Alpelisib(PIQRAY)
Acetylcysteine Injection, FLUIMUCIL, Acetylcysteine InjectionAcetylcysteine Injection, FLUIMUCIL, Acetylcysteine InjectionAcetylcysteine Injection, FLUIMUCIL, Acetylcysteine Injection
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Formulation:
TABLET
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Reminder: The outer packaging is for reference only, please purchase and use under the guidance of a pharmacist. For read by medical and pharmaceutical professionals only.

VIJOICE (alpelisib) is an oral kinase inhibitor primarily used in the treatment of PIK3CA-Related Overgrowth Spectrum (PROS). PROS is a group of disorders characterized by abnormal tissue overgrowth, often associated with mutations in the PIK3CA gene. Alpelisib functions by selectively inhibiting the alpha isoform of phosphoinositide 3-kinase (PI3Kα), an enzyme implicated in the pathogenesis of many cancers and overgrowth syndromes. The drug works by reducing hyperactivity of the PI3K signaling pathway, which helps in controlling abnormal growth and proliferation of affected tissues.

This drug is specifically designed for patients who experience severe manifestations of PROS that cannot be managed with local therapy alone. The treatment is approved based on clinical trial results that showed promising efficacy in reducing the severity and progression of PROS. VIJOICE is administered orally, either in tablet or granule form, with a daily dose tailored according to patient age and response to therapy. It is important for patients to be monitored for potential adverse effects, including severe hypersensitivity, hyperglycemia, and gastrointestinal issues.

Generic name

Alpelisib(PIQRAY)
English name
Alpelisib
Alternative Names
PIQRAY
Drug prices
Indications
VIJOICE is indicated for the treatment of adult and pediatric patients ≥2 years with severe manifestations of PIK3CA-Related Overgrowth Spectrum (PROS) requiring systemic therapy.

Accelerated Approval: Based on response rate and duration of response. Continued approval contingent on confirmatory trial(s)

Therapeutic Target
Phosphatidylinositol-3-kinase alpha (PI3Kα).
Active Ingredients
Alpelisib
Dosage form
TABLET
specifications
50 mg;125 mg;200 mg
Description

Pharmacologic Class: Kinase inhibitor (PI3Kα-specific).

Physical Properties:

Tablets: Light yellow (50 mg), dark yellow (125 mg), pale yellow (200 mg); debossed with identifiers.

Granules: White to off-white powder/granules.

Inactive Ingredients: Hypromellose, mannitol, microcrystalline cellulose, magnesium stearate, and sodium starch glycolate.

Dosage and Administration

Recommended Dosage

Adults: 250 mg once daily with food.

Pediatrics (2–<18 years):

≥6 years: After 24 weeks, may increase to 125 mg if response suboptimal.

At 18 years: Gradually increase to adult dose (250 mg).

Initial: 50 mg once daily.

Dose Increase:

Administration Instructions

Tablets: Swallow whole; do not crush/chew. For patients unable to swallow, prepare oral suspension in water.

Granules: Mix with water/milk/juice/applesauce/yogurt; administer immediately.

Missed Dose: Take within 9 hours; skip if >9 hours.

Vomiting: Do not redose; resume next day.

Dose Modifications for Adverse Reactions

Adults:

First reduction: 125 mg → Second reduction: 50 mg.

Pediatrics:

125 mg → 50 mg (no further reduction).

Permanent Discontinuation: Intolerance to 50 mg or Grade 4 reactions.

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