Slides
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1 © 2026 Revolution Medicines, Inc. RASONQUE (daraxonrasib) U.S. FDA Approval August 26, 2026
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2 Legal Disclaimer This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act. All st atements other than statements of historical facts contained in this presentation, including statements regarding our future results of operations and financial position, busin ess strategy, product candidates, availability of funding, ability to manage existing collaborations and establish new strategic collaborations, licensing or other arrangement s, the scope, progress, results and costs of developing our product candidates or any other future product candidates, conducting clinical trials, the broad potential of RAS(ON) inhibition, the potential market size and size of the potential patient populations for our product candidates, commercialization plans and capabilities, our launch readine ss and the timing and success of our U.S. launch and our launch readiness and plans outside the United States, RASONQUE becoming, or being positioned or poised to become, a new or p ractice-changing standard of care, expected treatment practices for pancreatic cancer and the treatment experience associated with RASONQUE, the potential toler ability, safety and efficacy of our product candidates and of RASONQUE in settings outside its FDA -approved indication, the timing and likelihood of success of obtaining pr oduct approvals, plans and objectives of management for future operations, future results of anticipated products and the impact of global events and other macroecono mic conditions on our business are forward- looking statements. These statements involve known and unknown risks, uncertainties and other important factors that may caus e our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forw ard-looking statements. Because forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified and some of whi ch are beyond our control, you should not rely on these forward-looking statements as predictions of future events. The events and circumstances reflected in our forward -looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward -looking statements. The information included in these materials is provided as of August 26, 2026, unless specified elsewhere herein, and is qualified as such. Except as required by applicable law, we undertake no obligation to update any forward-looking statements or other information contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. For a further description of the risks and uncertainties that could cause actual results to differ from those anticipated in thes e forward-looking statements, as well as risks relating to the business of Revolution Medicines in general, see Revolution Medicines’ Quarterly Report on Form 10 -Q filed with the Securities and Exchange Commission on August 5, 2026. Except for RASONQUE in its FDA -approved indication, all other Revolution Medicines product candidates and uses d iscussed in this presentation are currently limited by federal law to investigational use, and no representation is made as to their safety or effectiveness for the purp oses for which they are being investigated. This presentation includes certain information regarding publicly available results from clinical trials by third parties eva luating other products and product candidates. Such trials were not head-to-head trials with any of Revolution Medicines' product candidates and include differences in study protocols, pa tient populations and reporting standards, and caution should be exercised when comparing data across trials. The summaries of RASONQUE's indication, dosage, warnings and precautions and adverse reactions included herein are not comple te and do not include all of the information needed to use RASONQUE safely and effectively. Please see the Important Safety Information included in this presentation and the full Prescribing Information for RASONQUE at RASONQUE.com. Outside the United States, daraxonrasib is investigational and has not been approved by any regulatory authority. All copyrights and trademarks used herein are the property of their respective owners. RASONQUE and (ON)Path are trademarks o f Revolution Medicines, Inc.
