tofacitinib (Xeljanz, Xeljanz XR)

Brand Names: Xeljanz, Xeljanz XR

Generic Name: tofacitinib

• What is tofacitinib (Xeljanz, Xeljanz XR)?
• What are the possible side effects of tofacitinib (Xeljanz, Xeljanz XR)?
• What is the most important information I should know about tofacitinib (Xeljanz, Xeljanz XR)?
• What should I discuss with my healthcare provider before taking tofacitinib (Xeljanz, Xeljanz XR)?
• How should I take tofacitinib (Xeljanz, Xeljanz XR)?
• What happens if I miss a dose (Xeljanz, Xeljanz XR)?
• What happens if I overdose (Xeljanz, Xeljanz XR)?
• What should I avoid while taking tofacitinib (Xeljanz, Xeljanz XR)?
• What other drugs will affect tofacitinib (Xeljanz, Xeljanz XR)?
• Where can I get more information (Xeljanz, Xeljanz XR)?

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

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Some people taking high doses of tofacitinib have developed serious or fatal blood clots. Stop taking tofacitinib and seek emergency medical attention if you have:

• sudden shortness of breath;
• pain while breathing;
• cough with pink or red mucus;
• pain in your chest or back;
• clammy or blue-colored skin, heavy sweating; or
• pain, swelling, or redness in an arm or a leg.

You may get infections more easily, even serious or fatal infections. Call your doctor right away if you have signs of infection such as:

• fever, chills, sweating, tiredness, muscle pain;
• feeling short of breath;
• skin sores with warmth, redness, or swelling;
• increased urination, pain or burning when you urinate;
• mouth sores, stomach pain, diarrhea; or
• signs of tuberculosis: fever, cough, night sweats, loss of appetite, weight loss, and feeling very tired.

Further doses may be delayed until your infection clears up.

Also call your doctor at once if you have:

• low red blood cells (anemia)--pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet;
• signs of hepatitis--loss of appetite, vomiting, stomach pain (upper right side), dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• shingles--burning pain, numbness, tingling, itching, skin rash or blisters; or
• signs of perforation (a hole or tear) in your stomach or intestines--fever, ongoing stomach pain, change in bowel habits.

Common side effects may include:

• skin rash, shingles;
• increased blood pressure;
• abnormal blood tests;
• headache;
• 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.

You should not use tofacitinib if you have a serious infection. Before you start treatment, your doctor may perform tests to make sure you do not have an infection.

Tofacitinib affects your immune system. You may get infections more easily, even serious or fatal infections. Call your doctor if you have a fever, chills, aches, tiredness, cough, trouble breathing, skin sores, diarrhea, weight loss, or burning when you urinate.

If you've ever had hepatitis B or C, using tofacitinib can cause this virus to become active or get worse. Tell your doctor if you don't feel well and you have right-sided upper stomach pain, vomiting, loss of appetite, or yellowing of your skin or eyes.

You should not use tofacitinib if you are allergic to it, or if you have any kind of infection.

Tell your doctor if you have ever had:

• liver disease (especially hepatitis B or C);
• heart problems (especially if you are 50 or older);
• lung disease;
• a blood clot;
• a chronic infection;
• HIV, or a weak immune system;
• a stomach or intestinal problem such as diverticulitis or an ulcer;
• kidney disease (or if you are on dialysis);
• diabetes; or
• if you are scheduled to receive any vaccine.

Taking tofacitinib at too high a dose may increase the risk of death in people with rheumatoid arthritis who are 50 and older and have at least 1 risk for heart disease. This includes high blood pressure, high cholesterol, diabetes, smoking, being overweight, or having a family history of heart disease. Talk to your doctor about your specific risk, and take only your recommended dose.

Tell your doctor if you have ever had tuberculosis or if anyone in your household has tuberculosis. Also tell your doctor if you have recently traveled. Tuberculosis and some fungal infections are more common in certain parts of the world, and you may have been exposed during travel.

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

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant. Tofacitinib may affect your ability to have children during treatment and in the future.

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

Do not breastfeed while you are using this medicine, and for at least 18 hours after your last dose (36 hours if you take extended-release tablets). If you use a breast pump during this time, do not feed the milk to your baby.

Tofacitinib is not approved for use by anyone younger than 18 years old.

Before you start treatment, your doctor may perform tests to make sure you do not have an infection.

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.

A safe dose of tofacitinib is not the same for all conditions. Avoid medication errors by using only the form and strength your doctor prescribes.

You may take tofacitinib with or without food.

Swallow the extended-release tablet whole and do not crush, chew, or break it.

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.

You will need frequent medical tests.

Store in the original container at room temperature away from moisture and heat.

Some tablets are made with a shell that is not absorbed or melted in the body. Part of this shell may appear in your stool. This is normal and will not make the medicine less effective.

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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.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Do not receive a "live" vaccine while using tofacitinib, or you could develop a serious infection. Live vaccines include measles, mumps, rubella (MMR), polio, rotavirus, typhoid, yellow fever, varicella (chickenpox), and zoster (shingles).

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.

Your doctor or pharmacist can provide more information about tofacitinib.

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