Deuruxolitinib

Deuruxolitinib is used in adults to treat a specific type of hair loss known as severe alopecia areata.

Your doctor will conduct tests to confirm that deuruxolitinib is the appropriate treatment for you.

Deuruxolitinib may also be used for other reasons that are not mentioned in this medication guide.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Before you use deuruxolitinib, your doctor will test you for tuberculosis or other infections. Your blood will be tested before and during treatment with deuruxolitinib.

Deuruxolitinib is usually taken twice per day with or without food.

You may get infections more easily, even serious or fatal infections. You will need other medical tests before and during treatment with deuruxolitinib.

This medicine can affect the results of certain medical tests. Tell any doctor who treats you that you are using deuruxolitinib.

Store this medicine in the original container at room temperature away from moisture and heat.

Taking deuruxolitinib may increase your risk of serious medical issues that could be life-threatening. This includes serious infections, a heart attack or stroke, blood clots, or cancer.

Call your doctor right away if you experience a fever, chills, cough, body aches, tiredness, open sores or skin wounds, diarrhea, stomach pain, weight loss, painful urination, or coughing up blood.

Seek emergency medical help if you have sudden shortness of breath, chest pain or discomfort that spreads to your neck or arms, nausea, feeling light-headed, swelling, cold sweat, weakness on one side of your body, slurred speech, or pain or tenderness in one or both legs.

Tell your doctor if you notice any signs of infection, such as fever, chills, cough, body aches, tiredness, open sores or skin wounds, diarrhea, stomach pain, weight loss, painful urination, or coughing up blood.

Tell your doctor if you have or have ever had:

• an active or chronic infection;
• any other medications you are using;
• a weak immune system (this can be caused by diseases like HIV or certain medications);
• herpes zoster (also known as shingles);
• chronic lung disease;
• a blood clot, stroke, heart attack, or other heart issues;
• high cholesterol;
• diverticulitis or an ulcer in your stomach or intestines;
• diabetes;
• low red or white blood cell counts;
• any kind of cancer;
• if you smoke or have smoked in the past; or
• liver problems (especially hepatitis B or hepatitis C) or kidney disease.

Tell your doctor if you have had or been exposed to tuberculosis or other infections, or if you have traveled recently. Tuberculosis and some fungal infections are more common in certain areas of the world, and you may have been exposed during your travels.

Tell your doctor if you have recently received a vaccine or are scheduled for a vaccine. Make sure you are up to date on all vaccines before starting deuruxolitinib.

Using deuruxolitinib may increase your risk of developing certain cancers, such as lymphoma, lung, and skin cancers. Ask your doctor about your individual risk and what skin symptoms to watch for.

It is not known if deuruxolitinib will harm an unborn baby. Use birth control and inform your doctor if you are pregnant or plan to become pregnant.

If you are pregnant, your name may be included in a pregnancy registry to monitor the effects of deuruxolitinib on the baby.

Do not breastfeed while taking deuruxolitinib, and for at least 1 day after your last dose.

Get emergency medical help if you have signs of an allergic reaction: hives, difficulty breathing, swelling of your face, lips, tongue, or throat.

Some people taking deuruxolitinib have had heart attacks, strokes, or serious blood clots. Stop taking deuruxolitinib and seek emergency medical attention if you have:

• signs of a heart attack or stroke--chest pain spreading to your jaw or shoulder, sudden numbness or weakness on one side of the body, slurred speech, feeling short of breath; or
• signs of a blood clot--severe headache, sudden chest or back pain, sudden cough or shortness of breath, or pain, swelling, or warmth in one or both legs.

Deuruxolitinib may cause serious side effects. Call your doctor right away if you have:

• signs of infection--fever, chills, sore throat, body aches, easy bruising or bleeding;
• signs of tuberculosis--cough, night sweats, loss of appetite, weight loss, and feeling very tired;
• a hole (perforation) in your digestive tract--severe stomach pain, change in bowel habits; or
• symptoms of herpes zoster (shingles)--skin sores or blisters, itching, tingling, burning pain, rash on your face or torso.

Your treatments may be delayed or permanently stopped if you have certain side effects.

Common side effects of deuruxolitinib may include:

• headache, tiredness, weight gain;
• acne, a skin infection, cold sores around your mouth, skin sores or blisters;
• cold symptoms such as stuffy nose, sneezing, sore throat; or
• abnormal blood tests.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Usual Adult Dose for Alopecia:

8 mg orally twice a dayComments:-This drug is not recommended for use in combination with other Janus kinase (JAK) inhibitors, biologic immunomodulators, cyclosporine, or any other potent immunosuppressants.Use: For the treatment of adults with severe alopecia areata

Skip the missed dose and take your next dose at the usual time. Do not take two doses at once.

Seek emergency medical help or call the Poison Help line at 1-800-222-1222.

Do not receive a "live" vaccine while you are being treated with deuruxolitinib or right before starting treatment. Live vaccines may include measles, mumps, rubella (MMR), varicella (chickenpox), nasal flu vaccine, and others.

Sometimes, it is not safe to use certain medicines together. Some drugs can change how much of other drugs is in your blood, which may increase side effects or make the medicines less effective.

Tell your doctor about all your current medicines. Many drugs can affect deuruxolitinib, especially:

• drugs that weaken the immune system such as cyclosporine; or
• medicines to treat psoriasis, rheumatoid arthritis, or other autoimmune disorders.

Many drugs can affect deuruxolitinib, and some drugs should not be used together. Tell your doctor about all other medicines you use. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here.