Patient Medication Information: uses, side effects, how to take - Vyvgart
What VYVGART is used for:
VYVGART is used to treat adults with generalised Myasthenia Gravis (gMG), an autoimmune disease that causes muscle weakness. gMG can affect multiple muscle groups throughout the body. The condition can also lead to shortness of breath, extreme fatigue and difficulties swallowing.
In patients with gMG, IgG autoantibodies attack and damage proteins at the neuromuscular junction. Because of this damage, the nerves are not able to make the muscles contract as well as normal, leading to muscle weakness and difficulty moving. By binding to the neonatal Fc receptor (FcRn) protein and reducing autoantibody levels, VYVGART can improve the ability of muscles to contract and reduce the symptoms of the disease and their impact on daily activities.
How VYVGART works:
VYVGART contains the active substance efgartigimod alfa. Efgartigimod alfa binds to and blocks a protein in the body called FcRn. By blocking FcRn, efgartigimod alfa decreases the level of IgG autoantibodies which are proteins of the immune system that attack parts of a person’s own body by mistake.
The ingredients in VYVGART are:
Medicinal ingredients: efgartigimod alfa
Non-medicinal ingredients for Formulation 1: L-arginine hydrochloride, polysorbate 80, sodium chloride, sodium phosphate dibasic anhydrous, sodium phosphate monobasic monohydrate, water for injection.
Non-medicinal ingredients for Formulation 2: L-arginine hydrochloride, L-histidine, L-histidine hydrochloride monohydrate, L-methionine, polysorbate 80, sodium chloride, sucrose, water for injection.
VYVGART comes in the following dosage form:
400 mg/20 mL (20 mg/mL) solution, for intravenous use
Do not use VYVGART if:
- you are allergic to efgartigimod alfa or any other ingredients in VYVGART.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take VYVGART. Talk about any health conditions or problems you may have, including if you:
- have a history of infection or think you have an infection.
- have had a recent vaccination or are scheduled to receive any vaccinations. You should receive any required vaccines at least 4 weeks before you start treatment with VYVGART.
are pregnant or plan to become pregnant. It is not known if VYVGART will harm your unborn baby.
- are breastfeeding or plan to breastfeed. It is not known if VYVGART passes into your breast milk.
- have had an allergic reaction to VYVGART in the past.
Other warnings you should know about:
It is not known whether VYVGART may affect your fertility. Talk to your healthcare practitioner if you are planning on having children.
VYVGART may cause serious side effects, including:
- Infections: VYVGART may increase the risk of infection. Tell your healthcare professional right away if you have signs or symptoms of an infection during treatment with VYVGART such as fever, chills, frequent and/or painful urination, cough, pain and blockage of nasal passages/sinus, wheezing, shortness of breath, fatigue, sore throat, excess of secretion, nasal discharge, back pain, and/or chest pain.
- Undesirable immune reactions (hypersensitivity reactions): VYVGART can cause the immune system to have undesirable reactions such as rashes, swelling under the skin, itchiness, and shortness of breath. Tell your healthcare professional immediately about any undesirable reactions to VYVGART.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may also interact with VYVGART:
No relevant drug-drug interactions are known, however, use of VYVGART with medications that bind to the human FcRn (e.g., immunoglobulin products, monoclonal antibodies, or antibody derivates containing the human Fc domain of the IgG subclass) may reduce effectiveness of such medications. Inform your healthcare professional of any other medications you are taking.
How to take VYVGART:
VYVGART will be given to you by a healthcare professional. The product will be diluted and administered from a drip bag through a tube directly into one of your veins.
Usual dose:
The dose you receive will depend on your bodyweight and will be administered in cycles of one infusion per week for 4 weeks. Your doctor will determine when further treatment cycles are needed.
Overdose:
If you suspect that you have been accidentally administered a higher dose of VYVGART than prescribed, please contact your healthcare professional.
| If you think you, or a person you are caring for, have taken too much VYVGART, contact a healthcare professional, hospital emergency department, regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms. |
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Missed dose:
If you forget an appointment, please contact your healthcare professional immediately.
Interrupting or stopping treatment with VYVGART may cause your gMG symptoms to come back. Please speak to your doctor before stopping VYVGART. Your healthcare professional will discuss the possible side effects and risks with you. Your healthcare professional will also want to monitor you closely.
Possible side effects from using VYVGART:
These are not all the possible side effects you may have when taking VYVGART. If you experience any side effects not listed here, tell your healthcare professional.
Serious side effects and what to do about them
| Frequency/Side Effect/Symptom | Talk to your healthcare professional | Stop taking this drug and get immediate medical help | |||
|---|---|---|---|---|---|
| Only if severe | In all cases | ||||
| Very Common | |||||
| Upper Respiratory Tract Infection: nose and throat | ✓ | ||||
| Common | |||||
| Urinary Tract Infection: pain or a burning sensation during urination | ✓ | ||||
| Bronchitis: inflammation of the airways in the lungs | ✓ | ||||
| Myalgia: muscle pain | ✓ | ||||
| Headache during or after the administration | ✓ | ||||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
Reporting side effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
NOTE: Contact your healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice. |
Storage:
Store in a refrigerator at 2°C to 8°C in the original carton.
Do not freeze. Do not shake. Protect from light.
Do not use if visible particles are observed and/or the liquid in the vial is discoloured.
Keep out of reach and sight of children.
If you want more information about VYVGART:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes the Patient Medication Information by visiting the Health Canada Drug Product Database website (Drug Product Database: Access the database); the manufacturer’s website (argenx.ca) or by calling 1-800-731-8917.
Date of Authorization: