Tocilizumab Injection

Tocilizumab injection is available as different products that are biologic medications (medications made from living organisms). These biologic products are considered to be "biosimilar" to tocilizumab injection which means they work just as well and are just as safe to use as tocilizumab injection. Tocilizumab injection mentioned in the monograph below refers to any of these products.

Tocilizumab injection may make it harder for your body to fight infections and increase the chance that you will develop a serious or life-threatening infection. Tell your doctor if you think you may have any type of infection or have had a history of frequent infections. This includes minor infections (such as open cuts or sores), infections that come and go (such as cold sores), and ongoing infections that do not go away. Also tell your doctor if you have or have ever had diabetes, human immunodeficiency virus (HIV), low white blood cell counts, or any condition that affects your immune system, and if you live, have ever lived, or traveled to areas such as the Ohio and Mississippi River valleys and the Southwest where severe fungal infections are more common. Ask your doctor if you do not know if these infections are common in your area. Tell your doctor if you are taking medication that decrease the activity of your immune system.

Your doctor will monitor you for signs of infection during and after your treatment. If you have any of the following symptoms before you begin your treatment or if you experience any of the following symptoms during or shortly after your treatment, call your doctor immediately: fever; chills; sweating; difficulty breathing; sore throat; cough; weight loss; diarrhea; stomach pain; blood in phlegm; extreme tiredness; muscle aches; warm, red, or painful skin; sores on the skin or in the mouth; burning when you urinate; frequent urination; or other signs of infection.

You may be infected with tuberculosis (TB; a type of lung infection) or hepatitis B (a type of liver disease) but not have any symptoms of the disease. In this case, tocilizumab injection may increase the risk that your infection will become more serious and you will develop symptoms. Your doctor will perform a skin test to see if you have an inactive TB infection and may order blood tests to see if you have an inactive hepatitis B infection. If necessary, your doctor will give you medication to treat this infection before you start using a tocilizumab injection. Tell your doctor if you have or have ever had TB or hepatitis B, if you have visited any country where TB is common, or if you have been around someone who has TB. If you have any of the following symptoms of TB, or if you develop any of these symptoms during your treatment, call your doctor immediately: cough, chest pain, coughing up blood or mucus, weakness or tiredness, weight loss, loss of appetite, chills, fever, or night sweats. Also call your doctor immediately if you have any of these symptoms of hepatitis B or if you develop any of these symptoms during or after your treatment: excessive tiredness, yellowing of the skin or eyes, loss of appetite, nausea, vomiting, muscle aches, dark urine, clay-colored bowel movements, fever, chills, stomach pain, or rash.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests before and during your treatment to check your body's response to tocilizumab injection.

You will be given the Medication Guide when you begin treatment with tocilizumab injection and each time you receive the medication. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit https://www.fda.gov/Drugs/DrugSafety/ucm085729.htm to obtain the Medication Guide.

Talk to your doctor about the risks of using tocilizumab injection.

Tocilizumab injection is used to treat certain autoimmune disorders (conditions in which the immune system attacks healthy parts of the body and causes pain, swelling, and damage) including the following:

• rheumatoid arthritis (a condition in which the body attacks its own joints, causing pain, swelling, and loss of function)
• giant cell arteritis (a condition that causes swelling of blood vessels, especially in the scalp and head)
• polyarticular juvenile idiopathic arthritis (PJIA; a type of childhood arthritis that affects five or more joints during the first six months of the condition, causing pain, swelling, and loss of function)
• systemic juvenile idiopathic arthritis (SJIA; a condition in children that causes inflammation in different areas of the body, causing fever, joint pain and swelling, loss of function, and delays in growth and development)
• systemic sclerosis-associated interstitial lung disease (SSc-ILD; also known as scleroderma-associated ILD: a lung disease that involves scarring of the lungs)

Tocilizizumab injection is also used to treat cytokine release syndrome (a severe and possibly life-threatening reaction) and coronavirus disease 2019 (COVID-19 infection) caused by the SARS-CoV-2 virus in hospitalized adults who require supplemental oxygen or a ventilator

Tocilizumab injection is in a class of medications called interleukin-6 (IL-6) receptor inhibitors. It work by blocking the activity of interleukin-6, a substance in the body that causes inflammation.

Tocilizumab injection comes as a solution (liquid) to be injected intravenously (into a vein) over about 1 hour by a doctor or nurse in a medical office or hospital outpatient clinic. Tocilizumab injection also comes as a solution (liquid) in a single-dose prefilled syringe and an automatic injection device to inject subcutaneously (just under the skin) by yourself or a caregiver at home. Your doctor will tell you how often you will receive tocilizumab injection based on your condition, age, and weight.

Use tocilizumab injection exactly as directed. Do not inject more or less of it or inject it more often than prescribed by your doctor.

You will receive your first subcutaneous dose of tocilizumab injection in your doctor's office. Your doctor will show you or the person who will be injecting the medication how to inject it. After that, you can inject tocilizumab injection yourself or have a caregiver give the injections. Before you use tocilizumab injection yourself the first time, read the written instructions for use that come with it. Ask your doctor or pharmacist if you have any questions about how to inject the medication.

