RASONQUE daraxonrasib 150 mg Tablet, Film Coated, 30-count
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| Price system | Per each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Rasonque 150 mgthis 85219-0104-01 | Revolution | 30 tablets | — | — | FDA listed | — |
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 85219-0104-01 You're viewing this | 1 BOTTLE in 1 CARTON (85219-104-01) / 30 TABLET, FILM COATED in 1 BOTTLE | 2026-08-26 | Active |
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| NDC identity (package / product / labeler codes) | ✓ Available |
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| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
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| Inactive ingredients (structured) | — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available. |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
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| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
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📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 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. RASONQUE is an inhibitor of the RAS GTPase family, 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. ( 1 )
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Recommended dosage: 300 mg orally once daily. ( 2.2 ) Swallow tablets whole with or without food. ( 2.2 ) Administer prophylactic and concomitant medications to reduce the risk of dermatologic reactions. ( 2.1 )
2.1Prophylactic and Concomitant Medication When initiating RASONQUE and throughout treatment, prophylactic and concomitant medications are recommended to reduce the risk of dermatologic reactions [see Warnings and Precautions (5.1) ] : 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)
2.2Recommended Dosage The recommended dosage of RASONQUE is 300 mg orally once daily until disease progression or unacceptable toxicity. Take RASONQUE at the same time each day with or without food. Swallow tablets whole.
Do not chew, crush, or split tablets. If a dose is missed for more than 4 hours, skip the missed dose, and take the next dose at the next regularly scheduled time. If vomiting occurs after taking the dose, do not take an additional dose.
Resume dosing at the next regularly scheduled time.
2.3Dosage Modifications for Adverse Reactions Recommended dosage reductions for adverse reactions are provided in Table 1 . Permanently discontinue RASONQUE in patients who are unable to tolerate 150 mg orally once daily. Table 1: Recommended Dosage Reductions for Adverse Reactions Dose Reduction Level Dosage First dose reduction 200 mg once daily Second dose reduction 150 mg once daily Recommended dosage modifications for adverse reactions are provided in Table 2 .
Table 2: Recommended Dosage Modifications for Adverse Reactions Adverse Reaction Severity Graded per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0. Dosage Modification Dermatologic Toxicity (rash) [see Warnings and Precautions (5.1) ] Grade 2 Consider withholding RASONQUE until recovery to ≤ Grade 1. Initiate supportive measures, as necessary.
Resume RASONQUE at the same dose level or the next lower dose level. Grade 3 Withhold RASONQUE until recovery to ≤ Grade 1. Initiate supportive measures, as necessary, and consider consultation with a dermatologist.
Resume RASONQUE at the next lower dose level. Grade 4 Permanently discontinue. Stomatitis [see Warnings and Precautions (5.2) ] Grade 2 Consider withholding RASONQUE until recovery to ≤ Grade 1.
Initiate supportive measures, as necessary. Resume RASONQUE at the same dose level or the next lower dose level. Grade 3 Withhold RASONQUE until recovery to ≤ Grade 1.
Initiate supportive measures, as necessary. Resume RASONQUE at the next lower dose level. Grade 4 Permanently discontinue.
Diarrhea [see Warnings and Precautions (5.3) ] Grade 2 Consider withholding RASONQUE until recovery to ≤ Grade 1. Initiate antidiarrheal treatment. Resume RASONQUE at the same dose level or the next lower dose level.
Grade 3 Withhold RASONQUE until recovery to ≤ Grade 1. Initiate antidiarrheal treatment. Resume RASONQUE at the next lower dose level.
Grade 4 Permanently discontinue. Gastrointestinal Perforation [see Warnings and Precautions (5.4) ] Grade 3 Withhold RASONQUE until recovery to ≤ Grade 1. If appropriate, resume RASONQUE at the next lower dose level.
Grade 4 Permanently discontinue. Interstitial Lung Disease/Pneumonitis [see Warnings and Precautions (5.5) ] Grade 2 Withhold RASONQUE until recovery to ≤ Grade 1. If appropriate, resume RASONQUE at the next lower dose level.
