Xeljanz

Generic Name: tofacitinib (TOE fa SYE ti nib)
Brand Names: Xeljanz

What is Xeljanz?

Xeljanz (tofacitinib) works by blocking certain enzymes in the body that affect immune system function.

Xeljanz 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 medications.

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

Important information

Xeljanz is used to treat moderate to severe rheumatoid arthritis in adults who have tried methotrexate without successful treatment of symptoms.

You should not use Xeljanz if you have severe liver disease.

Stop using Xeljanz 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.

Slideshow: Drug Treatment for Rheumatoid Arthritis - What Are Your Options?

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

Do not receive a "live" vaccine while using Xeljanz, 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.

Before taking this medicine

You should not use Xeljanz if you are allergic to tofacitinib, or if you have severe liver disease.

To make sure Xeljanz 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;

  • an infected skin wound;

  • diabetes;

  • liver disease (especially hepatitis B or C);

  • kidney disease;

  • HIV or AIDS;

  • 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;

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.

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

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

FDA pregnancy category C. It is not known whether Xeljanz will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

See also: Pregnancy and breastfeeding warnings (in more detail)

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 Xeljanz 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 Xeljanz?

Take Xeljanz exactly as prescribed by your doctor. 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 Xeljanz with or without food.

You may need frequent medical tests at your doctor's office to be sure this medication is not causing harmful effects. Your treatments may be delayed based on the results of these tests.

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

Store Xeljanz in its 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?

Do not receive a "live" vaccine while using Xeljanz, 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 Xeljanz and lead to unwanted side effects. Discuss the use of grapefruit products with your doctor.

Xeljanz side effects

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

Serious and sometimes fatal infections may occur during treatment with Xeljanz. 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, 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.

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

  • low fever, itching;

  • upper stomach pain, loss of appetite;

  • dark urine, clay-colored stools; or

  • jaundice (yellowing of the skin or eyes).

Common Xeljanz side effects may include:

  • headache; or

  • mild cold symptoms such as runny or stuffy nose.

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.

See also: Side effects (in more detail)

What other drugs will affect Xeljanz?

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

  • aprepitant;

  • bosentan;

  • conivaptan;

  • haloperidol;

  • imatinib;

  • isoniazid;

  • St. John's wort;

  • ticlopidine;

  • an antibiotic--nafcillin, clarithromycin, telithromycin, ciprofloxacin, doxycycline, erythromycin, metronidazole, norfloxacin, rifabutin, rifapentine, rifampin, tetracycline;

  • an antidepressant--fluoxetine, nefazodone, desipramine, sertraline;

  • antifungal medication--clotrimazole, fluconazole, voriconazole, itraconazole, ketoconazole, posaconazole, voriconazole;

  • the hepatitis C medications boceprevir or telaprevir;

  • heart or blood pressure medicine--diltiazem, verapamil, nicardipine, quinidine, amiodarone, dronedarone, lidocaine;

  • HIV or AIDS medicine--efavirenz, darunavir when given with ritonavir, saquinavir, atazanavir, delavirdine, fosamprenavir, indinavir, nelfinavir, nevirapine, ritonavir, saquinavir;

  • medication to treat excess stomach acid--cimetidine, esomeprazole, omeprazole;

  • medicines to prevent organ transplant rejection--azathioprine, cyclosporine, tacrolimus;

  • NSAIDs (non-steroidal anti-inflammatory drugs) such as ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others;

  • other arthritis medications--abatacept, adalimumab, anakinra, certolizumab, etanercept, golimumab, infliximab, methotrexate, rituximab, tocilizumab;

  • seizure medication--carbamazepine, fosphenytoin, oxcarbazepine, phenobarbital, phenytoin, primidone; or

  • steroid medicine--prednisone and others.

This list is not complete and many other drugs can interact with Xeljanz. 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 Xeljanz.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Xeljanz only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2014 Cerner Multum, Inc. Version: 1.01. Revision Date: 2013-02-12, 2:41:54 PM.

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