If you are using tocilizumab injection that has been refrigerated, place it on a flat surface and allow it to reach room temperature (30 minutes for the prefilled syringe and 45 minutes for the automatic injection device) before you inject the medication. Do not try to warm it by heating it in a microwave, placing it in warm water, or through any other method. Do not remove the cap from the prefilled syringe or automatic injection until after warming and before you are ready to use it. Do not use the syringe or device if you drop it on the floor.

Always look at tocilizumab injection solution before injecting it. Check that the expiration date has not passed. The medication should be clear and colorless to pale yellow and should not be cloudy or discolored or contain lumps or particles. Call your pharmacist if there are any problems with the package or the syringe and do not inject the medication.

You can inject tocilizumab injection on the front of the thighs or anywhere on your stomach except your navel (belly button) and the area 2 inches around it. If another person is injecting your medication, the outer area of the upper arms also may be used. Do not inject the medication into skin that is tender, bruised, red, hard, or not intact, or that has scars, moles, or bruises. Choose a different spot each time you inject the medication, at least 1 inch away from a spot that you have used before. If the full dose is not injected, call your doctor or pharmacist.

Use each syringe or automatic injection device once and inject all the solution in the syringe or automatic injection device. Even if there is still some solution left in the syringe or device, do not use it again. Do not recap the syringes or device after use. Discard any used syringes in a puncture-resistant container. Ask your pharmacist how to throw away the container.

Tocilizumab injection may help control your symptoms, but it will not cure your condition. Your doctor will watch you carefully to see how well tocilizumab injection works for you. Your doctor may adjust your dose or delay your treatment if you have certain changes in your laboratory results. It is important to tell your doctor how you are feeling during your treatment.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before receiving tocilizumab injection,

• tell your doctor or pharmacist if you are allergic to this drug, any part of this drug, or any other drugs, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take while receiving toclizumab injection. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you have or have ever had any of the conditions mentioned in the IMPORTANT WARNING section; cancer; diverticulitis (small pouches in the lining of the large intestine that can become inflamed); ulcers in your stomach or intestines; high cholesterol and triglycerides; high blood pressure; any condition that affects the nervous system such as multiple sclerosis (MS; a disease in which the nerves do not function properly and people may experience weakness, numbness, loss of muscle coordination and problems with vision, speech, and bladder control) or chronic inflammatory demyelinating polyneuropathy (CIDP; a disorder of the immune and nervous systems); low platelet (a type of blood cell) count; or liver disease.
• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while receiving tocilizumab injection, call your doctor.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are receiving tocilizumab injection.
• ask your doctor whether you should receive any vaccinations before you begin your treatment with a tocilizumab injection. If possible, all vaccinations for children should be brought up to date before beginning treatment. Do not have any vaccinations during your treatment without talking to your doctor.

Unless your doctor tells you otherwise, continue your normal diet.

If you miss an appointment to receive a dose of a tocilizumab injection, call your doctor.

If you forget to inject a subcutaneous dose of tocilizumab injection, inject the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not inject a double dose to make up for a missed one. Call your doctor or pharmacist if you do not know when to inject tocilizumab injection.

Tocilizumab injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• headache
• runny nose or sneezing
• redness, itching, pain, or swelling in the place where tocilizumab was injected
• constipation
• diarrhea
• anxiety
• difficulty falling asleep or staying asleep

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately or get emergency medical treatment:

• rash; flushing; hives; itching; swelling of the eyes, face, lips, tongue, or throat; wheezing; difficulty breathing or swallowing; dizziness or fainting; sweating; fast or racing heartbeat; or chest pain
• swelling of the hands, feet, ankles, or lower legs
• fever, ongoing stomach-area pain, or change in bowel habits
• yellow eyes or skin; right upper abdominal pain; unexplained bruising or bleeding; loss of appetite; confusion; yellow or brown-colored urine; or pale stools

Tocilizumab injection may increase the risk of developing certain types of cancer. Talk to your doctor about the risks of receiving this medication.

Tocilizumab injection may cause other side effects. Call your doctor if you have any unusual problems while receiving this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep this medication in the package it came in, away from light, tightly closed, and out of reach of children. Store tocilizumab injection in the refrigerator, but do not freeze them. Keep the prefilled syringes and automatic injection devices dry. Discard any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

If needed, tocilizumab injection may be stored at room temperature in the original carton to protect it from light. Talk to you doctor about how long tocilizumab injection can be stored at room temperature.

Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org

Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website https://goo.gl/c4Rm4p for more information.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Ask your pharmacist any questions you have about tocilizumab injection.

Do not let anyone else use your medication. Ask your pharmacist any questions you have about refilling your prescription.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.

• Actemra^®
• Tofidence^® (tocilizumab-bavi)
• Tyenne^® (tocilizumab-aazg)
• Avtozma^® (tocilizumab-anoh)