Tofacitinib
Taking tofacitinib 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, 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 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: abatacept (Orencia); adalimumab (Humira); anakinra (Kineret); azathioprine (Azasan); certolizumab (Cimzia); cyclosporine (Gengraf, Neoral, Sandimmune); etanercept (Enbrel); golimumab (Simponi); infliximab (Remicade); methotrexate (Otrexup, Rasuvo, Trexall); rituximab (Rituxan); steroids including dexamethasone, methylprednisolone (Medrol), prednisolone (Orapred ODT, Prelone), and prednisone (Rayos); tacrolimus (Astagraf, Envarsus XR, Prograf); and tocilizumab (Actemra).
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; painful or difficult swallowing; cough; shortness of breath; weight loss; warm, red, or painful skin; painful rash; headache, sensitivity to light, neck stiffness, confusion; frequent, painful, or burning feeling during urination; stomach pain; diarrhea; or excessive tiredness.
You may already be infected with tuberculosis (TB; a serious lung infection) but not have any symptoms of the disease. In this case, using tofacitinib may make your infection more serious and cause you to develop symptoms. Your doctor will perform a skin test to see if you have an inactive TB infection before you begin your treatment with tofacitinib. If necessary, your doctor will give you medication to treat this infection before you start using tofacitinib. Tell your doctor if you have or have ever had TB, if you have lived in or visited 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, coughing up bloody mucus, weight loss, loss of muscle tone, or fever.
Taking tofacitinib may cause serious or life-threatening heart problems, such as a heart attack or stroke, or serious or life-threatening blood clots in the legs, arms, lungs, or in the arteries during your treatment. Tell your doctor if you smoke or if you have ever smoked. Also tell your doctor if have or have ever had a heart attack or other heart problems; a stroke; a blood clot in your legs, arms, or lungs, or in the arteries; high cholesterol; high blood pressure; or diabetes. If you experience any of the following symptoms during your treatment, call your doctor immediately or get emergency medical treatment: pain in the chest, arms, back, neck, jaw, or stomach; breaking out in cold sweat; feeling light-headed; dizziness; numbness or weakness in face, arm, or legs; slow or difficult speech; sudden shortness of breath or difficulty breathing; swelling of a leg or arm; leg pain; redness, discoloration, or warmth in the legs or arms.
Taking tofacitinib may increase the risk that you will develop a lymphoma (cancer that begins in the blood cells that fight infection) or other types of cancers, including lung cancer and skin cancer. Some people who took tofacitinib with other medications after they had a kidney transplant developed a condition that caused their bodies to produce too many white blood cells. Tell your doctor if you have or have ever had any type of cancer or have had a kidney transplant. Also tell your doctor if you smoke or if you have ever smoked.
Your doctor or pharmacist will give you the manufacturer’s patient information sheet (Medication Guide) when you begin treatment with tofacitinib 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) or the manufacturer’s website to obtain the Medication Guide.
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🔔 Why is this medication prescribed?
Tofacitinib is used alone or with other medications to treat rheumatoid arthritis (condition in which the body attacks its own joints causing pain, swelling, and loss of function) in adults who are unable to take or did not respond to one or more tumor necrosis factor (TNF) inhibitor medication(s). It is also used to treat psoriatic arthritis (a condition that causes joint pain and swelling and scales on the skin) in adults who are unable to take or did not respond to or tolerate one or more TNF inhibitor medication(s). Tofacitinib is used to treat ulcerative colitis (a condition which causes swelling and sores in the lining of the colon [large intestine] and rectum) in adults who are unable to take or who did not respond to one or more TNF inhibitor medication(s). It is also used to treat polyarticular juvenile idiopathic arthritis (PJIA; a type of childhood arthritis that affects five or more joints during the first six months of the condition, causing pain, swelling, and loss of function) in children 2 years and older who are unable to take or who did not respond to one or more TNF inhibitor medication(s). Tofacitinib is in a class of medications called Janus kinase (JAK) inhibitors. It works by decreasing the activity of the immune system.
🔔 How should this medicine be used?
Tofacitinib comes as a tablet, an extended-release (long-acting) tablet, and as an oral solution (liquid) to take by mouth. For the treatment of ulcerative colitis, rheumatoid arthritis, or psoriatic arthritis, the tablet is usually taken twice daily with or without food and the extended-release tablet is usually taken once daily with or without food. For the treatment of polyarticular course juvenile idiopathic arthritis, the tablet or the oral solution is usually taken twice daily with or without food. Take tofacitinib at around the same time(s) every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take tofacitinib exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
Swallow the extended-release tablets whole; do not split, chew, or crush them.
Always use the oral dosing syringe that comes with tofacitinib solution to measure your dose. Talk to your doctor or pharmacist if you have questions about how to measure your dose of tofacitinib solution.
If you or your child are taking tofacitinib oral solution, ask your pharmacist or doctor for a copy of the manufacturer’s instructions for use. Carefully read these instructions.
Your doctor may need to decrease your dose or stop your treatment if you experience certain severe side effects. Be sure to tell your doctor how you are feeling during your treatment.
