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148    <h1 data-reveal="" style="margin: 0px;"><img src="https://priovant.com/wp-content/uploads/2026/08/lisrayalogo.svg" alt="Lisraya (brepocitinib)" style="width: clamp(260px, 38vw, 460px); height: auto; display: block;"></h1>
149    <p data-reveal="" data-reveal-delay="60" style="margin-top: clamp(1.2rem, 2.4vw, 1.8rem); font-size: clamp(1.1rem, 1.7vw, 1.45rem); font-weight: 400; line-height: 1.5; color: rgba(2, 35, 69, 0.72);">For adults with dermatomyositis</p>
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151      <a href="https://lisraya.com" target="_blank" rel="noopener noreferrer" style="display: inline-flex; align-items: center; justify-content: center; width: clamp(240px, 28vw, 320px); gap: 0.7rem; min-height: 52px; padding: 0.95rem 1.9rem; background: rgb(0, 82, 155); color: rgb(251, 252, 253); border: 1px solid rgb(0, 82, 155); border-radius: 12px; font-size: 1rem; font-weight: 500; transition: background 0.42s, color 0.42s, border-color 0.42s;">Patient Website<span data-arrow="1">↗</span><span style="position: absolute; width: 1px; height: 1px; overflow: hidden; clip: rect(0px, 0px, 0px, 0px); white-space: nowrap;">(opens in a new tab)</span></a>
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157<section data-screen-label="Important Safety Information"
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161      <span data-eyebrow="" style="font-size: 0.72rem; font-weight: 700; letter-spacing: 0.14em; text-transform: uppercase; color: rgba(2, 35, 69, 0.55);">IMPORTANT SAFETY INFORMATION and INDICATION AND USAGE</span>
162            <div class="prv-isi-html"><p><strong>IMPORTANT SAFETY INFORMATION</strong></p>
163<p><strong>WARNING: SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS (MACE), and THROMBOSIS</strong></p>
164<p><strong>INDICATIONS AND USAGE</strong></p>
165<p>LISRAYA (brepocitinib) is indicated for the treatment of adults with dermatomyositis (DM).</p>
166<p><strong>Limitations of Use</strong></p>
167<p>Not recommended for use in combination with other JAK inhibitors, other TYK2 inhibitors, or biologic DMARDs.</p>
168
169<p><strong>WARNINGS and PRECAUTIONS:</strong></p>
170
171<p><strong>Serious infections.</strong> Patients treated with LISRAYA are at increased risk of developing serious bacterial, fungal, viral, and opportunistic infections that may lead to hospitalization or death.</p>
172
173<p>Reported infections with use of Janus kinase (JAK) inhibitors, including LISRAYA:</p>
174<ul>
175<li>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 for a latent TB infection prior to LISRAYA treatment.</li>
176<li>Invasive fungal infections. Patients with invasive fungal infections may present with disseminated, rather than localized, disease.</li>
177<li>Bacterial, viral (including herpes zoster), and other infections due to opportunistic pathogens.</li>
178</ul>
179
180<p>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.</p>
181
182<p><strong>Mortality.</strong> 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) 50 years of age and older with at least one cardiovascular risk factor. LISRAYA is not approved for use in patients with RA.</p>
183
184<p><strong>Malignancy.</strong> 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.</p>
185
186<p><strong>Major Adverse Cardiovascular Events (MACE).</strong> 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 50 years of age and older with at least one cardiovascular risk factor. 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.</p>
187
188<p><strong>Thrombosis.</strong> 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 50 years of age and older with at least one cardiovascular risk factor. 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.</p>
189
190<p><strong>Hypersensitivity.</strong> LISRAYA is contraindicated in patients with known hypersensitivity to brepocitinib or any of its excipients. Hypersensitivity reactions were reported in patients receiving LISRAYA. Some events were serious.</p>
191
192<p><strong>Gastrointestinal Perforations.</strong> Gastrointestinal perforation has been reported in patients treated with JAK inhibitors, including LISRAYA. Monitor L
192ISRAYA-treated patients who may be at risk for gastrointestinal perforation.</p>
193
194<p><strong>Hypoglycemia in Patients with Diabetes.</strong> LISRAYA may cause hypoglycemia in patients with diabetes. Hypoglycemia, including severe hypoglycemia, has been reported following initiation of JAK inhibitors in patients with diabetes. During treatment with LISRAYA, consider increased monitoring of blood glucose as clinically indicated in patients with diabetes.</p>
195
196<p><strong>Laboratory Abnormalities.</strong> LISRAYA has been associated with lab abnormalities including neutropenia, lymphopenia, anemia, increases in lipid parameters, and liver enzyme elevations.</p>
197
198<p><strong>Immunizations.</strong> Avoid use of live vaccines during or immediately prior to LISRAYA therapy initiation. Prior to initiating LISRAYA treatment, update immunizations, including prophylactic varicella zoster or herpes zoster vaccinations, according to current immunization guidelines.</p>
199
200<p><strong>Embryofetal Toxicity.</strong> Based on findings in animal studies, LISRAYA may cause fetal harm when administered to a pregnant woman. Verify the pregnancy status of females of reproductive potential prior to starting treatment. Advise pregnant women and females of reproductive potential of the potential risk to the fetus. Advise females of reproductive potential to use effective contraception during treatment with LISRAYA and for 3 days following the last dose.</p>
201
202<p><strong>ADVERSE REACTIONS</strong></p>
203<p>The most common adverse reactions occurring in ≥5% of DM subjects and ≥2% greater than placebo were upper respiratory tract infection, headache, fatigue, urinary tract infection, nausea, bronchitis, arthralgia, diarrhea, back pain, fall, influenza, and acne.</p>
204
205<p><strong>SPECIAL POPULATIONS</strong></p>
206<p><strong>Pregnancy.</strong> 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.</p>
207<p><strong>Lactation.</strong> There are no data on the presence of brepocitinib in human milk, the effects on the breastfed infant, or the effects on milk production.</p>
208<p><strong>Hepatic Impairment.</strong> LISRAYA is not recommended in patients with severe hepatic impairment.</p>
209<p><strong>Renal Impairment.</strong> LISRAYA is not recommended in patients with severe renal impairment.</p>
210
211<p><strong>Please see the Full Prescribing Information, including BOXED WARNING, and Medication Guide.</strong></p>
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