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LISRAYA brepocitinib 30 mg Tablet, Film Coated, 30-count — NDC 87211-0030-30 package photo

LISRAYA brepocitinib 30 mg Tablet, Film Coated, 30-count

by Priovant Therapeutics, Inc. · 1 BOTTLE in 1 CARTON (87211-030-30) / 30 TABLET, FILM COATED in 1 BOTTLE
NDC 87211-0030-30
🏷️ FDA NDC (as labeled) 87211-030-30 billing pads the product segment with a zero
Rx only Brand On market Non-controlled
🗂️ Data synced Sep 17, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🆔 Identity & classification

FDA NDC (as labeled) 87211-030-30
Product NDC 87211-030
11-digit billing NDC 87211003030
RxCUI 2751541, 2751547
UNII C960DPP15O
UPC 0387211030300
Application # NDA220106
SPL Set ID 5023a17b-e96a-67d4-e063-6394a90a14a7
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-08-27
Route ORAL
Dosage form TABLET, FILM COATED
Substance BREPOCITINIB TOSYLATE
Why two NDCs? The FDA registers this code as 87211-030-30 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 87211-0030-30. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏭 Manufacturer & labeler

LabelerPriovant Therapeutics, Inc.
FDA applicationNDA220106 (NDA)
Labeler code87211
First marketedAug 2026
Product typeHuman Prescription Drug
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

💊 What it looks like

Color pink
ShapeOval
ImprintBT30
Size12 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 1K09F3G675
    Ferric oxide red is an inorganic iron compound used as a colorant in medicines. It gives tablets, capsules, or other dosage forms a red or reddish tint for identification and appearance.
  • UNII 0WZ8WG20P6
    Hypromellose 2910 is a plant-based cellulose derivative that acts as a thickener, binder, and film-coating agent. It helps control how quickly the medicine dissolves and protects the tablet or capsule from moisture and light.
  • UNII EWQ57Q8I5X
    Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII H8AV0SQX4D
    A modified starch derived from potato or corn starch. It absorbs water quickly and helps tablets or capsules break apart and dissolve in the stomach, acting as a disintegrant to ensure the medicine releases its active ingredients properly.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
  • UNII XHX3C3X673
    Triacetin is a clear, oily liquid made from glycerin and acetic acid. It works as a plasticizer and solvent in medicines, helping soften coatings and improve how liquids mix together in formulations.

8 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Lisraya 30 mgthis 87211-0030-30 Priovant 30 tablets — — FDA listed —
About this product: this is the brand-name version. We did not find an FDA-approved generic match for this exact strength, form and route.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2026
On the market since
Aug 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
87211-0030-30 You're viewing this 1 BOTTLE in 1 CARTON (87211-030-30) / 30 TABLET, FILM COATED in 1 BOTTLE 2026-08-27 Active

🧭 About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 87211-030-30, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 87211-0030-30, written without dashes as 87211003030. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 87211-0030-30, the first segment (87211) is the labeler code FDA assigned to Priovant Therapeutics, Inc.; the middle segment (0030) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (30) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Priovant Therapeutics, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Priovant Therapeutics, Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide
🚨 Boxed Warning ~3 min read ▾

WARNING: SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS, and THROMBOSIS SERIOUS INFECTIONS Patients treated with LISRAYA are at increased risk of developing serious bacterial, fungal, viral, and opportunistic infections that may lead to hospitalization or death. Reported infections with use of Janus kinase (JAK) inhibitors, including LISRAYA: Active tuberculosis (TB), which may present with pulmonary or extrapulmonary disease. Evaluate and test patients for latent and active TB infection prior to and during LISRAYA treatment.

If positive, treat for TB. Monitor all patients for active TB during treatment including patients who tested negative of a latent TB infection prior to LISRAYA treatment. Invasive fungal infections.

Patients with invasive fungal infections may present with disseminated, rather than localized, disease. Bacterial, viral, including herpes zoster, and other infections due to opportunistic pathogens. Avoid use of LISRAYA in patients with an active, serious infection, including localized infections.

Consider the risks and benefits of LISRAYA in patients with chronic or recurrent infection prior to initiating treatment. Closely monitor patients for signs and symptoms of infection during and after treatment with LISRAYA. If a serious infection occurs, interrupt LISRAYA treatment until the infection resolves or is adequately treated [see Warnings and Precautions ( 5.1 )] .

MORTALITY A higher rate of all-cause mortality, including sudden cardiovascular death was observed with another Janus kinase (JAK) inhibitor when compared to tumor necrosis factor (TNF) blockers in patients with rheumatoid arthritis (RA) [see Warnings and Precautions ( 5.2 )]. LISRAYA is not approved for use in patients with RA. MALIGNANCY Malignancies have occurred in patients treated with LISRAYA.

A higher rate of malignancies (excluding non-melanoma skin cancer), lymphomas, and lung cancers was observed with another JAK inhibitor when compared to TNF blockers in patients with RA . LISRAYA is not approved for use in patients with RA. Patients who are current or past smokers are at additional increased risk [see Warnings and Precautions ( 5.3 )] .

