Prescription medicine
Brepocitinib Brand names: Lisraya
Brepocitinib (Lisraya) is a prescription medicine with an FDA approval on record since 2026. No generic is listed in FDA's NDC Directory.
- No generic listed
- Boxed warning
Check it at the source: the brepocitinib FDA label on DailyMed (effective August 28, 2026, Priovant Therapeutics, Inc.); the NDA 220106 record on Drugs@FDA; every brepocitinib label on DailyMed.
Highlights of the record
FDA label of August 28, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
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. […]
Used for
From the label: indications and usageLISRAYA is indicated for the treatment of dermatomyositis in adult patients.
Forms and strengths
- 30 mg
Film-coated tablet.
On the market
- Earliest approval on file
- August 27, 2026 Lisraya, Priovant Therap; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 8 through July 30, 2026
What is brepocitinib used for?
From the label: indications and usageLISRAYA 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.
Source: FDA drug label (LISRAYA), Priovant Therapeutics, Inc., effective August 28, 2026 (SPL set 5023a17b-e96a-67d4-e063-6394a90a14a7), via openFDA; the full label on DailyMed
What does the patient leaflet for brepocitinib say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: 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. […]
From the patient leaflet: How should I store LISRAYA?Store LISRAYA tablets below 86°F (30°C). Keep LISRAYA and all medicines out of the reach of children.
Source: FDA drug label (LISRAYA), Priovant Therapeutics, Inc., effective August 28, 2026 (SPL set 5023a17b-e96a-67d4-e063-6394a90a14a7), via openFDA; the full label on DailyMed
Is there a generic for brepocitinib (Lisraya)?
No generic brepocitinib is approved (Drugs@FDA, October 8, 2026).
- 2026 earliest approval on file
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do FAERS reports show for brepocitinib?
The FDA Adverse Event Reporting System holds 8 reports that list brepocitinib among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 1 are coded as a death and 4 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Brepocitinib side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other