Generic Name: tofacitinib (TOE-fa-SYE-ti-nib)
Brand Name: Xeljanz
Tofacitinib may increase the risk of serious and sometimes fatal infection. Patients who also take medicine to suppress the immune system (eg, methotrexate, corticosteroids) may be at greater risk. Reported infections have included tuberculosis (TB), shingles, and other bacterial, viral, and fungal infections. You should be tested for TB before you start tofacitinib. Discuss with your doctor the benefits and risks of using tofacitinib.
Contact your doctor right away if you develop symptoms of infection (eg, fever; chills; persistent cough or sore throat; increased or painful urination; unusual muscle aches; red, warm, swollen, painful, or blistered skin; tiredness; loss of appetite or unusual weight loss; night sweats).
Lymphoma and other types of cancer have been seen in patients treated with tofacitinib. Patients who have had a kidney transplant and take medicine to suppress the immune system may be at greater risk for a problem with certain white blood cells growing out of control. Discuss any questions or concerns with your doctor.
Tofacitinib is used for:
Treating moderate to severe rheumatoid arthritis in patients who did not respond to methotrexate. It may also be used for other conditions as determined by your doctor.
Tofacitinib is a kinase inhibitor. It works by blocking certain substances in the body that contribute to inflammation.
Do NOT use tofacitinib if:
- you are allergic to any ingredient in tofacitinib
- you have a serious infection
- you have certain severe liver problems
- you are taking azathioprine, cyclosporine, or other medicine to suppress your immune system
- you are taking a biologic medicine to treat rheumatoid arthritis (eg, abatacept, adalimumab, anakinra, certolizumab, etanercept, golimumab, infliximab, rituximab, tocilizumab)
Contact your doctor or health care provider right away if any of these apply to you.
Before using tofacitinib:
Some medical conditions may interact with tofacitinib. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have immune system problems, HIV, diabetes, anemia, or low white blood cell counts
- if you have an infection (bacterial, viral, fungal, or mycobacterial) or a history of hepatitis, other serious infection, or infection that keeps coming back
- if you have a history of TB, you have been exposed to TB, or you have lived in an area where TB is common. Check with your doctor if you are not sure if you have lived in an area where TB is common
- if you live or have lived in certain parts of the country (eg, Ohio or Mississippi river valleys, the Southwest) where certain types of fungal infections (eg, histoplasmosis, coccidioidomycosis, blastomycosis) are common. Check with your doctor if you are not sure if you have lived in an area where these infections are common
- if you have a history of cancer, stomach or bowel problems (eg, pain, ulcers, inflammation), high cholesterol, liver problems, or kidney problems
- if you take medicine that may weaken your immune system. Check with your doctor if you are unsure if any of your medicine may weaken your immune system.
Some MEDICINES MAY INTERACT with tofacitinib. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Azathioprine, azole antifungals (eg, ketoconazole, fluconazole), biologic medicine to treat rheumatoid arthritis (eg, abatacept, adalimumab, anakinra, certolizumab, etanercept, golimumab, infliximab, rituximab, tocilizumab), corticosteroids (eg, prednisone), cyclosporine, methotrexate, nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen), or tacrolimus because they may increase the risk of tofacitinib's side effects
- Rifamycins (eg, rifampin) because it may decrease tofacitinib's effectiveness
This may not be a complete list of all interactions that may occur. Ask your health care provider if tofacitinib may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use tofacitinib:
Use tofacitinib as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Tofacitinib comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get tofacitinib refilled.
- Take tofacitinib by mouth with or without food.
- Continue to take tofacitinib even if you feel well. Do not miss any doses.
- If you miss a dose of tofacitinib, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use tofacitinib.
Important safety information:
- Do not change your dose or stop taking tofacitinib without checking with your doctor.
- Do not receive a live vaccine (eg, measles, mumps) while you are taking tofacitinib. Talk with your doctor before you receive any vaccine.
- Tofacitinib may lower the ability of your body to fight infection, including shingles. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, chills, or increased or painful urination. Symptoms of shingles may include painful skin rash or blisters.
- Lab tests, including complete blood cell counts, liver function, or cholesterol levels, may be performed while you use tofacitinib. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Use tofacitinib with caution in the ELDERLY; they may be more sensitive to its effects, especially infection.
- Tofacitinib should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using tofacitinib while you are pregnant. It is not known if tofacitinib is found in breast milk. Do not breast-feed while taking tofacitinib.
Possible side effects of tofacitinib:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Seek medical attention right away if any of these SEVERE side effects occur:
Diarrhea; headache; runny or stuffy nose; sore throat.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black, tarry, or bloody stools; burning, numbness, or tingling; change in bowel habits; chest pain or shortness of breath; coughing up blood; severe or persistent diarrhea or stomach pain; severe or persistent headache or dizziness; severe or persistent joint pain or swelling; swelling of the hands, ankles, or feet; symptoms of infection (eg, fever; chills; persistent cough or sore throat; increased or painful urination; unusual muscle aches; red, warm, swollen, painful, or blistered skin; tiredness; unusual weight loss; night sweats); symptoms of liver problems (eg, yellowing of the skin or eyes, dark urine, pale stools, unusual nausea or loss of appetite); unusual tiredness or weakness; very dry mouth, eyes, or skin; vomit that looks like coffee grounds.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.Proper storage of tofacitinib:
Store tofacitinib at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep tofacitinib out of the reach of children and away from pets.
- If you have any questions about tofacitinib, please talk with your doctor, pharmacist, or other health care provider.
- Tofacitinib is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
- Check with your pharmacist about how to dispose of unused medicine.
This information should not be used to decide whether or not to take tofacitinib or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about tofacitinib. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to tofacitinib. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using tofacitinib.
Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.