MAJOR ADVERSE CARDIOVASCULAR EVENTS Major adverse cardiovascular events (MACE) (defined as cardiovascular death, myocardial infarction, and stroke) have occurred in patients treated with LISRAYA. A higher rate of MACE was observed with another JAK inhibitor when compared to TNF blockers in patients with RA. LISRAYA is not approved for use in patients with RA.

Patients who are current or past smokers are at additional increased risk. Discontinue LISRAYA in patients who have experienced a myocardial infarction or stroke [see Warnings and Precautions ( 5.4 )] . THROMBOSIS Thromboses, including deep venous thrombosis, pulmonary embolism, and arterial thrombosis, have occurred in patients treated for inflammatory conditions with JAK inhibitors, including LISRAYA.

Many of these adverse reactions were serious and some resulted in death. A higher rate of thromboses was observed with another JAK inhibitor when compared to TNF blockers in patients with RA. LISRAYA is not approved for use in patients with RA.

Avoid LISRAYA in patients who may be at risk of thrombosis. If symptoms of thrombosis occur, discontinue LISRAYA, promptly evaluate, and appropriately treat [see Warnings and Precautions ( 5.5 )]. WARNING: SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS, and THROMBOSIS See full prescribing information for complete boxed warning.

Increased risk of serious bacterial, fungal, viral, and opportunistic infections, including tuberculosis (TB), leading to hospitalization or death. Test for latent and active TB prior to LISRAYA treatment; treat if positive. Monitor for active TB, even with initial negative latent TB test.

Interrupt LISRAYA if a serious infection occurs until the infection resolves or is adequately treated. ( 5.1 ) Higher rate of all-cau…

🎯 Indications and Usage 81 words ▾

1 INDICATIONS AND USAGE LISRAYA is indicated for the treatment of dermatomyositis in adult patients. LISRAYA is a Janus kinase (JAK) and tyrosine kinase 2 (TYK2) inhibitor indicated for the treatment of dermatomyositis in adult patients. ( 1 ) Limitations of Use LISRAYA is not recommended for use in combination with other JAK inhibitors, other TYK2 inhibitors, or biologic DMARDs.

Limitations of Use LISRAYA is not recommended for use in combination with other JAK inhibitors, other TYK2 inhibitors, or biologic DMARDs.

⏱️ Dosage and Administration ~2 min read ▾

2 DOSAGE AND ADMINISTRATION Prior to LISRAYA treatment initiation, consider performing active and latent tuberculosis (TB) infection evaluation, viral hepatitis screening, a complete blood count, baseline hepatic and renal function tests, verifying pregnancy status, and updating immunizations. Avoid LISRAYA treatment in patients with active hepatitis B or hepatitis C, an absolute lymphocyte count less than 500 cells/mm 3 , absolute neutrophil count less than 1,000 cells/mm 3 , or hemoglobin level less than 8 g/dL. ( 2.1 ) The recommended dosage is 30 mg once daily, administered orally with or without food.

( 2.2 ) See Full Prescribing Information for recommended dosage interruption due to laboratory abnormalities. ( 2.3 )

2.1Recommended Evaluations and Immunizations Prior to Treatment Initiation Prior to LISRAYA treatment initiation, consider performing the following: Active and latent tuberculosis (TB) infection evaluation: If positive, treat for TB prior to LISRAYA treatment [see Warnings and Precautions ( 5.1 )] . Viral hepatitis screening in accordance with clinical guidelines: LISRAYA is not recommended in patients with active hepatitis B or hepatitis C [see Warnings and Precautions ( 5.1 )] . A complete blood count: Avoid LISRAYA in patients with an absolute lymphocyte count less than 500 cells/mm 3 , absolute neutrophil count less than 1,000 cells/mm 3 , or hemoglobin level less than 8 g/dL [see Warnings and Precautions ( 5.9 )].

Baseline hepatic and renal function tests: LISRAYA is not recommended in patients with severe hepatic or severe renal impairment [see Use in Specific Populations ( 8.6 , 8.7 ) and Clinical Pharmacology ( 12.3 )]. Pregnancy Status: Verify the pregnancy status of females of reproductive potential prior to treatment with LISRAYA [see Warnings and Precautions ( 5.11 ) and Use in Specific Populations ( 8.1 , 8.3 )]. Update immunizations according to current immunization guidelines [see Warnings and Precautions ( 5.10 )].

2.2Recommended Dosage and Administration The recommended dosage of LISRAYA is 30 mg once daily, administered orally with or without food [see Clinical Pharmacology ( 12.3 )] .

