Trilandia Adventures: Resources for You and Your Child

VOICE-OVER: Watch this video with your child for information about staying on track with TRIKAFTA^® (elexacaftor/tezacaftor/ivacaftor and ivacaftor).

Introduction Song

CHARACTER VOICE-OVER: When they read this book, that was all it took for their journey to start up. With Trey’s creative lines, Trina’s inventive mind, and their supercool robo-pup, these siblings have a plan to learn all they can. Together in Trilandia!

Adventures With Trina and Trey: The Routine Roller Coaster

CYBARK: Before our journey begins, let’s listen to who TRIKAFTA is for and Important Safety Information. Join us afterward as we set out on our adventure.

VOICE-OVER: TRIKAFTA is a prescription medicine used for the treatment of cystic fibrosis, or CF, in patients aged 6 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 6 years of age.

Important Safety Information

Do not take TRIKAFTA if you take certain medicines such as: antibiotics such as rifampin or rifabutin; seizure medicines such as phenobarbital, carbamazepine, or phenytoin; St. John’s wort.

Talk to your doctor before taking TRIKAFTA if you take any of these medicines or herbal supplements.

Stay tuned for additional Important Safety Information at the end of this video.

CYBARK: Trina and Trey have had a fun day exploring the Keep-in-Mind Carnival. Now it’s time to learn about staying on track with their treatment routine.

TREY: Okay, Mom was right. There is such a thing as too much cotton candy.

TRINA: I tried to tell you.

CYBARK: Your parents are calling.

MOM: I hope you’ve all had fun so far. We have more activities planned for today’s adventures in Trilandia.

DAD: You’re going to learn about staying on track with your treatment routine.

DR. LORI: That’s right. I worked with your parents to create a challenge that won’t be forgotten. It’s all about making sure treatment time is always part of your routine. Someone who knows all this by heart will help you from the start.

MOM, DAD, DR.: Have a magical time.

TREY: Someone who knows all this by heart? Who could that be?

TRINA AND TREY: Whoa.

MAGICIAN: I think she means me. It is I, the Memory Magician, master of remembering, wizard of routines. Dr. Lori and your parents told me you could both use a few ideas for staying on track with your treatment. For your quest to begin, you must first reach inside my hat.

TRINA: The Routine Roller Coaster?

TREY: Awesome.

MAGICIAN: Ready to take a spin?

TREY: Mom, Dad, we get to ride a roller coaster.

DAD: Oh, we heard all about it. Since you’re going to be learning about your treatment routine, we wanted to remind you that we’re always here to help, no matter what.

MOM: Also, don’t forget to buckle your seat belts.

TREY: Hmm, how do we get it started?

TRINA: Let’s see. Cybark, mind if I play around a little?

CYBARK: My circuits are your circuits.

TRINA: Okay, so I just need to move this wire over here, reroute the processor, tighten this bolt.

CYBARK: Ooh, that tickles. Arr, me pirate mode has been activated.

TRINA: Whoops.

CYBARK: Switching to pilot mode.

TRINA: There we go.

Trina and Trey’s Routine Roller Coaster Checklist

MAGICIAN: This is no ordinary ride, you see. For each twist and turn will help you learn a bit more about staying on track with your treatment routine. First, you’ll figure out a few tips for remembering treatment time. Then, you’ll discover how to make treatment time part of your regular routine. And finally, you’ll learn about staying on track when your routine changes. Now sit back, hang on, and get ready for quite a ride.

TREY: We want to go left.

TRINA: Whoa, is that a calendar?

TREY: It is. And actually, it looks just like the one Dr. Lori gave us.

TRINA: Oh right, she told us we can use it to keep track of our treatments by marking each day we take our medicine.

TREY: I think she mentioned that there are other ways to stay on track, too.

MAGICIAN: Indeed there are. You can ask your parents about setting reminders on a mobile device, too.

Remembering treatment time… Check.

TREY: Can’t wait to see what’s next.

TRINA: Right.

TREY: Hey, this looks familiar. Is it my room?

TRINA: Yeah, but much cleaner.

TREY: Hey, what’s that?

TRINA: I can’t tell. We’re heading right for it.

TRINA AND TREY: Wow. Whee!

CYBARK: Woof-woof.

TRINA AND TREY: Wow.

TRINA: Who knew staying on track would be such a wild ride?

MAGICIAN: Here’s a little trick to not letting treatment time slip by, you see: Treat it like it’s part of your regular routine.

TREY: Like brushing my teeth.

TRINA: And taking Cybark out for walks.

MAGICIAN: Precisely. It’s all about getting into a routine with your routine.

Making treatment time part of your routine… Check.

CYBARK: Your adventure is 66 percent complete.

TRINA: That means 1 more item left.

TREY: Ready when you are.

Routine Twister

DR. LORI: Hey kids, before the twister pulls you in, just remember that I’m always here to help if your routine ever takes an unexpected turn. That way, you can keep doing what you enjoy.