Recurrent Grade 2, or Grade 3-4 Permanently discontinue. Nausea or Vomiting [see Adverse Reactions (6.1) ] Grade 3 Withhold RASONQUE until recovery to ≤ Grade 1. Initiate or modify anti-emetic regimen.
Resume RASONQUE at the next lower dose level. Grade 4 Permanently discontinue. Other Adverse Reactions [see Adverse Reactions (6.1) ] Grade 3 Withhold RASONQUE until recovery to ≤ Grade 1 o…
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Tablets: 100 mg, blue, oval, biconvex, film-coated, debossed with “R” on one side and “100 M” on the other side. Tablets: 150 mg, blue, oval, biconvex, film-coated, debossed with “R” on one side and “150 M” on the other side. Tablets: 100 mg; 150 mg. ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS None. None. ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Dermatologic and Soft Tissue Toxicity : RASONQUE can cause dermatologic or soft tissue toxicities, including rash, pruritus, and dry skin. Advise patients to limit sun exposure, use sunscreen, and use emollient creams. Withhold, reduce the dose, or permanently discontinue based on severity.
( 2.3 , 5.1 ) Stomatitis and Oral Disorders : RASONQUE can cause stomatitis, including mouth ulcers and oral mucositis. Withhold, reduce the dose, or permanently discontinue based on severity. ( 2.3 , 5.2 ) Diarrhea : RASONQUE can cause diarrhea.
Withhold, reduce the dose, or permanently discontinue based on severity. ( 2.3 , 5.3 ) Gastrointestinal Perforation : Monitor for gastrointestinal perforation. Withhold if suspected.
If appropriate, reduce the dose or permanently discontinue if no other potential causes of gastrointestinal perforation are identified. ( 2.3 , 5.4 ) Interstitial Lung Disease (ILD)/Pneumonitis : Monitor for new or worsening pulmonary symptoms. Withhold if suspected.
If appropriate, reduce the dose or permanently discontinue if no other potential causes of ILD/pneumonitis are identified. ( 2.3 , 5.5 ) Embryo-Fetal Toxicity : RASONQUE can cause fetal harm. Advise of the potential risk to the fetus and to use effective contraception.
( 5.6 , 8.1 , 8.3 )
5.1Dermatologic and Soft Tissue Toxicity RASONQUE can cause dermatologic toxicity, which may be severe. Clinical manifestations included, but were not limited to, rash, 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.
The median time to first onset was 13 days (range: 1 to 106 days). The median time to improvement from Grade 3 to Grade 1 or resolution was 16 days (range: 8 to 218 days). Dermatologic toxicity led to interruption of RASONQUE in 24% of patients, dose reduction in 16% of patients, and dose discontinuation in 0.5% of patients.
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 patients to limit sun exposure while taking RASONQUE.
Initiate supportive measures (e.g., oral corticosteroids) as clinically indicated, and consider dermatologic consultation. Withhold, reduce the dose, or permanently discontinue RASONQUE based on severity [see Dosage and Administration (2.3) ].
5.2Stomatitis and Oral Disorders RASONQUE can cause stomatitis, including mouth ulcers and oral mucositis. In clinical trials of patients with pancreatic adenocarcinoma, stomatitis occurred in 57% of patients, of which 9% were Grade 3. The median time to first onset was 22 days (range: 1 to 343 days).
The median time to improvement from Grade 3 to Grade 1 or resolution was 12 days (range: 1 to 127 days). Stomatitis led to interruption of RASONQUE in 17% of patients and dose reduction in 8% of patients. Monitor patients for signs and symptoms of stomatitis while receiving RASONQUE.
Initiate a steroid-containing mouthwash for treatment of stomatitis and administer other topical treatments (e.g., chlorhexidine mouthwash, 2% lidocaine viscous) as clinically indicated. Withhold, reduce the dose, or permanently discontinue RASONQUE based on severity [see Dosage and Administration (2.3) ].
