Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Actemra (Tocilizumab).
HEALTH CANADA ADVISORY
May 21, 2019
Health Canada has issued new restrictions concerning the use of Actemra (Tocilizumab). To read the full Health Canada Advisory, visit Health Canada's web site at www.hc-sc.gc.ca.
Allergic reactions: In rare cases, some people may develop a severe allergic reaction to Actemra (Tocilizumab). Even if these reactions do not occur with the first infusion of the medication, they may still happen with future doses of Actemra (Tocilizumab). Your health care provider will monitor you while you are receiving Actemra (Tocilizumab) by infusion. Signs of an allergic reaction include a severe rash, Hives, swollen face or throat, difficulty breathing, lightheadedness, or dizziness. If any of these occur, contact your doctor immediately.
Bleeding: Actemra (Tocilizumab) may cause a reduced number of platelets in the blood, which can make it difficult to stop cuts from bleeding. If you notice any signs of bleeding, such as frequent nosebleeds, unexplained bruising, or black and tarry stools, notify your doctor as soon as possible. Your doctor will order routine blood tests to make sure potential problems are caught early.
Blood pressure: Actemra (Tocilizumab) can cause an increase in blood pressure that is associated with an increased risk of heart disease. Your blood pressure should be monitored after starting Actemra (Tocilizumab). If you have a history of high blood pressure, discuss with your doctor how Actemra (Tocilizumab) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Actemra (Tocilizumab), and whether any special monitoring is needed.
Cancer: People taking Actemra (Tocilizumab) for rheumatoid arthritis in clinical trials developed cancer more often than the general population. The role of Actemra (Tocilizumab) in developing cancer is not known.
Dizziness: Actemra (Tocilizumab) may cause dizziness, affecting your ability to drive or operate machinery. Avoid driving, operating machinery, or performing other potentially hazardous tasks until you have determined how Actemra (Tocilizumab) affects you.
Gastrointestinal problems: People receiving Actemra (Tocilizumab) have experienced perforations in the lining of their digestive system, usually as a complication of diverticulitis (infection of the large intestine). If you have a history of ulcers or diverticulitis, discuss with your doctor how Actemra (Tocilizumab) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Actemra (Tocilizumab), and whether any special monitoring is needed.
Heart disease: People with rheumatoid arthritis are at an increased risk for heart and blood vessel disorders. If you have heart disease or are at risk of developing heart disease or blood vessel disorders, discuss with your doctor how Actemra (Tocilizumab) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Actemra (Tocilizumab), and whether any special monitoring is needed. Talk to your doctor about managing your risk factors for heart disease.
Infection: Actemra (Tocilizumab) can reduce the number of cells that fight infection in the body (white blood cells). Tell your doctor immediately if you notice signs of an infection, such as fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness. Your doctor will do blood tests regularly to monitor the number of specific types of blood cells in your blood.
Liver function: People with active liver disease or liver dysfunction should not take Actemra (Tocilizumab). Actemra (Tocilizumab) may reduce liver function and can cause liver failure. If you have liver problems, discuss with your doctor how Actemra (Tocilizumab) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Actemra (Tocilizumab), and whether any special monitoring is needed. Your doctor may want to test your liver function regularly with blood tests while you are taking Actemra (Tocilizumab).
Macrophage activation syndrome: This is a serious life-threatening complication of sJIA, in which the body's immune system becomes over-activated. This condition develops quickly and may be identified by a sudden fever that doesn't go away, irritability, confusion, and tiredness. This condition is a medical emergency, as it may be fatal. If you notice any of these signs, contact your doctor or get medical attention as soon as possible.
Multiple sclerosis: There have been rare reports of multiple sclerosis in people receiving Actemra (Tocilizumab). If you have a history of diseases of the nerves or nervous system, discuss with your doctor how Actemra (Tocilizumab) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Actemra (Tocilizumab), and whether any special monitoring is needed. Report any symptoms such as blurred vision; loss of vision; eye pain; dizziness; or numbness or weakness in the face, arms, or legs to your doctor.
Serious infections: Actemra (Tocilizumab) can increase the risk of developing serious infections, including blood infections (sepsis), Tuberculosis (TB), fungal, and different opportunistic infections. If any of the symptoms of infection appear (e.g., fever, chills, persistent cough, weight loss, throat pain or soreness, wheezing, red or swollen skin blisters, wounds, severe weakness or tiredness), contact your doctor immediately to get appropriate treatment. Before starting Actemra (Tocilizumab), your doctor may test you to see if you have TB, hepatitis, or other active infections.
People infected with hepatitis B or C virus (an infection that can damage the liver) may have a relapse of their condition while receiving Actemra (Tocilizumab). Talk to your doctor if you have any concerns.
Vaccinations: Live vaccines are not recommended for people receiving Actemra (Tocilizumab). Talk to your doctor if you need any vaccinations while receiving Actemra (Tocilizumab).
Pregnancy: Actemra (Tocilizumab) should not be used during pregnancy unless the benefits outweigh the risks. Effective birth control must be used to prevent pregnancy during treatment and for 3 months after the last dose of Actemra (Tocilizumab). If you become pregnant while receiving Actemra (Tocilizumab), contact your doctor immediately.
Breast-feeding: It is not known if Actemra (Tocilizumab) passes into breast milk. If you are a breast-feeding mother and are receiving Actemra (Tocilizumab), it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.
Children: The safety and effectiveness of Actemra (Tocilizumab) have not been established for children with sJIA or pJIA less than 2 years of age, or children with CRS less than 3 years of age. The safety and effectiveness of Actemra (Tocilizumab) for the treatment of conditions other than sJIA, pJIA, or CRS have not been established for children less than 18 years of age.
Seniors: Serious infections occur more often in people older than 65 receiving Actemra (Tocilizumab) compared to people under 65 years old. Talk to your doctor if you have any questions.
