Gedatolisib: uses, dosing, side effects & brands
Gedatolisib is a medicine sold in the U.S. under one brand. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Available as
- Powder
- Sold as
- Revtorpyk
- Prescription?
- Prescription only
- Generic available?
- Not in our catalog
How gedatolisib is dosed
From the FDA label for Revtorpyk (application NDA219908). Other gedatolisib products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Recommended dosage : 180 mg intravenously as a 30-minute infusion once weekly on Days 1, 8, and 15 of a 28-day cycle ( 2.2 ) Prophylactically initiate steroid-containing alcohol-free mouthwash to reduce the incidence and severity of stomatitis. ( 2.3 ) See Full Prescribing Information for dosage modifications due to adverse reactions. ( 2.4 ) See Full Prescribing Information for instructions on preparation and administration. ( 2.5 ) 2.1 Patient Selection Select patients for treatment of HR-positive, HER2-negative locally advanced or metastatic breast cancer with REVTORPYK based on the absence of detected PIK3CA mutations in breast cancer [see Clinical Studies (14) ] . An FDA-authorized test for the determination of PIK3CA mutation status in patients with HR-positive, HER2-negative locally advanced or metastatic breast cancer is not available. 2.2 Recommended Dosage and Administration The recommended dosage of REVTORPYK is 180 mg as an intravenous infusion over 30 minutes once weekly on Days 1, 8, and 15 of every 28-day cycle, in combination with fulvestrant, with or without palbociclib, until disease progression or unacceptable toxicity. If a planned dose is delayed or missed, administer as soon as possible thereafter. Do not wait until the next planned dose in the cycle. Adjust the timing of the subsequent dose to maintain the 3 weeks on followed by 1 week off schedule.…
Gedatolisib side effects
The following clinically significant adverse reactions are described elsewhere in the labeling: Stomatitis [see Warnings and Precautions (5.1) ] Dermatologic adverse reactions [see Warnings and Precautions (5.2) ] Hyperglycemia [see Warnings and Precautions (5.3) ] The most common (≥20%) adverse reactions, including laboratory abnormalities when given in combination with fulvestrant and palbociclib were decreased white blood cells, decreased neutrophils, decreased hemoglobin, decreased lymphocytes, stomatitis, nausea, decreased platelets, increased fasting glucose, fatigue, vomiting, rash, constipation, diarrhea, increased alanine aminotransferase (ALT), increased aspartate aminotransferase (AST), musculoskeletal pain, decreased sodium, and increased eosinophils. ( 6.1 ) The most common (≥20%) adverse reactions, including laboratory abnormalities when given in combination with fulvestrant were stomatitis, increased fasting glucose, increased eosinophils, decreased hemoglobin, nausea, rash, increased ALT, fatigue, musculoskeletal pain, decreased lymphocytes, vomiting, increased AST, pruritus, and diarrhea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Celcuity Inc. at 1-877-4-CELCUITY (1-877-423-5284) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction…
Who shouldn’t take gedatolisib
None. None. ( 4 )
Every gedatolisib product we track (1)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
Only one: Revtorpyk.
What people report to the FDA about gedatolisib
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 20 reports naming gedatolisib, and the FDA flagged 90% 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:
- hyperglycaemia7 reports
- anaemia5 reports
- escherichia bacteraemia4 reports
- leukopenia4 reports
- pyrexia4 reports
- pulmonary embolism2 reports
- cellulitis1 reports
- colitis1 reports
Read these as a signal, not a rate. A report does not mean gedatolisib 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 30, 2026.
Related calculators
Frequently asked questions
What is gedatolisib?
REVTORPYK for injection contains gedatolisib, a kinase inhibitor.
Can you take gedatolisib 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 gedatolisib against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What forms does gedatolisib come in?
Across the brands we track, gedatolisib is currently marketed as 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 gedatolisib?
We do not currently list a generic-labelled gedatolisib 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). Gedatolisib: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/gedatolisib
- MLA
- “Gedatolisib: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/gedatolisib.
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 gedatolisib on DailyMed (NIH) ↗.