LISRAYA

LISRAYA is an FDA-registered drug product whose active ingredient is BREPOCITINIB. It is labelled by Priovant Therapeutics, Inc. taken by oral and marketed as a human prescription drug product. Identifiers on file: NDC 87211-030, application NDA220106, label effective 20260828. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing BREPOCITINIB are most often described in connection with: treatment dermatomyositis, adult patients, jak inhibitors, biologic dmards, usage lisraya, janus kinase, tyk inhibitor. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

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.

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 ) 2.1 Recommended 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 )]. 2.2 Recommended Dosage and Administration The recommended dosage of LISRAYA is 30 mg once daily, administered orally with or without food [see Clinical Pharmacology ( 12.3 )] . 2.3 Recommended 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.

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 )

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 . 6.1 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 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 liver injury (mixed pattern with marked GGT elevation, normal bilirubin, and low concurrent creatine kinase [CK]) was reported in a patient who received brepocitinib 15 mg. The event resolved following discontinuation of brepocitinib. Lipid Elevations: During the 52-week treatment period of Trial DM, LISRAYA treatment was associated with increases in total cholesterol, HDL cholesterol, and LDL cholesterol. Elevation in LDL and HDL cholesterol peaked by Week 8 and remained stable thereafter. In the 52-week treatment period of Trial DM, changes from baseline in lipid parameters in LISRAYA-treated patients are summarized below: Mean LDL cholesterol increased by 3.8 mg/dL. Mean HDL cholesterol increased by 4.5 mg/dL. Mean LDL/HDL ratio remained stable.

What is LISRAYA used for?
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 …

Who makes LISRAYA?
Priovant Therapeutics, Inc. is the labeler of record for LISRAYA.

What form does LISRAYA come in?
administered by oral. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is LISRAYA prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Has LISRAYA been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.