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Vijoice alpelisib 50 mg Granule, 28-count — NDC 00078-1175-51 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Vijoice alpelisib 50 mg Granule, 28-count — NDC 0078-1175-51 (Billing 00078-1175-51)

by Novartis Pharmaceuticals Corporation · 28 PACKET in 1 CARTON / 1 GRANULE in 1 PACKET

This is a package of 28 granules of Vijoice alpelisib 50 mg Granule from Novartis Pharmaceuticals Corporation, marketed since Apr 2024 and currently FDA-listed. It is this product's only package size.

NDC 00078-1175-51
🏷️ FDA NDC (as labeled) 0078-1175-51 billing pads the labeler segment with a zero
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 0078-1175-51 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
0078 labeler · 1175 product · 51 package
Package marketed since
Apr 24, 2024
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Billing quantity
28 EA per package
Barcode (UPC-A, from the NDC)
3 0078117551 6
Medicaid fills, this package
146 prescriptions in the last four reported quarters
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0078-1175-51
Product NDC 0078-1175
11-digit billing NDC 00078117551
NCPDP billing unit EA — each (per item)
RxCUI 2169310, 2169316, 2169319, 2598459, 2598461, 2598463, 2598464, 2598465,
UNII 08W5N2C97Q
Application # NDA218466
SPL Set ID 638069a4-aee0-46c9-9e21-54ad449c163c
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-04-24
Route ORAL
Dosage form GRANULE
Substance ALPELISIB

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 99486010003020
GCN Seq No 086008
GCN 55627
HICL code 045761
Ingredient (HICL) Alpelisib
HIC1 code Z
Therapeutic class — broad (HIC1) Body As A Whole
HIC2 code Z2
Therapeutic class — intermediate (HIC2) Antihistamines, Antiserotonins, Immunosuppressants
HIC3 code Z2H
Therapeutic class — specific (HIC3) Systemic Enzyme Inhibitors
AHFS code 44:04.00.00
AHFS class Enzyme Inhibitors
FDB label name VIJOICE 50 MG GRANULE PACKET
FDB brand name Vijoice
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 086008
  • GCN: 55627
  • GPI-14 (Medi-Span): 99486010003020
  • HICL (First Databank): 045761
  • AHFS class code: 44:04.00.00
  • RxCUI (RxNorm): 2169310
Why two NDCs? The FDA registers this code as 0078-1175-51 — a 4-4-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the labeler segment → 00078-1175-51. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Phosphatidylinositol-3-kinase (Pi3K) inhibitors class.

Drug family (ATC) Phosphatidylinositol-3-kinase (Pi3K) inhibitors
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name VIJOICE 50 MG GRANULE PACKET Ingredient Alpelisib
📖 What it is MedlinePlus · NLM

Alpelisib (Piqray) is used in combination with fulvestrant (Faslodex) to treat a certain type of breast cancer that has spread to nearby tissues or other parts of the body in adults whose cancer got worse during or after certain other treatments. Alpelisib (Vijoice) is used to treat adults and children 2 years of age or older who have certain types of PIK3CA Related Overgrowth Spectrum (PROS; a genetic condition that causes overgrowth and abnormalities in certain body tissues). Alpelisib is in a class of medications called kinase inhibitors. It works to treat cancer by blocking the signals th...

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It depends on the brand. Piqray is used with fulvestrant for certain advanced breast cancers that are HR-positive, HER2-negative and PIK3CA-mutated. Vijoice is used for severe PROS...
  • Take it once a day with food, at about the same time each day. Swallow tablets whole unless your Vijoice instructions say to mix them in water. If you miss a dose, take it with foo...
  • Diarrhea, rash, nausea, tiredness, lower appetite, mouth sores and high blood sugar are common, especially with Piqray. Let your care team know early, since there are ways to manag...
  • Call for trouble breathing, a spreading or blistering rash with fever, severe or bloody diarrhea, new cough or shortness of breath, or signs of high blood sugar like extreme thirst...
📖 Read our full Alpelisib guide →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer gPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo $1,152.25 —
Medicare drug plans payPart D · Q2 2026 $1,258.51 —
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
00078-1175-51 You're viewing this Main listing 28 PACKET in 1 CARTON / 1 GRANULE in 1 PACKET 2024-04-24 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Vijoice 50 mgthis 00078-1175-51 Novartis 28 granules — — FDA listed —
About this product: this is the brand-name version. We did not find an FDA-approved generic match for this exact strength, form and route.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2024
First FDA approval
Apr 2024
📍
2026
Currently FDA-listed
2 years listed
🛡️
2037
Latest patent/protection listed
not a guaranteed launch date
🔒No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route. Patent/protection dates below may affect future generic timing.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Feb 2037. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Apr 24, 2024 RLD RS ⏳ ~10.4 yr to latest listed protection

Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.

Patents & exclusivity — FDA Orange Book
US 12427141 — method of use (U-4288)
US 11433059 — method of use (U-4359)
US 8476268 — drug substance
US 8227462 — drug substance
2024 2026 2028 2030 2032 2034 2036
Today
LOE
Substance patent Formulation patent Method-of-use patent Exclusivity Pediatric +6mo
🏛️FDA exclusivity
FDA-granted marketing protection. It’s separate from patents and may be shorter than patent protection.
🧪Product / substance patents
Patents covering the active ingredient, product, formulation, or related drug features.
🎯Method-of-use patents
Patents covering specific approved uses. These can sometimes be carved out with a “skinny label,” but not always.
🛈 What do these terms mean?
Patent
Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
Substance patent
Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
Formulation (product) patent
Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
Method-of-use patent
A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
Skinny label
A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
Exclusivity
FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
Paragraph IV
A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
RLD / RS
Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
TE / AB rating
FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
LOE (loss of exclusivity)
The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.

Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.

Listed patents (4)
PatentTypeUse codeExpires
US 12427141 ↗ Method of use U-4288 Feb 17, 2037
US 11433059 ↗ Method of use U-4359 Feb 17, 2037
US 8476268 ↗ Drug substance — Sep 10, 2029
US 8227462 ↗ Drug substance — Apr 29, 2033
Common questions
Is there a generic version of VIJOICE 50 MG GRANULE PACKET?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for VIJOICE 50 MG GRANULE PACKET. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until Feb 2037 — an estimate, not a guaranteed launch date.
The FDA approved a generic — why can’t I get it at my pharmacy yet?
FDA approval and pharmacy availability are two different things. The FDA can approve a generic years before it actually reaches pharmacies, because the brand company may still hold patents or have a settlement that delays the launch. A manufacturer also has to choose to make and sell it, and have supply ready. So a drug can be “FDA-approved generic exists” and still be brand-only at the counter today.
Why do different websites show different generic release dates?
Generic availability is not based on one single date. Some sources use the first exclusivity expiration, some use the last product patent, and others use the latest method-of-use patent. Patent challenges, settlements, licenses, and label carve-outs can also change the real-world launch date. This page shows the underlying Orange Book dates so you can see why estimates may differ.
What does “FDA listed” mean?
It means the product appears in the FDA’s official NDC directory. That’s a good sign a product exists and is intended for the U.S. market, but on its own it does not confirm a pharmacy can fill it today. Where we have recent retail pricing data (NADAC) for a product, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Orange Book for a patent or exclusivity on the brand product. It can affect when a full generic version becomes widely available — but it is not a guaranteed generic launch date. Generics sometimes arrive earlier (through a settlement or patent challenge) or later (a manufacturer still has to make and sell one).
What does “current Orange Book estimate” mean?
It means we are using the latest patent and exclusivity dates currently listed in the FDA Orange Book. It is not a guaranteed launch date.
Can a generic come out before the last patent expires?
Sometimes. A generic company may challenge a patent, settle with the brand manufacturer, receive a license, or obtain approval with a narrower label that avoids a patented use. In other cases, the last listed protection may delay full-label generic competition.
Can a generic come out after the listed dates?
Yes. Even after patents or exclusivity expire, a generic still needs FDA approval and a manufacturer must choose to market it. Supply, litigation, business decisions, or regulatory issues can delay actual availability.
What is the difference between patents and exclusivity?
Patents are legal protections usually issued by the U.S. Patent and Trademark Office. FDA exclusivity is marketing protection granted by the FDA. They are separate, and either one can affect generic timing.
Why are there multiple patent dates?
One drug can have several patents covering different things: the active ingredient, a formulation, a manufacturing process, or a specific approved use. That is why a page may show several expiration dates instead of one simple generic date.
Built from FDA Orange Book patent and exclusivity data. Dates are refreshed from public FDA data when available; the marker is max(latest patent expiry, latest exclusivity expiry). Paragraph-IV settlements and first-filer 180-day exclusivity can shift the real date; a method-of-use patent may allow an earlier skinny-label generic for non-protected indications. Generic launch timing is an estimate, not a guarantee.
Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

What it looks like

Color Yellow
ShapeRound
ImprintC7;NVR
Size7 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

🧪 Avoiding an ingredient? See Alpelisib inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII 3NXW29V3WO
    Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII 3OWL53L36A
    A natural sugar alcohol derived from seaweed or synthesized in the lab. It's used as a filler to add bulk, a sweetener in sugar-free formulas, and a disintegrant to help tablets break apart in the stomach.
  • UNII 5856J3G2A2
    A starch-based powder made from potatoes and processed with sodium. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the medicine can be absorbed.

5 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerNovartis Pharmaceuticals Corporation
Application holderNOVARTIS PHARMACEUTICALS CORP
FDA applicationNDA218466 (NDA)
Labeler code00078
First marketedApr 2024
Product typeHuman Prescription Drug
Portfolio209 products on file

More NDCs from Novartis Pharmaceuticals Corporation labeler code 00078

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Patient Package Insert 📖 Instructions for Use 📄 Recent Major Changes 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 136 words ▾

1 INDICATIONS AND USAGE VIJOICE 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 a confirmatory trial(s).

VIJOICE is a kinase inhibitor 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 a confirmatory trial(s).

( 1 )

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Recommended Dose: Pediatric patients (2 to less than 18 years of age): 50 mg taken orally once daily with food. ( 2.1 ) Adult patients: 250 mg taken orally once daily with food. ( 2.1 ) Administration: Swallow tablets whole.

Do not chew, divide, or crush. ( 2.4 ) For patients who cannot swallow tablets whole, use tablets or oral granules to create a suspension or a mixture. ( 2.4 ) VIJOICE suspension made with water can be administered orally or via a nasogastric or gastric tube.

( 2.4 ) See full prescribing information for preparation and administration instructions.

2.1Recommended 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, 2.3, 2.4)] 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, 2.3, 2.4)] 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 Dose can be administered as VIJOICE tablets or VIJOICE oral granules. b A recommended increased dose has not been established.

Patient age (years) Initial dose Dose increase 2 to < 6 50 mg a Not applicable b 6 to < 18 50 mg a 125 mg

2.2VIJOICE 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 [see Dosage and Administration (2.4)] . VIJOICE Oral Granules (50 mg per packet): For patients who are prescribed a 50 mg daily dose only [see Dosage and Administration (2.1)] . 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 [see Clinical Pharmacology (12.3)] .

Do not combine VIJOICE tablets and VIJOICE oral granules to achieve the prescribed dose.

2.3VIJOICE Administration Overview Take VIJOICE with food at approximately the same time each day [see Clinical Pharmacology (12.3)] . 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.

2.4VIJOICE Preparation and Administration Instructions VIJOICE Tablets Swallow VIJOICE tablets whole, or prepare as a suspension to administer orally, or via feeding tubes. 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 a Suspension for Oral use, or Feeding Tubes (Nasogastric or Gastric Tube) Administration For patients who are not able to swallow tablets, or who are using a feeding tube, prepare and administer VIJOICE as a suspension and take with food [see Clinical Pharmacology (12.3)] . To prepare VIJOICE tablets as a suspension for oral use, place VIJOICE tablets in a cup containing 2 to 4 ounces of water.

To prepare VIJOICE tablets as a suspension for feeding tubes ad… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 116 words ▾

3 DOSAGE FORMS AND STRENGTHS Tablets 50 mg: Light yellow, unscored, round and curved with beveled edges film-coated tablet, debossed with “C7” on one side and “NVR” on the other side. 125 mg: Dark yellow, unscored, ovaloid and curved with beveled edges film-coated tablet, debossed with “Y7” on one side and “NVR” on the other side. 200 mg: Pale yellow, unscored, ovaloid and curved with beveled edges film-coated tablet, debossed with “CL7” on one side and “NVR” on the other side.

Oral Granules 50 mg: White to almost white free flowing mixture of powder and granules in packets. Tablets: 50 mg, 125 mg, and 200 mg ( 3 ) Oral Granules: 50 mg ( 3 )

⛔ Contraindications 36 words ▾

4 CONTRAINDICATIONS VIJOICE is contraindicated in patients with severe hypersensitivity to alpelisib or any of its ingredients [see Warnings and Precautions (5.1)] . Severe hypersensitivity to VIJOICE or to any of its ingredients. ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Severe Hypersensitivity : Permanently discontinue VIJOICE. Promptly initiate appropriate treatment. ( 5.1 ) Severe Cutaneous Adverse Reactions (SCARs) : VIJOICE can cause SCARs, including Stevens-Johnson syndrome (SJS), erythema multiforme (EM), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS).

Interrupt VIJOICE for signs or symptoms of SCARs. Permanently discontinue VIJOICE if SCARs are confirmed. ( 2.5 , 5.2 ) Hyperglycemia : VIJOICE can cause severe hyperglycemia, in some cases associated with hyperglycemic hyperosmolar non-ketotic syndrome (HHNKS) or ketoacidosis.

The safety of VIJOICE in patients with Type 1 or uncontrolled Type 2 diabetes has not been established. Before initiating treatment with VIJOICE, test fasting plasma glucose (FPG), HbA1c, and optimize blood glucose. After initiating treatment, monitor periodically.

Initiate or optimize anti-hyperglycemic medications as clinically indicated. Interrupt, reduce dose, or discontinue VIJOICE if severe hyperglycemia occurs. ( 2.5 , 5.3 ) Pneumonitis : VIJOICE can cause severe pneumonitis and interstitial lung disease.

Monitor for clinical symptoms or radiological changes. Permanently discontinue VIJOICE if pneumonitis occurs. ( 2.5 , 5.4 ) Diarrhea or Colitis : VIJOICE can cause severe diarrhea, resulting in dehydration and in some cases in acute kidney injury, as well as colitis.

Monitor for diarrhea and additional symptoms of colitis, including abdominal pain and mucus or blood in stool. Interrupt, reduce dose, or permanently discontinue VIJOICE based on severity of diarrhea or colitis. Patients with colitis may require additional treatment, such as enteric-acting and/or systemic steroids.

( 2.5 , 5.5 ) Embryo-Fetal Toxicity : VIJOICE can cause fetal harm. Advise patients of potential risk to a fetus and to use effective contraception. ( 5.6 , 8.1 , 8.3 )

5.1Severe Hypersensitivity Severe hypersensitivity reactions, including anaphylaxis, anaphylactic shock, and angioedema, have occurred in adult patients treated with alpelisib in the oncology setting and in patients treated with VIJOICE [see Adverse Reactions (6.1)] . VIJOICE is not approved for use in the oncology setting. Permanently discontinue VIJOICE in the event of severe hypersensitivity [see Contraindications (4)] .

5.2Severe Cutaneous Adverse Reactions Severe cutaneous adverse reactions (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. VIJOICE is not approved for use in the oncology setting. 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 or systemic corticosteroids, or oral antihistamine treatment as described in Table 4 [see Dosage and Administration (2.5)] .

5.3Hyperglycemia Severe hyperglycemia, in some cases associated with hyperglycemic hyperosmolar non-ketotic 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. VIJOICE is not approved for use in the oncology setting. In the EPIK-P1 study, Grade 1 or 2 hyperglycemia was reported in 12% of patients treated with VIJOICE [see Adverse Reactions (6.1)] .

