Understand what to expect as you get started with TAKHZYRO.
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Meet some people who've stayed on track with TAKHZYRO by setting goals with their doctor and tracking their progress.
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KIM: TAKHZYRO® (lanadelumab-flyo) is a prescription medicine used to prevent attacks of hereditary angioedema (HAE) in patients 2 years of age and older. TAKHZYRO may cause serious side effects, including allergic reactions. Continue watching until the end of this video for additional Important Safety Information.
KIM: Hi! I’m Kim, and I’m a physician assistant that works with the HAE community. You’ve made the decision to start preventive treatment with TAKHZYRO for your hereditary angioedema, or HAE, attacks. TAKHZYRO is an important part of the HAE management plan you created with your HAE specialist to help prevent HAE attacks. Today, I’m going to show you what your first few months of treatment with TAKHZYRO may look like. But...I won’t be doing it alone.
LINDA: Hello! I'm Linda, and I started treatment with TAKHZYRO within a month of its approval. Whether you've been on preventive treatment before or TAKHZYRO is your first experience with one, we know this is a big decision on your HAE journey. I remember when I first started treatment, it felt overwhelming at times. I had never tried preventive treatment before. It was hard to picture how it would all play out, but in the end, I'm glad I stuck with it. Throughout this video, I'll be sharing some of my experiences and even a little advice in the hopes that they will help you as you begin treatment with TAKHZYRO.
LINDA: If you’re like me, you and your doctor chose TAKHZYRO because you wanted effective prevention for your HAE attacks. But what exactly does that mean?
KIM: I can answer that! In a clinical study that lasted 6.5 months and included 125 people with HAE aged 2 years and older, TAKHZYRO was clinically proven to help reduce HAE attacks by 87% on average compared with placebo.
LINDA: I remember my doctor telling me that TAKHZYRO also helps reduce the frequency and severity of HAE attacks.
KIM: That's right, Linda! People in this clinical study also had an average of 83% fewer moderate or severe attacks and 87% fewer attacks requiring on-demand treatment compared with placebo.
LINDA: You know, I’ve experienced periods of time when I had no attacks while taking TAKHZYRO!
KIM: You’re not alone! In the same 6.5-month clinical study, 44% of people taking TAKHZYRO had zero attacks during the entire study compared with 2% taking placebo.
LINDA: Should we mention that TAKHZYRO was also looked at in a long-term, open-label extension clinical study?
KIM: Yes! That study lasted 2.5 years and included 212 people with HAE aged 2 years and older. It looked at the long-term safety and efficacy of TAKHZYRO. And patients knew they were receiving TAKHZYRO, which could have influenced the results. This second study showed similar and consistent results to the first study. If you’d like to learn more about the data, check out TAKHZYRO.com/studyresults. But, Linda, what does 'effective prevention' mean in your own words?
LINDA: For me, effective prevention comes down to 3 things: A significant reduction in the frequency and severity of my HAE attacks. Experiencing periods of freedom from HAE attacks. And freedom from daily dosing, with just 1 dose every 2 weeks.
KIM: Now that we know more about the idea behind effective prevention, let’s talk about dosing.
LINDA: As you know, TAKHZYRO is taken once every 2 weeks as a subcutaneous injection after you’ve been trained by a healthcare professional. Subcutaneous injection means you inject it under your skin.
KIM: In the clinical trial, most people taking TAKHZYRO were able to self-inject in 1 minute or less.
KIM: You’ll also have options of where you’d like to administer TAKHZYRO; there are 3 locations: your abdomen, thigh, or upper arm.
LINDA: Being able to switch injection sites is really important to me. That training session helped me feel confident about injecting myself and set me up for success moving forward.
KIM: This is just the beginning of your journey: the first step toward helping to prevent HAE attacks with TAKHZYRO.
KIM: Hey, Linda. I think now is a good time to talk about setting goals and expectations with your medical team. It's an important part of your HAE management plan, which now includes treatment with TAKHZYRO.
LINDA: That’s a great idea, Kim!
KIM: You and your doctor have decided to make TAKHZYRO a part of your HAE management plan to help you achieve your personal treatment goals.
LINDA: If you haven't already, think about what expectations you have for your HAE management plan.
KIM: What are your overall treatment goals? Where do you picture yourself on this journey a year from now? Take some time to write down answers to the following questions: How often do you experience HAE attacks? How severe are they? How often do you use on-demand medication?
KIM: Logging this information will allow you to keep track of your HAE attacks and plan future goals. Because the 2020 US HAEA guidelines recommend reassessing your goals with your doctor periodically, it’s important to share this information. That way you can both see how you’re doing with your HAE management plan.
LINDA: When I was starting on TAKHZYRO, I discussed my HAE experience with my doctor. We talked about what it was like living with the unpredictability of my HAE attacks. We looked at the frequency of my HAE attacks and how often I was treating them with on-demand medication. We also talked about what I hoped to achieve by taking TAKHZYRO. He encouraged me to keep track of my HAE attacks so that I could look back and see how far I’d come after being on TAKHZYRO for a few months. In the end, that initial discussion was so important to me because it helped establish a starting point for my treatment journey. And helped me understand what to expect along the way.
KIM: Thanks, Linda! Collaborating with your doctor is one of the most important steps at the start of your treatment journey with TAKHZYRO.
