Sotoracib (AMG510) Instructions

1. Common nameSotorasibu

Product name:Lumakras

Full names:Sotorasiib,Lumakras,AMG510, Sotorasiib

2. Indications

Sotoracib (AMG510)is indicated for the treatment of adult patients with KRAS G12C- mutated locally advanced or metastatic non-small cell lung cancer(NSCLC).

3. Dosage and usage

Recommended dose: 960mg, taken orally once daily.

4. Dosage form and strength

Tablets: 320mg, 120mg.

5. Contraindications

None

6. Warnings and Notes

1Hepatotoxicity

Sotoraxib can cause hepatotoxicity, which may lead to drug-induced liver injury and hepatitis. 357 treated with sotorasiib in Code Cracking100of patients. The incidence of hepatotoxicity was 1.7% (all grades) and 1.4% (grade 3). Alanine aminotransferase (ALT)/Aspartate aminotransferase (AST) is elevated; 6% is grade three, and 0.6% is grade four. The median time to first onset of ALT/AST elevation was 9 weeks (range: 0.3 to 42 weeks). 7%of patients experienced ALT/AST elevations leading to dose interruption or reduction. Sotoracib was discontinued due to elevated ALT/AST in 2.0% of patients. In addition to dose interruption or reduction, 5%of patients received corticosteroids for treatment of hepatotoxicity.

Monitor liver function tests (ALT, < /span>ASTand total bilirubin) and then monthly or as clinically indicated, more frequently in patients with elevated transaminases and / or bilirubin. Discontinue, reduce the dose, or permanently discontinue sotoraxib based on the severity of the adverse reaction.

2.Interstitial lung disease (ILD)/Pneumonia

Sotoracib can cause fatalILD/pneumonia. ILD/The median time to first onset of pneumonia was 2 weeks. 0.6%of patients discontinued sotoraxib due to ILD/pneumonitis. Monitor patients for new or worsening symptoms of ILD/pneumonia (e.g., dyspnea, cough, fever). If no other potential cause of ILD/pneumonitis is identified, sotorasib should be discontinued immediately and permanently discontinued in patients with suspected ILD/pneumonitis.

7. Adverse reactions

The most common adverse reactions (≥ 20%) were diarrhea, musculoskeletal pain, nausea, fatigue, hepatotoxicity and cough. The most common laboratory abnormalities(≥ 25%)are lymphopenia, decreased hemoglobin, increased aspartate aminotransferase, increased alanine aminotransferase, decreased calcium, increased alkaline phosphatase, increased urinary protein, and decreased sodium.

8. Drug interactions

Acid-reducing agents: Avoid combinations with proton pump inhibitors (PPIs) and H2 receptor antagonists. If use of acid-reducing agents cannot be avoided, take LUMAKRAS 4 hours before or 10 hours after topical antacid use.

StrongCYP3A4Inducers: Avoid coadministration with strongCYP3A4 inducers.

CYP3A4Substrates: Avoid coadministration withCYP3A4substrates as minimal concentration changes may result in therapeutic failure of the substrate. If coadministration cannot be avoided, adjust the substrate dosage according to its prescribing information.

P-gpSubstrates: Avoid coadministration withP-gpsubstrates as minimal concentration changes may result in severe toxicity. If coadministration cannot be avoided, reduce the base dose according to its prescribing information.

9. Used by specific groups of people

Lactation:It is recommended not to breastfeed.

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