Actemra ACTPen 162 mg/0.9 mL subcutaneous pen injector

Generic name:
Tocilizumab - subcutaneous injection

Pronunciation
(TOE-si-LIZ-ue-mab)

Brand name(s)
Actemra , Tyenne

This medication may lower your ability to fight an infection. This may make you more likely to get a serious (rarely fatal) infection or make any infection you have worse. Your risk may be increased if you are also taking other drugs that can lower your ability to fight an infection (such as methotrexate or corticosteroids). Before using tocilizumab, tell your doctor your medical history, especially of any kind of infection. During treatment, get medical help right away if you have any signs of infection (such as sore throat that doesn't go away, fever, swollen lymph nodes, chills, cough, pain when urinating).

Before and during treatment with this medication, your doctor will test you for tuberculosis (TB). Your doctor should also monitor you for symptoms of TB during and after treatment with this drug. If needed, treatment for tuberculosis or other infections should be given before receiving this medication.

This medication is used to treat rheumatoid arthritis in adults and in children (such as polyarticular juvenile idiopathic arthritis-PJIA, systemic juvenile idiopathic arthritis-SJIA). It helps to reduce pain and swelling due to rheumatoid arthritis. Tocilizumab is used to treat giant cell arteritis. It helps to reduce swelling in your blood vessels so blood can flow more easily. This medication is also used to slow down the decrease in lung function in people with a certain type of lung disease (systemic sclerosis-associated interstitial lung disease - SSc-ILD). Tocilizumab belongs to a class of drugs known as Interleukin-6 (IL-6) blockers. It works by blocking IL-6, a substance made by the body that causes swelling (inflammation).

This monograph is about the following tocilizumab products: tocilizumab and tocilizumab-aazg.

Read the Medication Guide and Instructions for Use provided by your pharmacist before you start using tocilizumab and each time you get a refill. Ask your health care professional how to prepare and use this medication. If you have any questions, ask your doctor or pharmacist.

Inject this medication under the skin as directed by your doctor. The injection is given in the upper arms, thighs, or abdomen. The dosage is based on your medical condition, weight, labs, and response to treatment.

Depending on your product, take the medication out of the refrigerator at least 30 or 45 minutes before you inject it to allow it to reach room temperature. Do not warm up this medication any other way (for example, do not heat it in the microwave, place it in hot water, or leave it in direct sunlight). Check this product for particles or discoloration. If either is present, do not use the liquid. Before injecting each dose, clean the skin you are going to inject into (the injection site) with rubbing alcohol. Change the injection site each time to lessen injury under the skin. Do not inject into skin that is tender, red, hard, or broken, or into moles, scars, or bruises. To lessen bruising, do not rub the injection site after a shot. Learn how to store and discard medical supplies safely.

Use this medication regularly to get the most benefit from it. To help you remember, mark your calendar with a reminder.

Tell your doctor if your condition does not get better or if it gets worse.

See also Warning section.

Headache or irritation/redness/pain at the injection site may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including:

• stomach/abdominal pain

Tocilizumab has rarely caused very serious (possibly fatal) liver disease. This effect may occur months to years after starting this medication. Tell your doctor right away if you develop symptoms of liver disease, such as nausea/vomiting that doesn't stop, loss of appetite, yellowing eyes/skin, dark urine.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before using tocilizumab, tell your doctor or pharmacist if you are allergic to it; or to any tocilizumab products; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• diabetes
• infections (including past/current/returning)
• liver problems
• low blood cell count
• nervous system problems (such as multiple sclerosis)
• stomach/abdominal problems (such as ulcers, diverticulitis)

Tocilizumab can make you more likely to get infections or may make current infections worse. Stay away from anyone who has an infection that may easily spread (such as chickenpox, COVID-19, measles, tuberculosis, flu). Tell your doctor if you live in, have lived in, or have traveled to certain areas where there is an increased chance of getting certain kinds of fungal infections (blastomycosis, coccidioidomycosis, histoplasmosis). Talk to your doctor if you have been exposed to an infection or for more details.

Tell your health care professional that you are using tocilizumab before having any immunizations/vaccinations. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

Drugs that affect the immune system (such as tocilizumab) may increase your risk of certain cancers. Tell your doctor if you have ever had any type of cancer.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include:

• other drugs that can affect the immune system (such as certolizumab, corticosteroids including prednisone)

This medication can speed up the removal of other medications from your body, which may affect how they work. Examples of affected drugs include omeprazole, warfarin, and some cholesterol drugs such as atorvastatin/lovastatin/simvastatin, among others.

This medication may decrease the effectiveness of hormonal birth control such as pills, patch, or ring. This could cause pregnancy. Discuss with your doctor or pharmacist if you should use reliable backup birth control methods while using this medication. Also tell your doctor if you have any new spotting or breakthrough bleeding, because these may be signs that your birth control is not working well.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Do not share this medication with others.

Lab and/or medical tests (such as complete blood counts, liver function, cholesterol tests) should be done before you start using this medication and while you are using it. Keep all medical and lab appointments. Consult your doctor for more details.

It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule.

Store in the refrigerator. Do not freeze. Do not use this medication if it has been frozen. Keep the medication in the original carton to protect from light. This medication may also be stored at room temperature if needed. If the medication is stored at room temperature, do not put it back in the refrigerator and discard after 14 days. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.