2.3Recommended Dosage Interruption Infections If a patient develops a serious infection, including serious opportunistic infection, interrupt LISRAYA treatment until the infection resolves or is adequately treated. [see Warnings and Precautions ( 5.1 )]. Laboratory Abnormalities Interruption of LISRAYA treatment may be needed for management of laboratory abnormalities as described in Table 1 [see Warnings and Precautions ( 5.9 )]. Table 1: Recommended Dosage Interruptions for Laboratory Abnormalities Laboratory Measure Action Absolute Neutrophil Count (ANC) Interrupt LISRAYA treatment if ANC is less than 1,000 cells/mm 3 ; treatment may be restarted once ANC returns above this value Absolute Lymphocyte Count (ALC) Interrupt LISRAYA treatment if ALC is less than 500 cells/mm 3 ; treatment may be restarted once ALC returns above this value Hemoglobin (Hb) Interrupt LISRAYA treatment if Hb is less than 8 g/dL; treatment may be restarted once Hb returns above this value Hepatic transaminases (ALT/AST) Interrupt LISRAYA treatment if drug-induced liver injury is suspected, until this diagnosis is excluded.

💊 Dosage Forms and Strengths 27 words ▾

3 DOSAGE FORMS AND STRENGTHS Tablets: 30 mg of brepocitinib; pink, capsule-shaped, immediate-release, film-coated, and debossed with “BT30” on one side Tablets: 30 mg ( 3 )

⛔ Contraindications 53 words ▾

4 CONTRAINDICATIONS LISRAYA is contraindicated in patients with a history of hypersensitivity reactions to brepocitinib or any of the excipients in LISRAYA [see Warnings and Precautions ( 5.6 )] . LISRAYA is contraindicated in patients with a history of hypersensitivity reactions to brepocitinib or any of the excipients in LISRAYA. ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Serious Infections: Avoid use of LISRAYA during an active serious infection, including localized infections. ( 5.1 ) Hypersensitivity Reactions: Serious hypersensitivity reactions have been reported. Discontinue LISRAYA if a clinically significant hypersensitivity reaction occurs.

( 5.6 ) Gastrointestinal (GI) Perforations: Monitor patients at risk for GI perforations and promptly evaluate patients with symptoms. ( 5.7 ) Hypoglycemia in Patients with Diabetes: Consider increased monitoring of blood glucose. Advise patients with diabetes to notify their healthcare provider if they develop signs or symptoms of hypoglycemia.

( 5.8 ) Laboratory Abnormalities: Monitor lymphocyte counts, neutrophil counts, hemoglobin, liver enzymes, including GGT, and lipids during LISRAYA treatment. ( 5.9 ) Immunizations: Avoid use with live vaccines. ( 5.10 ) Embryofetal Toxicity: Based on animal studies, LISRAYA may cause fetal harm.

Advise female patients of reproductive potential of the potential risk to a fetus and to use effective contraception. ( 5.11 , 8.1 , 8.3 )

5.1Serious Infections LISRAYA increases the risk of infections, including serious bacterial, fungal, viral, and opportunistic infections that may lead to hospitalization or death. The most common serious infections reported with LISRAYA were pneumonia and sepsis [see Adverse Reactions ( 6.1 )]. Other reported infections with use of JAK inhibitors, including LISRAYA, were tuberculosis, which may present with pulmonary or extrapulmonary disease, invasive fungal infections which may present with disseminated rather than localized disease, bacterial infections, viral infections (including herpes zoster), and other infections due to opportunistic pathogens.

Avoid use of LISRAYA in patients with an active, serious infection, including localized infections. Consider the risks and benefits of treatment prior to initiating LISRAYA in patients: with chronic or recurrent infection who have been exposed to TB with a history of a serious or an opportunistic infection who have resided or traveled in areas of endemic TB or endemic mycoses; or with underlying conditions that may predispose them to infection. Closely monitor patients for signs and symptoms of infection during and after treatment with LISRAYA.

If a patient develops a serious infection, including a serious opportunistic infection, interrupt LISRAYA treatment until the infection resolves or is adequately treated. In patients who develop a new infection during treatment with LISRAYA, promptly complete diagnostic testing, initiate appropriate antimicrobial therapy, and monitor the patients closely. LISRAYA may be resumed once the infection resolves or is adequately treated.

Tuberculosis Evaluate and test patients for latent and active TB infection prior to and during administration of LISRAYA. If positive, treat for TB prior to LISRAYA treatment. Consider anti-TB therapy prior to initiation of LISRAYA in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed.

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, including patients who tested negative for latent TB infection prior to LISRAYA treatment, for signs and symptoms of active TB during LISRAYA treatment. Viral Reactivation Viral reactivation, including cases of herpes virus reactivation (e.g., herpes zoster) were reported in patients who received LISRAYA.

If a patient develops herpes zoster, consider interrupting LISRAYA until the episode resolves. Prior to initiating LISRAYA treatment, perform viral hepatitis screening in accordance with clinical guidelines. Monitor patients for viral hepatitis reactivation during therapy with LISRAYA.

