Understanding PIK3CA and PROS | VIJOICE® (alpelisib) tablets

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What is PROS?

PROS stands for PIK3CA-Related Overgrowth Spectrum.

PROS is the name for a group of conditions that are caused by a mutation in a gene called PIK3CA. The term mutation means the gene isn’t working correctly.

Image showing what PROS medical abbreviation stands for. P stands for PIK3CA-, R stands for Related, O stands for overgrowth, and S stands for Spectrum.

Did you know?

In 2013, researchers proposed grouping abnormal growth, vascular conditions, and lymphatic conditions caused by PIK3CA mutations under the term PROS. By uniting these many different conditions under one new term, researchers hoped to improve diagnosis, help manage symptoms, and establish future clinical trials. The criteria for PROS may change as research develops.

What conditions are PROS conditions?

You may have been diagnosed with PROS or one of the following PROS conditions:

This website can provide you with important information, guidance, and support as you learn about your PROS condition and either consider or navigate treatment with VIJOICE. See how VIJOICE may help.

KIDS' Q&A
	What if my child has questions about their PROS condition or VIJOICE?
	To help you explain certain aspects of their treatment journey, you will find tips for talking to your child throughout this website.

How do PIK3CA mutations cause PROS?

Your condition has been diagnosed as a PROS condition because it is caused by PIK3CA mutations. Let’s take a closer look at the role these mutations play in the body.

Think of your body as a machine. In the machine, there are gears that are responsible for keeping it running. One of these gears is called the PI3Kα protein, which receives instructions from the PIK3CA gene to help ensure the machine operates correctly. When these gears move at the right speed, the machine can function properly.

When a PIK3CA mutation occurs, the instructions cause the PI3Kα protein to move too quickly. As a result, the machine malfunctions, resulting in the signs and features of your PROS condition.

The PI3Kα protein is responsible for ensuring that many different parts of the body work correctly. That’s why each PROS condition, and how it shows up in a person’s body, is different.

While all PROS conditions are different, the role of the PI3Kα protein is the same.
Find out how VIJOICE works.

KIDS' Q&A
	Why do I have PROS condition?
	Before you were born, a change to your DNA randomly occurred inside of your body. This change is called a mutation, and it’s why you have a PROS condition.

Next: Signs and Features >

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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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What is PROS?

Did you know?

What conditions are PROS conditions?

KIDS' Q&A

How do PIK3CA mutations cause PROS?

KIDS' Q&A

Questions About PROS and VIJOICE?

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Important Safety Information

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