Important safety information

Clinical use:
The safety and efficacy of VYVGART® in children and adolescents below the age of 18 years has not been established. VYVGART® is not indicated for use in pediatric patients.
 
Contraindications:

  • VYVGART® is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.

 
Other relevant warnings and precautions:

  • Increased risk of infections including upper respiratory tract infections and urinary tract infections; monitor patients for signs and symptoms of infections during treatment and delay administration in patients with an active infection until the infection is resolved.
  • Vaccination with live or live attenuated vaccines is not recommended in patients taking VYVGART®; for all other vaccines, vaccination should take place at least 2 weeks after the last infusion of a treatment cycle and 4 weeks before initiating the next cycle.
  • There is no clinical experience with VYVGART® use and its potential effect on fertility.
  • Hypersensitivity and infusion related reactions; monitor patients during administration and for 1 hour thereafter for clinical signs and symptoms of infusion reactions.
  • There is no available clinical data on the use of VYVGART® during pregnancy; risk and benefits should be considered prior to administering live vaccines to infants exposed to VYVGART® in utero.
  • There is no information regarding the presence of VYVGART® in human milk, the effects on the breastfed infant, or the effects on milk production; a risk to the breastfed newborn/infant cannot be excluded.

 
For more information:
Please consult the Product Monograph at https://www.argenx.com/product/vyvgart_product_monograph.pdf for important information relating to adverse reactions, drug interactions, and dosing information which have not been discussed in this advertisement. The Product Monograph is also available by calling argenx Medical Information at 1-800-731-8917. Please submit any inquiries at https://argenxmedical.com/en-ca/medical-inquiry.html.