Actemra decreases immune system function (immunosuppression), which can result in serious infections including invasive fungal infections or worsening of an existing infection. Deaths from serious infections have been reported in patients receiving these medications. Before starting Actemra, tell your doctor if you:

• have HIV
• have tuberculosis (TB), or have been in close contact with someone with TB
• were born in, lived in, or traveled to countries where there is more risk for getting TB. Ask your doctor if you are not sure.
• live or have lived in certain parts of the country (such as the Ohio and Mississippi River valleys) where there is an increased risk for getting certain kinds of fungal infections (histoplasmosis, coccidioidomycosis, blastomycosis). These infections may develop or become more severe if you take Actemra. If you do not know if you have lived in an area where histoplasmosis, coccidioidomycosis, or blastomycosis is common, ask your doctor.
• have or have had hepatitis B

Before starting treatment with Actemra your doctor will arrange for you to have a tuberculosis skin test done to check for tuberculosis that may not be causing any symptoms (latent tuberculosis). If you have been diagnosed with tuberculosis, anti-tuberculosis medicines must be started before you start therapy. This will reduce the likelihood of a serious tuberculosis infection. You also will be tested for Hepatitis B.

Tell your doctor if you have been diagnosed with an infection, are on antibiotics or if you are prone to recurrent infections. Tell your doctor immediately if you have any complaints that may indicate an infection. These include but are not limited to pink eye, ear pain or drainage, sinus pain or drainage, sore throat, hoarse voice, cough, difficulty breathing, fevers, chills, sweats, vomiting, abdominal pain, diarrhea, burning with urination, increased frequency of urination, vaginal discharge, and cuts or wounds that are red, swollen or draining pus. You should not receive Actemra while you have an infection or while you are on antibiotics. The medication can be restarted once you have completed your antibiotic course, and your infection has been resolved.

Tell your doctor if you have a planned surgery, as you will need to stop Actemra temporarily around the time of your surgery

Serious side effects have happened in patients taking Actemra including:

• Certain Types of Cancers – There have been cases of certain types of cancer in people taking Actemra. People with RA, especially more serious RA, may have a higher chance of getting a kind of cancer called lymphoma.
• Gastrointestinal perforations have been reported in clinical trials, usually in people with diverticulitis. Tell your doctor if you have been diagnosed with diverticulitis.
• Nervous System Problems such as multiple sclerosis may occur. Symptoms may include dizziness, numbness or tingling, problems with your vision, and weakness in your arms or legs.
• Infusion/Allergic Reactions. The most common reactions are high blood pressure, headache and skin reactions. Serious allergic reactions may occur. Death from a suspected severe allergic reaction has been reported.
• Cholesterol levels may be elevated by Actemra and should be monitored.
• Hepatitis B virus reactivation in patients who carry the virus in their blood.
• Liver test and blood cell count abnormalities. Serious cases of liver damage have occurred. Let your doctor know if you notice bruising, bleeding, paleness or yellowness of the skin.

You should not receive live vaccines (for eg. polio, smallpox, the Zostavax for Shingles) while on Actemra, without speaking with your doctor. The injected flu vaccine and pneumonia vaccine and injectable killed Shingles vaccine can be safely administered while on Actemra. The nasal spray version of the flu vaccine (which is a live vaccine) or live shingles vaccine should not be administered while on Actemra. Please let your doctor know if someone in your household has received or will receive a live virus vaccine.

Tell your doctor if you are pregnant, planning to become pregnant, or breastfeeding. Actemra, have NOT been studied in pregnant or nursing women.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins and herbal supplements. Your doctor will tell you if it is okay to take your other medicines while taking Actemra.

You should not take Actemra while you are taking any other biologic medication – these include Enbrel, Humira, Remicade, Kineret, Orencia and Rituxan. Actemra and Kevzara should not be taken with other biologic medications.

The most common side effects from Actemra are respiratory infections, headache, high blood pressure and abnormal liver function tests.

Injection site reactions can occur with subcutaneous Actemra.

Actemra can be given as a self administered weekly or biweekly subcutaneous injection, or as a monthly intravenous infusion lasting approximately one hour. You will see your physician in follow-up to monitor your progress and response to the medication. Also, please call us if you experience any side effects.

In case of an emergency, you can call 911 or go to the nearest emergency room. You can also contact our office at (916)- 677-4744 from 8:00 am to 5:00 pm Monday – Friday.

I certify that I have read and understand this consent form and agree to receive Actemra intravenous infusions. I have had an opportunity to discuss this treatment with my physician and ask questions regarding the treatment. I will be given a signed copy of this form for my records.