Lisraya

Lisraya (brepocitinib) is a once-daily tablet used to treat dermatomyositis in adults, a rare autoimmune disease where the immune system attacks the muscles and skin, causing chronic inflammation, progressive muscle weakness, and distinctive skin rashes.

Lisraya is a Janus kinase (JAK) and tyrosine kinase 2 (TYK2) inhibitor. In dermatomyositis, these pathways carry overactive immune signals that cause inflammation, which damages the muscles and skin. By blocking them, Lisraya helps reduce that inflammation.

Lisraya FDA approval was granted on August 27, 2026, to treat dermatomyositis in adult patients.

Lisraya should not be used in combination with other JAK inhibitors, other TYK2 inhibitors, or biologic DMARDs.

The recommended Lisraya dosage is 30 mg once daily, administered orally with or without food.

Lisraya is a JAK/TYK2 inhibitor. It works by blocking two proteins inside your cells called JAK1 and TYK2.

JAK1 and TYK2 carry signals from your immune system into your cells, and many of those signals cause inflammation. By blocking them, Lisraya lowers the immune activity that drives dermatomyositis.

Lisraya blocks JAK1 and TYK2 more strongly than the related proteins JAK2 and JAK3. Researchers do not yet know which of these blocking actions matters most for treating the disease.

Lisraya has a boxed warning for serious infections, death, cancer, major heart problems, and blood clots. A boxed warning is the most serious warning the FDA requires on a medicine label.

Serious infections

Lisraya raises your risk of serious infections caused by bacteria, fungi, and viruses. Some of these infections can lead to a hospital stay or death.

Infections reported with JAK inhibitors like Lisraya include:

• tuberculosis (TB), which can affect the lungs or other parts of the body
• invasive fungal infections, which may spread through the body rather than staying in one spot
• shingles and other viral infections
• infections caused by organisms that usually do not make healthy people sick, called opportunistic infections

You will be tested for TB before you start Lisraya. If the test is positive, you will be treated for TB first. Your doctor will keep watching for signs of TB during treatment, even if your first test was negative.

You should not start Lisraya while you have an active serious infection, including an infection in just one part of the body. If you get a serious infection during treatment, your doctor will pause Lisraya until the infection clears up.

Death

In a large safety study of a different JAK inhibitor in people with rheumatoid arthritis, more people died from any cause, including sudden heart-related death, than people taking a type of medicine called a TNF blocker. The people in that study were 50 or older and had at least one heart risk factor. Lisraya is not approved for rheumatoid arthritis.

Cancer

Cancers have happened in people taking Lisraya during clinical trials.

In a rheumatoid arthritis safety study of a different JAK inhibitor, more people developed cancer, including lymphoma and lung cancer, than people taking a TNF blocker. People who smoke now or smoked in the past had a higher risk.

Your doctor may recommend regular skin checks. It also helps to limit time in the sun and in tanning beds, wear clothing that covers your skin, and use a broad-spectrum sunscreen.

Major heart problems

Heart attack, stroke, and death from heart disease have happened in people taking this medicine. Doctors group these together as major adverse cardiovascular events, or MACE.

In the main Lisraya trial, including the open-label part where everyone knew what they were taking, 3 people had one of these events. That works out to about 1.1 events for every 100 years of patient treatment time.

People who smoke now or smoked in the past have a higher risk. If you have a heart attack or stroke, your doctor will stop Lisraya for good.

Blood clots

Blood clots have happened in people taking JAK inhibitors, including Lisraya. These include clots in the deep veins of the legs, clots that travel to the lungs, and clots in the arteries. Many of these were serious, and some caused death.

If you have signs of a blood clot, stop taking Lisraya and get medical help right away.

You should not take Lisraya if you have ever had an allergic reaction to the active ingredient brepocitinib or to any of the other ingredients in the tablet. This is the only listed reason a person cannot take Lisraya at all.

Lisraya is also not recommended if you have:

• an active serious infection
• active hepatitis B or hepatitis C
• severe kidney problems
• severe liver problems
• certain low blood counts before starting, described in the testing section below

Tell your doctor about your full health history before you start this medicine. This is especially important if you:

• get infections often or have an infection that keeps coming back
• have been around someone with TB, or have lived or traveled where TB or certain fungal infections are common
• have had a serious or unusual infection in the past
• have ever had any type of cancer
• smoke now or smoked in the past
• have had a heart attack, stroke, or blood clot
• have heart disease or heart risk factors
• have diabetes
• have had diverticulitis, which is inflammation of small pouches in the wall of the colon
• have liver or kidney problems
• are pregnant, could become pregnant, or are breastfeeding

Also tell your doctor about all the medicines you take, including over-the-counter medicines, vitamins, and herbal products.

