Understanding Side Effects

VIJOICE® (alpelisib) tablets

What side effects may occur?

VIJOICE® (alpelisib) tablets can cause side effects that you may not be familiar with, so it’s important to know what to expect and be prepared if side effects do occur.

The serious side effects of VIJOICE include:

Severe allergic reactions icon

Severe allergic reactions

Tell your doctor or get medical help right away if you have trouble breathing, flushing, rash, fever, or a fast heart rate during treatment with VIJOICE.

Severe skin reactions icon

Severe skin reactions

Tell your doctor 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; or blisters on the skin or peeling skin, with or without fever.

Hyperglycemia icon

Hyperglycemia, or high blood sugar
Hyperglycemia is common with VIJOICE and can be severe. Your doctor will monitor your blood sugar levels before you start, and during treatment with, VIJOICE. Your doctor may monitor your blood sugar levels more often if you have a history of diabetes. Tell your doctor 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
Pneumonitis icon

Pneumonitis, or lung problems
Tell your doctor right away if you develop new or worsening symptoms of lung problems, including:

  • shortness of breath or trouble breathing
  • cough
  • chest pain
Diarrhea icon

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 doctor right away if you develop diarrhea during treatment with VIJOICE. Your doctor may tell you to drink more fluids or take medicines to treat diarrhea.

Serious side effects occurred in 12% of people who received VIJOICE. Dehydration and cellulitis, or a type of skin infection, were the only serious side effects that occurred in multiple people (2 people).

 

If you develop certain serious side effects during treatment, your doctor may:

  • decrease the dose
  • recommend taking a break from treatment, or 
  • tell you to completely stop taking VIJOICE

Some side effects are more common than others, including:

Stomatitis icon

Stomatitis, or mouth sores

Headache icon

Headache

Dry skin icon

Dry skin

Alopecia icon

Alopecia, or hair loss

Tell your doctor if you have any side effects that are bothersome or don’t go away. These are not all the possible side effects of VIJOICE.

 

Contact your doctor for medical advice about side effects.