke.
- CYP2C9 poor metabolizers: People with a specific genetic variant that slows drug breakdown will have much higher drug exposure and face greater risk of serious side effects. Genetic testing is mandatory before starting.
- Blood counts and lipids: Leqselvi can lower red and white blood cell counts and raise cholesterol and triglycerides. Regular blood tests are needed throughout treatment.
- Gastrointestinal perforation: A hole in the stomach or intestinal wall has been reported. New or worsening abdominal pain should be evaluated promptly.
- Hypoglycemia in diabetes: Low blood sugar has been reported with JAK inhibitors in patients with diabetes. Increased blood glucose monitoring is advised.
- Live vaccines: Avoid live vaccines during treatment or immediately before starting Leqselvi.
Deuruxolitinib interactions
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Deuruxolitinib is broken down mainly by two liver enzymes (CYP2C9 and CYP3A4), so drugs that affect these enzymes can significantly change how much deuruxolitinib is in your body:
- Moderate or strong CYP2C9 inhibitors (e.g., fluconazole, certain other antifungals): Contraindicated — they raise deuruxolitinib levels sharply, increasing the risk of serious side effects like blood clots
- Strong CYP3A4 and moderate/strong CYP2C9 inducers (e.g., rifampin): Avoid — they reduce deuruxolitinib levels by up to 78%, which may make Leqselvi ineffective
- Other JAK inhibitors: Not recommended in combination — additive immunosuppression increases risk
- Biologic immunomodulators or cyclosporine: Not recommended in combination with Leqselvi
- Live vaccines: Avoid during or immediately before treatment — immune suppression makes live vaccines unsafe
- Oral contraceptives: No significant interaction observed — Leqselvi does not appear to affect how birth control pills work
Interactions listed in the FDA-approved label
From the Deuruxolitinib prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.
- Strong CYP3A and moderate or strong CYP2C9 inducers: Concomitant use decreases deuruxolitinib exposure (Cmax and AUC), which may reduce LEQSELVI efficacy. Avoid concomitant use of LEQSELVI with strong CYP3A and moderate or strong CYP2C9 inducers.
- Moderate or strong CYP2C9 inhibitors: Concomitant use is estimated to increase deuruxolitinib exposure (Cmax and AUC), which may increase the risk of LEQSELVI serious adverse reactions such as thrombosis. Contraindicated in patients taking moderate or strong CYP2C9 inhibitors.
Read the label’s full interactions text
7 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 )
Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.
Before taking Deuruxolitinib
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- CYP2C9 poor metabolizers: Must not take Leqselvi — a mandatory genetic test is required before starting to identify this
- Taking moderate or strong CYP2C9 inhibitors: Contraindicated — you cannot take Leqselvi while on these medications
- Active tuberculosis or high TB risk: Leqselvi is not recommended with active TB; latent TB must be treated before starting
- Active hepatitis B or hepatitis C: Leqselvi is not recommended; screening required before starting
- Pregnancy: Animal studies showed fetal harm; advise your doctor if you are pregnant or trying to conceive
- Breastfeeding: Not recommended during treatment or for one day after the last dose — the drug may pass into breast milk
- Children: Safety and effectiveness have not been established in patients under 18
- Severe kidney disease (eGFR below 30 mL/min) or severe liver disease (Child-Pugh C): Leqselvi is not recommended
- Smokers (current or former): At additional risk for cancers and major cardiovascular events — discuss this with your prescriber
- History of blood clots, cardiovascular disease, or gastrointestinal problems: Tell your prescriber before starting
Deuruxolitinib overdose
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There is no specific antidote for a Leqselvi overdose. If you or someone else takes too much, call the Poison Control Center at 1-800-222-1222 right away or go to the nearest emergency room. Treatment focuses on monitoring for and managing any signs or symptoms of side effects.
What Deuruxolitinib does in the body
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Deuruxolitinib measurably suppresses immune signaling within hours of a dose. Specifically, it inhibits an immune pathway triggered by IL-6 (a pro-inflammatory protein), reducing activation of a signaling molecule called STAT3 — this has been shown in blood samples from healthy volunteers within 2 hours of taking a dose, though how directly this relates to its effects in alopecia areata patients is not fully established. At doses studied in clinical trials, deuruxolitinib does not cause any meaningful changes in heart rhythm (it does not prolong the QT interval).
