Ruxolitinib Topical
Using topical ruxolitinib may decrease your ability to fight infection and increase the risk that you will get a serious infection, including severe fungal, bacterial, or viral infections that spread through the body. These infections may need to be treated in a hospital and may cause death. Tell your doctor if you often get any type of infection or if you think you may have any type of infection now. This includes minor infections (such as open cuts or sores), infections that come and go (such as cold sores), and chronic infections that do not go away. Also tell your doctor if you have or have ever had diabetes, human immunodeficiency virus (HIV), acquired immunodeficiency syndrome (AIDS), a lung disease, hepatitis B virus infection (HBV; an ongoing liver infection), hepatitis C virus infection (HCV; an ongoing liver infection), or herpes zoster (shingles; a rash that can occur in people who have had chickenpox in the past), or any other condition that affects your immune system. You should also tell your doctor if you live or have ever lived in areas such as the Ohio or Mississippi river valleys or the Southwest where severe fungal infections are more common. Ask your doctor if you are not sure if these infections are common in your area. Tell your doctor if you are taking medications that decrease the activity of the immune system such as the following: azathioprine (Azasan, Imuran), baricitinib (Olumiant), cyclosporine (Gengraf, Neoral, Sandimmune), fedratinib (Inrebic), methotrexate (Xatmep, Trexall), mycophenolate (Cellcept), pimecrolimus (Elidel), tacrolimus (Astagraf, Envarsus XR, Prograf, Protopic), tofacitinib (Xeljanz), and upadacitinib (Rinvoq).
Your doctor will monitor you for signs of infection during and after your treatment. If you have any of the following symptoms before you begin your treatment or if you experience any of the following symptoms during or shortly after your treatment, call your doctor immediately: fever; sweating; chills; muscle aches; cough; coughing up bloody mucus; shortness of breath; weight loss; warm, red, or painful skin; sores on the skin; urination that is frequent, painful, or causes a burning feeling; diarrhea; stomach pain; or excessive tiredness.
You may be infected with tuberculosis (TB, a type of lung infection), but not have any symptoms of the disease. In this case, using topical ruxolitinib may increase the risk that your infection will become more serious and that you will develop symptoms. Your doctor will perform a skin test to see if you have an inactive TB infection. If necessary, your doctor will give you medicine to treat this infection before you begin using ruxolitinib. Tell your doctor if you have or have ever had TB, if you have lived in a country where TB is common, or if you have been around someone who has TB. If you have any of the following symptoms of TB, or if you develop any of these symptoms during your treatment, call your doctor immediately: cough, weight loss, loss of muscle tone, or fever.
Ruxolitinib may increase the risk that you will develop a lymphoma (cancer that begins in the cells that fight infection) or other types of cancers such as skin cancer. Tell your doctor if you have or have ever had any type of cancer or if you are a current or past smoker. Your doctor will check your skin during your treatment with topical ruxolitinib for signs of skin cancer.
Ruxolitinib may increase the risk of serious and potentially fatal heart-related events such as heart attack or stroke. Tell your doctor if you are a current or past smoker, or have had a heart attack or other heart problems. If you experience any of the following side effects, call your doctor or get emergency medical treatment immediately: crushing chest pain or chest heaviness; shortness of breath; pain in arms, back, neck, jaw, or stomach; sudden, severe headache; cold sweat; sudden, severe nausea or vomiting; speech problems; dizziness or faintness; or weakness or numbness of an arm or a leg.
Ruxolitinib may increase the risk of serious and possibly life-threatening blood clot in the lungs or legs. Tell your doctor if you have or have ever had a blood clot in your legs or lungs. If you experience any of the following side effects, call your doctor or get emergency medical treatment immediately: crushing chest pain or chest heaviness; shortness of breath; cough; pain, warmth, redness, swelling, or leg tenderness; cold sensation in the arms, hands, or legs; or muscle pain.
Preventable medical errors kill about 22,000 patients a year, according to research from the Yale School of Medicine. That’s much less than a previously reported number of 250,000 deaths a year where medical error is to blame.
Keep all appointments with your doctor and the laboratory. Your doctor may order certain tests to check your body’s response to ruxolitinib.
Your doctor or pharmacist will give you the manufacturer’s patient information sheet (Medication Guide) when you begin treatment with topical ruxolitinib and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) to obtain the Medication Guide.
Talk to your doctor about the risk(s) of using ruxolitinib.