KIM: Hi! When deciding to start TAKHZYRO, you may have heard of OnePath Product Support, a program that offers patients a range of services. Let’s talk a little about that and what they do. But before I begin, I’d like to introduce someone who's going to help me out.
ANDREW: Thanks, Kim! I’m Andrew, a patient ambassador for TAKHZYRO. I'll be sharing some of the experiences I’ve had with the OnePath team and how they helped me get started with TAKHZYRO.
KIM: When you're prescribed TAKHZYRO, your doctor will help fill out a Start Form, which will enroll you in the program. Soon after enrollment, you'll receive a call from your Patient Support Manager, or PSM, from the main OnePath phone number. They will act as your primary point of contact during your treatment journey. Save this number to your phone so you can recognize calls from OnePath in the future!
KIM: Your PSM will work with you one-on-one to make sure you have access to your prescribed medication. They’ll also help with the following: Working with your insurance provider to help make sure your treatment is covered. Enrolling you in the OnePath Co-Pay Assistance Program, if you qualify. Arranging for a trained nursing professional to teach you how to self-inject TAKHZYRO at home, or virtually.
ANDREW: Admittedly, the early stages of my journey were a bit overwhelming. But my PSM was there to help alleviate some of that stress.
KIM: When it comes to insurance, your PSM and the rest of the OnePath team will walk you through the process step by step. They’ll also help you understand what’s covered and what’s not, and what to do next. Their goal is to help make it all a little easier.
ANDREW: I was initially denied TAKHZYRO, but OnePath Product Support worked with my insurance company and doctor to get me approved and started on treatment.
ANDREW: They also addressed any questions and concerns I had about accessing TAKHZYRO. In fact, my PSM continues to offer support throughout my journey. It’s good to know you’re not alone in this.
KIM: OnePath will also work with your specialty pharmacy to make sure your medicine is delivered. These pharmacies help coordinate many aspects of care for patients taking medications that have specialized handling, storage, and distribution requirements, just like TAKHZYRO.
ANDREW: When I was approved for TAKHZYRO, it took some time to receive my first delivery from the specialty pharmacy. But that’s normal. My OnePath team was able to get in touch with the pharmacy to help. And they let me know if there would be any changes to the delivery of my medication. Best of all, this support is provided to you free of cost.
KIM: Now let’s talk about at-home injection training. This is extremely important, as you should never try to inject TAKHZYRO without being properly trained by a healthcare professional. Your PSM will call you to explain how that process works. First, a nurse will come to your house Then, they will show you how to inject your TAKHZYRO and stay with you while you do it. Lastly, they’ll help answer any questions you may have about the administration process.
KIM: Andrew, what was your experience with injection training?
ANDREW: The nurse who came to my house told me about the 3 areas where I could inject, which I was happy to learn about. She showed me and my wife how to prepare the medication and how to inject it. The injection itself took about a minute. That training session really set me up for success! Beforehand, I wasn’t quite sure how confident I would be with self-injections.
ANDREW: With OnePath Product Support, you’re not alone when you start your journey on TAKHZYRO. In the end, it was great to have the OnePath team on my side, especially during those first few months of treatment, when I wasn’t quite sure what to expect.
KIM: OnePath has been helping people with HAE for over 10 years—from helping with the insurance process to making sure you have consistent access to medication and at-home injection training.
KIM: Hey, Linda! I think it’s a good time to talk about the most common side effects of TAKHZYRO.
LINDA: Sounds good, Kim! It’s really important for people to understand the side effects associated with any medication they take.
KIM: When we say “most common side effects,” we’re talking about the side effects that were experienced by most people in the clinical trial. These were injection site reactions, upper respiratory infection (an example of this is when someone gets a cold), headache, rash, muscle pain, dizziness, and diarrhea. You can see the percentage of patients that experienced these side effects in the table. Today let’s talk about injection site reactions.
KIM: If you’d like to read more about the other side effects of TAKHZYRO, you can visit the website URL shown here.
LINDA: Kim, some people may not know what injection site reactions are. Can you explain them?
KIM: Of course! Injection site reactions are most commonly pain, redness, or bruising in the area where TAKHZYRO was injected. In the clinical trial, 52% of the 84 people who received TAKHZYRO reported injection site reactions.
KIM: These reactions are expected, though.
LINDA: When I first started TAKHZYRO, I wasn’t sure how I felt about injecting myself. Would it hurt? Would I have a reaction? Thankfully, my doctor reassured me. I was informed that it may hurt a bit, but to keep taking TAKHZYRO exactly as directed.
LINDA: My PSM set up an at-home injection training session for me. It made me feel confident injecting my medication moving forward.
KIM: Glad you brought that up! If you haven't already, you'll be trained how to inject TAKHZYRO by a healthcare professional before your first dose. Be sure to use that time to ask any questions you may have about the injection process.
KIM: And remember! Call your doctor right away, or get emergency help, if you experience any of the following symptoms of an allergic reaction while taking TAKHZYRO: wheezing, difficulty breathing, chest tightness, fast heartbeat, faintness, rash, or hives.
KIM: Just as everyone’s experience with HAE is different, every person will respond to medication differently. That's why it's important to understand what the side effects of TAKHZYRO are, and what you can do if you experience them.
KIM: Hey, Linda and Andrew! Today I want to talk about staying on track with TAKHZYRO and steady state. Do you remember what steady state is?
