Important Safety Information
Patients who receive ACTEMRA® (tocilizumab) infusions may be at an increased risk of developing serious infections. Your doctor should closely monitor treatment and check for signs of infection. In the case of developing an infection, treatment with Actrema should be paused until the infection is controlled.
What is the most important information I should know about ACTEMRA®?
ACTEMRA® affects how the immune system works, making it less likely to effectively fight viruses and bacteria. Reported infections include tuberculosis, candidiasis, aspergillosis, and pneumocystis. ACTEMRA® should not be used by patients with a known hypersensitivity to tocilizumab.
ACTEMRA® Side Effects
Because ACTEMRA® changes the way your immune system works, it could make you more susceptible to other illnesses. The most common side effects include:
- High blood pressure
- Upper respiratory tract infections
Infections caused by bacteria, fungi, or viruses — such as tuberculosis — are more likely to occur while taking ACTEMRA®. Before commencing treatment, tell your doctor if you have an infection, think you have an infection, or get recurring infections. Also let your doctor know if you have HIV, diabetes, a week immune system, or have or previously had hepatitis B, tuberculosis, or have lived or traveled to places where there’s an increased risk of infection.
Perforation of the Gastrointestinal Tract
ACTEMRA® may cause patients to develop perforations on the wall of the stomach or intestines — especially on those who are taking nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroids, or methotrexate. Tell your doctor immediately if you experience fever, abdominal pain, or a change in bowel movements.
ACTEMRA® may cause or worsen liver problems. Tell your doctor if you feel weak or are experiencing fatigue, yellowing of the skin or whites of the eyes, lack of appetite, nausea, vomiting, and/or confusion. Check the color of your urine and stools. If your urine is dark or stools are light, it may be an indication of hepatotoxicity.
Hepatitis B may become active on people who are carriers of the virus. Prior to starting treatment, your doctor should run blood tests to see if this would be an issue for you. Tell your healthcare provider if you feel tired or are experiencing fever, chills, yellowing of the skin and/or whites of the eyes, stomach pain, muscular aches, skin rashes, loss of appetite, or dark urine.
ACTEMRA® may increase the risk of certain cancers due to the way it suppresses the immune system. Malignant growths were observed in clinical studies of the medication. The impact of treatment with Actrema on the development of malignancies is unknown.
Tell your doctor if you experience any negative side effects. You are also encouraged to report such side effects to the Food and Drug Administration (FDA) by visiting www.fda.gov/medwatch, or by calling 1-800-FDA-1088.
Females Who Can Become Pregnant
If you are pregnant or planning to become pregnant — or if you’re breastfeeding or planning to breastfeed — talk to your doctor about whether ACTEMRA® is the right solution for you. If you take Actrema while pregnant, join the pregnancy registry. Its purpose is to check your health and the health of your baby. To learn more, talk to your healthcare provider or call 1-877-311-8972.
ACTEMRA® is a prescription infusion medication designed to treat adults with rheumatoid arthritis (RA), giant cell arteritis (GCA), and children with active polyarticular juvenile idiopathic arthritis (PDIA) or active systemic juvenile idiopathic arthritis (SJIA).
Please refer to Actrema’s full Prescribing Information.