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).
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.
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 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.
