Skip to main content

Patient Support Line 1-800-282-7630 Monday through Friday: 8:00 am – 8:00 pm ET

Image showing a teenage girl floating in pool with her friends swimming around her. Text on image says “How VIJOICE may help.”
VIJOICE is the first and only therapy approved to treat the cause of PROS in children and adults

The safety and effectiveness of VIJOICE were initially assessed in 57 adults and children aged 2 years and older with a PIK3CA-Related Overgrowth Spectrum (PROS) condition, including CLOVES syndrome, MCAP or M-CM, KTS, and FIL. All of the people in this retrospective, real-world study, known as EPIK-P1, had a PIK3CA mutation confirmed by their doctor. In EPIK-P1, those enrolled had follow-up visits for at least 6 months while taking VIJOICE.

Of the original 57 people in EPIK-P1, 48 enrolled in an extension study to evaluate the longer-term safety and effectiveness of VIJOICE. This additional study is known as EPIK-P3, and it assessed people taking VIJOICE for an additional 18 months to 66 months after the initial study.

In the initial study, some experienced a clinically meaningful reduction in the size of overgrowth
27% (10/37) of people taking VIJOICE saw their overgrowth shrink by at least 20% at the 6-month evaluation

These reductions were maintained for at least 6 months in 70% of people

These reductions were maintained for at least 12 months in 60% of people


Most experienced any improvement in overgrowth
74.2% (23/31) of people taking VIJOICE saw any shrinkage in the size of their overgrowth at the 6-month evaluation

Results for other symptoms of PROS

At the 6-month evaluation, after starting treatment with VIJOICE: 
90.9% (20/22) of people experienced less pain. 78.9% (30/38) of people experienced improvements in vascular malformations, or when vessels like veins, arteries, and capillaries grow in abnormal ways. 76.2% (32/42) of people experienced less fatigue. 69% (20/29) of people experienced improvements in limb asymmetry, or when one arm or leg is longer than the other. 55.2% (16/29) of people experienced improvements in disseminated intravascular coagulation, or DIC, a clotting and bleeding condition.
In an extension of the initial study that continued for up to 6 years for each person:
87% (20/23) of people experienced less pain. 92.1% (35/38) of people experienced improvements in vascular malformations, or when vessels like veins, arteries, and capillaries grow in abnormal ways. 100% (42/42) of people experienced less fatigue. 86.2% (25/29) of people experienced improvements in limb asymmetry, or when one arm or leg is longer than the other. 86.2% (25/29) of people experienced improvements in disseminated intravascular coagulation, or DIC, a clotting and bleeding condition.
In the longer-term study, people reported functional improvement
Approximately 81% (38/47) of people taking VIJOICE saw improvements in their ability to do things

The first scale measured a person’s daily activity, physical ability, and ability to care for themselves. An improvement  was defined as a decrease by at least 1 point, and worsening  was defined as an increase by at least 1 point.

The second scale measured a person's ability to perform normal activities of daily living and functional status. An improvement  was defined as an increase by at least 20 points, and worsening  was defined as a decrease by at least 20 points.

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.

1/24     382874

Approved Use

What is VIJOICE?

VIJOICE® (alpelisib) tablets is a prescription medicine used to treat adults and children 2 years of age and older with severe phosphatidylinositol-3-kinase catalytic subunit alpha (PIK3CA)-Related Overgrowth Spectrum (PROS)...

What is VIJOICE?

VIJOICE® (alpelisib) tablets is a prescription medicine used to treat adults and children 2 years of age and older with severe phosphatidylinositol-3-kinase catalytic subunit alpha (PIK3CA)-Related Overgrowth Spectrum (PROS).

There are ongoing studies to confirm the benefit of VIJOICE.

It is not known if VIJOICE is safe and effective in children younger than 2 years of age.