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WHAT IS TOFIDENCE?

TOFIDENCE is a prescription medicine called an Interleukin-6 (IL-6) receptor antagonist.

TOFIDENCE is used:

  • To treat adults with moderately to severely active rheumatoid arthritis (RA), after at least one other medicine called a Disease-Modifying Anti-Rheumatic Drug (DMARD) has been used and did not work well.
  • To treat adults with giant cell arteritis (GCA).
  • To treat people with active polyarticular juvenile idiopathic arthritis (PJIA) ages 2 and above.
  • To treat people with active systemic juvenile idiopathic arthritis (SJIA) ages 2 and above.
  • To treat hospitalized adults with coronavirus disease 2019 (COVID-19) receiving systemic corticosteroids and requiring supplemental oxygen or mechanical ventilation.

It is not known if TOFIDENCE is safe and effective in children with PJIA or SJIA under 2 years of age or in children with conditions other than PJIA or SJIA.

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about TOFIDENCE?

TOFIDENCE can cause serious side effects including Serious Infections:

  • TOFIDENCE is a medicine that affects your immune system. TOFIDENCE can lower the ability of your immune system to fight infections. Some people have serious infections while taking TOFIDENCE, 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 assess you for TB before starting TOFIDENCE (except if you have COVID-19).

    If you have COVID-19, your healthcare provider should monitor you for signs and symptoms of new infections during and after treatment with TOFIDENCE. Your healthcare provider should monitor you closely for signs and symptoms of TB during and after treatment with TOFIDENCE.

  • You should not start taking TOFIDENCE if you have any kind of infection unless your healthcare provider says it is okay.

What should I tell my doctor BEFORE taking TOFIDENCE?

Tell your healthcare provider if you have:

  • An infection, think you may have an infection, are being treated for an infection or get a lot of infections that return. Symptoms of an infection, with or without fever, may include sweating or chills; shortness of breath; warm, red, or painful skin or sores on your body; feeling very tired; muscle aches; blood in phlegm; diarrhea or stomach pain; cough; weight loss; burning when you urinate or urinating more than normal.
  • Diabetes, HIV, or a weak immune system.
  • TB or have been in close contact with someone with TB.
  • Lived or live in 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.
  • Or have had hepatitis B.

What should I watch for AFTER starting TOFIDENCE?

Contact your healthcare provider right away if you have any symptoms of an infection or signs of these serious side effects:

  • Tears (Perforations) of the Stomach or Intestines
    Talk to 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 TOFIDENCE get tears in their stomach or intestine. 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 new onset stomach-area pain that does not go away, and a change in your bowel habits.
  • Liver Problems (Hepatotoxicity)
    Some people have experienced serious life-threatening liver problems, which required a liver transplant or led to death. Your healthcare provider may tell you to stop taking TOFIDENCE if you develop new or worse liver problems during treatment with TOFIDENCE. Tell your healthcare provider right away if you have any of the following symptoms:
    • feeling tired (fatigue)
    • lack of appetite for several days or longer (anorexia)
    • yellowing of your skin or the whites of your eyes (jaundice)
    • abdominal swelling and pain on the right side of your stomach-area
    • light colored stools
    • weakness
    • nausea and vomiting
    • confusion
    • dark "tea-colored" urine
  • Changes in Laboratory Test Results
    Your healthcare provider should do blood tests before you start receiving TOFIDENCE. If you have rheumatoid arthritis (RA) or giant cell arteritis (GCA) your healthcare provider should do blood tests every 4 to 8 weeks after you start receiving TOFIDENCE for the first 6 months and then every 3 months after that. If you have polyarticular juvenile idiopathic arthritis (PJIA), you will have blood tests done every 4 to 8 weeks during treatment. If you have systemic juvenile idiopathic arthritis (SJIA), you will have blood tests done every 2 to 4 weeks during treatment. These blood tests are to check for the following side effects of TOFIDENCE:
    • low neutrophil count. Neutrophils are white blood cells that help the body fight off bacterial infections.
    • low platelet count. Platelets are blood cells that help with blood clotting and stop bleeding.
    • increase in certain liver function tests.
    • increase in blood cholesterol levels. Your cholesterol levels should be checked 4 to 8 weeks after you start receiving TOFIDENCE.

Your healthcare provider will determine how often you will have follow-up blood tests. Make sure you get all your follow-up blood tests done as ordered by your healthcare provider.

You should not receive TOFIDENCE if your neutrophil or platelet counts are too low or your liver function tests are too high. Changes in test results may cause your healthcare provider to stop your TOFIDENCE treatment for a period of time or change your dose.

  • Cancer
    TOFIDENCE may increase your risk of certain cancers by changing the way your immune system works. Tell your healthcare provider if you have ever had any type of cancer.
  • Hepatitis B Infection
    If you are a carrier of the hepatitis B virus (a virus that affects the liver), the virus may become active while you use TOFIDENCE. Your healthcare provider may do blood tests before you start treatment with TOFIDENCE and while you are using TOFIDENCE. Tell your healthcare provider if you have any of the following symptoms: feel very tired; vomiting; chills, dark urine; skin or eyes look yellow; clay-colored bowel movements; stomach discomfort; skin rash, little or no appetite; fevers; muscle aches.
  • Serious Allergic Reactions
    Serious allergic reactions, including death, can happen with TOFIDENCE. These reactions can happen with any infusion of TOFIDENCE, even if they did not occur with an earlier infusion. Stop taking TOFIDENCE, contact your healthcare provider, and get emergency help right away if you have any of the following signs of a serious allergic reaction: trouble breathing; swelling of your mouth, lips, tongue, or face; wheezing; severe itching; skin rash, hives, redness, or swelling outside of the injection site area; dizziness or fainting; fast heartbeat or pounding in your chest (tachycardia); sweating.
  • Nervous System Problems
    While rare, Multiple Sclerosis has been diagnosed in people who take TOFIDENCE. It is not known what effect TOFIDENCE may have on some nervous system disorders.

Most common side effects of TOFIDENCE include: upper respiratory tract infections (common cold, sinus infections), headache, and increased blood pressure (hypertension).

Tell your healthcare provider about any side effect that bothers you or does not go away. These are not all the possible side effects of TOFIDENCE.

Do not take TOFIDENCE if you are allergic to tocilizumab, or any of the ingredients in TOFIDENCE.

This is the most important information to know about TOFIDENCE. For more information, talk to your healthcare provider.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088.

Please read the Medication Guide for TOFIDENCE, including the information about serious infections, and discuss it with your doctor. The Physician Prescribing Information also is available.