Summer Break

TREY: Our routines can change during summer break, but we can still have fun while staying on track. Go left.

MAGICIAN: Here’s a trick: Try not to schedule summer activities during your usual treatment times.

After-School Plans

TRINA: Our after-school plans may keep us busy, but no matter what we do, we need to find time for our treatment routine.

TREY: Let’s stay on track. Go right.

MAGICIAN: Here’s a trick: Plan activities that are easy to take a break from, like reading or playing with friends, so you won’t miss out during treatment time.

Holidays

TREY: During the holidays, there’s a lot going on, so we may not be as focused on our treatment routine.

TRINA: We can celebrate while staying on track.

TRINA AND TREY: Let’s go right.

MAGICIAN: Here’s a trick: Ask your parents to make a list each morning of what you need to do that day and be sure to include your treatments.

Staying on track during routine changes… Check.

TRINA AND TREY: We did it!

MAGICIAN: Your journey is now complete. Before you continue your adventure in Trilandia, remember that treatment routines are there to help, just like me.

MOM: So, feeling good about sticking to your treatment routine?

TREY: You know it.

DAD: That’s great, because life is full of ups and downs and twists and turns, but sticking to your treatment routine is always important.

MOM: And we’ll be right here to help.

TRINA: Thanks for teaching us how to stick to our treatment routines.

MAGICIAN: Well, I’ve got plenty more tricks up my sleeve.

TRINA: Maybe we should’ve grabbed that giant toothbrush.

VOICE-OVER: Caregivers, we hope you and your child enjoyed exploring with Trina and Trey. Please continue watching for more Important Safety Information. As always, talk to your child’s healthcare provider if you have any questions about treatment.

Additional Important Safety Information

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.

TRIKAFTA may affect the way other medicines work, and other medicines may affect how TRIKAFTA works. Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. 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. Make sure the list includes medicines from all your pharmacies, if you have more than one.

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

What should I avoid while taking TRIKAFTA?

TRIKAFTA can cause dizziness in some people who take it. Do not drive a car, use machinery, or do anything that needs you to be alert until you know how TRIKAFTA affects you. Avoid food or drink that contains grapefruit while you are taking TRIKAFTA.

What are the possible side effects of 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 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.

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

VOICE-OVER: Watch this video with your child for information about taking TRIKAFTA^® (elexacaftor/tezacaftor/ivacaftor and ivacaftor).

Introduction Song

CHARACTER VOICE-OVER: When they read this book that was all it took for their journey to start up. With Trey’s creative lines. Trina’s inventive mind. And their supercool robo-pup. These siblings have a plan to learn all they can. Together in Trilandia.

Adventures With Trina and Trey: How to Take TRIKAFTA

CYBARK: Before our journey begins, let’s listen to who TRIKAFTA is for and Important Safety Information. Join us afterward as we set out on our adventure.

VOICE-OVER: TRIKAFTA is a prescription medicine used for the treatment of cystic fibrosis, or CF, in patients aged 6 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 6 years of age.

Important Safety Information. Do not take TRIKAFTA if you take certain medicines such as: antibiotics such as rifampin or rifabutin; seizure medicines such as phenobarbital, carbamazepine, or phenytoin; St. John’s wort. Talk to your doctor before taking TRIKAFTA if you take any of these medicines or herbal supplements. Stay tuned for additional Important Safety Information at the end of this video.

CYBARK: After visiting Dr. Lori with their parents, Trina and Trey head to the Forest of Flavorful Foods to learn how to take TRIKAFTA.

TRINA: We made it to the Forest of Flavorful Foods.

TREY: Wow! Ah, cheese! Want some, Cybark?

CYBARK: Oh no. I only eat solar energy.

TREY: You’re missing out.

CYBARK: Trina, Trey, your parents are calling.

MOM: Hey, kids. We’re visiting your CF doctor, Dr. Lori Laboratory, and she wanted to give you a challenge for this part of your adventure in Trilandia.

DR. LORI: That’s right. I want to see if you can remember our talk at the CF Care Center about how to take TRIKAFTA and what your parents and you can do if you miss a dose. Are you up for the task?

KIDS: Yeah.

Trina and Trey’s Checklist

DR. LORI: Okay, first let’s review how to take each dose. Then we’ll see if you can remember the prescribed dose your parents will give you and some foods to eat with TRIKAFTA. Lastly, you’ll have to figure out where in Trilandia you can see what to do if a dose is missed. If you’re 6 through 11 years old, like you, Trina and Trey, your TRIKAFTA dose will be different depending on your weight. Kids who weigh less than 30 kilograms, or about 66 pounds, will get their TRIKAFTA from this box.

And kids who weigh 30 kilograms, or about 66 pounds, or more will get their TRIKAFTA from this different box. The morning dose should be taken with fat-containing food. Then about 12 hours later, the evening dose is taken with fat-containing food.

How to take each dose… Check.

MOM: Look at that, you’ve already checked 1 item off your list. Have fun with the rest.

