Alpelisib
Alpelisib is a kinase inhibitor taken by mouth that treats a certain type of advanced breast cancer (as Piqray) and severe PIK3CA-Related Overgrowth Spectrum, or PROS (as Vijoice).
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 2 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
Alpelisib is a targeted medicine taken by mouth, on the U.S. market since about 2019, that blocks PI3K alpha, a growth signal switched on too much by PIK3CA gene changes; as Piqray it is a specialist add-on to fulvestrant for hormone receptor (HR)-positive, HER2-negative, PIK3CA-mutated advanced breast cancer after hormone therapy, and as Vijoice it treats severe PIK3CA-Related Overgrowth Spectrum (PROS). It is one of the tougher targeted drugs to tolerate, with diarrhea and rash the side effects most people notice. The one thing to look for is high blood sugar, which is very common, so expect regular checks and report unusual thirst or urinating more.
Clinical pearls
- Take it with food at the same time daily; a missed dose is fine with food within 9 hours.
- Swallow Piqray tablets whole and never use a cracked one; Vijoice tablets can be mixed in water if swallowing is hard.
- Tell any prescriber you take alpelisib before steroid tablets or injections, since they push blood sugar higher still.
- Report new cough, breathing trouble, or rash with fever or mouth sores right away; these can signal lung or skin reactions.
Patient information guide A plain-language walkthrough of Alpelisib, written from its FDA label.
What Alpelisib is used for
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Alpelisib is used for two different conditions, depending on the product.
- Piqray (tablets): with fulvestrant for adults with HR-positive, HER2-negative, PIK3CA-mutated advanced or metastatic breast cancer, after progression on or after an endocrine-based regimen. An FDA-approved test must detect the mutation.
- Vijoice (tablets and oral granules): severe PIK3CA-Related Overgrowth Spectrum (PROS) in adults and children 2 years and older who need systemic therapy. This is an accelerated approval based on response rate and duration of response.
How Alpelisib works
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Alpelisib blocks PI3K, a growth-signaling protein, especially its alpha form. Mutations in the PIK3CA gene keep this signal switched on, which can lead to tumors or to the overgrowth seen in PROS.
Blocking the signal reduced tumor growth in breast cancer models. In an animal model of a PROS condition, it prevented or improved organ abnormalities, but those findings reversed after the drug was stopped.
Alpelisib dosage
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Alpelisib is taken by mouth once a day with food, at about the same time each day. Treatment continues until the disease progresses or side effects become unacceptable.
- Piqray: tablets swallowed whole, together with fulvestrant given by injection.
- Vijoice: tablets swallowed whole or mixed in water, or oral granules for those prescribed the lowest dose only.
- Missed dose: take it with food within 9 hours of the usual time. After that, skip it.
- Vomiting after a dose: don't take an extra dose that day.
Dosing details from the FDA-approved label
From the Alpelisib prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.
- Vijoice: Pediatric patients (2 to less than 18 years of age), initial dosage
- 50 mg orally, once daily with food, until disease progression or unacceptable toxicity
- Ages 2 to < 6: initial dose 50 mg, a recommended increased dose has not been established. Tablets or oral granules may be used for 50 mg.
- Vijoice: Pediatric patients ≥ 6 years old (6 to < 18 years), dose increase
- Consider a dose increase to 125 mg once daily for response optimization (clinical/radiological) after 24 weeks of treatment at 50 mg once daily
- When a pediatric patient turns 18 years old, consider a gradual dose increase up to 250 mg. Do not use oral granule packets for a 125 mg dose.
- Vijoice: Adult patients
- 250 mg orally, once daily with food, until disease progression or unacceptable toxicity
- Take with food at approximately the same time each day; a missed dose can be taken with food within 9 hours of the usual time, otherwise skip it.
- Piqray: HR-positive, HER2-negative advanced or metastatic breast cancer with PIK3CA mutation
- 300 mg (two 150 mg film-coated tablets) taken orally, once daily, with food, until disease progression or unacceptable toxicity
- Given with fulvestrant 500 mg on Days 1, 15, and 29, and once monthly thereafter
- First dose reduction 250 mg once daily; second dose reduction 200 mg once daily; if further reduction below 200 mg once daily is required, discontinue. Only one dose reduction is permitted for pancreatitis.
Read the label’s full dosing text
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. 2.1 Recommended 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 2.2 VIJOICE Dosage Form Overview VIJOICE is available in two dosage forms: tablets and oral granules. Prescribe the most appropriate dosage form of VIJOICE according to the dose required and patient needs. VIJOICE Tablets (50 mg, 125 mg, and 200 mg) may be administered as: Whole tablets: For patients who can swallow whole tablets. Tablets prepared as an oral suspension: For patients who have difficulty swallowing whole tablets [see Dosage and Administration (2.4)] .
Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →
Alpelisib side effects
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The most common side effects, mainly seen with Piqray plus fulvestrant, include:
Common side effects
- Diarrhea
- Nausea and vomiting
- Rash
- High blood sugar
- Fatigue
- Decreased appetite
- Mouth sores (stomatitis)
- Hair loss and weight loss
When to get medical help
- Call your doctor right away for signs of a severe allergic reaction, such as trouble breathing, flushing, rash, fever or a fast heartbeat.
- Get help for a worsening skin rash, fever, flu-like symptoms or sores in the mouth or other mucous membranes. These can be severe skin reactions.
- Tell your doctor about excessive thirst, urinating more than usual, or increased appetite with weight loss. These can be signs of high blood sugar.
- Report new or worsening cough or breathing problems right away, since they may signal lung inflammation (pneumonitis).
- Call about diarrhea, especially if it is severe, or if you have belly pain or mucus or blood in your stool. Severe diarrhea can cause dehydration and kidney injury.
- Tell your doctor about jaw pain or problems. Osteonecrosis of the jaw (bone damage) was reported with Piqray.
Call your care team about severe rash, breathing problems, symptoms of high blood sugar, or severe or bloody diarrhea. Lab changes such as higher creatinine and liver enzymes were also common.
Alpelisib warnings and precautions
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- High blood sugar: can be severe, sometimes with ketoacidosis (a dangerous buildup of acids in the blood) or HHNKS (very high blood sugar with severe dehydration). Fatal ketoacidosis has been reported after approval.
- Severe skin reactions: include Stevens-Johnson syndrome and DRESS. They require stopping the medicine if confirmed.
- Pneumonitis: lung inflammation that can be severe.
- Diarrhea and colitis: can cause dehydration and kidney injury.
- Severe allergic reactions: including anaphylaxis and angioedema (swelling).
- Pregnancy: can cause fetal harm.
Alpelisib interactions
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A few drug types change how much alpelisib is in your body or how safe it is.
- Strong CYP3A4 inducers (such as rifampin): lower alpelisib levels, which may make it work less well.
- BCRP inhibitors: may raise alpelisib levels and the risk of side effects.
- Corticosteroids: raise the risk of high blood sugar.
- Metformin: may lessen high blood sugar but can worsen nausea, vomiting and diarrhea.
Interactions listed in the FDA-approved label
From the Alpelisib prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.
- Strong CYP3A4 inducers: Alpelisib is metabolized by CYP3A4, and concomitant use of Vijoice with a strong CYP3A4 inducer may decrease alpelisib concentration, which may decrease alpelisib activity. Avoid coadministration and consider an alternative concomitant drug with no or minimal potential to induce CYP3A4.
- Breast Cancer Resistance Protein (BCRP) inhibitors: Alpelisib is transported by BCRP, and concomitant use of Vijoice with a BCRP inhibitor may increase alpelisib exposure, which may increase the risk of adverse reactions. Avoid use of BCRP inhibitors; if unable to use alternative drugs, closely monitor for increased adverse reactions.
Read the label’s full interactions text
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 ) 7.1 Effect 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.
Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.
Before taking Alpelisib
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- Do not use if you have had a severe allergic reaction to alpelisib or its ingredients.
- Tell your doctor about diabetes or high blood sugar. Piqray's safety in type 1 and uncontrolled type 2 diabetes has not been established.
- Pregnancy: it can harm a baby. Use effective contraception during treatment and for 1 week after.
- Breastfeeding: avoid it during Vijoice treatment and for 1 week after the last dose.
- Children: Vijoice is studied in ages 2 and up. Growth and development should be monitored.
- Older adults: Vijoice was not studied in patients 65 and older with PROS. Piqray users aged 75 or older have a higher risk of high blood sugar.
- Severe kidney impairment: the effect on alpelisib levels is unknown.
Alpelisib overdose
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Overdose experience is limited. In Piqray studies, accidental overdose caused high blood sugar, nausea, weakness and rash. There is no known antidote, so care focuses on treating symptoms and supportive measures.
What Alpelisib does in the body
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At the recommended Piqray dose, alpelisib did not have a large effect on the heart's QTcF interval, with or without fulvestrant. The Vijoice label says the relationship between drug exposure and its effects has not been fully characterized.
How your body processes Alpelisib
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Alpelisib reaches peak blood levels about 2 to 4 hours after a dose. Its half-life is predicted to be 8 to 9 hours, and steady levels are reached within about 3 days of daily dosing. Taking tablets with food raised alpelisib levels in studies, which is why it is taken with food. It is broken down mostly by hydrolysis and the CYP3A4 enzyme. Most of a dose leaves in the stool, with a smaller amount in urine.
How to store Alpelisib
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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) .
