Laos Element Pharmaceuticals Sotorasibu Instructions

1. Generic name: sotoraxibu (AMG510)

Product name:Lumakras

Full names: Sotorasibu, Lumakras, AMG510, Sotorasibu

2. Indications

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

Three. Dosage and usage

The recommended dose is960mg once daily and continued until disease progression or unacceptable toxicity occurs.

Four. adverse reactions

1.Hematology: lymphopenia (up to48%), hemoglobin reduction(< span>up to43%), increased activated partial thromboplastin time(up to23%), anemia

2.Gastrointestinal system: Diarrhea (up to42%), nausea(up to26%), vomiting(up to17%), constipation(up to 16%), abdominal pain(including abdominal pain, upper abdominal pain, lower abdominal pain; up to 15%)

3.Liverviscera: ASTincreased(up to 39%), ALTincreased(up to 38%) , liver toxicity(including ALT elevation, AST elevation, blood bilirubin elevation, drug-induced liver injury, hepatitis, hepatotoxicity, liver function test elevation, transaminase elevation; up to 25%)

4.Musculoskeletal: Musculoskeletal pain (Including back pain, bone pain, musculoskeletal chest pain, musculoskeletal discomfort, musculoskeletal pain, myalgia, neck pain, non-cardiac Chest pain, pain in limbs; up to 35%), joint pain (up to 12%)

5.Urogenital: Increased urinary protein (up to29%), Urinary tract infection

6.Respiratory system: Cough (Including cough, sputum, upper respiratory tract cough syndrome; up to 20%), shortness of breath(Including dyspnea, exertional dyspnea; up to 16%), pneumonia(Including pneumonia, aspiration pneumonia, bacterial pneumonia, staphylococcal pneumonia; up to 12%)

7.Cardiovascular: Hypertension, Cardiac arrest, heart failure

8.Metabolism: Decreased appetite (Up to13%), Hypokalemia, Hyponatremia, Hypocalcemia

9.Others: Reduced calcium (up to35%), increased alkaline phosphatase(< /span>Up to33%), Sodium reduction(Up to28%), Fatigue(Including fatigue and weakness; up to 26%), albumin reduction (up to 22% ), edema(including generalized edema, localized edema, edema, peripheral edema, periorbital edema, testicular edema; up to 15%), fever

Five. 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 with CYP3A4 substrates as minimal concentration changes may result in therapeutic failure of the substrate.

6. Things to note

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 sotoraxib.

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

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