Tofacitinib, Oral

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KEY POINTS

• This medicine is taken by mouth to treat rheumatoid arthritis. Take it exactly as directed.
• This medicine increases your risk for serious or life-threatening infections. Contact your healthcare provider right away if you develop a fever or ANY other symptoms of infection. Keep all appointments for tests to see how this medicine affects you.
• This medicine may cause unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: Janus kinase inhibitor

Generic and brand names: tofacitinib, oral; Xeljanz; Xeljanz XR

What is this medicine used for?

This medicine is taken by mouth to treat rheumatoid arthritis. It may be used alone or along with other medicines.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine, to benzyl alcohol, or to yeast
• A weakened immune system from cancer treatment, diseases such as HIV/AIDS, or from taking steroid medicines or medicines to prevent organ transplant rejection
• Diabetes
• Diverticulitis or ulcers
• Liver disease such as hepatitis B or C
• Kidney disease
• Tuberculosis (TB), a positive skin test for TB, or close contact with someone who has TB (your healthcare provider may give you a skin test to check for this).

Tell your healthcare provider if you currently have an infection such as the flu or an open cut or sore, or if you often have infections that come back. Also, tell your healthcare provider if you have recently received or are scheduled to receive a vaccine.

Females of childbearing age: Talk with your healthcare provider if you are pregnant or plan to become pregnant. It is not known whether this medicine will harm an unborn baby. Do not breast-feed while taking this medicine without your healthcare provider's approval.

How do I take it?

Read the Medication Guide that comes in the medicine package when you start taking this medicine and each time you get a refill.

Check the label on the medicine for directions about your specific dose. Take this medicine exactly as your healthcare provider prescribes. Do not take more or less than prescribed. Your healthcare provider may adjust your dose based on your lab tests. Do not stop taking this medicine without your healthcare provider's approval.

Check with your healthcare provider before using this medicine in children under age 18.

This medicine may come in different forms. If you have extended-release tablets, do not break, crush, or chew them. Swallow them whole. Ask your pharmacist if you have the extended-release tablets.

You may take this medicine with or without food. Taking it with meals may lessen the chance the drug will upset your stomach.

What if I miss a dose?

If you miss a dose, take it as soon as you remember unless it is almost time for the next scheduled dose. In that case, skip the missed dose and take the next one as directed. Do not take double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose have not been reported.

What should I watch out for?

This medicine increases your risk for serious or life-threatening infections. Stay away from people with colds, flu, or other infections. Contact your healthcare provider right away if you develop a fever or ANY other symptoms of infection. Also, do not have any vaccines without getting your healthcare provider's approval first.

Your healthcare provider will check you regularly while you are receiving this medicine. You will need blood tests to see how this medicine affects you. Keep all appointments.

This medicine may increase your risk for lymphoma, leukemia, skin cancer, or immune system problems. Talk to your healthcare provider about this.

If you have extended-release tablets, you may see partially digested tablets in your bowel movements. This is not harmful.

Adults over the age of 65 may be at greater risk for side effects, such as infections. Talk with your healthcare provider about this.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you have received this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): Signs of infection such as fever, chills, sore throat, runny or stuffy nose, cough; unusual tiredness or weakness; shortness of breath; skin sores, rash, or blisters; severe nausea or vomiting; severe stomach pain; bloody diarrhea; black, tarry bowel movements; pain or burning with urinating; urinating more often than normal; yellowing of your skin or eyes; dark urine; light-colored bowel movements; unexplained loss of appetite or weight loss.

Other: headache, mild diarrhea, trouble sleeping.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Antibiotics such as chloramphenicol, clarithromycin (Biaxin), erythromycin (E.E.S., Ery-Tab, Erythrocin), isoniazid, metronidazole, nafcillin, rifabutin (Mycobutin), rifampin (Rifadin), rifapentine (Priftin), and telithromycin (Ketek)
• Antifungal medicines such as clotrimazole, fluconazole (Diflucan), itraconazole (Sporanox), ketoconazole (Nizoral), miconazole (Monistat, Oravig), posaconazole (Noxafil), and voriconazole (Vfend)
• Antiseizure medicines such as carbamazepine (Carbatrol, Epitol, Equetro, Tegretol), phenytoin (Dilantin, Phenytek), and primidone (Mysoline)
• Aprepitant (Emend)
• Barbiturates such as butabarbital (Butisol), pentobarbital (Nembutal), phenobarbital, and secobarbital (Seconal)
• Bosentan (Tracleer)
• Cancer medicines such as abiraterone (Zytiga), crizotinib (Xalkori), dabrafenib (Tafinlar), enzalutamide (Xtandi), and imatinib (Gleevec)
• Cimetidine (Tagamet)
• Conivaptan (Vaprisol)
• Corticosteroids such as betamethasone, cortisone, dexamethasone, fludrocortisone, hydrocortisone (A-Hydrocort, Cortef), methylprednisolone (Medrol, Solu-Medrol), prednisolone (Omnipred, Orapred, Prelone), prednisone (Prednisone Intensol), and triamcinolone (Aristospan, Kenalog)
• Heart medicines such as amiodarone (Cordarone, Pacerone), diltiazem (Cardizem, Cartia, Tiazac), dronedarone (Multaq), nicardipine (Cardene), and verapamil (Calan, Covera, Verelan)
• Heart medicines such as amiodarone (Cordarone, Pacerone), diltiazem (Cardizem, Cartia, Tiazac), dronedarone (Multaq), nicardipine (Cardene), and verapamil (Calan, Covera, Verelan)
• HIV medicines such as atazanavir (Reyataz), cobicistat (Tybost), darunavir (Prezista), delavirdine (Rescriptor), efavirenz (Sustiva), elvitegravir/cobicistat/emtricitabine/tenofovir (Stribild), etravirine (Intelence), fosamprenavir (Lexiva), indinavir (Crixivan), lopinavir/ritonavir (Kaletra), nelfinavir (Viracept), nevirapine (Viramune), ritonavir (Norvir), and saquinavir (Invirase)
• Immunosuppressants such as azathioprine (Azasan, Imuran), cyclosporine (Gengraf, Neoral, Sandimmune), mycophenolate (CellCept, Myfortic), sirolimus (Rapamune), and tacrolimus (Astagraf, Prograf, Protopic)
• Medicines to treat psoriasis, rheumatoid arthritis, and other immune disorders such as abatacept (Orencia), adalimumab (Humira), anakinra (Kineret), certolizumab (Cimzia), etanercept (Enbrel), golimumab (Simponi), infliximab (Remicade), rituximab (Rituxan), and tocilizumab (Actemra)
• Natalizumab (Tysabri)
• Nefazodone
• Nonsteroidal anti-inflammatory medicines (NSAIDs) such as aspirin, diclofenac (Cambia, Cataflam, Voltaren, Zipsor), ibuprofen (Advil, Motrin), indomethacin (Indocin), ketoprofen, ketorolac, nabumetone (Relafen), naproxen (Aleve, Anaprox, Naprelan), oxaprozin (Daypro), piroxicam (Feldene), and sulindac (Clinoril)
• St. John's wort
• Stimulants such as armodafinil (Nuvigil) and modafinil (Provigil)
• Vaccines

Ask your healthcare provider or pharmacist if you need to avoid products that contain grapefruit, Seville oranges, or tangelos while you are taking this medicine. These fruits and juices can affect the way this medicine works and may increase your risk of serious side effects.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Keep all medicines out of the reach of children.

Do not share medicines with other people.