ANDREW: Hi, Kim! It’s been a while, but I remember my doctor telling me that it’s when the amount of TAKHZYRO in the body becomes constant.
KIM: That’s right. Starting with your first dose of TAKHZYRO, the medicine builds in your body over time. Over the course of your first 6 doses, the amount of TAKHZYRO in your body will reach a constant level that is known as steady state. That’s why it’s important to give TAKHZYRO about two and a half months to reach steady state.
KIM: Keep in mind that TAKHZYRO is a medication that continues to work as you take it. That means you need to take it as prescribed by your doctor and avoid missing or skipping doses.
KIM: Once you start taking TAKHZYRO, it’s important to know that breakthrough HAE attacks can still occur.
ANDREW: I started experiencing fewer HAE attacks shortly after beginning treatment. But not all patients are the same. Experiences, and expectations, may vary. Right, Linda?
LINDA: Of course. When I was starting out on TAKHZYRO, I was still experiencing HAE attacks. To be honest, I was disappointed. I had expected fewer attacks after starting treatment. So I called my doctor. He reassured me right away that this was normal. He explained that the medicine needed time to build up in my body. Once I understood that, I was convinced I needed to give it time and keep taking TAKHZYRO. After a few months, I noticed my HAE attacks were less frequent and less severe than they had been before. I was proud of myself for sticking to my plan.
KIM: So if a breakthrough attack happens, don’t be discouraged. Talk to your doctor about your goals and expectations with preventive treatment, as well as the importance of continuing to take TAKHZYRO as prescribed.
KIM: Like Linda, you may notice that over time your HAE attacks are less frequent and less severe or that you are using your on-demand treatment less. These are signs that TAKHZYRO is working!
LINDA: If you have any questions about steady state or the clinical study data as you begin to take TAKHZYRO, speak with your doctor, like I did!
KIM: Remember, in order for TAKHZYRO to work effectively, you need to keep taking it as prescribed.
KIM: Andrew, Linda, let’s talk about patients staying on TAKHZYRO for the long term. After all, we want their HAE management plan to be successful!
LINDA: Sounds great, Kim!
KIM: We’ll discuss follow-up visits with the doctor and tips on how to remember to take TAKHZYRO.
KIM: As you get comfortable with your TAKHZYRO routine, it’s important to revisit the treatment goals you and your doctor made at the start of your journey.
KIM: Ask yourself this: Have the frequency and severity of your HAE attacks changed in the months since you’ve started TAKHZYRO? If they have, talk to your doctor about those changes and what your next set of goals may be.
LINDA: Setting goals helped me see how I was doing with my HAE management plan.
LINDA: It helps to have realistic goals for your treatment. For me, I wanted fewer and less severe HAE attacks. So when I started taking TAKHZYRO, I tracked 3 things: The frequency of my attacks. Their severity. And how often I used my on-demand treatment. Once I started to see progress, my doctor and I decided TAKHZYRO was the right choice for me.
ANDREW: At this point in your journey, it’s important to have these moments of reflection. These are the moments that helped me realize the bigger picture: my life before and after I started preventive treatment with TAKHZYRO. Moments like these showed me how much TAKHZYRO has helped and can continue to help manage my HAE. Since starting TAKHZYRO, my HAE attacks have been less frequent and less severe. I've gone several months without an attack! I’ve come a long way since the beginning of my journey. All thanks to choosing effective prevention with my doctor.
KIM: Remember, TAKHZYRO continues to work as you take it, so it’s important to keep taking it as prescribed by your doctor. You should also avoid skipping and missing doses.
KIM: Takeda is committed to helping you stay on track with your treatment.
LINDA: It’s true! The TAKHZYRO Text Reminder Program has been a big help when it comes to taking my medication on schedule. Just text SIGNUP to 36395 to start receiving reminders.
KIM: You can get more information about the Text Reminder Program by visiting the TAKHZYRO website.
KIM: In addition to the Text Reminder Program, what are some other ways you remember to take your TAKHZYRO as prescribed?
ANDREW: On my dosing days, right before my wife and I start our morning errands, she reminds me to take my TAKHZYRO injection. Injecting takes about a minute. And it’s something that I’ve gotten used to. Hopefully, you will too!
LINDA: I like to take my TAKHZYRO right after my morning cup of coffee on injection days. It’s easy for me to remember it that way.
KIM: Andrew, Linda, can you share what long-term prevention has meant for you?
LINDA: I like knowing I’m taking a medication that has been studied for as long as it has. Plus, TAKHZYRO has been prescribed to over 2,500 people. Being one of those people is reassuring. It's also reassuring to see the results I've had with TAKHZYRO.
ANDREW: I like the fact that I can inject TAKHZYRO and then not think about it again until my next dose. TAKHZYRO has helped me have fewer attacks, allowing me to reimagine my possibilities.
KIM: Your journey may be just beginning, but know you're part of a growing community that recognizes the importance of having a preventive treatment as part of their HAE management plan. You have the tools to get started and stay on track with TAKHZYRO. Now it's your turn to draw the next chapter of your journey. Keep exploring TAKHZYRO.com for more information as well as stories from patients like you.