Before you start Lisraya, your doctor will usually check for TB, screen for hepatitis, run blood tests, and confirm you are not pregnant. Your vaccines should be up to date before you begin.

Blood tests before treatment usually include a complete blood count and tests of how your liver and kidneys are working. Lisraya should be avoided if your results show:

• an absolute lymphocyte count below 500 cells per cubic millimeter
• an absolute neutrophil count below 1,000 cells per cubic millimeter
• a hemoglobin level below 8 g/dL

Lymphocytes and neutrophils are types of white blood cells that fight infection. Hemoglobin is the protein in red blood cells that carries oxygen.

Tests during treatment

Your doctor will keep checking your blood counts and liver enzymes while you take Lisraya. Cholesterol and other blood fats are usually checked about 12 weeks after you start.

Liver testing includes a test called GGT. In dermatomyositis, two of the usual liver tests, AST and ALT, can be raised by the disease itself rather than by a liver problem, so GGT helps tell the difference.

If you have diabetes, your doctor may ask you to check your blood sugar more often than usual. Lisraya can cause low blood sugar, also called hypoglycemia, and some cases have been severe. Tell your doctor if you notice signs of low blood sugar. This extra checking is not needed for people who do not have diabetes.

Your doctor may pause Lisraya if certain results fall outside a safe range.

Common side effects

The most common Lisraya side effects are upper respiratory tract infection, headache, tiredness, and urinary tract infection. Serious side effects include infections, cancer, heart problems, and blood clots.

These side effects happened in at least 5% of people taking Lisraya during the 52-week trial, and at least 2% more often than with placebo.

Infections in the trial

During the 52-week trial, 69% of people taking Lisraya had an infection of some kind, compared with 57% of people taking placebo. The most common were upper respiratory infections, urinary tract infections, bronchitis, and COVID-19.

Serious infections happened in 10% of people taking Lisraya, compared with 1% on placebo. The most common serious infections were pneumonia and sepsis, which is the body's extreme response to an infection.

Shingles (herpes zoster) occurred in 5% of people taking Lisraya. Shingles is caused by the chickenpox virus becoming active again.

Changes in blood tests

Lisraya can change several blood test results.

• Low white blood cells. Lisraya can lower neutrophils and lymphocytes, which help fight infection.
• Low red blood cells. Hemoglobin can drop below 8 g/dL in some people.
• Cholesterol changes. In the trial, LDL cholesterol rose by an average of 3.8 mg/dL and HDL cholesterol rose by an average of 4.5 mg/dL. These peaked by week 8 and then stayed steady. It is not known what effect this has on heart health.
• Liver enzyme changes. ALT rose to at least three times the normal upper limit in about 10% of people taking Lisraya, and in 9% on placebo.

Other serious side effects

Allergic reactions

Serious allergic reactions have been reported. If you have signs of an allergic reaction, stop taking Lisraya and get medical help right away.

Tears in the stomach or intestines

A tear in the wall of the stomach or intestines, called a perforation, has been reported with JAK inhibitors including Lisraya. Your risk may be higher if you take NSAID pain relievers or steroids, or if you have had diverticulitis.

Get medical care right away if you develop new stomach pain along with fever, chills, nausea, or vomiting.

Low blood sugar in people with diabetes

Lisraya can cause low blood sugar in people with diabetes, and some cases have been severe. If you have diabetes, your doctor may ask you to check your blood sugar more often. Tell your doctor if you notice signs of low blood sugar.

This is not a complete list of side effects. Others may occur.

The numbers above come from one clinical trial. Side effect rates in a trial may not match what happens in everyday use, and they cannot be compared directly with rates from trials of other medicines.

Call your doctor if a side effect bothers you or does not go away. You can report side effects to Priovant Therapeutics at 1-800-511-9141, or to the FDA at 1-800-FDA-1088.

Lisraya can raise the levels of some other medicines in your body, and smoking can lower the level of Lisraya. Tell your doctor and pharmacist about all prescription and over-the-counter medicines that you take.

Medicines Lisraya can affect

Lisraya blocks several transporters, which are proteins that move medicines into and out of cells. Blocking them can make certain other medicines build up to higher levels.

This applies to medicines that rely on transporters called P-gp, BCRP, OCT2, MATE1, and MATE2-K. Your doctor may want to monitor you more closely if you take one of these.

