Alpelisib: uses, dosing, side effects & brands
Alpelisib is a medicine sold in the U.S. under 2 brand and generic names, for breast neoplasms and male breast neoplasms. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Treats (across its forms)
- Breast Neoplasms and Male Breast Neoplasms
- Available as
- Tablet · Kit · Powder
- Sold as
- 2 products — Piqray and Vijoice
- Prescription?
- Prescription only
- Generic available?
- Not in our catalog
How Piqray is dosed
From the FDA label for Piqray (application NDA212526). Other alpelisib products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Recommended Dose: 300 mg (two 150 mg tablets) taken orally once daily with food. ( 2.2 ) For adverse reactions, consider dose interruption, dose reduction, or discontinuation. ( 2.3 ) 2.1 Patient Selection Select patients for the treatment of HR-positive, HER2-negative advanced or metastatic breast cancer with PIQRAY, based on the presence of one or more PIK3CA mutations in tumor tissue or plasma specimens [see Clinical Studies (14)] . If no mutation is detected in a plasma specimen, test tumor tissue. Information on FDA-approved tests for the detection of PIK3CA mutations in breast cancer is available at: http://www.fda.gov/CompanionDiagnostics. 2.2 Dosage and Administration The recommended dose of PIQRAY is 300 mg (two 150 mg film-coated tablets) taken orally, once daily, with food [see Clinical Pharmacology (12.3)] . Continue treatment until disease progression or unacceptable toxicity occurs [see Dosage and Administration (2.3)] . Patients should take their dose of PIQRAY at approximately the same time each day. Swallow PIQRAY tablets whole (tablets should not be chewed, crushed or split prior to swallowing). No tablet should be ingested if it is broken, cracked, or otherwise not intact. If a dose of PIQRAY 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 PIQRAY…
Everything below is the FDA label for Piqray (tablet, kit). Alpelisib is also sold as powder, and those are different medicines to take — follow the label for the one you were prescribed.
Piqray side effects
The following adverse reactions are discussed in greater detail in other sections of 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, including laboratory abnormalities (all Grades, incidence ≥ 20%) were glucose increased, creatinine increased, diarrhea, rash, lymphocyte count decreased, gamma-glutamyl transferase (GGT) increased, nausea, alanine aminotransferase (ALT) increased, fatigue, hemoglobin decreased, lipase increased, decreased appetite, stomatitis, vomiting, weight decreased, calcium decreased, glucose decreased, activated partial thromboplastin time (aPTT) prolonged, and alopecia. ( 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 . 6.1 Clinical 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 PIQRAY was evaluated in a randomized,…
Who shouldn’t take Piqray
PIQRAY is contraindicated in patients with severe hypersensitivity to it or any of its components [see Warnings and Precautions (5.1)] . Severe hypersensitivity to PIQRAY or to any of its components. ( 4 )
Piqray drug interactions
CYP3A4 Inducers : Avoid coadministration of PIQRAY 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 PIQRAY. If unable to use alternative drugs, closely monitor for increased adverse reactions. ( 7.1 ) 7.1 Effect of Other Drugs on PIQRAY CYP3A4 Inducer Coadministration of PIQRAY with a strong CYP3A4 inducer decreases alpelisib concentration [see Clinical Pharmacology (12.3)] , which may reduce alpelisib efficacy. Avoid concomitant use of strong CYP3A4 inducers and consider an alternative concomitant drug with no or minimal potential to induce CYP3A4. Breast Cancer Resistance Protein Inhibitors Coadministration of PIQRAY with a breast cancer resistance protein (BCRP) inhibitor may increase alpelisib concentration [see Clinical Pharmacology (12.3)] , which may increase the risk of toxicities. Avoid the use of BCRP inhibitors in patients treated with PIQRAY. If unable to use alternative drugs, when PIQRAY is used in combination with BCRP inhibitors, closely monitor for increased adverse reactions.
Every alpelisib product we track (2)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Pharmacy pays | |
|---|---|---|---|---|---|---|---|
| 1 | 70/100 | Prescription | Tablet | No data | — | View → | |
| 2 | 70/100 | Prescription | Powder | No data | — | View → |
What alpelisib pills look like
Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.
Can you crush or split alpelisib?
At least one alpelisibproduct is labelled to be swallowed whole — crushing an extended-release tablet releases the whole day’s dose at once. Which applies depends on the form you were given.
What each alpelisib label says about crushing, splitting and chewingWhat people report to the FDA about alpelisib
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 1,429 reports naming alpelisib, and the FDA flagged 88% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:
- hyperglycaemia327 reports
- malignant neoplasm progression237 reports
- rash191 reports
- diarrhoea152 reports
- fatigue104 reports
- breast cancer metastatic103 reports
- nausea103 reports
- metastases to bone90 reports
Read these as a signal, not a rate. A report does not mean alpelisib caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label section above.
Source: openFDA drug/event (FAERS), retrieved July 25, 2026.
Related calculators
Frequently asked questions
What is Piqray?
Piqray (Alpelisib) is a medication used to treat Breast Neoplasms, Male Breast Neoplasms.
Can you take alpelisib with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run alpelisib against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What brand names is alpelisib sold under?
We track 2 alpelisib-containing products in the U.S.: Piqray and Vijoice. They are the same active ingredient; they differ in form, manufacturer, price and FDA recall record.
What forms does alpelisib come in?
Across the brands we track, alpelisib is currently marketed as tablet, kit and powder, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic alpelisib?
We do not currently list a generic-labelled alpelisib product. That does not always mean none exists — it means none appears under a generic name in the FDA data we track. Ask your pharmacist.
Cite this page
- APA
- pharmaranks. (2026, July 24). Alpelisib: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/alpelisib
- MLA
- “Alpelisib: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/alpelisib.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Read the full FDA label for alpelisib on DailyMed (NIH) ↗.