Must-read for patients: An overview of the basic information in the Chinese instructions for sotorasibu (AMG510)

1. Generic names: Sotorasib,AMG510, Sotorasib

Product name:Lumakras, Lumykras

Other names: Sotolasib, Sotolasib, Luomanshu

2. Who can take sotorasib? Indications?

Sotorasiib (AMG510) is indicated for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic cancer (NSCLC), as determined by a U.S. Food and Drug Administration (FDA)-approved test, who have received at least one prior systemic therapy.

3. What are the side effects of sotolaxib?

The most common side effects of sotorasiib are diarrhea, musculoskeletal pain, nausea, fatigue, hepatotoxicity, and cough; the most serious side effects are pneumonia, hepatotoxicity, and diarrhea. The most common laboratory abnormalities are lymphopenia, decreased hemoglobin, increased aspartate aminotransferase, increased alanine aminotransferase, decreased calcium, increased alkaline phosphatase, increased urinary protein, and decreased sodium.

4. How to take sotorasibu?

The recommended dose of sotoraxib is 960 mg orally once daily until disease progression or unacceptable toxicity. Take your daily dose of sotorasiib at the same time each day, with or without food. Swallow the tablet whole. Do not chew, crush, or split tablets. For patients who have difficulty swallowing solids, sotoraxib tablets can be dispersed in 120 mL of non-carbonated room temperature water without crushing. No other liquids should be used. Stir or swirl the cup for about 3 minutes until the tablets are dispersed into small pieces (the tablets will not completely dissolve), then drink immediately or within 2 hours, swallowing the tablet dispersion without chewing the tablets. Rinse the container with an additional 120 mL of water and drink, stirring the mixture again to ensure tablet dispersion if the mixture is not consumed immediately.

5. How to store Sotoraxibu?

Sotorasiib is available as a tablet and should be stored at 20°C to 25°C (68°F to 77°F), with an allowable drift of 15°C to 30°C (59°F to 86°F).

6. How does Sotolasib work?

Sotoracib is an inhibitor of KRAS G12C, a tumor-limiting, mutated, oncogenic form of the RAS GTPase KRAS. Sotorasiib forms an irreversible covalent bond with the KRAS G12C-unique cysteine, locking the protein in an inactive state, preventing downstream signaling without affecting wild-type KRAS, and promoting apoptosis only in the KRAS G12C tumor cell line. Sotorasiib inhibits KRASG12C in vitro and in vivo with minimal detectable off-target activity. Treatment with sotoraxib resulted in tumor regression and prolonged survival in a mouse tumor xenograft model and was associated with anti-tumor immunity in the KRAS G12C model.

7. What will happen if you take too much sotorasiib?

Data on overdose with sotoraxib are not readily available. However, in clinical trials, no evidence of dose-limiting toxicities was found. Adverse reactions such as diarrhea, nausea, vomiting, fatigue, and elevated transaminases may occur in patients who overdose, with increased risk and severity.

8. Who cannot use Sotoraxibu?

Due to the potential for serious adverse reactions in breastfed children, women are advised not to breastfeed during treatment with sotoraxib and for 1 week after the last dose