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STACEY: Celebrating my son’s 6th birthday was a happy time for the whole family and knowing that TRIKAFTA^® was approved for children his age with the same mutations made me feel even better. Hi, everybody. I’m Stacey.

MASSI: Hi, I’m Massimo, but everybody calls me Massi.

STACEY: I’m going to share why we decided TRIKAFTA was right for our son, Massimo, and what it’s meant for us. Massi is a smiley, happy kid who other parents and kids just love to be around. He’s energetic and loves playing soccer, basketball, and baseball. He always has a positive attitude and he’s living his life with CF to the fullest.

VOICE-OVER: TRIKAFTA (elexacaftor/tezacaftor/ivacaftor and ivacaftor) is a prescription medicine used for the treatment of cystic fibrosis (or CF) in patients aged 2 years and older who have at least one copy of the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene or another mutation that is responsive to treatment with TRIKAFTA.

Talk to your doctor to learn if you have an indicated CF gene mutation.

It is not known if TRIKAFTA is safe and effective in children under 2 years of age.

Did you have any hesitations about starting Massimo on TRIKAFTA?

STACEY: The short answer is yes. I don’t tend to give my kids medicine without doing the research. I just want to make sure I’m prepared and understand what to watch for, including potential benefits and possible side effects. I guess it all goes back to when Massi was first diagnosed.

It was a very emotional time and we had a lot of hard days. I can recall our doctor telling me that I needed to stay positive because of the research underway for potential medicines that might help Massi. Staying informed and talking to our care team gave me a lot of hope.

Do you have any advice for other parents?

STACEY: I’d say find a routine that works for you and your child and stick to it. We established a routine early on and that made it easier for Massi to stay on track with his medicine. Also, if your child can have the opportunity to live a life that’s defined by more than their CF, it’s worth doing everything you can.

Start the conversation with your care team about potential treatments. I know that helped me feel more confident that TRIKAFTA was the right decision for our family.

What helped us make the decision to start TRIKAFTA?

When we were talking to our care team about TRIKAFTA, for us, what was really important was, first of all, was he in fact going to qualify for it with his particular mutations?

Once we got past that, it got more serious. What were the side effects of TRIKAFTA? We had all heard, anecdotally, some of the great outcomes, but what was our care team seeing firsthand? You know, they’re the ones on the ground seeing all the patients that are taking TRIKAFTA. What were they seeing?

For us, what was really important were considering the risk/benefit of taking a drug like TRIKAFTA. Were the risks or the side effects going to outweigh the benefit? In their opinion, when we were talking it through and making an educated decision about it, the benefits for Massi outweighed the risks. We started as soon as we could.

Before I get to more of your questions, please listen to this Important Safety Information.

Before taking TRIKAFTA, tell your doctor about all of your medical conditions, including if you are allergic to TRIKAFTA or any ingredients in TRIKAFTA. See the Patient Information for a list of ingredients. Have kidney problems; have or have had liver problems; are pregnant or plan to become pregnant. It is not known if TRIKAFTA will harm your unborn baby. You and your doctor should decide if you will take TRIKAFTA while you are pregnant. Are breastfeeding or planning to breastfeed. It is not known if TRIKAFTA passes into your breast milk. You and your doctor should decide if you will take TRIKAFTA while you are breastfeeding.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How has treatment been going so far?

STACEY: Any improvement for Massi was going to be a win for us. So from early on, we made sure to create a routine that helped him stay on track so he’d reach his treatment goals. I’m happy to say that he’s definitely seen an improvement. He’s in first grade. He’s doing really well. He loves to read. And it’s fun just to celebrate those normal victories that you come to know with your kids in school. It makes me glad we started TRIKAFTA when we did.

Thanks for listening to our story. I hope it answered some of your questions and gave you ideas for what to discuss with your doctor. Please keep watching for some more Important Safety Information.

VOICE-OVER: TRIKAFTA may affect the way other medicines work, and other medicines may affect how TRIKAFTA works. The dose of TRIKAFTA may need to be adjusted when taken with certain medicines. Ask your doctor or pharmacist for a list of these medicines if you are not sure.

Especially tell your doctor if you take: antibiotics such as rifampin (RIFAMATE^®, RIFATER^®) or rifabutin (MYCOBUTIN^®). Seizure medicines such as phenobarbital, carbamazepine (TEGRETOL^®, CARBATROL^®, EQUETRO^®), or phenytoin (DILANTIN^®, PHENYTEK^®). St. John’s wort. Antifungal medicines including ketoconazole, itraconazole (such as SPORANOX^®), posaconazole (such as NOXAFIL^®), voriconazole (such as VFEND^®), or fluconazole (such as DIFLUCAN^®). Antibiotics including telithromycin, clarithromycin (such as BIAXIN^®), or erythromycin (such as ERY-TAB^®)

Avoid food or drink that contains grapefruit while you are taking TRIKAFTA.

TRIKAFTA can cause serious side effects, including liver damage and worsening of liver function in people with severe liver disease that can be serious and may require transplantation. Liver damage has also happened in people without liver disease.

High liver enzymes in the blood, which is a common side effect in people treated with TRIKAFTA. These can be serious and may be a sign of liver injury. Your doctor will do blood tests to check your liver before you start TRIKAFTA, every 3 months during your first year of taking TRIKAFTA, and every year while you are taking TRIKAFTA. Your doctor may do blood tests to check the liver more often if you have had high liver enzymes in your blood in the past.

Call your doctor right away if you have any of the following symptoms of liver problems: pain or discomfort in the upper right stomach, or abdominal, area; yellowing of your skin or the white part of your eyes; loss of appetite; nausea or vomiting; dark, amber-colored urine.

