Using 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), 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, Imuran); certolizumab (Cimzia); cyclosporine (Gengraf, Neoral, Sandimmune); etanercept (Enbrel); golimumab (Simponi); infliximab (Remicade); methotrexate (Rheumatrex, Trexall); rituximab (Rituxan); steroids including dexamethasone, methylprednisolone (Medrol), prednisolone (Prelone), and prednisone; tacrolimus (Prograf); and tocilizumab (Actemra).
Your doctor will monitor your 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; shortness of breath; weight loss; warm, red, or painful skin; sores on the skin; frequent or painful urination; 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 increase the risk that you will develop lymphoma (cancer that begins in the cells that fight infection) or other types of cancers. 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.
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 ( Web Site) or the manufacturer's website to obtain the Medication Guide.
WHY is this medicine 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 cannot be treated with methotrexate (Rheumatrex, Trexall) alone. 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 to take by mouth. It is usually taken with or without food twice a day. Take tofacitinib at around the same times 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.
Your symptoms may improve as soon as 2 weeks after you begin taking tofacitinib, but it may take 3-6 months for you to feel the full benefit of the medication. Talk to your doctor about how tofacitinib works for you.
Tofacitinib may help control your condition but will not cure it. Continue to take tofacitinib even if you feel well. Do not stop taking tofacitinib without talking to your doctor.
Are there OTHER USES for this medicine?
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
What SPECIAL PRECAUTIONS should I follow?
Before taking tofacitinib,
- tell your doctor and pharmacist if you are allergic to tofacitinib, any other medications, or any of the ingredients in tofacitinib tablets. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
- tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, and nutritional supplements you are taking or plan to take. Be sure to mention the medications listed in the IMPORTANT WARNING section and any of the following: certain antiviral medications such as fluconazole (Diflucan), itraconazole (Sporanox), and ketoconazole (Nizoral); aspirin and other non-steroidal anti-inflammatory medications (NSAIDs) such as ibuprofen (Advil, Motrin) and naproxen (Naprosyn, Aleve); carbamazepine (Carbatrol, Tegretol, Equetro); clarithromycin (Biaxin); certain medications for HIV including indinavir (Crixivan), nelfinavir (Viracept), and ritonavir (Norvir, in Kaletra); nefazodone; phenobarbital; phenytoin (Dilantin); rifabutin (Mycobutin), and rifampin (Rifadin, Rimactane, in Rifater, in Rifamate).Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
- tell your doctor what herbal products you are taking, especially St. John's wort.
- tell your doctor if you have stomach pain that has not been diagnosed and if you have or have ever had ulcers (sores in the lining of your stomach or intestine), diverticulitis (swelling of the lining of the large intestine), liver disease including hepatitis B or hepatitis C, or kidney disease.
- tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking tofacitinib, call your doctor.
- tell your doctor if you have recently received or are scheduled to receive any vaccinations. If you need any vaccinations, you may have to receive the vaccinations and then wait some time before beginning your treatment with tofacitinib. Do not have any vaccinations during your treatment without talking to your doctor.
What SPECIAL DIETARY instructions should I follow?
Talk to your doctor about eating grapefruit and drinking grapefruit juice while taking this medication.
What should I do IF I FORGET to take a dose?
Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.
What SIDE EFFECTS can this medicine cause?
Tofacitinib may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- stuffy or runny nose
Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately or get emergency medical treatment:
- stomach pain, especially if it comes along with fever and diarrhea or constipation
- yellowing of the skin or eyes
- loss of appetite
- dark urine
- clay-colored bowel movements
- pale skin
- shortness of breath
Tofacitinib may cause an increase in your blood cholesterol levels. Your doctor will order tests to monitor your cholesterol levels during your treatment. Talk to your doctor about the risks of taking this medication.
Tofacitinib may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at Web Site] or by phone [1-800-332-1088].
What should I know about STORAGE and DISPOSAL of this medication?
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.
What should I do in case of OVERDOSE?
In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.
What OTHER INFORMATION should I know?
Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to tofacitinib.
Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
AHFS® Consumer Medication Information. © Copyright, The American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.
Selected Revisions: June 15, 2013.