Revision Year: 2026
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.
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)]:
The recommended dosage of RASONQUE is 300 mg orally once daily until disease progression or unacceptable toxicity.
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* | 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 or baseline. • Resume RASONQUE at the next lower dose level. |
| Grade 4 | • Permanently discontinue. |
* Graded per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0.
Reduce the dosage of RASONQUE from 300 mg once daily to 150 mg once daily when used concomitantly with a strong CYP3A inhibitor without P-gp inhibition [see Drug Interactions (7.1)].
After the strong CYP3A inhibitor without P-gp inhibition has been discontinued for 5 days or 3 to 5 half-lives, whichever is longer, resume the RASONQUE dosage taken prior to initiating the inhibitor.
Reduce the dosage of RASONQUE from 300 mg once daily to 100 mg once daily when used concomitantly with a moderate CYP3A inhibitor with P-gp inhibition [see Drug Interactions (7.1)].
After the moderate CYP3A inhibitor with P-gp inhibition has been discontinued for 3 to 5 half-lives, resume the RASONQUE dosage taken prior to initiating the inhibitor.
Reduce the dosage of RASONQUE from 300 mg once daily to 200 mg once daily when used concomitantly with a moderate CYP3A inhibitor without P-gp inhibition [see Drug Interactions (7.1)].
After the moderate CYP3A inhibitor without P-gp inhibition has been discontinued for 3 to 5 half-lives, resume the RASONQUE dosage taken prior to initiating the inhibitor.
Reduce the dosage of RASONQUE from 300 mg once daily to 150 mg once daily when used concomitantly with a P-gp inhibitor [see Drug Interactions (7.1)].
After the P-gp inhibitor has been discontinued, resume the RASONQUE dosage taken prior to initiating the inhibitor.
If a strong CYP3A inducer cannot be avoided, increase the dosage of RASONQUE from 300 mg once daily to 400 mg once daily when used concomitantly with a strong CYP3A inducer [see Drug Interactions (7.1)].
After discontinuing use of the strong CYP3A inducer, resume RASONQUE dosage (7 to 14 days after discontinuing the strong CYP3A inducer) that was taken prior to initiating the inducer.
Increase the dosage of RASONQUE from 300 mg once daily to 400 mg once daily when used concomitantly with a moderate CYP3A inducer [see Drug Interactions (7.1)].
After discontinuing use of the moderate CYP3A inducer, resume RASONQUE dosage (7 to 14 days after discontinuing the moderate CYP3A inducer) that was taken prior to initiating the inducer.
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].
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