The effectiveness of VYVGART Hytrulo was established through 2 studies.
AChR=acetylcholine receptor; gMG=generalized myasthenia gravis
IV=intravenous
VYVGART Hytrulo study design: The study compared antibody reduction in 110 adults (18 years or older) with gMG who remained on their current gMG treatment and were given either VYVGART Hytrulo for subcutaneous injection or VYVGART for IV infusion.
The criteria for participating in the study were the same as in the study that measured the safety and effectiveness of VYVGART for IV infusion.
MG-ADL=Myasthenia Gravis Activities of Daily Living
VYVGART for IV infusion was evaluated in a global study of adults with anti-AChR antibody positive gMG.
The study examined the effectiveness and safety of VYVGART for IV infusion in 167 adults (18 years or older) with gMG. In addition to their current treatment, patients received either VYVGART for IV infusion or placebo.
Patients in this study needed to meet the following criteria:
Patients represented a range of adults with gMG:
The MG-ADL scale was used to measure gMG symptoms.
MGFA=Myasthenia Gravis Foundation of America
The safety of VYVGART Hytrulo was established through 2 studies.
The overall safety of VYVGART Hytrulo for subcutaneous injection was consistent with the safety profile of VYVGART for IV infusion, except patients on VYVGART Hytrulo for subcutaneous injection experienced more injection site reactions.
In the VYVGART for IV infusion study, the most common side effects for VYVGART for IV infusion-treated patients were respiratory tract infection, headache, and urinary tract infection. Additionally, more patients on VYVGART for IV infusion vs. placebo had lower white blood cell counts that were mild to moderate in severity.
Learn more about the safety data in the VYVGART for IV infusion study.
In the VYVGART Hytrulo study, the most common side effects of VYVGART Hytrulo-treated patients were injection site reactions, 38% (21 of 55), and headache. Injection site reactions included injection site rash, redness of the skin, itching sensation, bruising, pain, and hives.
In the VYVGART Hytrulo study and its long-term safety study:
VYVGART Hytrulo may increase the risk of allergic reactions including rash, swelling under the skin, shortness of breath, and hives. It may also increase the risk of serious allergic reactions such as trouble breathing and decrease in blood pressure leading to fainting, as well as infusion-related reactions including increase in blood pressure, chills, shivering, and chest, abdominal, and back pain. These reactions can occur during or after treatment and can cause doctors to pause or, in some cases, stop treatment.
Pregnancy registry: There is a pregnancy registry for pregnant women who take VYVGART Hytrulo. The purpose of this registry is to collect information about the health of you and your baby if you take VYVGART Hytrulo during pregnancy. To learn more, call 1-855-272-6524 or visit VYVGARTpregnancy.com. You may also talk to your healthcare provider about how you can take part in this registry.
§If additional cycles are needed.
IgG=immunoglobulin G
Do not use VYVGART if you have a serious allergy to efgartigimod alfa or any of the other ingredients in VYVGART. Do not use VYVGART HYTRULO if you have a serious allergy to efgartigimod alfa, hyaluronidase, or any of the other ingredients in VYVGART HYTRULO. VYVGART and VYVGART HYTRULO can cause serious allergic reactions and a decrease in blood pressure leading to fainting.
Tell your doctor if you have signs or symptoms of an infection, allergic reaction, or infusion-related reaction. These can happen while you are receiving your VYVGART or VYVGART HYTRULO treatment or afterward. Your doctor may need to pause or stop your treatment. Contact your doctor immediately if you have signs or symptoms of a serious allergic reaction.
The most common side effects in efgartigimod-alfa-fcab-treated patients were respiratory tract infection, headache, and urinary tract infection. Additional common side effects with VYVGART HYTRULO are injection site reactions, including rash, redness of the skin, itching sensation, bruising, pain, and hives.
These are not all the possible side effects of VYVGART and VYVGART HYTRULO. Call your doctor for medical advice about side effects. You may report side effects to the US Food and Drug Administration at 1-800-FDA-1088.
VYVGART and VYVGART HYTRULO are both prescription medicines, each used to treat a condition called generalized myasthenia gravis, which causes muscles to tire and weaken easily throughout the body, in adults who are positive for antibodies directed toward a protein called acetylcholine receptor (anti-AChR antibody positive).
Please see the full Prescribing Information for VYVGART and the full Prescribing Information for VYVGART HYTRULO, and talk to your doctor.
Do not use VYVGART if you have a serious allergy to efgartigimod alfa or any of the other ingredients in VYVGART. Do not use VYVGART HYTRULO if you have a serious allergy to efgartigimod alfa, hyaluronidase, or any of the other ingredients in VYVGART HYTRULO. VYVGART and VYVGART HYTRULO can cause serious allergic reactions and a decrease in blood pressure leading to fainting.
Tell your doctor if you have signs or symptoms of an infection, allergic reaction, or infusion-related reaction. These can happen while you are receiving your VYVGART or VYVGART HYTRULO treatment or afterward. Your doctor may need to pause or stop your treatment. Contact your doctor immediately if you have signs or symptoms of a serious allergic reaction.
The most common side effects in efgartigimod-alfa-fcab-treated patients were respiratory tract infection, headache, and urinary tract infection. Additional common side effects with VYVGART HYTRULO are injection site reactions, including rash, redness of the skin, itching sensation, bruising, pain, and hives.
These are not all the possible side effects of VYVGART and VYVGART HYTRULO. Call your doctor for medical advice about side effects. You may report side effects to the US Food and Drug Administration at 1-800-FDA-1088.
VYVGART and VYVGART HYTRULO are both prescription medicines, each used to treat a condition called generalized myasthenia gravis, which causes muscles to tire and weaken easily throughout the body, in adults who are positive for antibodies directed toward a protein called acetylcholine receptor (anti-AChR antibody positive).
Please see the full Prescribing Information for VYVGART and the full Prescribing Information for VYVGART HYTRULO, and talk to your doctor.