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Commonly asked questions about IMAAVY
You may be eligible for IMAAVY if you are 12 years of age and older and have generalized myasthenia gravis (gMG) that is antibody-positive (anti-acetylcholine receptor [AChR] or anti-muscle-specific tyrosine kinase [MuSK]). Talk to your healthcare provider to find out if IMAAVY is the right choice for you.
IMAAVY is
*It is not known if IMAAVY is safe and effective in children under 12 years of age.
As a neonatal fragment crystallizable receptor (FcRn) blocker, IMAAVY binds to FcRn to help reduce the amount of circulating immunoglobulin G (IgG) antibodies, including harmful anti-AChR and anti-MuSK antibodies, in your body.
See the science
behind IMAAVY
If you have a reaction during your IMAAVY infusion, your healthcare provider may decide to give IMAAVY more slowly or to stop your infusion.
If you miss a scheduled IMAAVY infusion, you should receive your next dose as soon as possible.
IMAAVY will be given to you by your healthcare provider through intravenous (IV) infusion into your vein.
The most common side effects in people with gMG treated with IMAAVY include:
If you have a reaction during your IMAAVY infusion, your healthcare provider may decide to give IMAAVY more slowly or to stop your infusion.
IMAAVY may cause serious side effects, including:
These are not all of the possible side effects of IMAAVY. Call your healthcare provider for medical advice
about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Terms and definitions
Autoimmune: Refers to a category of conditions in which the immune system mistakenly attacks the body's own organs or tissues. Myasthenia gravis (MG) is considered an autoimmune disease.
Clinical study: A research study conducted by investigators to determine the effectiveness and safety of a treatment like IMAAVY. The U.S. Food and Drug Administration, or FDA, reviews clinical trial data to determine if an investigational treatment is safe and effective to be approved for use.
FcRn (neonatal fragment crystallizable receptor) blocker: A class of medications that IMAAVY belongs to. FcRn blockers bind to FcRn, a protein in your body, to help reduce the levels of IgG antibodies, including harmful IgG antibodies.
Food and Drug Administration (FDA): A government agency responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, and the safety of our nation's food supply, cosmetics, and products that emit radiation.
Generalized myasthenia gravis (gMG): The most common form of MG, a rare autoimmune neuromuscular disease that interrupts the communication between the nerves and muscles, causing muscle weakness and tiredness.
Harmful IgG antibodies: Also known as autoantibodies, they are a type of antibody that attacks the body's own tissues and organs, leading to symptoms such as those seen in autoimmune disorders like gMG. In gMG, these harmful IgG antibodies can include harmful anti-AChR and anti-MuSK antibodies.
Immunoglobulin G (IgG): A type of antibody and the most common type found in the body. They are produced by the immune system to help protect the body from infection and disease.
Intravenous (IV) infusion: A process that delivers fluids or medication directly to the bloodstream through a vein. IMAAVY is given as an IV infusion by your healthcare provider or trained infusion specialist.
Myasthenia gravis (MG): A rare, chronic autoimmune condition that disrupts communication between muscles and nerves.
Neonatal fragment crystallizable receptor (FcRn): A protein that helps regulate the amount of immunoglobulin G (IgG) antibodies circulating through your body. FcRn blockers like IMAAVY bind to this protein in order to help reduce IgG antibody levels.
Neuromuscular junction: A region in your body where the nerves and muscles meet, allowing for signals to be sent between them. MG affects the neuromuscular junction's ability to send these signals.
Receptors: In generalized myasthenia gravis (gMG), receptors refer to proteins at the neuromuscular junction (such as acetylcholine receptor [AChR] and muscle-specific tyrosine kinase [MuSK]) that help nerves communicate with muscles.
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