Serious allergic reactions have happened to people who are treated with TRIKAFTA. Call your healthcare provider or go to the emergency room right away if you have any symptoms of an allergic reaction. Symptoms of an allergic reaction may include: rash or hives; tightness of the chest or throat or difficulty breathing; swelling of the face, lips, and/or tongue, or difficulty swallowing; or light-headedness or dizziness.

Abnormality of the eye lens, also known as cataract, which has happened in some children and adolescents treated with TRIKAFTA. If you are a child or adolescent, your doctor should perform eye examinations before and during treatment with TRIKAFTA to look for cataracts.

The most common side effects of TRIKAFTA include headache; upper respiratory tract infection, or common cold, including stuffy and runny nose; stomach, or abdominal, pain; diarrhea; rash; increase in liver enzymes; increase in a certain blood enzyme called creatine phosphokinase; flu, or influenza; inflamed sinuses; or increase in blood bilirubin.

Tell your doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of TRIKAFTA. For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

To learn more about TRIKAFTA and if it could be right for you, please talk to your healthcare provider and visit TRIKAFTA.com. Please see the links for Important Safety Information and full Prescribing Information, including Patient Information below.

This video is brought to you by Vertex Pharmaceuticals Incorporated.

BLAIR: Hi, I’m Blair.

THOMAS: Hi, I’m Thomas.

BLAIR: I’m going to answer some questions that other parents may have about TRIKAFTA, like how my husband, Bobby, and I decided TRIKAFTA was right for our son and how it’s been going so far. In school, Thomas was voted most likely to put a smile on your face, and I think that sums him up perfectly. He is never going to let somebody else tell him who he is. He is his own person that has a quick wit and zest for his family, and his friends, and his life.

Thomas’ humor and outlook show me every day that there is so much more to him than his CF. Sure, it’s a part of his life, but it is just one part of his life.

VOICE-OVER: TRIKAFTA (elexacaftor/tezacaftor/ivacaftor and ivacaftor) is a prescription medicine used for the treatment of cystic fibrosis, or CF, in patients aged 2 years and older who have at least one copy of the F508del mutation in the cystic fibrosis transmembrane conductance regulator, or CFTR, gene or another mutation that is responsive to treatment with TRIKAFTA. Talk to your doctor to learn if you have an indicated CF gene mutation. It is not known if TRIKAFTA is safe and effective in children under 2 years of age.

Thomas’s Diagnosis

BLAIR: We learned Thomas had CF when he was just 10 weeks old. Getting that diagnosis is, of course, life-changing for parents. It’s incredibly scary and overwhelming. But Bobby and I both had the feeling that the only thing that we could do to fight the disease was research, find out every possibility, every avenue. As a parent, you only want what’s best for your children. Why should CF change that?

How about I answer some of your questions?

How did you hear about TRIKAFTA?

How did we hear about TRIKAFTA? So, from early on, we’ve been following the developments in the CF community, always keeping an eye on what was new, and we’d also ask our care team about different treatments in what might be right for Thomas. Eventually, we heard about TRIKAFTA. We wondered if it could be the right option for him.

How did you decide to start Thomas on TRIKAFTA?

How we decided to start Thomas on TRIKAFTA. Every decision we made about Thomas’s care comes down to trust. Trust in our CF Care Center, trust in our CF care team, and, of course, trust in each other to decide what’s right for Thomas.

So when it came time to decide if TRIKAFTA was right for Thomas, we discussed the benefits and the risks with our CF care team. We wanted to learn what sort of side effects Thomas could experience and make sure we knew what to watch out for. We also discussed how TRIKAFTA works. We’d heard about it, but hearing what it might do for Thomas was encouraging.

After we got the information we needed, it was just a matter of when we would get him started.

Before I get to more of your questions, listen to this Important Safety Information.

VOICE-OVER: Before taking TRIKAFTA, tell your doctor about all of your medical conditions, including if you are allergic to TRIKAFTA or any ingredients in TRIKAFTA. See the Patient Information for a list of ingredients. Have kidney problems; have or have had liver problems; are pregnant or plan to become pregnant. It is not known if TRIKAFTA will harm your unborn baby. You and your doctor should decide if you will take TRIKAFTA while you are pregnant. Are breastfeeding or planning to breastfeed. It is not known if TRIKAFTA passes into your breast milk. You and your doctor should decide if you will take TRIKAFTA while you are breastfeeding.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

TRIKAFTA may affect the way other medicines work, and other medicines may affect how TRIKAFTA works. The dose of TRIKAFTA may need to be adjusted when taken with certain medicines. Ask your doctor or pharmacist for a list of these medicines if you are not sure.

Especially tell your doctor if you take: antibiotics such as rifampin (RIFAMATE^®, RIFATER^®) or rifabutin (MYCOBUTIN^®). Seizure medicines such as phenobarbital, carbamazepine (TEGRETOL^®, CARBATROL^®, EQUETRO^®), or phenytoin (DILANTIN^®, PHENYTEK^®). St. John’s wort. Antifungal medicines including ketoconazole, itraconazole (such as SPORANOX^®), posaconazole (such as NOXAFIL^®), voriconazole (such as VFEND^®), or fluconazole (such as DIFLUCAN^®). Antibiotics including telithromycin, clarithromycin (such as BIAXIN^®), or erythromycin (such as ERY-TAB^®)

Avoid food or drink that contains grapefruit while you are taking TRIKAFTA.

How has treatment been going for Thomas?

