Uses
- What is Vijoice (alpelisib), and what is it used for?
Warnings
- Warnings
Side Effects
- What are the side effects of Vijoice?
Dosage
- What is the dosage for Vijoice?
Overdose
- Addiction/overdose
Drug Interactions
- What drugs interact with Vijoice?
Pregnancy & Breastfeeding
- Pregnancy and breastfeeding

Brand Name: Vijoice

Generic Name: alpelisib

Drug Class: Antineoplastics, P13K Inhibitors

What is Vijoice (alpelisib), and what is it used for?

Vijoice belongs to a class of drugs called Antineoplastics, P13K Inhibitors.

It is not known if Vijoice is safe and effective in children younger than 2 years of age.

The PROS indication is approved under accelerated approval based on response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

Warnings

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

What are the side effects of Vijoice?

Vijoice may cause serious side effects including:

hives,
difficulty breathing,
swelling of your face, lips, tongue, or throat,
chest pain,
cough,
shortness of breath,
severe or ongoing diarrhea,
blisters or ulcers in your mouth,
red or swollen gums,
trouble swallowing,
pale skin,
unusual tiredness,
cold hands and feet,
little or no urination,
increased thirst,
increased urination,
dry mouth,
fruity breath odor,
confusion,
hunger, and
weight loss

Get medical help right away, if you have any of the symptoms listed above.

The most common side effects of Vijoice include:

nausea,
vomiting,
loss of appetite,
weight loss,
weakness,
tiredness,
mouth sores,
rash,
hair loss, and
abnormal blood tests

Tell the doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Vijoice. For more information, ask your doctor or pharmacist.

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

What is the dosage for Vijoice?

Adult Patients

The recommended dosage of Vijoice in adult patients is 250 mg orally, once daily, administered as recommended until disease progression or unacceptable toxicity.

Pediatric Patients (2 to less than 18 years of age)

The recommended initial dosage of Vijoice in pediatric patients is 50 mg orally, once daily, administered as recommended until disease progression or unacceptable toxicity.
Consider a dose increase to 125 mg once daily in pediatric patients ≥ 6 years old for response optimization (clinical/radiological) after 24 weeks of treatment with Vijoice at 50 mg once daily.
When a pediatric patient turns 18 years old, consider a gradual dose increase up to 250 mg. Recommended dose increases by age group are listed in Table 1.

Table 1: Recommended Daily Vijoice Dose Levels for Pediatric Patients (2 to less than 18 years of age)

Patient age (years)	Initial dose	Dose increase
2 to < 6	50 mg	Not applicable*
6 to < 18	50 mg	125 mg
*A recommended increased dose has not been established.

Administration

Take Vijoice with food at approximately the same time each day.
No tablet should be used if it is broken, cracked, or otherwise damaged at the time of opening the blister pack.
Swallow Vijoice tablets whole. Do not split or chew.
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.
If the patient vomits after taking the dose, advise the patient not to take an additional dose on that day, and to resume the dosing schedule the next day at the usual time.

Preparation And Administration For Patients Who Have Difficulty Swallowing Tablets

For patients who are not able to swallow tablets, administer Vijoice as an oral suspension with food.
- Place Vijoice tablets in a glass containing 2 to 4 ounces of water and let it stand for approximately 5 minutes. Make the suspension with water only.
- Crush the tablets with a spoon and stir until an oral suspension is obtained.
- Administer the oral suspension immediately after preparation. Discard the oral suspension if it is not administered within 60 minutes after preparation.
- After administration of the oral suspension, add approximately 2 to 3 tablespoons of water to the same glass. Stir with the same spoon to re-suspend any remaining particles and administer the entire contents of the glass. Repeat if particles remain.

Dosage Modifications For Adverse Reactions

The recommended Vijoice dose reductions for adverse reactions in adult and pediatric patients are listed in Table 2 and Table 3, respectively.

Table 2: Vijoice Dosage Reduction Recommendations for Adverse Reactions in Adult Patients

Vijoice dose level	Dose and schedule
First-dose reduction	125 mg once daily
Second-dose reduction	50 mg once daily

Table 3: Vijoice Dosage Reduction Recommendations for Adverse Reactions in Pediatric Patients

Action	Vijoice dose prior to dose reduction
Action	125 mg once daily	50 mg once daily
Dose reduction	50 mg once daily	Not applicable

Discontinue Vijoice in adults or pediatric patients who cannot tolerate 50 mg daily.
Tables 4, 5, 6, 7, 8, and 9 summarize recommendations for dose interruption, reduction, or discontinuation of Vijoice in the management of specific adverse reactions.