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3 Participants Alan Sandler, M.D. Chief Development Officer Mark A. Goldsmith, M.D., Ph.D. Chief Executive Officer and Chairman Jack Anders Chief Financial Officer Wei Lin, M.D. Chief Medical Officer Anthony Mancini Chief Global Commercialization Officer
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4 Opening Remarks
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6 RASONQUE | Ke y Ta ke a w ay s Unprecedented overall survival in registrational Phase 3 trial Fully launch ready and operational in the U.S. First approval proof point for RevMed’s bold RAS(ON) inhibitor strategy PDAC, pancreatic adenocarcinoma Poised to become new practice-changing standard of care in eligible patients with metastatic PDAC
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8 Historical PDAC T reatment Landscape and RASONQUE Clinical Evidence
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9 Historical U.S. Metastatic Pancreatic Cancer Management 1L, first line; 2L, second line; 5-FU, 5-fluorouracil; PDAC, pancreatic adenocarcinoma. References: 1. Oracle CancerMPact Patient Metrics, Stage IV newly incident + recurrent from earlier stages; accessed July 2026 2. King G, Ittershagen S, He L, Shen Y, Li F, Villacorta R. Treatment patterns in US patients receiving first-line and second-line therapy for metastatic pancreatic adenocarcinoma in the real world. Adv Ther. 2022;39(12):5433-5452. doi:10.1007/s12325-022-02317-9 74% received 1L treatment2 46% received 2L treatment2 ~ 19,000 ~ 55,0001 (de novo or recurrent) ~ 41,000 New Metastatic PDAC Patients Per Y ear in U.S. T ypical cytotoxic chemotherapy regimens for all treatment lines based on 5-FU or gemcitabine/paclitaxel
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10 RASONQUE Monotherapy Showed Encouraging Antitumor Activity and Manageable Safety Profile in Phase 1 Studies Across T umor T ypes and T reatment Settings Compelling Phase 1 results drove initiation of broad Phase 3 program Previously Treated Metastatic PDAC1 Patient populations, doses, and duration of follow-up differ; cross-population comparisons are not intended. ¹Wolpin BM, et al. N Engl J Med. 2026;394:1790-1802. Previously treated PDAC: RAS mutant, n=38. ²O’Reilly EM, et al. Cancer Res. 2026;86(8 Suppl):LB337. AACR Annual Meeting 2026. First-line PDAC: RAS mutant, n=38. ³Punekar SR, et al. J Thorac Oncol. 2025;20(3):S10-S11. ELCC 2025. Previously treated NSCLC: RAS G12X, n=40. Data cutoffs: ¹30 Jun 2025; ²1 Dec 2025; ³30 Sep 2024. ORR, objective response rate; DCR, disease control rate; PDAC, pancreatic adenocarcinoma; NSCLC, non-small cell lung cancer; SOD, sum of diameters. Ongoing studies and uses outside the approved indication remain investigational. First-line Metastatic PDAC2 Previously Treated NSCLC³ ORR 29% DCR 95% ORR 47% DCR 92% ORR 38% DCR 85% Best % Change in SOD from Baseline in Target Tumor Burden
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11 RASONQUE in Five Global, Randomized Phase 3 T rials to Date Tumor Phase 3 Trial Treatment Setting Status Previously treated metastatic PDAC First-line metastatic PDAC Adjuvant for resectable PDAC First-line RAS G12D metastatic PDAC Previously treated RAS mutant NSCLC PDAC PDAC PDAC PDAC NSCLC >2,000 patients treated with RASONQUE across clinical studies in multiple tumor types and treatment settings Completed Ongoing Ongoing Initiated Ongoing Ongoing studies and uses remain investigational. PDAC, pancreatic adenocarcinoma; NSCLC, non-small cell lung cancer.
