Vijoice

Vijoice (alpelisib) is a treatment for PIK3CA-Related Overgrowth Spectrum (PROS) to help reduce overgrowth and improve PROS symptoms or prevent them from worsening. Vijoice is a targeted therapy from a class of medicines called oral kinase inhibitors. Vijoice works by inhibiting the PI3K pathway, one of the most important intracellular pathways involved in cell proliferation, cell regulation, and cell death.

Vijoice granules or tablets are taken once daily.

PROS is a spectrum of rare conditions characterized by abnormal overgrowth and structural abnormalities in blood vessels, the lymphatic system, and other tissues. PROS is caused by a mutation in the PIK3CA gene, which results in cells growing and dividing abnormally.

Vijoice FDA approval is for the treatment of patients with severe phosphatidylinositol-3-kinase catalytic subunit alpha (PIK3CA)-Related Overgrowth Spectrum (PROS), who require systemic therapy and are 2 years of age and older. It was approved on April 6, 2022, under an accelerated approval designation, and continued approval may be subject to favorable results from further clinical trials.

Vijoice and Piqray contain the same active ingredient, alpelisib, but are FDA-approved for different conditions. Piqray is FDA-approved to treat types of breast cancer in men and postmenopausal women. Vijoice (alpelisib) is FDA-approved to treat PIK3CA-Related Overgrowth Spectrum (PROS). Piqray and Vijoice are both distributed by Novartis Pharmaceuticals Corporation.

• Take Vijoice exactly as your healthcare provider tells you.
• Read the detailed "Instructions for Use" that comes with Vijoice for information about the right way to prepare and take or give a dose of Vijoice tablets or oral granules.
• Do not change your dose or stop treatment unless your healthcare provider tells you.
• If your prescribed daily dose is 50mg, your healthcare provider can prescribe either tablets or oral granules.
• If your prescribed dose is 125mg or 250mg, you will be prescribed Vijoice tablets.
• Do not use multiple packets of 50 mg oral granules or part of a packet to prepare a dose. Do not combine Vijoice tablets with Vijoice oral granules to prepare your prescribed dose.

Vijoice Tablet Instructions

• Take Vijoice tablets 1 time each day, at about the same time every day.
• Take the tablets with food.
• Swallow the tablets whole. Do not split or chew the tablets.
• Do not take tablets that are broken, cracked or that look damaged at the time of opening the blister pack.
• If you cannot swallow tablets whole or need to use a feeding tube, Vijoice tablets can be prepared as a suspension to take or give by mouth or through a feeding tube. To take by mouth, prepare as follows:
• If you miss a dose, 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, do not take another dose on that day. Take your next dose at your usual time.
• If you take too much or overdose, call your healthcare provider or go to the nearest hospital emergency room right away.

Vijoice Granule Instructions

Each packet is for single use only. Do not use the packet if the packet seal is broken.

Open the packet of Vijoice granules by holding them with the cut line on top.

• Shake the packet gently to ensure the granules are in the lower part of the packet.
• Using scissors, open the packet along the cut line.

Vijoice granules may be taken by mouth or mixed with water to give through a feeding tube. To take by mouth, use one of the following ways:

• Pour the oral granules from 1 packet directly onto the tongue by tapping the side and top of the packet and then swallowing with about 4 to 8 tablespoons (2 to 4 ounces) of water. If there is any medicine remaining in the mouth, rinse the mouth with additional water and swallow to make sure the entire dose is taken OR
• Pour the oral granules from 1 packet into a cup by tapping the side and top of the packet. Add 1 to 3 teaspoons (about 0.5 ounces) of a beverage (water, milk, or apple juice) or soft food (applesauce or yogurt) and take the mixture right away. Rinse the cup with up to 4 tablespoons (2 ounces) of water, milk or apple juice. Take the mixture right away to make sure the entire dose is taken. Repeat this step until there is no medicine remaining in the cup. Throw away any granules mixed with water, milk, apple juice, applesauce, or yogurt that is not taken within 2 hours after it is prepared.

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

Before you start treatment, 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.

Pregnancy

Tell your Doctor or healthcare provider if you 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.
• You should use effective birth control during treatment, 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, and for 1 week after the last dose. If your female partner becomes pregnant, tell your healthcare provider right away.

Breastfeeding

Tell your Doctor or healthcare provider if you are breastfeeding or plan to breastfeed. It is not known if Vijoice passes into your breast milk. Do not breastfeed during treatment, and for 1 week after the last dose.

The most common Vijoice side effects are diarrhea, high blood sugar, dry skin, mouth sores (stomatitis), headache and hair loss (alopecia).

Serious side effects include

Severe allergic reactions. Tell your healthcare 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.

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 or inflammation of your intestines (colitis). 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, stomach-area (abdominal) pain, or see mucus or blood in your stool during treatment with this medicine. during treatment. Your healthcare provider may tell you to drink more fluids or take medicines to treat diarrhea or colitis.

Fertility This medicine may affect fertility in males and in females who can become pregnant. Talk to your healthcare provider if this is a concern for you.

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.

These are not all of the possible side effects. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Usual Adult Dosage for PIK3CA-Related Overgrowth Spectrum

• 250 mg taken orally once daily with food.

Usual Pediatric Dosage for PIK3CA-Related Overgrowth Spectrum

• 2 to less than 18 years of age: 50 mg taken orally once daily with food.

Doses may be modified due to side effects.

Click on the link below for more detailed dosing information.

Vijoice Tablets: 50 mg, 125 mg, and 200 mg

Vijoice Granules: 50 mg

Review the Vijoice Package Insert for more detailed information about this medicine. It contains comprehensive information on Indications and Usage, Dosage and Administration, Clinical Pharmacology, Clinical Studies, Drug Interaction, and more. Discuss any medication or medical questions you have with your doctor or other health care provider. This is not all the information you need to know about this medicine for safe and effective use, and it does not take the place of talking to your doctor about your treatment. The Package Insert is sometimes called Vijoice Prescribing Information or Vijoice label.

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.

• Store 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 all medicines out of the reach of children and pets.

Vijoice tablets

Active ingredient: alpelisib Inactive ingredients: hypromellose, magnesium stearate, mannitol, microcrystalline cellulose, and sodium starch glycolate.

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.

Vijoice granules

Active ingredient: alpelisib Inactive ingredients: hypromellose, magnesium stearate, mannitol, microcrystalline cellulose, and sodium starch glycolate.

Vijoice Novartis Pharmaceuticals Corporation.