Vijoice

What is 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 Vijoice is safe and effective in children below 2 years of age.

Who should not take Vijoice?

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

• See the end of this Patient Information leaflet for a complete list of the ingredients in Vijoice.
• See “What are the possible side effects of Vijoice?” for signs and symptoms of severe allergic reactions.

What should I tell my healthcare provider before taking Vijoice?

Before you take Vijoice, tell your healthcare provider about all of 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 skin peeling.
• are pregnant or plan to become pregnant. Vijoice can harm your unborn baby.
  Females who are able to become pregnant:
  • Your healthcare 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 healthcare 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 healthcare provider right away.
  Males with female partners who are able to 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 healthcare provider right away.
• 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.

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.

How should I take Vijoice?

• Take Vijoice exactly as your healthcare provider tells you.
• Do not change your dose or stop taking Vijoice unless your healthcare provider tells you.
• Take Vijoice 1 time each day, at about the same time each day.
• Take Vijoice with food.
• Swallow Vijoice tablets whole. Do not split or chew the tablets.
• Do not take Vijoice tablets that are broken, cracked or that look damaged at the time of opening the blister pack.
• If you cannot swallow tablets, you can take Vijoice mixed with water (suspension) as follows:
  • Place Vijoice tablets into a glass that contains 2 to 4 ounces of water and let it stand for about 5 minutes.
    Use water only.
  • Crush the tablets with a spoon and stir to dissolve. The liquid will be cloudy and you may see tablet pieces.
  • Swallow the mixture right away.
  • Next, add about 2 to 3 tablespoons of water to the same glass and stir with the same spoon. Then swallow the entire contents of the glass to ensure the entire dose is consumed. Repeat this step if necessary.
  • Throw away any of the Vijoice that is not taken within 60 minutes after it is prepared.
• If you miss a dose of Vijoice, you may still take it with food up to 9 hours after the time you usually take it. If it has been more than 9 hours after you usually take your dose, skip the dose for that day. The next day, take the dose at your usual time. Do not take 2 doses to make up for a missed dose.
• If you vomit after taking a dose of Vijoice, do not take another dose on that day. Take your next dose at your usual time.
• If you take too much Vijoice, call your healthcare provider or go to the nearest hospital emergency room right away.

What are the possible side effects of Vijoice?

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 with Vijoice.
• 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 with Vijoice. 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 with Vijoice. 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 with Vijoice if you get certain serious side effects.

The most common side effects of Vijoice 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 of Vijoice.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

General information about the safe and effective use of Vijoice

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Vijoice for a condition for which it was not prescribed. Do not give Vijoice to other people, even if they have the same symptoms you have. It may harm them. You can ask your healthcare provider or pharmacist for more information about Vijoice that is written for health professionals.

How should I store Vijoice?

• Store Vijoice at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (59°F and 86°F).

Keep Vijoice and all medicines out of the reach of children.

What are the ingredients in Vijoice?

Active ingredient: alpelisib

Inactive ingredients: hypromellose, magnesium stearate, mannitol, microcrystalline cellulose, and sodium starch glycolate. The film-coating contains hypromellose, iron oxide red (applicable only to 50 mg and 200 mg strengths), iron oxide yellow, macrogol/polyethylene glycol (PEG) 4000, talc, and titanium dioxide.

For more information, go to www.VIJOICE.com or call 1-888-VIJOICE (1-888-845-6423).