Tocilizumab can be used in adults to treat:

• moderate to severe rheumatoid arthritis after other treatments did not work or stopped working;
• giant cell arteritis, (inflammation in the lining of the blood vessels that carry blood from your heart to other parts of your body);
• to slow the decline in lung function caused by scleroderma with interstitial lung disease; and
• hospitalized adults with coronavirus disease 2019 (COVID-19) who are receiving steroid medicine and require supplemental oxygen, a ventilator, or ECMO (a heart-lung machine that helps increase oxygen in the blood).

Tocilizumab is used in adults and children 2 years and older to treat:

• active polyarticular or systemic juvenile idiopathic arthritis; and
• severe cytokine release syndrome, an overactive immune response after treatment with a certain type of immunotherapy.

Tocilizumab may also be used for purposes not listed in this medication guide.

You should not use tocilizumab if you are allergic to it.

Tocilizumab affects your immune system. Tell your doctor if you have any signs of infection such as fever, chills, sweating, muscle pain, cough, shortness of breath, bloody mucus, weight loss, skin problems, diarrhea, stomach pain, or urination problems.

Tell your doctor where you live and if you have recently traveled or plan to travel. You may have been exposed to infections that are common to certain areas of the world.

Tell your doctor if you have or have ever had:

• an active, chronic, recent infection, or been prone to infections;
• tuberculosis, or been exposed to tuberculosis;
• low levels of white blood cells or platelets in your blood;
• diverticulitis, ulcers in your stomach or intestines;
• a nerve-muscle disorder such as multiple sclerosis;
• a planned surgery or medical procedure;
• diabetes;
• HIV, or a weak immune system;
• hepatitis B (or if you are a carrier of the virus);
• cancer;
• recently received or are scheduled to receive any vaccines; or
• liver disease.

Make sure you are current on all vaccines before you start using tocilizumab.

Using tocilizumab may increase your risk of developing certain cancers and nervous system disorders. Ask your doctor about your individual risk.

Tocilizumab may harm an unborn baby. Tell your doctor if you are pregnant or think you may be pregnant.

Ask a doctor if it is safe to breastfeed while using this medicine.

If you are using tocilizumab while pregnant, your name may be listed on a pregnancy registry to track the effects of tocilizumab on you and the baby.

Use Tyenne Prefilled Syringe (Subcutaneous) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Get emergency medical help if you have signs of an allergic reaction: hives, difficult breathing, swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• severe stomach cramps, bloating, diarrhea or constipation;
• nervous system problems--numbness, pain, tingling, weakness, burning or prickly feeling, vision or hearing problems, trouble breathing;
• easy bruising, unusual bleeding, purple or red spots under your skin;
• liver problems--loss of appetite, nausea, vomiting, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• signs of infection--fever, chills, aches, skin sores, diarrhea, burning when you urinate;
• signs of tuberculosis--cough, shortness of breath, night sweats, loss of appetite, weight loss, and feeling very tired; or
• signs of perforation (a hole or tear) in your stomach or intestines--fever, ongoing stomach pain, change in bowel habits.

Common side effects may include:

• cold symptoms such as stuffy nose, sneezing, sore throat;
• headache;
• increased blood pressure;
• abnormal liver function tests; or
• pain, swelling, burning, or irritation where an injection was given.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Avoid receiving a "live" vaccine while you are being treated with tocilizumab. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), and zoster (shingles).