RECORDING: TAKHZYRO® (lanadelumab-flyo) is a prescription medicine used to prevent attacks of hereditary angioedema (HAE) in people 2 years of age and older. It is not known if TAKHZYRO is safe and effective in children under 2 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, hives. The most common side effects seen with TAKHZYRO were injection site reactions (pain, redness, and bruising), upper respiratory infection, headache, rash, dizziness, diarrhea, and muscle aches. 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 FDA at 1-800-FDA-1088. 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.
Chapter 1: Setting the Stage for Your Journey
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Get the basics about TAKHZYRO and learn what effective prevention means for patients.
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KIM: TAKHZYRO® (lanadelumab-flyo) is a prescription medicine used to prevent attacks of hereditary angioedema (HAE) in patients 2 years of age and older.
KIM: TAKHZYRO may cause serious side effects, including allergic reactions.
KIM: Continue watching until the end of this video for additional Important Safety Information.
KIM: Hi! I’m Kim, and I’m a physician assistant that works with the HAE community. You’ve made the decision to start preventive treatment with TAKHZYRO for your hereditary angioedema, or HAE, attacks.
KIM: TAKHZYRO is an important part of the HAE management plan you created with your HAE specialist to help prevent HAE attacks.
KIM: Today, I’m going to show you what your first few months of treatment with TAKHZYRO may look like. But...I won’t be doing it alone.
LINDA: Hello! I'm Linda, and I started treatment with TAKHZYRO within a month of its approval.
LINDA: Whether you've been on preventive treatment before or TAKHZYRO is your first experience with one, we know this is a big decision on your HAE journey.
LINDA: I remember when I first started treatment, it felt overwhelming at times. I had never tried preventive treatment before. It was hard to picture how it would all play out, but in the end, I'm glad I stuck with it.
LINDA: Throughout this video, I'll be sharing some of my experiences and even a little advice in the hopes that they will help you as you begin treatment with TAKHZYRO.
LINDA: If you’re like me, you and your doctor chose TAKHZYRO because you wanted effective prevention for your HAE attacks. But what exactly does that mean?
KIM: I can answer that! In a clinical study that lasted 6.5 months and included 125 people with HAE aged 12 years and older, TAKHZYRO was clinically proven to help reduce HAE attacks by 87% on average compared to placebo.
LINDA: I remember my doctor telling me that TAKHZYRO also helps reduce the frequency and severity of HAE attacks.
KIM: That's right, Linda! People in this clinical study also had an average of 83% fewer moderate or severe attacks and 87% fewer attacks requiring on-demand treatment compared with placebo.
LINDA: You know, I’ve experienced periods of time when I had no attacks while taking TAKHZYRO!
KIM: You’re not alone! In the same 6.5-month clinical study, 44% of people taking TAKHZYRO had zero attacks during the entire study compared with 2% taking placebo.
LINDA: Should we mention that TAKHZYRO was also looked at in a long-term, open-label extension clinical study?
KIM: Yes! That study lasted 2.5 years and included 212 people with HAE aged 12 years and older.
KIM: It looked at the long-term safety and efficacy of TAKHZYRO. And patients knew they were receiving TAKHZYRO, which could have influenced the results. This second study showed similar and consistent results to the first study.
KIM: If you’d like to learn more about the data, check out TAKHZYRO.com/studyresults. But, Linda, what does "effective prevention" mean in your own words?
LINDA: For me, effective prevention comes down to 3 things: A significant reduction in the frequency and severity of my HAE attacks. Experiencing periods of freedom from HAE attacks. And freedom from daily dosing, with just 1 dose every 2 weeks.
KIM: Now that we know more about the idea behind effective prevention, let’s talk about dosing.
LINDA: As you know, TAKHZYRO is taken once every 2 weeks as a subcutaneous injection after being trained by a healthcare professional. Subcutaneous injection means you inject it under your skin.
KIM: In the clinical trial, most people taking TAKHZYRO were able to self-inject in 1 minute or less.
KIM: You’ll also have options of where you’d like to administer TAKHZYRO; there are 3 locations: your abdomen, thigh, or upper arm.
LINDA: Being able to switch injection sites is really important to me. That training session helped me feel confident about injecting myself and set me up for success moving forward.
KIM: This is just the beginning of your journey: the first step toward helping to prevent HAE attacks with TAKHZYRO.
VO RECORDING: TAKHZYRO® (lanadelumab-flyo) is a prescription medicine used to prevent attacks of hereditary angioedema (HAE) in people 2 years of age and older.
VO RECORDING: It is not known if TAKHZYRO is safe and effective in children under 2 years of age.
VO RECORDING: 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, hives.
VO RECORDING: The most common side effects seen with TAKHZYRO were injection site reactions (pain, redness, and bruising), upper respiratory infection, headache, rash, dizziness, diarrhea, and muscle aches.
VO RECORDING: 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 FDA at 1-800-FDA-1088.
VO RECORDING: 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.
Chapter 2: Embarking on a Planned Journey
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Learn how to set goals and expectations with your medical team.
View Transcript
KIM: TAKHZYRO® (lanadelumab-flyo) is a prescription medicine used to prevent attacks of hereditary angioedema (HAE) in patients 2 years of age and older. TAKHZYRO may cause serious side effects, including allergic reactions. Continue watching until the end of this video for additional Important Safety Information.
KIM: Hey there, I’m Kim! I’m a physician assistant that works with the HAE community. In this video, I’d like to talk about setting goals and expectations with your medical team. I’ll be joined by Linda, who has been taking TAKHZYRO since its approval in 2018.
