Vijoice Dosage

Generic name: ALPELISIB 50mg
Dosage form: tablet
Drug class: PI3K inhibitors

Medically reviewed by Drugs.com. Last updated on Apr 24, 2024.

2.1 Recommended Dosage

Adult Patients

The recommended dosage of VIJOICE in adult patients is 250 mg orally, once daily, administered as recommended [see Dosage and Administration (2.2, 2.3, 2.4)] 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 [see Dosage and Administration (2.2, 2.3, 2.4)] 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)
aDose can be administered as VIJOICE tablets or VIJOICE oral granules. bA recommended increased dose has not been established.
Patient age (years)	Initial dose	Dose increase
2 to < 6	50 mga	Not applicableb
6 to < 18	50 mga	125 mg

2.2 VIJOICE Dosage Form Overview

VIJOICE is available in two dosage forms: tablets and oral granules.

Prescribe the most appropriate dosage form of VIJOICE according to the dose required and patient needs.

VIJOICE Tablets (50 mg, 125 mg, and 200 mg) may be administered as:

Whole tablets: For patients who can swallow whole tablets.
Tablets prepared as an oral suspension: For patients who have difficulty swallowing whole tablets [see Dosage and Administration (2.4)].

VIJOICE Oral Granules (50 mg per packet):

For patients who are prescribed a 50 mg daily dose only [see Dosage and Administration (2.1)].
Do not use multiple 50 mg packets or a partial packet of oral granules for patients prescribed a 125 mg or a 250 mg dose [see Clinical Pharmacology (12.3)].
Do not combine VIJOICE tablets and VIJOICE oral granules to achieve the prescribed dose.

2.3 VIJOICE Administration Overview

Take VIJOICE with food at approximately the same time each day [see Clinical Pharmacology (12.3)].

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.

2.4 VIJOICE Preparation and Administration Instructions

VIJOICE Tablets

VIJOICE Tablets, Whole

Swallow VIJOICE tablets whole and take with food. Do not chew, divide, or crush.
Do not use broken, cracked, or damaged tablets.

VIJOICE Tablets Prepared as an Oral Suspension

For patients who are not able to swallow tablets, prepare and administer VIJOICE as an oral suspension and take with food [see Clinical Pharmacology (12.3)].
- Place VIJOICE tablets in a cup 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 1 to 2 ounces of water to the same cup. Stir with the same spoon to re-suspend any remaining particles and administer the entire contents of the cup. Repeat if particles remain.

VIJOICE Oral Granules

Each packet is for single use only.

No packet should be used if the packet seal is broken.

Do not attempt to use partial quantities of oral granules from 50 mg granules packets to prepare a dose. Do not combine VIJOICE tablets and VIJOICE oral granules to achieve the prescribed dose of 125 mg or 250 mg.

For patients for whom a daily dose of 50 mg is prescribed, administer VIJOICE oral granules [see Clinical Pharmacology (12.3)] in one of the following ways:
- Pour the contents of one VIJOICE oral granules packet directly onto the tongue and swallow with approximately 2 to 4 ounces of water. If needed, rinse the mouth with additional water and swallow to ensure no particles remain in the mouth.
- Pour the contents of one VIJOICE oral granules packet into a cup. Add 1 to 3 teaspoons (about 0.5 ounces) of a beverage (water, milk, or apple juice) or soft food (applesauce or yogurt) and administer the mixture immediately. Rinse the cup with up to 2 ounces of a beverage (water, milk or apple juice) and administer the mixture immediately to ensure the entire dose is administered. If particles remain, repeat until the full dose is administered. Discard the oral granules mixed with water, milk, apple juice, applesauce, or yogurt if they are not administered within 2 hours after preparation.

2.5 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
aDose can be administered as VIJOICE tablets or VIJOICE oral granules.
VIJOICE dose level	Dose and schedule
First-dose reduction	125 mg once daily
Second-dose reduction	50 mg once dailya

Table 3: VIJOICE Dosage Reduction Recommendations for Adverse Reactions in Pediatric Patients
aDose can be administered as VIJOICE tablets or VIJOICE oral granules.
Action	VIJOICE dose prior to dose reduction
	125 mg once daily	50 mg once daily
Dose reduction	50 mg once dailya	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 [see Warnings and Precautions (5.2)].

Table 4: Dosage Modification and Management for Rash and Severe Cutaneous Adverse Reactions (SCARs)
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.
[see Warnings and Precautions (5.1, 5.2)]
Gradea,b	Recommendation for adult and pediatric patientsc
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.

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 [see Warnings and Precautions (5.3)].

Table 5: Dosage Modification and Management for Hyperglycemia
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 [see Warnings and Precautions (5.3)].
[see Warnings and Precautions (5.3)]
Fasting plasma glucose (FPG)/Fasting blood glucose valuesa	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 treatmentb, 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 treatmentb, 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 treatmentb. 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.

Pneumonitis

Table 6: Dosage Modification for Pneumonitis
aGrading according to CTCAE Version 5.0.
[see Warnings and Precautions (5.4)]
Gradea	Recommendation for adult and pediatric patients
Any Grade	• Interrupt VIJOICE if pneumonitis is suspected. • Permanently discontinue VIJOICE if pneumonitis is confirmed.

Diarrhea or Colitis

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

Table 7: Dosage Modification and Management for Diarrhea or Colitis
aGrading according to CTCAE Version 5.0. bFor Grade 2 and 3 colitis consider additional treatment, such as enteric-acting and/or systemic steroids.
[see Warnings and Precautions (5.5)]
Gradea	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 indicatedb. Adult Patients: For recurrent Grade ≥ 2, interrupt VIJOICE dose until improvement to Grade ≤ 1, then resume VIJOICE at the next lower dose level. Pediatric Patients: For recurrent 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 indicatedb. 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. For recurrent Grade ≥ 3, consider permanent discontinuation of VIJOICE.
Grade 4	Permanently discontinue VIJOICE.

Pancreatitis

Table 8: Dosage Modification for Pancreatitis
aGrading according to CTCAE Version 5.0.
Gradea	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.

Other Adverse Reactions

Table 9: Dosage Modification and Management for Other Adverse Reactions (Excluding Rash and Severe Cutaneous Adverse Reactions, Hyperglycemia, Pneumonitis, Diarrhea or Colitis, and Pancreatitis)
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.
Gradea	Recommendation for adult and pediatric patients
Grade 1 or 2b,c	No VIJOICE dosage modification is required. Initiate appropriate medical therapy and monitor as clinically indicatedb,c.
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.