Uses of Tofacitinib Extended-Release Tablets:

• It is used to treat some types of arthritis.
• It is used to treat ulcerative colitis.

What do I need to tell my doctor BEFORE I take Tofacitinib Extended-Release Tablets?

• If you are allergic to this medicine (tofacitinib extended-release tablets); any part of this medicine (tofacitinib extended-release tablets); or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have any of these health problems: Kidney disease or liver disease.
• If you have anemia.
• If you have an infection or a low white blood cell count.
• If you are taking rifampin.
• If you are taking any of these drugs: Abatacept, adalimumab, anakinra, certolizumab, etanercept, golimumab, infliximab, rituximab, secukinumab, tocilizumab, ustekinumab, or vedolizumab.
• If you are taking any drugs used to suppress your immune system like azathioprine or cyclosporine. There are many drugs that can do this. Ask your doctor or pharmacist if you are not sure.
• If you are breast-feeding. Do not breast-feed while you take this medicine (tofacitinib extended-release tablets) and for at least 36 hours after your last dose.

This is not a list of all drugs or health problems that interact with this medicine (tofacitinib extended-release tablets).

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine (tofacitinib extended-release tablets) with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Tofacitinib Extended-Release Tablets?

• Tell all of your health care providers that you take this medicine (tofacitinib extended-release tablets). This includes your doctors, nurses, pharmacists, and dentists.
• Some viral infections like herpes zoster have become active again with this medicine (tofacitinib extended-release tablets). Tell your doctor if you have ever had a viral infection like herpes zoster. Talk with your doctor.
• Hepatitis B or C testing may be done. A hepatitis B or C infection may get worse while taking this medicine (tofacitinib extended-release tablets).
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• High cholesterol has happened with this medicine (tofacitinib extended-release tablets). If you have questions, talk with the doctor.
• You may need to have your skin checked while you take this medicine (tofacitinib extended-release tablets). Talk with your doctor.
• If you drink grapefruit juice or eat grapefruit often, talk with your doctor.
• This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take this medicine (tofacitinib extended-release tablets).
• Make sure you are up to date with all your vaccines before treatment with this medicine (tofacitinib extended-release tablets).
• Talk with your doctor before getting any vaccines. Use of some vaccines with this medicine (tofacitinib extended-release tablets) may either raise the chance of an infection or make the vaccine not work as well.
• You may have more chance of getting an infection. Wash hands often. Stay away from people with infections, colds, or flu.
• If you have high blood sugar (diabetes), talk with your doctor. You may be more likely to get infections.
• This medicine may be used with other drugs to treat your health condition. If you are also taking other drugs, talk with your doctor about the risks and side effects that may happen.
• If you are 65 or older, use this medicine (tofacitinib extended-release tablets) with care. You could have more side effects.
• You may see the tablet shell in your stool. This is normal and not a cause for concern.
• This medicine may cause fertility problems. This may affect being able to have children. It is not known if this will go back to normal. If you have questions, talk with your doctor.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine (tofacitinib extended-release tablets) while you are pregnant.

How is this medicine (Tofacitinib Extended-Release Tablets) best taken?

Use this medicine (tofacitinib extended-release tablets) as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take with or without food.
• Keep taking this medicine (tofacitinib extended-release tablets) as you have been told by your doctor or other health care provider, even if you feel well.
• Do not take more than what your doctor told you to take. Taking more than you are told may raise your chance of very bad side effects.
• If you are on dialysis and are taking this medicine (tofacitinib extended-release tablets) on the day you get dialysis, take it after your dialysis. If you have questions, talk with your doctor.
• Swallow whole. Do not chew, break, or crush.

What do I do if I miss a dose?

• Skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
• Signs of infection like fever, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or wound that will not heal.
• Warm, red, or painful skin or sores on the body.
• Shingles.
• Change in color or size of a mole.
• A skin lump or growth.
• Feeling very tired or weak.
• Change in bowel habits.
• Muscle pain or weakness.
• Slow heartbeat.
• A heartbeat that does not feel normal.
• Call your doctor right away if you have a swollen gland, night sweats, shortness of breath, or weight loss without trying.
• Tears in the stomach or bowel wall have happened in certain people taking this medicine (tofacitinib extended-release tablets). Call your doctor right away if you have swelling or pain in your stomach that is very bad, gets worse, or does not go away. Call your doctor right away if you throw up blood or have throw up that looks like coffee grounds; upset stomach or throwing up that does not go away; or black, tarry, or bloody stools.
• Some people have had lung problems with this medicine (tofacitinib extended-release tablets). Sometimes, this has been deadly. Call your doctor right away if you have signs of lung problems like shortness of breath or other trouble breathing, cough that is new or worse, or fever.

What are some other side effects of Tofacitinib Extended-Release Tablets?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Headache.
• Diarrhea.
• Signs of a common cold.
• Nose or throat irritation.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If OVERDOSE is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Tofacitinib Extended-Release Tablets?

• Store in the original container at room temperature.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Consumer Information Use and Disclaimer

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time this medicine (tofacitinib extended-release tablets) is refilled. If you have any questions about this medicine (tofacitinib extended-release tablets), please talk with the doctor, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

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