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 Benlysta (Belimumab).
HEALTH CANADA ADVISORY
April 4, 2019
Health Canada has issued information concerning the use of Benlysta (Belimumab). 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 serious allergic reaction to Benlysta (Belimumab). Signs of an allergic reaction include a severe rash, Hives, swollen face or throat, or difficulty breathing. If these occur, get immediate medical attention.
Cancer: As with other medications that reduce the effectiveness of the immune system, Benlysta (Belimumab) may increase the risk of developing cancer. Discuss any concerns you may have with your doctor. Report any unusual infections, swelling or persistent pain, or unintentional weight loss to your doctor as soon as possible.
Depression: Benlysta (Belimumab) may cause or worsen symptoms of depression. If you have depression or a history of depression, discuss with your doctor how Benlysta (Belimumab) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Benlysta (Belimumab), and whether any special monitoring is needed.
If you experience symptoms of depression such as poor concentration, changes in weight, changes in sleep, decreased interest in activities, or notice them in a family member who is taking Benlysta (Belimumab), contact your doctor as soon as possible.
Infection: Benlysta (Belimumab) can reduce the number of cells that fight infection in the body (white blood cells), increasing the risk of developing an infection or reactivating an inactive infection (e.g., herpes, Shingles). Avoid contact with people with contagious infections when possible.
If you notice signs of an infection such as fever, chills, pain, redness and swelling, pus, cough, or difficult or painful urination, contact your doctor as soon as possible.
Benlysta (Belimumab) should also not be started while you have an active infection or a weakened immune system. While you are taking Benlysta (Belimumab), your doctor will monitor you for signs of infection.
Infusion-related reactions: As with other biologic therapies, Benlysta (Belimumab) can cause severe infusion-related reactions, sometimes resulting in death. Your health care provider will closely monitor you during and after the infusion. These reactions usually occur within 30 minutes to 2 hours of starting the infusion.
If you experience symptoms of an infusion reaction, such as fever, chills, difficulty breathing, tightness of chest or throat, stomach upset, and rash, tell your health care provider immediately.
It is important to take the medication(s) recommended by your doctor before your infusion of Benlysta (Belimumab). If you experience a severe infusion reaction, your doctor will give you additional medications to treat the reaction. Ask your doctor for more information.
Progressive multifocal leukoencephalopathy (PML): There have been reports of PML after using Benlysta (Belimumab). PML is a rare disorder that causes nerve damage in the brain. If you experience memory loss, vision loss, trouble thinking, or difficulty walking, contact your doctor immediately.
Suicide or self-harm: People using Benlysta (Belimumab) sometimes have thoughts of suicide or self-harm. If you have depression when you start to use Benlysta (Belimumab), you may be at an increased risk of feeling agitated (restless, anxious, aggressive, emotional, and feeling not like yourself), or wanting to hurt yourself or others. If you experience these side effects or notice them in a family member who is taking Benlysta (Belimumab), contact your doctor immediately.
Vaccines: Benlysta (Belimumab) may reduce the effectiveness of these vaccines. Live vaccines should not be given within 30 days of receiving Benlysta (Belimumab), or while using Benlysta (Belimumab). Talk to your doctor if you need any vaccinations while taking Benlysta (Belimumab).
Pregnancy: Benlysta (Belimumab) is not recommended for use during pregnancy. If you may become pregnant, use an effective method of birth control while you are using Benlysta (Belimumab), and for at least 4 months after the last treatment. Tell your doctor immediately if you become pregnant.
Breast-feeding: It is not known if Benlysta (Belimumab) passes into breast milk. If you are a breast-feeding mother and are taking Benlysta (Belimumab), it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.
Children: The safety and effectiveness of using Benlysta (Belimumab) have not been established for children.
