Benlysta

Benlysta (Belimumab) can be given as an intravenous (into a vein) infusion or a subcutaneous (under the skin) injection.

When Benlysta (Belimumab) is given as an intravenous (into a vein) infusion, the recommended adult dose is calculated as 10 mg per kilogram of body weight. It is given over 1 hour every 2 weeks for the first 3 doses. After the first 3 doses, it is given once every 4 weeks. Careful handling of Benlysta (Belimumab) is required. It is always given under the supervision of a doctor in a hospital or similar setting with access to sterile equipment for preparation.

When Benlysta (Belimumab) is given as a subcutaneous (under the skin) injection, the recommended adult dose is 200 mg injected, once a week, on the same day each week.

Subcutaneous Benlysta (Belimumab) is used with the guidance and supervision of a doctor. Your doctor or nurse will assist you in the preparation and injection of your first dose (or first few doses). Do not attempt to inject Benlysta (Belimumab) on your own until you completely understand how to inject a dose. Rotate the injection sites (stomach, upper thighs) to minimize injection site skin irritation.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important Benlysta (Belimumab) be given exactly as recommended by your doctor. If you miss an appointment to receive Benlysta (Belimumab), contact your doctor as soon as possible to reschedule your appointment. If you are injecting the medication yourself and you miss a dose, take it as soon as possible. After that you can go back to having your injection on the usual day or you can start a new weekly schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Refrigerate Benlysta (Belimumab) between 2°C and 8°C, protect it from direct sunlight, and keep it out of the reach of children. Do not allow the medication to freeze. Store Benlysta (Belimumab) in its original box until ready for use. If you are using the subcutaneous injection, remove it from the refrigerator 30 minutes prior to injection. Do not use if it is left out at room temperature for more than 12 hours.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

In addition to its desired action, this medication may cause some adverse effects, notably: it may cause headaches; it may cause mood changes and, occasionally, may lead to depression; it may cause diarrhea; it may cause sleep disturbances or insomnia; it may lower your white blood cell count, which can lead to fever, chills, sore throat or infections - if you experience any of these symptoms, contact your doctor right away; it may cause nausea or, rarely, vomiting. Each person may react differently to a treatment. If you think this medication may be causing adverse effects (including those described here, or others), talk to your health care professional. He or she can help you to determine whether or not the medication is the source of the problem.

120 mg/5 mL vial
After reconstitution with sterile water for injection, each vial containing a sterile white-to-off-white, preservative-free, lyophilized powder contains 120 mg of Benlysta (Belimumab) in a concentration of 80 mg/mL. Nonmedicinal ingredients: citric acid, polysorbate 80, sodium citrate, and sucrose.

400 mg/20 mL vial
After reconstitution with sterile water for injection, each vial containing a sterile white-to-off-white, preservative-free, lyophilized powder contains 400 mg of Benlysta (Belimumab) in a concentration of 80 mg/mL. Nonmedicinal ingredients: citric acid, polysorbate 80, sodium citrate, and sucrose.

200 mg/mL Subcutaneous Injection
Each mL of clear to opalescent, colourless-to-pale-yellow solution contains 200 mg of Benlysta (Belimumab). Nonmedicinal ingredients: L-arginine hydrochloride, L-histidine, L-histidine monohydrochloride, polysorbate 80, sodium chloride, and water for injections.

Do not take Benlysta (Belimumab) if you are allergic to Benlysta (Belimumab) or any ingredients of the medication.

There may be an interaction between Benlysta (Belimumab) and any of the following:

• Abatacept
• Anakinra
• Baricitinib
• BCG
• Cladribine
• Cyclophosphamide
• Denosumab
• echinacea
• Etanercept
• Fingolimod
• Leflunomide
• other monoclonal antibodies (e.g., Adalimumab, Golimumab, Infliximab, Ipilimumab)
• Natalizumab
• Nivolumab
• Pimecrolimus
• Roflumilast
• Tacrolimus
• Tofacitinib
• Trastuzumab
• vaccines

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Benlysta (Belimumab). Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

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.

This product must be injected under the skin (subcutaneously), according to the technique you were shown. Be sure to choose a different injection site each time. This medication is typically used only once a week. However, your pharmacist may have suggested a different schedule that is more appropriate for you. Take it regularly and continuously to maintain its beneficial effects.