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12 Supporting Data and Approved Label
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13 13 Oral, once-daily RASONQUE demonstrated statistically significant and clinically meaningful improvements in overall survival, progression-free survival, and patient reported outcomes compared with SOC IV chemotherapy RASONQUE outcomes in the overall, intent-to-treat population: 1Please see Important Safety Information on slides 32 and 33 and Full Prescribing Information at rasonque.com Data cutoff: 10 Feb 2026; data from overall intent-to-treat population. Intent-to-treat population includes patients with and without identified tumor RAS mutations. OS, overall survival; PFS, progression-free survival; SOC, standard of care. RASolute 302: Unprecedented Overall Survival Benefit in Patients with Previously T reated Metastatic Pancreatic Cancer OS hazard ratio: 0.40 60% reduction in the risk of death Near doubling median OS to 13.2 months Generally well tolerated1 Manageable safety profile
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14 Overall Survival in the Overall Study Population RASONQUE (n=248) Chemotherapy (n=252) mOS, months (95% CI) 13.2 (10.0–NE) 6.7 (5.8–8.0) HR (95% CI)a P-valueb 0.40 (0.30–0.53) p4.6×10−11 Presented at ASCO Annual meeting 2026. Data from O'Reilly EM, et al. N Engl J Med. 2026. DOI: 10.1056/NEJMoa2605555. Data cutoff: 10 Feb 2026. Median (range) follow-up time was 8.5 (3.2−15.9) months; number of events: RASONQUE: 79 (32%); chemotherapy: 141 (56%). A HRs and 95% CIs were based on the stratified Cox model with Efron’s method of tie handling. b P-values were calculated using the stratified log-rank test. m, median; NE, not estimable; OS, overall survival. RASONQUE
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15 Overall Survival Benefit was Consistent Across All Subgroups Presented at ASCO Annual meeting 2026. Data from O'Reilly EM, et al. N Engl J Med. 2026. DOI: 10.1056/NEJMoa2605555. Data cutoff: 10 Feb 2026. 5-FU, 5-fluorouracil; ECOG, Eastern Cooperative Oncology Group; PS, performance status. aThe size of diamonds is relative to the size of the population in each subgroup. HRs and 95% CIs were based on the unstratified Cox model with Efron’s method of tie handling. bThree patients (including 2 patients randomized to the RASONQUE arm and 1 patient randomized to the chemotherapy arm) had ECOG PS >1 at baseline. These patients were not dosed due to no longer meeting trial eligibility criteria. Events/N Population RASONQUE Chemotherapy HR (95% CI)a Overall 79/248 141/252 0.42 (0.32–0.55) Age, years <65 37/114 68/121 0.41 (0.27–0.61) ≥65 42/134 73/131 0.43 (0.29–0.63) Sex Male 45/131 77/144 0.50 (0.35–0.73) Female 34/117 64/108 0.33 (0.22–0.51) ECOG PS 0 33/129 51/118 0.48 (0.31–0.75) 1b 46/119 90/134 0.38 (0.27–0.55) Tumor RAS mutational status RAS G12D/V 59/197 110/197 0.38 (0.28–0.53) Other RAS G12 13/31 17/34 0.70 (0.34–1.44) RAS G13 or Q61, or no RAS mutation identified 7/20 14/21 0.37 (0.15–0.93) Metastatic disease at diagnosis Yes 51/154 94/154 0.38 (0.27–0.54) No 28/94 47/98 0.49 (0.31–0.78) Prior 5-FU-based regimen Yes 62/181 103/186 0.46 (0.34–0.64) No 17/67 38/66 0.31 (0.17–0.55) Prior gemcitabine-based regimen Yes 31/110 61/114 0.39 (0.25–0.61) No 48/138 80/138 0.44 (0.30–0.63) Prior pancreatectomy Yes 21/83 40/92 0.47 (0.27–0.79) No 58/165 101/160 0.38 (0.28–0.53) Liver metastases at baseline Yes 68/174 113/176 0.43 (0.32–0.58) No 11/74 28/76 0.31 (0.15–0.63) Peritoneal metastases at baseline Yes 28/76 48/83 0.44 (0.28–0.71) No 51/172 93/169 0.41 (0.29–0.57) CA19-9 level at baseline ≥40 U/mL 70/211 121/195 0.37 (0.28–0.50) <40 U/mL 9/36 19/56 0.67 (0.30–1.49) 0.5 1.00.1 2.0 Favors Chemotherapy Favors RASONQUE