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 indicate… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following clinically significant adverse reactions are discussed elsewhere in the labeling: Severe Hypersensitivity [see Warnings and Precautions (5.1)] Severe Cutaneous Adverse Reactions [see Warnings and Precautions (5.2)] Hyperglycemia [see Warnings and Precautions (5.3)] Pneumonitis [see Warnings and Precautions (5.4)] Diarrhea or Colitis [see Warnings and Precautions (5.5)] Most common adverse reactions (Grades 1 to 4, incidence ≥ 10%) were diarrhea, stomatitis, and hyperglycemia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Novartis Pharmaceuticals Corporation at 1-888-669-6682 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

6.1Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of VIJOICE was evaluated in EPIK-P1 (NCT04285723), a single-arm clinical study in patients who were treated as part of an expanded access program for compassionate use. Fifty-seven patients 2 years of age and older with severe or life-threatening PIK3CA-Related Overgrowth Spectrum (PROS) received VIJOICE based on age at dosages ranging from 50 mg to 250 mg orally once daily [see Clinical Studies (14)] .

Among patients who received VIJOICE, 95% were exposed for 6 months or longer and 79% were exposed for greater than one year. The median age of patients who received VIJOICE was 14 years (range, 2 to 50); 58% were female; 12% were White and race was not reported for 88%. Serious adverse reactions occurred in 12% of patients who received VIJOICE.

Serious adverse reactions occurring in two or more patients included dehydration (n = 2) and cellulitis (n = 2). Dosage interruption of VIJOICE due to an adverse reaction occurred in 11% of patients. Adverse reactions which required dosage interruption in two or more patients included dizziness (n = 2) and vomiting (n = 2).

Dose reductions of VIJOICE due to an adverse reaction occurred in 5% of patients. Adverse reactions which required dose reduction included alopecia, memory impairment, and soft tissue infection. The most common adverse reactions (≥ 10%) were diarrhea, stomatitis, and hyperglycemia.

The most common Grade 3 or 4 laboratory abnormalities (≥ 2%) were increased glucose, decreased hemoglobin, decreased phosphate, increased bilirubin, decreased sodium, and decreased platelets. Adverse reactions and laboratory abnormalities are listed in Table 10 and Table 11, respectively. Table 10: Adverse Reactions (≥ 5%) in Patients with PROS Who Received VIJOICE in EPIK-P1 Grading according to CTCAE Version 4.03. a Stomatitis: including stomatitis and aphthous ulcer.

VIJOICE N = 57 Adverse reactions All Grades (%) Grade 3 or 4 (%) Gastrointestinal disorders Diarrhea 16 0 Stomatitis a 16 0 Metabolism and nutrition disorders Hyperglycemia 12 0 Skin and subcutaneous tissue disorders Eczema 7 0 Dry skin 7 0 Alopecia 5 0 Nervous system disorders Headache 5 0 Infections and infestations Cellulitis 5

3.5Clinically relevant adverse reactions in < 5% of patients who received VIJOICE included nausea, vomiting, dehydration, and mucosal dryness. Table 11: Laboratory Abnormalities Worsening from Baseline in ≥ 10% of Patients with PROS Who Received VIJOICE in EPIK-P1 Grading according to CTCAE Version 4.03. Abbreviation: N/A, not available. a The denominator used to calculate the rate varied from 9 to 50 based on the number of patients with a baseline value and at least one post-treatment value. b No Grade 4 laboratory abnormalities were reported. c Glucose increase is an expected laboratory abnormality of PI3K inhibition. d No CTCAE grade available.

For HbA1c, baseline values increasing post-treatment to a value above the upper limit of the normal range (≥ 5.7%) are considered increased. Laboratory abnormality VIJOICE a N = 57 All Grades… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions 191 words ▾

7 DRUG INTERACTIONS CYP3A4 Inducers : Avoid coadministration of VIJOICE with a strong CYP3A4 inducer. Consider an alternative concomitant drug with no or minimal potential to induce CYP3A4. ( 7.1 ) Breast Cancer Resistance Protein (BCRP) Inhibitors : Avoid the use of BCRP inhibitors in patients treated with VIJOICE. If unable to use alternative drugs, closely monitor for increased adverse reactions. ( 7.1 )

7.1Effect of Other Drugs on VIJOICE CYP3A4 Inducers Avoid coadministration of VIJOICE with strong CYP3A4 inducers and consider an alternative concomitant drug with no or minimal potential to induce CYP3A4. Alpelisib is metabolized by CYP3A4. Concomitant use of VIJOICE with a strong CYP3A4 inducer may decrease alpelisib concentration [see Clinical Pharmacology (12.3)] , which may decrease alpelisib activity.

Breast Cancer Resistance Protein Inhibitors (BCRP) Avoid the use of BCRP inhibitors in patients treated with VIJOICE. If unable to use alternative drugs, when VIJOICE is used in combination with BCRP inhibitors, closely monitor for increased adverse reactions. Alpelisib is transported by BCRP.

Concomitant use of VIJOICE with a BCRP inhibitor may increase alpelisib exposure [see Clinical Pharmacology (12.3)] , which may increase the risk of adverse reactions.

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Lactation : Advise not to breastfeed. ( 8.2 )

8.1Pregnancy Risk Summary Based on animal data and mechanism of action, VIJOICE can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1)] . There are no available data in pregnant women to inform the drug-associated risk. In animal reproduction studies, oral administration of alpelisib to pregnant rats and rabbits during organogenesis caused adverse developmental outcomes, including embryo-fetal mortality (post-implantation loss), reduced fetal weights, and increased incidences of fetal malformations at doses described below ( see Data ).

Advise pregnant women of the potential risk to a fetus. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. However, the estimated background risk of major birth defects is 2% to 4% and of miscarriage is 15% to 20% of clinically recognized pregnancies in the U.S. general population.

Data Animal Data In embryo-fetal development studies in rats and rabbits, pregnant animals received oral doses of alpelisib during the period of organogenesis. In the rat study, animals were dosed at 3, 10, or 30 mg/kg/day from gestation day 6 to 17; and in the rabbit study, animals were dosed at 3, 15, 25, and 30 mg/kg/day from gestation day 7 to 20. In rats, oral administration of alpelisib resulted in maternal toxicity (body weight loss, low food consumption) and no viable fetuses (post-implantation loss) at 30 mg/kg/day (approximately 3.6 to 1.2 times the initial recommended doses of 50 mg and 250 mg in pediatric and adult patients, respectively, based on BSA).

At a dose of 10 mg/kg/day (approximately 1.2 to 0.4 times the initial recommended doses of 50 mg and 250 mg in pediatric and adult patients, respectively, based on BSA), toxicities included reduced fetal weight and increased incidences of skeletal malformations (bent scapula and thickened or bent long bones) and fetal variations (enlarged brain ventricle, decreased bone ossification). In a pilot embryo-fetal development study in rabbits, a dose of 30 mg/kg/day (approximately 7 to 2.2 times the initial recommended doses of 50 mg and 250 mg in pediatric and adult patients based on BSA) resulted in no viable fetuses (post-implantation loss).

Doses ≥ 15 mg/kg/day (approximately 3.5 to 1.1 times the initial recommended doses of 50 mg and 250 mg in pediatric and adult patients, respectively, based on BSA) resulted in increased embryo-fetal deaths, reduced fetal weights, and malformations, mostly related to the tail and head.

8.2Lactation Risk Summary There are no data on the presence of alpelisib in human milk, its effects on milk production, or the breastfed child. Because of the potential for serious adverse reactions in the breastfed child, advise lactating women to not breastfeed during treatment with VIJOICE and for 1 week after the last dose.

8.3Females and Males of Reproductive Potential Pregnancy Testing Verify the pregnancy status in females of reproductive potential prior to initiating VIJOICE. Contraception Females VIJOICE can cause fetal harm when administered to a pregnant woman [see Use in Specific Populations (8.1)] . Advise females of reproductive potential to use effective contraception during treatment with VIJOICE and for 1 week after the last dose.