5.3Diarrhea RASONQUE can cause diarrhea. In clinical trials of patients with pancreatic adenocarcinoma, diarrhea occurred in 63% of patients, of which 6% were Grade 3. The median time to first onset was 3 days (range: 1 to 260 days).
The median time to improvement from Grade 3 to Grade 1 or resolution was 3 days (range: 1 to 21 days). Diarrhea led to interruption of RASONQUE in 8% of patients and dose reduction in 4% of patients. If diarrhea occurs, administer antidiarr…
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Dermatologic and Soft Tissue Toxicity [see Warnings and Precautions (5.1) ] Stomatitis and Oral Disorders [see Warnings and Precautions (5.2) ] Diarrhea [see Warnings and Precautions (5.3) ] Gastrointestinal Perforation [see Warnings and Precautions (5.4) ] Interstitial Lung Disease (ILD)/Pneumonitis [see Warnings and Precautions (5.5 )] Most common adverse reactions (≥ 20%) were rash, diarrhea, stomatitis, nausea, fatigue, vomiting, abdominal pain, edema, decreased appetite, and hemorrhage.
( 6.1 ) Most common laboratory abnormalities (≥ 20%) were decreased albumin, decreased calcium, decreased hemoglobin, increased aspartate aminotransferase, decreased lymphocytes, decreased platelets, increased alanine aminotransferase, decreased sodium, decreased white blood cells, decreased magnesium, increased alkaline phosphatase, increased creatinine, and decreased potassium. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Revolution Medicines, Inc. at 1-844-2-REVMED (1-844-273-8633) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1Clinical Trials 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 pooled safety population of RASONQUE described in the WARNINGS AND PRECAUTIONS section reflects exposure to RASONQUE 300 mg once daily in 241 patients with pancreatic adenocarcinoma enrolled in RASolute 302 and 184 patients with pancreatic adenocarcinoma enrolled in the open-label trial RMC-6236-001.
Metastatic Pancreatic Adenocarcinoma The safety of RASONQUE was evaluated in RASolute 302 [see Clinical Studies (14) ] . Patients with metastatic pancreatic adenocarcinoma received either RASONQUE 300 mg once daily (N = 241) or physician’s choice of standard of care (SOC) chemotherapy regimens (N = 214). Among patients who received RASONQUE, 52% were exposed for 6 months or longer and 2% were exposed for greater than one year.
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 discontinued due to rash (0.8%).
Adverse reactions leading to dose interruptions occurred in 69% of patients who received RASONQUE. Adverse reactions which required dose interruptions in ≥ 5% of patients were rash (27%), stomatitis (20%), fatigue (9%), diarrhea (8%), vomiting (8%), nausea (7%), and pyrexia (6%). Adverse reactions leading to dose reductions occurred in 37% of patients who received RASONQUE.
Adverse reactions which required dose reductions in ≥ 5% of patients were rash (18%), stomatitis (8%), and diarrhea (5%). 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. Table 3 and Table 4 summarize adverse reactions and laboratory abnormalities in RASolute 302, respectively.
Table 3: Adverse Reactions (≥ 10%) in Patients Who Received RASONQUE in RASolute 302 Adverse Reaction Graded per NCI CTCAE Version 5.0. RASONQUE N = 241 Physician’s Choice SOC Chemotherapy Regimens Chemotherapy: mFOLFIRINOX, gemcitabine and nab-paclitaxel, FOLFOX, or nal-IRI+5-FU/LV. N = 214 All Grades (%) Grade 3 or 4 (%) All Grades (%) Grade 3 or 4 (%) Skin and subcutaneous tissue disorders Rash Includes multiple related terms.
87 13 9 0 Dry skin 14 0 3 0 Pruritus 11 0.4 4 0 Gastrointestinal disorders Diarrhea 67 7 44 8 Stomatitis 56 12 19 3 Nausea 52 3 42 2 Vomiting 42 1 25 1 Abdominal pa…
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS Strong CYP3A Inhibitors with P-gp Inhibition : Avoid concomitant use. ( 7.1 ) Strong CYP3A Inhibitors without P-gp Inhibition : Reduce RASONQUE dosage. ( 2.4 ) Moderate CYP3A Inhibitors with or without P-gp Inhibition : Reduce RASONQUE dosage.
