Vyvgart Hytrulo
Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) is an injection used to treat certain adults with generalized myasthenia gravis (gMG). It's also FDA approved as a treatment for chronic inflammatory demyelinating polyneuropathy (CIDP). The medication comes in a vial or prefilled syringe, and it's injected under your skin. Common side effects include injection site reactions and headache.
What is Vyvgart Hytrulo?
What is Vyvgart Hytrulo used for?
- Generalized myasthenia gravis (gMG) in adults with anti-AChR antibodies
- Chronic inflammatory demyelinating polyneuropathy (CIDP)
How Vyvgart Hytrulo works
Vyvgart Hytrulo is a combination of two medications that help reduce inflammation, improve muscle strength, and protect your nerves:
- Efgartigimod alfa is a neonatal Fc receptor (FcRn) blocker. It targets a protein in your body called FcRn, which normally protects antibodies from being broken down. By blocking FcRn, this medication helps your body remove harmful antibodies that cause gMG and CIDP symptoms.
- Hyaluronidase is an endoglycosidase. It helps efgartigimod alfa absorb better when injected under the skin, allowing the medication to work more effectively.
Drug facts
Side effects of Vyvgart Hytrulo
The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.
Common Side Effects
gMG
- Injection site reactions (38%)
- Headache (at least 10%)
CIDP
- Injection site reactions (15%)
Vyvgart Hytrulo serious side effects
Contact your healthcare provider immediately if you experience any of the following.
- Allergic reaction: swelling of the face or throat, trouble breathing, rash, fainting
The following Vyvgart Hytrulo side effects have also been reported
Side effects that you should report to your care team as soon as possible:
- Allergic reactions or angioedema—skin rash, itching or hives, swelling of the face, eyes, lips, tongue, arms, or legs, trouble swallowing or breathing
- Infection—fever, chills, cough, sore throat, wounds that don't heal, pain or trouble when passing urine, general feeling of discomfort or being unwell
- Infusion reactions—chest pain, shortness of breath or trouble breathing, feeling faint or lightheaded
Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):
- Burning or tingling sensation in hands or feet
- Headache
- Muscle pain
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Pros and cons of Vyvgart Hytrulo
Pros
- Can be injected at home
- Injected under the skin
- FDA approved for both gMG and CIDP
Cons
- Commonly causes injection site reactions
- Can raise the risk of infections
- Only approved for people with gMG who have anti-AChR antibodies
Pharmacist tips for Vyvgart Hytrulo
- You can get Vyvgart Hytrulo at your prescriber's office, or they can teach you to give the injection safely at home.
- After injecting Vyvgart Hytrulo, you or your care team should watch for signs of an allergic reaction for at least 30 minutes. If you notice symptoms like rash, swelling, or trouble breathing, get medical help right away.
- If you miss a dose of Vyvgart Hytrulo, you can inject it within 3 days of the missed shot. If more than 3 days have passed, contact your prescriber for instructions.
- Tell your prescriber if you’ve had any recent or ongoing infections before starting Vyvgart Hytrulo. Also, let them know if you develop fever, chills, cough, or a runny nose since this medication can raise your risk of infections.
- Avoid getting live vaccines while using Vyvgart Hytrulo. It isn't known whether live vaccines are safe or work well while you're taking this medication.
- There isn't enough information to know if Vyvgart Hytrulo is safe during pregnancy. If you're pregnant and taking this medication, you can join a pregnancy registry to track you and your baby’s health. For more information, call 1-855-272-6524 or visit https://www.Vyvgartpregnancy.com.
- Store Vyvgart Hytrulo in the refrigerator in its original packaging to protect it from light. You can keep the prefilled syringes at room temperature for up to 30 days, but throw them away if you don’t use them within that time.
- Don't put Vyvgart Hytrulo back in the refrigerator once it has warmed to room temperature.
How to inject Vyvgart Hytrulo with the prefilled syringe:
- Let Vyvgart Hytrulo sit at room temperature for about 30 minutes before injecting to make it more comfortable.
- Clean your injection site on your stomach (at least 2 inches from the belly button) with an alcohol swab. Don't inject into red, bruised, or hard areas, and never inject into a vein.
- Pinch the skin and inject Vyvgart Hytrulo at a 45 to 90 degree angle over 20 to 30 seconds.