Males 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. Infertility Based on findings from animal studies, VIJOICE may impair fertility in males and females of reproductive potential [see Nonclinical Toxicology (13.1)] .

8.4Pediatric Use The safety and effectiveness of VIJOICE have been established in pediatric patients 2 to less than 18 years of age with PROS based on results from a single-arm clinical study of VIJOICE (EPIK-P1) that enrolled 39 pediatric patients: 11 patients aged 2 to 5 years, 12… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Risk Summary Based on animal data and mechanism of action, VIJOICE can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1)] . There are no available data in pregnant women to inform the drug-associated risk. In animal reproduction studies, oral administration of alpelisib to pregnant rats and rabbits during organogenesis caused adverse developmental outcomes, including embryo-fetal mortality (post-implantation loss), reduced fetal weights, and increased incidences of fetal malformations at doses described below ( see Data ).

Advise pregnant women of the potential risk to a fetus. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. However, the estimated background risk of major birth defects is 2% to 4% and of miscarriage is 15% to 20% of clinically recognized pregnancies in the U.S. general population.

Data Animal Data In embryo-fetal development studies in rats and rabbits, pregnant animals received oral doses of alpelisib during the period of organogenesis. In the rat study, animals were dosed at 3, 10, or 30 mg/kg/day from gestation day 6 to 17; and in the rabbit study, animals were dosed at 3, 15, 25, and 30 mg/kg/day from gestation day 7 to 20. In rats, oral administration of alpelisib resulted in maternal toxicity (body weight loss, low food consumption) and no viable fetuses (post-implantation loss) at 30 mg/kg/day (approximately 3.6 to 1.2 times the initial recommended doses of 50 mg and 250 mg in pediatric and adult patients, respectively, based on BSA).

At a dose of 10 mg/kg/day (approximately 1.2 to 0.4 times the initial recommended doses of 50 mg and 250 mg in pediatric and adult patients, respectively, based on BSA), toxicities included reduced fetal weight and increased incidences of skeletal malformations (bent scapula and thickened or bent long bones) and fetal variations (enlarged brain ventricle, decreased bone ossification). In a pilot embryo-fetal development study in rabbits, a dose of 30 mg/kg/day (approximately 7 to 2.2 times the initial recommended doses of 50 mg and 250 mg in pediatric and adult patients based on BSA) resulted in no viable fetuses (post-implantation loss).

Doses ≥ 15 mg/kg/day (approximately 3.5 to 1.1 times the initial recommended doses of 50 mg and 250 mg in pediatric and adult patients, respectively, based on BSA) resulted in increased embryo-fetal deaths, reduced fetal weights, and malformations, mostly related to the tail and head.

🧒 Pediatric Use ~1 min read ▾

8.4Pediatric Use The safety and effectiveness of VIJOICE have been established in pediatric patients 2 to less than 18 years of age with PROS based on results from a single-arm clinical study of VIJOICE (EPIK-P1) that enrolled 39 pediatric patients: 11 patients aged 2 to 5 years, 12 patients aged 6 to 11 years, and 16 patients aged 12 to less than 18 years of age [see Adverse Reactions (6.1) and Clinical Studies (14)] . The safety and effectiveness of VIJOICE in pediatric patients below the age of 2 years have not been established.

Although there were no new safety signals observed in pediatric patients, there is insufficient data to determine whether VIJOICE has an adverse impact on growth and development in pediatric patients with PROS. Based on the animal toxicity data (described below), regular monitoring of growth and development in pediatric patients treated with VIJOICE is recommended. Animal Toxicity Data In a 4-week general toxicology study, rats administered alpelisib had growth plate thickening and decreased trabeculae of the knee joint, dentin thinning, and degenerative odontoblasts at the dose of 30 mg/kg/day (approximately 2.8 to 1.2 times the initial recommended doses of 50 mg and 250 mg in pediatric and adult patients, respectively, based on BSA).

Dentin thinning/irregular dentin was also observed in the 13-week toxicology study in rats at the high dose of 20 mg/kg/day (approximately 2 to 0.8 times the initial recommended doses of 50 mg and 250 mg in pediatric and adult patients, respectively, based on BSA).

🧓 Geriatric Use 20 words ▾

8.5Geriatric Use There were no adult patients aged 65 years of age or older who received VIJOICE in EPIK-P1.

🆘 Overdosage 69 words ▾

10 OVERDOSAGE There is limited experience of overdose with alpelisib in clinical trials. In cases where accidental overdosage of alpelisib was reported in the clinical studies, the adverse reactions associated with the overdose were consistent with the known safety profile of alpelisib and included hyperglycemia, nausea, asthenia, and rash. Initiate general symptomatic and supportive measures in all cases of overdosage where necessary.

There is no known antidote for VIJOICE.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Alpelisib is an inhibitor of phosphatidylinositol-3-kinase (PI3K) with inhibitory activity predominantly against PI3Kα. Gain-of-function mutations in the gene encoding the catalytic α-subunit of PI3K (PIK3CA) lead to activation of PI3Kα and Akt-signaling, cellular transformation and the generation of tumors in in vitro and in vivo models. Activating mutations in PIK3CA have been found to induce a spectrum of overgrowths and malformations comprising a wide group of clinically recognizable disorders commonly known as PROS.

In an inducible mouse model of Congenital Lipomatous Overgrowth, Vascular Malformations, Epidermal Nevi, Scoliosis/Skeletal and Spinal syndrome (CLOVES), a phenotype of PROS, alpelisib inhibition of the PI3K pathway resulted in the prevention or improvement of organ abnormalities associated with the disease, depending on when alpelisib treatment was started. These findings were reversed after withdrawal of alpelisib.

12.2Pharmacodynamics The exposure-response relationship and time course of pharmacodynamic response for the safety and effectiveness of VIJOICE have not been characterized. Cardiac Electrophysiology At a dose of 300 mg, alpelisib does not prolong the QT interval to any clinically relevant extent in the oncology setting. VIJOICE is not approved for use in the oncology setting.

12.3Pharmacokinetics The pharmacokinetics of alpelisib has been studied in healthy subjects and adult patients with solid tumors and are presented as mean (% CV) under fed conditions unless otherwise specified. Alpelisib maximum plasma concentration (C max ) was 277 ng/mL (24%) and area under the curve (AUC) was 2,090 hr*ng/mL (24%) following administration of a single 50 mg dose of VIJOICE. Steady state alpelisib C max and AUC increased proportionally over the dose range of 30 mg (0.6 times the lowest approved recommended dosage) to 450 mg (1.8 times the highest approved recommended dosage) under fed conditions.

The mean accumulation of alpelisib was 1.3 to 1.5 and steady state plasma concentrations were reached within 3 days following daily dosage. Absorption The median time to reach peak plasma concentration (T max ) ranged between 2.0 to 4.0 hours. Effect of Food A high-fat high-calorie (HFHC) meal (985 calories with 58.1 g of fat) increased alpelisib AUC by 73% and C max by 84%, and a low-fat low-calorie (LFLC) meal (334 calories with 8.7 g of fat) increased alpelisib AUC by 77% and C max by 145% following administration of a single 300 mg dose of alpelisib as tablets.

No clinically relevant differences in alpelisib AUC were observed between LFLC and HFHC meals. No clinically relevant food effect on alpelisib pharmacokinetics was observed after a single 50 mg oral dose of VIJOICE as granules taken with a LFLC meal as compared to that taken under fasted conditions. No clinically relevant differences in alpelisib C max and AUC were observed following administration of a single 50 mg dose of VIJOICE as granules or tablets taken with a LFLC meal.

Distribution The apparent volume of distribution of alpelisib at steady state is 114 L (46%). Protein binding of alpelisib is 89% and is independent of concentration. Elimination The half-life of alpelisib is predicted to be 8 to 9 hours.

The clearance of alpelisib is

9.2L/hr (21%) under fed conditions. Metabolism Alpelisib is primarily metabolized by chemical and enzymatic hydrolysis to form its metabolite BZG791 and followed by CYP3A4 mediated hydroxylation. Excretion Following a single oral dose of 400 mg (1.6 times the highest approved recommended dosage) radiolabeled alpelisib under fasted condition, 81% of the administered dose was recovered in feces (36% unchanged) and 14% (2% unchanged) in urine.

CYP3A4-mediated metabolites (12%) and glucuronides amounted to approximately 15% of the dose. Specific Populations No clinically significant differences in the pharmacokinetics of alpelisib were predicted based on age (21 to 87 ye… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 133 words ▾

12.1Mechanism of Action Alpelisib is an inhibitor of phosphatidylinositol-3-kinase (PI3K) with inhibitory activity predominantly against PI3Kα. Gain-of-function mutations in the gene encoding the catalytic α-subunit of PI3K (PIK3CA) lead to activation of PI3Kα and Akt-signaling, cellular transformation and the generation of tumors in in vitro and in vivo models. Activating mutations in PIK3CA have been found to induce a spectrum of overgrowths and malformations comprising a wide group of clinically recognizable disorders commonly known as PROS.

In an inducible mouse model of Congenital Lipomatous Overgrowth, Vascular Malformations, Epidermal Nevi, Scoliosis/Skeletal and Spinal syndrome (CLOVES), a phenotype of PROS, alpelisib inhibition of the PI3K pathway resulted in the prevention or improvement of organ abnormalities associated with the disease, depending on when alpelisib treatment was started. These findings were reversed after withdrawal of alpelisib.

📦 How Supplied / Storage and Handling ~1 min read ▾

16 HOW SUPPLIED/STORAGE AND HANDLING VIJOICE (alpelisib) 50 mg, 125 mg, and 200 mg film-coated tablets are available in blister packs based on daily dose as described in Table 13. Table 13: VIJOICE Tablets Daily Dose Blister Packs Daily dose Each carton contains Each child-resistant blister pack contains Appearance of tablet NDC 50 mg daily dose One 28-day supply blister pack 28 tablets: 50 mg alpelisib per tablet Light yellow, unscored, round and curved with beveled edges, debossed with “C7” on one side and “NVR” on the other side NDC 0078-1021-84 125 mg daily dose One 28-day supply blister pack 28 tablets: 125 mg alpelisib per tablet Dark yellow, unscored, ovaloid and curved with beveled edges, debossed with “Y7” on one side and “NVR” on the other side NDC 0078-1028-84 250 mg daily dose Two 14-day supply blister packs (56 tablets total) 14 tablets: 200 mg alpelisib per tablet, and 14 tablets: 50 mg alpelisib per tablet Pale yellow, unscored, ovaloid and curved with beveled edges, debossed with “CL7” on one side and “NVR” on the other side Light yellow, unscored, round and curved with beveled edges, debossed with “C7” on one side and “NVR” on the other side NDC 0078-1035-02 Table 14: VIJOICE Oral Granules Daily dose Each carton contains Each child-resistant packet contains Appearance NDC 50 mg daily dose 28 packets (28-day supply of single-use packets) 50 mg alpelisib White to almost white free flowing mixture of powder and granules NDC 0078-1175-51 Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature].

📋 Description 174 words ▾

11 DESCRIPTION VIJOICE (alpelisib) is a kinase inhibitor. The chemical name of alpelisib is (2 S )- N 1 -[4-Methyl-5-[2-(2,2,2-trifluoro-1,1-dimethylethyl)-4-pyridinyl]-2-thiazolyl]-1,2-pyrrolidinedicarboxamide. Alpelisib is a white to almost white powder.

The molecular formula for alpelisib is C 19 H 22 F 3 N 5 O 2 S and the relative molecular mass is 441.47 g/mol. The pH of a 1.0% (m/V) solution of alpelisib in water/ethanol (50:50 V/V) is approximately 6.2. The chemical structure of alpelisib is shown below: VIJOICE film-coated tablets are supplied for oral administration with three strengths that contain 50 mg, 125 mg, and 200 mg of alpelisib.

The tablets also contain hypromellose, magnesium stearate, mannitol, microcrystalline cellulose, and sodium starch glycolate. The film-coating contains hypromellose, iron oxide red (applicable only to 50 mg and 200 mg strengths), iron oxide yellow, macrogol/polyethylene glycol (PEG) 4000, talc, and titanium dioxide. VIJOICE oral granules are supplied for oral administration with one strength that contains 50 mg of alpelisib.

The granules also contain hypromellose, magnesium stearate, mannitol, microcrystalline cellulose, and sodium starch glycolate. alpelisib structural formula

💬 Information for Patients ~3 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient and their caregivers to read the FDA-approved patient labeling (Patient Information). Severe Hypersensitivity Inform patients and their caregivers of the signs and symptoms of hypersensitivity. Advise patients and their caregivers to contact their healthcare provider immediately for signs and symptoms of hypersensitivity [see Warnings and Precautions (5.1)] .

Severe Cutaneous Adverse Reactions Inform patients and their caregivers of the signs and symptoms of severe cutaneous adverse reactions (SCARs). Advise patients and their caregivers to contact their healthcare provider immediately for signs and symptoms of SCARs (e.g., a prodrome of fever, flu-like symptoms, mucosal lesions, progressive skin rash, or lymphadenopathy) [see Warnings and Precautions (5.2)] . Hyperglycemia Advise patients and their caregivers that VIJOICE may cause hyperglycemia and the need to monitor fasting glucose periodically during therapy.

Advise patients and their caregivers of the signs and symptoms of hyperglycemia (e.g., excessive thirst, urinating more often than usual or higher amount of urine than usual, or increased appetite with weight loss) [see Warnings and Precautions (5.3)] . Pneumonitis Inform patients and their caregivers that VIJOICE may cause pneumonitis and to immediately report new or worsening respiratory symptoms [see Warnings and Precautions (5.4)] . Diarrhea or Colitis Advise patients and their caregivers that VIJOICE may cause diarrhea, which may be severe, and to start anti-diarrheal treatment, increase oral fluids, and notify their healthcare provider if diarrhea occurs while taking VIJOICE [see Warnings and Precautions (5.5)] .

Advise patients and their caregivers that VIJOICE may cause colitis and to notify their healthcare provider immediately of any symptoms of colitis, such as abdominal pain and mucus or blood in stool, while taking VIJOICE [see Warnings and Precautions (5.5)] . Alopecia Advise patients and caregivers that VIJOICE may cause alopecia [see Adverse Reactions (6.1)] . Advise patients and caregivers to contact a dermatologist if alopecia becomes a concern [see Dosage and Administration (2.5)] .

Embryo-Fetal Toxicity Inform pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females to inform their healthcare provider of a known or suspected pregnancy [see Warnings and Precautions (5.6) and Use in Specific Populations (8.1)] . Advise females of reproductive potential to use effective contraception during treatment with VIJOICE and for 1 week after the last dose [see Use in Specific Populations (8.3)] .

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 [see Use in Specific Populations (8.3)]. Lactation Advise women not to breastfeed during treatment with VIJOICE and for 1 week after the last dose [see Use in Specific Populations (8.2)] . Infertility Advise males and females of reproductive potential that VIJOICE may impair fertility [see Use in Specific Populations (8.3)] .

Drug Interactions Advise patients and their caregivers to inform their healthcare providers of all concomitant medications, herbal and dietary supplements [see Drug Interactions (7.1)] . Dosing Instruct patients and their caregivers of the following: Take VIJOICE with food at approximately the same time each day [see Dosage and Administration (2.3)] . Swallow the tablets whole (tablets should not be crushed, chewed, or split prior to swallowing) [see Dosage and Administration (2.4)] .

