Adagraxibu Chinese instruction manual

1. Common name: Adagrasib, Adagrasib

Product name:KRAZATI tablets

2. Indications:

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

3. Usage and dosage:

1. Before treatment: Select patients with locally advanced or metastatic non-small cell lung cancer to use adagrasiib based on the presence of KRAS G12C mutations in plasma or tumor specimens. If no mutations are detected in the plasma specimen, tumor tissue is tested.

2. Recommended dose: The recommended dose of adagrasiib is 600 mg orally twice daily until disease progression or unacceptable toxicity. Take it at the same time every day, with or without food.

3. Dose adjustment: Adverse events may occur during the treatment of patients with adagrasiib. The doctor will adjust the drug dosage according to the severity of the condition. The first dose will be reduced to 400 mg orally twice a day, and the second dose will be reduced to 600 mg orally once a day. A maximum of two dose reductions are allowed. Patients who cannot tolerate 600 mg once daily should permanently discontinue adagrasiib.

4. Adverse reactions:

In clinical studies of adagrasib, the most common (≥25%) adverse reactions were nausea, diarrhea, vomiting, fatigue, musculoskeletal pain, liver toxicity, renal impairment, edema, and dyspnea; the most common grade 3 or 4 (≥2%) laboratory abnormalities were lymphopenia, decreased hemoglobin, increased alanine aminotransferase, increased aspartate aminotransferase, hypokalemia, hyponatremia, increased lipase, and decreased leukocytes.

5. Storage:

Adagrasiib is available as a tablet. Tablets may be storedat room temperature between 20°C and 25°C (68°F and 77°F). Allow temperature to fluctuate between 15°C to 30°C (59°F to 86°F).

6.Special groups:

Based on animal studies, adagrasib may impair fertility in women and men of reproductive potential; due to the potential for serious adverse reactions in breastfed children, women are advised not to breastfeed during treatment with the drug and for 1 week after the last dose.

7. Mechanism of action:

Adagrasib is an irreversible inhibitor of KRAS G12C. It covalently binds to the mutated cysteine in KRAS G12C and locks the mutated KRAS protein in its inactive state, thereby preventing downstream signaling without affecting the wild-type KRAS protein. Adagrasibinhibits tumor cell growth and viability in cells harboring the KRAS G12C mutation and results in tumor regression with minimal off-target activity in a KRAS G12C-mutated tumor xenograft model .