Cutaneous Adverse Reactions

If a severe cutaneous adverse reaction (SCAR) is confirmed, permanently discontinue Vijoice. Do not reintroduce Vijoice in patients who have experienced previous SCAR during Vijoice treatment.

Table 4: Dosage Modification and Management for Rash and Severe Cutaneous Adverse Reactions (SCARs)

Grade^a,b	Recommendation for adult and pediatric patients^c
Grade 1 (< 10% body surface area (BSA) with active skin toxicity)	No Vijoice dosage modification is required unless the etiology is determined to be SCAR. Initiate topical corticosteroid treatment. Consider adding oral antihistamine to manage symptoms. If active rash is not improved within 28 days of appropriate treatment, add a low dose systemic corticosteroid. If the etiology is determined to be SCAR, permanently discontinue Vijoice.
Grade 2 (10% to 30% BSA with active skin toxicity)	No Vijoice dosage modification is required unless the etiology is determined to be SCAR. Initiate or intensify topical corticosteroid and oral antihistamine treatment. Consider low dose systemic corticosteroid treatment. If rash improves to Grade ≤ 1 within 10 days, systemic corticosteroid may be discontinued. If the etiology is determined to be SCAR, permanently discontinue Vijoice.
Grade 3 (e.g., severe rash not responsive to medical management) (> 30% BSA with active skin toxicity)	Interrupt Vijoice and initiate or intensify topical/systemic corticosteroid and oral antihistamine treatment. If the etiology is determined to be SCAR, permanently discontinue Vijoice. For rashes other than SCAR Adult Patients: Upon improvement to Grade ≤ 1, resume Vijoice at the next lower dose level. Pediatric Patients: Upon improvement to Grade < 1, either resume Vijoice at 50 mg while continuing oral antihistamine treatment or permanently discontinue Vijoice. Permanently discontinue Vijoice if: Patient was receiving antihistamines at the time of rash onset and antihistamine dose cannot be increased Grade ≥ 3 rash recurs
Grade 4 (e.g., severe bullous, blistering or exfoliating skin conditions) (any % BSA associated with extensive superinfection, with IV antibiotics indicated; life-threatening consequences)	Permanently discontinue Vijoice.
^aGrading according to Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. ^bFor all grades of rash, consider consultation with a dermatologist. ^cAntihistamines administered prior to rash onset may decrease incidence and severity of rash.

Hyperglycemia

Before initiating treatment with Vijoice, test fasting plasma glucose (FPG), HbA1c, and optimize blood glucose.
After initiating treatment with Vijoice, monitor fasting glucose (FPG or fasting blood glucose) at least once every week for the first 2 weeks, then at least once every 4 weeks, and as clinically indicated.
Monitor HbA1c every 3 months and as clinically indicated. In patients with risk factors for hyperglycemia, monitor fasting glucose more closely and as clinically indicated.

