Medication Guide
Tofacitinib (toe" fa sye' ti nib) Extended-Release Tablets, for oral use
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What is the most important information I should know about tofacitinib extended-release tablets?
Tofacitinib extended-release tablets may cause serious side effects including:
1. Serious infections.
Tofacitinib extended-release tablet is a medicine that affects your immune system. Tofacitinib extended-release tablets 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).
People taking the higher dose of tofacitinib (10 mg twice daily) or tofacitinib extended-release tablets (22 mg one time each day) have a higher risk of serious infections and shingles.
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:
○ fever, sweating, or chills
○ cough
○ blood in phlegm
○ warm, red, or painful skin or sores on your body
○ burning when you urinate or urinating more often than normal
○ muscle aches
○ shortness of breath
○ weight loss
○ diarrhea or stomach pain
○ 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 use 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 with rheumatoid arthritis who have at least 1 heart disease (cardiovascular) risk factor and who are taking a higher than recommended dose of tofacitinib extended-release tablets. The recommended dose in patients with rheumatoid arthritis and psoriatic arthritis is tofacitinib extended-release tablets 11 mg one time each day.
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 patients taking tofacitinib extended-release tablets. People taking the higher dose of tofacitinib (10 mg twice daily) or tofacitinib extended-release tablets (22 mg one time each day) have a higher risk of skin cancers. 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. Blood clots in the lungs, veins of the legs or arms, and arteries. Blood clots in the lungs (pulmonary embolism, PE), veins of the legs (deep vein thrombosis, DVT) and arteries (arterial thrombosis) have happened more often in patients with rheumatoid arthritis who are 50 years of age and older and with at least 1 heart disease (cardiovascular) risk factor taking a higher than recommended dose of tofacitinib extended-release tablets. The recommended dose in patients with rheumatoid arthritis and psoriatic arthritis is tofacitinib extended-release tablets 11 mg one time each day. Blood clots in the lungs have also happened in patients with ulcerative colitis. Some people have died from these blood clots.
- Stop taking tofacitinib extended-release tablets and tell your healthcare provider right away if you develop signs and symptoms of a blood clot, such as sudden shortness of breath or difficulty breathing, chest pain, swelling of the leg or arm, leg pain or tenderness, or redness or discoloration in the leg or arm.
5. Tears (perforation) in the stomach or intestines.
- Tell your healthcare provider if you have had diverticulitis (inflammation in parts of the large intestine) or ulcers in your stomach or intestines. Some people taking tofacitinib extended-release tablets can get tears in their stomach or intestines. This happens most often in people who also take nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroids, or methotrexate.
Tell your healthcare provider right away if you have fever and stomach-area pain that does not go away, and a change in your bowel habits.
6. Allergic reactions.
- Symptoms such as swelling of your lips, tongue, or throat, or hives (raised, red patches of skin that are often very itchy) that may mean you are having an allergic reaction have been seen in patients taking tofacitinib extended-release tablets. Some of these reactions were serious. If any of these symptoms occur while you are taking tofacitinib extended-release tablets, stop tofacitinib extended-release tablets and call your healthcare provider right away.
7. Changes in certain laboratory test results. Your healthcare provider should do blood tests before you start receiving tofacitinib extended-release tablets and while you take tofacitinib extended-release tablets to check for the following side effects:
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changes in lymphocyte counts. Lymphocytes are white blood cells that help the body fight off infections.
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low neutrophil counts. Neutrophils are white blood cells that help the body fight off infections.
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low red blood cell count. This may mean that you have anemia, which may make you feel weak and tired.
Your healthcare provider should routinely check certain liver tests.
You should not receive tofacitinib extended-release tablets if your lymphocyte count, neutrophil count, or red blood cell count is too low or your liver tests are too high.
Your healthcare provider may stop your tofacitinib extended-release tablets treatment for a period of time if needed because of changes in these blood test results.
You may also have changes in other laboratory tests, such as your blood cholesterol levels. Your healthcare provider should do blood tests to check your cholesterol levels 4 to 8 weeks after you start receiving tofacitinib extended-release tablets, and as needed after that. Normal cholesterol levels are important to good heart health.