Patients who were positive for hepatitis C antibody and hepatitis C virus RNA were excluded from clinical tri…

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Serious Infections [see Warnings and Precautions ( 5.1 )] Mortality [see Warnings and Precautions ( 5.2 )] Malignancy and Lymphoproliferative Disorders [see Warnings and Precautions ( 5.3 )] Major Adverse Cardiovascular Events (MACE) [see Warnings and Precautions ( 5.4 )] Thrombosis [see Warnings and Precautions ( 5.5 )] Hypersensitivity Reactions [see Warnings and Precautions ( 5.6 )] Gastrointestinal Perforations [see Warnings and Precautions ( 5.7 )] Hypoglycemia in Patients with Diabetes [see Warnings and Precautions ( 5.8 )] Laboratory Abnormalities [see Warnings and Precautions ( 5.9 )] Most common adverse reactions (≥ 5% with LISRAYA and ≥ 2% greater than placebo) are upper respiratory tract infection, headache, fatigue, urinary tract infection, nausea, bronchitis, arthralgia, diarrhea, back pain, fall, influenza, and acne.

( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Priovant Therapeutics, Inc. at 1-800-511-9141 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

6.1Clinical 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 LISRAYA in adult patients with dermatomyositis was evaluated in a 52-week Phase 3, double-blind, placebo-controlled trial (Trial DM) [ see Clinical Studies ( 14 )] . In this trial, 241 adult patients were randomized to receive LISRAYA 30 mg once daily (81 patients), brepocitinib 15 mg once daily (unapproved dosage) (81 patients), or placebo (79 patients) once daily for 52 weeks.

Table 2 summarizes the adverse reactions that occurred in ≥ 5% of LISRAYA-treated patients and ≥ 2% greater than placebo-treated patients in the 52-week placebo-controlled period. A total of 81 adult patients with dermatomyositis were exposed to LISRAYA during this period. Table 2: Adverse Reactions Reported in ≥ 5% of Adult Patients with Dermatomyositis Who Received LISRAYA and ≥ 2% Greater Than Patients Who Received Placebo (Trial DM) Adverse Reaction (any severity) Placebo LISRAYA N= 79 (%) N= 81 (%) Upper Respiratory Tract Infection 11 15 Headache 3 15 Fatigue 3 12 Urinary Tract Infection 5 11 Nausea 4 11 Bronchitis 4 10 Arthralgia 8 10 Diarrhea 5 9 Back pain 6 9 Fall 3 7 Influenza 4 6 Acne 0 6 Specific Adverse Reactions Thrombosis Thromboses were observed in clinical trials of LISRAYA.

During the open-label extension period of Trial DM, a case of peripheral arterial thrombosis was reported in a LISRAYA-treated patient. Overall Infections During the 52-week treatment period of Trial DM, infections were reported in 45 (57%) placebo-treated patients and 56 (69%) LISRAYA-treated patients. The most commonly reported infections with LISRAYA were upper respiratory tract infections, urinary tract infections, bronchitis, and COVID-19.

Serious Infections: During the 52-week treatment period of Trial DM, serious infections were reported in one (1%) placebo-treated patient and 8 (10%) LISRAYA-treated patients. The most common serious infections in LISRAYA-treated patients were pneumonia (two patients) and sepsis (two patients). Viral Reactivation: During the 52-week treatment period of Trial DM, viral reactivations were reported in 4 (5%) LISRAYA-treated patients.

All viral reactivations with LISRAYA were herpes zoster. Laboratory Abnormalities Hepatic Transaminase Elevations: During the 52-week treatment period of Trial DM, Alanine transaminase (ALT) ≥ 3 x upper limit of normal (ULN) were observed in 7 (9%) placebo-treated patients and 8 (9.9%) LISRAYA-treated patients. Aspartate transaminase (AST) elevations ≥ 3 x upper limit of normal (ULN) were observed in 3 (3.8%) placebo-treated patients and 4 (4.9%) LISRAYA-treated patients.

One case of probable drug-induced l…

🔄 Drug Interactions 175 words ▾

7 DRUG INTERACTIONS

7.1Effects of Other Drugs on LISRAYA Smoking Smoking causes induction of CYP1A1 and CYP1A2 levels. The exposure of brepocitinib in current smokers is lower than in non-current smokers, and therefore, the effectiveness of LISRAYA may be reduced in smokers [see Clinical Pharmacology ( 12.3 )] .

7.2Effects of LISRAYA on Other Drugs Substrates of P-gp and BCRP Brepocitinib is a P-gp and BCRP inhibitor. Concomitant use of LISRAYA with an orally administered P-gp or BCRP substrate may increase the systemic exposure of the P-gp or BCRP substrate [see Clinical Pharmacology ( 12.3 )]. Substrates of OCT2 or MATEs Transporters Brepocitinib inhibits renal uptake transporters, OCT2 and MATEs (MATE1, MATE2-K) [see Clinical Pharmacology ( 12.3 )] .

Concomitant use of LISRAYA with drugs that are substrates of OCT2 and MATEs transporters may increase plasma concentrations of the substrates. Closely monitor patients when LISRAYA is concomitantly used with drugs that are substrates of OCT2 or MATEs transporters for which minimal concentration changes in substrate plasma concentration may lead to serious adverse reactions.

