What are the contents of the Chinese instruction manual of Sotoraxibu?

Drug name
Common name: Sotoraxibu
English name: Sotorasib
Product name: Lumakras (the product name may be different in some areas)
Ingredients
The main ingredient of this product is sotoraxibu. Excipients include microcrystalline cellulose, lactose monohydrate, hydroxypropyl cellulose, polyvinylpyrrolidone, magnesium stearate, etc.
Indications
Sotorasiib is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring a KRAS G12C mutation who are confirmed positive for the KRAS G12C mutation by a companion diagnostic test approved by the FDA or other recognized agency and whose disease has progressed after at least one prior systemic therapy.
Usage and dosage

The recommended dose is 960mg, taken orally once daily. Tablets should be swallowed whole, not crushed, chewed or taken separately, with or without food. If you miss a dose and it is more than 6 hours before the next dose, you can take it in time; if it is less than 6 hours, skip the missed dose and continue taking the medicine as originally planned.

Contraindications
It is contraindicated for those who are allergic to sotoraxibu or any ingredients of this product.
Things to note
1. Hepatotoxicity: Sotoraxib may cause an increase in transaminase, and liver function should be tested regularly during use. If grade ≥3 hepatotoxicity occurs, the drug should be suspended and the dose should be adjusted or discontinued as necessary.
2. Pulmonary toxicity: Drug-related interstitial lung disease or pneumonia may occur during treatment. Once suspected, the medication should be suspended and evaluated. Once confirmed, the medication must be permanently discontinued.
3. Gastrointestinal reactions: Diarrhea, nausea, and vomiting are common and can be treated symptomatically if necessary.
4. Drug interactions: Sotoracib is a substrate of CYP3A enzyme. Strong CYP3A inducers or inhibitors may affect its blood concentration. Pay attention to drug combinations when using it.
5. Medication for pregnant and lactating women: Use by pregnant women may cause harm to the fetus, so the use of sotorasibu during pregnancy should be avoided. It is unknown whether sotorasiib is excreted in breast milk, and breastfeeding should be suspended during treatment.
Adverse reactions
Common adverse reactions include diarrhea, nausea, fatigue, myalgia, decreased appetite, elevated transaminases, etc.
Serious adverse reactions include hepatotoxicity, interstitial lung disease/pneumonitis, etc. Most adverse reactions can be managed with dose adjustment, supportive care, or short-term discontinuation of the drug. Some patients may need to permanently discontinue the drug.
Drug Interactions
Concomitant use with strong CYP3A inducers (such as rifampicin) may reduce sotoraxib plasma concentrations.
Coadministration with CYP3A inhibitors (such as ketoconazole) may increase sotoraxib concentrations.
Sotorasiib may also induce the metabolism of other drugs, and attention should be paid to the risks of concomitant use with sensitive CYP3A substrate drugs.
Pharmacokinetics
Sotoracib is rapidly absorbed after oral administration, with the peak time being 1 to 2 hours after taking the drug. Exposure increases proportionally with dose within a certain range, and the half-life is approximately 5 hours. It is mainly metabolized by the liver and excreted in small amounts through urine.
Storage
Store at room temperature (15°C to 30°C), away from light and moisture. Keep out of reach of children.
Packaging specifications
The common packaging of sotoraxibu is 120 tablets/bottle, each tablet is 240mg.
Approval number and marketing authorization holder
Approval numbers may vary according to different countries or regions.
The marketing authorization holder is Amgen Inc.
Supplementary Notes
KRAS G12C mutation status needs to be tested using an approved companion diagnostic before treatment. Efficacy and safety should be evaluated periodically during treatment with sotoraxib, including imaging evaluation and laboratory testing. If unacceptable toxicity occurs, dosage adjustment or discontinuation of the drug is required according to the instructions.
Reference: https://www.lumakras.com/