Overview: Lisraya is used to treat a rare condition called dermatomyositis. It works by blocking signals that lead to inflammation. Common side effects may include headache, tiredness, nausea, joint pain, and diarrhea. Infections are another common side effect, and they can sometimes be serious. Tell your health care provider if you have any symptoms of an infection, such as fever, chills, or other flu-like symptoms. Get emergency help if you have chest pain, trouble breathing, or sudden weakness on one side of your body, severe headache, slurred speech, or trouble understanding speech. Keep all appointments with your health care provider while taking this medicine. Lisraya is a tablet that is taken by mouth.
Uses
What is Lisraya used for?
Lisraya (brepocitinib) is commonly used to treat dermatomyositis, which is a rare condition where the immune system attacks healthy tissues. This can lead to symptoms such as skin rashes and muscle weakness.
Your Guide to Lisraya for Dermatomyositis
Lisraya may also be used for other conditions as determined by your health care provider.
How does Lisraya work (mechanism of action)?
Dermatomyositis is an inflammatory condition that can affect the skin and muscles. Certain proteins in the body, called Janus kinase (JAK) proteins and tyrosine kinase 2 (TYK2) proteins, play an important role in sending signals that lead to inflammation.
Lisraya is a medicine known as a JAK/TYK2 inhibitor. It blocks this signaling pathway, which can reduce the inflammation that happens with dermatomyositis.
How is Lisraya supplied (dosage forms)?
Brands and other names
- Lisraya
Dosage forms and strengths
- 30 mg oral tablets
How should I store Lisraya?
Lisraya should be stored at a temperature below 86 F (30 C). Store in a cool, dry place.
Side Effects
What are the most common side effects of Lisraya?
The most common side effects of Lisraya are listed below. Tell your health care provider if you have any of these side effects that bother you.
- Infections (see below)
- Headache
- Tiredness
- Nausea
- Bronchitis
- Joint pain
- Diarrhea
- Back pain
- Falls
- Acne
There may be other side effects of Lisraya that are not listed here. Contact your health care provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088 (800-332-1088). In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.
What are the serious side effects of Lisraya?
While less common, the most serious side effects of Lisraya are described below, along with what to do if they happen.
Severe Allergic Reactions. Lisraya may cause allergic reactions, which can be serious. Stop taking Lisraya and get help right away if you have any of the following symptoms of a serious allergic reaction.
- Breathing problems or wheezing
- Racing heart
- Fever or general ill feeling
- Swollen lymph nodes
- Swelling of the face, lips, mouth, tongue, or throat
- Trouble swallowing or throat tightness
- Itching or skin rash
- Bumps on the skin called hives that can be red, pink, white, or brown depending on your skin tone
- Nausea or vomiting
- Dizziness, feeling lightheaded, or fainting
- Stomach cramps
- Joint pain
Infections. Lisraya can increase your risk of infections, including serious infections that can lead to death. Serious infections that have happened with Lisraya include pneumonia, shingles, sepsis, and tuberculosis (TB). Call your health care provider right away if you have an infection or any of the following symptoms.
- Burning or stinging when you pee
- Coughing, or coughing up blood
- Fever, sweats, chills, muscle aches, or other flu-like symptoms
- Shortness of breath
- Diarrhea or stomach pain
- Weight loss
- Sores or skin that is warm, painful, or discolored
- Tiredness
Heart Attack and Stroke. Lisraya can increase your risk of a heart attack or stroke that can lead to death. Your risk may be higher if you are age 50 or older, at risk of heart disease, or if you smoke or used to smoke. Get emergency help if you have any of the following symptoms of a heart attack or stroke.
- Chest pain or pressure
- Fast or abnormal heartbeat
- Trouble breathing
- Pain in your back, jaw, throat, or arm
- Sweating, upset stomach, vomiting, or dizziness
- Sudden weakness on one side of your body
- Sudden and severe headache
- Slurred speech or trouble understanding speech
Cancer. Lisraya can cause a new cancer to develop or cause a previously treated cancer to come back. Your risk may be higher if you smoke or used to smoke. Tell your health care provider about any cancers that you or your family members have had in the past. Limit sun exposure, avoid tanning beds or sun lamps, and wear sunscreen and clothes to cover your skin if you need to be in the sun. Keep any appointments to get your skin checked. Tell your health care provider about any new symptoms that you may get.
Blood Clots. Lisraya may cause a blood clot in your arteries or veins and could cause venous thromboembolism, including a blood clot in the lungs (pulmonary embolism) or deep vein thrombosis (DVT). These clots can be serious or lead to death. Stop taking Lisraya and get emergency help if you have any of the following signs of blood clots.
- Chest pain or pressure
- Fast or abnormal heartbeat
- Trouble breathing
- Pain in your back, jaw, throat, or arm
- Sweating, upset stomach, vomiting, or dizziness
- Sudden weakness on one side of your body
- Sudden and severe headache
- Slurred speech or trouble understanding speech
- Pain, swelling, or tenderness in your arm or leg
- Vision loss
- Bulging eyes
- Double vision
Gut Damage. Lisraya may cause a hole or tear (perforation) in the stomach or intestines. Your risk may be higher if you take certain medicines, such as a nonsteroidal anti-inflammatory drug (NSAID) or corticosteroid. Contact your health care provider right away if you have any of the following symptoms.