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16 16 Progression-Free Survival in the Overall Study Population Presented at ASCO Annual meeting 2026. Data from O'Reilly EM, et al. N Engl J Med. 2026. DOI: 10.1056/NEJMoa2605555. Progression-free survival was assessed by blinded independent central review (BICR). Data cutoff: 10 Feb 2026. Median (range) follow-up time was 8.5 (3.2−15.9) months; number of events: RASONQUE: 127 (51%); chemotherapy: 130 (52%). a HRs and 95% CIs were based on the stratified Cox model with Efron’s method of tie handling. b P-values were calculated using the stratified log-rank test. m, median; PFS, progression-free survival. RASONQUE (n=248) Chemotherapy (n=252) mPFS, months (95% CI) 7.2 (5.7–7.5) 3.6 (2.9–4.2) HR (95% CI)a P-valueb 0.49 (0.38–0.64) p5.2×10−8 RASONQUE
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17 Patient-Reported Outcomes in the Overall Study Population Presented at ASCO Annual meeting 2026. Data from O'Reilly EM, et al. N Engl J Med. 2026. DOI: 10.1056/NEJMoa2605555. Data cutoff: 10 Feb 2026. EORTC QLQ-C30, European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire; EORTC QLQ-PAN26, European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire – Pancreatic Cancer Module. a Time to deterioration in clinically relevant symptom of pain was defined as the time from randomization to an increase of at least 10 points from baseline in pain, or death, whichever occurs first, in the EORTC QLQ-PAN26 pain scale. b Time to deterioration in global health status/quality of life was defined as the time from randomization to a decrease of at least 10 points from baseline in global health status/quality of life, or death, whichever occurs first, in EORTC QLQ-C30. Median time to deterioration, months HR (95% CI) 0.51 (0.37–0.71) p<0.0001 HR (95% CI) 0.60 (0.46–0.79) p0.0002 ChemotherapyRASONQUE • EORTC QLQ-PAN26 and EORTC QLQ-C30 questionnaires were administered on day 1 of each cycle and at end of treatment visit • RASONQUE significantly delayed time to deterioration in both symptom of pain and global health status/quality of life compared with chemotherapy Paina Global Health Status/ Quality of Lifeb Overall Population
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18 Source: RASONQUE U.S. Prescribing Information. Data cutoff: 10 Feb 2026. TEAE, treatment-emergent adverse event. a Medians across each component of the chemotherapy regimens. RASONQUE (N=241) Chemotherapy (N=214) Median time on treatment, months (range) 6.2 (0.03-14.1) 1.5-3.2 a (0.03-12.9) Any TEAEs, n (%) 241 (100) 209 (98) TEAEs leading to dose interruption 167 (69) 135 (63) TEAEs leading to dose reduction 90 (37) 126 (59) TEAEs leading to discontinuation 7 (3) 31 (15) Grade ≥3 TEAEs 149 (62) 149 (70) Serious TEAEs 73 (30) 71 (33) Grade 5 TEAEs 5 (2) 4 (2) Safety Overview • Median dose intensity: • 93% with daraxonrasib • 65-95%a across chemotherapy regimens • RASONQUE exposure • 52% of patients exposed to RASONQUE for 6 months or longer • 2% exposed for greater than 1 year • Most common (≥5%) TEAEs leading to dose reduction: • RASONQUE: rash (18%), stomatitis (8%) and diarrhea (5%)
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19 RASONQUE U.S. Label: Highlights of Prescribing Information Indications and Usage RASONQUE is indicated for the treatment of adult patients with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy or who are not candidates for multiagent systemic therapy. Dosage and Administration Recommended dosage: 300 mg orally once daily with or without food. Dosage Form and Strengths T ablets: 100 mg and 150 mg. Warnings and Precautions Dermatologic and soft tissue toxicity, stomatitis and oral disorders, diarrhea, gastrointestinal perforation, interstitial lung disease/pneumonitis, and embryo-fetal toxicity. Adverse Reactions Most common adverse reactions (≥ 20%) were rash, diarrhea, stomatitis,nausea, fatigue, vomiting, abdominal pain, edema, decreased appetite, andhemorrhage RASONQUE U.S. Prescribing Information. This summary does not include all information needed to use RASONQUE safely and effectively. Please see full Prescribing Information at rasonque.com.