( 2.4 ) P-gp Inhibitors : Reduce RASONQUE dosage. ( 2.4 ) Cyclosporine A : Avoid concomitant use. ( 7.1 ) Strong CYP3A Inducers : Avoid concomitant use.
Increase RASONQUE dosage if concomitant use cannot be avoided. ( 2.4 , 7.1 ) Moderate CYP3A Inducers : Increase RASONQUE dosage. ( 2.4 ) P-gp Substrates : Take at least 4 hours apart from RASONQUE.
( 7.2 )
7.1Effects of Other Drugs on RASONQUE Table 5: Effects of Other Drugs on RASONQUE Strong or Moderate CYP3A Inhibitors with or without P-gp Inhibition Prevention or Management Strong CYP3A inhibitors with P-glycoprotein (P-gp) inhibition : Avoid concomitant use. Strong CYP3A inhibitors without P-gp inhibition : Reduce RASONQUE dosage to 150 mg once daily [see Dosage and Administration (2.4) ] . Moderate CYP3A inhibitors with P-gp inhibition : Reduce RASONQUE dosage to 100 mg once daily [see Dosage and Administration (2.4) ] .
Moderate CYP3A inhibitors without P-gp inhibition : Reduce RASONQUE dosage to 200 mg once daily [see Dosage and Administration (2.4) ] . Mechanism and Clinical Effect Daraxonrasib is a CYP3A and P-gp substrate. Moderate or strong CYP3A inhibitors with or without P-gp inhibition increase daraxonrasib exposure [see Clinical Pharmacology (12.3) ] , which may increase the risk of adverse reactions.
P-gp Inhibitors Prevention or Management Reduce RASONQUE dosage to 150 mg once daily [see Dosage and Administration (2.4) ] . Mechanism and Clinical Effect Daraxonrasib is a P-gp substrate. P-gp inhibitors increase daraxonrasib exposure [see Clinical Pharmacology (12.3) ] , which may increase the risk of adverse reactions.
Cyclosporine A Prevention or Management Avoid concomitant use of RASONQUE with systemic cyclosporine A or its derivatives. Mechanism and Clinical Effect Cyclosporine A or its derivatives and daraxonrasib bind to cyclophilin A. Coadministration of systemic cyclosporine A or its derivatives and RASONQUE may have the potential to alter daraxonrasib pharmacokinetics, efficacy, and safety.
Strong or Moderate CYP3A Inducers Prevention or Management Strong CYP3A inducers : Avoid concomitant use. If concomitant use cannot be avoided, increase RASONQUE dosage to 400 mg once daily [see Dosage and Administration (2.4) ] . Moderate CYP3A inducers : Increase RASONQUE dosage to 400 mg once daily [see Dosage and Administration (2.4) ] .
Mechanism and Clinical Effect Daraxonrasib is a CYP3A substrate. Strong CYP3A inducers reduce daraxonrasib exposure [see Clinical Pharmacology (12.3) ] , which may reduce the effectiveness of RASONQUE.
7.2Effects of RASONQUE on Other Drugs P-gp Substrates Take a P-gp substrate at least 4 hours apart from RASONQUE. Daraxonrasib is a P-gp inhibitor. Coadministration with RASONQUE increases exposure of P-gp substrates [see Clinical Pharmacology (12.3) ] , which may increase the risk of adverse reactions related to these substrates.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS Lactation : Advise women not to breastfeed. ( 8.2 )
8.1Pregnancy Risk Summary Based on findings in animals, RASONQUE can cause fetal harm when administered to pregnant women. There are no available data on RASONQUE use in pregnant women to inform a drug-associated risk. In an animal reproduction study, oral administration of daraxonrasib to pregnant female mice during the period of organogenesis resulted in adverse developmental outcomes including mortality, alterations to growth, and structural abnormalities at exposures ≥ 2.5 times the recommended dose based on AUC (see Data ) .