How your body processes Deuruxolitinib
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Deuruxolitinib is well absorbed when taken by mouth — about 90% of the dose reaches the bloodstream — with peak levels in the blood reached within about 1.5 hours. Food does not affect how it is absorbed. The drug is processed primarily by liver enzymes CYP2C9 (about 76%) and CYP3A4 (about 21%), and it clears from the body fairly quickly, with a half-life of approximately 4 hours. Steady, stable blood levels are reached within 1 to 2 days of starting twice-daily dosing, with little buildup over time.
How to store Deuruxolitinib
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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) . Store in the original bottle to protect from moisture.
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Deuruxolitinib: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Deuruxolitinib — the kind of thing our pharmacy team would talk through with you at the counter.
What exactly is Leqselvi and what is it supposed to do for my hair loss?
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Why do I need a genetic test before I can start this medication?
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What side effects should I actually expect, and which ones should make me call my doctor?
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Is it safe to take Leqselvi with my other medications?
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Can I take Leqselvi if I'm pregnant, trying to get pregnant, or breastfeeding?
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Do I need any tests or vaccinations before I start Leqselvi?
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Is Deuruxolitinib available over the counter?
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When was Deuruxolitinib first available?
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Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Deuruxolitinib on HelloPharmacist
Deuruxolitinib forms and strengths (how it comes)
Deuruxolitinib is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Tablet
How this form is used
- Leqselvi tablets are approved to treat severe alopecia areata in adults
- Leqselvi is not approved for use in children (safety and effectiveness not established)
- Leqselvi tablets are taken by mouth twice daily
- Leqselvi tablets can be taken with or without food
- Before starting Leqselvi, a CYP2C9 genetic test, TB evaluation, viral hepatitis screening, and blood count (CBC) must be completed
- Follow your prescriber's instructions exactly; do not adjust the dose on your own
Deuruxolitinib on the U.S. market: products, makers and brands
How Deuruxolitinib appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
1 company lists 1 Deuruxolitinib product record with the FDA, mostly as tablet; the earliest marketing or approval year on record is 2024. Brand names on the directory include Leqselvi; the rest are generics.
Also listed with the FDA, not a patient dose form: Powder (1) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
Compare Deuruxolitinib products
A representative set of FDA-listed product records for Deuruxolitinib — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Tablet | ||||
| 8 mg | Oral | Sun Pharmaceutical Industries, Inc. | NDA | View NDC → |
Showing 1 of 1 products — FDA National Drug Code Directory. See every product, package size and price: browse all 1 Deuruxolitinib NDCs →
Deuruxolitinib side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Deuruxolitinib — a signal of what to watch for, not proof the drug caused it.
The effects most often named in FDA reports that mention Deuruxolitinib are therapy cessation, acne, headache; about 3% of the reports were classed as serious. These are voluntary reports, so they show what people report, not how often it happens.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Deuruxolitinib in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
Deuruxolitinib FDA approval history
How Deuruxolitinib went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Deuruxolitinib was first approved by the FDA in 2024 (Brand: LEQSELVI · Sun Pharm Inds Inc). It remains available in U.S. pharmacies today.
Source: Drugs@FDA.
Deuruxolitinib recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
The FDA’s enforcement reports list no Deuruxolitinib recalls since July 2021.
✅No Deuruxolitinib recalls on record since July 2021Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 2716558 1 dose form · 1 strength
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Dose form (SCDF) Oral Tablet RxCUI 2716562In current FDA listingsClinical drug / strength (SCD) 8 MGRxCUI 2716563
Look up RxCUI 2716558 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
Deuruxolitinib supply and shortage status
Whether Deuruxolitinib is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
Deuruxolitinib brand names
Deuruxolitinib is sold under one brand name in the FDA directory — Leqselvi. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Deuruxolitinib: manufacturers and labelers
One company lists Deuruxolitinib products with the FDA. By number of product records, the largest are Sun Pharmaceutical Industries, Inc.. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
Deuruxolitinib drug class (RxNorm)
Deuruxolitinib belongs to the Janus Kinase Inhibitor class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
Sources for this Deuruxolitinib page
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How this page is built
HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Sun Pharmaceutical Industries, Inc. is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →