Vijoice (Alpelisib) 50mg/125mg/200mg Tablets | FDA-Approved PROS Therapy | GLT

Generic Information: Vijoice (Alpelisib) — The First Approved PROS Therapy

Vijoice is the Novartis brand of alpelisib tablets, and it holds a distinction no other medicine can claim: in April 2022 the US FDA granted it accelerated approval as the first and only systemic therapy for PIK3CA-Related Overgrowth Spectrum (PROS), after orphan-drug designation. It matters immediately that Vijoice is not an oncology product in everyday practice — the same molecule is sold under the name Piqray for breast cancer, but Vijoice itself is developed, dosed and packaged for a rare genetic overgrowth disease that usually begins in childhood. The US presentation GLT supplies contains film-coated tablets in 50 mg, 125 mg and 200 mg strengths, joined since 2024 by 50 mg single-use oral granules for patients who cannot swallow tablets.

What Is PIK3CA-Related Overgrowth Spectrum (PROS)?

PROS is a spectrum of rare conditions caused by a somatic mutation in the PIK3CA gene, which keeps the PI3K growth pathway permanently switched on in affected tissues. The result is disproportionate, progressive overgrowth of parts of the body — limbs, fingers and toes, fat tissue, blood vessels, lymphatics — together with vascular malformations. Recognized PROS syndromes include CLOVES syndrome, megalencephaly-capillary malformation polymicrogyria (MCAP), Klippel-Trenaunay syndrome (KTS) and facial infiltrating lipomatosis. Vijoice is indicated for adult and pediatric patients 2 years of age and older whose PROS manifestations are severe and who require systemic therapy — in other words, patients in whom surgery or local procedures alone cannot control the disease.

How Does Vijoice (Alpelisib) Work?

Alpelisib is a selective inhibitor of PI3K alpha, the enzyme loop that the mutated PIK3CA gene keeps running. By dialing that signal down, Vijoice shrinks overgrown target lesions rather than masking symptoms. Because there is no comparable approved drug, regulators judged effectiveness on real-world data from the EPIK-P1 program: among 37 evaluable patients with severe PROS, 27% achieved a confirmed radiological response (at least a 20% reduction in measurable target-lesion volume) by week 24, and 60% of those responses lasted 12 months or longer. For a condition previously managed only with surgery and symptom care, that was practice-changing.

Indications of Vijoice

The approved use reads precisely: treatment of adult and pediatric patients 2 years of age and older with severe manifestations of PIK3CA-Related Overgrowth Spectrum who require systemic therapy. Three conditions sit behind that sentence — a documented PIK3CA mutation from a qualified laboratory, imaging-identifiable measurable lesions, and a physician's judgment that the disease is severe or life-threatening enough to need drug therapy. Vijoice is not indicated for breast cancer, and Piqray is not indicated for PROS; the two brands answer two different diseases even though the molecule inside is the same.

Dosage and Administration

Dosing is age-based and refreshingly simple compared with oncology regimens. Children and adolescents from 2 to under 18 years take 50 mg once daily with food; for patients 6 years and older, the dose may be raised to 125 mg once daily after 24 weeks of treatment if the clinical and radiological response calls for it; adults take 250 mg once daily, supplied as one 200 mg tablet plus one 50 mg tablet together each morning — there is no single 250 mg tablet in the current presentation. Tablets are swallowed whole, never chewed, split or crushed; for patients unable to swallow, the tablets or the 50 mg oral granules can be prepared as a suspension in water, which can also be given through a nasogastric or gastric tube. A missed dose is taken with food as soon as remembered on the same day.

Side Effects of Vijoice

The reactions reported most often are diarrhea, mouth sores (stomatitis) and high blood sugar — the same class effects seen with alpelisib generally, but monitored with particular care in children. Before starting, the care team checks fasting glucose and HbA1c, because severe hyperglycemia is the label's headline risk and diabetes must be optimized first. Serious warnings include severe hypersensitivity, severe skin reactions (Stevens-Johnson syndrome and related conditions), pneumonitis, and diarrhea or colitis severe enough to cause dehydration; any suspected severe skin reaction leads to interruption and usually permanent discontinuation. Contraception is required during treatment because the drug can harm a fetus. Families should keep scheduled glucose checks and report mouth pain, loose stools or breathing changes early — dose interruptions reverse most problems when caught in time.

Storage Instructions

Store Vijoice tablets and granules at 20°C to 25°C (68°F to 77°F), with short excursions allowed between 15°C and 30°C, in the original carton away from moisture and direct light. No refrigeration. Keep every carton out of children's reach — this is a medicine dosed to children, so storage discipline at home genuinely matters. Return unused medicine to a pharmacy take-back point rather than the household bin.

Why Choose Vijoice from GLT?

Drugs for ultra-rare diseases are the hardest medicines on earth to source outside their home market: national programs are small, specialty pharmacies are single-channel, and families travelling abroad often cannot refill at all. GLT closes that gap — we supply sealed Novartis Vijoice cartons with batch documentation, we routinely serve families coordinating care across borders, and we understand that PROS treatment is measured in years, so recurring monthly supply can be scheduled in advance. Because the adult daily dose uses the 200 mg + 50 mg combination carton, tell us the patient's age and current schedule and we will configure the right monthly quantity. Every enquiry is answered personally on WhatsApp +86 15234153837 or at [email protected], with quotation and paperwork usually within one working day.

How to Order Vijoice (Alpelisib)

Message GLT on WhatsApp +86 15234153837 or write to [email protected] with the patient's required strengths and monthly quantity. We reply with a formal quotation, shipping options and payment details, and dispatch sealed stock with full export documentation once the order is confirmed. Institutional and hospital buyers can request batch records, CoA copies and photographs of the actual cartons before payment — for a rare-disease therapy we expect and encourage that diligence.

FAQ

Is Vijoice the same medicine as Piqray? The active molecule is identical (alpelisib), but the products are not interchangeable in purpose: Vijoice is approved and dosed for PROS in children and adults, while Piqray is approved for PIK3CA-mutated breast cancer. Use the brand matched to your diagnosis.

Why do sources mention a 250 mg tablet that the pack doesn't contain? The adult 250 mg daily dose is taken as one 200 mg tablet plus one 50 mg tablet; the current US presentation has 50 mg, 125 mg and 200 mg tablets (plus 50 mg granules), so a correct monthly supply contains both strengths.

How long does response to Vijoice last? In the EPIK-P1 evidence base, 27% of patients had a confirmed radiological response by week 24, and most of those responses (60%) lasted at least 12 months; treatment continues while benefit persists.

Can my child swallow tablets? If not, the tablets — or the 50 mg oral granules — can be prepared as a suspension given by mouth or feeding tube; we can supply guidance alongside the medicine.

What documents do you ship with the order? Batch/lot details and the standard export set come with every parcel; institutions can request CoA copies in advance.