Tocilizumab, Injection

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KEY POINTS

• This medicine is given by IV to rheumatoid arthritis or juvenile idiopathic arthritis.
• You may get serious or life-threatening infections while you are receiving this medicine.
• Keep all appointments for tests to see how this medicine affects you.
• This medicine may cause unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: interleukin-6 (IL-6) receptor inhibitor

Generic and brand names: tocilizumab, injection; Actemra

What is this medicine used for?

This medicine is given by IV infusion (slow drip through a needle into a large vein) or by injection under the skin to treat:

• Rheumatoid arthritis (RA) in adults who have not responded well to other treatment
• Juvenile idiopathic arthritis (JIA) in children over the age of 2 years

This medicine may be used alone or along with another medicine.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• A blood disorder
• A weakened immune system from cancer treatment, diseases such as HIV/AIDS, or from taking steroid medicines or medicines to prevent organ transplant rejection
• Diverticulitis or an ulcer
• High cholesterol or high triglycerides
• Diabetes
• High blood pressure
• Hepatitis B or other liver problems
• Lymphoma or other cancer
• Multiple sclerosis, Guillain-Barré syndrome, neuropathy, or any condition that causes numbness or tingling
• Seizures
• Tuberculosis (TB), a positive skin test for TB, or close contact with someone who has TB (your healthcare provider may give you a skin test to check for this).

You should NOT receive shots of this medicine if you have any kind of infection. Tell your healthcare provider if you:

• Currently have an infection
• Have any open cuts or sores
• Often have infections or infections come back
• Are scheduled to receive any vaccines
• Are scheduled to have major surgery

Some infections are more likely in certain parts of the country. Tell your provider where you have lived or recently traveled or where you plan to travel to during treatment.

Tell your provider if you take any other medicines for RA or JIA, especially abatacept (Orencia), anakinra (Kineret), certolizumab (Cimzia), etanercept (Enbrel), golimumab (Simponi), adalimumab (Humira), rituximab (Rituxan), infliximab (Remicade), or tocilizumab (Actemra).

Females of childbearing age: Tell your healthcare provider if you are pregnant or plan to become pregnant. It is not known whether this medicine will harm an unborn baby. Do not breast-feed while taking this medicine without your healthcare provider's approval.

How do I use it?

Read the Medication Guide that comes in the medicine package when you start taking this medicine and each time you have a treatment.

The infusions or injections may be given by your healthcare provider. Keep all appointments.

Check with your healthcare provider before using this medicine in children under age 18.

Sometimes you can give yourself these shots or have someone at home give them to you. The shots are given just under the skin. Check the label on the medicine for directions about your specific dose. Be sure you know how and when to have shots and how much medicine to use. If you are not sure of how to give yourself the shots, ask your healthcare provider or pharmacist for help.

Carefully read and follow the directions that come in the package of medicine for preparing and giving the shots. Wash your hands before using this medicine.

Do NOT remove the needle cap until you are ready to inject the medicine. If the medicine is not used within 5 minutes of needle cap removal, dispose of the syringe and use a new syringe.

Let the medicine warm to room temperature outside the carton for 30 minutes before you inject it. The shots should not be given into areas where the skin is tender, bruised, or red, or where you have scars or stretch marks.

Use each prefilled syringe or pen only once and dispose of it safely, following your healthcare provider's instructions. Do not use the medicine if it looks cloudy or contains particles.

Do not stop using this medicine without your healthcare provider's approval.

What if I miss a dose?

Subcutaneous injection: If you miss a dose, use it as soon as you remember unless it is almost time for the next scheduled dose. In that case, skip the missed dose and use the next one as directed. Do not use double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

If you miss an infusion, contact your healthcare provider for another appointment as soon as possible.

What if I overdose?

Symptoms of an acute overdose have not been reported.

What should I watch out for?

This medicine increases your risk for serious or life-threatening infections. Stay away from people with colds, flu, or other infections. Contact your healthcare provider right away if you develop a fever or ANY other symptoms of infection. Also, do not have any vaccines without getting your healthcare provider's approval first.

This medicine may increase your risk for lymphoma, leukemia, melanoma, and other cancers. Talk to your healthcare provider about this.

You will need to have checkups and blood tests regularly to see how this medicine affects you. Keep all appointments.

