Tocilizumab

Tocilizumab can be used in adults to treat:

• moderate to severe rheumatoid arthritis when other treatments did not work or stopped working;
• giant cell arteritis, which is 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

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

• active polyarticular or systemic juvenile idiopathic arthritis; and
• Coronavirus Disease 2019 (COVID-19) in hospitalized adults and children aged 2 years and older who are receiving systemic corticosteroids and need supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO); and
• severe cytokine release syndrome, which is an overactive immune response after treatment with a certain type of immunotherapy.

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

You may get infections more easily, including serious or fatal infections. Call your doctor if you have a fever, chills, aches, tiredness, cough, shortness of breath, skin sores, diarrhea, weight loss, or burning when you urinate.

Tocilizumab may also cause liver problems or a perforation (a hole or tear) in your stomach or intestines. Tell your doctor right away if you have right-sided stomach pain, vomiting, loss of appetite, tiredness, dark urine, clay-colored stools, yellowing of your skin or eyes, or fever and stomach pain with a change in your bowel habits.

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

Tocilizumab affects your immune system. Tell your doctor if you notice 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 problems urinating.

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

Tell your doctor if you have or have ever had:

• an active, chronic, or recent infection, or if you are prone to infections;
• tuberculosis, or if you have been exposed to tuberculosis;
• low levels of white blood cells or platelets in your blood;
• diverticulitis, or ulcers in your stomach or intestines;
• a nerve-muscle disorder such as multiple sclerosis;
• a planned surgery or medical procedure;
• diabetes;
• HIV, or a weakened 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 up to date 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 tocilizumab.

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

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

Tocilizumab may cause serious side effects. Call your doctor right away if you experience:

• severe stomach cramps, bloating, diarrhea or constipation;
• nervous system issues--numbness, pain, tingling, weakness, burning or prickly feelings, vision or hearing problems, trouble breathing;
• easy bruising, unusual bleeding, purple or red spots under your skin;
• liver issues--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 sensation when you urinate;
• signs of tuberculosis--cough, shortness of breath, night sweats, loss of appetite, weight loss, and extreme tiredness; or
• signs of perforation (a hole or tear) in your stomach or intestines--fever, persistent stomach pain, changes in bowel habits.

Common side effects of tocilizumab 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 at the injection site.

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

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Before you use tocilizumab, your doctor should test you for tuberculosis or other infections.

Doses may be based on weight. Your dose may change if you gain or lose weight.

A healthcare provider may inject tocilizumab into a vein. In other cases, doses may be injected under the skin by yourself, your caregiver, or a healthcare provider. Your doctor will determine your treatment schedule based on your age and condition to treat.

Read and carefully follow any Instructions for Use provided with your medicine. A healthcare provider may teach you or your caregiver how to properly use this medicine. Ask your doctor or pharmacist if you don't understand these instructions.

Prepare a prefilled syringe or autoinjector only when you are ready to give it. Call your pharmacist if the medicine looks cloudy, has changed colors or has particles in it. Do not inject into the same place two times in a row. Avoid injecting into skin that is hard, red, bruised, swollen, or tender.

Each prefilled syringe or autoinjector is for one use only. Throw away after one use, even if there is still medicine left inside. Place them in a puncture-proof "sharps" container and dispose of it following state or local laws. Keep out of the reach of children and pets.

You may get infections more easily, even serious or fatal infections. You will need frequent medical tests, and your dose or medication schedule may be changed based on the results.

Tell your doctor if you have a planned surgery or medical procedure.

You may be given other medications to help treat your condition. Keep taking these medicines for as long as your doctor has prescribed.

Store the prefilled syringe or autoinjector in the original container in the refrigerator. Protect from light and moisture. Do not freeze.

Take the prefilled syringe or autoinjector out of the refrigerator and let it reach room temperature for 30 to 45 minutes before using. Do not warm the medicine with hot water, sunlight, or a microwave.

Tocilizumab may also be stored in the original container at room temperature, away from moisture and light. Do not return the medicine to the refrigerator. Throw the medicine away after 2 weeks if stored at room temperature.

Call your doctor for instructions if you miss a dose or an appointment for your tocilizumab injection.

Seek emergency medical help or call the Poison Help line at 1-800-222-1222.

Do not receive a "live" vaccine while you are being treated with tocilizumab. Live vaccines may include measles, mumps, rubella (MMR), varicella (chickenpox), nasal flu vaccine, and others.

Sometimes it is not safe to use certain medications together. Some drugs can change how much of other drugs are in your blood, which may increase side effects or make the medications less effective.

Tell your doctor about all your other medicines, especially:

• medicines for psoriasis, rheumatoid arthritis, or other autoimmune disorders -- etanercept, anakinra, rituximab, certolizumab, abatacept, golimumab, adalimumab, infliximab, non-steroidal anti-inflammatory drugs (NSAIDs), steroid medicine, or methotrexate.

This list is not complete, and many other drugs may affect tocilizumab. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Biosimilar and interchangeable products are biological products that are very similar to and have no significant differences from the reference product.

Reference products

These are biological products that have already been approved by the FDA and are used as a comparison for biosimilar products. There is 1 for tocilizumab.

Actemra (tocilizumab) - Genentech, Inc.

View Actemra information in detail.

Actemra interchangeable products

Interchangeable biosimilar products can be given by a pharmacist without needing approval from the prescriber of the reference product.

Pharmacy laws for biosimilar prescribing may vary by state.

Avtozma (tocilizumab-anoh) - CELLTRION, Inc.

View Avtozma information in detail.

Actemra biosimilar products

Biosimilar products can only be given instead of the reference product if the healthcare provider specifically prescribes the biosimilar product by name.

Pharmacy laws for biosimilar prescribing may vary by state.

Avtozma (tocilizumab-anoh) - CELLTRION, Inc.

View Avtozma information in detail.

Tofidence (tocilizumab-bavi) - Biogen MA Inc.

View Tofidence information in detail.

Tyenne (tocilizumab-aazg) - Fresenius Kabi USA, LLC

View Tyenne information in detail.