PI3K inhibitors
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Vijoice Dosage

Drug Detail:Vijoice (Alpelisib)

Generic Name: ALPELISIB 50mg

Dosage Form: tablet

Drug Class: PI3K inhibitors

Contents
Uses Warnings Before Taking Dosage Side effects Interactions

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

2.2 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 [see Clinical Pharmacology (12.3)].
    • 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.

2.3 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
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 [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.
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