Meet Kiki | VIJOICE® (alpelisib) tablets

This webpage has been created to help kids, together with their parents or caregivers, learn about PIK3CA-Related Overgrowth Spectrum (PROS) and treatment with VIJOICE. It is meant to help you understand what’s happening inside your body, learn about your medicine, and find out what to expect along the way—all in a friendly and fun way!

Meet Kiki!

Your science-smart sidekick

Hey there! My name is Kiki, and I am here to be your friendly, science-smart sidekick as you learn about your body and how it grows. I know that PROS (PIK3CA-Related Overgrowth Spectrum) can feel confusing, and medicines like VIJOICE come with lots of BIG words that sound like they came from a dusty old book. So, I thought, “What if someone smart and supportive explained this stuff?” And that’s where I come in! Let's break it down together—no dictionary required!

It can be confusing and scary when your body grows in ways that feel…strange. There may be changes you weren’t expecting, or you may have questions about what’s happening—that’s A-okay! You can always ask your parents, caregivers, or doctors. It is their job to listen and make sure you are all right.

I can help explain what’s going on inside your one-of-a-kind body, what a medicine called VIJOICE is, and how you may feel after you take VIJOICE.

I’ll cheer you on the whole time—because you deserve someone on your team who helps you understand a little more about your condition and your medicine.

Let’s start this journey together, the Kiki way: with care, support, and fun along the way!

Being YOU is your superpower

It’s okay to look different

Before we get into all this stuff about your condition (called PROS) and a medicine called VIJOICE, I want to remind you of something: there is only one YOU in the world. That’s really amazing when you think about it! Our bodies can look different, grow differently, and do things in their own way. So, remember this: your differences aren’t mistakes; they are what make you special.

What is PROS?

Let’s break it down together!

PROS stands for PIK3CA-Related Overgrowth Spectrum.

I know…PROS sounds like it belongs in outer space but, nope, it’s a real thing that can happen in kids and even adults, too.

Kiki holding her hand up to her face with a thinking expression.

The PIK3CA gene

PIK3CA is something inside of your body called a gene. No, not the jeans your dad wears! Think of a gene like an instruction book. You have a bunch of tiny instruction books in your body, and each one gives your body different directions, like:

What color your eyes are
What color your hair is
How tall you are

But, sometimes, the instructions can get mixed up.

“PIK3CA…it’s a big word. But you can do big things!” - Kiki

So what happens when the instructions get mixed up?

One of those instruction books helps control how much your body grows. To understand how that works, let’s imagine your body has a little bathtub inside just for growing.

The bathtub has a faucet that is controlled by the instruction book. When everything is working the right way, the faucet turns on to fill the bathtub and then turns off when it’s full. But when the instructions are mixed up, the faucet hears the wrong message, gets stuck on, and suddenly...there's too much water in the tub!

When that happens in a person with PROS, some bumps or growths on body parts are told to grow more than they should. It's not your fault. It's just like the bathtub getting too full because the instructions didn’t tell the faucet to turn the water off.

Ummm hey, faucet? This is a bathtub, not a swimming pool!” - Kiki

PROS can change the way you grow, not who you are!

Living with PROS means certain parts of your body may grow differently than expected. Trust me… I know how it feels to look different from your friends. But remember this: Everybody is unique in their own way, and it’s something doctors understand and know how to help you with.

Some of the most common things kids with PROS may experience are:

Bigger body parts—like one arm, leg, finger, or toe being larger than the other.

Kiki with an enlarged green arm and enlarged pink leg.

A bigger head—if the brain or skull grows extra.

Extra squishy bumps—like fatty lumps that pop up or soft tissue that pops up where they weren't invited.

Kiki with an enlarged bump on her face/neck.

Kiki pointing to the port wine stain on her stomach.

A colored patch on the skin—kind of like a birthmark—that can look pink, red, or purple.

Bone growth surprises—like bones growing faster or in a different shape or size.

Kiki raising her green arm with two enlarged fingers sticking upwards.

Kiki holding her green enlarged arm to represent pain.

Pain—parts of your body might hurt or feel achy.

Feeling extra tired—like a wave of sleepiness comes out of nowhere.

Kiki wearing a blue sleep cap and a tired facial expression while holding a small teddy bear.

Let’s talk about VIJOICE

What is it?

VIJOICE is a once-a-day medicine designed for kids (2 and up!) and grown-ups who have PROS and need help with bumps or growths on body parts that are growing too much.

“Did you know? It’s the first medicine ever designed just for our condition, PROS. How cool is that?!” - Kiki

Your doctor may talk about VIJOICE when PROS starts causing trouble because it’s a medicine that can help from the inside of your body, not just on the outside.

Have you ever been to a carnival? My favorite things to do at a carnival are eat as much cotton candy as possible and play lots of games! Speaking of games…

Think of VIJOICE like those water-gun games where you aim at the target. Well, VIJOICE is a targeted therapy, meaning it’s designed to focus on the thing that got mixed up inside of your body. It helps block that extra growth signal.

What to expect while taking VIJOICE

When kids take VIJOICE every day, some changes start to happen over time!

The fast-growing body parts might start to get smaller
The sore spots could start to feel better
And because you feel better, your favorite activities may feel more doable again

Even though your body won't change overnight, there are many kids like us who have kept feeling better for months, and even years, on VIJOICE!

With time, and helping hands from your doctors, VIJOICE can help you start to feel better.

“Just remember, slow and steady wins the race…that’s what my pet turtle used to say!” - Kiki

Side view of Kiki holding a wooden pointer.

Things you might notice at first

Sometimes when you first start VIJOICE, your body might feel a bit…yucky.

