Reimagine effective HAE prevention
TAKHZYRO (lanadelumab-flyo) is clinically proven to help prevent hereditary angioedema (HAE) attacks with every-2-weeks dosing that takes ≤1minute to administer.1*SEE IMPORTANT SAFETY INFORMATION
*Most people in the clinical trials were able to self-inject in 10 to 60 seconds. These injection times are based on vial administration.1
Results from the 6.5-month clinical study that led to FDA approval
The safety and efficacy of TAKHZYRO (lanadelumab-flyo) were assessed in a 26-week pivotal trial of 125 HAE patients ≥12 years of age. The primary efficacy endpoint was the rate of investigator-confirmed attacks during the treatment period compared to placebo.1,2
Significant reduction in mean attack rate* vs placebo at 6.5 months in the pivotal trial1,2
REDUCTION IN ATTACKS
vs placebo (Adjusted P<0.001)1†
All data presented are for TAKHZYRO 300 mg every 2 weeks unless otherwise indicated.
HELP study: A multicenter, double-blind, parallel group, placebo-controlled clinical study assessed the efficacy and safety of TAKHZYRO in 125 HAE Type I/II patients (≥12 years of age) for 26 weeks. Patients were treated with TAKHZYRO 150mg q4wks, TAKHZYRO 300 mg q2wks, TAKHZYRO 300 mg q4wks or placebo. Primary endpoint: rate of investigator-confirmed attacks during the treatment.1,2
Long-term data were consistent with the safety and efficacy in the pivotal trial.1,3
Consistent safety results in one of the largest prevention studies in HAE1,3-6
The safety of TAKHZYRO (lanadelumab-flyo) 300 mg every 2 weeks was consistent across the 6.5-month clinical trial and 2.5-year long-term open-label extension study.1explore safety profile
Freedom from daily dosing
Just 1 subcutaneous self-injection every 2 weeks, requiring no reconstitution. The recommended starting dose is 300 mg every 2 weeks.1review dosing & administration
Help patients set proper treatment expectations
Understand the impact of HAE from a patient's point of view
JACK: Hi, my name is Jack, and this is My Reimagine Vlog.
JACK: Hello. My name is Jack, and I've been taking TAKHZYRO for more than 2 years. Hereditary angioedema, or HAE, has been a large part of my family's life. Thirteen members of my immediate and extended family had been diagnosed with HAE. Because growing up I knew and cared about so many people with this rare disease, it inspired me to want to take care of others. I was actually diagnosed with HAE at 13, but I didn't have any severe symptoms until much later in life. Some of my family members were so much worse off than I was and I found myself putting to the side that I had HAE as well. I tried to help out as much as any kid could – I’d go to the hospital with my mom, and I'd sit with her while the doctors tried to find a way to manage her pain. From that point on, I made it one of my primary goals in life to pursue a medical career in which I could help other patients. But achieving that was a challenge, as my goals and expectations changed and evolved along the way.
JACK: Fortunately, or unfortunately, my HAE didn't become apparent until I was in nursing school. I started to get swells, and it seemed that stress started to trigger my HAE. The attacks came every few months at first, but then they progressed to every other month. Eventually, I was experiencing attacks every month. After graduation, I got a job as a pediatric oncology nurse, but at this point in my life, my attacks were becoming more frequent and more severe. I wasn't sure how I was going to keep my attacks under control, and it was hard to stay focused at my job. It got to the point where I missed so much work that I was asked to step down from my position.
JACK: I use this time to get really involved with the HAE community. I did some advocacy work. I was mentoring young children with HAE. The more I was involved in the community, the more I learned about HAE and about the treatment options available to us patients. I wasn't interested in trying any preventive medications at the time, but as each year passed, I realized my attacks were becoming more frequent and more severe, and it became clear that I needed to take a closer look at preventive therapies that might be able to help. I wanted a treatment that could reduce the amount of swells I was having. I think fate intervened when I learned about TAKHZYRO during one of my regular doctor's visits. A nurse told us that TAKHZYRO, a once-every-2-weeks subcutaneous injection used to prevent HAE attacks in people 12 years of age and older, had been approved.
JACK: Right then and there, my doctor and I talked about it. We also discussed what to expect and set goals to manage my HAE. Reducing my attack frequency was the primary goal–from having swells every week to less frequently. We also discussed the potential risks such as serious side effects, including allergic reactions, as well as more common side effects, including injection site reactions, upper respiratory infections, and headaches. As far as allergic reactions, my doctor told me to call or get emergency help right away if I experienced any of the following: wheezing, difficulty breathing, chest tightness, fast heartbeat, faintness, rash, or hives.
JACK: Since starting TAKHZYRO, the frequency and severity of my attacks have decreased. I was accustomed to multiple attacks a week. After starting TAKHZYRO, I've gone a month or two without an attack. I even had a span as long as 6 months when I had zero attacks. And if I do experience an attack, it's usually less severe than before. This is just my experience with TAKHZYRO, and it may not be the same for everyone. 2020 was one of the most stressful years of my life, and like I said earlier, stress is one of my triggers. I built a new house, so my wife and I had to deal with the stress of moving. On top of that, being a nurse during the COVID-19 pandemic has not been easy, to say the least. With all of this happening, I'm glad I had a management plan for my HAE.
JACK: These days, my wife and I are discussing a new goal: starting a family. We're ready to see how we can fill our new place with more joy. And I've been spending my free time exercising. I feel like it's a great way for me to get back into shape, and it helps that we encourage each other to stay fit and follow our workout goals.
JACK: When I was first managing my HAE, all I wanted was to simply reduce the amount of swells from weekly to maybe once a month. After that, the goal was to not go to the hospital as often. Setting goals and expectations is very important. I did it for myself when it came to my career, and I did it for my HAE management plan. I encourage you to talk to your doctor about your individual HAE goals and expectations. This journey has taken me through many ups and downs, and things have evolved along the way. Now I feel my HAE is better managed. I know one goal I can continue to work closely on with my doctor: reimagining life with HAE.
NARRATOR: TAKHZYRO (lanadelumab) is a prescription medicine used to prevent attacks of hereditary angioedema (HAE) in people 12 years of age and older. It is not known if TAKHZYRO is safe and effective in children under 12 years of age. TAKHZYRO may cause serious side effects, including allergic reactions. Call your healthcare provider or get emergency help right away if you have any of the following symptoms: wheezing, difficulty breathing, chest tightness, fast heartbeat, faintness, rash, and/or hives.
NARRATOR: The most common side effects seen with TAKHZYRO were injection site reactions (pain, redness, and bruising), upper respiratory infection, and headache. These are not all the possible side effects of TAKHZYRO. For more information, ask your healthcare provider or pharmacist. You may report side effects to the FDA at 1-800-FDA-1088.
NARRATOR: TAKHZYRO has not been studied in pregnant or breastfeeding women. Talk to your healthcare provider about the risk of taking TAKHZYRO if you are pregnant, plan to be pregnant, are breastfeeding, or plan to breastfeed. Talk to your healthcare provider about TAKHZYRO, the only preventive HAE treatment you take as a subcutaneous injection just once every 2 weeks.
Personalized product support for patients every step of the way
Remind patients that OnePath® helps people who have been prescribed TAKHZYRO per the approved indication get access to their medication.