LINDA: Thanks, Kim!
KIM: You and your doctor have decided to make TAKHZYRO a part of your HAE management plan to help you achieve your personal treatment goals.
LINDA: If you haven't already, think about what expectations you have for your HAE management plan.
KIM: What are your overall treatment goals? Where do you picture yourself on this journey a year from now? Take some time to write down answers to the following questions: How often do you experience HAE attacks? How severe are they? How often do you use on-demand medication?
KIM: Logging this information will allow you to keep track of your HAE attacks and plan future goals. Because the 2020 US HAEA guidelines recommend reassessing your goals with your doctor periodically, it’s important to share this information with them. That way you can both see how you’re doing with your HAE management plan.
LINDA: When I was starting on TAKHZYRO, I discussed my HAE experience with my doctor. We talked about what it was like living with the unpredictability of my HAE attacks. We looked at the frequency of my HAE attacks and how often I was treating them with on-demand medication. We also talked about what I hoped to achieve by taking TAKHZYRO.
LINDA: He encouraged me to keep track of my HAE attacks so that I could look back and see how far I’d come after being on TAKHZYRO for a few months. In the end, that initial discussion was so important to me because it helped establish a starting point for my treatment journey. And helped me understand what to expect along the way.
KIM: Thanks, Linda! Collaborating with your doctor is one of the most important steps at the start of your treatment journey with TAKHZYRO.
VO RECORDING: TAKHZYRO® (lanadelumab-flyo) is a prescription medicine used to prevent attacks of hereditary angioedema (HAE) in people 2 years of age and older.
VO RECORDING: It is not known if TAKHZYRO is safe and effective in children under 2 years of age.
VO RECORDING: 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, hives.
VO RECORDING: The most common side effects seen with TAKHZYRO were injection site reactions (pain, redness, and bruising), upper respiratory infection, headache, rash, dizziness, diarrhea, and muscle aches.
VO RECORDING: 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 FDA at 1-800-FDA-1088.
VO RECORDING: 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.
Chapter 3: The OnePath® Product Support Team
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Hear about our support program and its wide range of services.
View Transcript
KIM: TAKHZYRO® (lanadelumab-flyo) is a prescription medicine used to prevent attacks of hereditary angioedema (HAE) in patients 2 years of age and older. TAKHZYRO may cause serious side effects, including allergic reactions. Continue watching until the end of this video for additional Important Safety Information.
KIM: Hi! I’m Kim, and I’m a physician assistant that works with the HAE community. When deciding to start TAKHZYRO, you may have heard of OnePath Product Support, a program that offers patients a range of services. Let’s talk a little about that and what they do. But before I begin, I’d like to introduce someone who's going to help me out.
ANDREW: Thanks, Kim! I’m Andrew, a patient ambassador for TAKHZYRO. I'll be sharing some of the experiences I’ve had with the OnePath team and how they helped me get started with TAKHZYRO.
KIM: When you're prescribed TAKHZYRO, your doctor will help fill out a Start Form, which will enroll you in the program. Soon after enrollment, you'll receive a call from your Patient Support Manager, or PSM, from the main OnePath phone number. They will act as your primary point of contact during your treatment journey. Save this number to your phone so you can recognize calls from OnePath in the future!
KIM: Your PSM will work with you one-on-one to make sure you have access to your prescribed medication. They’ll also help with the following: Working with your insurance provider to help make sure your treatment is covered. Enrolling you in the OnePath Co-Pay Assistance Program, if you qualify. Arranging for a trained nursing professional to teach you how to self-inject TAKHZYRO at home, or virtually.
ANDREW: Admittedly, the early stages of my journey were a bit overwhelming. But my PSM was there to help alleviate some of that stress.
KIM: When it comes to insurance, your PSM and the rest of the OnePath team will walk you through the process step by step. They’ll also help you understand what’s covered and what’s not, and what to do next. Their goal is to help make it all a little easier.
ANDREW: I was initially denied TAKHZYRO, but OnePath Product Support worked with my insurance company and doctor to get me approved and started on treatment.
ANDREW: They also addressed any questions and concerns I had about accessing TAKHZYRO. In fact, my PSM continues to offer support throughout my journey. It’s good to know you’re not alone in this.
KIM: OnePath will also work with your specialty pharmacy to make sure your medicine is delivered. These pharmacies help coordinate many aspects of care for patients taking medications that have specialized handling, storage, and distribution requirements, just like TAKHZYRO.
ANDREW: When I was approved for TAKHZYRO, it took some time to receive my first delivery from the specialty pharmacy. But that’s normal. My OnePath team was able to get in touch with the pharmacy to help. And they let me know if there would be any changes to the delivery of my medication. Best of all, this support is provided to you free of cost.
KIM: Now let’s talk about at-home injection training. This is extremely important, as you should never try to inject TAKHZYRO without being properly trained by a healthcare professional. Your PSM will call you to explain how that process works. First, a nurse will come to your house. Then, they will show you how to inject your TAKHZYRO and stay with you while you do it. Lastly, they’ll help answer any questions you may have about the administration process.
KIM: Andrew, what was your experience with injection training?
ANDREW: The nurse who came to my house told me about the 3 areas where I could inject, which I was happy to learn about. She showed me and my wife how to prepare the medication and how to inject it. The injection itself took about a minute. That training session really set me up for success! Beforehand, I wasn’t quite sure how confident I would be with self-injections.