Advise pregnant women of the potential risk to a fetus. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data Daraxonrasib was administered orally to pregnant female mice during the period of organogenesis at doses of 25, 50, and 75 mg/kg/day.
Daraxonrasib at a dose of ≥ 50 mg/kg/day (≥ 2.5 times the exposure at the recommended dose based on AUC) was associated with post-implantation loss, reduced number of live fetuses, decreased fetal body weights, and malformations including eyes, limbs, palate, gonads, great vessels, kidneys, and bones.
8.2Lactation Risk Summary There are no data on the presence of daraxonrasib or its metabolites in human milk, the effects on the breastfed child, or the effects on milk production. Because of the potential for serious adverse reactions in the breastfed child, advise women not to breastfeed during treatment with RASONQUE and for 1 week after the last dose.
8.3Females and Males of Reproductive Potential RASONQUE can cause fetal harm when administered to pregnant women [see Use in Specific Populations (8.1) ] . Pregnancy Testing Verify pregnancy status in females of reproductive potential prior to initiating RASONQUE. Contraception Females Advise females of reproductive potential to use effective contraception during treatment with RASONQUE and for 1 week after the last dose.
Males Advise males with female partners of reproductive potential to use effective contraception during treatment with RASONQUE and for 1 week after the last dose.
8.4Pediatric Use The safety and effectiveness of RASONQUE have not been established in pediatric patients.
8.5Geriatric Use Of the 248 patients with pancreatic adenocarcinoma randomized to the RASONQUE arm in the RASolute 302 study, 54% (134 patients) were ≥ 65 years of age and 18% (45 patients) were ≥ 75 years of age. No overall differences in safety or efficacy were observed between patients who were ≥ 65 years of age and younger patients.
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary Based on findings in animals, RASONQUE can cause fetal harm when administered to pregnant women. There are no available data on RASONQUE use in pregnant women to inform a drug-associated risk. In an animal reproduction study, oral administration of daraxonrasib to pregnant female mice during the period of organogenesis resulted in adverse developmental outcomes including mortality, alterations to growth, and structural abnormalities at exposures ≥ 2.5 times the recommended dose based on AUC (see Data ) .
Advise pregnant women of the potential risk to a fetus. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data Daraxonrasib was administered orally to pregnant female mice during the period of organogenesis at doses of 25, 50, and 75 mg/kg/day.
Daraxonrasib at a dose of ≥ 50 mg/kg/day (≥ 2.5 times the exposure at the recommended dose based on AUC) was associated with post-implantation loss, reduced number of live fetuses, decreased fetal body weights, and malformations including eyes, limbs, palate, gonads, great vessels, kidneys, and bones.
🧒 Pediatric Use ▾
8.4Pediatric Use The safety and effectiveness of RASONQUE have not been established in pediatric patients.
🧓 Geriatric Use ▾
8.5Geriatric Use Of the 248 patients with pancreatic adenocarcinoma randomized to the RASONQUE arm in the RASolute 302 study, 54% (134 patients) were ≥ 65 years of age and 18% (45 patients) were ≥ 75 years of age. No overall differences in safety or efficacy were observed between patients who were ≥ 65 years of age and younger patients.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Daraxonrasib is an inhibitor of the RAS GTPase family. Daraxonrasib binds to cyclophilin A, resulting in a binary complex that binds to the active, GTP-bound state of RAS. The tri-complex inhibits RAS signaling by blocking interactions with downstream effectors and promoting GTP hydrolysis to the inactive GDP-bound state of RAS.
Daraxonrasib inhibition of wild-type and mutant variants of KRAS, NRAS, and HRAS induces tumor growth suppression and apoptosis. In RAS-dependent models of pancreatic adenocarcinoma, daraxonrasib treatment led to tumor growth inhibition and regression and is associated with antitumor immunity.