BLAIR: How has treatment been going for Thomas? The question every parent wants to know. Like with many of his treatments, we’ve had to keep an eye out for side effects for TRIKAFTA and monitor how he’s doing. And so far, we think TRIKAFTA was the right choice for him. Needless to say, I am very grateful. Getting the news that he could get TRIKAFTA was truly one of the best days.

What advice can you offer other parents?

Let’s see, what advice can I offer other parents? Definitely talk to your CF care team and get their recommendation. Once you have all the facts, think about what’s right for your child. Because we were informed and trusted our CF care team, it made the decision easier. I think we all have to be our own best advocates both for ourselves and for our family members. The more you can read and learn, the better. Get involved with other parents just to find out if there’s anything out there that can help your child.

Thanks so much for listening. I hope our story answers some of your questions and makes it a little easier when you talk to your doctor. Before you go, stick around for some more Important Safety Information.

VOICE-OVER: TRIKAFTA can cause serious side effects, including liver damage and worsening of liver function in people with severe liver disease that can be serious and may require transplantation. Liver damage has also happened in people without liver disease.

High liver enzymes in the blood, which is a common side effect in people treated with TRIKAFTA. These can be serious and may be a sign of liver injury. Your doctor will do blood tests to check your liver before you start TRIKAFTA, every 3 months during your first year of taking TRIKAFTA, and every year while you are taking TRIKAFTA. Your doctor may do blood tests to check the liver more often if you have had high liver enzymes in your blood in the past.

Call your doctor right away if you have any of the following symptoms of liver problems: pain or discomfort in the upper right stomach, or abdominal, area; yellowing of your skin or the white part of your eyes; loss of appetite; nausea or vomiting; dark, amber-colored urine.

Serious allergic reactions have happened to people who are treated with TRIKAFTA. Call your healthcare provider or go to the emergency room right away if you have any symptoms of an allergic reaction. Symptoms of an allergic reaction may include: rash or hives; tightness of the chest or throat or difficulty breathing; swelling of the face, lips, and/or tongue, or difficulty swallowing; or light-headedness or dizziness.

Abnormality of the eye lens, also known as cataract, which has happened in some children and adolescents treated with TRIKAFTA. If you are a child or adolescent, your doctor should perform eye examinations before and during treatment with TRIKAFTA to look for cataracts.

The most common side effects of TRIKAFTA include headache; upper respiratory tract infection, or common cold, including stuffy and runny nose; stomach, or abdominal, pain; diarrhea; rash; increase in liver enzymes; increase in a certain blood enzyme called creatine phosphokinase; flu, or influenza; inflamed sinuses; or increase in blood bilirubin.

Tell your doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of TRIKAFTA. For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

To learn more about TRIKAFTA and if it could be right for you, please talk to your healthcare provider and visit TRIKAFTA.com.

For Important Safety Information and full Prescribing Information, including Patient Information, please see below.

This video is brought to you by Vertex Pharmaceuticals Incorporated.

TAYLOR: I think that back in high school, I was feeling pretty hopeless, and I think kind of where I am now, high school Taylor probably wouldn’t even believe it.

BRENNA: If I was talking to younger me, I think it would be important to mention that while the journey with CF is not always easy, and that it can be more difficult at times and create more challenges in life, it’s also a hopeful journey.

TAYLOR: I have my own personal goals that I really want to achieve. It also feels like cystic fibrosis has given me so much and taken so much, but I really want to use that to my advantage and move forward to try to help as many people as I can.

BRENNA: I am feeling very optimistic about what’s to come in my life and where I’m headed personally. And that is something I am very thankful for today and every day.

TAYLOR: Hi, I’m Taylor, I’m 28, and living with cystic fibrosis (CF).

BRENNA: I’m Brenna, I’m 22, and I’m living with cystic fibrosis too. It’s time for you to hear my TRIKAFTA story.

TAYLOR: Because it’s just getting started.

VOICE-OVER: TRIKAFTA® (elexacaftor/tezacaftor/ivacaftor and ivacaftor) is a prescription medicine used for the treatment of cystic fibrosis, or CF, in patients aged 2 years and older who have at least one copy of the F508del mutation in the cystic fibrosis transmembrane conductance regulator, or CFTR, gene or another mutation that is responsive to treatment with TRIKAFTA.

Talk to your doctor to learn if you have an indicated CF gene mutation.

It is not known if TRIKAFTA is safe and effective in children under 2 years of age.

CF is part of our story, but it’s not the whole story.

TAYLOR: I’m currently completing my last year of training, which will allow me to be a pediatric psychologist and help kids who grew up like me. I want to be someone who really understands their perspective, but also has the science background and training to really help them.

It was really when I applied to grad school that I decided, okay, I’m going to do work with kids. Then as I started studying the work with kids in grad school, I realized that the general mental health stuff was a missing piece. So that’s really when I decided to work with kids with chronic illnesses.

BRENNA: I’ve always been interested in the arts since a very young age. I thought I was going to grow up and be an actress. Dance and theater both were a very important part of maintaining some sense of normalcy. It was something that became an outlet when CF became a bigger part of my life, and even before that.

My CF journey started when I was only 4 months old. It’s kind of been up and down throughout my life. There have been really great times, and times where I’ve been sicker and been in the hospital. So things are always changing and always evolving.

So when my doctor mentioned TRIKAFTA, we decided together that if it could help, it was worth a try.

TAYLOR: For those out there that are maybe thinking about trying TRIKAFTA or even hesitant about starting TRIKAFTA, inform yourself. Talk to your doctors. Go onto the TRIKAFTA website and just kind of see like, what other people’s experiences have been.

