Important Safety Information
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.
VYVGART is a registered trademark of argenx.
VYVGART Hytrulo is a trademark of argenx.
For U.S. audiences only.
©2024 argenx US-VYV_HYT-24-00157 V1 07/2024
Explore VYVGART Hytrulo, by argenx
VYVGART Hytrulo is a prescription medicine for adults with chronic inflammatory demyelinating polyneuropathy (CIDP) and is the first innovation in CIDP treatment in over 30 years.
About argenx
argenx is a global leader in immunology, developing medicines for people with severe autoimmune diseases, including CIDP. Driven by innovation, we developed the first in-class FcRn blocker, offering solutions for people living with rare autoimmune disease.
An Overview of VYVGART Hytrulo
VYVGART Hytrulo is a one-of-a-kind treatment for a one-of-a-kind you.
A different approach to CIDP
- Works differently than other CIDP treatments, including IVIg, SCIg, PLEX, and steroids
- The first and only plasma-free treatment approved by the FDA for CIDP
- A first for CIDP—one weekly injection, given under the skin by a healthcare professional, that takes ~30 to 90 seconds*
*After administering your injection, your healthcare provider will monitor you for allergic reactions for at least 30 minutes.
IVIg=intravenous immunoglobulin; PLEX=plasma exchange; SCIg=subcutaneous immunoglobulin
Ask your doctor if VYVGART Hytrulo is right for you. If you are considering VYVGART Hytrulo and looking for more resources, the VYVGART Hytrulo Education Line can help you find the answers. Our educators are available 6 days a week (Monday through Saturday, 8 AM to 9 PM ET).
Call 1-833-VYV-CIDP (1-833-898-2437) to speak with an educator.
How VYVGART Hytrulo Is Administered
VYVGART Hytrulo is one subcutaneous injection given weekly that takes ~30 to 90 seconds.
It is a single injection, delivered under the skin, that does not require vein access and is given at a doctor’s office, infusion center, or at home by a healthcare professional.* After administering your injection, your healthcare provider will monitor you for allergic reactions for at least 30 minutes.
*In some cases, VYVGART Hytrulo may also be given at home by a trained nurse.
Patient Support Program
My VYVGART Path
It may feel overwhelming getting started on a new treatment. With My VYVGART Path, you’ll have access to resources and one-on-one support throughout your treatment journey.
My VYVGART Path is a Patient Support Program that pairs you with a dedicated Nurse Case Manager (NCM) who will provide support throughout your treatment journey—all just a phone call away, including:
- A personalized understanding of your treatment: My VYVGART Path NCMs are knowledgeable about VYVGART Hytrulo and are dedicated to listening to you and answering questions you may have
- Empowering resources and information: NCMs can support you throughout your treatment journey to help you in following your doctor’s treatment plan
- Hands-on help navigating the insurance process: Dealing with insurance can be complicated. An NCM can help answer questions you have, help you understand the process, and verify what is covered by your insurance
- Helpful information about a co-pay program and financial assistance programs: If you have financial concerns or gaps in insurance coverage for your VYVGART Hytrulo therapy, an NCM is here for you with information and support
Already taking VYVGART Hytrulo? A Nurse Case Manager is ready to help. Give them a call at: 1-833-MY-PATH-1 (1-833-697-2841)
Downloadable Patient Resource
Download the VYVGART Hytrulo Patient Brochure to discover more about VYVGART Hytrulo—including how it works, what makes it a different approach to CIDP treatment, its safety and effectiveness, and how to receive personalized support.
Sign up for the latest VYVGART Hytrulo news and be the first to hear about exciting events for the CIDP community and caregivers—plus get access to helpful CIDP resources.
Ask your neurologist if VYVGART Hytrulo for CIDP is right for you or your loved one.
