LuciDarax(Daraxonrasib) Medication Guide

LuciDarax(Daraxonrasib) is an oral pan-RAS inhibitor for adults with metastatic pancreatic adenocarcinoma whose disease has failed at least one prior line of systemic therapy or who are not suitable for multi-drug combination systemic therapy. The recommended dose is 300 mg once daily.

Pre-treatment Assessments for LuciDarax(Daraxonrasib)

1. Confirm disease: The pathological type must be metastatic pancreatic adenocarcinoma, and the patient must have received at least one prior systemic therapy or be unsuitable for multi-drug combination systemic therapy.

2. For women of childbearing potential, confirm pregnancy status first.

3. Reduce the risk of moderate-to-severe skin reactions: Apply topical corticosteroids to the face and chest. Use moisturizer over the body. Limit sun exposure; use broad-spectrum sunscreen with SPF 30 or higher; add clothing, hats, and other physical barriers when necessary.

LuciDarax(Daraxonrasib) Dosing Guide

1. Dose: 300 mg orally once daily until disease progression or unacceptable toxicity.

2. Time: Take at the same fixed time every day.

3. Food: May be taken with or without food.

4. Administration: Swallow whole; do not chew, crush, or split.

5. Missed dose: If more than 4 hours past the scheduled time, skip the dose and take the next dose at the regular time; do not take a double dose at one time.

6. Vomiting: If vomiting occurs after taking the dose, do not take an extra dose; take the next dose at the regular time.

Monitoring During LuciDarax(Daraxonrasib) Treatment

During treatment with LuciDarax(Daraxonrasib), regularly monitor skin and soft tissue symptoms, oral and mucosal symptoms, frequency and character of bowel movements, abdominal symptoms, and new or worsening pulmonary symptoms.

Diarrhea occurs earliest, with median first onset on Day 3; skin toxicity median Day 13; stomatitis median Day 22; interstitial lung disease/pneumonitis median Day 111; and gastrointestinal perforation median Day 134.

LuciDarax(Daraxonrasib) Dose Adjustments

General Principles

Dose adjustment principles for LuciDarax(Daraxonrasib):

First dose reduction: 200 mg once daily.

Second dose reduction: 150 mg once daily.

Discontinuation: If 150 mg once daily is not tolerated, permanently discontinue.

Dose Adjustments for Adverse Reactions

1. Skin toxicity: For Grade 2, consider withholding until recovery to Grade 1 or lower, initiate supportive care, then resume at the original dose or one dose level lower; for Grade 3, withhold, initiate supportive care, and consider dermatology consultation, then resume at one dose level lower after recovery; for Grade 4, permanently discontinue.

2. Stomatitis and diarrhea: Grade 2 and Grade 3 follow the same pathway, both resuming at one dose level lower; Grade 4 requires permanent discontinuation.

3. Gastrointestinal perforation: For Grade 3, withhold until recovery to Grade 1 or lower, and if appropriate resume at one dose level lower; for Grade 4, permanently discontinue.

4. Interstitial lung disease/pneumonitis: For Grade 2, after withholding, if appropriate, resume at one dose level lower; if Grade 2 recurs or Grade 3 to 4 occurs, permanently discontinue.

5. Nausea or vomiting: For Grade 3, withhold, initiate or adjust the antiemetic regimen, and resume at one dose level lower after recovery; for Grade 4, permanently discontinue.

6. Other adverse reactions: For Grade 3, withhold until recovery to Grade 1 or lower or baseline, then resume at one dose level lower after recovery; for Grade 4, permanently discontinue.

Dose Adjustments for Concomitant Medications

1. With a strong CYP3A inhibitor that does not inhibit P-gp: reduce to 150 mg once daily.

2. With a moderate CYP3A inhibitor that inhibits P-gp: reduce to 100 mg once daily.

3. With a moderate CYP3A inhibitor that does not inhibit P-gp: reduce to 200 mg once daily.

4. With a P-gp inhibitor: reduce to 150 mg once daily.

5. With a strong CYP3A inhibitor that inhibits P-gp: avoid concomitant use.

6. With a strong or moderate CYP3A inducer: increase to 400 mg once daily.

Important Note: LuciDarax(Daraxonrasib) is a prescription drug. The dose and timing of dose reduction must be determined by a physician. Do not adjust or stop the drug by yourself.