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Stomatitis cases typically occurred during the first week of treatment1,2

Most resolved to a lower grade in about 2 weeks2,3

  • REVTORPYK triplet
  • REVTORPYK doublet

In VIKTORIA-1, stomatitis occurred in 72% of patients who received the REVTORPYK triplet, and 22% of patients experienced a grade 3 event.1*†

  • Median time to onset was 7 days (range: 1-457 days)1
  • Stomatitis led to dose reduction in 19% of patients and permanent discontinuation in 3.8% of patients1
Additional data‡

The majority of patients experienced grade 1 stomatitis as the first event.3

Safety data of REVTORPYK triplet Safety data of REVTORPYK triplet

*Stomatitis included ulcers and oral mucositis.1

†Dexamethasone mouthwash was required prophylactic treatment prior to first infusion and daily for 8 weeks or longer if clinically indicated.2

‡In this additional data analysis, stomatitis terms included the following: stomatitis, oral mucosal inflammation, mouth ulceration, aphthous ulcer, glossitis, lip ulceration, gingivitis, and gingival pain.2

In VIKTORIA-1, stomatitis occurred in 58% of patients who received the REVTORPYK doublet, and 12% of patients experienced a grade 3 event.1*†

  • Median time to onset was 4 days (range: 1-524 days)1
  • Stomatitis led to dose reduction in 9% of patients and permanent discontinuation in 1.5% of patients1
Additional data‡

The majority of patients experienced grade 1 stomatitis as the first event.3

Safety data of REVTORPYK triplet Safety data of REVTORPYK triplet

*Stomatitis included ulcers and oral mucositis.1

†Dexamethasone mouthwash was required prophylactic treatment prior to first infusion and daily for 8 weeks or longer if clinically indicated.2

‡In this additional data analysis, stomatitis terms included the following: stomatitis, oral mucosal inflammation, mouth ulceration, aphthous ulcer, glossitis, lip ulceration, gingivitis, and gingival pain.2

Stomatitis prophylaxis and management

1

To reduce the incidence and severity of stomatitis,‡ administer a steroid-containing, alcohol-free mouthwash before initiating treatment.1

2

Instruct patient to continue administering the mouthwash1,5:

For 2 minutes
or as directed

4X
a day

The first
8 weeks
of treatment‡§

  • Instruct patients not to eat or drink anything for at least 1 hour after administration of mouthwash1

3

If stomatitis occurs, increase the frequency of mouthwash and administer other topical treatments as clinically indicated.1

See dosing for REVTORPYK

‡REVTORPYK can cause severe stomatitis, including ulcers and oral mucositis. Monitor patients for signs and symptoms of stomatitis. Advise patients to contact their healthcare provider if they experience any symptoms of stomatitis.1

§Longer if needed.1

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

Stomatitis: REVTORPYK can cause severe stomatitis, including ulcers and oral mucositis. Stomatitis occurred in 72% of patients treated with REVTORPYK with fulvestrant and palbociclib, including Grade 3 events in 22% of patients. Stomatitis occurred in 58% of patients treated with REVTORPYK with fulvestrant, including Grade 3 events in 12% of patients. Initiate a steroid-containing, alcohol-free mouthwash prior to starting treatment with REVTORPYK and continue prophylactically during treatment. Monitor patients for signs and symptoms of stomatitis. Withhold, reduce dose, or permanently discontinue REVTORPYK based on severity.

Dermatologic Adverse Reactions: REVTORPYK can cause severe rash. Rash occurred in 30% of patients treated with REVTORPYK in combination with fulvestrant and palbociclib, including Grade 3 events in 6% of patients. Rash occurred in 40% of patients treated with REVTORPYK with fulvestrant, including 5% of patients with Grade 3 events. Monitor patients for rash and infectious sequelae. Instruct patients to limit sun exposure during REVTORPYK treatment. Withhold, reduce dose, or permanently discontinue REVTORPYK based on severity.