For patients unable to swallow tablets, advise how to prepare an oral suspension using the tablets or how to take the oral granules (if applicable) [see Dosage and Administration (2.4)] . 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 da… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacokinetics ~3 min read ▾

12.3Pharmacokinetics The pharmacokinetics of alpelisib has been studied in healthy subjects and adult patients with solid tumors and are presented as mean (% CV) under fed conditions unless otherwise specified. Alpelisib maximum plasma concentration (C max ) was 277 ng/mL (24%) and area under the curve (AUC) was 2,090 hr*ng/mL (24%) following administration of a single 50 mg dose of VIJOICE. Steady state alpelisib C max and AUC increased proportionally over the dose range of 30 mg (0.6 times the lowest approved recommended dosage) to 450 mg (1.8 times the highest approved recommended dosage) under fed conditions.

The mean accumulation of alpelisib was 1.3 to 1.5 and steady state plasma concentrations were reached within 3 days following daily dosage. Absorption The median time to reach peak plasma concentration (T max ) ranged between 2.0 to 4.0 hours. Effect of Food A high-fat high-calorie (HFHC) meal (985 calories with 58.1 g of fat) increased alpelisib AUC by 73% and C max by 84%, and a low-fat low-calorie (LFLC) meal (334 calories with 8.7 g of fat) increased alpelisib AUC by 77% and C max by 145% following administration of a single 300 mg dose of alpelisib as tablets.

No clinically relevant differences in alpelisib AUC were observed between LFLC and HFHC meals. No clinically relevant food effect on alpelisib pharmacokinetics was observed after a single 50 mg oral dose of VIJOICE as granules taken with a LFLC meal as compared to that taken under fasted conditions. No clinically relevant differences in alpelisib C max and AUC were observed following administration of a single 50 mg dose of VIJOICE as granules or tablets taken with a LFLC meal.

Distribution The apparent volume of distribution of alpelisib at steady state is 114 L (46%). Protein binding of alpelisib is 89% and is independent of concentration. Elimination The half-life of alpelisib is predicted to be 8 to 9 hours.

The clearance of alpelisib is

9.2L/hr (21%) under fed conditions. Metabolism Alpelisib is primarily metabolized by chemical and enzymatic hydrolysis to form its metabolite BZG791 and followed by CYP3A4 mediated hydroxylation. Excretion Following a single oral dose of 400 mg (1.6 times the highest approved recommended dosage) radiolabeled alpelisib under fasted condition, 81% of the administered dose was recovered in feces (36% unchanged) and 14% (2% unchanged) in urine.

CYP3A4-mediated metabolites (12%) and glucuronides amounted to approximately 15% of the dose. Specific Populations No clinically significant differences in the pharmacokinetics of alpelisib were predicted based on age (21 to 87 years), sex, race/ethnicity (Japanese or Caucasian), body weight (37 to 181 kg), mild to moderate renal impairment (CLcr 30 to < 90 mL/min based on the Cockcroft-Gault formula), or mild to severe hepatic impairment (Child-Pugh Class A, B, and C). The effect of severe renal impairment (CLcr < 30 mL/min) on the pharmacokinetics of alpelisib is unknown.

Drug Interaction Studies Clinical Studies and Model-Informed Approaches Acid Reducing Agents: No clinically significant differences in the pharmacokinetics of alpelisib were observed when used concomitantly with ranitidine (H2 receptor antagonist) and administered with food as directed. Concomitant use of ranitidine decreased alpelisib AUC approximately 30% and C max by 51% with a single 300 mg oral dose (1.2 times the highest approved recommended dosage) of alpelisib under the fasted state. In the presence of a low-fat low-calorie meal, AUC was decreased by 21% and C max by 36% with ranitidine.

CYP3A4, CYP2C8, CYP2C9, CYP2C19 and CYP2B6 Substrates : Coadministration of repeated doses of alpelisib 300 mg with a single-dose of sensitive substrates of CYP3A4 (midazolam), CYP2C8 (repaglinide), CYP2C9 (warfarin), CYP2C19 (omeprazole) and CYP2B6 (bupropion), administered as a cocktail did not show clinically significant pharmacokinetic interactions. No clinically significant differences in pharmacokinetics of everoli… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacodynamics 56 words ▾

12.2Pharmacodynamics The exposure-response relationship and time course of pharmacodynamic response for the safety and effectiveness of VIJOICE have not been characterized. Cardiac Electrophysiology At a dose of 300 mg, alpelisib does not prolong the QT interval to any clinically relevant extent in the oncology setting. VIJOICE is not approved for use in the oncology setting.

🔬 Clinical Studies ~2 min read ▾

14 CLINICAL STUDIES The efficacy of VIJOICE was assessed in EPIK-P1 (NCT04285723), a single-arm clinical study in patients who were treated as part of an expanded access program for compassionate use which enrolled patients across seven sites in five countries (France, Spain, US, Ireland, and Australia). Eligible patients 2 years of age and older with PIK3CA-Related Overgrowth Spectrum (PROS) who received VIJOICE had clinical manifestations of PROS that were assessed by the treating physician as severe or life-threatening and necessitating systemic treatment and had documented evidence of mutation in the PIK3CA gene.

Patients received VIJOICE at dosages based on age ranging from 50 mg to 250 mg orally once daily. The efficacy of VIJOICE was evaluated in a total of 37 patients with at least one target lesion identified on imaging performed within 24 weeks prior to receipt of the first dose of VIJOICE. The median age of patients was 14 years (range: 2 to 38); 22% of patients were 2 to 5 years, 22% were 6 to 11 years, 27% were 12 to less than 18 years of age, and 30% were ≥ 18 years; 57% were female, 11% were White and race was not reported for 89%.

Ninety-two percent of patients had congenital overgrowth and 8% had early childhood-onset. Patients had heterogeneous manifestations of PROS, including CLOVES (81%), Megalencephaly-Capillary Malformation Polymicrogyria (MCAP; 8%), Klippel-Trenaunay Syndrome (KTS; 2.7%), Facial Infiltrating Lipomatosis (FIL; 8%), and Other (5%). Five percent (5%) of patients had concurrent manifestations of CLOVES and MCAP.

The major efficacy outcome measure for the study was the proportion of patients with radiological response at Week 24 as determined by blinded independent central review (BICR), defined as a ≥ 20% reduction from baseline in the sum of measurable target lesion volume (1 to 3 lesions) confirmed by at least one subsequent imaging assessment, in the absence of a ≥ 20% increase from baseline in any target lesion, progression of non-target lesions, or appearance of a new lesion. An additional efficacy outcome measure was duration of response, defined as the time from the first documented response to the date of the first documented disease progression or death due to any cause.

Efficacy results are presented in Table 12. Table 12: Efficacy Results at Week 24 in EPIK-P1 Abbreviation: +, censored observation. a Confirmed response as determined by blinded independent central review (BICR). b Patients without any response assessment at Week 24 were considered non-responders. Efficacy parameters All patients N = 37 Response rate a,b Responders, n (%) 95% CI 10 (27) (14, 44) Duration of response (DOR) Median in months (range) NR (0.9+, 42.9+) % ≥ 6 months 70 % ≥ 12 months 60

🧪 Nonclinical Toxicology ~2 min read ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Alpelisib was not carcinogenic in a 2-year carcinogenicity study conducted in rats when administered by daily oral gavage at doses up to 4 mg/kg (approximately 0.5 to 0.2 times the initial recommended doses of 50 mg and 250 mg in pediatric and adult patients, respectively, based on BSA). Alpelisib was not mutagenic in an in vitro bacterial reverse mutation (Ames) assay, or aneugenic or clastogenic in human cell micronucleus and chromosome aberration tests. Alpelisib was not genotoxic in an in vivo rat micronucleus test.

In a fertility and early embryonic development study in rats, female animals were administered alpelisib doses of 3, 10, and 20 mg/kg/day orally. Animals were dosed for 4-weeks prior to pairing, during the mating period, and up to Gestation Day 6. At the dose of 20 mg/kg/day, alpelisib increased pre- and post-implantation losses, leading to reduced numbers of implantation sites and live embryos.

