TOFACITINIB

(TOE fa SYE ti nib) Brand: Xeljanz

What is the most significant information I must know about tofacitinib?

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

• You must not use tofacitinib if you have severe liver disease.

Stop using this medication 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.

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 till and during your treatment with 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.

What is tofacitinib?

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

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

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

What must I discuss with my healthcare provider till taking tofacitinib?

• You must not use tofacitinib if you are allergic to it, or if you have severe liver disease.

• To create certain tofacitinib is safety for you, speak 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 malady (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 malady or by using determined 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.

Tofacitinib may magnify your risk of determined cancers by changing the way your immune system works. If you have had a kidney transplant, tofacitinib may reason your body to manufacture too many of a determined type of white blood cell.

• Till you start treatment with tofacitinib, your doctor may perform trials to create certain you do not have tuberculosis or another infections.

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

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

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

How must I take tofacitinib?

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

• You may take tofacitinib with or without food.

• You may need frequent medical trials at your doctor's office to be certain this medicine is not causing deleterious 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 till and during your treatment with tofacitinib.

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

What happens if I miss a dose?

• Take the missed doze as soon as you remember. Skip the missed doze if it is nearly time for your following scheduled doze. Do not take extra medication to create up the missed dose.

What happens if I overdose?

• Search abnormal medical attention or call the Poison Help line at 1-800-222-1222.

What must 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 commodity with your doctor.

What are the possible side effects of tofacitinib?

• Get abnormal medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your person, lips, tongue, or throat.

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

· fever, chills, weary 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.

Tofacitinib may also reason 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).

• General side effects may include:

· headache; or

· mild cool 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 message side effects to FDA at 1-800-FDA-1088.

What another drugs will affect tofacitinib?

• Much drugs can interact with tofacitinib. Not all possible interactions are listed here. Speak your doctor about all your medications and any you start or stop using during treatment with tofacitinib, 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;

· medicine 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;

· another 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 much another drugs can interact with tofacitinib. This includes prescription and over-the-counter medicines, vitamins, and herbal commodity. 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, hold this and all another medicines out of the reach of children, never share your medicines with others, and use this medicine only for the indication prescribed.

Disclaim: Each 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 external 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 must be construed to indicate that the drug or drug combination is safety, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the help 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.

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