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Supplements & herbs that interact with Alpelisib
139 supplements and herbal products have documented interactions with Alpelisib in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 3
- Moderate · 96
- Minor · 40
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
Alpelisib: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Alpelisib — the kind of thing our pharmacy team would talk through with you at the counter.
What is alpelisib used for?
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How should I take it?
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What side effects should I expect?
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When should I call my doctor right away?
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Why do I need blood sugar checks?
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Is it safe in pregnancy or while breastfeeding?
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Is Alpelisib available over the counter?
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When was Alpelisib first available?
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Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Alpelisib on HelloPharmacist
Alpelisib forms and strengths (how it comes)
Alpelisib is available in 2 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Tablet
How this form is used
- Piqray tablets are used with fulvestrant for HR-positive, HER2-negative, PIK3CA-mutated advanced or metastatic breast cancer in adults.
- Vijoice tablets are used for severe PROS in adults and children 2 years and older who need systemic therapy.
- Piqray tablets are taken once daily with food and swallowed whole, not chewed, crushed or split.
- Vijoice tablets are taken with food and swallowed whole, or prepared as a suspension in water for those who can't swallow them.
- Vijoice tablet suspension made with water can be given by mouth or through a nasogastric or gastric feeding tube.
- Do not use broken or cracked Piqray or Vijoice tablets.
Oral powder
How this form is used
- Vijoice is used for severe PIK3CA-Related Overgrowth Spectrum (PROS) in adults and children 2 years and older who need systemic therapy.
- Vijoice oral granules are for patients prescribed the lowest daily dose only (one 50 mg packet).
- Do not use multiple packets or a partial packet of Vijoice granules for higher prescribed doses.
- Do not combine Vijoice tablets and granules to reach a prescribed dose.
- Vijoice is taken with food at about the same time each day.
Alpelisib on the U.S. market: products, makers and brands
How Alpelisib appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
1 company lists 7 Alpelisib product records with the FDA, mostly as tablet, oral powder; the earliest marketing or approval year on record is 2019. Brand names on the directory include Piqray, Vijoice; the rest are generics.
FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
Also listed with the FDA, not a patient dose form: Kit (6) · Powder (2) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
How widely Alpelisib is used (Medicaid data)
A general measure of how commonly Alpelisib is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Alpelisib is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Alpelisib prescribed? Of the 1,601 medications we measure, Alpelisib ranks #1,240 by Medicaid prescriptions — more than 23% of them.
Utilization by Alpelisib product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
Other Alpelisib products — combination packs and listings not yet matched to a specific clinical product (kept visible so every prescription is accounted for)
Summed across the 5 of 28 listed NDC products with Medicaid activity.
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Alpelisib, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 5 of 28 listed Alpelisib NDCs with Medicaid activity.
Compare Alpelisib products
A representative set of FDA-listed product records for Alpelisib — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Oral powder | ||||
| 50 mg | Oral | Novartis Pharmaceuticals Corporation | NDA | View NDC → |
| 💊Tablet | ||||
| 50 mg | Oral | Novartis Pharmaceuticals Corporation | NDA | View NDC → |
| 125 mg | Oral | Novartis Pharmaceuticals Corporation | NDA | View NDC → |
| 150 mg | Oral | Novartis Pharmaceuticals Corporation | NDA | View NDC → |
| 200 mg | Oral | Novartis Pharmaceuticals Corporation | NDA | View NDC → |
| 💊Kits | ||||
| — | — | Novartis Pharmaceuticals Corporation × 2 listings | NDA | View NDC → |
Showing 7 of 7 products — FDA National Drug Code Directory. See every product, package size and price: browse all 7 Alpelisib NDCs →
Alpelisib side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Alpelisib — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Alpelisib in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
Alpelisib FDA approval history
How Alpelisib went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
Alpelisib recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
The FDA’s enforcement reports list no Alpelisib recalls since July 2021.
✅No Alpelisib recalls on record since July 2021Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 2169285 2 dose forms · 5 strengths
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Dose form (SCDF) Oral Granules RxCUI 2680134In current FDA listingsClinical drug / strength (SCD) 50 MGRxCUI 2680135 -
Dose form (SCDF) Oral Tablet RxCUI 2169299In current FDA listings
Look up RxCUI 2169285 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
Alpelisib supply and shortage status
Whether Alpelisib is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
Alpelisib brand names
Alpelisib is sold under 2 brand names in the FDA directory — Piqray, Vijoice. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Alpelisib: manufacturers and labelers
One company lists Alpelisib products with the FDA. By number of product records, the largest are Novartis Pharmaceuticals Corporation. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
Alpelisib drug class (RxNorm)
Alpelisib belongs to the Phosphatidylinositol-3-kinase (Pi3K) inhibitors class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
Sources for this Alpelisib page
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How this page is built
HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Novartis Pharmaceuticals Corporation is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →