Learn more about Pemgarda, a groundbreaking preventative treatment offering the immunocompromised a new layer of defense against Covid-19.
The FDA's recent emergency use authorization (EUA) of Pemgarda (pemivibart) is a beacon of hope for those most vulnerable to COVID-19. This groundbreaking, preventative treatment offers a new layer of defense for individuals with weakened immune systems who might not be fully protected by vaccines.
What is Pemgarda and how does it work?
Pemgarda is a monoclonal antibody (mAb) drug designed to prevent COVID-19 infection in high-risk individuals. Monoclonal antibodies are laboratory-made proteins that mimic the immune system's ability to fight off harmful pathogens like viruses. Pemgarda works by targeting the spike protein of the SARS-CoV-2 virus, the part that allows the virus to enter and infect human cells.
By binding to the spike protein, Pemgarda effectively blocks the virus's entry into cells, preventing infection and replication. This targeted approach provides a shield against the virus, helping to protect vulnerable individuals who may not mount a sufficient immune response to vaccination alone.
How is Pemgarda different from other COVID-19 medications like Paxlovid and Remdesivir?
Unlike Paxlovid and Remdesivir, which are antiviral medications used to treat COVID-19 after someone has been infected, Pemgarda is used to prevent COVID-19 infection in high-risk individuals before exposure to the virus. This makes it a pre-exposure prophylaxis (PrEP) treatment, offering a proactive approach to protecting those most vulnerable.
Other key differences include:
- Mechanism of action: Paxlovid inhibits viral replication, while Remdesivir interferes with the virus's genetic material. Pemgarda, on the other hand, works by directly neutralizing the virus before it can enter cells.
- Timing of administration: Paxlovid and Remdesivir are administered orally after a COVID-19 diagnosis, while Pemgarda is given as an IV infusion before exposure to the virus.
- Target population: While Paxlovid and Remdesivir are used for the treatment of mild to moderate COVID-19 in adults and children, Pemgarda is specifically authorized for the prevention of COVID-19 in immunocompromised individuals who are at high risk of severe disease.
Who is Pemgarda specifically authorized for?
Pemgarda is authorized for individuals aged 12 and older who meet all of the following criteria:
- Weigh at least 88 pounds
- Moderately to severely immunocompromised
This includes a wide range of conditions that weaken the immune system, such as certain cancers (e.g., blood cancers), organ transplants, HIV/AIDS, primary immunodeficiency diseases (e.g., common variable immunodeficiency or CVID), and autoimmune diseases (e.g., rheumatoid arthritis, lupus). It also includes those receiving immunosuppressive therapies, such as chemotherapy, radiation therapy, or medications that suppress the immune system to prevent organ transplant rejection or manage autoimmune conditions.
- Unlikely to mount an adequate immune response to COVID-19 vaccination
This means that even after receiving all recommended doses of a COVID-19 vaccine, the individual's immune system may not produce enough antibodies to effectively protect them from the virus.
Why is Pemgarda necessary for immunocompromised individuals?
While COVID-19 vaccines are highly effective for most people, individuals with weakened immune systems may not develop a strong enough immune response to be fully protected, even after vaccination. This is due to their underlying medical conditions or the medications they take to manage those conditions. Pemgarda offers an additional layer of defense for these individuals by directly providing antibodies that can neutralize the virus, offering protection that may not be achievable through vaccination alone.
How does Pemgarda work?
Pemgarda works by binding to the spike protein of the SARS-CoV-2 virus, the part of the virus that allows it to enter and infect human cells. By attaching to the spike protein, Pemgarda effectively blocks the virus's entry into cells, preventing infection and replication. This targeted approach provides a shield against the virus, helping to protect vulnerable individuals.
How is Pemgarda administered, and what is the typical dosing schedule?
Pemgarda is administered as a single intravenous (IV) infusion in a healthcare setting like Local Infusion. This means the medication is delivered directly into your vein through a small tube over approximately 60 minutes. To prepare the infusion, healthcare professionals withdraw the Pemgarda solution from vials and dilute it with 0.9% sodium chloride (normal saline) in a special IV bag. Throughout the infusion process, you'll be comfortably seated and monitored by an Infusion Guide to ensure your safety and well-being.
The recommended dosing schedule for Pemgarda is once every three months. However, your doctor may adjust this schedule based on your individual needs and health circumstances, considering the duration of protection Pemgarda provides in your specific case. They will create a personalized plan to maximize your protection against COVID-19.
Is Pemgarda effective in preventing COVID-19?
Yes, clinical trials have demonstrated that Pemgarda is highly effective at preventing COVID-19 in high-risk individuals.
Data from the pivotal Phase 2/3 clinical trial (CANOPY study), which evaluated the efficacy and safety of adintrevimab (the antibody from which Pemgarda is derived), demonstrated an approximate 70% relative risk reduction in symptomatic COVID-19 compared to placebo in individuals who are moderately to severely immunocompromised. While the full results of the CANOPY study are still pending peer review, this significant reduction in risk underscores the potential of Pemgarda as a crucial preventive measure for those who are most vulnerable to the virus.
Is Pemgarda safe?
Pemgarda is generally safe and well-tolerated. The most common side effects reported in clinical trials include reactions at the infusion site (pain, redness, swelling), headache, and fatigue. Serious side effects, such as allergic reactions, are rare but possible. It's essential to discuss any concerns about side effects with your doctor so they can help you weigh the potential risks and benefits based on your individual health history and circumstances.
How much does Pemgarda cost, and is it covered by insurance?
The cost of Pemgarda can vary depending on several factors, including your location and specific insurance plan.
Good news for those with Medicare: Medicare Part B covers Pemgarda for eligible patients, and there is no cost-sharing for people with Medicare for COVID-19 monoclonal antibody products or their administration. If you have private insurance, your coverage may vary. It's crucial to contact your insurance provider to get the most accurate information about your specific costs and coverage details.
While Invivyd, the manufacturer of Pemgarda, does not currently have a patient assistance program, your healthcare provider or Local Infusion can help you explore potential financial assistance options.
Interested in learning more about how to receive Pemgarda at Local Infusion?
Local Infusion is ready to offer Pemgarda in all of its locations once a patient is referred.
Our modern, state-of-the-art centers feature private suites designed with your comfort in mind.
From questions on what to expect in your first treatment, to providing financial guidance and support, a dedicated Infusion Guide works with you and your physician to provide clear answers and assistance every step of the way. Plus, we handle everything having to do with prior authorization.
We’ll reach out within hours of a physician referral and get you digitally on board in less than two minutes, allowing our staff more time to focus on you.
Should you have questions regarding pricing and insurance, our team will work with you to provide financial assistance support and minimize costs, providing a simple and stress-free experience.
Local Infusion Editorial : Aug 20, 2024 9:00:07 AM