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20 Commercialization Strategy
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21 Launch is Focused on Three Strategic Priorities RASONQUE as the new standard of care for eligible patients with metastatic PDAC broad coverage and seamless patient access patients and HCPs to achieve optimal treatment experience Establish EnsureEnable HCP, healthcare professional; PDAC, pancreatic adenocarcinoma
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22 ACADEMIC HCPs U.S. PDAC Patients Treated by Site of Care Key Access Stakeholders 40% Payers Community & IDN/AMC GPOs T op 15 Payers ~80% of U.S. Covered Lives Fit-for-purpose Field Teams in Place Medical Affairs / MSLs Academic HCPs / Opinion Leaders Sales Academic & Community HCPs National Account T eams Primary: Payers, Integrated Delivery Networks & Group Purchasing Organizations T op 25 Stakeholders ~50% of Volume Fit-for-purpose Access Teams Ready to Reach All Key U.S. PDAC Stakeholders COMMUNITY ONCOLOGY HCPs Large treatment volume; focus on broad education & account reach 60% P A YERS | IDNs | GPOs HCP: Healthcare Professionals; IDN: Integrated Delivery Networks; GPO: Group Purchasing Organizations; AMC: Academic Medical Center; MSL: Medical Science Liaison; KOL, key opinion leader; PDAC, pancreatic adenocarcinoma
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2323 U.S. Launch Access Strategy Patient Services Program • As little as $0 co-pay for eligible commercially insured patients* • Support available from prescription through treatment journey Integrated services at launch 1 Coverage navigation 2 Financial support 3 Adherence support 4 Education & resources * Program eligibility, terms and conditions apply. Comprehensive Patient Support at Launch to Enable Broad Access • Broad coverage and seamless patient access • Integrated access, affordability and adherence support designed to help eligible patients initiate and remain on therapy
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24 Launching in the U.S. and Accelerating Global Launch Readiness UNITED STATES Full U.S. launch now underway Commercial supply, distribution, patient services and field teams operational EUROPE + JAPAN Launch readiness advancing Core teams established and rapidly expanding capabilities GLOBAL ACCESS International opportunity prioritized in phases Broader international opportunity to be addressed market-by- market over time GLOBAL NAMED PATIENT ACCESS 1: Please visit revmed.com/pre-approval-access-to-investigational-medicines/ (1) Ability to access the drug will vary from country to country depending on local and regional requirements for the supply of unapproved medicinal products.
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25 Closing Messages
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26 Pancreatic Cancer | Our Broad Strategy Aimed at Changing Standard of Care Across Early- to Late-Stage Disease Settings Strategy designed to transform treatment with a comprehensive franchise spanning every major stage of disease Objectives: • Establish RASONQUE as the new standard of care • First approved targeted medicine designed to broadly address metastatic PDAC by inhibiting RAS, its main driver • Foundation for commercial leadership in pancreatic cancer • Expand across the treatment continuum • Four global Phase 3 registrational programs underway across first-line metastatic and adjuvant PDAC • Complementary monotherapy and combination strategies designed to address diverse patient needs First Line Trials RASolute 303 | RASolute 305 | RASolute 309 Adjuvant Trial RASolute 304 Approved in Metastatic PDAC RASONQUE PDAC, pancreatic adenocarcinoma
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27 Molecule Target Trial Treatment Setting Regimen Status RASONQUE MULTI 2L metastatic Mono RASONQUE MULTI 1L metastatic Mono & Combo RASONQUE MULTI Adjuvant in resectable Mono Zoldonrasib G12D 1L metastatic Combo Zoldonrasib + RASONQUE G12D 1L metastatic Combo RASONQUE MULTI 2L/3L metastatic Mono Zoldonrasib G12D 1L metastatic Combo Elironrasib G12C 1L metastatic Combo NSCLC PDAC Approved* Phase 3 Registrational T rials RASONQUETM (daraxonrasib) is approved in the U.S. and is also being evaluated in other settings, where it remains investigational. Zoldonrasib (G12D), elironrasib (G12C), and RMC-5127 (G12V) are being evaluated in solid tumors across a range of monotherapy and combination treatment strategies. RM-055 is currently advancing through IND-enabling studies. For more information, visit ClinicalTrials.gov. Ongoing Initiated Phase 1/2 Clinical Development Ongoing Ongoing Ongoing Initiated Pending Momentum with Broad and Differentiated Pipeline of RAS(ON) Inhibitors 1L, first line; 2L, second line; 3L, third line; NSCLC, non-small cell lung cancer; PDAC, pancreatic adenocarcinoma *RASONQUE is approved for adult patients with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy or who are not candidates for multiagent systemic therapy.