ANDREW: With OnePath Product Support, you’re not alone when you start your journey on TAKHZYRO. In the end, it was great to have the OnePath team on my side, especially during those first few months of treatment, when I wasn’t quite sure what to expect.
KIM: OnePath has been helping people with HAE for over 10 years—from helping with the insurance process to making sure you have consistent access to medication and at-home injection training.
VO RECORDING: TAKHZYRO® (lanadelumab-flyo) is a prescription medicine used to prevent attacks of hereditary angioedema (HAE) in people 2 years of age and older.
VO RECORDING: It is not known if TAKHZYRO is safe and effective in children under 2 years of age.
VO RECORDING: 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, hives.
VO RECORDING: The most common side effects seen with TAKHZYRO were injection site reactions (pain, redness, and bruising), upper respiratory infection, headache, rash, dizziness, diarrhea, and muscle aches.
VO RECORDING: 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 FDA at 1-800-FDA-1088.
VO RECORDING: 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.
Chapter 4: Side Effects of TAKHZYRO
More Info
Understand the potential side effects associated with taking TAKHZYRO.
View Transcript
KIM: TAKHZYRO® (lanadelumab-flyo) is a prescription medicine used to prevent attacks of hereditary angioedema (HAE) in patients 2 years of age and older. Continue watching until the end of this video for Important Safety Information.
KIM: Hi! I’m Kim, and I’m a physician assistant that works with the HAE community. Today, I want to talk about the safety information of TAKHZYRO with Linda, who is currently taking TAKHZYRO.
LINDA: Thanks, Kim! It’s really important for people to understand the side effects associated with any medication they take.
KIM: TAKHZYRO may cause serious side effects, including allergic reactions. If you experience any of the following symptoms of an allergic reaction while taking TAKHZYRO, call your doctor or get emergency help right away: wheezing, difficulty breathing, chest tightness, fast heartbeat, faintness, rash, or hives.
KIM: Now let’s discuss the most common side effects seen with TAKHZYRO. These refer to the side effects that were experienced by the most people in the clinical trial. These were injection site reactions, upper respiratory infection (an example of this is when someone gets a cold), headache, rash, muscle pain, dizziness, and diarrhea. You can see the percentage of patients that experienced these side effects in the table.
KIM: If you’d like to read more about the other side effects of TAKHZYRO, you can visit the website URL shown here. Let’s focus on injection site reactions.
LINDA: Kim, some people may not know what injection site reactions are. Can you explain them?
KIM: Of course! Injection site reactions are most commonly pain, redness, or bruising in the area where TAKHZYRO was injected. In the clinical trial, 52% of the 84 people who received TAKHZYRO reported injection site reactions.
KIM: These reactions are expected, though.
LINDA: When I first started TAKHZYRO, I wasn’t sure how I felt about injecting myself. Would it hurt? Would I have a reaction? Thankfully, my doctor reassured me. I was informed that it may hurt a bit, but to keep taking TAKHZYRO exactly as directed.
LINDA: My OnePath Patient Support Manager set up an at-home injection training session for me. It made me feel confident injecting my medication moving forward.
KIM: Glad you brought that up! If you haven't already, you'll be trained how to inject TAKHZYRO by a healthcare professional before your first dose. Be sure to use that time to ask any questions you may have about the injection process.
KIM: And remember! Call your doctor right away, or get emergency help, if you experience any symptoms of an allergic reaction while taking TAKHZYRO.
KIM: Just as everyone’s experience with HAE is different, every person will respond to medication differently. That's why it's important to understand what the side effects of TAKHZYRO are, and what you can do if you experience them.
VO RECORDING: TAKHZYRO® (lanadelumab-flyo) is a prescription medicine used to prevent attacks of hereditary angioedema (HAE) in people 2 years of age and older.
VO RECORDING: It is not known if TAKHZYRO is safe and effective in children under 2 years of age.
VO RECORDING: 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, hives.
VO RECORDING: The most common side effects seen with TAKHZYRO were injection site reactions (pain, redness, and bruising), upper respiratory infection, headache, rash, dizziness, diarrhea, and muscle aches.
VO RECORDING: 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 FDA at 1-800-FDA-1088.
VO RECORDING: 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.
Chapter 5: Looking Ahead to Steady State
More Info
Find out what steady state is and how to reach it.
View Transcript
KIM: TAKHZYRO® (lanadelumab-flyo) is a prescription medicine used to prevent attacks of hereditary angioedema (HAE) in patients 2 years of age and older. TAKHZYRO may cause serious side effects, including allergic reactions. Continue watching until the end of this video for additional Important Safety Information.
KIM: Hi! I’m Kim, a physician assistant that works with the HAE community. Today, I’d like to talk about staying on track with TAKHZYRO and steady state. To do that, Linda and Andrew, 2 people taking TAKHZYRO, will be helping me out. Linda, do you remember what steady state is?
LINDA: Hi, Kim! It’s been a while, but I remember my doctor telling me that it’s when the amount of TAKHZYRO in the body becomes constant.
KIM: That’s right. Starting with your first dose of TAKHZYRO, the medicine builds in your body over time. Over the course of your first 6 doses, the amount of TAKHZYRO in your body will reach a constant level that is known as steady state. That’s why it’s important to give TAKHZYRO about two and a half months to reach steady state.
