Understanding LISRAYA side effects

LISRAYA side effects in the VALOR study

When considering treatment, talk to your doctor about potential benefits and side effects. The most common side effects seen with LISRAYA in the VALOR study were:

Side Effects
(any severity)		 LISRAYA 30 mg
(n=81)
Upper Respiratory Tract Infection
15%
Headache
15%
Fatigue
12%
Urinary Tract Infection
11%
Nausea
11%
Bronchitis
10%
Arthralgia
10%
Diarrhea
9%
Back pain
9%
Fall
7%
Influenza
6%
Acne
6%
Very few patients stopped taking LISRAYA due to side effects
Most patients in the VALOR study were able to stay on treatment, despite any side effects. Fewer patients stopped taking LISRAYA due to side effects compared with patients taking placebo (6% vs. 11%).

Please see the full Important Safety Information for more details. 

Talk to your doctor about LISRAYA 

LISRAYA may cause serious side effects, including those described in its Boxed Warning. Before beginning treatment, it is important to speak with your doctor about the potential benefits and risks of LISRAYA.

Additional support and resources

Inform Your Doctor

Throughout your LISRAYA treatment, it is important to inform your doctor as soon as possible about any side effects you may experience.

Reporting Side Effects

To report suspected adverse reactions of LISRAYA, contact Priovant Therapeutics, Inc. by calling 1-800-511-9141 or emailing ContactCenter@priovant.com. You can also contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Use My Compass Support

A dedicated Patient Access Liaison (PAL) is available to provide personalized support for
your treatment with LISRAYA. 

1-800-LISRAYA

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Indication

LISRAYA (brepocitinib) is used for the treatment of adults with dermatomyositis (DM).

Limitations of Use
LISRAYA should not be used in combination with other JAK inhibitors, other TYK2 inhibitors, or biologic DMARDs.

Important Safety Information

WARNING: SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS (MACE), and THROMBOSIS

USE
LISRAYA (brepocitinib) is used for the treatment of adults with dermatomyositis (DM).

Limitations of Use
LISRAYA should not be used in combination with other JAK inhibitors, other TYK2 inhibitors, or biologic DMARDs.

LISRAYA can cause serious side effects, including:
Serious infections. LISRAYA can lower your ability to fight infections. Serious infections have happened while taking LISRAYA, including active tuberculosis (TB), and infections caused by bacteria, fungi, or viruses that can spread throughout the body. Some people have died from these infections. Your healthcare provider (HCP) should test you for TB before starting LISRAYA and check you closely for signs and symptoms of TB during treatment with LISRAYA. You should not start taking LISRAYA if you have any kind of infection unless your HCP tells you it is okay. If you get a serious infection, your HCP may stop your treatment until your infection is controlled. You may be at higher risk of developing shingles (herpes zoster).

Increased risk of death in people 50 years of age and older who have at least 1 heart disease 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. Lymphoma and other cancers, including skin cancers, can happen. Current or past smokers are at higher risk of certain cancers, including lymphoma and lung cancer. Follow your HCP’s advice about having your skin checked for skin cancer during treatment with LISRAYA. Limit the amount of time you spend in sunlight. Wear protective clothing when you are in the sun and use sunscreen.

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 are taking a JAK inhibitor, especially if you are a current or past smoker.

Blood clots. Blood clots in the veins of your legs or lungs and arteries can happen in some people taking LISRAYA. This may be life-threatening and cause death. Blood clots in the veins of the legs and lungs have happened more often in people who are 50 years of age and older with at least 1 heart disease (cardiovascular) risk factor taking a JAK inhibitor.

Allergic Reactions. Symptoms such as rash (hives), trouble breathing, feeling faint or dizzy, or swelling of your lips, tongue, or throat that may mean you are having an allergic reaction have been seen in people taking LISRAYA. Some of these reactions were serious. If any of these symptoms occur during treatment with LISRAYA, stop taking LISRAYA and get emergency medical help right away.

Tears in the stomach or intestines. Some people taking LISRAYA can get tears in their stomach or intestines. This happens most often in people who take nonsteroidal anti-inflammatory drugs (NSAIDs) or corticosteroids. Get medical help right away if you get stomach-area pain, fever, chills, nausea, or vomiting.

Low blood sugar in people with diabetes. If you have diabetes, your healthcare provider may tell you to check your blood sugar (glucose) more often during treatment with LISRAYA. Call your healthcare provider if you have any problems with low blood sugar.

Changes in certain laboratory tests. Your HCP should do blood tests before you start taking LISRAYA and while you take it. Your HCP may stop your LISRAYA treatment for a period of time if needed because of changes in these blood test results.

Before taking LISRAYA, tell your HCP if you:

  • have an infection.
  • are a current or past smoker.
  • have had any type of cancer.
  • have had a heart attack or other heart problems, or stroke.
  • have liver or kidney problems.
  • have unexplained stomach (abdominal) pain, have a history of diverticulitis or ulcers in your stomach or intestines, or are taking NSAIDs.
  • have diabetes.
  • have low red or white blood cell counts.
  • have recently received or are scheduled to receive an immunization (vaccine). People taking LISRAYA should not receive live vaccines.
  • are pregnant or plan to become pregnant. LISRAYA may harm your unborn baby.
  • are breastfeeding or plan to breastfeed. LISRAYA may pass into your breast milk. Do not breastfeed during treatment with LISRAYA and for 3 days after your last dose of LISRAYA. 

Females who are able to become pregnant:

  • Your healthcare provider will check whether or not you are pregnant before you start treatment with LISRAYA.
  • You should use effective birth control (contraception) to avoid becoming pregnant during treatment with LISRAYA and for 3 days after your last dose of LISRAYA.
  • Tell your healthcare provider if you think you are pregnant or become pregnant during treatment with LISRAYA.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. LISRAYA and other medicines may affect each other, causing side effects.

Especially tell your healthcare provider if you take medicines that affect your immune system as these medicines may increase your risk of infection. Ask your healthcare provider or pharmacist if you are not sure if you are taking any of these medicines.

The most common side effects of LISRAYA include:

  • common cold, sinus infections, or sore throat (upper respiratory tract infections)
  • headache
  • tired or lack of energy (fatigue)
  • urinary tract infection
  • nausea
  • acne
  • diarrhea
  • falls
  • bronchitis
  • flu (influenza)
  • joint pain (arthralgia)
  • back pain

Please see the Full Prescribing Information, including BOXED WARNING, and Medication Guide.