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28 Our Vision | Creating an Industry-Leading Global T argeted Medicines Franchise for Patients with RAS-Addicted Cancers Insights from all three pillars drive a virtuous cycle that fuels innovation and impact Continuous innovation through unique platform and insights to sustain leadership position and impact DISCOVER Broad clinical development of multiple investigational medicines across tumor types and treatment settings DEVELOP Bringing transformative targeted medicines to patients through commercial excellence and global expansion DELIVER
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Thank you Patients and their families who participated in RASolute 302 and other Revolution Medicines clinical studies Investigators, nurses, support staff and KOLs in the US and internationally Patient advocacy organizations Revolution Medicines employees who have worked tirelessly to bring RASONQUE to patients
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30 Q&A
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On T arget to Outsmart Cancer ® 31 ® 31 The information included in these materials is provided as part of an oral presentation on August 26, 2026 and is qualified as such. Revolution Medicines disclaims any duty to update the information contained in this presentation. This presentation concerns RASONQUE (daraxonrasib), which has been approved for marketing by the U.S. Food and Drug Administration (FDA), as well as other product candidates and other uses of RASONQUE that are under clinical or pre-clinical investigation. Except for RASONQUE in its FDA-approved indication, the products and uses discussed in this presentation have not been approved for marketing by the FDA, are currently limited by Federal law to investigational use, and no representation is made as to their safety or effectiveness for the purposes for which they are being investigated. Outside the United States, daraxonrasib is investigational and has not been approved by any regulatory authority. Please see the full Prescribing Information for RASONQUE at rasonque.com.
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32 IMPORTANT SAFETY INFORMATION (1 of 2) RASONQUE is associated with the following Warnings and Precautions: Dermatologic and Soft Tissue Toxicity, Stomatitis and Ora l Disorders, Diarrhea, Gastrointestinal Perforation, Interstitial Lung Disease (ILD)/Pneumonitis, and Embryo-Fetal Toxicity. WARNINGS AND PRECAUTIONS Dermatologic and Soft Tissue Toxicity RASONQUE can cause dermatologic toxicity, which may be severe. Clinical manifestations included, but were not limited to, ras h, pruritus, paronychia, dry skin, and skin fissures. In clinical trials of patients with pancreatic adenocarcinoma, dermatologic toxicity occurred in 86% of patients treated with RASONQUE, of which 10% were Grade 3. Monitor patients who develop dermatologic or soft tissue toxicities while receiving RASONQUE. Initiate prophylactic measures (e.g., topical corticosteroids, emollient creams, sunscreen, oral antibiotics) prior to the first dose of RASONQUE to reduce the risk of moderate to severe dermatologic reactions. Advise pati ents to limit sun exposure while taking RASONQUE. Initiate supportive measures (e.g., oral corticosteroids) as clinically indicated, and consider dermatologic consultation. Withhold, r educe the dose, or permanently discontinue RASONQUE based on severity. Stomatitis and Oral Disorders RASONQUE can cause stomatitis, including mouth ulcers and oral mucositis. In clinical trials of patients with pancreatic aden ocarcinoma, stomatitis occurred in 57% of patients, of which 9% were Grade 3. Monitor patients for signs and symptoms of stomatitis while receiving RASONQUE. Initiate a steroid -containing mouthwash for trea tment of stomatitis and administer other topical