Introductions, please...
What is VYVGART® Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) for subcutaneous injection?
VYVGART Hytrulo, which contains efgartigimod alfa and hyaluronidase, is a prescription medicine used for the treatment of adult patients with chronic inflammatory demyelinating polyneuropathy, otherwise known as CIDP.
What are the common side effects of VYVGART Hytrulo?
The most common side effects of VYVGART Hytrulo are respiratory tract infection, headache, urinary tract infection, tingling sensation, muscle pain, and injection site reactions. Most common injection site reactions include injection site 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 U.S. Food and Drug Administration at 1-800-FDA-1088.
What is CIDP (chronic inflammatory demyelinating polyneuropathy)?
CIDP (chronic inflammatory demyelinating polyneuropathy) is a rare autoimmune condition that affects people differently, causing weakness and numbness in the arms and legs. Autoimmune conditions happen when the immune system mistakenly attacks the body’s own cells and tissues. For some, CIDP continuously worsens over time, others have symptoms that stabilize and relapse, and some experience a CIDP episode that lasts one to three years and does not return.
How does VYVGART Hytrulo work?
: VYVGART Hytrulo is specifically designed to cause a reduction in the number of circulating IgG antibodies, including harmful IgG antibodies. VYVGART Hytrulo has two active ingredients: efgartigimod alfa, which binds to the FcRn receptor, and hyaluronidase (human recombinant), which helps to increase the distribution and absorption of ingredients into the body. When antibodies, including harmful ones, attach to receptors called neonatal FC (FcRn), their time in the body is extended. Those that don’t attach to FcRn receptors are removed by the body. VYVGART Hytrulo is designed to attach to FcRn receptors. By keeping some FcRn receptors occupied, more IgG antibodies remain unattached. When IgG antibodies, including harmful IgG antibodies, cannot attach to an FcRn receptor, they are removed by the body.
Is there anyone who shouldn’t take VYVGART Hytrulo?
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 such as trouble breathing and a decrease in blood pressure leading to fainting. 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. It is important to talk to your doctor to see if VYVGART Hytrulo is right for you.
What causes CIDP?
CIDP is an autoimmune disease, which means that your immune system is mistakenly attacking you instead of protecting you. In some people with CIDP, the immune system produces harmful immunoglobulin (IgG) antibodies that work against you, along with the IgG antibodies that work to protect you. Your nerves have a protective layer around them called myelin. Damage to the myelin over time makes it harder for signals to travel quickly along the nerve. That means signals to and from the arms or legs may slow down or, in some cases, be lost completely. Although the complete cause of CIDP is not fully understood, recent studies suggest that, in some people, harmful IgG antibodies may be involved in damaging the myelin. Physical symptoms like muscle weakness, tingling, or numbness can affect your ability to perform daily tasks. Damage to the myelin is why some people experience CIDP symptoms. In some cases, the damage may be debilitating and irreversible.
How effective is VYVGART Hytrulo?
The effectiveness of VYVGART Hytrulo was established in two stages of a clinical study. The goal of Stage A was to identify patients who showed symptom improvements with VYVGART Hytrulo at two consecutive visits. During Stage A of the clinical study, about 7 out of 10 patients (221 out of 322) on VYVGART Hytrulo experienced improvements and moved on to Stage B. Symptom improvements were measured using one of the following: - Arm and leg function (aINCAT) - Grip strength - Ability to perform 24 daily activities, such as walking, showering, and dressing (I-RODS)" The main study goal of Stage B was to determine how long arm and leg function were maintained from the start of Stage B compared to those who were moved onto placebo. During Stage B of the clinical study, patients who continued on VYVGART Hytrulo maintained arm and leg improvement or function longer than those who were moved onto placebo, and the risk of CIDP getting worse was 61% lower for patients taking VYVGART Hytrulo compared to those who were moved onto placebo. Not everybody responds to VYVGART Hytrulo. It is important to talk to your doctor to see if VYVGART Hytrulo is right for you.
What if I miss an injection on its scheduled day?
If you miss a scheduled dose, VYVGART Hytrulo may be administered up to three days after the scheduled day. After that, you should resume the original dosing schedule. You should work with your doctor to reschedule your next dose.
Are there different types of CIDP?
There are different types of CIDP, each with varying symptoms, all related to changes in the arms and legs. These types include: • Typical CIDP: symmetrical muscle weakness and sensory loss affecting both the arms and legs • Distal CIDP: muscle weakness and sensory loss primarily in the legs • Multifocal CIDP: muscle weakness and sensory loss, usually asymmetrically, affecting primarily the arms • Focal CIDP: muscle weakness and sensory loss in only one limb • Motor CIDP: muscle weakness without sensory symptoms
Does VYVGART Hytrulo work in all types of chronic inflammatory demyelinating polyneuropathy?
: The studies for VYVGART Hytrulo included patients who had the following types of CIDP: • Typical • Distal • Multifocal • Motor It is important to talk to your doctor to see if VYVGART Hytrulo is right for you.
What is myelin, and what does it have to do with CIDP?
In the nervous system, nerve cells, also called neurons, are responsible for sending messages to and from the brain using electrical currents. Neurons are coated with an insulating layer of fat and protein called myelin. Myelin acts as an insulator to keep the electric currents inside the neuron so messages can travel quickly to and from the brain. Myelin is essential to the functioning of nerves because it facilitates communication between the brain and all parts of the body. In people with CIDP, myelin becomes damaged, causing electrical signals to weaken or stop. It is unclear why this happens, but it is thought that the body’s immune system perceives myelin as foreign and attacks it, causing damage and leading to loss of function. With CIDP, the damage to the myelin occurs gradually over time. This progressive damage generally results in muscle weakness and sensory loss in the arms and/or legs.
Can I continue my current CIDP therapy if I start VYVGART Hytrulo?
Talk to your doctor as they are able to provide medical information specific to your situation. For the patients in the clinical study, VYVGART Hytrulo was given to patients after they stopped their current CIDP treatment.
What are the signs and symptoms of CIDP?
Possible symptoms of CIDP include but are not limited to tingling or sensory loss in the arms and legs, weakness of arms and legs, loss of balance, difficulty walking, burning pain, difficulty lifting objects, and fatigue. It can be helpful to write down your symptoms and share this information with your doctor.