Tofacitinib may lower your ability to fight infections. This may make you more likely to get a serious (rarely fatal) infection (such as fungal infections, bacterial infections including tuberculosis) or make any infection you have worse. The risk for infections may be higher if you also take other drugs that suppress the immune system (such as cyclosporine, tacrolimus).
You should have a tuberculosis (TB) skin test before and during treatment with this medication. Tell your doctor your medical history, especially of past/recent/current infections. You should also tell your doctor if you have lived or traveled in areas where certain fungal infections (such as coccidioidomycosis, histoplasmosis) are common or if you have been near someone with tuberculosis. Areas where these types of fungal infections are commonly found include the Ohio and Mississippi River valleys and the southwestern United States. See Side Effects section for symptoms of infections to watch out for, and tell your doctor right away if you develop any of these symptoms.
Though it is very unlikely to occur, there may be a risk of developing cancer (such as lymphoma, skin cancer) with this medication. Discuss the risks and benefits of treatment with your doctor. Tell your doctor right away if you develop symptoms such as unusual lumps/growths, unexplained weight loss, persistent fever, night sweats, change in appearance or size of moles, or unusual skin changes.
In patients with a kidney transplant who are also taking other drugs that suppress the immune system, there may also be a risk of developing a certain white blood cell disorder (Epstein Barr Virus-associated post-transplant lymphoproliferative disorder) with this medication. Discuss the risks and benefits of treatment with your doctor.
Read the Medication Guide provided by your pharmacist before you start taking tofacitinib and each time you get a refill. If you have any questions, ask your doctor or pharmacist.
Take this medication by mouth with or without food as directed by your doctor, usually once or twice daily.
The dosage is based on your medical condition, response to treatment, laboratory tests, and other medications you may be taking. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Do not increase your dose or use this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of serious side effects will increase.
Take this medication regularly to get the most benefit from it. Remember to take it at the same time(s) each day.
Tell your doctor if your condition does not improve or if it worsens.
See also Warning section.
Many people using this medication have serious side effects. However, your doctor has prescribed this drug because he or she has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.
Tell your doctor right away if you have any serious side effects, including: unusual tiredness, fast heartbeat, shortness of breath, severe stomach/abdominal pain, signs of liver disease (such as dark urine, yellowing eyes/skin, persistent nausea/vomiting).
Tell your doctor right away if you have any signs of infection, including: fever, chills, persistent sore throat, persistent cough, night sweats, trouble breathing, painful/frequent urination, warm/red/painful skin.
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Before taking tofacitinib, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease (such as hepatitis B or C), kidney disease, blood/bone marrow disorders (such as anemia, low lymphocyte/neutrophil count), past/recent/current infections (such as tuberculosis, herpes zoster, HIV infection), cancer, stomach/intestinal disorders (such as ulcers, diverticulitis).
Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
Do not have immunizations/vaccinations without the consent of your doctor. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose). Wash your hands well to prevent the spread of infections.
Older adults may be at greater risk for infections while using this drug.
During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.
It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.
Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.
Some products that may interact with this drug include: other drugs that can weaken the immune system (such as abatacept, adalimumab, anakinra, azathioprine, certolizumab, cyclosporine, etanercept, golimumab, infliximab, rituximab, tocilizumab).
Other medications can affect the removal of tofacitinib from your body, which may affect how tofacitinib works. Examples include rifamycins (such as rifampin), azole antifungals (such as ketoconazole), among others.
If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
Do not share this medication with others.
Laboratory and/or medical tests (such as liver/kidney function, complete blood count, cholesterol levels, skin exams) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.
If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.
Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.
Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).
Information last revised April 2014. Copyright(c) 2014 First Databank, Inc.
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