Tocilizumab-bavi (toe-si-LIZ-oo-mab - bavi)

Treats rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis, and COVID-19.

Brand Name(s):

Tofidence

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• Your doctor will prescribe your dose and schedule. This medicine is given through a needle placed in a vein. This medicine must be given slowly, so the IV will have to remain in place for 60 minutes.
• A nurse or other health provider will give you this medicine.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how tocilizumab-bavi works. Tell your doctor if you are using any of the following:
  • Abatacept, adalimumab, anakinra, certolizumab, cyclosporine, dextromethorphan, etanercept, golimumab, infliximab, methotrexate, omeprazole, rituximab, theophylline
  • Birth control pills
  • Blood thinner (including warfarin)
  • Medicine to lower cholesterol (including atorvastatin, lovastatin, simvastatin)
  • Medicine that weakens the immune system (including a cancer or steroid medicine)
  • NSAIDs or arthritis medicine
• This medicine may interfere with vaccines. Ask your doctor before you get a flu shot or any other vaccines.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have kidney disease, liver disease, diabetes, high cholesterol, multiple sclerosis, stomach or bowel disease (including diverticulitis, ulcers), or a weak immune system (including HIV, cancer). Tell your doctor if you have any type of infection (including hepatitis B or tuberculosis) or an infection that keeps coming back.
• This medicine may cause the following problems:
  • Increased risk for serious infections
  • Stomach or bowel problems
  • Liver problems
  • High cholesterol in the blood
  • Increased risk of cancer
  • Serious skin reactions
• You will need to have a skin test for tuberculosis (TB) before you start using this medicine. Tell your doctor if you or anyone in your home has ever had a positive TB skin test or has been exposed to TB.
• This medicine may make you bleed, bruise, or get infections more easily. Take precautions to prevent illness and injury. Wash your hands often.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blistering, peeling, red skin rash
• Bloody, black, or tarry stools, severe stomach pain, diarrhea
• Change in how much or how often you urinate
• Chest pain, trouble breathing
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Dry mouth, increased thirst, muscle cramps
• Fast, slow, pounding, or uneven heartbeat
• Fever, chills, cough, stuffy or runny nose, sore throat, body aches
• Unusual bleeding, bruising, weakness
• Vomiting of material that looks like coffee grounds

If you notice these less serious side effects, talk with your doctor:

• Headache
• Pain, itching, burning, swelling, bleeding, or a lump under your skin where the needle was placed

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088