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 this medication.
HEALTH CANADA ADVISORY
August 6, 2014
Health Canada has issued new information concerning the use of Arzerra (ofatumumab). To read the full report, visit Health Canada's website at www.hc-sc.gc.ca.
A previous advisory on ofatumumab was issued on January 27, 2014. To read the full Health Canada Advisory, visit Health Canada's web site at www.hc-sc.gc.ca.
Anemia: Ofatumumab may cause low levels of red blood cells. If you experience symptoms of reduced red blood cell count (anemia) such as shortness of breath, feeling unusually tired, or pale skin, contact your doctor as soon as possible.
Your doctor will do blood tests regularly to monitor the number of specific types of blood cells, including red blood cells, in your blood.
Blood clotting: This medication can reduce the number of platelet cells in the blood. Platelets help the blood to clot, and a shortage could make you bleed more easily. Tell your doctor of any signs that your blood is not clotting as quickly as usual. Such symptoms may include black and tarry stools, blood in the urine, easy bruising, or cuts that won't stop bleeding.
Your doctor will do blood tests regularly to monitor the number of specific types of blood cells, including platelets, in your blood.
Heart disease: Serious blood pressure changes, fluid build-up around the lungs, and heart attack may occur with the use of this medication. If you have a history of heart problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Hepatitis B infection: As it kills cancer cells, ofatumumab also damages the cells that are responsible for protecting the body from infection. If you have hepatitis B infection or are a carrier of the hepatitis B virus, this may allow the hepatitis B infection to flare up, possibly causing fatal liver damage. If you have a history of hepatitis B infection, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Infection: As well as killing cancer cells, ofatumumab can reduce the number of cells that fight infection in the body (white blood cells). If possible, avoid contact with people with contagious infections.
Tell your doctor immediately if you notice signs of an infection, such as fever or chills, severe diarrhea, cough, shortness of breath, prolonged dizziness, headache, stiff neck, or listlessness. Your doctor will do blood tests regularly to monitor the number of specific types of blood cells in your blood.
Progressive multifocal leukoencephalopathy (PML): This is a rare disease of the brain that is caused by viruses attacking the nerve cells in the brain. Rarely, it may occur when using medications like ofatumumab. If you have had a previous episode of PML, ofatumumab is not an appropriate medication for you. Contact your doctor immediately if you experience signs and symptoms of PML, such as unusual clumsiness, memory loss, gradually worsening weakness, and possible visual, speech or personality changes.
Tumour lysis syndrome: Ofatumumab, like many other cancer medications, causes many cancer cells to be suddenly killed when treatment is first started. This can overwhelm the body with waste products from the cells. As a result, the body may not be able to keep up with getting rid of all the waste. When this happens, you may experience nausea, shortness of breath, cloudy urine, or joint pain. This is called tumour lysis syndrome. Your doctor may prescribe some medications to help your body get rid of the waste products. Make sure you understand how to use these medications and report any of these signs or symptoms to your doctor immediately.
Pregnancy: There is no information about the effect of ofatumumab on an unborn baby if this medication is used during pregnancy. Effective birth control should be practiced while using this medication and for 6 months after your last treatment. If you become pregnant while taking this medication, contact your doctor immediately.
Breast-feeding: It is not known if ofatumumab passes into breast milk. If you are a breast-feeding mother and are taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.
Children: The safety and effectiveness of using this medication have not been established for children.