tofacitinib

What is the most important information I should know about tofacitinib?

Taking tofacitinib may increase your risk of life-threatening medical problems including serious infections, a hole or tear in your digestive tract, a heart attack or stroke, blood clots, or cancer.

Tell your doctor if you have a weak immune system, diabetes, chronic lung disease, or an infection such as hepatitis, tuberculosis, shingles, or HIV. Also tell your doctor if you've ever had diverticulitis, an ulcer in your stomach or intestines, cancer, a kidney transplant, heart problems, or a history of smoking, heart attack, stroke, or blood clots.

What is tofacitinib?

Tofacitinib is used to treat moderate to severe rheumatoid arthritis or active psoriatic arthritis in adults who have tried methotrexate or other medications without successful treatment of symptoms. Tofacitinib is sometimes given in combination with methotrexate or other arthritis medicines.

Tofacitinib is also used to treat moderate to severe ulcerative colitis in adults who cannot use certain other medications, or after other treatments have failed.

Tofacitinib is also used to treat polyarticular juvenile arthritis in adults and in children at least 2 years old.

Tofacitinib may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking tofacitinib?

• a weak immune system or chronic infection (such as tuberculosis, shingles, HIV, or hepatitis);
• any type of cancer;
• kidney disease, a kidney transplant, or if you are on dialysis;
• diverticulitis, an ulcer in your stomach or intestines;
• heart problems;
• a heart attack, stroke, or blood clot;
• high cholesterol; or
• if you've ever smoked.

Tell your doctor if you've been sick with signs of infection, such as fever, chills, muscle aches, cough, trouble breathing, skin sores, diarrhea, or painful urination.

Tell your doctor if you've had or been exposed to tuberculosis, or if you recently traveled. Some infections are more common in certain parts of the world, and you may have been exposed during travel.

Also tell your doctor if you have ever had:

• liver disease (especially hepatitis B or C);
• chronic lung disease;
• diabetes; or
• if you are scheduled to receive any vaccine.

Using tofacitinib may increase your risk of developing certain cancers, such as lymphoma or lung cancer. Ask your doctor about this risk.

Tell your doctor if you are pregnant or plan to become pregnant. Having rheumatoid arthritis or ulcerative colitis during pregnancy may increase the risk of premature birth or low birth weight. The benefit of treating these conditions with tofacitinib may outweigh any risks to the baby.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of tofacitinib on the baby.

If you are a woman, tofacitinib may affect your ability to have children during treatment and in the future.

Do not give this medicine to a child without medical advice. The extended-release tablets are not approved for use by anyone younger than 18 years old.

How should I take tofacitinib?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

You may take tofacitinib with or without food.

Measure liquid medicine with the supplied measuring device (not a kitchen spoon).

Doses are based on weight in children and teenagers. Your child's dose may change if the child gains or loses weight.

You may get infections more easily, even serious or fatal infections. You will need frequent medical tests.

If you've ever had shingles (herpes zoster) or hepatitis B or C, using tofacitinib can cause these viruses to become active or get worse.

Part of a tablet shell may appear in your stool but this will not make the medicine less effective.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

What happens if I overdose?

What should I avoid while taking tofacitinib?

Avoid receiving a "live" vaccine. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), and zoster (shingles).

What are the possible side effects of tofacitinib?

• sudden shortness of breath;
• chest pain or pressure that may spread to your jaw, shoulder, arms, or back;
• nausea, vomiting, cold sweat;
• a light-headed feeling, like you might pass out;
• weakness on one side of your body;
• slurred speech, drooping on one side of your mouth; or
• pain, swelling, or redness in an arm or a leg.

• fever, chills, night sweats, constant tiredness;
• wheezing, trouble breathing, severe or worsening cough;
• increased urination, pain or burning when you urinate;
• unexplained weight loss;
• lumps in your neck, armpits, or groin;
• signs of shingles --flu-like symptoms, tingly or painful blistering rash on one side of your body;
• a hole (perforation) in your digestive tract --fever, severe stomach pain, diarrhea or changes in bowel habits; or
• signs of hepatitis --loss of appetite, vomiting, stomach pain (upper right side), dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Common side effects may include:

• skin rash, shingles;
• increased blood pressure;
• abnormal blood tests;
• fever;
• headache;
• nausea, vomiting, diarrhea; or
• cold symptoms such as stuffy nose, sneezing, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect tofacitinib?

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Tell your doctor about all your current medicines. Many drugs can affect tofacitinib, especially:

• azathioprine;
• cyclosporine; or
• other drugs to treat arthritis or ulcerative colitis --abatacept, adalimumab, anakinra, certolizumab, etanercept, golimumab, infliximab, rituximab, secukinumab, tocilizumab, ustekinumab, vedolizumab.

This list is not complete and many other drugs may affect tofacitinib. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Where can I get more information?

Your doctor or pharmacist can provide more information about tofacitinib.