BRENNA: After being on TRIKAFTA for a bit, I started to notice some improvement in my health and, almost as importantly, my friends and family did, as well, overall. I think for all of us, it was very exciting and created a new sense of hope.

Keep in mind that your results may be different from what is mentioned in these stories.

TAYLOR: The biggest thing that I noticed was just how good I was feeling. Another big thing that showed us that TRIKAFTA was working was the increase in my lung function. About a month after starting TRIKAFTA, I went to the doctor for a visit and my lung function was back up to a number that I had not seen in a really long time.

BRENNA: I started seeing improvements in my lung function, which was very exciting for me and has become a new motivation to continue working on my health.

VOICE-OVER: Before taking TRIKAFTA, tell your doctor about all of your medical conditions, including if you have kidney problems, have or have had liver problems, are pregnant or plan to become pregnant. It is not known if TRIKAFTA will harm your unborn baby. You and your doctor should decide if you will take TRIKAFTA while you are pregnant. Are breastfeeding or planning to breastfeed. It is not known if TRIKAFTA passes into your breast milk. You and your doctor should decide if you will take TRIKAFTA while you are breastfeeding. Stay tuned for additional Important Safety Information.

What’s kept us on track all this time?

BRENNA: Building this routine that works around your schedule and works with your life is very important because your health comes first. I know I struggled a lot with finding a routine, especially when I went to college, where I was handling all of this on my own. And once I had that down, it became a lot easier to manage everything else, so I was able to figure out school, work, and other things that I wanted to do because I built that routine for my health first.

TAYLOR: And I think being your own advocate and really saying what you need in each moment is the best advice I can give. I wish someone had told me that back when I was in high school.

BRENNA: My friends push me more than anyone to make sure I’m on top of my treatments and taking medications. They’ve made me feel so comfortable with having CF that I don’t have to shy away from being myself and being honest about how I’m feeling or what’s going on related to CF. I would also say my grandparents are a huge part of that support network and have been for my entire life.

TAYLOR: I would say that if you’re ever feeling like you really need help or you’re ever saying to yourself, “Wow, this is a really heavy burden to carry,” know that you don’t have to carry it by yourself. There are other people who want to help you.

Looking ahead to the next chapter

Sometimes when I’m feeling down about my CF, I’ll use it like a crutch to stop myself from living life, but I try to remember that it doesn’t have to define me, and I don’t have to stop myself.

BRENNA: I’d say that these past couple of years I’ve really started to understand the importance of living every day to the fullest. As cheesy as it might sound, it really is important.

TAYLOR: I’m looking forward to really getting settled and then being able to pursue my dream of being that pediatric psychologist and helping children and families with chronic medical conditions. Really continuing to be a face or a voice for the people who need it.

BRENNA: Time made it clear—

TAYLOR: Time made it clear that TRIKAFTA was the right choice.

BRENNA: —that TRIKAFTA was the right choice for me.

Important Safety Information

VOICE-OVER: Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

TRIKAFTA may affect the way other medicines work, and other medicines may affect how TRIKAFTA works. The dose of TRIKAFTA may need to be adjusted when taken with certain medicines. Ask your doctor or pharmacist for a list of these medicines if you are not sure.

Especially tell your doctor if you take: antibiotics such as rifampin or rifabutin; seizure medicines such as phenobarbital, carbamazepine, or phenytoin; St. John’s wort; antifungal medicines including ketoconazole, itraconazole, posaconazole, voriconazole, or fluconazole; antibiotics including telithromycin, clarithromycin, or erythromycin. Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.

Avoid food or drink that contains grapefruit while you are taking TRIKAFTA.

TRIKAFTA can cause serious side effects, including liver damage and worsening of liver function in people with severe liver disease that can be serious and may require transplantation. Liver damage has also happened in people without liver disease.

High liver enzymes in the blood, which is a common side effect in people treated with TRIKAFTA. These can be serious and may be a sign of liver injury. Your doctor will do blood tests to check your liver before you start TRIKAFTA, every 3 months during your first year of taking TRIKAFTA, and every year while you are taking TRIKAFTA. Your doctor may do blood tests to check the liver more often if you have had high liver enzymes in your blood in the past.

Call your doctor right away if you have any of the following symptoms of liver problems: pain or discomfort in the upper right stomach, or abdominal, area; yellowing of your skin or the white part of your eyes; loss of appetite; nausea or vomiting; dark, amber-colored urine.

Abnormality of the eye lens, also known as cataract, has happened in some children and adolescents treated with TRIKAFTA. If you are a child or adolescent, your doctor should perform eye examinations before and during treatment with TRIKAFTA to look for cataracts.

The most common side effects of TRIKAFTA include headache; upper respiratory tract infection, or common cold, including stuffy and runny nose; stomach, or abdominal, pain; diarrhea; rash; increase in liver enzymes; increase in a certain blood enzyme called creatine phosphokinase; flu, or influenza; inflamed sinuses; or increase in blood bilirubin.

Tell your doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of TRIKAFTA. For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects. You are encouraged to report side effects to FDA at 1-800-FDA-1088.

To learn more about TRIKAFTA and if it could be right for you, please talk to your healthcare provider and visit TRIKAFTA.com. Please see the links for Important Safety Information and full Prescribing Information, including Patient Information below.

This video is brought to you by Vertex Pharmaceuticals Incorporated.

CANDI: Hey everyone. I’m Candi. I have cystic fibrosis and 2 copies of the F508del mutation. Today, I’m going to answer some questions about my decision to start TRIKAFTA, what my thoughts were at the time, and what my experience has been like so far. Even though CF is a part of me, there’s so much more to who I am. I always like to say that when it comes to my CF, I drive the car and CF rides along in the passenger seat.

