Tofacitinib Extended-release Tablets

What is this medication?

TOFACITINIB (TOE fa SYE it nib) treats rheumatoid arthritis, psoriatic arthritis, and polyarticular juvenile idiopathic arthritis. It is also used to treat ankylosing spondylitis and ulcerative colitis. It works on the immune system. It belongs to a group of medicines called JAK inhibitors.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Xeljanz XR

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• blood clots
• cancer
• diabetes (high blood sugar)
• heart disease
• high blood pressure
• high cholesterol
• HIV or AIDS
• immune system problems
• infection especially a virus infection such as chickenpox, cold sores, hepatitis B or herpes
• infection such as tuberculosis (TB) or other bacterial, fungal or viral infections
• kidney disease
• liver disease
• low blood counts (white cells, platelets, or red blood cells)
• lung or breathing disease (asthma, COPD)
• organ transplant
• smoke tobacco cigarettes
• stomach or intestine problems
• an unusual or allergic reaction to tofacitinib, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medication?

Take this medicine by mouth with water. Take it as directed on the prescription label at the same time every day. Do not cut, crush or chew this medicine. Swallow the tablets whole. You can take it with or without food. If it upsets your stomach, take it with food. Keep taking it unless your health care provider tells you to stop.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your health care provider about the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medication?

Do not take this medicine with any of the following medications:

• upadacitinib

This medicine may also interact with the following medications:

• antiviral medicines for hepatitis, HIV or AIDS
• azathioprine
• biologic medicines such as abatacept, adalimumab, anakinra, certolizumab, etanercept, golimumab, infliximab, ofatumumab, rituximab, sarilumab, secukinumab, tocilizumab, ustekinumab, vedolizumab
• certain medicines for fungal infections like fluconazole, itraconazole, ketoconazole, voriconazole
• certain medicines for seizures like carbamazepine, phenobarbital, phenytoin
• cyclosporine
• live vaccines
• medicines that lower your chance of fighting infection
• rifampin
• supplements, such as St. John's wort
• tacrolimus

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your health care provider for regular checks on your progress. Tell your health care provider if your symptoms do not start to get better or if they get worse.

You may need blood work while you are taking this medicine.

The tablet shell of this medicine does not dissolve. This is normal. The tablet shell may appear whole in the stool. This is not a cause for concern.

This medicine may increase your risk of getting an infection. Call your health care provider for advice if you get a fever, chills, sore throat, or other symptoms of a cold or flu. Do not treat yourself. Try to avoid being around people who are sick.

Avoid taking medicines that contain aspirin, acetaminophen, ibuprofen, naproxen, or ketoprofen unless instructed by your health care provider. These medicines may hide a fever.

Talk to your health care provider about your risk of cancer. You may be more at risk for certain types of cancer if you take this medicine.

Do not become pregnant while taking this medicine. Women should inform their health care provider if they wish to become pregnant or think they might be pregnant. There is potential for serious harm to an unborn child. Talk to your health care provider for more information.

Do not breast-feed an infant while taking this medicine or for at least 36 hours after stopping it.

What side effects may I notice from receiving this medication?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions (skin rash, itching or hives; swelling of the face, lips, or tongue)
• blood clot (chest pain; shortness of breath; pain, swelling, or warmth in the leg)
• heart attack (trouble breathing; pain or tightness in the chest, neck, back or arms; unusually weak or tired)
• infection (fever, chills, cough, sore throat, pain or trouble passing urine)
• light colored stool
• liver injury (dark yellow or brown urine; general ill feeling or flu-like symptoms; loss of appetite, right upper belly pain; unusually weak or tired, yellowing of the eyes or skin)
• low red blood cell counts (trouble breathing; feeling faint; lightheaded, falls; unusually weak or tired)
• stroke (changes in vision; confusion; trouble speaking or understanding; severe headaches; sudden numbness or weakness of the face, arm or leg; trouble walking; dizziness; loss of balance or coordination)
• tears in the stomach or intestines (fever; stomach pain; sudden change in bowel habits)

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• diarrhea
• headache
• muscle pain
• nasal congestion (runny or stuffy nose)

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Get rid of any unused medicine after the expiration date.

To get rid of medicines that are no longer needed or have expired:

• Take the medicine to a medicine take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medicine, check the label or package insert to see if the medicine should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your health care provider. If it is safe to put it in the trash, empty the medicine out of the container. Mix the medicine with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.