Tofacitinib

The most important thing to know

Tofacitinib extended-release tablets may cause serious side effects including: 1. Serious infections. Tofacitinib extended-release tablets are medicines that affect your immune system. Tofacitinib can lower the ability of your immune system to fight infections. Some people can have serious infections while taking tofacitinib extended-release tablets, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses that can spread throughout the body.

Some people have died from these infections. Your healthcare provider should test you for TB before starting tofacitinib extended-release tablets and during treatment. Your healthcare provider should monitor you closely for signs and symptoms of TB infection during treatment with tofacitinib extended-release tablets. You should not start taking tofacitinib extended-release tablets if you have any kind of infection unless your healthcare provider tells you it is okay.

You may be at a higher risk of developing shingles (herpes zoster). Before starting tofacitinib extended-release tablets, tell your healthcare provider if you: think you have an infection or have symptoms of an infection such as: o fever, sweating, or chills o cough o blood in phlegm o warm, red, or painful skin or sores on your body o burning when you urinate or urinating more often than normal o muscle aches o shortness of breath o weight loss o diarrhea or stomach pain o feeling very tired are being treated for an infection.

get a lot of infections or have infections that keep coming back. have diabetes, chronic lung disease, HIV, or a weak immune system. People with these conditions have a higher chance for infections. have TB, or have been in close contact with someone with TB. live or have lived, or have traveled to certain parts of the country (such as the Ohio and Mississippi River valleys and the Southwest) where there is an increased chance for getting certain kinds of fungal infections (histoplasmosis, coccidioidomycosis, or blastomycosis).

These infections may happen or become more severe if you take tofacitinib extended-release tablets. Ask your healthcare provider if you do not know if you have lived in an area where these infections are common. have or have had hepatitis B or C. After starting tofacitinib extended-release tablets, call your healthcare provider right away if you have any symptoms of an infection.

Tofacitinib extended-release tablets can make you more likely to get infections or make worse any infection that you have. 2. Increased risk of death in people 50 years of age and older who have at least 1 heart disease (cardiovascular) risk factor and are taking tofacitinib tablets 5 mg or 10 mg twice daily. 3. Cancer and immune system problems.

Tofacitinib extended-release tablets may increase your risk of certain cancers by changing the way your immune system works. Lymphoma and other cancers including skin cancers can happen in people taking tofacitinib extended-release tablets. People taking tofacitinib tablets 5 mg twice daily or tofacitinib tablets 10 mg twice daily have a higher risk of certain cancers including lymphoma and lung cancer, especially if you are a current or past smoker.

Tell your healthcare provider if you have ever had any type of cancer. Some people who have taken tofacitinib with certain other medicines to prevent kidney transplant rejection have had a problem with certain white blood cells growing out of control (Epstein Barr Virus-associated post-transplant lymphoproliferative disorder).

4. Increased risk of major cardiovascular events such as heart attack, stroke or death in people 50 years of age and older who have at least 1 heart disease (cardiovascular) risk factor and are taking tofacitinib tablets 5 mg or 10 mg twice daily, especially if you are a current or past smoker. Get emergency help right away if you have any symptoms of a heart attack or stroke while taking tofacitinib extended-release tablets, including: discomfort in the center of you

How to take it

Take tofacitinib extended-release tablets exactly as your healthcare provider tells you to take it. Take tofacitinib extended-release tablets 1 time a day with or without food. Swallow tofacitinib extended-release tablets whole and intact. Do not crush, split, or chew. When you take tofacitinib extended-release tablets, you may see something in your stool that looks like a tablet.

This is the empty shell from the tablet after the medicine has been absorbed by your body. If you take too much tofacitinib extended-release tablets, call your healthcare provider or go to the nearest hospital emergency room right away. For the treatment of psoriatic arthritis, take tofacitinib extended-release tablets in combination with methotrexate, sulfasalazine or leflunomide as instructed by your healthcare provider.

Tofacitinib extended-release tablets should not be used instead of XELJANZ oral solution. What are the possible side effects of tofacitinib extended-release tablets? Tofacitinib extended-release tablets may cause serious side effects, including: Hepatitis B or C activation infection in people who carry the virus in their blood.