VOICE-OVER: TRIKAFTA^® (elexacaftor/tezacaftor/ivacaftor and ivacaftor) is a prescription medicine used for the treatment of cystic fibrosis (CF) in people aged 2 years and older who have at least one copy of the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene or another mutation that is responsive to treatment with TRIKAFTA.

Talk to your doctor to learn if you have an indicated CF gene mutation.

It is not known if TRIKAFTA is safe and effective in children under 2 years of age.

Before taking TRIKAFTA, tell your doctor about all your medical conditions, including if you: are allergic to TRIKAFTA or any ingredients in TRIKAFTA. See the Patient Information for a list of ingredients. Have kidney problems, have or have had liver problems, are pregnant or breastfeeding or plan to become pregnant or breastfeed.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

TRIKAFTA may affect the way other medicines work, and other medicines may affect how TRIKAFTA works. The dose of TRIKAFTA may need to be adjusted when taken with certain medicines. Ask your doctor or pharmacist for a list of these medicines if you are not sure.

Especially tell your doctor if you take: antibiotics such as rifampin or rifabutin; seizure medicines such as phenobarbital, carbamazepine, or phenytoin; St. John’s wort; antifungal medicines; or other antibiotics. Avoid food or drink that contains grapefruit while you are taking TRIKAFTA.

TRIKAFTA can cause serious side effects, including: Liver damage and worsening of liver function in people with severe liver disease that can be serious and may require transplantation. Liver damage has also happened in people without liver disease. High liver enzymes in the blood, which can be serious and may be a sign of liver injury. Before and during treatment with TRIKAFTA, your doctor will do blood tests to check your liver. Serious allergic reactions have happened to people who are treated with TRIKAFTA. Call your healthcare provider or go to the emergency room right away if you have any symptoms of an allergic reaction. Abnormality of the eye lens (cataract) has happened in some children and adolescents treated with TRIKAFTA. If you are a child or adolescent, your doctor should perform eye examinations before and during treatment with TRIKAFTA to look for cataracts.

The most common side effects of TRIKAFTA include: headache; diarrhea; upper respiratory tract infection (common cold) including stuffy and runny nose; stomach (abdominal) pain; inflamed sinuses; increase in liver enzymes; increase in a certain blood enzyme called creatine phosphokinase; rash; flu (influenza); and increase in blood bilirubin.

These are not all the possible side effects of TRIKAFTA. Call your doctor for medical advice about side effects.

Please stay tuned for additional safety information at the end of this video. You may also visit TRIKAFTA.COM to see the full Prescribing Information, including Patient Information.

CANDI: First, let me tell you a bit about me. I have two dogs, who I adore. And in my free time, I like to go hiking. I also love gardening, and I really enjoy nurturing these small seedlings and watching them grow into something big and beautiful. As a photographer, my work has taken me all around the world. I love meeting new people and telling their stories visually.

My next project is to combine these two passions into a photo shoot of my personal garden. So that’s me. Now let’s get to those questions.

What did you think when you first heard of TRIKAFTA?

CANDI: I was optimistic, but also skeptical. There have often been options on the horizon, but they haven’t always been right for me. There have been times in the past where I’ve had to interrupt or change my treatments for different reasons. So with TRIKAFTA, I wanted to make sure I took the time to understand the risks and the benefits.

What did you ask your care team before starting TRIKAFTA?

CANDI: First I asked my care team about any potential side effects. I wanted to know what to do if I experienced any side effects, and how my doctor would monitor them. Then we discussed the possible benefits, like increased lung function, and improved CF respiratory symptoms, which made me hopeful that TRIKAFTA could be right for me. After going over everything with my care team, I decided to give TRIKAFTA a try.

What has your experience been like on TRIKAFTA?

Keep in mind that your results may be different from what is mentioned in this story. Respiratory symptoms were measured using a questionnaire that produced a composite score for mucus production, waking up from coughing, coughing, difficulty breathing, wheezing, and congestion. An improvement in the score does not mean there was an improvement in every symptom.

CANDI: I’m happy to say I’ve seen an improvement in my lung function. That means a lot to me, and it means a lot to my doctors, too. And I saw improvements in my respiratory symptoms as well, which I know can be different for everyone. But for me, the improvement has been noticeable. While I’m happy with my experience on TRIKAFTA, I do want to tell you about a side effect that I had. Shortly after I started, I got a rash, but I contacted my healthcare team right away, just like they asked me to do. And together, we monitored it.

Any tips for someone considering TRIKAFTA?

CANDI: First things first, if you’re eligible, even if you have hesitations like I did, talk to your doctor. Be upfront about any concerns and then proceed with caution and awareness. In the end, I can only speak to my personal experience. Taking TRIKAFTA was the right decision for me, and I’m not taking it for granted.

Well, I hope hearing my story helps inspire you to talk to your healthcare team.

Thanks for listening. Take a moment to listen to this Important Safety Information.

IMPORTANT SAFETY INFORMATION

VOICE-OVER: Before taking TRIKAFTA, tell your doctor about all of your medical conditions, including if you are allergic to TRIKAFTA, or any ingredients in TRIKAFTA. See the Patient Information for a list of ingredients. Have kidney problems, have or have had liver problems, are pregnant or plan to become pregnant. It is not known if TRIKAFTA will harm your unborn baby. You and your doctor should decide if you will take TRIKAFTA while you are pregnant. Are breastfeeding or planning to breastfeed. It is not known if TRIKAFTA passes into your breast milk. You and your doctor should decide if you will take TRIKAFTA while you are breastfeeding.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

TRIKAFTA may affect the way other medicines work, and other medicines may affect how TRIKAFTA works. The dose of TRIKAFTA may need to be adjusted when taken with certain medicines. Ask your doctor or pharmacist for a list of these medicines if you are not sure.

