Vijoice

Generic name: Alpelisib
Dosage form: tablets
Drug class: PI3K inhibitors

Usage of Vijoice

Vijoice 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).

It is not known if this medicine is safe and effective in children below 2 years of age.

Vijoice side effects

Vijoice may cause serious side effects, including:

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

    • Your healthcare provider may tell you to decrease your dose, temporarily stop your treatment, or completely stop your treatment if you get certain serious side effects.

    The most common side effects include:

  • diarrhea
  • high blood sugar
  • dry skin
  • mouth sores (stomatitis)
  • headache
  • hair loss (alopecia)

    • Vijoice may affect fertility in males and in females who are able to become pregnant. Talk to your healthcare provider if this is a concern for you. These are not all of the possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

    Before taking Vijoice

    You should not take Vijoice if you have had a severe allergic reaction to alpelisib or are allergic to any of the ingredients.

  • See the end of this page for a complete list of the ingredients.
  • See Vijoice side effects for signs and symptoms of severe allergic reactions.

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    How to use Vijoice

    Usual Adult Dosage for PIK3CA-Related Overgrowth Spectrum

    - 250 mg taken orally once daily with food.

    - Use: treatment of adult patients with severe manifestations of PIK3CARelated Overgrowth Spectrum (PROS) who require systemic therapy.

    Usual Pediatric Dosage for PIK3CA-Related Overgrowth Spectrum

    - 50 mg taken orally once daily with food.

    - Use: treatment of pediatric patients (2 years to less than 18 years of age) with severe manifestations of PIK3CARelated Overgrowth Spectrum (PROS) who require systemic therapy.

    What other drugs will affect Vijoice

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

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