12.2Pharmacodynamics Exposure-Response Relationships Daraxonrasib exposure-response relationships and time course of pharmacodynamic response have not been fully characterized. Based on exposure and safety data from patients with pancreatic adenocarcinoma receiving 10 to 400 mg once daily of daraxonrasib (n = 466), higher daraxonrasib exposure was associated with higher incidence of dose interruption/reduction/discontinuation, Grade ≥ 3 adverse reactions, Grade ≥ 2 dermatologic reactions, mucositis/stomatitis, nausea/vomiting, and diarrhea.
Cardiac Electrophysiology At the recommended dosage, a mean increase in the QTc interval > 20 msec was not observed.
12.3Pharmacokinetics The pharmacokinetics of daraxonrasib were studied in healthy subjects and patients with advanced solid tumors, including patients with pancreatic adenocarcinoma treated with 300 mg once daily, and are presented as geometric mean (geometric percent coefficient of variation), unless otherwise specified. Daraxonrasib maximum concentration is 365 ng/mL (50%) and total systemic exposure (AUC) is 3760 ng·h/mL (46%). Daraxonrasib AUC increases in an approximately dose proportional manner whereas C max increases in a less than dose proportional manner over the dose range of 80 mg (0.27 times the recommended dose) to 300 mg.
Minimal to no accumulation was observed for AUC. Absorption Daraxonrasib median (min, max) time to reach maximum concentration (T max ) is approximately 2.2 hours (0.67, 8.0). Effect of Food No clinically significant differences in daraxonrasib pharmacokinetics were observed following administration of a high-fat, high-calorie meal (800 to 1000 calories, 50% from fat).
Distribution Daraxonrasib apparent (oral) volume of distribution during the terminal elimination phase is 1060 L (48%). Daraxonrasib plasma protein binding is approximately 98% in vitro and is not concentration-dependent. Daraxonrasib blood to plasma ratio is concentration-dependent and ranges from 1.7 to 2.6 in healthy subjects.
Elimination Daraxonrasib mean (SD) terminal elimination half-life is 9.2 (±2.7) hours with an apparent (oral) clearance (CL/F) of
80.4L/h (44%). Metabolism Daraxonrasib is primarily metabolized by CYP3A. Excretion After a single oral dose of radiolabeled daraxonrasib 220 mg to healthy subjects, approximately 93% of the dose was recovered in feces (51% unchanged) and approximately 1% was recovered in urine (1% unchanged).
Specific Populations No clinically significant differences in the pharmacokinetics of daraxonrasib were observed based on age (19 to 87 years old), sex, race (72% White, 11% Asian, 4% Black or African American), body weight (37 to 171 kg), ECOG PS (0, 1), tumor burden, CLcr 30 to 89 mL/min, or mild (total bilirubin > ULN to 1.5 × ULN or AST > ULN (with bilirubin normal)) or moderate (total bilirubin > 1.5 to 3 × ULN (with any AST level)) hepatic impairment per NCI-ODWG classification. The effects of CLcr < 30 mL/min or severe hepatic impairment (total bilirubin > 3 to 10 × ULN (with any AST level)) on daraxonrasib pharmacokinetics are unknown.
Drug Interaction Studies Clinical Studies and Model-Informed Approaches Strong CYP3A Inhibitors with P-gp Inhibition : Daraxonrasib AUC was observed to increase 5.1-fold following concomitant use of itraconazole 200 mg once daily (…
🧬 Mechanism of Action ▾
12.1Mechanism of Action Daraxonrasib is an inhibitor of the RAS GTPase family. Daraxonrasib binds to cyclophilin A, resulting in a binary complex that binds to the active, GTP-bound state of RAS. The tri-complex inhibits RAS signaling by blocking interactions with downstream effectors and promoting GTP hydrolysis to the inactive GDP-bound state of RAS.