Especially tell your doctor if you take: antibiotics such as rifampin or rifabutin; seizure medicines such as phenobarbital, carbamazepine, or phenytoin; St. John’s wort; antifungal medicines including ketoconazole, itraconazole, posaconazole, voriconazole, or fluconazole; antibiotics including telithromycin, clarithromycin, or erythromycin.

Avoid food or drink that contains grapefruit while you are taking TRIKAFTA.

TRIKAFTA can cause serious side effects, including liver damage and worsening of liver function in people with severe liver disease that can be serious and may require transplantation. Liver damage has also happened in people without liver disease.

High liver enzymes in the blood, which is a common side effect in people treated with TRIKAFTA. These can be serious and may be a sign of liver injury. Your doctor will do blood tests to check your liver before you start TRIKAFTA, every 3 months during your first year of taking TRIKAFTA, and every year while you are taking TRIKAFTA. Your doctor may do blood tests to check the liver more often if you have had high liver enzymes in your blood in the past.

Call your doctor right away if you have any of the following symptoms of liver problems: pain or discomfort in the upper right stomach (abdominal) area; yellowing of your skin or the white part of your eyes; loss of appetite; nausea or vomiting; dark, amber-colored urine

Serious allergic reactions have happened to people who are treated with TRIKAFTA. Call your healthcare provider or go to the emergency room right away if you have any symptoms of an allergic reaction. Symptoms of an allergic reaction may include: rash or hives; tightness of the chest or throat or difficulty breathing; swelling of the face, lips, and/or tongue, or difficulty swallowing; light-headedness or dizziness

Abnormality of the eye lens (cataract), which has happened in some children and adolescents treated with TRIKAFTA. If you are a child or adolescent, your doctor should perform eye examinations before and during treatment with TRIKAFTA to look for cataracts.

The most common side effects of TRIKAFTA include headache; upper respiratory tract infection, or common cold, including stuffy and runny nose; stomach or abdominal pain; diarrhea; rash; increase in liver enzymes; increase in a certain blood enzyme called creatine phosphokinase; flu, or influenza; inflamed sinuses; or increase in blood bilirubin.

Tell your doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of TRIKAFTA. For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

To learn more about TRIKAFTA and if it could be right for you, please talk to your healthcare provider and visit TRIKAFTA.com.

Please see the links for Important Safety Information and full Prescribing Information, including Patient Information, below.

This video is brought to you by Vertex Pharmaceuticals Incorporated.

OLIVIA: Since I was a kid, my mom and dad’s attitude about my cystic fibrosis really helped me stay positive about it. That attitude has made me who I am today. I’m Olivia, I’m 26, and I have cystic fibrosis with 2 copies of the F508del mutation. In this video, I’m going to answer some questions you may have about TRIKAFTA^®. I’ll tell you why I was initially hesitant to start TRIKAFTA, why I decided to start, and what my journey with TRIKAFTA has been like so far.

Through it all, my positive mindset helps me remember there’s so much more to me than my CF. It’s a part of my life, but it’s not my whole life.

VOICE-OVER: TRIKAFTA (elexacaftor/tezacaftor/ivacaftor and ivacaftor) is a prescription medicine used for the treatment of cystic fibrosis, or CF, in patients aged 2 years and older who have at least one copy of the F508del mutation in the cystic fibrosis transmembrane conductance regulator, or CFTR, gene or another mutation that is responsive to treatment with TRIKAFTA.

Talk to your doctor to learn if you have an indicated CF gene mutation.

It is not known if TRIKAFTA is safe and effective in children under 2 years of age.

Before taking TRIKAFTA, tell your doctor about all of your medical conditions, including if you are allergic to TRIKAFTA or any ingredients in TRIKAFTA. See the Patient Information for a list of ingredients. Have kidney problems; have or have had liver problems; are pregnant or plan to become pregnant. It is not known if TRIKAFTA will harm your unborn baby. You and your doctor should decide if you will take TRIKAFTA while you are pregnant. Are breastfeeding or planning to breastfeed. It is not known if TRIKAFTA passes into your breast milk. You and your doctor should decide if you will take TRIKAFTA while you are breastfeeding.

All about Olivia

OLIVIA: Let me tell you a little bit about myself. My parents have always encouraged me to do the things I wanted, while keeping my health in mind. So growing up, I joined a bunch of groups and tried a lot of different activities (such as theater and band). I started playing volleyball in elementary school, and I just fell in love with it. Being part of a team, working toward a shared goal, and getting that perfect ace is the best feeling.

Today, I coach high school and traveling club teams. I’m also a middle school English teacher, and I’m working on my master’s in professional and technical writing, with the ultimate goal of publishing a novel. I definitely like to stay busy! Now let’s answer those questions.

What did you think when your doctor told you about TRIKAFTA?

I’ve always been comfortable with my lung function, so I’ve been hesitant to make changes to my treatment routine. But I’ve been with the same CF care team since I was diagnosed, so typically, when they recommend a new treatment, we talk through all my concerns before I decide to move forward.

What did you want to know before starting TRIKAFTA?

My first thought was, what are the side effects? I wanted to know what to look out for and how we would monitor things. Then, when my doctor talked to me about the clinical data, I became hopeful about what it could do for me, and it actually made me excited to start. So when my insurance approved me for TRIKAFTA, my mom and I both got a little emotional. I remember crying because we had talked about TRIKAFTA so much, and now I knew I’d be starting it.

