Pronunciation: TOE fa SYE ti nib

Brand: Xeljanz, Xeljanz XR

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

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.

Serious and sometimes fatal infections may occur during treatment with tofacitinib. Stop using this medicine and call your doctor right away if you have signs of infection such as: fever, chills, sore throat, flu symptoms, sores or white patches in your mouth or throat, night sweats, stomach pain, diarrhea, weight loss, skin redness and swelling, or cough and chest pain.

What is tofacitinib?

Tofacitinib works by blocking certain enzymes in the body that affect immune system function.

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

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

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

You should not use tofacitinib if you are allergic to it, or if you have a serious infection.

Tell your doctor if you have ever had tuberculosis, if anyone in your household has tuberculosis, or if you have recently traveled to an area where tuberculosis is common.

To make sure tofacitinib is safe for you, tell your doctor if you have:

  • an active or chronic infection;
  • any type of infection caused by bacteria, fungus, or virus;
  • a history of shingles (herpes zoster);
  • an infected skin wound;
  • diabetes;
  • liver disease (especially hepatitis B or C);
  • kidney disease;
  • HIV or AIDS;
  • a history of skin cancer or melanoma;
  • a history of diverticulitis, stomach ulcer, or perforation (a hole or tear) in your esophagus, stomach, or intestines; or
  • a weak immune system caused by disease or by using certain medicines (especially methotrexate or steroid medicine such as dexamethasone).

Tofacitinib may increase your risk of certain cancers by changing the way your immune system works. If you have had a kidney transplant, tofacitinib may cause your body to produce too much of a certain type of white blood cell.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

If you are pregnant, your name may be listed on a pregnancy registry. This is to track the outcome of the pregnancy and to evaluate any effects of tofacitinib on the baby.

It is not known whether tofacitinib passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

How should I take tofacitinib?

Before you start treatment with tofacitinib, your doctor may perform tests to make sure you do not have tuberculosis or other infections.

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

You may take tofacitinib with or without food.

Do not crush, chew, or break an extended-release tablet. Swallow it whole.

Tofacitinib can lower blood cells that help your body fight infections and help your blood to clot. Your blood will need to be tested often. Further doses may be delayed based on the results of these tests. Your doctor may also want to check your skin for signs of cancer.

If you have hepatitis B or C you may develop liver symptoms while taking this medicine. Your doctor may want to check your liver function before and during your treatment with tofacitinib.

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

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

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

What should I avoid while taking tofacitinib?

Do not receive a "live" vaccine while using tofacitinib, and avoid coming into contact with anyone who has recently received a live vaccine. There is a chance that the virus could be passed on to you. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

Grapefruit and grapefruit juice may interact with tofacitinib and lead to unwanted side effects. Discuss the use of grapefruit products with your doctor.

What are the possible side effects of tofacitinib?

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

Serious and sometimes fatal infections may occur during treatment with tofacitinib. Stop using this medicine and call your doctor right away if you have signs of infection such as:

  • fever, chills, tired feeling, night sweats;
  • stomach pain, loss of appetite, diarrhea, weight loss, or a change in your bowel habits;
  • pain or burning when you urinate;
  • body aches, sore throat, cough, flu symptoms, sores in your mouth and throat;
  • stabbing chest pain, wheezing, feeling short of breath, cough with mucus or blood; or
  • skin redness and swelling.

Tofacitinib may also cause severe liver symptoms. Call your doctor at once if you have any of these liver symptoms:

  • low fever, itching, tiredness;
  • upper stomach pain, loss of appetite;
  • dark urine, clay-colored stools; or
  • jaundice (yellowing of the skin or eyes).

Common side effects may include:

  • 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.

What other drugs will affect tofacitinib?

Many drugs can interact with tofacitinib. Not all possible interactions are listed here. Tell your doctor about all your medications and any you start or stop using during treatment with tofacitinib, especially:

  • aprepitant, bosentan, haloperidol, imatinib, St. John's wort, ticlopidine;
  • an antibiotic --ciprofloxacin, doxycycline, erythromycin, metronidazole, norfloxacin, tetracycline;
  • an antidepressant --desipramine, fluoxetine, sertraline;
  • antifungal medicine --clotrimazole, fluconazole, voriconazole;
  • heart or blood pressure medicine --amiodarone, diltiazem, dronedarone, lidocaine, verapamil;
  • HIV/AIDS medication --atazanavir, efavirenz, darunavir when given with ritonavir, fosamprenavir, nevirapine, saquinavir;
  • medicines to prevent organ transplant rejection --azathioprine, cyclosporine, tacrolimus;
  • other arthritis medicines --abatacept, adalimumab, anakinra, certolizumab, etanercept, golimumab, infliximab, rituximab, tocilizumab;
  • seizure medicine --carbamazepine, fosphenytoin, oxcarbazepine, phenobarbital, phenytoin, primidone;
  • a stomach acid-reducer --cimetidine, esomeprazole, omeprazole; or
  • tuberculosis medicine --rifabutin, rifampin, rifapentine.

This list is not complete and many other drugs can interact with tofacitinib. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Give a list of all your medicines to any healthcare provider who treats you.

Where can I get more information?

Your pharmacist can provide more information about tofacitinib.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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