Tocilizumab Injection

Tocilizumab injection is used alone or in combination with other medications to relieve the symptoms of certain types of arthritis and other conditions including:

• rheumatoid arthritis (a condition in which the body attacks its own joints, causing pain, swelling, and loss of function) in adults who have not been helped by other disease-modifying antirheumatic drugs (DMARDs),

• giant cell arteritis (a condition that causes swelling of blood vessels, especially in the scalp and head) in adults,

• systemic sclerosis-associated interstitial lung disease (SSc-ILD; also known as scleroderma-associated ILD: a lung disease that involves scarring of the lungs) in adults,

• 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) in children 2 years of age or older.

• 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) in children 2 years of age or older,

• cytokine release syndrome (a severe and possibly life-threatening reaction) in adults and children 2 years of age or older after receiving certain immunotherapy infusions.

Tocilizumab injection is in a class of medications called interleukin-6 (IL-6) receptor inhibitors. It works 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) about over 1 hour by a doctor or nurse in a medical office or hospital outpatient clinic or as a prefilled syringe to inject subcutaneously (just under the skin) by yourself at home.

When tocilizumab is given to treat rheumatoid arthritis, it is usually given intravenously once every 4 weeks or subcutaneously once every week or every other week.

When tocilizumab is given to treat giant cell arteritis, it is usually given subcutaneously once every 4 weeks.

When tocilizumab is given to treat systemic sclerosis-associated interstitial lung disease, it is usually given subcutaneously once weekly.

When tocilizumab is given to treat polyarticular juvenile idiopathic arthritis, it is usually given intravenously once every 4 weeks or subcutaneously once every 2 or 3 weeks.

When tocilizumab is given to treat systemic juvenile idiopathic arthritis, it is usually given intravenously once every 2 weeks or subcutaneously once every week or once every 2 weeks.

When tocilizumab is given intravenously to treat cytokine release syndrome, it is usually given as one dose, but up to 3 additional doses may be given at least 8 hours apart.

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.

Thirty minutes before you are ready to inject tocilizumab injection, you will need to remove the medication from the refrigerator, take it out of its carton, and allow it to reach room temperature. When removing a prefilled syringe from the box, be careful not to touch the trigger fingers on the syringe. 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 while the medication is warming. You should remove the cap no more than 5 minutes before you inject the medication. Do not replace the cap after you remove it. Do not use the syringe if you drop it on the floor.

Check the prefilled syringe to be sure that the expiration date printed on the package has not passed, Holding the syringe with the covered needle pointing down, look closely at the liquid in the syringe. The liquid should be clear or 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.

Do not reuse tocilizumab prefilled syringes and do not recap the syringes after use. Discard any used syringes in a puncture-resistant container and 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 and pharmacist if you are allergic to tocilizumab, 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 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; 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); 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 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 tocilizumab infusion, call your doctor.

If you forget to inject a subcutaneous dose of tocilizumab, 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

• 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, throat, arms, hands, feet, ankles, or lower legs

  • difficulty breathing or swallowing

  • chest pain

  • dizziness or fainting

  • 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 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 (http://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 it. Keep the prefilled syringes 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. http://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 (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

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.

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.