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Lactation: Advise not to breastfeed during treatment with LISRAYA and for 3 days after the last dose. ( 8.2 ) Renal impairment : LISRAYA is not recommended in patients with severe renal impairment. ( 8.6 ) Hepatic impairment: LISRAYA is not recommended in patients with severe hepatic impairment. ( 8.7 )

8.1Pregnancy Risk Summary Based on findings in animal studies, LISRAYA may cause fetal harm when administered to a pregnant woman. Available data from LISRAYA use in pregnant women are insufficient to establish a drug associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. In animal reproduction studies, fetal skeletal malformations, and post-implantation loss were observed when brepocitinib was administered to pregnant rats and rabbits during the period of organogenesis at 1.6- and 3-times the exposure at the MRHD, respectively.

In a pre- and postnatal study in rats, brepocitinib did not cause adverse effects in maternal animals or offspring at exposures up to 5.5 times the MRHD. The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15 % to 20%, respectively. There is a pregnancy safety study for LISRAYA. If LISRAYA is administered during pregnancy, healthcare providers or patients should report LISRAYA exposure to Priovant Therapeutics by calling 1-800-511-9141 or by emailing [email protected].

Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk Published data suggest that increased disease activity is associated with the risk of developing adverse pregnancy outcomes in women with dermatomyositis. Adverse pregnancy outcomes include preterm delivery (before 37 weeks of gestation), low birth weight (less than 2500 g) infants, and small for gestational age at birth. Data Animal Data In rat embryofetal developmental studies, pregnant rats were administered brepocitinib orally during the period of organogenesis.

Skeletal malformations, early and late resorptions, post-implantation loss, and lower mean numbers of viable fetuses were observed with exposures 1.6 times the MRHD. No adverse effects were observed at 1.3 times the MRHD. In a rabbit embryofetal developmental study, pregnant rabbits were administered brepocitinib orally during the period of organogenesis.

Increase of late resorptions, post-implantation loss, lower mean numbers of viable fetuses, and skeletal malformations were observed at 3 times the MRHD. No developmental toxicity was observed in rabbits at 0.8 times the MRHD. In a pre- and postnatal development study, pregnant rats were administered brepocitinib orally from gestation day 6 through day 21 of lactation.

No effects on postnatal developmental, neurobehavioral, or reproductive performance of offspring were noted at 5.5 times the MRHD.

8.2Lactation Risk Summary There are no data on the presence of brepocitinib in human or animal milk, the effects on the breastfed infant, or the effects on milk production. Because of the potential for serious adverse reactions in the breastfed infant, including infections, GI perforation, and malignancy, advise patients that breastfeeding is not recommended during treatment with LISRAYA and for 3 days (approximately 5 half-lives) after the last dose.

8.3Females and Males of Reproductive Potential Based on animal studies, brepocitinib may cause fetal harm when administered to pregnant women [see Use in Specific Populations ( 8.1 )] . Pregnancy Testing Verify the pregnancy status of females of reproductive potential prior to starting treatment with LISRAYA [see Use in Specific Populations ( 8.1 )] . Contraception Females: Advise females of reproductive potential to use effective contraception dur…

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Risk Summary Based on findings in animal studies, LISRAYA may cause fetal harm when administered to a pregnant woman. Available data from LISRAYA use in pregnant women are insufficient to establish a drug associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. In animal reproduction studies, fetal skeletal malformations, and post-implantation loss were observed when brepocitinib was administered to pregnant rats and rabbits during the period of organogenesis at 1.6- and 3-times the exposure at the MRHD, respectively.

In a pre- and postnatal study in rats, brepocitinib did not cause adverse effects in maternal animals or offspring at exposures up to 5.5 times the MRHD. The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15 % to 20%, respectively. There is a pregnancy safety study for LISRAYA. If LISRAYA is administered during pregnancy, healthcare providers or patients should report LISRAYA exposure to Priovant Therapeutics by calling 1-800-511-9141 or by emailing [email protected].

Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk Published data suggest that increased disease activity is associated with the risk of developing adverse pregnancy outcomes in women with dermatomyositis. Adverse pregnancy outcomes include preterm delivery (before 37 weeks of gestation), low birth weight (less than 2500 g) infants, and small for gestational age at birth. Data Animal Data In rat embryofetal developmental studies, pregnant rats were administered brepocitinib orally during the period of organogenesis.

Skeletal malformations, early and late resorptions, post-implantation loss, and lower mean numbers of viable fetuses were observed with exposures 1.6 times the MRHD. No adverse effects were observed at 1.3 times the MRHD. In a rabbit embryofetal developmental study, pregnant rabbits were administered brepocitinib orally during the period of organogenesis.

Increase of late resorptions, post-implantation loss, lower mean numbers of viable fetuses, and skeletal malformations were observed at 3 times the MRHD. No developmental toxicity was observed in rabbits at 0.8 times the MRHD. In a pre- and postnatal development study, pregnant rats were administered brepocitinib orally from gestation day 6 through day 21 of lactation.

