Tocilizumab (Injection)

Introduction

Tocilizumab (toe-si-LIZ-oo-mab)

Treats moderate to severe rheumatoid arthritis. Also used to treat systemic juvenile idiopathic arthritis (SJIA) in children 2 years of age and older. This medicine is used alone or together with other medicines.

Brand Name(s)

Actemra

Drugs and Foods to Avoid

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Make sure your doctor knows if you are using cyclosporine (Gengraf®, Neoral®, or Sandimmune®), omeprazole (Prilosec®), theophylline (Theo-Dur®), medicine to lower cholesterol (such as atorvastatin, lovastatin, simvastatin, Altocor®, Lipitor®, or Mevacor®, or Zocor®), a blood thinner (such as warfarin or Coumadin®), or birth control pills. Tell your doctor if you are using medicines that may weaken your immune system, such as cancer medicines or steroids.
• Make sure your doctor knows if you are also using other medicines to treat rheumatoid arthritis (such as abatacept, adalimumab, anakinra, certolizumab, etanercept, golimumab, infliximab, rituximab, Cimzia®, Enbrel®, Humira®, Kineret®, Orencia®, Remicade®, Rituxan®, or Simponi®).
• Talk to your doctor before getting flu shots or other vaccines while you are receiving this medicine. Vaccines may not work as well, or they could make you ill while you are using this medicine. Your child's vaccines need to be current before he or she begins using tocilizumab. Be sure to ask your child's doctor if you have any questions about this.

Possible Side Effects While Using This Medicine

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Bloody, black, or tarry stools.
• Change in how much or how often you urinate.
• Chest pain.
• Dark-colored urine or pale stools.
• Fast, slow, or pounding heartbeat.
• Fever, chills, cough, stuffy or runny nose, sore throat, and body aches.
• Severe stomach pain.
• Shortness of breath or troubled breathing.
• Swelling in your hands, ankles, or feet.
• Vomiting of blood that looks like coffee grounds.
• Warmth or redness in your face, neck, arms, or upper chest.
• Yellowing of your skin or the whites of your eyes.

If you notice these less serious side effects, talk with your doctor:

• Diarrhea, constipation, loss of appetite, nausea, or stomach pain.
• Headache or dizziness.
• Pain, itching, burning, swelling, bleeding, or a lump under your skin where the needle is placed.
• Rash.
• Sores or ulcers in the mouth.

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088

When This Medicine Should Not Be Used

How to Use This Medicine

Injectable

• Your doctor will prescribe your exact dose and tell you how often it should be given. This medicine is given through a needle placed in one of your veins. This medicine must be given slowly, so the needle will remain in place for at least one hour.
• A nurse or other trained health professional will give you this medicine.
• This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions. Ask your pharmacist for the Medication Guide if you do not have one.

If a dose is missed:

• This medicine needs to be given on a fixed schedule. If you miss a dose, call your doctor, home health caregiver, or treatment clinic for instructions.

Warnings While Using This Medicine

• Tell your doctor if you are pregnant or if you plan to become pregnant. If you become pregnant while receiving this medicine, your doctor may want you to join a registry for pregnant patients.
• Make sure your doctor knows if you are breastfeeding, or if you have a history of hyperlipidemia (high fats in the blood), liver disease, multiple sclerosis, stomach or bowel problems (such as diverticulosis, perforations, or ulcers), tuberculosis, or a weak immune system. Tell your doctor if you have a fever, an infection, or a condition that may weaken your immune system, such as cancer or the use of steroid medicines.
• You will need to have a skin test for tuberculosis before you or your child start using this medicine. Tell your doctor if you or anyone in your home has ever had a positive reaction to a tuberculosis skin test.
• This medicine may cause headaches and skin reactions, such as a rash or itching, while you are receiving the injection or within 24 hours after you receive it. Check with your doctor or nurse right away if you or your child have any of these symptoms.
• This medicine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Tell your doctor right away if you or your child have a rash; hives; itching; swelling of the face, tongue, and throat; trouble breathing; or chest pain after you receive this medicine.
• This medicine lowers the number of some types of blood cells in your body. Because of this, you may bleed or get infections more easily. To help with these problems, avoid being near people who are sick or have infections. Wash your hands often. Stay away from rough sports or other situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be careful when using sharp objects, including razors and fingernail clippers.
• Using this medicine may increase your risk of having certain cancers. Talk to your doctor if you or your child have concerns about this risk.
• Call your doctor right away if you or your child start to have a cough that won't go away, weight loss, night sweats, fever, chills, or flu-like symptoms, such as a runny or stuffy nose, headache, blurred vision, or feeling generally ill. These may be signs that you have an infection.
• This medicine may cause serious stomach and bowel problems, especially if you have a history of ulcers or diverticulosis. Check with your doctor right away if you or your child start having severe stomach cramps or pain; black, tarry stools; diarrhea; fever; or vomiting that is severe and sometimes bloody while being treated with this medicine.
• This medicine may increase the level of cholesterol and fats in your blood. If this condition occurs, your doctor may give you or your child a medicine to lower the cholesterol and fats. Talk to your doctor if you have concerns.
• Your doctor will need to check your progress at regular visits while you are using this medicine. Be sure to keep all appointments. Blood tests may be needed to check for unwanted effects.