SOTORMAKS Laos State-owned Plant No. 2 sotorasib 120mg 112tables

Drug Name

Generic Name: Sotorasib
Product Name: SOTORMAKS

Indications

Sotorasib is indicated for the treatment of patients with:

• KRAS G12C mutation-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) : For patients whose disease has progressed after at least one prior systemic therapy.

Note : The presence of KRAS G12C mutation in the patient must be confirmed by an approved companion diagnostic test prior to use.

Mechanism of action

Sotorasib is a covalent inhibitor of KRAS G12C . KRAS G12C is a common gene mutation in cancer that can activate downstream signaling pathways, thereby promoting tumor cell growth and survival. Sotorasib selectively binds to the mutation site of KRAS G12C protein, inhibits its activity, and blocks the growth signal of tumor cells.

Dosage

1. Recommended dose :

   • The recommended dose of sotorasib is 960 mg (8 120 mg tablets) taken orally once daily.
   • May be taken with or without food.

2. Directions :

   • Tablets should be swallowed whole and should not be crushed, chewed or dissolved.
   • If you miss a dose and it is less than 6 hours until your next dose, skip that dose and continue with your next dose.

3. Dosage adjustments :

   • If serious adverse reactions occur (e.g., hepatotoxicity or gastrointestinal intolerance), dose interruption or reduction may be necessary.
   • The commonly used dosage adjustment scheme is:
     • 960 mg → 480 mg → 240 mg until symptoms are tolerated.

Precautions

1. Side Effect Monitoring :

   • Common side effects (occurring in ≥20% of patients): diarrhea, nausea, vomiting, fatigue, musculoskeletal pain, and elevated liver enzymes (ALT/AST).
   • Serious side effects : hepatotoxicity, interstitial lung disease (ILD)/pneumonitis, etc.

2. Use in special populations :

   • Hepatic impairment : Use with caution in patients with moderate to severe hepatic impairment.
   • Renal impairment : No dosage adjustment is required for patients with mild and moderate renal impairment, but patients with severe renal impairment should consult a physician.
   • Pregnant and lactating women : Not recommended for use during pregnancy as it may be harmful to the fetus; lactating women are advised to stop breastfeeding or stop taking the medication.

3. Drug Interactions :

   • CYP3A4 inducers (such as rifampicin, carbamazepine) may reduce the plasma concentration of Sotorasib and their co-use should be avoided.
   • CYP3A4 inhibitors (such as ketoconazole) may increase blood drug concentrations and should be used with caution.
   • Acid inhibitors (such as proton pump inhibitors) may affect drug absorption, and the dosage should be adjusted according to the doctor's advice.

4. Interstitial Lung Disease (ILD)/Pneumonitis :

   • If a patient experiences unexplained dyspnea or lung symptoms, treatment should be suspended immediately and a comprehensive evaluation should be performed.

Contraindications

• Sotorasib is contraindicated in patients with a history of severe allergic reaction to it or its components.

Storage conditions

• Store at 20°C to 25°C away from moisture and light.
• Keep medicines out of the reach of children.

Important Tips

1. Liver and lung functions need to be monitored regularly during treatment to detect potential adverse reactions in a timely manner.
2. This drug can only delay disease progression and needs to be combined with other therapies or long-term follow-up for comprehensive management.
3. If serious adverse reactions occur, please contact your doctor immediately.

Note : The above content is for reference only. The specific plan should be based on the professional advice of doctors and pharmacists. If you need more help, please let me know!