What are the precautions for Sotorasib?

Sotorasib (Sotorasib) is a new drug for the treatment of KRAS G12C mutant non-small cell lung cancer (NSCLC). It has been approved by the US Food and Drug Administration (FDA) for marketing. Sotorasib is being studied for the treatment of colorectal cancer, appendiceal cancer and other diseases. Patients should pay attention to the occurrence of hepatotoxicity, interstitial lung disease (ILD)/pneumonitis and other events during the treatment of diseases with sotorasiib.

1. Hepatotoxicity:

Hepatotoxicity may lead to drug-induced liver injury and hepatitis in patients. In the CodeBreaK 100 trial, the incidence of hepatotoxicity was 1.7% and 1.4%, respectively, and 18% of patients had elevated alanine aminotransferase (ALT)/aspartate aminotransferase (AST). The median time to first ALT/AST elevation was 9 weeks. ALT/AST elevations occurred in 7% of patients resulting in dose interruption or reduction. Sotoraxib was discontinued due to elevated ALT/AST in 2.0% of patients. In addition to dose interruption or reduction of sotorasiib, 5% of patients received corticosteroids for treatment of hepatotoxicity.

Patients need to monitor liver function tests (such as ALT, AST, and total bilirubin) every 3 weeks for 3 months before starting treatment with sotoraxib. Patients with elevated transaminases and/or bilirubin should undergo frequent testing. Depending on the severity of the patient's adverse reactions, sotoraxib should be discontinued, the dose reduced, or permanently discontinued.

2. Interstitial lung disease (ILD)/pneumonia:

InCodeBreaK 100 trial , Interstitial lung disease/pneumonitis occurred in 0.8% of patients, all cases were grade 3 or 4 at onset, and 1 patient died. The median time to first episode of interstitial lung disease/pneumonitis was 2 weeks, and 0.6% of patients discontinued sotorasib due to ILD/pneumonitis. Monitor patients for new or worsening symptoms of ILD/pneumonitis (e.g., dyspnea, cough, fever) and discontinue sotoraseib immediately in patients with suspected ILD/pneumonitis or permanently if no other potential cause of ILD/pneumonitis is identified.

3. Special groups:

Because sotoracib may cause potentially serious adverse reactions in breastfed children, women are advised not to breastfeed during treatment with sotoracib and for 1 week after the last dose

SotoracibThe original drug has not yet been launched in China, so it is not covered by medical insurance. Domestic patients cannot yet purchase this drug. The price of Hong Kong original research versionsotorasibuSpecifications120mg*240 tablets is about RMB 80,000, and the European original research version 120mg*240 tablets is priced at about RMB 44,040 (the price may fluctuate due to the exchange rate), which is relatively expensive. There are also cheaper generic drugs for sale in other countries. The specifications of the Laos Element Pharmaceutical Factory are 120mg*56 tablets and the price is around 4800 yuan (the price may fluctuate due to the exchange rate). The price is relatively cheap. The ingredients of foreign generic drugs are basically the same as the original drugs.