Improved symptoms
~7 out of 10 patients (221 out of 322) on VYVGART Hytrulo had improvements and moved onto stage B.
How was VYVGART Hytrulo studied?
The VYVGART Hytrulo clinical study was the largest in chronic inflammatory demyelinating polyneuropathy (CIDP) history and included patients who had:
- Different types of CIDP (typical, distal, multifocal, and motor)
- Never been treated for CIDP
- Been previously treated for CIDP with IVIg, SCIg, or steroids
IVIg=intravenous immunoglobulin; SCIg=subcutaneous immunoglobulin
The effectiveness of VYVGART Hytrulo was established in 2 stages of a clinical study
Stage A
- Goal: Identify patients who had symptom improvements with VYVGART Hytrulo at 2 consecutive visits. These patients moved onto stage B
- Symptom improvements were measured using 1 of the following:
- Arm and leg function (aINCAT)
- Grip strength
- Ability to perform daily activities, for example, walking, showering, and dressing (I-RODS)
- All 322 patients in stage A received VYVGART Hytrulo
aINCAT=adjusted Inflammatory Neuropathy Cause and Treatment; I-RODS=Inflammatory Rasch-built Overall Disability Scale
VYVGART Hytrulo significantly reduced the risk of CIDP getting worse
Stage B (main part of the study)
- Main study goal: From the start of stage B, determine how long arm and leg function was maintained without getting worse for patients who received VYVGART Hytrulo, compared to those who were given placebo
- Arm and leg function (aINCAT) was measured every 4 weeks
- 111 patients received VYVGART Hytrulo, and 110 patients were given placebo
Maintained function
Patients who received VYVGART Hytrulo maintained their level of arm and leg function longer than those who were given placebo.
Reduced risk of CIDP getting worse
The risk of CIDP getting worse was 61% lower for patients taking VYVGART Hytrulo, compared to those who received placebo.
VYVGART Hytrulo has an established safety profile
When considering treatment, talking to your doctor about the potential benefits and side effects can help you know what to expect.
Most common side effects
- Respiratory tract infection
- Headache
- Urinary tract infection
- Tingling sensation
- Muscle pain
- Injection site reaction
Most common injection site reactions
- Injection site rash
- Redness of the skin
- Itching sensation
- Bruising
- Pain
- Hives
- All injection site reactions were mild to moderate
- Most injection site reactions occurred during the first 3 months of treatment
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.
These are not all the possible side effects of 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.
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 www.VYVGARTpregnancy.com. You may also talk to your healthcare provider about how you can take part in this registry.
Discover more about VYVGART Hytrulo
How VYVGART Hytrulo works
Discover how VYVGART Hytrulo is specifically designed to help cause a reduction in the number of IgG antibodies, including harmful IgG antibodies.
About VYVGART Hytrulo injections
A first for CIDP—one subcutaneous injection given weekly that takes ~30 to 90 seconds.*
*After administering your injection, your healthcare provider will monitor you for allergic reactions for at least 30 minutes.
IgG=Immunoglobulin G
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 HYTRULO can cause serious allergic reactions and a decrease in blood pressure leading to fainting.
VYVGART HYTRULO may cause serious side effects, including:
- Infection. VYVGART HYTRULO may increase the risk of infection. The most common infections for efgartigimod alfa-fcab-treated patients were urinary tract and respiratory tract infections. Signs or symptoms of an infection may include fever, chills, frequent and/or painful urination, cough, pain and blockage of nasal passages/sinus, wheezing, shortness of breath, fatigue, sore throat, excess phlegm, nasal discharge, back pain, and/or chest pain.
- Allergic Reactions (hypersensitivity reactions). VYVGART HYTRULO can cause allergic reactions such as rashes, swelling under the skin, and shortness of breath. Hives were also observed in patients treated with VYVGART HYTRULO. Serious allergic reactions, such as trouble breathing and decrease in blood pressure leading to fainting have been reported with efgartigimod alfa-fcab.
- Infusion-Related Reactions. VYVGART HYTRULO can cause infusion-related reactions. The most frequent symptoms and signs reported with efgartigimod alfa-fcab were high blood pressure, chills, shivering, and chest, abdominal, and back pain.
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 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.
Before taking VYVGART HYTRULO, tell your doctor if you:
- take any medicines, including prescription and non-prescription medicines, supplements, or herbal medicines,
- have received or are scheduled to receive a vaccine (immunization), or
- have any allergies or medical conditions, including if you are pregnant or planning to become pregnant, or are breastfeeding.