What has your experience been like on TRIKAFTA?

Keep in mind that your results may be different from what is mentioned in this story.

At my first check-up, I did my lung function test. I wasn’t sure what to expect, since my lung function has always been pretty consistent. So when the respiratory therapist, who has been with me since I was first diagnosed, brought out the paper and she was holding it to her chest. And she was like, “Okay, are you, are you ready to see these results?” And so, she showed it to me and I couldn’t believe the improvement.

Any tips for someone considering TRIKAFTA?

Definitely talk to your CF care team and get the recommendation. Then think about what you want and make the decision that’s right for you. My thought was, maybe it’ll be right for me or maybe it won’t. But now that I’m on it, I’m positive it was the right decision for me.

Well, I hope this gives you some insight into my experience with TRIKAFTA. Thanks for listening. Before you go, listen to some more Important Safety Information.

VOICE-OVER: Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

TRIKAFTA may affect the way other medicines work, and other medicines may affect how TRIKAFTA works. The dose of TRIKAFTA may need to be adjusted when taken with certain medicines. Ask your doctor or pharmacist for a list of these medicines if you are not sure.

Especially tell your doctor if you take: antibiotics such as rifampin (RIFAMATE^®, RIFATER^®) or rifabutin (MYCOBUTIN^®). Seizure medicines such as phenobarbital, carbamazepine (TEGRETOL^®, CARBATROL^®, EQUETRO^®), or phenytoin (DILANTIN^®, PHENYTEK^®). St. John’s wort. Antifungal medicines including ketoconazole, itraconazole (such as SPORANOX^®), posaconazole (such as NOXAFIL^®), voriconazole (such as VFEND^®), or fluconazole (such as DIFLUCAN^®). Antibiotics including telithromycin, clarithromycin (such as BIAXIN^®), or erythromycin (such as ERY-TAB^®)

Avoid food or drink that contains grapefruit while you are taking TRIKAFTA.

TRIKAFTA can cause serious side effects, including liver damage and worsening of liver function in people with severe liver disease that can be serious and may require transplantation. Liver damage has also happened in people without liver disease.

High liver enzymes in the blood, which is a common side effect in people treated with TRIKAFTA. These can be serious and may be a sign of liver injury. Your doctor will do blood tests to check your liver before you start TRIKAFTA, every 3 months during your first year of taking TRIKAFTA, and every year while you are taking TRIKAFTA. Your doctor may do blood tests to check the liver more often if you have had high liver enzymes in your blood in the past.

Call your doctor right away if you have any of the following symptoms of liver problems: pain or discomfort in the upper right stomach, or abdominal, area; yellowing of your skin or the white part of your eyes; loss of appetite; nausea or vomiting; dark, amber-colored urine.

Serious allergic reactions have happened to people who are treated with TRIKAFTA. Call your healthcare provider or go to the emergency room right away if you have any symptoms of an allergic reaction. Symptoms of an allergic reaction may include: rash or hives; tightness of the chest or throat or difficulty breathing; swelling of the face, lips, and/or tongue, or difficulty swallowing; light-headedness or dizziness.

Abnormality of the eye lens, also known as cataract, which has happened in some children and adolescents treated with TRIKAFTA. If you are a child or adolescent, your doctor should perform eye examinations before and during treatment with TRIKAFTA to look for cataracts.

The most common side effects of TRIKAFTA include headache; upper respiratory tract infection, or common cold, including stuffy and runny nose; stomach, or abdominal, pain; diarrhea; rash; increase in liver enzymes; increase in a certain blood enzyme called creatine phosphokinase; flu, or influenza; inflamed sinuses; or increase in blood bilirubin.

Tell your doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of TRIKAFTA. For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

To learn more about TRIKAFTA and if it could be right for you, please talk to your healthcare provider and visit TRIKAFTA.com.

Please see the links for Important Safety Information and full Prescribing Information, including Patient Information, below.

This video is brought to you by Vertex Pharmaceuticals Incorporated.

APRIL: I’ve waited basically my entire life for something like this. I mean, I was speechless. We all cried. So if you’re eligible and considering it, at least have that conversation with your doctor.

Hi, I’m April and I have cystic fibrosis. I have one copy of the F508 delta mutation. And I’m here to tell you my story. My CF is a big part of me. It always comes first, but I don’t let it really define me as a person.

VOICE-OVER: TRIKAFTA^® (elexacaftor/tezacaftor/ivacaftor and ivacaftor) is a prescription medicine used for the treatment of cystic fibrosis (or CF) in patients aged 2 years and older who have at least one copy of the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene or another mutation that is responsive to treatment with TRIKAFTA.

Talk to your doctor to learn if you have an indicated CF gene mutation.

It is not known if TRIKAFTA is safe and effective in children under 2 years of age.

APRIL: I love being outdoors and just staying as active as I can, so archery started as a sport to get me active and going. Also, I know it’s important for people with cystic fibrosis to be active. I fell in love with it instantly. Also, working out when you go to the gym—I feel like it helps you focus more. It’s not always about my CF, it’s about me and how I want to be as an individual.

When I learned I was eligible

I’ve waited basically my entire life for something like this. Although my F508 delta mutation is common, my other mutation is pretty rare. So when I found out that I was eligible, I was speechless. We all cried. I cried. My family cried. I always get emotional about it.

I had concerns about the possible side effects, so I asked my doctors what they were and what things would need to be monitored.

