Sotoraib Sotorasib 120mg 120 tablets Approval No. 07 L 0986/23 Expiry Date 03-7-2026

【Indications】 Sotoraib (Sotorasib) is an inhibitor of the RAS GTPase family.

Indicated for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring a KRAS G12C mutation who have received at least one prior systemic therapy.

Recommended dose: 960 mg (8 tablets) orally once daily until disease progression or unacceptable toxicity occurs.

• The first dose is reduced to 480 mg (4 tablets) orally once a day

• The second dose is reduced to 240 mg (2 tablets) orally once a day

Recommended dose adjustments for adverse reactions

Hepatotoxicity

• Grade 2 (elevated alanine aminotransferase or aspartate aminotransferase with symptoms)

• Withhold the drug until grade ≤1 or baseline level;

• After recovery, resume tamoxifen at the next lower dose level

• Grade 3 (elevated alanine aminotransferase or aspartate aminotransferase)

• ALT or AST > 3 × ULN and total bilirubin > 2 × ULN Permanently discontinue this product

Interstitial lung disease (ILD)/pneumonitis of any grade

• If ILD/pneumonitis is suspected, discontinue use of this product;

• If ILD/pneumonitis is confirmed, permanently discontinue this drug

Nausea or vomiting grade 3-4

• Withhold the drug until grade ≤1 or baseline level;

• After recovery, resume tamoxifen at the next lower dose level

Diarrhea grade 3-4

• Withhold the drug until grade ≤1 or baseline level;

• After recovery, resume tamoxifen at the next lower dose level

Other adverse reactions grade 3-4

• Withhold the drug until grade ≤1 or baseline level;

• After recovery, resume tamoxifen at the next lower dose level

Adverse Reactions

1. The most common adverse reactions (≥20%) were diarrhea, musculoskeletal pain, nausea, fatigue, liver injury, and cough.

2. The most common laboratory abnormalities ≥ 25% were lymphocytopenia, decreased hemoglobin, increased aspartate aminotransferase, increased alanine aminotransferase, decreased calcium, increased alkaline phosphatase, increased urine protein, and decreased sodium.

3. Serious adverse reactions (3.4%) were respiratory failure, pneumonia, cardiac arrest, heart failure, gastric ulcer, and pneumonia.

Storage method

• Store at 20°C to 25°C. Storage within a certain range (15°C to 30°C) is permitted.

Drug interactions

1. Sotolacib should be avoided in combination with acid-suppressing drugs such as proton pump inhibitors and H2 receptor antagonists. If it is necessary to use them together, they should be taken 4 hours before or 10 hours after the acid-suppressing drug.

2. Coadministration of sotolacizumab with strong CYP3A4 inducers should be avoided.

3. Coadministration of sotolacizumab with CYP3A4 substrates should also be avoided. If coadministration cannot be avoided, adjust the substrate dose according to its prescribing information.

4. Co-administration of sotolacib with P-gp substrates (digoxin) should be avoided whenever possible.

Precautions

• Hepatotoxicity: Monitor liver function every 3 weeks during the first 3 months after starting medication;

• Monitor monthly thereafter or more frequently as clinically indicated for patients who develop elevated transaminases or bilirubin.

• Depending on the severity of the adverse reaction, withhold, reduce the dose, or permanently discontinue the drug.

• Interstitial Lung Disease (ILD)/Pneumonitis: Monitor for new or worsening pulmonary symptoms.

Patients need to pay attention to the above precautions when using sotolacizumab for treatment to avoid harm.