Tocilizumab Injection

IMPORTANT WARNING:

While receiving tocilizumab injection, it may be harder for your body to fight infections from bacteria, virus, or fungi. You may be at risk of 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. Make sure you have discussed any medications you are currently taking or plan to take with your doctor and pharmacist before starting tocilizumab injection. Other medications may also effect 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.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with a tocilizumab injection product 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 the Food and Drug Administration (FDA) website (https://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer's website to obtain the Medication Guide.

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

IMPORTANT NOTICE:

Tocilizumab injection, tocilizumab-bavi injection, and tocilizumab-aazg injection are biologic medications (medications made from living organisms).Tocilizumab-bavi injection and tocilizumab-aazg injections 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 3 products.

WHY is this medicine prescribed?

Tocilizumab injection is used to treat 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). and systemic sclerosis-associated interstitial lung disease (SSc-ILD; also known as scleroderma-associated ILD: a lung disease that involves scarring of the lungs) and cytokine release syndrome (a severe and possibly life-threatening reaction).Tocilizumab injection may also be used to treat 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. They work by blocking the activity of interleukin-6, a substance in the body that causes inflammation.

Are there OTHER USES for this medicine?

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

HOW should this medicine be used?

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 may also come as a solution (liquid) in a single-dose prefilled syringe and an automatic injection device to inject subcutaneously (just under the skin) by yourself at home.It may be injected subcutaneously once every 1 to 3 weeks.When tocilizumab injection is given intravenously, they may be given as one dose or once every 2 or 4 weeks.Your doctor will decide what dosing frequency is right for you.

You will receive your first subcutaneous dose of tocilizumab injection in your doctor's office. If you will be injecting tocilizumab injection subcutaneously by yourself at home or having a friend or relative inject the medication for you, your doctor will show you or the person who will be injecting the medication how to inject it. You and the person who will be injecting the medication should also read the written instructions for use that come with the medication. Be sure to ask your doctor or pharmacist if you have any questions about how to inject the medication.

If you are using a prefilled syringe or an automatic injection device that has been refrigerated, place the syringe or device 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 are ready to inject the medication.Do not try to warm the medication 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 device while the medication is warming. You should remove the cap right before you inject the medication.Do not use the syringe or device if you drop it on the floor.

Before you use tocilizumab injection, look at the solution in the prefilled syringe or automatic injection device closely. 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 may 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 prefilled syringe or automatic injection device once and inject all the solution in the syringe or automatic injection device. Do not reuse tocilizumab prefilled syringes or automatic injection devices and 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.

What SPECIAL PRECAUTIONS should I follow?

Before receiving tocilizumab injection,

• tell your doctor and pharmacist if you are allergic to tocilizumab, tocilizumab-bavi, tocilizumab-aazg, any other medications, or any of the ingredients in tocilizumab injection.Ask your pharmacist or check the Medication Guide for a list of the ingredients.

• In addition to the medications listed in the IMPORTANT WARNING section, be sure to tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take while taking toclizumab. 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.

• 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.

What SPECIAL DIETARY instructions should I follow?

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

What should I do IF I FORGET to take a dose?

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.

What SIDE EFFECTS can this medicine cause?

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

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 heart beat; 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).

What should I know about STORAGE and DISPOSAL of this medication?

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. If needed, tocilizumab injection may be stored at room temperature for up to 2 weeks. 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.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (https://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

What should I do in case of OVERDOSE?

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.

What OTHER INFORMATION should I know?

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.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.