Tocilizumab is used in adults to treat:

• moderate to severe rheumatoid arthritis after at least one other medicine has been used and did not work;
• 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
• coronavirus disease 2019 (COVID-19) in hospitalized people who receive 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:

• polyarticular or systemic juvenile idiopathic arthritis ("Still disease"); and
• severe cytokine release syndrome (CRS, an overactive immune response to certain blood cell treatments for cancer).

The US Food and Drug Administration (FDA) has authorized emergency use of tocilizumab with steroid medicine to treat children at least 2 years old who are hospitalized with COVID-19 and using supplemental oxygen, a ventilator, or ECMO (a heart-lung machine that helps increase oxygen in the blood).

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

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

Tell your doctor if you have any signs of infection such as fever, chills, cough, body aches, tiredness, open sores or skin wounds, diarrhea, stomach pain, weight loss, painful urination, or coughing up blood.

Tell your doctor if you've had or been exposed to tuberculosis, or if you recently traveled. Some infections are more common in certain parts of the world, and you may have been exposed during travel.

Tell your doctor if you have ever had:

• an active or chronic infection;
• liver disease;
• diverticulitis, ulcers in your stomach or intestines;
• a nerve-muscle disease such as multiple sclerosis;
• diabetes;
• HIV, or a weak immune system;
• hepatitis B (or if you are a carrier of the virus);
• cancer; or
• if you have received or are scheduled to receive any vaccines.

Using tocilizumab may increase your risk of developing other cancers. Ask your doctor about this risk.

Tell your doctor if you are pregnant or breastfeeding.

Tell your baby's doctor if you used tocilizumab during pregnancy. It could affect your baby's vaccination schedule during the first months of life. Your name may be listed on a pregnancy registry to track the effects of tocilizumab on the baby.

Use Actemra Actpen (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; chest pain, difficulty breathing, feeling like you might pass out; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• severe stomach cramps, bloating, diarrhea or constipation;
• unusual bleeding--nosebleeds, bleeding gums, abnormal vaginal bleeding, any bleeding that will not stop, blood in your urine or stools, coughing up blood or vomit that looks like coffee grounds;
• liver problems--loss of appetite, right-sided stomach pain, vomiting, confusion, 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:

• runny or stuffy nose, sinus pain, 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, or you could develop a serious infection. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), and zoster (shingles).

You may still be able to receive a yearly flu shot, or an "inactivated" or other vaccine to prevent diseases such as hepatitis, meningitis, pneumonia, shingles, HPV, or whooping cough. Ask your doctor before getting any vaccine.

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.