sotorasib AMG510 Sotoxen of Bengal

[Product Name] Sotorasib

[English Name] Sotorasib

[Specification] 120 mg × 56 tablets/box

[Manufacturer] Everest Pharmaceuticals (Bangladesh)

Sotorasib is a novel targeted therapy drug primarily used for the treatment of certain mutated tumors in non-small cell lung cancer (NSCLC). This medication targets specific gene mutations to inhibit tumor growth and metastasis, thereby improving patient survival rates and quality of life. The use of Sotorasib requires strict adherence to specific administration instructions and dosage regimens to ensure both efficacy and safety.

[Indications]

Sotorasib is primarily indicated for patients with NSCLC whose tumors harbor the *KRAS* G12C gene mutation. Prior to initiating Sotorasib treatment, physicians will conduct genetic mutation testing to confirm the presence of this specific mutation in the patient's tumor, as only tumors with this mutation are responsive to Sotorasib therapy. Sotorasib is not indicated for other types of lung cancer or for patients whose tumors do not carry the *KRAS* G12C mutation.

[Recommended Dosage]

Sotorasib is typically administered orally as a tablet, taken once daily at the same time each day. Ideally, the medication should be taken at a fixed time—either before or after a meal—to ensure consistent absorption and distribution.

The recommended dosage for Sotorasib is 960 mg (8 tablets), taken once daily until disease progression occurs or until unacceptable toxicity develops. The tablets should be swallowed whole; do not chew, crush, or split the tablets.

[Dosage Adjustments]

1. Dosage Adjustments for Adverse Reactions

Table 1 summarizes the dosage reduction steps for this product. Table 2 provides specific dosage adjustment guidelines for adverse reactions.

In the event of adverse reactions, a maximum of two dosage reductions are permitted. If the patient is unable to tolerate the minimum dosage of 240 mg once daily, treatment with this product should be discontinued. Table 1. Recommended Dose Reductions for Adverse Reactions

Table 2. Recommended Dose Adjustments for Adverse Reactions

ALT = Alanine aminotransferase; AST = Aspartate aminotransferase; ULN = Upper limit of normal

a Grading defined by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0

2. Use with Acid-Reducing Agents

Avoid co-administration of proton pump inhibitors (PPIs) and H2-receptor antagonists with this product. If acid-reducing therapy cannot be avoided, administer this product at least 4 hours before or 10 hours after taking a local antacid.

[Adverse Reactions]

The 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, hypocalcemia, increased alkaline phosphatase, proteinuria, and hyponatremia.

Product Specifications

Product Name: Sotorasib (AMG510, Sotoxen)

Common Name: Sotorasib

Composition: Sotorasib

Dosage Form: Tablets

Specification: 120 mg × 56 tablets/box

Manufacturer: Everest Pharmaceuticals (Bangladesh)

Indications: This product 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.

Dosage and Administration:The recommended dose is 960 mg (8 tablets) taken orally once daily, until disease progression or unacceptable toxicity occurs.