TREY: How are we going to figure out which TRIKAFTA we get in the middle of the forest? Cybark, you got anything in there to help us?

CYBARK: Hey, that tickles.

TRINA: That gives me an idea, but I’ll need to make some changes to Cybark. Do you trust me, buddy?

CYBARK: With all my circuits.

TRINA: Okay, I’ll just take my trusty tool belt. With a little rewiring, some small changes, and voilà.

CYBARK: Weighing mode has been activated. Hop on.

TREY: Looks like Mom and Dad will give me my TRIKAFTA from this box.

TRINA: And they’ll give me my TRIKAFTA from this box.

MOM: Well, I see you both remembered your prescribed doses.

CYBARK: That’s ruff-ruff-right.

DR. LORI: Good work. Your parents will keep me updated on all the medicines you take, just in case a dose of TRIKAFTA needs to be adjusted.

MOM: Your dad and I will make sure you take every dose of TRIKAFTA just like Dr. Lori prescribed. You’re doing great, kids.

Your child’s prescribed dose… Check.

DR. LORI: Keep going until you complete the challenge.

MOM: Bye, now.

TREY: Wait, why do we have to take TRIKAFTA with foods that have fat?

TRINA: Remember when we visited Dr. Lori? She told Mom and Dad that foods with fat help our bodies absorb the medicine better. Oh, that’s right. She also said to avoid grapefruit, since it may affect the amount of TRIKAFTA in our bodies.

CYBARK: That’s correct. And this forest is full of foods with fat. Can you find 5 of them?

TREY: Oh, I got this. I’ll just use my lucky pen and pad to help me find them. Hmm, I see whole milk, peanut butter, whole-milk yogurt, an egg, and guacamole. Say, why don’t we go get some of this food to take with us? I want yogurt.

TRINA: And I want guacamole.

CYBARK: Just remember to avoid the grapefruit patch.

TRINA: Holy guacamole! I could stay here all day.

TREY: Oh, my favorite.

What to eat with TRIKAFTA… Check.

CYBARK: Bow-wow-wowza. Great job, guys. We just have one more thing to remember.

TRINA: Look, Mom and Dad are calling.

MOM: Great job, kids. Here’s a riddle to help with the last part of your adventure. It’s round and spins just like a clock, surrounded by games that never stop. Go take a ride up to the top.

TREY: Hmm, spins like a clock.

TRINA: Surrounded by games. I know–

TRINA AND TREY: It’s a Ferris wheel at Keep-in-Mind Carnival.

TREY: This must be it. Ah. Now would be a great time to have paws.

CYBARK: If I may.

TREY: Oh, thanks, Cybark.

MOM: You figured out my riddle. I’m so glad.

DR. LORI: Now enjoy the ride while we review ways to handle a missed dose. Keep in mind, the instructions for what to do in case of a missed dose will depend on whether you missed an a.m. or p.m. dose, and how long it’s been since your scheduled dose.

If your child missed a morning or evening dose and it’s been 6 hours or less from when they usually take it, they should take the missed dose with a food that contains fat as soon as possible.

TREY: But what if it’s been more than 6 hours?

MOM: Oh, I can answer that. If it’s been more than 6 hours after the time my child usually takes a morning dose, they should take it as soon as possible with a food that contains fat, but they do not take that day’s evening dose. Did I get that right, Dr. Lori?

DR. LORI: You did. And if it’s been more than 6 hours after the time your child usually takes an evening dose, they should skip that dose only and take their next dose as scheduled.

MOM: Oh, and Dr. Lori, don’t forget what you told me. They should never take more than their usual dose of TRIKAFTA to make up for a missed dose.

DR. LORI: Wow, you’ve really got this.

MOM: Kids, just know that when it comes to taking your TRIKAFTA, you can depend on me, your dad, and Dr. Lori.

DR. LORI: That’s right. Great job with my challenge, kids. Now it’s on to the next adventure.

What to do if a dose is missed… Check.

TRINA: Well, I guess it’s time to hit the road again.

TREY: Uh, mind if we head back to the forest? I gotta stock up on yogurt.

VOICE-OVER: Caregivers, we hope you and your child enjoyed exploring with Trina and Trey. Please continue watching for more Important Safety Information. As always, talk to your child’s healthcare provider if you have any questions about treatment. Important Safety Information.

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.

TRIKAFTA may affect the way other medicines work, and other medicines may affect how TRIKAFTA works. Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. 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. Make sure the list includes medicines from all your pharmacies, if you have more than one.

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

What should I avoid while taking TRIKAFTA? TRIKAFTA can cause dizziness in some people who take it. Do not drive a car, use machinery, or do anything that needs you to be alert until you know how TRIKAFTA affects you. Avoid food or drink that contains grapefruit while you are taking TRIKAFTA.

What are the possible side effects of 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 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 your 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.

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

This video is brought to you by Vertex Pharmaceuticals Incorporated.