- Stomach pain
- Fever or chills
- Nausea or vomiting
Changes in Lab Test Results. Lisraya can cause changes in the results of certain lab tests. This can include low white blood cell levels (neutropenia or lymphopenia) and low red blood cell levels (anemia). Lisraya may also cause increased cholesterol levels or increased liver enzymes. This medicine should not be used if your white blood cell or red blood cell levels are too low or if your liver enzymes are too high. Keep all appointments to check your blood work. Tell your health care provider if you have any new or unusual symptoms.
Warnings & Precautions
Who should not use Lisraya?
Allergies to Ingredients. People who are allergic to any of the following should not take Lisraya.
- Brepocitinib
- Lisraya
- Any of the ingredients in the specific product dispensed
Your pharmacist can tell you all of the ingredients in Lisraya.
What should I know about Lisraya before using it?
Do not take Lisraya unless it has been prescribed to you by a health care provider. Take it as prescribed.
Do not share Lisraya with other people, even if they have the same condition as you. It may harm them.
Keep Lisraya out of the reach of children.
It is very important to keep all appointments with your health care provider, including for blood work and lab tests, before starting and while you are taking Lisraya. This will help your health care provider make sure the medicine is safe and working well for you.
People who are age 65 and older can be at greater risk of some side effects from Lisraya. Talk to your health care provider about your risks if you are in this age group.
What should I tell my health care provider before using Lisraya?
Tell your health care provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them know if Lisraya is right for you.
In particular, make sure that you discuss any of the following.
Current and Past Health Conditions. Tell your health care provider if you have or have had any of the following.
- Any type of infection, including a long-term infection or an infection that keeps coming back
- Tuberculosis (TB), or close contact with someone who has TB
- Hepatitis
- Shingles
- A weakened immune system or HIV
- A heart attack, stroke, or blood clots
- Risk factors for heart disease, such as high cholesterol or high blood pressure
- Smoke or used to smoke
- Kidney or liver problems
- Low blood cell levels
- Diabetes
- Lung or breathing problems
- Cancer
- Stomach or intestinal problems, such as diverticulitis or ulcers
- Live, lived, or traveled to parts of the country like the Ohio or Mississippi River Valley or the southwestern United States
Vaccines. Talk with your health care provider about any vaccines that you may need. You should not receive certain vaccines right before or while taking Lisraya. Tell your health care provider about any vaccines you have recently received or have scheduled.
Other Medicines and Supplements. Lisraya may interact with other medicines and supplements. Before taking Lisraya, tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details.
Pregnancy. Lisraya may cause harm to a fetus. You should not be pregnant before starting Lisraya. If you can get pregnant, you should use effective birth control while taking Lisraya and for 3 days after your last dose. Tell your health care provider if you are pregnant or plan to become pregnant. If you become pregnant while taking Lisraya, you can sign up for a pregnancy safety study by calling 800-511-9141 or emailing [email protected]. This study collects safety information about the use of Lisraya during pregnancy.
Breastfeeding. It is not known if Lisraya passes into breast milk. Do not breastfeed while you are taking Lisraya and for 3 days after your last dose. Tell your health care provider if you are breastfeeding or plan to breastfeed.
How can I get more information about Lisraya?
For more information about Lisraya, you can visit the drugmaker’s website at www.lisraya.com or call them at 800-511-9141.
Interactions
Does Lisraya interact with foods or drinks?
There are no known interactions between Lisraya and foods or drinks.
It is unknown if drinking alcohol will affect Lisraya. The risk of certain side effects, such as tiredness or infections, may be increased if you drink alcohol while taking Lisraya.
Does Lisraya interact with other medicines (drug interactions)?
Always tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.
In particular, make sure that you discuss if you are using any of the following before taking Lisraya.
- Any other JAK inhibitor, such as abrocitinib (Cibinqo), baricitinib (Olumiant), ritlecitinib (Litfulo), ruxolitinib (Jakafi), or tofacitinib (Xeljanz), which is a medicine used to treat various inflammatory conditions
- A biologic to treat autoimmune conditions, such as abatacept (Orencia), adalimumab (Humira), anakinra (Kineret), certolizumab (Cimzia), etanercept (Enbrel), golimumab (Simponi), infliximab (Remicade), ixekizumab (Taltz), rituximab (Rituxan), secukinumab (Cosentyx), tocilizumab (Actemra), ustekinumab (Stelara), or vedolizumab (Entyvio)
- A nonsteroidal anti-inflammatory drug (NSAID), such as ibuprofen, naproxen, and others, which is in many prescription and over-the-counter (OTC) products for pain, swelling, and fever
- A corticosteroid, such as dexamethasone, methylprednisolone, or prednisone, which is a medicine for certain inflammatory conditions
- A medicine for diabetes
Lisraya may alter the blood levels of some other medicines. Tell your health care provider about all medicines that you take or have recently taken.
This may not be a complete list of medicines that can interact with Lisraya. Always check with your health care provider.
Overdose/Missed Dose
What should I do if I accidentally use too much Lisraya?
If you or someone else has used too much Lisraya, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.
What should I do if I miss a dose of Lisraya?
If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and only take the next dose. Do not take double or extra doses.
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