Daraxonrasib inhibition of wild-type and mutant variants of KRAS, NRAS, and HRAS induces tumor growth suppression and apoptosis. In RAS-dependent models of pancreatic adenocarcinoma, daraxonrasib treatment led to tumor growth inhibition and regression and is associated with antitumor immunity.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING RASONQUE tablets are packaged in a bottle containing one desiccant and a child-resistant cap, available as follows: Strength Description Bottle NDC Number 100 mg blue, oval, biconvex, film-coated, debossed with “R” on one side and “100 M” on the other side 30 tablets 85219-101-01 150 mg blue, oval, biconvex, film-coated, debossed with “R” on one side and “150 M” on the other side 30 tablets 85219-104-01 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) [see USP Controlled Room Temperature].
📋 Description ▾
11 DESCRIPTION Daraxonrasib is an inhibitor of the RAS GTPase family. The molecular formula is C 44 H 58 N 8 O 5 S and the molecular weight is 811.06 g/mol. The chemical name is Cyclopropanecarboxamide, N -[(2 R ,14 S ,18 S )-1-ethyl-18,19,20,21-tetrahydro-2-[2-[(1 S )-1-methoxyethyl]-5-(4-methyl-1-piperazinyl)-3-pyridinyl]-25,25-dimethyl-15,22-dioxo-17 H -5,3-([4,2]- endo -thiazolopropano[1,3]- endo -pyridazinomethanoxypropano)-1 H -indol-14-yl]-2-methyl-, (1 S ,2 S )-.
Daraxonrasib has the following chemical structure: Daraxonrasib is a white to yellow crystalline solid; formulated as a spray-dried dispersion (SDD) and incorporated into a tablet for oral use. Daraxonrasib shows a pH-dependent aqueous solubility across the physiological pH range. Daraxonrasib thermodynamic solubility at 24 hours is greater than 10 mg/mL at pH 1.2, while daraxonrasib solubility is approximately 0.009 mg/mL at pH 6.8.
RASONQUE (daraxonrasib) is supplied as film-coated tablets for oral use containing 150 mg or 100 mg of daraxonrasib. Inactive ingredients in the tablet core are butylated hydroxytoluene, colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl cellulose, hydroxypropyl methylcellulose acetate succinate, magnesium stearate, mannitol, and microcrystalline cellulose. The tablet film coating contains FD&C blue #2/indigo carmine aluminum lake, glyceryl mono and dicaprylocaprate, polyvinyl alcohol, sodium lauryl sulfate, talc, and titanium dioxide. chemical structure
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling ( Medication Guide ). Dermatologic Reactions Advise patients of the risk of dermatologic reactions including rash and to use prophylactic measures. Advise patients to limit sun exposure and contact their healthcare provider if they experience dermatologic reactions [see Dosage and Administration (2.1) and Warnings and Precautions (5.1) ] .
Stomatitis Advise patients of the risk of stomatitis. Advise patients to contact their healthcare provider for new onset or worsening stomatitis [see Warnings and Precautions (5.2) ] . Diarrhea Advise patients to contact their healthcare provider if they experience new onset or worsening diarrhea [see Warnings and Precautions (5.3) ] .
Gastrointestinal Perforation Advise patients to contact their healthcare provider immediately if they experience severe abdominal pain or other symptoms of gastrointestinal perforation [see Warnings and Precautions (5.4) ] . Interstitial Lung Disease (ILD)/Pneumonitis Advise patients to contact their healthcare provider immediately if they experience new or worsening respiratory symptoms [see Warnings and Precautions (5.5) ] . Embryo-Fetal Toxicity Advise females to inform their healthcare provider if they are pregnant or become pregnant.
Inform females of the potential risk to a fetus [see Warnings and Precautions (5.6) ] . Advise females of reproductive potential to use effective contraception during treatment with RASONQUE and for 1 week after the last dose [see Warnings and Precautions (5.6) and Use in Specific Populations (8.3) ] . Advise males with female partners of reproductive potential to use effective contraception during treatment with RASONQUE and for 1 week after the last dose [see Warnings and Precautions (5.6) and Use in Specific Populations (8.3) ] .
