Important Safety Information:

VIJOICE® (alpelisib) tablets is contraindicated in patients with severe hypersensitivity to alpelisib or any of its ingredients...

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Indication: VIJOICE® (alpelisib) tablets is indicated for the treatment of adult and pediatric patients 2 years of age and older with severe manifestations of PIK3CA-Related Overgrowth Spectrum (PROS) who require systemic therapy.

This 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 confirmatory trials.

Dosing & Administration

Pediatric Dosing

Recommended starting dose and dose modifications for pediatric patients (ages 2 to <18 years)

VIJOICE® (alpelisib) tablets is taken orally, once daily, with food, and at approximately the same time every day until disease progression or unacceptable toxicity occurs.1

The starting dose for pediatric patients is 50 mg qd (One 50-mg tablet)

For pediatric patients ≥6 years: Consider a dose increase to 125 mg (one 125-mg tablet) for response optimization after 24 weeks of treatment with VIJOICE.

Dose reduction back to 50 mg may be required if ARs occur.
Discontinue VIJOICE in patients who cannot tolerate the 50-mg dose.

The dose increase for pediatric and adult patients is 125 mg qd (One 125-mg tablet)


For pediatric patients who turn 18 years:
Consider a gradual dose increase up to 250 mg.

 

Additional information:

  • 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
  • If an AR occurs, there are dose reduction and interruption guidelines for VIJOICE. Some patients may need to stop taking the drug

Patients who are able to swallow tablets should swallow VIJOICE tablets whole. Tablets should not be chewed or split prior to swallowing. Click here if your patient is unable to swallow tablets.

 

qd, once daily.

 

Adult Dosing

Recommended starting dose and dose modifications for adult patients (ages ≥18 years)

VIJOICE is taken orally, once daily, with food, and at approximately the same time every day until disease progression or unacceptable toxicity occurs.1

The starting dose for adult patients is 250 mg qd (One 200-mg tablet + one 50-mg tablet)

Additional information:

  • 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
  • If an AR occurs, there are dose reduction and interruption guidelines for VIJOICE. Some patients may need to stop taking the drug

Patients who are able to swallow tablets should swallow VIJOICE tablets whole. Tablets should not be chewed or split prior to swallowing. Click here if your patient is unable to swallow tablets.

 

 

Patients Who Are Unable to Swallow Tablets

Patients who are unable to swallow tablets should take VIJOICE by following these steps1:

Number 1 icon

Place VIJOICE tablet or 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.

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Crush the tablet or tablets with a spoon, and stir until an oral suspension is obtained.

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Administer the oral suspension immediately after preparation. Discard the oral suspension if it is not administered within 60 minutes after preparation.

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After administration of the oral suspension, add approximately 2 to 3 tablespoons of water to the same glass. Stir with the same spoon to resuspend any remaining particles, and administer the entire contents of the glass. Repeat if particles remain.

Liquids other than water should not be used for making the oral suspension.

 

Reference:

  1. Vijoice [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corp; 2022.

INDICATION

VIJOICE® (alpelisib) tablets is indicated for the treatment of adult and pediatric patients 2 years of age and older with severe manifestations of PIK3CA-Related Overgrowth Spectrum (PROS) who require systemic therapy.

This 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 confirmatory trials.

IMPORTANT SAFETY INFORMATION

VIJOICE is contraindicated in patients with severe hypersensitivity to alpelisib or any of its ingredients.

Severe Hypersensitivity. Severe hypersensitivity reactions, including anaphylaxis and anaphylactic shock, have occurred in adult patients treated with alpelisib in the oncology setting and may occur in patients treated with VIJOICE. VIJOICE is not approved for use in the oncology setting. Permanently discontinue VIJOICE in the event of severe hypersensitivity.

Severe Cutaneous Adverse Reactions (SCARs). SCARs, including Stevens-Johnson syndrome (SJS), erythema multiforme (EM), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS), have occurred in adult patients treated with alpelisib in the oncology setting and may occur in patients treated with VIJOICE. If signs or symptoms of SCARs occur, interrupt VIJOICE until the etiology of the reaction has been determined. Consultation with a dermatologist is recommended. If a SCAR is confirmed, permanently discontinue VIJOICE. If a SCAR is not confirmed, VIJOICE may require dose modifications, topical corticosteroids, or oral antihistamine treatment.

Hyperglycemia. Severe hyperglycemia, in some cases associated with hyperglycemic hyperosmolar nonketotic syndrome (HHNKS) or fatal cases of ketoacidosis, has occurred in adult patients treated with alpelisib in the oncology setting and may occur in patients treated with VIJOICE.

In the EPIK-P1 study, grade 1 or 2 hyperglycemia was reported in 12% of patients treated with VIJOICE.

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. Monitor fasting glucose more frequently for the first few weeks during treatment with VIJOICE in patients with risk factors for hyperglycemia, such as obesity (body mass index ≥30), elevated FPG, HbA1c at the upper limit of normal or above, use of concomitant systemic corticosteroids, or age ≥75.

If a patient experiences hyperglycemia after initiating treatment with VIJOICE, monitor fasting glucose as clinically indicated and at least twice weekly until fasting glucose decreases to normal levels. During treatment with antihyperglycemic medication, continue monitoring fasting glucose at least once a week for 8 weeks, followed by once every 2 weeks, and as clinically indicated. Consider consultation with a health care provider with expertise in the treatment of hyperglycemia, and counsel patients on lifestyle changes.

The safety of VIJOICE in patients with type 1 and uncontrolled type 2 diabetes has not been established. Patients with a history of diabetes mellitus may require intensified hyperglycemic treatment. Closely monitor patients with diabetes.

Interrupt, reduce the dose of, or permanently discontinue VIJOICE based on severity.

Pneumonitis. Severe pneumonitis, including acute interstitial pneumonitis and interstitial lung disease, has occurred in adult patients treated with alpelisib in the oncology setting and may occur in patients treated with VIJOICE.

In patients who have new or worsening respiratory symptoms or are suspected to have developed pneumonitis, interrupt VIJOICE immediately and evaluate the patient for pneumonitis. Consider a diagnosis of noninfectious pneumonitis in patients presenting with nonspecific respiratory signs and symptoms, such as hypoxia, cough, dyspnea, or interstitial infiltrates on radiologic examinations and in whom infectious, neoplastic, and other causes have been excluded by means of appropriate investigations.

Permanently discontinue VIJOICE in all patients with confirmed pneumonitis.

Diarrhea. Severe diarrhea, including cases resulting in dehydration and acute kidney injury, has occurred in adult patients treated with alpelisib in the oncology setting and may occur in patients treated with VIJOICE. In the EPIK-P1 study, 16% of patients experienced grade 1 diarrhea during treatment with VIJOICE. Interrupt, reduce the dose of, or permanently discontinue VIJOICE based on severity.

Embryo-Fetal Toxicity. Based on findings in animals and its mechanism of action, VIJOICE can cause fetal harm when administered to a pregnant woman. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. 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.

The most common adverse reactions (all grades, incidence ≥10%) were diarrhea (16%), stomatitis (16%), and hyperglycemia (12%).

The most common laboratory abnormalities (all grades, incidence ≥20%) were decreased calcium (corrected) (60%), decreased phosphate (59%), increased glucose (56%), increased HbA1c (38%), increased creatinine (31%), increased bilirubin (29%), decreased magnesium (26%), increased potassium (24%), decreased leukocyte (22%), decreased lymphocyte (20%), and decreased hemoglobin (20%).

Please see full Prescribing Information for VIJOICE® (alpelisib) tablets.