If you are a carrier of the hepatitis B or C virus (viruses that affect the liver), the virus may become active while you use tofacitinib extended-release tablets. Your healthcare provider may do blood tests before you start treatment with tofacitinib extended-release tablets and while you are taking tofacitinib extended-release tablets.

Tell your healthcare provider if you have any of the following symptoms of a possible hepatitis B or C infection: o feel very tired o little or no appetite o clay-colored bowel movements o chills o muscle aches o skin rash o skin or eyes look yellow o vomiting o fevers o stomach discomfort o dark urine Common side effects of tofacitinib extended-release tablets in people with rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis include: upper respiratory tract infections (common cold, sinus infections) headache diarrhea nasal congestion, sore throat, and runny nose (nasopharyngitis) high blood pressure (hypertension) acne Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of tofacitinib extended-release tablets. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Ajanta Pharma USA Inc. at 855-664-7744.

Side effects, and when to stop

” for more information about side effects. What are tofacitinib extended-release tablets? Tofacitinib extended-release tablets are a prescription medicine called a Janus kinase (JAK) inhibitor. Tofacitinib extended-release tablets are used to treat adults with moderately to severely active rheumatoid arthritis when 1 or more medicines called tumor necrosis factor (TNF) blockers have been used and did not work well or cannot be tolerated.

Tofacitinib extended-release tablets are used to treat adults with active psoriatic arthritis when 1 or more TNF blocker medicines have been used, and did not work well or cannot be tolerated. Tofacitinib extended-release tablets are used to treat adults with active ankylosing spondylitis when 1 or more TNF blocker medicines have been used and did not work well or cannot be tolerated.

It is not known if tofacitinib extended-release tablets are safe and effective in people with Hepatitis B or C. Tofacitinib extended-release tablets are not recommended for people with severe liver problems. It is not known if tofacitinib extended-release tablets are safe and effective in children.

What to say before you start

Before taking tofacitinib extended-release tablets, tell your healthcare provider about all of your medical conditions, including if you: have an infection. are a current or past smoker. have had any type of cancer. have had a heart attack, other heart problems or stroke. have had blood clots in the veins of your legs, arms, or lungs, or clots in the arteries in the past.

have liver problems. have kidney problems. have any stomach area (abdominal) pain or been diagnosed with diverticulitis or ulcers in your stomach or intestines. have had a reaction to tofacitinib or any of the ingredients in tofacitinib extended-release tablets. have recently received or are scheduled to receive a vaccine.

People who take tofacitinib extended-release tablets should not receive live vaccines. People taking tofacitinib extended-release tablets can receive non-live vaccines. plan to become pregnant or are pregnant. Tofacitinib extended-release tablets may affect the ability of females to get pregnant. It is not known if this will change after stopping tofacitinib extended-release tablets.

It is not known if tofacitinib extended-release tablets will harm an unborn baby. plan to breastfeed or are breastfeeding. You and your healthcare provider should decide if you will take tofacitinib extended-release tablets or breastfeed. You should not do both. After you stop your treatment with tofacitinib extended-release tablets do not start breastfeeding again until: 36 hours after your last dose of tofacitinib extended-release tablets Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Tofacitinib extended-release tablets and other medicines may affect each other causing side effects. Especially tell your healthcare provider if you take: any other medicines to treat your rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis. You should not take tocilizumab (Actemra), etanercept (Enbrel), adalimumab (Humira), infliximab (Remicade), rituximab (Rituxan), abatacept (Orencia), anakinra (Kineret), certolizumab (Cimzia), golimumab (Simponi), ustekinumab (Stelara), secukinumab (Cosentyx), vedolizumab (Entyvio), ixekizumab (Taltz), azathioprine, cyclosporine, or other immunosuppressive drugs while you are taking tofacitinib extended-release tablets.

Taking tofacitinib extended-release tablets with these medicines may increase your risk of infection. medicines that affect the way certain liver enzymes work. Ask your healthcare provider if you are not sure if your medicine is one of these. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

Storing it

Tofacitinib extended-release tablets comes in a child-resistant package. Store tofacitinib extended-release tablets at room temperature between 68°F to 77°F (20°C to 25°C). Keep tofacitinib extended-release tablets and all medicines out of the reach of children.