Lactation Advise women not to breastfeed during treatment with RASONQUE and for 1 week after the last dose [see Use in Specific Populations (8.2) ] . Drug Interactions Advise patients to inform their healthcare provider of all concomitant medications, including prescription medicines, over-the-counter drugs, vitamins, and herbal products [see Drug Interactions (7.1) ] . Manufactured for: Revolution Medicines, Inc.
Redwood City, CA 94063 USA RASONQUE ™ is a trademark of Revolution Medicines, Inc. © 2026 Revolution Medicines, Inc. Pat.: http://www.revmed.com/patents/
💬 Medication Guide ▾
MEDICATION GUIDE RASONQUE TM (RAS-ON-cue) (daraxonrasib) tablets This Medication Guide has been approved by the U.S. Food and Drug Administration. Issued: 08/2026 What is the most important information I should know about RASONQUE?
RASONQUE can cause serious side effects, including: Skin reactions. Skin reactions may be severe. To help reduce your risk of skin reactions and protect your skin when starting and during treatment with RASONQUE: use a topical steroid cream on your face and chest use a moisturizing cream on your skin limit your time in the sun and use sunscreen (broad spectrum SPF 30 or higher) and other sun protection measures such as clothing and hats if you must be in the sun take any other medicines if prescribed by your healthcare provider Tell your healthcare provider right away if you develop any signs or symptoms of skin reactions, including: rash itching red, swollen, and painful skin around your finger or toenails dry skin cracked skin Swelling or sores in the mouth (stomatitis).
Mouth sores may be severe. Your healthcare provider may prescribe a mouthwash or other medicines to treat your mouth reactions. Tell your healthcare provider right away if you develop trouble eating, talking, swallowing, or develop any new or worsening signs or symptoms in your mouth, including: pain redness swelling ulcers or sores Diarrhea.
Diarrhea may be severe. If you develop diarrhea during treatment with RASONQUE, your healthcare provider may prescribe medicines to treat your diarrhea. Tell your healthcare provider right away if you develop new or worsening diarrhea or if the number of bowel movements you have in a day increases by 6 or more.
See “ What are the possible side effects of RASONQUE? ” for more information about side effects. What is RASONQUE? RASONQUE is a prescription medicine used to treat adults with a type of pancreatic cancer called pancreatic adenocarcinoma: that has spread to other parts of the body, and who have received at least 1 prior treatment or who cannot receive a combination of cancer treatments.
It is not known if RASONQUE is safe and effective in children. Before taking RASONQUE, tell your healthcare provider about all of your medical conditions, including if you: are pregnant or plan to become pregnant. RASONQUE can harm your unborn baby.
Females who are able to become pregnant: Your healthcare provider will do a pregnancy test before you start treatment with RASONQUE. Use effective birth control (contraception) during treatment with RASONQUE and for 1 week after the last dose. Tell your healthcare provider right away if you become pregnant during treatment with RASONQUE.
Males with female partners who are able to become pregnant: Use effective contraception during treatment with RASONQUE and for 1 week after the last dose. are breastfeeding or plan to breastfeed. It is not known if RASONQUE passes into your breast milk. Do not breastfeed during treatment and for 1 week after your last dose of RASONQUE.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. RASONQUE can affect the way other medicines work, and other medicines can affect how RASONQUE works, and may increase your risk of side effects. How should I take RASONQUE?
Take RASONQUE exactly as your healthcare provider tells you to take it. Do not change your dose or stop taking RASONQUE unless your healthcare provider tells you to. Take RASONQUE 1 time each day, at the same time each day.
Take RASONQUE with or without food. Swallow RASONQUE tablets whole. Do not chew, crush, or split tablets.
If you miss a dose, take the dose as soon as you remember. If it has been more than 4 hours, skip the missed dose and take your next dose at your next regularly scheduled time. Do not take 2 doses at the same time to make up for a missed dose.
If you vomit after taking a dose, do not take an extra dose. Take your next dose at your regularly scheduled…