Instructions for Sotorasibu produced by Bangladesh Zisika Pharmaceuticals

1. Indications and Usage

Sotoracib (AMG510)is an inhibitor of theRAS GTPenzyme family and is indicated for the treatment of adult patients with the following diseasesKRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer(NSCLC), as determined by an FDA-approved test and who have received at least one prior systemic therapy.

2. Dosage and usage

Recommended dose: 960mg, taken orally once daily.

Swallow tablet whole with or without food.

Three. Dosage form and strength

Tablets: 320mg, 120mg.

Four. Contraindications

No.

Five. Warnings and Precautions

Hepatotoxicity:Monitor liver function tests every 3 weeks for the first 3 months of treatment and then monthly as clinically indicated. Depending on severity, withhold, reduce dose, or permanently discontinue soteracib.

Interstitial Lung Disease(ILD)/Pneumonia:Monitor for new or worsening pulmonary symptoms. For suspected ILD/pneumonia, discontinue soteracib immediately or permanently if no other potential cause of ILD/pneumonia is identified.

6. Adverse reactions

Most common adverse reactions(≥ 20%)are 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.

7. Drug interactions

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

StrongCYP3A4Inducers:Avoid coadministration with strongCYP3A4 inducers.

CYP3A4Substrates:Avoid coadministration with CYP3A4 substrates 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-gpsubstrate:Avoid coadministration with P-gpsubstrate as minimal concentration changes may result in severe toxicity. If coadministration cannot be avoided, reduce the base dose according to its prescribing information.

8. Use among specific groups of people

Lactation:It is recommended not to breastfeed.

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