Vijoice Dosage
Generic name: ALPELISIB 50mg
Dosage form: tablet
Drug class: PI3K inhibitors
Medically reviewed by Drugs.com. Last updated on Jul 23, 2024.
2.1 Recommended Dosage
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.
| 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.
VIJOICE Oral Granules (50 mg per packet):
- For patients who are prescribed a 50 mg daily dose only.
- 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.
- 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.
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.
- 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 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.
| 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 |
| 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.
| 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. |
|
| 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:
|
| 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.
| 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. |
|
| 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:
|
| 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:
|
| 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.
|
Pneumonitis
| aGrading according to CTCAE Version 5.0. | |
| 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.
| aGrading according to CTCAE Version 5.0. bFor Grade 2 and 3 colitis consider additional treatment, such as enteric-acting and/or systemic steroids. |
|
| 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:
|
| Grade 3 | Interrupt VIJOICE dose until improvement to Grade ≤ 1. Initiate or intensify appropriate medical therapy and monitor as clinically indicatedb. Adult Patients:
|
| Grade 4 | Permanently discontinue VIJOICE. |
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:
|
| Grade 3 | Adult Patients:
|
| Grade 4 | Permanently discontinue VIJOICE. |
Other Adverse Reactions
| 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:
|
| Grade 4 | Permanently discontinue VIJOICE. |
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