What are the common side effects of VYVGART HYTRULO?
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 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.
What is VYVGART® HYTRULO (efgartigimod alfa and hyaluronidase-qvfc)?
VYVGART HYTRULO is a prescription medicine used for the treatment of adult patients with chronic inflammatory demyelinating polyneuropathy (CIDP)
Please see the full Prescribing Information for VYVGART HYTRULO and talk to your doctor.
IMPORTANT SAFETY INFORMATION
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 HYTRULO can cause serious allergic reactions and a decrease in blood pressure leading to fainting.
VYVGART HYTRULO may cause serious side effects, including:
- Infection. VYVGART HYTRULO may increase the risk of infection. The most common infections for efgartigimod alfa-fcab-treated patients were urinary tract and respiratory tract infections. Signs or symptoms of an infection may include fever, chills, frequent and/or painful urination, cough, pain and blockage of nasal passages/sinus, wheezing, shortness of breath, fatigue, sore throat, excess phlegm, nasal discharge, back pain, and/or chest pain.
- Allergic Reactions (hypersensitivity reactions). VYVGART HYTRULO can cause allergic reactions such as rashes, swelling under the skin, and shortness of breath. Hives were also observed in patients treated with VYVGART HYTRULO. Serious allergic reactions, such as trouble breathing and decrease in blood pressure leading to fainting have been reported with efgartigimod alfa-fcab.
- Infusion-Related Reactions. VYVGART HYTRULO can cause infusion-related reactions. The most frequent symptoms and signs reported with efgartigimod alfa-fcab were high blood pressure, chills, shivering, and chest, abdominal, and back pain.
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 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.
Before taking VYVGART HYTRULO, tell your doctor if you:
- take any medicines, including prescription and non-prescription medicines, supplements, or herbal medicines,
- have received or are scheduled to receive a vaccine (immunization), or
- have any allergies or medical conditions, including if you are pregnant or planning to become pregnant, or are breastfeeding.
What are the common side effects of VYVGART HYTRULO?
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 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.
What is VYVGART® HYTRULO (efgartigimod alfa and hyaluronidase-qvfc)?
VYVGART HYTRULO is a prescription medicine used for the treatment of adult patients with chronic inflammatory demyelinating polyneuropathy (CIDP)
Please see the full Prescribing Information for VYVGART HYTRULO and talk to your doctor.
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 HYTRULO can cause serious allergic reactions and a decrease in blood pressure leading to fainting.
VYVGART HYTRULO may cause serious side effects, including:
- Infection. VYVGART HYTRULO may increase the risk of infection. The most common infections for efgartigimod alfa-fcab-treated patients were urinary tract and respiratory tract infections. Signs or symptoms of an infection may include fever, chills, frequent and/or painful urination, cough, pain and blockage of nasal passages/sinus, wheezing, shortness of breath, fatigue, sore throat, excess phlegm, nasal discharge, back pain, and/or chest pain.
- Allergic Reactions (hypersensitivity reactions). VYVGART HYTRULO can cause allergic reactions such as rashes, swelling under the skin, and shortness of breath. Hives were also observed in patients treated with VYVGART HYTRULO. Serious allergic reactions, such as trouble breathing and decrease in blood pressure leading to fainting have been reported with efgartigimod alfa-fcab.
- Infusion-Related Reactions. VYVGART HYTRULO can cause infusion-related reactions. The most frequent symptoms and signs reported with efgartigimod alfa-fcab were high blood pressure, chills, shivering, and chest, abdominal, and back pain.
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 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.
Before taking VYVGART HYTRULO, tell your doctor if you:
- take any medicines, including prescription and non-prescription medicines, supplements, or herbal medicines,
- have received or are scheduled to receive a vaccine (immunization), or
- have any allergies or medical conditions, including if you are pregnant or planning to become pregnant, or are breastfeeding.
What are the common side effects of VYVGART HYTRULO?
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 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.
What is VYVGART® HYTRULO (efgartigimod alfa and hyaluronidase-qvfc)?
VYVGART HYTRULO is a prescription medicine used for the treatment of adult patients with chronic inflammatory demyelinating polyneuropathy (CIDP)
Please see the full Prescribing Information for VYVGART HYTRULO and talk to your doctor.
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