Lisraya does not appear to change the levels of birth control pills that contain ethinylestradiol and levonorgestrel.

Smoking

Smoking lowers the amount of Lisraya in your blood, and Lisraya may not work as well in people who smoke. In studies, blood levels of the medicine were about 45% lower in current smokers than in people who do not currently smoke.

Vaccines

Avoid live vaccines just before and during Lisraya treatment. A live vaccine contains a weakened form of a germ. Your doctor will want your vaccines up to date before you start, which may include a shingles or chickenpox vaccine.

Tell any healthcare provider that you take Lisraya before you get a vaccine.

This is not a complete list of interactions. Other medicines can affect Lisraya, and Lisraya can affect other medicines.

Give your doctor and pharmacist a list of everything you take, including prescription medicines, over-the-counter medicines, vitamins, and herbal products. Do not start or stop any medicine while taking Lisraya without checking first.

The usual dose of Lisraya is one 30 mg tablet by mouth once a day. You can take it with or without food.

Taking Lisraya with a high-fat meal lowers the amount your body absorbs by a small amount. This is not expected to change how well it works, so you do not need to time it around meals.

Take Lisraya exactly as your doctor tells you. Do not stop taking it without talking to your doctor first.

Lisraya 30 mg tablets are pink, capsule-shaped, and film-coated. They are stamped with "BT30" on one side and come in bottles of 30 tablets.

In the VALOR trial (NCT05437263), adults with dermatomyositis who took Lisraya (brepocitinib) improved more over 52 weeks than adults who took a placebo, and were more likely to lower or stop their steroid medicine.

VALOR was a phase 3 study in 241 adults with dermatomyositis, an autoimmune disease that causes muscle weakness and painful, itchy skin rashes. The results below compare the approved 30 mg once-daily dose with placebo. Everyone kept taking their usual dermatomyositis medicines, so Lisraya was added on top of existing treatment.

How much did Lisraya improve dermatomyositis?

Improvement was measured with the Total Improvement Score (TIS), a combined score that tracks muscle strength, skin and other symptoms, daily activities, and blood tests for muscle damage.

At week 52, the average Total Improvement Score was 47.5 with Lisraya and 33.3 with placebo, a difference of 14.2 points. The score runs from 0 to 100, and a higher number means more improvement. A score of 60 or higher counts as major improvement.

Did Lisraya help people reduce their steroid dose?

Yes. More people taking Lisraya were able to cut back or stop their steroids than people taking placebo. At the start of the trial, people on steroids were taking an average of 11.4 mg a day of prednisone or an equivalent steroid.

Lisraya also improved skin disease activity, mainly by reducing redness, and improved physical function.

Lisraya may harm an unborn baby, based on animal studies. There is not enough information from human pregnancies to know the risk.

In pregnant rats and rabbits, the active ingredient brepocitinib caused bone malformations and pregnancy loss at doses higher than the human dose. Your doctor will confirm you are not pregnant before you start.

If you can become pregnant, use effective birth control while taking Lisraya and for 3 days after your last dose. Tell your doctor right away if you become pregnant or think you might be.

There is a pregnancy safety study for Lisraya. Pregnancies can be reported to Priovant Therapeutics at 1-800-511-9141.

Dermatomyositis itself can affect pregnancy. Research suggests that more active disease raises the chance of early delivery and low birth weight.

Breastfeeding

Do not breastfeed while taking Lisraya or for 3 days after your last dose. It is not known whether brepocitinib passes into breast milk, and there is a risk of serious side effects in a nursing baby.

Yes, but older adults may have a higher chance of serious side effects. In the trial, 17% of people taking Lisraya were 65 or older, and Lisraya worked about as well in this group as in younger adults.

Serious side effects were reported in 21% of people 65 and older taking Lisraya, compared with 15% of people the same age taking placebo. Shingles was also more common in older adults.

You can usually take the same dose of Lisraya if your kidney or liver problems are mild or moderate. No dose change is needed.

This medicine is not recommended if you have severe kidney problems (eGFR: < 30 mL/min).

This medicine is not recommended in people with severe liver problems (Child-Pugh C) as it has not been studied in this group of people.

There is no specific antidote for a Lisraya overdose. Call Poison Help at 1-800-222-1222 for advice, or seek emergency care.

Store tablets below 30°C (86°F). Keep them in the original bottle and out of reach of children.

Active ingredient: 30 mg of brepocitinib (equivalent to 43.27 mg brepocitinib tosylate) Inactive ingredients: hydroxypropyl methylcellulose, iron oxide red, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, titanium dioxide, and triacetin.