No effects on postnatal developmental, neurobehavioral, or reproductive performance of offspring were noted at 5.5 times the MRHD.

🧒 Pediatric Use 16 words ▾

8.4Pediatric Use The safety and effectiveness of LISRAYA have not been established in pediatric patients.

🧓 Geriatric Use 158 words ▾

8.5Geriatric Use Of the 81 LISRAYA-treated patients, 14 (17%) were 65 years of age and older. No overall differences in effectiveness of LISRAYA have been observed between patients 65 years of age and older and younger adult patients. During the 52-week treatment period of Trial DM, overall rates of adverse events were similar between patients 65 years of age and older and younger adult patients; however, older adults experienced higher rates of serious adverse events (SAEs).

In the general study population, SAEs occurred in 16% of LISRAYA-treated patients compared to 13% of placebo-treated patients. Among patients 65 years of age and older, SAEs were reported in 2 placebo-treated patients (15%) compared to 3 LISRAYA-treated patients (21%), including one viral reactivation (herpes zoster). Viral reactivations were reported in 2 LISRAYA-treated patients (15 per 100 patient-years) 65 years of age and older, compared to 2 LISRAYA-treated patients (3 per 100 patient-years) 18 to less than 65 years of age.

🆘 Overdosage 32 words ▾

10 OVERDOSAGE There is no specific antidote for overdose with LISRAYA. If an overdose of LISRAYA occurs, consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for overdose management recommendations.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Brepocitinib is a Janus kinase (JAK) and tyrosine kinase 2 (TYK2) inhibitor. In a cell-free isolated enzyme assay, brepocitinib had greater inhibitory potency at TYK2 and JAK1 than JAK2 (≥ 3.4-fold) and JAK3 (≥ 286-fold). The JAK family comprises cytoplasmic tyrosine kinases that mediate signal transduction of cytokine receptors to influence immune cell function.

Within the signaling pathway, JAKs phosphorylate and activate signal transducers and activators of transcription (STATs) which modulate intracellular activity including gene expression. JAKs mediate cytokine signaling through hetero- or homodimeric pairing. In human cellular assays, brepocitinib inhibited signaling of TYK2- and JAK1-mediated cytokine-induced STAT phosphorylation, including signaling of TYK2/JAK1, TYK2/JAK2, JAK1/JAK3, and TYK2/JAK1/JAK2.

The relevance of inhibition of specific JAK combinations to therapeutic effectiveness is not known.

12.2Pharmacodynamics Inhibition of Type I IFN and IL-6 induced STAT1 and STAT3 phosphorylation In peripheral blood mononuclear cells isolated from dermatomyositis patients, brepocitinib resulted in concentration-dependent inhibition of Type I IFN induced and IL-6 induced phosphorylation of STAT1 and STAT3. Inhibition of IFNγ, IL-10, IL-12, IL-13, and IL-23 induced STAT phosphorylation In whole blood from healthy donors, brepocitinib resulted in concentration-dependent inhibition of IFNγ, IL-10, IL-12, IL-13, and IL-23 induced STAT1, STAT3, STAT4, STAT6, and STAT3 phosphorylation, respectively.

Gene Expression After administration of LISRAYA 30 mg once daily to patients with dermatomyositis, expression of genes associated with Type I signaling were reduced by Week 12 and sustained through Week 52 in whole blood. The clinical relevance is unclear. Cardiac Electrophysiology LISRAYA caused concentration-dependent QTc interval prolongation with a supratherapeutic dose of 200 mg (6.67 times the approved recommended dose).

At the maximum recommended LISRAYA oral dose of 30 mg once daily, clinically significant QTc interval prolongation is not expected.

12.3Pharmacokinetics Absorption Following oral administration of LISRAYA, the median T max of brepocitinib is 1 hour. The absolute oral bioavailability of LISRAYA is approximately 75%. Effect of Food Coadministration of LISRAYA with a high-fat meal (approximately 50% fat and 800-1000 calories) resulted in 18% decrease in AUC and 36% decrease in C max [see Dosage and Administration ( 2.2 )].

Distribution Brepocitinib is 39% bound to plasma proteins. The blood to plasma partition ratio is 0.84. Elimination Metabolism Brepocitinib is primarily cleared by metabolism, which is mediated mainly by cytochrome P450 (CYP)1A1 and CYP1A2 with minor contribution from CYP3A4.

The pharmacologic activity of brepocitinib is attributed to the parent molecule. In a human radiolabeled study, unchanged brepocitinib and the major inactive metabolite M1 accounted for 48% and 37% of the total circulating radioactivity in plasma, respectively. Excretion Following oral administration of radiolabeled brepocitinib in healthy subjects, 88% (7.7% as unchanged and 51% as M1) and 8.7% (0.8% as unchanged and 0.7% as M1) of the total radioactivity was recovered in urine and feces, respectively.