See "What are the possible side effects of tofacitinib extended-release tablets?" for more information about side effects.
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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 in whom methotrexate did not work well or cannot be tolerated.
Tofacitinib extended-release tablets are used to treat adults with active psoriatic arthritis in which methotrexate or other similar medicines called nonbiologic disease-modifying antirheumatic drugs (DMARDs) did not work well or cannot be tolerated.
Tofacitinib extended-release tablets are used to treat adults with moderately to severely active
ulcerative colitis when medicines called tumor necrosis factor (TNF) blockers 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.
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What should I tell my healthcare provider before taking tofacitinib extended-release tablets?
Before taking tofacitinib extended-release tablets, tell your healthcare provider about all of your medical conditions, including if you:
- have an infection. See "What is the most important information I should know about tofacitinib extended-release tablets?"
- 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 ulcerative colitis. 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®), 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.
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How should I take tofacitinib extended-release tablets? 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.
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What are possible side effects of tofacitinib extended-release tablets?
Tofacitinib extended-release tablets may cause serious side effects, including:
- See "What is the most important information I should know about tofacitinib extended-release tablets?"
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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 using tofacitinib extended-release tablets. Tell your healthcare provider if you have any of the following symptoms of a possible hepatitis B or C infection:
○ feel very tired
○ little or no appetite
○ clay-colored bowel movements
○ chills
○ muscle aches
○ skin rash
○ skin or eyes look yellow
○ vomiting
○ fevers
○ stomach discomfort
○ dark urine
Common side effects of tofacitinib extended-release tablets in rheumatoid arthritis patients and psoriatic arthritis patients include:
- upper respiratory tract infections (common cold, sinus infections)
- headache
- diarrhea
- nasal congestion, sore throat, and runny nose (nasopharyngitis)
- high blood pressure (hypertension)
Common side effects of tofacitinib extended-release tablets in ulcerative colitis patients include:
- nasal congestion, sore throat, and runny nose (nasopharyngitis)
- increased cholesterol levels
- headache
- upper respiratory tract infections (common cold, sinus infections)
- increased muscle enzyme levels
- rash
- diarrhea
- shingles (herpes zoster)
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 Zydus Pharmaceuticals (USA) Inc. at 1-877-993-8779.
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How should I store tofacitinib extended-release tablets?
- Store tofacitinib extended-release tablets at room temperature between 68°F to 77°F (20°C to 25°C) [see USP Controlled Room Temperature].
- Safely throw away medicine that is out of date or no longer needed.
Keep tofacitinib extended-release tablets and all medicines out of the reach of children.
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General information about the safe and effective use of tofacitinib extended-release tablets.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use tofacitinib extended-release tablets for a condition for which it was not prescribed. Do not give tofacitinib extended-release tablets to other people, even if they have the same symptoms you have. It may harm them.
This Medication Guide summarizes the most important information about tofacitinib extended-release tablets. If you would like more information, talk to your healthcare provider. You can ask your pharmacist or healthcare provider for information about tofacitinib extended-release tablets that is written for health professionals.
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What are the ingredients in tofacitinib extended-release tablets?
Active ingredient: tofacitinib citrate
Inactive ingredients: ethyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, sodium lauryl sulfate and titanium dioxide.
Additionally each 11 mg tablet contains D&C red #27 Aluminum Lake, FD&C blue #2 Aluminum Lake, and iron oxide red.
The tablet is imprinted with black ink and contains following inactive ingredients: black iron oxide, propylene glycol and shellac.
Medication Guide available at www.zydususa.com/medguides or call 1-877-993-8779.
The brands listed are registered trademarks of their respective owners.
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Manufactured by:
Cadila Healthcare Ltd.
Ahmedabad, India
Distributed by:
Zydus Pharmaceuticals (USA) Inc.
Pennington, NJ 08534
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Rev: 12/20
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This Medication Guide has been approved by the U.S. Food and Drug Administration.
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