Hyperglycemia: REVTORPYK can cause severe hyperglycemia. Monitor fasting glucose prior to initiating treatment with REVTORPYK and periodically during treatment. Monitor HbA1c level if clinically indicated. Increased fasting glucose occurred in 46% of patients receiving REVTORPYK in combination with fulvestrant and palbociclib (Grade 3: 0.9%) and in 57% of patients receiving REVTORPYK in combination with fulvestrant (Grade 3: 1.8%). The safety of REVTORPYK has not been established in patients with Type 1 or uncontrolled Type 2 diabetes mellitus. Patients with well-controlled Type 2 diabetes may require intensified antihyperglycemic therapy and close monitoring of fasting glucose. Manage hyperglycemia with antihyperglycemic medications as clinically indicated. Evaluate fasting blood glucose and HbA1c levels prior to starting and at regular intervals during treatment. Withhold, reduce dose, or permanently discontinue REVTORPYK based on severity.

Embryo-Fetal Toxicity: Based on its mechanism of action, REVTORPYK can cause fetal harm when administered to a pregnant woman. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with REVTORPYK and for 2 weeks after the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during treatment and for 2 weeks after the last dose.

Advise women not to breastfeed during treatment with REVTORPYK and for 2 weeks after the last dose. When REVTORPYK is used in combination, advise patients to use effective contraception during treatment and for the longest post-treatment duration recommended in the Prescribing Information of any of the individual products. Verify the pregnancy status of females of reproductive potential prior to initiating treatment.

ADVERSE REACTIONS

REVTORPYK in Combination with Fulvestrant and Palbociclib: 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.

REVTORPYK in Combination with Fulvestrant: The most common (≥20%) adverse reactions, including laboratory abnormalities when given in combination with fulvestrant were stomatitis, glucose increased, eosinophils increased, hemoglobin decreased, nausea, rash, ALT increased, fatigue, musculoskeletal pain, lymphocytes decreased, vomiting, AST increased, pruritus, and diarrhea.

INDICATION AND USAGE

REVTORPYK is a kinase inhibitor indicated in combination with fulvestrant, with or without palbociclib, for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer without a PIK3CA mutation detected following progression on or after treatment with at least one line of endocrine therapy in the metastatic setting.

INDICATION AND USAGE

REVTORPYK is a kinase inhibitor indicated in combination with fulvestrant, with or without palbociclib, for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer without a PIK3CA mutation detected following progression on or after treatment with at least one line of endocrine therapy in the metastatic setting.

Please see the full Prescribing Information for REVTORPYK.

You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Celcuity at 877-4-CELCUITY (877-423-5284).

References: 1. Revtorpyk. Prescribing information. Celcuity Inc; 2026. 2. Hurvitz SA, Layman RM, Curigliano G, et al. VIKTORIA-1 trial of gedatolisib plus fulvestrant with or without palbociclib in hormone receptor-positive/HER2-/PIK3CA wild-type advanced breast cancer. J Clin Oncol. 2026;44(12):1108-1119. Supplemental appendix. Accessed May 19, 2026. https://pmc.ncbi.nlm.nih.gov/articles/instance/13075786/bin/jco-44-1108-s001.pdf 3. Hurvitz SA, Layman RM, Curigliano G, et al. VIKTORIA-1 trial of gedatolisib plus fulvestrant with or without palbociclib in hormone receptor-positive/HER2-/PIK3CA wild-type advanced breast cancer. J Clin Oncol. 2026;44(12):1108-1119. 4. Pistilli B, Layman RM, Curigliano G, et al. Gedatolisib, a multitarget PI3K/AKT/mTOR inhibitor, plus fulvestrant with or without palbociclib for second-line treatment of patients with HR+/HER2-/PIK3CA-WT advanced breast cancer: updated results from the randomized, phase 3 VIKTORIA-1 trial. Presented at: San Antonio Breast Cancer Symposium; December 9-12, 2025; San Antonio, TX. 5. Rugo HS, Seneviratne L, Beck JT, et al. Prevention of everolimus-related stomatitis in women with hormone receptor-positive, HER2-negative metastatic breast cancer using dexamethasone mouthwash (SWISH): a single-arm, phase 2 trial. Lancet Oncol. 2017;18(5):654-662.