Table 5: Dosage Modification and Management for Hyperglycemia

Fasting plasma glucose (FPG)/Fasting blood glucose values^a	Recommendation for adult and pediatric patients
Dose modifications and management should only be based on fasting glucose values (FPG or fasting blood glucose).
Grade 1 Fasting glucose > ULN -160 mg/dL or > ULN -8.9 mmol/L	No Vijoice dosage modification is required. Initiate or intensify oral anti-hyperglycemic treatmentb.
Grade 2 Fasting glucose > 160 -250 mg/dL or > 8.9 -13.9 mmol/L	No Vijoice dosage modification is required. Initiate or intensify oral anti-hyperglycemic treatmentb. Adult Patients: If fasting glucose does not decrease to ≤ 160 mg/dL or 8.9 mmol/L within 21 days under appropriate anti-hyperglycemic treatmentb, reduce Vijoice dose by 1 dose level and follow fasting glucose value specific recommendations. Pediatric Patients: If fasting glucose does not decrease to ≤ 160 mg/dL or 8.9 mmol/L within 21 days under appropriate anti-hyperglycemic treatmentb, interrupt Vijoice until improvement to Grade ≤1, then resume Vijoice at 50 mg and follow fasting glucose value specific recommendations.
Grade 3 Fasting glucose > 250 -500 mg/dL or > 13.9 -27.8 mmol/L	Interrupt Vijoice. Initiate or intensify oral anti-hyperglycemic treatmentb and consider additional anti-hyperglycemic medications for 1-2 days until hyperglycemia improves, as clinically indicated. Administer intravenous hydration and consider appropriate treatment (e.g., intervention for electrolyte/ketoacidosis/hyperosmolar disturbances).
	Adult Patients: If fasting glucose decreases to ≤ 160 mg/dL or 8.9 mmol/L within 3 to 5 days under appropriate anti-hyperglycemic treatment, resume Vijoice at 1 lower dose level. If fasting glucose does not decrease to ≤ 160 mg/dL or 8.9 mmol/L within 3 to 5 days under appropriate anti-hyperglycemic treatment, consultation with a physician with expertise in the treatment of hyperglycemia is recommended. If fasting glucose does not decrease to ≤160 mg/dL or 8.9 mmol/L within 21 days following appropriate anti-hyperglycemic treatment^b, permanently discontinue Vijoice. Pediatric Patients: If fasting glucose decreases to ≤ 160 mg/dL or 8.9 mmol/L within 3 to 5 days under appropriate anti-hyperglycemic treatment, resume Vijoice at 50 mg. If fasting glucose does not decrease to ≤ 160 mg/dL or 8.9 mmol/L within 3 to 5 days under appropriate anti-hyperglycemic treatment, consultation with a physician with expertise in the treatment of hyperglycemia is recommended to determine if treatment with Vijoice should be resumed or permanently discontinued. If fasting glucose does not decrease to ≤ 160 mg/dL or 8.9 mmol/L within 21 days following appropriate anti-hyperglycemic treatment^b, permanently discontinue Vijoice. If hyperglycemia recurs at Grade ≥ 3, consider permanent discontinuation of Vijoice.
Grade 4 Fasting glucose > 500 mg/dL or ≥ 27.8 mmol/L	Interrupt Vijoice. Initiate or intensify appropriate oral anti-hyperglycemic treatment^b. Administer intravenous hydration and consider appropriate treatment (e.g., intervention for electrolyte/ketoacidosis/hyperosmolar disturbances). Re-check fasting glucose within 24 hours and as clinically indicated. If fasting glucose decreases to ≤ 500 mg/dL or 27.8 mmol/L, follow fasting glucose value- specific recommendations for Grade 3. If fasting glucose is confirmed at > 500 mg/dL or 27.8 mmol/L, permanently discontinue Vijoice.
Abbreviation: ULN, upper limit of normal. ^aFPG/Fasting Blood Glucose/Grade levels reflect hyperglycemia grading according to Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03. ^bInitiate applicable anti-hyperglycemic medications, including metformin in adult and pediatric patients = 10 years, SGLT2 inhibitors or insulin sensitizers (such as thiazolidinediones or dipeptidyl peptidase-4 inhibitors) in adult patients, and review respective prescribing information for dosing and dose titration recommendations, including local hyperglycemic treatment guidelines.

Pneumonitis

Table 6: Dosage Modification for Pneumonitis

Grade^a	Recommendation for adult and pediatric patients
Any Grade	Interrupt Vijoice if pneumonitis is suspected. Permanently discontinue Vijoice if pneumonitis is confirmed.
^aGrading according to CTCAE Version 5.0.

Diarrhea

In pediatric patients, consider consultation with a physician with experience in the treatment of gastrointestinal conditions.

Table 7: Dosage Modification and Management for Diarrhea

Grade^a	Recommendation for adult and pediatric patients
Grade 1	No Vijoice dosage modification is required. Initiate appropriate medical therapy and monitor as clinically indicated.
Grade 2	Interrupt Vijoice dose until improvement to Grade < 1, then resume Vijoice at the same dose level. Initiate or intensify appropriate medical therapy and monitor as clinically indicated. Adult Patients: If diarrhea recurs at Grade ≥ 2, interrupt Vijoice dose until improvement to Grade < 1, then resume Vijoice at the next lower dose level. Pediatric Patients: If diarrhea recurs at Grade ≥ 2, interrupt Vijoice dose until improvement to Grade < 1, then resume Vijoice at 50 mg.
Grade 3	Interrupt Vijoice dose until improvement to Grade ≤ 1. Initiate or intensify appropriate medical therapy and monitor as clinically indicated.Adult Patients: Once improved to Grade ≤ 1, then resume Vijoice at the next lower dose level. Pediatric Patients: Once improved to Grade ≤ 1, either resume Vijoice at 50 mg or permanently discontinue Vijoice. If diarrhea recurs at Grade > 3, consider permanent discontinuation of Vijoice.
Grade 4	Permanently discontinue Vijoice.
^aGrading according to CTCAE Version 5.0.

Pancreatitis

Table 8: Dosage Modification for Pancreatitis

Grade^a	Recommendation for adult and pediatric patients
Grade 2	Interrupt Vijoice dose until improvement to Grade < 2. Adult Patients: Resume Vijoice at the next lower dose level (only one dose reduction is permitted). If pancreatitis recurs, permanently discontinue Vijoice. Pediatric Patients: Resume Vijoice at 50 mg. If pancreatitis recurs, permanently discontinue Vijoice.
Grade 3	Adult Patients: Interrupt Vijoice dose until improvement to Grade < 2. Resume Vijoice at the next lower dose level (only one dose reduction is permitted). If pancreatitis recurs, permanently discontinue Vijoice. Pediatric Patients: Permanently discontinue Vijoice.
Grade 4	Permanently discontinue Vijoice.
^aGrading according to CTCAE Version 5.0.

Other Adverse Reactions

Table 9: Dosage Modification and Management for Other Adverse Reactions (Excluding Rash and Severe Cutaneous Adverse Reactions, Hyperglycemia, Pneumonitis, Diarrhea, and Pancreatitis)

Grade^a	Recommendation for adult and pediatric patients
Grade 1 or 2^b,c	No Vijoice dosage modification is required. Initiate appropriate medical therapy and monitor as clinically indicatedbc.
Grade 3	Interrupt Vijoice dose until improvement to Grade ≤ 1. Initiate or intensify appropriate medical therapy and monitor as clinically indicated. Adult Patients: Once improved to Grade ≤ 1, then resume Vijoice at the next lower dose level. Pediatric Patients: Once improved to Grade ≤ 1, either resume Vijoice at 50 mg or permanently discontinue Vijoice. If adverse reaction recurs at Grade ≥ 3, consider permanent discontinuation of Vijoice. Consider consultation with a qualified physician with specific expertise in the field of the concerned adverse reaction.
Grade 4	Permanently discontinue Vijoice.
^aGrading according to CTCAE Version 5.0. ^bFor Grade 2 total bilirubin elevation in adult patients, interrupt Vijoice dose until improvement to Grade ≤ 1. If improvement occurs in ≤ 14 days, resume at the same dose level. If improvement occurs in > 14 days, resume Vijoice at the next lower dose level. ^cFor Grade 2 total bilirubin elevation in pediatric patients, interrupt Vijoice dose until improvement to Grade ≤ 1. If improvement occurs in ≤ 14 days, resume at the same dose level. If improvement occurs in > 14 days, resume Vijoice at 50 mg.

Addiction/overdose

There is limited experience of overdose with alpelisib in clinical trials.
In cases where accidental overdosage of alpelisib was reported in the clinical studies, the adverse reactions associated with the overdose were consistent with the known safety profile of alpelisib and included hyperglycemia, nausea, asthenia, and rash.
Initiate general symptomatic and supportive measures in all cases of overdosage where necessary. There is no known antidote for Vijoice.

What drugs interact with Vijoice?

CYP3A4 Inducers

Avoid coadministration of Vijoice with strong CYP3A4 inducers.
Alpelisib is metabolized by CYP3A4. Concomitant use of Vijoice with a strong CYP3A4 inducer may decrease alpelisib concentration, which may decrease alpelisib activity.

Breast Cancer Resistance Protein Inhibitors (BCRP)

Avoid the use of BCRP inhibitors in patients treated with Vijoice. If unable to use alternative drugs, when Vijoice is used in combination with BCRP inhibitors, closely monitor for increased adverse reactions.
Alpelisib is transported by BCRP. Concomitant use of Vijoice with a BCRP inhibitor may increase alpelisib exposure, which may increase the risk of adverse reactions.

Effect Of Vijoice On Other Drugs

CYP2C9 Substrates

Closely monitor CYP2C9 substrates where minimal concentration changes of the CYP2C9 substrate may reduce activity when used concomitantly with Vijoice.
Alpelisib induces CYP2C9. Concomitant use of Vijoice with CYP2C9 substrates may reduce exposure of these drugs, which may reduce activity.

Pregnancy and breastfeeding

Based on animal data and mechanism of action, Vijoice can cause fetal harm when administered to a pregnant woman. There are no available data in pregnant women to inform the drug-associated risk.
There are no data on the presence of alpelisib in human milk, its effects on milk production, or the breastfed child.
Because of the potential for serious adverse reactions in the breastfed child, advise lactating women to not breastfeed during treatment with Vijoice and for 1 week after the last dose.

Summary

Vijoice (alpelisib) is a prescription medication used to treat the symptoms of breast cancer and severe manifestations of PIK3CA-related overgrowth spectrum (PROS) in adults and children 2 years of age and older who require systemic therapy. Vijoice may cause serious side effects, including hives, difficulty breathing, swelling of your face/lips/tongue/throat, chest pain, cough, shortness of breath, severe or ongoing diarrhea, blisters or ulcers in your mouth, red or swollen gums, trouble swallowing, pale skin, unusual tiredness, cold hands and feet, little or no urination, increased thirst, increased urination, and others. Vijoice can cause fetal harm when administered to a pregnant woman. Lactating women should not breastfeed during treatment with Vijoice.