Improved symptoms
~7 out of 10 patients on VYVGART Hytrulo had improvements and moved on to stage B (221 out of 322 patients).
How was VYVGART Hytrulo studied?
The VYVGART Hytrulo clinical study was the largest in CIDP history and included patients who had:
- Different types of CIDP: typical and atypical (asymmetrical, distal, and pure 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 on to stage B
- Symptom improvements were measured using 1 of the following:
- Arm and leg function (aINCAT)
- Grip strength
- Ability to perform 24 daily activities, such as 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 U.S. 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.
Self-injection with the VYVGART Hytrulo prefilled syringe
The first and only self-injection for CIDP that takes about 20-30 seconds.†
†Please see Patient Information. Follow appropriate administration steps in the Instructions for Use. Monitor for signs and symptoms of an allergic reaction for at least 30 minutes after injection. If an allergic reaction occurs, you should seek medical attention.
IgG=immunoglobulin G.
Do not take VYVGART HYTRULO if you are allergic to efgartigimod alfa, hyaluronidase, or any of the ingredients in VYVGART HYTRULO. VYVGART HYTRULO can cause serious allergic reactions and a decrease in blood pressure leading to fainting.
Before taking VYVGART HYTRULO, tell your healthcare provider about all of your medical conditions, including if you:
- have an infection or fever.
- have recently received or are scheduled to receive any vaccinations.
- have any history of allergic reactions.
- have kidney (renal) problems.
- are pregnant or plan to become pregnant. It is not known whether VYVGART HYTRULO will harm your unborn baby.
- Pregnancy Exposure Registry. There is a pregnancy exposure registry for women who use VYVGART HYTRULO during pregnancy. The purpose of this registry is to collect information about your health and your baby. Your healthcare provider can enroll you in this registry. You may also enroll yourself or get more information about the registry by calling 1-855-272-6524 or going to VYVGARTPregnancy.com
- are breastfeeding or plan to breastfeed. It is not known if VYVGART HYTRULO passes into your breast milk.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
VYVGART HYTRULO can cause side effects which can be serious, including:
- Infection. VYVGART HYTRULO may increase the risk of infection. If you have an active infection, your healthcare provider should delay your treatment with VYVGART HYTRULO until your infection is gone. Tell your healthcare provider right away if you get any of the following signs and symptoms of an infection:
- fever
- chills
- frequent and painful urination
- cough
- pain and blockage of nasal passages
- wheezing
- shortness of breath
- sore throat
- excess phlegm
- nasal discharge
- Allergic reactions (hypersensitivity reactions). VYVGART HYTRULO can cause allergic reactions that can be severe. These reactions can happen during, shortly after, or weeks after your VYVGART HYTRULO injection. Tell your healthcare provider or get emergency help right away if you have any of the following symptoms of an allergic reaction:
- rash
- swelling of the face, lips, throat, or tongue
- shortness of breath
- hives
- trouble breathing
- low blood pressure
- fainting
- Infusion or injection-related reactions. VYVGART HYTRULO can cause infusion or injection-related reactions. These reactions can happen during or shortly after your VYVGART HYTRULO injection. Tell your healthcare provider if you have any of the following symptoms of an infusion or injection-related reaction:
- high blood pressure
- chills
- shivering
- chest, stomach, or back pain
The most common side effects of VYVGART HYTRULO include respiratory tract infection, headache, urinary tract infection, and injection site reactions.
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 FDA at 1-800-FDA-1088.
What is VYVGART HYTRULO® (efgartigimod alfa and hyaluronidase-qvfc)?
VYVGART HYTRULO is a prescription medicine used to treat adults with chronic inflammatory demyelinating polyneuropathy (CIDP).
It is not known if VYVGART HYTRULO is safe and effective in children.
Please see full Prescribing and Patient Information for VYVGART HYTRULO.