Brepocitinib mean terminal half-life ranged from 5.4 to 12 hours. Specific Populations Body Weight, Sex, Age, and Race Based on population PK analysis, body weight (39-204 kg), sex, age (18-77 years) and race (White, Black, Asian, Native American, Pacific Islander, Other Race) did not have a clinically meaningful effect on brepocitinib exposure in adult patient populations. Patients with Renal Impairment Following a single oral administration of LISRAYA 30 mg, brepocitinib AUC was 29% lower, 48% higher, and 12% higher in subjects with mild (eGFR: 60 to 89 mL/min, based on Modification of Diet in Renal Disease formula), moderate (eGFR: 30 to 59 mL/min), and severe (eGFR:…

🧬 Mechanism of Action 125 words ▾

12.1Mechanism of Action Brepocitinib is a Janus kinase (JAK) and tyrosine kinase 2 (TYK2) inhibitor. In a cell-free isolated enzyme assay, brepocitinib had greater inhibitory potency at TYK2 and JAK1 than JAK2 (≥ 3.4-fold) and JAK3 (≥ 286-fold). The JAK family comprises cytoplasmic tyrosine kinases that mediate signal transduction of cytokine receptors to influence immune cell function.

Within the signaling pathway, JAKs phosphorylate and activate signal transducers and activators of transcription (STATs) which modulate intracellular activity including gene expression. JAKs mediate cytokine signaling through hetero- or homodimeric pairing. In human cellular assays, brepocitinib inhibited signaling of TYK2- and JAK1-mediated cytokine-induced STAT phosphorylation, including signaling of TYK2/JAK1, TYK2/JAK2, JAK1/JAK3, and TYK2/JAK1/JAK2.

The relevance of inhibition of specific JAK combinations to therapeutic effectiveness is not known.

📦 How Supplied / Storage and Handling 37 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING LISRAYA (brepocitinib) tablets, 30 mg, are pink, capsule-shaped, film-coated, and debossed with “BT30” on one side. They are supplied as follows: 30 tablets in a bottle; NDC: 87211-030-30 Store below 30°C (86°F).

📋 Description 139 words ▾

11 DESCRIPTION LISRAYA is formulated with the tosylate salt of brepocitinib, a TYK2/JAK1 inhibitor. Brepocitinib tosylate is a white to off-white crystalline solid, slightly soluble in water and alcohol, with the following chemical name: [(1 S )-2,2-difluorocyclopropyl][(1 R ,5 S )-3-{2-[(1-methyl-1 H -pyrazol-4-yl)amino]pyrimidin-4-yl}-3,8-diazabicyclo[3.2.1]oct-8-yl]methanone 4-methylbenzenesulfonate. Brepocitinib tosylate has a molecular weight of 561.61 daltons (or 389.41 daltons as the free base) and a molecular formula of C 25 H 29 F 2 N 7 O 4 S.

The chemical structure of brepocitinib tosylate is: LISRAYA (brepocitinib) tablets are supplied for oral administration as 30 mg pink, capsule-shaped tablets. Each tablet of LISRAYA contains 30 mg of brepocitinib (equivalent to 43.27 mg brepocitinib tosylate) and the inactive ingredients hydroxypropyl methylcellulose, iron oxide red, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, titanium dioxide, and triacetin. Chemical Structure of Brepocitinib Tosylate

💬 Information for Patients ~3 min read ▾

17 PATIENT COUNSELING INFORMATION Advise patients and caregivers to read the FDA-approved patient labeling ( Medication Guide ). Serious Infections Inform patients that they may be more likely to develop infections when taking LISRAYA. Instruct patients to contact their healthcare provider immediately during treatment if they develop any signs or symptoms of an infection [see Warnings and Precautions ( 5.1 )].

Advise patients that the risk of herpes zoster infection is increased in patients taking LISRAYA and some cases can be serious [see Warnings and Precautions ( 5.1 )]. Malignancies Inform patients that LISRAYA may increase their risk of certain cancers and that periodic skin examinations should be performed while using LISRAYA. Instruct patients to inform their healthcare provider if they have ever had any type of cancer [see Warnings and Precautions ( 5.3 )] .

Advise patients to limit exposure to ultraviolet light (natural or artificial) by wearing protective clothing and using a broad-spectrum sunscreen. Major Adverse Cardiovascular Events Inform patients that LISRAYA may increase their 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 [see Warnings and Precautions ( 5.4 )] .

Thrombosis Advise patients that LISRAYA may increase the risk of thromboembolic events. Instruct patients to seek immediate medical attention if they develop any signs or symptoms of a DVT or PE [see Warnings and Precautions ( 5.5 )] . Hypersensitivity Reactions Advise patients to discontinue LISRAYA and seek immediate medical attention if they develop any signs and symptoms of an allergic reaction [see Warnings and Precautions ( 5.6 )].

Gastrointestinal Perforations Inform patients that gastrointestinal perforation has been reported in clinical trials with LISRAYA and that risk factors include the use of NSAIDs, corticosteroids, and history of diverticulitis. Instruct patients to seek medical care immediately if they experience new onset of abdominal pain, fever, chills, nausea, or vomiting [ see Warnings and Precautions ( 5.7 )] . Hypoglycemia in Patients with Diabetes Inform patients with diabetes that LISRAYA can cause hypoglycemia.

