Sotorasib(Lumakras)Sotoldx

Introduction of Sotorasib

Sotorasib binds to the abnormal protein within cancer cells, inhibits its activity, and interferes with the chemical signaling required for cancer cell growth and spread, while also promoting cancer cell apoptosis.

Indications

Sotorasib monotherapy is indicated for adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to prior platinum-based chemotherapy and/or anti-PD-1/PD-L1 immunotherapy.

Overview

Dosage and Administration

Sotorasib therapy should be initiated under the guidance of a physician experienced in the use of antineoplastic agents.Presence of KRAS G12C mutation must be confirmed by a validated test prior to treatment initiation.

Recommended Dose

The recommended dose of sotorasib is 960 mg (eight 120 mg tablets) orally once daily at the same time each day, with or without food.

Duration of Treatment

Continue sotorasib until disease progression or unacceptable toxicity.

Missed Dose

If less than 6 hours have passed from the scheduled time, take the dose as normal.If more than 6 hours have passed, skip the dose and resume the regular schedule the next day. Do not double the dose.If vomiting occurs after dosing, do not take an extra dose; continue regular dosing the next day.

Administration Instructions

Swallow tablets whole.For patients with difficulty swallowing solids:Disperse tablets in 120 mL of room-temperature, non-carbonated drinking water without crushing. Stir gently until dispersed into small particles (not fully dissolved). Drink immediately.Rinse the container with an additional 120 mL of water and drink immediately.Re-stir before use if not consumed immediately. Discard if not used within 2 hours.For nasogastric or PEG tube administration, prepare as above and administer within 2 hours.

Dose Modification

Dose reduction may be performed up to two times for toxicity.Permanently discontinue if the 240 mg once daily lowest dose is not tolerated.

Dose Reduction Schedule

Starting dose: 960 mg once daily

First reduction: 480 mg once daily

Second reduction: 240 mg once daily

Dose Adjustment for Toxicity

Hepatotoxicity

Grade 2 symptomatic or ≥ Grade 3 ALT/AST: Interrupt until recovery to ≤ Grade 1 or baseline; resume at next lower dose.

ALT/AST >3× ULN with total bilirubin >2× ULN (no alternative cause): Permanently discontinue.

Interstitial Lung Disease (ILD)/Pneumonitis

Any grade: Interrupt immediately if suspected; permanently discontinue if confirmed.

Nausea/Vomiting or Diarrhea (Grade 3–4, despite supportive care)

Interrupt until recovery to ≤ Grade 1 or baseline; resume at next lower dose.

Other Adverse Reactions (Grade 3–4)

Interrupt until recovery to ≤ Grade 1 or baseline; resume at next lower dose.

Use in Special Populations

Pregnancy

No human data in pregnant women. Animal studies indicate reproductive toxicity.Advise patients of potential fetal risk if used during pregnancy or if pregnancy occurs.

Lactation

Excretion into human milk is unknown. A risk to infants cannot be excluded.Discontinue breastfeeding or discontinue sotorasib.

Fertility

No clinical data on effects on fertility.

Geriatric Use

No overall differences in safety or efficacy between patients ≥65 years and younger patients. No dose adjustment required.

Hepatic Impairment

No dose adjustment needed for mild (Child-Pugh A) or moderate (Child-Pugh B) impairment.Use with caution in severe (Child-Pugh C) impairment; no established dose.

Renal Impairment

No dose adjustment needed for mild impairment (CrCl ≥60 mL/min).Not studied in moderate or severe impairment.

Pediatric Population

Safety and efficacy not established in patients <18 years. No data available.

Adverse Reactions

Most Common Adverse Reactions

Diarrhea (34%), musculoskeletal pain (31%), nausea (25%), fatigue (21%), hepatotoxicity (19%), cough (16%).Most common Grade ≥3 reactions: increased ALT (5%), increased AST (4%), diarrhea (4%).Most common reactions leading to permanent discontinuation: increased ALT (1%), increased AST (1%), drug-induced liver injury (1%).Most common reactions leading to dose modification: increased ALT (6%), increased AST (6%), diarrhea (6%).

Most Common Laboratory Abnormalities (≥25%)

Lymphopenia, decreased hemoglobin, increased AST, decreased calcium, increased urine protein, increased ALT, increased alkaline phosphatase, decreased sodium.

Contraindications

Hypersensitivity to the active substance or any excipients.

Warnings and Precautions

Hepatotoxicity

Sotorasib can cause hepatotoxicity and drug-induced liver injury.Monitor liver function tests at baseline, every 3 weeks for the first 3 months, then monthly.Interrupt, reduce dose, or permanently discontinue based on severity.

Interstitial Lung Disease/Pneumonitis

Monitor for new or worsening respiratory symptoms.Interrupt treatment if ILD/pneumonitis is suspected; permanently discontinue if confirmed.

Lactose Intolerance

Patients with hereditary galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption should not take this product.

Sodium Content

Each tablet contains less than 1 mmol (23 mg) sodium, essentially sodium-free.

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