- Release your skin and pull the syringe straight out. Throw away the used syringe in a sharps container.
Common questions about Vyvgart Hytrulo
Yes, the Vyvgart Hytrulo prefilled syringes can be self administered at home after your healthcare professional shows you how. If you’re not comfortable giving yourself the injection, a caregiver or healthcare professional can help you with your doses.
Vyvgart Hytrulo is manufactured by argenx BV and Halozyme, Inc.
You can get Vyvgart Hytrulo from a healthcare professional at their office, or you can get a prescription for home use. If you're going to use the prefilled syringe at home, your prescriber needs to enroll you in the My Vyvgart Path program. This program helps you get your prescription through a specialty pharmacy.
Vyvgart (efgartigimod alfa) and Vyvgart Hytrulo both contain the same active ingredient, but Vyvgart Hytrulo has an extra ingredient called hyaluronidase. Hyaluronidase is a protein that helps efgartigimod alfa absorb better into your body when it’s injected under the skin. Vyvgart is given as an IV infusion, while Vyvgart Hytrulo is given as an injection under the skin. Talk with your prescriber to learn more about the other differences between these two medications.
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Risks and warnings for Vyvgart Hytrulo
Vyvgart Hytrulo can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Infections
- Risk factor: Active, long-term, or recurrent infection
Vyvgart Hytrulo can lower your body's ability to fight infections. In studies, the most common infections were urinary tract infections (UTIs) and respiratory tract infections like colds or sinus infections. Most of these infections were mild to moderate, but some can be serious. Tell your care team right away if you notice fever, chills, cough, or any other signs of infection.
Before starting a new cycle of Vyvgart Hytrulo, your prescriber might recommend that you get any vaccines you're due for. But you shouldn’t get live vaccines while being treated since it’s not known if they’re safe or effective during this time.
Allergic reactions
In rare cases, some people who received Vyvgart Hytrulo had allergic reactions. It's recommended to watch for these reactions for at least 30 minutes after your injection to make sure the medication is safe for you. But these reactions can happen anywhere from 1 hour to 3 weeks after an injection. Let your care team know if you experience signs and symptoms of allergic reactions like shortness of breath, hives, rash, or swelling of the face or throat.
Injection-related reactions
Some people who received Vyvgart Hytrulo or IV Vyvgart (efgartigimod alfa) have experienced injection-related reactions. Common symptoms include high blood pressure, chills, shaking, or pain in the chest, stomach, or back. These reactions can happen during the injection or within an hour afterward and might cause the treatment to be stopped. If a reaction occurs, your care team will provide the treatment you need and decide whether it’s safe to continue taking the medication.
Vyvgart Hytrulo dosage
Carton| Dosage | Quantity | Price as low as | Price per unit |
|---|---|---|---|
| four 5ml syringes of 1,000mg/10,000mg/5ml | 1 carton | $64,257.13 | $64,257.13 |
| 5ml syringe of 1,000mg/10,000mg/5ml | 4 cartons | $64,257.13 | $16,064.28 |
Typical dosage for Vyvgart Hytrulo
- gMG
- Prefilled syringe: The typical dose is 1,000 mg/10,000 units (efgartigimod alfa/hyaluronidase) injected under the skin over 20 to 30 seconds, once a week for 4 weeks (this is one treatment cycle).
- Vial: The typical dose is 1,008 mg/11,200 units (efgartigimod alfa/hyaluronidase) injected under the skin by a healthcare professional over 30 to 90 seconds, once a week for 4 weeks (this is one treatment cycle).
After you finish one cycle, your prescriber will decide if and when you need another round of treatment based on your symptoms.
- CIDP
- Prefilled syringe: The typical dose is 1,000 mg/10,000 units (efgartigimod alfa/hyaluronidase) injected under the skin over 20 to 30 seconds, once a week for 4 weeks.
- Vial: The typical dose is 1,008 mg/11,200 units (efgartigimod alfa/hyaluronidase) injected under the skin by a healthcare professional over 30 to 90 seconds, once a week.
How much does Vyvgart Hytrulo cost?
$64,257.13
What are alternatives to Vyvgart Hytrulo?
Vyvgart Hytrulo images