For the side effects, as soon as something happens, you call your doctor immediately. Just be very transparent to each other and explain exactly how you’re feeling. It was really important to have that discussion.

Before telling you more of my story, take a moment to listen to this Important Safety Information.

VOICE-OVER: Before taking TRIKAFTA, tell your doctor about all of your medical conditions, including if you are allergic to TRIKAFTA or any ingredients in TRIKAFTA. See the Patient Information for a list of ingredients. Have kidney problems; have or have had liver problems; are pregnant or plan to become pregnant. It is not known if TRIKAFTA will harm your unborn baby. You and your doctor should decide if you will take TRIKAFTA while you are pregnant. Are breastfeeding or planning to breastfeed. It is not known if TRIKAFTA passes into your breast milk. You and your doctor should decide if you will take TRIKAFTA while you are breastfeeding.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

TRIKAFTA may affect the way other medicines work, and other medicines may affect how TRIKAFTA works. The dose of TRIKAFTA may need to be adjusted when taken with certain medicines. Ask your doctor or pharmacist for a list of these medicines if you are not sure.

Especially tell your doctor if you take: antibiotics such as rifampin (RIFAMATE^®, RIFATER^®) or rifabutin (MYCOBUTIN^®). Seizure medicines such as phenobarbital, carbamazepine (TEGRETOL^®, CARBATROL^®, EQUETRO^®), or phenytoin (DILANTIN^®, PHENYTEK^®). St. John’s wort. Antifungal medicines including ketoconazole, itraconazole (such as SPORANOX^®), posaconazole (such as NOXAFIL^®), voriconazole (such as VFEND^®), or fluconazole (such as DIFLUCAN^®). Antibiotics including telithromycin, clarithromycin (such as BIAXIN^®), or erythromycin (such as ERY-TAB^®)

Avoid food or drink that contains grapefruit while you are taking TRIKAFTA.

Please see additional Important Safety Information later in this video and at TRIKAFTA.com.

My experience on TRIKAFTA

Keep in mind that your results may be different from what is mentioned in this story.

APRIL: The biggest change I saw was my lung function. It’s the highest it has been in a while. I’ve also noticed improvements in my respiratory symptoms. And I did start gaining weight on the drug, which is huge for people with cystic fibrosis. So when I went to the doctors and discussed with them, they were so excited. They were like, That is great, that is what you need. I mean, that is something I really fought for—to gain weight—my whole life.

Body mass index (BMI)* was evaluated in a study of people with one F508del mutation and another mutation defined in the study who took either TRIKAFTA or placebo.

*BMI=a measure of someone's weight in relation to their height.

I pay more attention to my diet, adding in some healthier fats, balancing out any junk food. I did experience a side effect. But before I tell you about that, take a look at some more Important Safety Information.

VOICE-OVER: TRIKAFTA can cause serious side effects, including liver damage and worsening of liver function in people with severe liver disease that can be serious and may require transplantation. Liver damage has also happened in people without liver disease.

High liver enzymes in the blood, which is a common side effect in people treated with TRIKAFTA. These can be serious and may be a sign of liver injury. Your doctor will do blood tests to check your liver before you start TRIKAFTA, every 3 months during your first year of taking TRIKAFTA, and every year while you are taking TRIKAFTA. Your doctor may do blood tests to check the liver more often if you have had high liver enzymes in your blood in the past.

Call your doctor right away if you have any of the following symptoms of liver problems: pain or discomfort in the upper right stomach, or abdominal, area; yellowing of your skin or the white part of your eyes; loss of appetite; nausea or vomiting; dark, amber-colored urine.

Serious allergic reactions have happened to people who are treated with TRIKAFTA. Call your healthcare provider or go to the emergency room right away if you have any symptoms of an allergic reaction. Symptoms of an allergic reaction may include: rash or hives; tightness of the chest or throat or difficulty breathing; swelling of the face, lips, and/or tongue, or difficulty swallowing; light-headedness or dizziness.

Abnormality of the eye lens, also known as cataract, which has happened in some children and adolescents treated with TRIKAFTA. If you are a child or adolescent, your doctor should perform eye examinations before and during treatment with TRIKAFTA to look for cataracts.

The most common side effects of TRIKAFTA include headache; upper respiratory tract infection, or common cold, including stuffy and runny nose; stomach, or abdominal, pain; diarrhea; rash; increase in liver enzymes; increase in a certain blood enzyme called creatine phosphokinase; flu, or influenza; inflamed sinuses; increase in blood bilirubin.

Tell your doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of TRIKAFTA. For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

My experience with side effects on TRIKAFTA

APRIL: My care team said they’d monitor me while I’m on treatment and that I should call them if I experience a side effect at any point. I did get a rash. My doctors and I decided to monitor it, and eventually it went away. It helped me that we discussed what to expect before starting. I’m grateful that I have doctors who are dedicated and know me very well.

Here’s what’s next for me!

I’m just so excited that I am going to be a science teacher so I can teach them about genetics and cystic fibrosis, so it’ll be pretty fun. I do want to inspire people. I want people to know that you’re not, you’re not the sick person. You’re more than that.

What I’d say if you’re considering TRIKAFTA

I’m always looking to do whatever I can for my CF. And after talking with my doctor, I knew that this was the right move for me. So if you’re eligible and considering it, at least have that conversation with your doctor.

VOICE-OVER: To learn more about TRIKAFTA and if it could be right for you, please talk to your healthcare provider and visit TRIKAFTA.com.

Please see the links for Important Safety Information and full Prescribing Information, including Patient Information, below.

This video is brought to you by Vertex Pharmaceuticals Incorporated.