Actemra ACTPen

This medication is used alone or with other medications to treat moderate to severe rheumatoid arthritis in adults. It is also used to treat rheumatoid arthritis 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 also used to treat giant cell arteritis. It helps to reduce swelling in your blood vessels so blood can flow more easily. 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).

Read the Medication Guide and Instructions for Use provided by your pharmacist before you start using tocilizumab and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

If you are using this medication at home, learn all preparation and usage instructions from your health care professional and the product package.

Before use, take this medication out of the refrigerator. If you are using the prefilled syringe, let it warm up to room temperature for at least 30 minutes. If you are using the autoinjector, let it warm up to room temperature for at least 45 minutes. Do not heat this medication any other way, such as by heating in the microwave or placing in hot water. Do not leave in direct sunlight. Check this product visually for particles or discoloration. If either is present, do not use the liquid.

If you are using this medication to treat rheumatoid arthritis in adults, inject this medication under the skin as directed by your doctor, usually starting with once every 2 weeks, then increasing to once a week.

If you are using this medication to treat PJIA in children, give this medication by injection under the skin as directed by the doctor, usually once every 2 or 3 weeks, based on your child's weight.

If you are using this medication to treat SJIA in children, give this medication by injection under the skin as directed by the doctor, usually once every 1 or 2 weeks, based on your child's weight.

If you are using this medication to treat giant cell arteritis, inject this medication under the skin as directed by your doctor, usually once a week.

Recommended injection sites include the abdomen or the front of your thigh. The outer area of the upper arms may also be used if another person is giving you the injection. Before injecting each dose, clean the injection site with rubbing alcohol. Change the injection site each time to lessen injury under the skin. Do not inject into moles, scars, bruises, or areas where the skin is tender, red, hard, or broken.

Learn how to store and discard medical supplies safely.

The dosage is based on your weight, laboratory tests, and response to treatment.

Use this medication regularly to get the most benefit from it. To help you remember, mark the days you need to inject the medication on a calendar.

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 persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she 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 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 worsen any current infections. Therefore, wash your hands well to prevent the spread of infection. Avoid contact with people who have infections that may spread to others (such as chickenpox, 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). Consult your doctor if you have been exposed to an infection or for more details.

Do not have immunizations/vaccinations without the consent of your doctor. 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 breast-feeding.

Store in the original package in the refrigerator away from moisture. Do not freeze. Do not store in the bathroom. 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.

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 additional reliable 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 their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

For the best possible benefit, it is important to receive each scheduled dose of this medication as directed. If you miss a dose, contact your doctor or pharmacist right away to establish a new dosing schedule.

Do not share this medication with others.

Laboratory and/or medical tests (such as complete blood counts, liver function, cholesterol tests) should be performed before you start treatment, periodically to monitor your progress, or to check for side effects. Consult your doctor for more details.