This medicine may make you dizzy. Do not drive or operate machinery unless you are fully alert.

Adults over the age of 65 may be at greater risk for side effects. Talk with your healthcare provider about this.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): Unexplained tiredness or weakness; yellowing of your skin or eyes; dark urine; light-colored bowel movements; loss of appetite; fever; unexplained cough or sore throat; mouth sores; unusual bruising or bleeding; unusual muscle pain; severe or persistent stomach pain; black or tarry bowel movements; severe diarrhea; severe nausea or vomiting; pain when urinating or urinating more often than usual; chest pain; trouble breathing; runny or stuffy nose; unusual numbness or tingling.

Other: Redness, swelling, or bruising around the injection site; headache; mild dizziness.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking any other medicines.

• Antianxiety medicines such as alprazolam (Xanax), clonazepam (Klonopin), clorazepate (Gen-Xene, Tranxene), and diazepam (Valium)
• Antibiotics such as bedaquiline (Sirturo), clarithromycin (Biaxin), erythromycin (E.E.S., Ery-Tab, Erythrocin), and telithromycin (Ketek)
• Antidepressants such as citalopram (Celexa) and escitalopram (Lexapro)
• Antifungal medicines such as itraconazole (Sporanox) and ketoconazole (Nizoral)
• Antipsychotic medicines such as aripiprazole (Abilify), haloperidol (Haldol), pimozide (Orap), quetiapine (Seroquel), and thioridazine
• Antiseizure medicines such as carbamazepine (Carbatrol, Epitol, Equetro, Tegretol), phenytoin (Dilantin, Phenytek), and primidone (Mysoline)
• Cancer medicine such as crizotinib (Xalkori), nilotinib (Tasigna), toremifene (Fareston), vandetanib (Caprelsa), and vemurafenib (Zelboraf)
• Cholesterol-lowering medicines such as atorvastatin (Lipitor), lovastatin (Altoprev), and simvastatin (Zocor)
• Echinacea
• Eliglustat (Cerdelga)
• Fingolimod (Gilenya)
• Heart medicines such as amiodarone (Cordarone, Pacerone), diltiazem (Cardizem, Cartia, Tiazac), disopyramide (Norpace), isradipine (DynaCirc), quinidine, and verapamil (Calan, Covera, Verelan)
• HIV medicines such as atazanavir (Reyataz), darunavir (Prezista), delavirdine (Rescriptor), elvitegravir/cobicistat/emtricitabine/tenofovir (Stribild), fosamprenavir (Lexiva), indinavir (Crixivan), lopinavir/ritonavir (Kaletra), nelfinavir (Viracept), nevirapine (Viramune), ritonavir (Norvir), saquinavir (Invirase), and tipranavir (Aptivus)
• Hormonal birth control implants, IUDs, patches, pills, shots, and vaginal rings (Talk to your healthcare provider if you need birth control.)
• Immunosuppressants such as cyclosporine (Gengraf, Neoral, Sandimmune), sirolimus (Rapamune), and tacrolimus (Astagraf, Prograf, Protopic)
• Malaria medicines such as artemether/lumefantrine (Coartem) and chloroquine
• Medicines to treat or prevent blood clots such as apixaban (Eliquis), rivaroxaban (Xarelto), and warfarin (Coumadin)
• Natalizumab (Tysabri)
• Omeprazole (Prilosec)
• Other medicines to treat psoriasis, rheumatoid arthritis, and other immune disorders such as abatacept (Orencia), adalimumab (Humira), anakinra (Kineret), belimumab (Benlysta), canakinumab (Ilaris), certolizumab (Cimzia), etanercept (Enbrel), golimumab (Simponi), infliximab (Remicade), leflunomide (Arava), rituximab (Rituxan), tocilizumab (Actemra), and tofacitinib (Xeljanz)
• Pain medicines such as hydrocodone/acetaminophen (Norco, Vicodin), methadone (Dolophine, Methadose), oxycodone (OxyContin, Roxicodone), and oxycodone/acetaminophen (Percocet, Roxicet)
• Theophylline
• Vaccines

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine in the original carton in the refrigerator. Do not let it freeze. Protect it from heat, high humidity, and bright light.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Keep all medicines out of the reach of children.

Do not share medicines with other people.