KIM: Keep in mind that TAKHZYRO is a medication that continues to work as you take it. That means you need to take it as prescribed by your doctor and avoid missing or skipping doses.
KIM: Once you start taking TAKHZYRO, it’s important to know that breakthrough HAE attacks can still occur.
KIM: In a clinical study that lasted 6.5 months and included 125 people with HAE aged 12 years and older, TAKHZYRO was clinically proven to help reduce HAE attacks by 87% on average compared to placebo. They also had an average of 83% fewer moderate or severe attacks and 87% fewer attacks requiring on-demand treatment compared with placebo.
ANDREW: I started experiencing fewer HAE attacks shortly after beginning treatment. But not all patients are the same. Experiences, and expectations, may vary. Right, Linda?
LINDA: Of course. When I was starting out on TAKHZYRO, I was still experiencing HAE attacks. To be honest, I was disappointed. I had expected fewer attacks after starting treatment. So I called my doctor. He reassured me right away that this was normal. He explained that the medicine needed time to build up in my body. Once I understood that, I was convinced I needed to give it time and keep taking TAKHZYRO. After a few months, I noticed my HAE attacks were less frequent and less severe than they had been before. I was proud of myself for sticking to my plan.
KIM: So if a breakthrough attack happens, don’t be discouraged. Talk to your doctor about your goals and expectations with preventive treatment, as well as the importance of continuing to take TAKHZYRO as prescribed.
KIM: Like Linda, you may notice that over time your HAE attacks are less frequent and less severe or that you are using your on-demand treatment less. These are signs that TAKHZYRO is working!
LINDA: If you have any questions about steady state or the clinical study data as you begin to take TAKHZYRO, speak with your doctor, like I did!
KIM: Remember, in order for TAKHZYRO to work effectively, you need to keep taking it as prescribed.
VO RECORDING: TAKHZYRO® (lanadelumab-flyo) is a prescription medicine used to prevent attacks of hereditary angioedema (HAE) in people 2 years of age and older.
VO RECORDING: It is not known if TAKHZYRO is safe and effective in children under 2 years of age.
VO RECORDING: 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, hives.
VO RECORDING: The most common side effects seen with TAKHZYRO were injection site reactions (pain, redness, and bruising), upper respiratory infection, headache, rash, dizziness, diarrhea, and muscle aches.
VO RECORDING: 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 FDA at 1-800-FDA-1088.
VO RECORDING: 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.
Chapter 6: Creating Your Success Story
More Info
Get some tips on how to make your management plan successful.
View Transcript
KIM: TAKHZYRO® (lanadelumab-flyo) is a prescription medicine used to prevent attacks of hereditary angioedema (HAE) in patients 2 years of age and older. TAKHZYRO may cause serious side effects, including allergic reactions. Continue watching until the end of this video for additional Important Safety Information.
KIM: Hi! I’m Kim, and I’m a physician assistant that works with the HAE community. Today, Andrew and Linda—2 people with HAE—and I will be talking about staying on treatment with TAKHZYRO for the long term.
LINDA: Sounds great, Kim!
KIM: We’ll discuss follow-up visits with their doctor and tips on how to remember to take TAKHZYRO.
KIM: As you get comfortable with your TAKHZYRO routine, it’s important to revisit the treatment goals you and your doctor made at the start of your journey.
KIM: Ask yourself this: Have the frequency and severity of your HAE attacks changed in the months since you’ve started TAKHZYRO? If they have, talk to your doctor about those changes and what your next set of goals may be.
LINDA: Setting goals helped me see how I was doing with my HAE management plan.
LINDA: It helps to have realistic goals for your treatment. For me, I wanted fewer and less severe HAE attacks. So when I started taking TAKHZYRO, I tracked 3 things: The frequency of my attacks. Their severity. And how often I used my on-demand treatment. Once I started to see progress, my doctor and I decided TAKHZYRO was the right choice for me.
KIM: Speaking of progress, let's take a look at the efficacy of TAKHZYRO. In a clinical study that lasted 6.5 months and included 125 people with HAE aged 12 years and older, taking TAKHZYRO was clinically proven to help reduce HAE attacks by 87% on average compared to placebo. They also had an average of 83% fewer moderate or severe attacks and 87% fewer attacks requiring on-demand treatment compared with placebo.
ANDREW: At this point in your journey, it’s important to have these moments of reflection. These are the moments that helped me realize the bigger picture: my life before and after I started preventive treatment with TAKHZYRO. Moments like these showed me how much TAKHZYRO has helped and can continue to help manage my HAE. Since starting TAKHZYRO, my HAE attacks have been less frequent and less severe.
KIM: That's so good to hear, Andrew! In fact, in the same 6.5-month clinical study, 44% of people taking TAKHZYRO 300 mg every 2 weeks had zero attacks during the entire study compared with 2% taking placebo. You've experienced periods of time without attacks, is that right?
ANDREW: Yes! I've gone several months without an attack! I’ve come a long way since the beginning of my journey. All thanks to choosing effective prevention with my doctor.
KIM: Remember, TAKHZYRO continues to work as you take it, so it is important to keep taking it as prescribed by your doctor. You should also avoid skipping and missing doses.
KIM: Takeda is committed to helping you stay on track with your treatment.