These findings were observed at doses approximately 2.4 to 0.8 times the initial recommended doses of 50 mg and 250 mg in pediatric and adult patients, respectively, based on body surface areas (BSA). In a repeated-dose toxicity study in rats, adverse effects in female reproductive organs included vaginal atrophy and estrous cycle variations in rats at doses ≥ 6 mg/kg/day (approximately 0.7 to 0.2 times the initial recommended doses of 50 mg and 250 mg in pediatric and adult patients, respectively, based on BSA). In a male fertility study, alpelisib administered orally at doses of 3, 10 and 20 mg/kg/day for up to 99 days (10-weeks prior to pairing, during mating period and continuing during post-pairing) to male rats, resulted in reduced weights of seminal vesicles and prostate, which correlated with atrophy and/or reduced secretion in prostate and seminal vesicles at ≥ 10 mg/kg/day (approximately 1.2 to 0.4 times the initial recommended doses of 50 mg and 250 mg in pediatric and adult patients, respectively, based on BSA).

No adverse effects on male fertility parameters were observed at doses up to 20 mg/kg/day.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ~2 min read ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Alpelisib was not carcinogenic in a 2-year carcinogenicity study conducted in rats when administered by daily oral gavage at doses up to 4 mg/kg (approximately 0.5 to 0.2 times the initial recommended doses of 50 mg and 250 mg in pediatric and adult patients, respectively, based on BSA). Alpelisib was not mutagenic in an in vitro bacterial reverse mutation (Ames) assay, or aneugenic or clastogenic in human cell micronucleus and chromosome aberration tests. Alpelisib was not genotoxic in an in vivo rat micronucleus test.

In a fertility and early embryonic development study in rats, female animals were administered alpelisib doses of 3, 10, and 20 mg/kg/day orally. Animals were dosed for 4-weeks prior to pairing, during the mating period, and up to Gestation Day 6. At the dose of 20 mg/kg/day, alpelisib increased pre- and post-implantation losses, leading to reduced numbers of implantation sites and live embryos.

These findings were observed at doses approximately 2.4 to 0.8 times the initial recommended doses of 50 mg and 250 mg in pediatric and adult patients, respectively, based on body surface areas (BSA). In a repeated-dose toxicity study in rats, adverse effects in female reproductive organs included vaginal atrophy and estrous cycle variations in rats at doses ≥ 6 mg/kg/day (approximately 0.7 to 0.2 times the initial recommended doses of 50 mg and 250 mg in pediatric and adult patients, respectively, based on BSA). In a male fertility study, alpelisib administered orally at doses of 3, 10 and 20 mg/kg/day for up to 99 days (10-weeks prior to pairing, during mating period and continuing during post-pairing) to male rats, resulted in reduced weights of seminal vesicles and prostate, which correlated with atrophy and/or reduced secretion in prostate and seminal vesicles at ≥ 10 mg/kg/day (approximately 1.2 to 0.4 times the initial recommended doses of 50 mg and 250 mg in pediatric and adult patients, respectively, based on BSA).

No adverse effects on male fertility parameters were observed at doses up to 20 mg/kg/day.

📄 Patient Package Insert ~3 min read ▾

This Patient Information has been approved by the U.S. Food and Drug Administration. Revised: 7/2025 PATIENT INFORMATION VIJOICE ® (vi’ joiz) (alpelisib) tablets VIJOICE ® (vi’ joiz) (alpelisib) oral granules What is VIJOICE?

VIJOICE is a prescription medicine used to treat adults and children 2 years of age and older with severe phosphatidylinositol-3-kinase catalytic subunit alpha (PIK3CA)-Related Overgrowth Spectrum (PROS). It is not known if VIJOICE is safe and effective in children below 2 years of age. Do not take VIJOICE if you have had a severe allergic reaction to alpelisib or are allergic to any of the ingredients in VIJOICE.

See the end of this Patient Information leaflet for a complete list of the ingredients in VIJOICE. See “What are the possible side effects of VIJOICE?” for signs and symptoms of severe allergic reactions. Before you take VIJOICE, tell your healthcare provider about all of your medical conditions, including if you: have a history of diabetes. have a history of skin rash, redness of skin, blistering of the lips, eyes or mouth, or skin peeling. are pregnant or plan to become pregnant.

VIJOICE can harm your unborn baby. Females who are able to become pregnant: Your healthcare provider will check to see if you are pregnant before you start treatment with VIJOICE. You should use effective birth control (contraception) during treatment with VIJOICE and for 1 week after the last dose.

Talk to your healthcare provider about birth control methods that may be right for you during this time. If you become pregnant or think you are pregnant, tell your healthcare provider right away. Males with female partners who are able to become pregnant should use condoms and effective birth control during treatment with VIJOICE and for 1 week after the last dose.

If your female partner becomes pregnant, tell your healthcare provider right away. are breastfeeding or plan to breastfeed. It is not known if VIJOICE passes into your breast milk. Do not breastfeed during treatment with VIJOICE and for 1 week after the last dose.

Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. VIJOICE and other medicines may affect each other causing side effects. Know the medicines you take.

Keep a list of them to show your healthcare provider or pharmacist when you get a new medicine. How should I take VIJOICE? Read the detailed “Instructions for Use” that comes with VIJOICE for information about the right way to prepare and take or give a dose of VIJOICE tablets or oral granules.

Take VIJOICE exactly as your healthcare provider tells you. Do not change your dose or stop taking VIJOICE unless your healthcare provider tells you. Take VIJOICE 1 time each day, at about the same time each day.

Take VIJOICE with food. VIJOICE comes as tablets and oral granules. Your healthcare provider will prescribe the dosage form that is right for you: If your prescribed daily dose is 50 mg, your healthcare provider may prescribe VIJOICE tablets or VIJOICE oral granules.

If your prescribed daily dose is 125 mg or 250 mg, you can only take VIJOICE tablets. Do not use multiple packets of 50 mg oral granules or part of a packet to prepare a dose. Do not combine VIJOICE tablets with VIJOICE oral granules to prepare your prescribed dose.

If you miss a dose of VIJOICE, you may take it with food up to 9 hours after the time you usually take it. If it has been more than 9 hours after you usually take your dose, skip the dose for that day. The next day, take the dose at your usual time.

Do not take 2 doses to make up for a missed dose. If you vomit after taking a dose of VIJOICE, do not take another dose on that day. Take your next dose at your usual time.

If you take too much VIJOICE, call your healthcare provider or go to the nearest hospital emergency room right away. VIJOICE tablets: VIJOICE tablets can be swallowed whole, or prepared as a suspension to take… [Excerpted — this section continues on DailyMed.]

📖 Instructions for Use ~3 min read ▾

This Instructions for Use has been approved by the U.S. Food and Drug Administration. Issued: 7/2025 INSTRUCTIONS FOR USE VIJOICE ® [vi’ joiz] (alpelisib) tablets This Instructions for Use contains information on how to prepare and take or give a dose of VIJOICE tablets.

Read this Instructions for Use carefully before taking or giving VIJOICE tablets. Talk to your healthcare provider or pharmacist if you have any questions. You can also call Novartis Pharmaceuticals Corporation at 1-888-845-6423 for more information.

Important Information You Need to Know Before Taking or Giving VIJOICE Take or give VIJOICE exactly as your healthcare provider tells you. Do not change your dose or stop taking VIJOICE unless your healthcare provider tells you. Take VIJOICE 1 time each day, at about the same time each day.

Take VIJOICE with food. Do not combine VIJOICE tablets with VIJOICE oral granules to prepare your prescribed dose. If you miss a dose of VIJOICE, you may take it with food up to 9 hours after the time you usually take it.

If it has been more than 9 hours after you usually take your dose, skip the dose for that day. The next day, take the dose at your usual time. Do not take 2 doses to make up for a missed dose.

If you vomit after taking a dose of VIJOICE, do not take another dose on that day. Take your next dose at your usual time. If you take too much VIJOICE, call your healthcare provider or go to the nearest hospital emergency room right away.