Dosage forms and strengths:
VYVGART Hytrulo is available as a single-dose subcutaneous injection containing: 200 mg/mL of efgartigimod alfa and 2,000 U/mL of hyaluronidase per prefilled syringe, or 180 mg/mL of efgartigimod alfa and 2,000 U/mL of hyaluronidase per vial.
IMPORTANT SAFETY INFORMATION
Do not take VYVGART HYTRULO if you are allergic to efgartigimod alfa, hyaluronidase, or any of the ingredients in VYVGART HYTRULO. VYVGART HYTRULO can cause serious allergic reactions and a decrease in blood pressure leading to fainting.
Before taking VYVGART HYTRULO, tell your healthcare provider about all of your medical conditions, including if you:
- have an infection or fever.
- have recently received or are scheduled to receive any vaccinations.
- have any history of allergic reactions.
- have kidney (renal) problems.
- are pregnant or plan to become pregnant. It is not known whether VYVGART HYTRULO will harm your unborn baby.
- Pregnancy Exposure Registry. There is a pregnancy exposure registry for women who use VYVGART HYTRULO during pregnancy. The purpose of this registry is to collect information about your health and your baby. Your healthcare provider can enroll you in this registry. You may also enroll yourself or get more information about the registry by calling 1-855-272-6524 or going to VYVGARTPregnancy.com
- are breastfeeding or plan to breastfeed. It is not known if VYVGART HYTRULO passes into your breast milk.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
VYVGART HYTRULO can cause side effects which can be serious, including:
- Infection. VYVGART HYTRULO may increase the risk of infection. If you have an active infection, your healthcare provider should delay your treatment with VYVGART HYTRULO until your infection is gone. Tell your healthcare provider right away if you get any of the following signs and symptoms of an infection:
- fever
- chills
- frequent and painful urination
- cough
- pain and blockage of nasal passages
- wheezing
- shortness of breath
- sore throat
- excess phlegm
- nasal discharge
- Allergic reactions (hypersensitivity reactions). VYVGART HYTRULO can cause allergic reactions that can be severe. These reactions can happen during, shortly after, or weeks after your VYVGART HYTRULO injection. Tell your healthcare provider or get emergency help right away if you have any of the following symptoms of an allergic reaction:
- rash
- swelling of the face, lips, throat, or tongue
- shortness of breath
- hives
- trouble breathing
- low blood pressure
- fainting
- Infusion or injection-related reactions. VYVGART HYTRULO can cause infusion or injection-related reactions. These reactions can happen during or shortly after your VYVGART HYTRULO injection. Tell your healthcare provider if you have any of the following symptoms of an infusion or injection-related reaction:
- high blood pressure
- chills
- shivering
- chest, stomach, or back pain
The most common side effects of VYVGART HYTRULO include respiratory tract infection, headache, urinary tract infection, and injection site reactions.
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 FDA at 1-800-FDA-1088.
What is VYVGART HYTRULO® (efgartigimod alfa and hyaluronidase-qvfc)?
VYVGART HYTRULO is a prescription medicine used to treat adults with chronic inflammatory demyelinating polyneuropathy (CIDP).
It is not known if VYVGART HYTRULO is safe and effective in children.
Please see full Prescribing and Patient Information for VYVGART HYTRULO.
Dosage forms and strengths:
VYVGART Hytrulo is available as a single-dose subcutaneous injection containing: 200 mg/mL of efgartigimod alfa and 2,000 U/mL of hyaluronidase per prefilled syringe, or 180 mg/mL of efgartigimod alfa and 2,000 U/mL of hyaluronidase per vial.
Facebook
Twitter
PinterestThis site is intended for patients and caregivers.
Disclaimer | Privacy Policy | Contact Us |
VYVGART and VYVGART Hytrulo are registered trademarks of argenx.
LIVE VYVIDLY and THAT’S LIVING VYVIDLY are trademarks of argenx.
For U.S. audiences only.
©2025 argenx
US-VYV_HYT-24-00514 V2 05/2025