treatments (e.g., chlorhexidine mouthwash, 2% lidocaine viscous) as clinically indicated. Withhold, reduce the dose, or permanently disc ontinue RASONQUE based on severity. Diarrhea RASONQUE can cause diarrhea. In clinical trials of patients with pancreatic adenocarcinoma, diarrhea occurred in 63% of patie nts, of which 6% were Grade 3. If diarrhea occurs, administer antidiarrheal treatment as clinically indicated. Withhold, reduce the dose, or permanently dis continue RASONQUE based on severity. Gastrointestinal Perforation RASONQUE can cause gastrointestinal perforation. In clinical trials of patients with pancreatic adenocarcinoma, gastrointesti nal perforation occurred in 0.9% of patients treated with RASONQUE, of which 0.5% were Grade 3, one event was Grade 4, and one event was fatal. Monitor patients for gastrointestinal perforation. Withhold RASONQUE if gastrointestinal perforation is suspected. Reduce the dose or permanently discontinue RASONQUE if no other potential causes of gastrointestinal perforation are identified. Interstitial Lung Disease (ILD)/Pneumonitis RASONQUE can cause interstitial lung disease or pneumonitis. In clinical trials of patients with pancreatic adenocarcinoma, I LD/pneumonitis occurred in 2.4% of patients treated with RASONQUE, of which 0.9% were Grade 3, and one event was fatal. Monitor patients for new or worsening pulmonary symptoms. Withhold RASONQUE if ILD/pneumonitis is suspected. Reduce the dose or permanently discontinue RASONQUE if no other potential causes of ILD/pneumonitis are identified. Embryo-Fetal Toxicity Based on findings in animals, RASONQUE can cause fetal harm when administered to a pregnant woman. Advise females of reproduc tive potential to use effective contraception during treatment with RASONQUE and for 1 week after the last dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with RASONQUE and for 1 week after the last dose.
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33 IMPORTANT SAFETY INFORMATION (2 of 2) RASONQUE is associated with the following Warnings and Precautions: Dermatologic and Soft Tissue Toxicity, Stomatitis and Ora l Disorders, Diarrhea, Gastrointestinal Perforation, Interstitial Lung Disease (ILD)/Pneumonitis, and Embryo-Fetal Toxicity. ADVERSE REACTIONS Serious adverse reactions occurred in 30% of patients treated with RASONQUE. Serious adverse reactions occurring in ≥ 2% of patients treated with RASONQUE were diarrhea (3.7%), pyrexia (3.3%), sepsis (2.9%), fatigue (2.1%), and hemorrhage (2.1%). Adverse reactions leading to permanent discontinuation of RASONQUE occurred in 2.9% of patients, including two patients who d iscontinued due to rash (0.8%). The most common (≥ 20%) adverse reactions in patients treated with RASONQUE were rash, diarrhea, stomatitis, nausea, fatigue, vomiting, abdominal pain, edema, decreased appetite, and hemorrhage. DRUG INTERACTIONS • Strong CYP3A Inhibitors with P-gp Inhibition: Avoid concomitant use. • Strong CYP3A Inhibitors without P-gp Inhibition: Reduce RASONQUE dosage. • Moderate CYP3A Inhibitors with or without P-gp Inhibition: Reduce RASONQUE dosage. • P-gp Inhibitors: Reduce RASONQUE dosage. • Cyclosporine A: Avoid concomitant use. • Strong CYP3A Inducers: Avoid concomitant use. Increase RASONQUE dosage if concomitant use cannot be avoided. • Moderate CYP3A Inducers: Increase RASONQUE dosage. • P-gp Substrates: Take at least 4 hours apart from RASONQUE. PROPHYLACTIC MEASURES When initiating RASONQUE and throughout treatment, prophylactic and concomitant medications are recommended to reduce the ris k of dermatologic reactions: • administer a topical corticosteroid (applied to the face and chest) and emollient creams • advise patients to limit sun exposure and use broad -spectrum sunscreen (SPF 30 or higher) • consider prophylactic oral antibiotics (e.g., doxycycline or minocycline)