LINDA: It’s true! The TAKHZYRO Text Reminder Program has been a big help when it comes to taking my medication on schedule. Just text SIGNUP to 36395 to start receiving reminders.
KIM: You can get more information about the Text Reminder Program by visiting the TAKHZYRO website.
KIM: In addition to the Text Reminder Program, what are some other ways you remember to take your TAKHZYRO as prescribed?
ANDREW: On my dosing days, right before my wife and I start our morning errands, she reminds me to take my TAKHZYRO injection. Injecting takes about a minute. And it’s something that I’ve gotten used to. Hopefully, you will too!
LINDA: I like to take my TAKHZYRO right after my morning cup of coffee on injection days. It’s easy for me to remember it that way.
KIM: Andrew, Linda, can you share what long-term prevention has meant for you?
LINDA: I like knowing I’m taking a medication that has been studied for as long as it has. Plus, TAKHZYRO has been prescribed to over 2,500 people. Being one of those people is reassuring. It's also reassuring to see the results I've had with TAKHZYRO.
ANDREW: I like the fact that I can inject TAKHZYRO and then not think about it again until my next dose. TAKHZYRO has helped me have fewer attacks, allowing me to reimagine my possibilities.
KIM: Your journey may be just beginning, but know you're part of a growing community that recognizes the importance of having a preventive treatment as part of their HAE management plan. You have the tools to get started and stay on track with TAKHZYRO. Now it's your turn to draw the next chapter of your journey. Keep exploring TAKHZYRO.com for more information as well as stories from patients like you.
VO RECORDING: TAKHZYRO® (lanadelumab-flyo) is a prescription medicine used to prevent attacks of hereditary angioedema (HAE) in people 2 years of age and older.
VO RECORDING: It is not known if TAKHZYRO is safe and effective in children under 2 years of age.
VO RECORDING: 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, hives.
VO RECORDING: The most common side effects seen with TAKHZYRO were injection site reactions (pain, redness, and bruising), upper respiratory infection, headache, rash, dizziness, diarrhea, and muscle aches.
VO RECORDING: 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 FDA at 1-800-FDA-1088.
VO RECORDING: 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.
TAKHZYRO gives you freedom from daily dosing
≤
1
MINUTE TO
SELF-INJECT
for most people in the
clinical trial*
2
WEEKS BETWEEN
EACH DOSE
for patients 2 years of age and older
3
CHOICES FOR
INJECTION SITE
stomach, thigh or upper arm
*Most adolescents and adults in the clinical studies self-administered TAKHZYRO within 10 to 60 seconds. These injection times are based on vial administration.
The recommended starting dosage for people 2 years of age and older is 300 mg every 2 weeks. It takes about 6 doses of TAKHZYRO for the amount of medication to become constant in your body. If you experience zero attacks for more than 6 months, your doctor may consider prescribing TAKHZYRO 300 mg every 4 weeks.
Before starting treatment with TAKHZYRO, you will receive training to ensure you know how to administer your therapy. Do not attempt to take TAKHZYRO without first being trained by a healthcare provider.
Make a commitment to yourself
and to TAKHZYRO
Give TAKHZYRO 2.5 months to reach steady state
With your first dose of TAKHZYRO, the medicine will start to build up in your body. Over the course of your first 6 doses, TAKHZYRO will reach a constant level—also known as "steady state." Once you get there, it’s important to keep taking TAKHZYRO exactly as prescribed to help maintain steady state.
The clinical study that lasted 6.5 months included 125 people with HAE aged 2 years and older.
(about 70 days)
month
2.5 dose 7
Take each dose as prescribed
TAKHZYRO continues to work as you take it, so it is important to take each dose as prescribed by your doctor. Remember also to avoid missing or skipping doses.
Breakthrough attacks
It's possible to experience breakthrough attacks while taking TAKHZYRO. Some people may experience them more frequently in the first few months of treatment.
Always keep your on-demand treatment nearby in case you have a breakthrough attack.
If you do experience a breakthrough attack, don't get discouraged. Let your doctor know, and continue to take TAKHZYRO as prescribed.
Stay the course
Over time, you may notice your attacks are less severe or that you’re using your on-demand treatment less. These are signs that TAKHZYRO is working.
- The goal of the 6.5 month clinical study was to evaluate the efficacy and safety of TAKHZYRO
- People 2 years and older taking TAKHZYRO 300 mg every 2 weeks saw a significant reduction in the number of monthly attacks by 87% on average compared with placebo
- They also had an average of 83% fewer moderate or severe attacks and 87% fewer attacks requiring on-demand treatment compared with placebo
- In a later analysis of the 6.5-month clinical study, after patients received their sixth dose of TAKHZYRO, 77% had zero attacks for the last 4 months of the study, compared to 3% of those taking placebo
- While supportive of the main findings, the results above were not the primary focus of the clinical study. It was not designed to measure the percentage of people who had zero attacks after 2.5 months of treatment through the end of the study
In the same study, 44% of people had zero attacks for the entire 6.5 months, compared with 2% of people taking placebo.
Take a look at these helpful tools
Getting Started with TAKHZYRO Brochure
Get an overview of what to expect upon starting treatment with TAKHZYRO.
TAKHZYRO Brochure
Learn all about TAKHZYRO, from study results to dosing information and more.
Need some help remembering to take TAKHZYRO?
