This Patient Information has been approved by the U.S. Food and Drug Administration.			Revised: April 2024
PATIENT INFORMATION
VIJOICE® (vi’ joiz) (alpelisib) tablets		VIJOICE® (vi’ joiz) (alpelisib) oral granules
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.
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.
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. VIJOICE comes as tablets and oral granules. Your healthcare provider will prescribe the dosage form that is right for you: If your prescribed daily dose is 50 mg, your healthcare provider may prescribe VIJOICE tablets or VIJOICE oral granules. If your prescribed daily dose is 125 mg or 250 mg, you can only take 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. If you miss a dose of VIJOICE, you may 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. VIJOICE Tablets: Swallow VIJOICE tablets whole. Do not chew, divide, or crush the tablets. Do not take VIJOICE tablets that are broken, cracked, or that look damaged. If you cannot swallow tablets, you can take VIJOICE mixed with water (suspension) as follows: Place VIJOICE tablets into a cup that contains 4 to 8 tablespoons (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 4 tablespoons (1 to 2 ounces) of water to the same cup and stir with the same spoon. Then swallow the entire contents of the cup to make sure the entire dose is taken. Repeat this step if there are tablet pieces remaining in the cup. Throw away any VIJOICE mixture that is not taken within 60 minutes after it is prepared. VIJOICE Oral Granules: Each packet is for single use only. Do not use the packet if the packet seal is broken. Take VIJOICE oral granules as follows: Hold the packet of oral granules with the cut line on top. Shake the packet gently to ensure the VIJOICE oral granules are in the lower part of the packet. Using scissors, open the packet along the cut line. Then take the oral granules in one of the following ways: Pour the oral granules from 1 VIJOICE oral granules packet directly onto the tongue, by tapping the side and top of the packet and swallow it 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 VIJOICE oral granules 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 VIJOICE oral granules mixed with water, milk, apple juice, applesauce, or yogurt that is not taken within 2 hours after it is prepared.
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, swelling of the face or throat, 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 may 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 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 healthcare provider right away if you develop diarrhea, stomach-area (abdominal) pain, or see mucus or blood in your stool during treatment with VIJOICE. Your healthcare provider may tell you to drink more fluids or take medicines to treat diarrhea or colitis.
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	• mouth sores (stomatitis)	• high blood sugar
VIJOICE may cause 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.
How should I store VIJOICE? Store VIJOICE at room temperature between 68°F to 77°F (20°C to 25°C). Keep VIJOICE and all medicines out of the reach of children.
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.
What are the ingredients in VIJOICE? Active ingredient: alpelisib Inactive ingredients for VIJOICE tablets: 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. Inactive ingredients for VIJOICE oral granules: hypromellose, magnesium stearate, mannitol, microcrystalline cellulose, and sodium starch glycolate. Distributed by: Novartis Pharmaceuticals Corporation, East Hanover, New Jersey 07936 © Novartis For more information, go to www.VIJOICE.com or call 1-888-VIJOICE (1-888-845-6423).

alpelisib

Product monograph

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