Consider advising patients with diabetes to increase monitoring of blood glucose. Advise patients with diabetes to notify their healthcare provider if they develop signs or symptoms of hypoglycemia [see Warnings and Precautions ( 5.8 )] . Laboratory Abnormalities Inform patients that LISRAYA may affect certain lab tests, and that blood tests are required before and during LISRAYA treatment [see Warnings and Precautions ( 5.9 )].

Immunizations Advise patients to avoid use of live vaccines with LISRAYA. Instruct patients to inform their healthcare provider that they are taking LISRAYA prior to a potential vaccination [see Warnings and Precautions ( 5.10 )]. Embryofetal Toxicity Advise pregnant women and females of reproductive potential that exposure to LISRAYA during pregnancy may result in fetal harm.

Advise females to inform their healthcare provider of a known or suspected pregnancy [see Warnings and Precautions ( 5.11 ) and Use in Specific Populations ( 8.1 )] . Advise females of reproductive potential that effective contraception should be used during treatment and for 3 days following the final dose of LISRAYA [see Use in Specific Populations ( 8.1 , 8.3 )]. Inform patients to report their pregnancy to Priovant Therapeutics by calling 1-800-511-9141 or emailing [email protected] [see Use in Specific Populations ( 8.1 )].

Lactation Advise women not to breastfeed during treatment with LISRAYA and for 3 days after the last dose [see Use in Specific Populations ( 8.2 )]. Manufactured for: Priovant Therapeutics, Inc. 1007 Slater Road, Suite 250 Durham NC,…

💬 Medication Guide ~3 min read ▾

This Medication Guide has been approved by the U.S. Food and Drug Administration. Issued: 8/2026 MEDICATION GUIDE LISRAYA™ [liss-rye-uh] (brepocitinib) tablets for oral use What is the most important information I should know about LISRAYA?

LISRAYA can cause serious side effects, including: Serious Infections. LISRAYA is a medicine that affects your immune system. LISRAYA can lower the ability of your immune system to fight infections.

Some people have had serious infections while taking LISRAYA, including tuberculosis (TB) and infections caused by bacteria, fungi, or viruses that can spread throughout your body. Some people have died from these infections. Your healthcare provider should test you for TB before starting treatment with LISRAYA.

Your healthcare provider should watch you closely for signs and symptoms of TB during and after treatment with LISRAYA. You should not start taking LISRAYA if you have any kind of infection unless your healthcare provider tells you it is okay. You may be at a higher risk of developing shingles (herpes zoster).

Before starting LISRAYA, tell your healthcare provider if you: are being treated for an infection. have had an infection that does not go away or have infections that keep coming back. have diabetes, chronic lung disease, HIV, or a weak immune system. People with these conditions have a higher chance of infections. have TB or have been in close contact with someone with TB. live or have lived, or have traveled to certain parts of the country (such as the Ohio and Mississippi River valleys and the Southwest) where there is an increased chance for getting certain kinds of fungal infections.

These infections may happen or become more severe if you take LISRAYA. Ask your healthcare provider if you do not know if you have lived in an area where these infections are common. have had shingles (herpes zoster) have or have had hepatitis B or C. think you have an infection or have symptoms of an infection such as: fever, sweating, or chills shortness of breath warm, red, or painful skin or sores on your body muscle aches feeling tired blood in your phlegm diarrhea or stomach pain cough weight loss burning when you urinate or urinating more often than usual After starting LISRAYA, call your healthcare provider right away if you have any symptoms of an infection.

LISRAYA can make you more likely to get infections or make any infections that you have worse. If you get a serious infection, your healthcare provider may stop your treatment with LISRAYA until your infection is controlled. Increased risk of death in people 50 years of age and older who have at least 1 heart disease (cardiovascular) risk factor and are taking a medicine in the class of medicines called Janus kinase (JAK) inhibitors.

LISRAYA is a JAK inhibitor medicine. Cancer and immune system problems. LISRAYA may increase your risk of certain cancers by changing the way your immune system works.

Lymphoma and other cancers, including skin cancers, can happen in people taking LISRAYA. People taking a medicine in the class of medicines called JAK inhibitors have a higher risk of certain cancers including lymphoma and lung cancer, especially if you are a current or past smoker. Tell your healthcare provider if you have ever had any type of cancer.

Follow your healthcare provider's advice about having your skin checked for skin cancer during treatment with LISRAYA. Limit the amount of time you spend in sunlight. Avoid using tanning beds or sunlamps.

Wear protective clothing when you are in the sun and use a sunscreen with a high protection factor (SPF 30 and above). This is especially important if your skin is very fair or if you have a family history of skin cancer. Increased risk of major cardiovascular events such as heart attack, stroke or death in people 50 years of age and older who have at least 1 heart disease (cardiovascular) risk factor and taking a medicine in the class of medicines called JAK inhibitors, especially if you ar…

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
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For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.