Those feelings in your body are called side effects. You may not feel like yourself when first starting your medicine, but I'll be here as a buddy to help you learn about what you may experience along the way.

Some of the most common side effects kids might experience are:

Tummy troubles or diarrhea
Sore spots in your mouth. Ouch!
Skin feeling dry or uncomfortable
Headaches…my least favorite!
Hair thinning or losing some hair

“Yup… there are some normal-ish icky feelings we may experience.” - Kiki

Let's talk about what can help

Talk to your parents, doctor, or caregiver so they can give you extra attention if you need it. Here are some of my favorite tips to help kids—like you—take VIJOICE:

Sip, sip, hooray! Drink lots of water or gentle drinks if your tummy is upset
Follow the BRAT diet...eat bananas, rice, applesauce, and toast
Tiny meals = big win. Nibbles through the day mean less tummy grumble!
Foods like chicken or eggs give your body extra “you got this” energy
Tell a grown-up if you’re super thirsty or extra tired—that can mean your blood sugar is misbehaving
Be kind to your mouth and skin. Stick to soft, easy foods and use gentle lotion if your skin is cranky.

“Stick to calm foods. My dad calls it the BRAT diet…focus on eating bananas, rice, applesauce, and toast.” - Kiki

How to take VIJOICE

Make it part of your day

Take VIJOICE at the same time, every day. There are three ways to take VIJOICE:

Tablets that you can swallow whole or make into a suspension
Granules that look like tiny white sprinkles you can take with water, milk, apple juice, or soft food
VIJOICE can be made into a suspension and even go through a feeding tube!

I’ll keep sharing tips, updates, and helpful information just for you.

You’re doing something really brave by learning about your body and taking care of it. Be proud of yourself!

“I’m your #1 fan. Keep being your awesome, unique self – I’ll be cheering you on!” - Kiki

That's all for now. Come back to visit Kiki soon!

Tap to see IMPORTANT SAFETY INFORMATION AND APPROVED USE

Important Safety Information

Do not take VIJOICE if you have had a severe allergic reaction to alpelisib or are allergic to any of the ingredients in VIJOICE.

VIJOICE may cause serious side effects, including:

Severe allergic reactions: Tell your health care provider or get medical help right away if you have trouble breathing, swelling of the face or...

Do not take VIJOICE if you have had a severe allergic reaction to alpelisib or are allergic to any of the ingredients in VIJOICE.

VIJOICE may cause serious side effects, including:

Severe allergic reactions: Tell your health care provider or get medical help right away if you have trouble breathing, swelling of the face or throat, flushing, rash, fever, or fast heart rate during treatment with VIJOICE
Severe skin reactions: Tell your health care provider or get medical help right away if you get a severe rash or a rash that keeps getting worse; reddened skin; flu-like symptoms; blistering of the lips, eyes, or mouth; blisters on the skin or peeling skin, with or without a fever
High blood sugar levels (hyperglycemia): Hyperglycemia is common with VIJOICE and can be severe. Your health care provider will monitor your blood sugar levels before you start, and during treatment with, VIJOICE. Your health care provider may monitor your blood sugar levels more often if you have a history of diabetes. Tell your health care provider right away if you develop symptoms of hyperglycemia, including excessive thirst, dry mouth, urinating more often than usual or having a higher amount of urine than normal, increased appetite with weight loss, confusion, nausea, vomiting, fruity odor on breath, difficulty breathing, or dry or flushed skin
Lung problems (pneumonitis): Tell your health care provider right away if you develop new or worsening symptoms of lung problems, including shortness of breath or trouble breathing, cough, or chest pain
Diarrhea or colitis (inflammation of your intestines): Diarrhea is common with VIJOICE and may be severe. Severe diarrhea can lead to the loss of too much body water (dehydration) and kidney injury. Tell your health care provider right away if you develop diarrhea or stomach-area (abdominal) pain, or see mucus or blood in your stool during treatment with VIJOICE. Your health care provider may tell you to drink more fluids or take medicines to treat diarrhea or colitis

Your health care provider may tell you to decrease your dose, temporarily stop your treatment, or completely stop your treatment with VIJOICE if you get certain serious side effects.

Before you take VIJOICE, tell your health care provider about all your medical conditions, including if you:

have a history of diabetes
have a history of skin rash, redness of skin, blistering of the lips, eyes, or mouth, or peeling skin
are pregnant or plan to become pregnant. VIJOICE can harm your unborn baby
are breastfeeding or plan to breastfeed. It is not known if VIJOICE passes into your breast milk. Do not breastfeed during treatment with VIJOICE and for 1 week after the last dose

Females who can become pregnant:

Your health care provider will check to see if you are pregnant before you start treatment with VIJOICE
You should use effective birth control during treatment with VIJOICE and for 1 week after the last dose. Talk to your health care provider about birth control methods that may be right for you during this time
If you become pregnant or think you are pregnant, tell your health care provider right away

Males with female partners who can become pregnant should use condoms and effective birth control during treatment with VIJOICE and for 1 week after the last dose. If your female partner becomes pregnant, tell your health care provider right away.

Tell your health care provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. VIJOICE and other medicines may affect each other and cause side effects. Know the medicines you take. Keep a list of them to show your health care provider or pharmacist when you get a new medicine.

The most common side effects of VIJOICE include diarrhea, mouth sores (stomatitis), high blood sugar, headache, dry skin, and hair loss (alopecia).

VIJOICE may affect fertility in males and in females who can become pregnant. Talk to your health care provider if this is a concern for you.

These are not all the possible side effects of VIJOICE. Call your health care provider for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch , or call 1-800-FDA-1088.

Please see full Prescribing Information, including Patient Information.

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