Dosage Form: tablets
Medically reviewed by A Ras. MD. Last updated April 7, 2022
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 this medicine is safe and effective in children below 2 years of age.
What are the ingredients in Vijoice?
VIJOICE (alpelisib) is a kinase inhibitor. The chemical name of alpelisib is (2S)-N1-[4-Methyl-5-[2-(2,2,2-trifluoro-1,1-
dimethylethyl)-4-pyridinyl]-2-thiazolyl]-1,2-pyrrolidinedicarboxamide. Alpelisib is a white to almost white powder. The
molecular formula for alpelisib is C19H22F3N5O2S and the relative molecular mass is 441.47 g/mol. The chemical structure
of alpelisib is shown below:
VIJOICE film-coated tablets are supplied for oral administration with three strengths that contain 50 mg, 125 mg and
200 mg of alpelisib. The tablets also contain 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.
Mechanism of Action
Alpelisib is an inhibitor of phosphatidylinositol-3-kinase (PI3K) with inhibitory activity predominantly against PI3Kα. Gain-of-function mutations in the gene encoding the catalytic α-subunit of PI3K (PIK3CA) lead to activation of PI3Kα and Akt-signaling, cellular transformation and the generation of tumors in in vitro and in vivo models.
Activating mutations in PIK3CA have been found to induce a spectrum of overgrowths and malformations comprising a wide group of clinically recognizable disorders commonly known as PROS.
In an inducible mouse model of Congenital Lipomatous Overgrowth, Vascular Malformations, Epidermal Nevi, Scoliosis/Skeletal and Spinal syndrome (CLOVES), a phenotype of PROS, alpelisib inhibition of the PI3K pathway resulted in the prevention or improvement of organ abnormalities associated with the disease, depending on when alpelisib treatment was started. These findings were reversed after withdrawal of alpelisib.¶
Who should not take 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.
Before you take Vijoice
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.
- 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.
- 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.
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.
How should I take Vijoice?
- Take Vijoice tablets exactly as your healthcare provider tells you.
- Do not change your dose or stop treatment unless your healthcare provider tells you.
- Take Vijoice tablets 1 time each day, at about the same time each 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, you can take them mixed with water (suspension) as follows:
- Place the 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 mixture that is not taken within 60 minutes after it is prepared.
- Place the tablets into a glass that contains 2 to 4 ounces of water and let it stand for about 5 minutes.
- 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.
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.
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:
- 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
- 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.
The most common side effects include:
- high blood sugar
- dry skin
- mouth sores (stomatitis)
- 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.
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 all medicines out of the reach of children and pets.
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 this medicine for a condition for which it was not prescribed. Do not give it 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 that is written for health professionals.
PATIENT COUNSELING INFORMATION
Advise the patient and their caregivers to read the FDA-approved patient labeling
Inform patients and their caregivers of the signs and symptoms of hypersensitivity. Advise patients and their caregivers to contact their healthcare provider immediately for signs and symptoms of hypersensitivity.
Severe Cutaneous Adverse Reactions
Inform patients and their caregivers of the signs and symptoms of severe cutaneous adverse reactions (SCARs). Advise patients and their caregivers to contact their healthcare provider immediately for signs and symptoms of SCARs (e.g., a prodrome of fever, flu-like symptoms, mucosal lesions, progressive skin rash, or lymphadenopathy).
Advise patients and their caregivers of the possibility of developing hyperglycemia and the need to monitor fasting glucose periodically during therapy. Advise patients and their caregivers of the signs and symptoms of hyperglycemia (e.g., excessive thirst, urinating more often than usual or higher amount of urine than usual, or increased appetite with weight loss).
Inform patients and their caregivers of the possibility of developing pneumonitis and to immediately report new or worsening respiratory symptoms.
Advise patients and their caregivers that VIJOICE may cause diarrhea, which may be severe in some cases. Inform patients and their caregivers to start anti-diarrheal treatment, increase oral fluids, and notify their healthcare provider if diarrhea occurs while taking VIJOICE.
Advise patients and caregivers that VIJOICE may cause alopecia.
- Inform pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females to inform their healthcare provider of a known or suspected pregnancy.
- Advise females of reproductive potential to use effective contraception during treatment with VIJOICE and for 1 week after the last dose.
- Advise male patients with female partners of reproductive potential to use condoms and effective contraception during treatment with VIJOICE and for 1 week after the last dose.
Advise women not to breastfeed during treatment with VIJOICE and for 1 week after the last dose.
Advise males and females of reproductive potential that VIJOICE may impair fertility.
Advise patients and their caregivers to inform their healthcare providers of all concomitant medications, herbal and dietary supplements.
Instruct patients and their caregivers of the following:
- Take VIJOICE with food at approximately the same time each day.
- Swallow the tablets whole (tablets should not be chewed or split prior to swallowing).
- For patients unable to swallow, advise how to prepare an oral suspension.
- If a dose of VIJOICE is missed, it can be taken with food within 9 hours after the time it is usually taken. After more than 9 hours, skip the dose for that day. The next day, take VIJOICE at the usual time. Instruct patients not to take 2 doses to make up for a missed dose.
- If vomiting occurs after taking the dose of VIJOICE, they should not take an additional dose on that day and should resume the usual dosing schedule the next day at the usual time.
Always check with your healthcare practitioner to make sure the information on this page pertains to your specific situation.