Storing VIJOICE tablets Store VIJOICE tablets at room temperature between 68°F to 77°F (20°C to 25°C). Keep VIJOICE and all medicines out of the reach of children. Preparing and taking or giving VIJOICE tablets You can take or give VIJOICE tablets whole by mouth, or mixed with water (suspension) by mouth or through a feeding tube as described in the sections below: Taking or giving VIJOICE tablets whole by mouth Swallow VIJOICE tablets whole and take with food.

Do not chew, divide, or crush the tablets. Do not take VIJOICE tablets that are broken, cracked, or that look damaged. Taking or giving VIJOICE tablets mixed with water (suspension) by mouth If you cannot swallow tablets whole, VIJOICE tablets can be prepared as a suspension and taken or given by mouth.

Gather the following supplies (see Figure A): the number of VIJOICE tablet(s) needed for your prescribed dose water a clean empty cup a spoon Step 1. Wash and dry your hands. Step 2.

Place VIJOICE tablets into a cup that contains 2 to 4 ounces of water. Use water only. Step 3.

Let the tablets stand in water for about 5 minutes . Step 4. Crush the tablets with a spoon and stir to disperse the tablets in water (suspension).

The suspension will be cloudy and you may see tablet particles (see Figure B ). Step 5. Drink all of the suspension right away.

If you cannot take or give it right away, take or give the suspension within 60 minutes of preparing the dose. Stir the suspension again with the same spoon before drinking it. Step 6.

Add about 1 to 2 ounces of water to the same cup and stir with the same spoon. Then drink all of the suspension to make sure the entire dose is taken. Step 7.

Repeat Step 6 until there are no tablet particles remaining in the cup. Step 8. Wash your hands and all supplies used to take or give VIJOICE tablets.

Throw away any VIJOICE suspension that is not taken within 60 minutes after it is prepared. Figure A Figure B Giving VIJOICE tablets mixed with water (suspension) through a feeding tube VIJOICE tablets may be given through a feeding tube, according to the manufacturer’s instructions and as directed by your healthcare provider. Only use silicone or polyurethane nasogastric tubes with a French size 5 to 12, or silicone gastric tubes with a French size 12 to 24.

Gather the following supplies (see Figure C): the number of VIJOICE tablet(s) needed for your prescribed dose water a clean empty cup a spoon an enteral syringe Figure C Step 1. Wash and dry your hands. Step 2.

Place VIJOICE tablets into a cup th… [Excerpted — this section continues on DailyMed.]

📄 Recent Major Changes 21 words ▾

Dosage and Administration, VIJOICE Preparation and Administration Instructions ( 2.4 ) 7/2025 Warnings and Precautions, Severe Hypersensitivity ( 5.1 ) 7/2025

📄 Package Label / Principal Display Panel ~3 min read ▾

PRINCIPAL DISPLAY PANEL Vijoice ® (alpelisib) tablets NDC 0078-1021-84 50 mg daily dose Take one 50 mg tablet once daily Rx only Recommended Dosage: Take one 50 mg tablet once daily with food. Swallow tablets whole. DO NOT chew, crush, or split tablets.

Directions: See enclosed Instructions for Use for administration instructions, including options for patients who are unable to swallow whole tablets. 28-Day Supply Contains: One blister pack containing 28 tablets NOVARTIS PRINCIPAL DISPLAY PANEL Vijoice® (alpelisib) tablets NDC 0078-1021-84 50 mg daily dose Take one 50 mg tablet once daily Rx only Recommended Dosage: Take one 50 mg tablet once daily with food. Swallow tablets whole.

DO NOT chew, crush, or split tablets. Directions: See enclosed Instructions for Use for administration instructions, including options for patients who are unable to swallow whole tablets. 28-Day Supply Contains: One blister pack containing 28 tablets NOVARTIS

PRINCIPAL DISPLAY PANEL Vijoice ® (alpelisib) tablets NDC 0078-1028-84 125 mg daily dose Take one 125 mg tablet once daily Rx only Recommended Dosage: Take one 125 mg tablet once daily with food. Swallow tablets whole. DO NOT chew, crush, or split tablets.

Directions: See enclosed Instructions for Use for administration instructions, including options for patients who are unable to swallow whole tablets. 28-Day Supply Contains: One blister pack containing 28 tablets NOVARTIS PRINCIPAL DISPLAY PANEL Vijoice® (alpelisib) tablets NDC 0078-1028-84 125 mg daily dose Take one 125 mg tablet once daily Rx only Recommended Dosage: Take one 125 mg tablet once daily with food. Swallow tablets whole.

DO NOT chew, crush, or split tablets. Directions: See enclosed Instructions for Use for administration instructions, including options for patients who are unable to swallow whole tablets. 28-Day Supply Contains: One blister pack containing 28 tablets NOVARTIS

PRINCIPAL DISPLAY PANEL Vijoice ® (alpelisib) tablets NDC 0078-1035-02 250 mg daily dose Take one 200 mg tablet and one 50 mg tablet once daily Rx only Recommended Dosage: Take one 200 mg tablet and one 50 mg tablet once daily with food. Swallow tablets whole. DO NOT chew, crush, or split tablets.

Directions: See enclosed Instructions for Use for administration instructions, including options for patients who are unable to swallow whole tablets. 28-Day Supply (56 Tablets) Contains: Two 14-day blister packs each containing 28 tablets: 200 mg 14 tablets per pack 50 mg 14 tablets per pack NOVARTIS PRINCIPAL DISPLAY PANEL Vijoice® (alpelisib) tablets NDC 0078-1035-02 250 mg daily dose Take one 200 mg tablet and one 50 mg tablet once daily Rx only Recommended Dosage: Take one 200 mg tablet and one 50 mg tablet once daily with food.

Swallow tablets whole. DO NOT chew, crush, or split tablets. Directions: See enclosed Instructions for Use for administration instructions, including options for patients who are unable to swallow whole tablets.

28-Day Supply (56 Tablets): Contains: Two 14-day blister packs each containing 28 tablets: 200 mg 14 tablets per pack 50 mg 14 tablets per pack NOVARTIS

PRINCIPAL DISPLAY PANEL Rx only NDC 0078-1175-51 Vijoice ® (alpelisib) oral granules 50 mg daily dose Take one 50 mg packet once daily Directions: See enclosed Instructions For Use for administration instructions. 28 Packets NOVARTIS PRINCIPAL DISPLAY PANEL Rx only NDC 0078-1175-51 Vijoice® (alpelisib) oral granules 50 mg daily dose Take one 50 mg packet once daily Directions: See enclosed Instructions For Use for administration instructions. 28 Packets NOVARTIS

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
146
Units reimbursed last 4 qtrs
4.7K
Gross reimbursed last 4 qtrs
$5.45M
Avg / prescription
$37,305.93
Avg / unit
$1,152.25
Latest quarter Q1 2026
45Rx
Fee-for-service vs managed care ⓘ
69% FFS 31% MCO
Fee-for-service · 101 Rx Managed care · 45 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: 1,731 units · 8.8 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: 1,400 units · 3.6 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: 1,120 units · 10.3 per 100k residents NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: 476 units · 2.1 per 100k residents FL
Units reimbursed · per 100k residents
2.110.3
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 North Carolina 10.3 /100k
2 New York 8.8 /100k
3 California 3.6 /100k
4 Florida 2.1 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Vijoice — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Vijoice. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$3.34M
Claims incl. refills
82
Beneficiaries
35
Spend / beneficiary
$95,295.23
Spend / claim
$40,674.79
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for VIJOICE (this brand).

Top reported reactions

Hyperglycaemia347
Malignant Neoplasm Progression243
Rash206
Diarrhoea202
Fatigue124
Nausea121
Death116

Age at onset

Child5
Adolescent2
Adult163
Elderly61

Reporter sex

1,809 reports
Male · 14%
Female · 86%

Serious outcomes

Hospitalization488
Reports over time (by year) — tap or hover for the count & year
2021 2022 2024 2026 402 112
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) ✓ Available
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Novartis Pharmaceuticals Corporation. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Novartis Pharmaceuticals Corporation is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 00078-1168-61 · Novartis 00078-1189-20 · Novartis →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.