Sotorasib (sotorasib)

Sotorasib is approved for: As a single agent: adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), determined by an FDA-approved test, who have received at least one prior systemic therapy (accelerated approval, first approved 28 May 2021); In combination with panitumumab: adult patients with KRAS G12C-mutated metastatic colorectal cancer (mCRC) who have received prior fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy (approved Jan 2025). It is a sotorasib (Oral KRAS G12C inhibitor), originally marketed as Lumakras (US); Lumykras (EU) by Amgen.

Standard dosing for sotorasib: 960 mg (three 320 mg tablets or four 240 mg tablets or eight 120 mg tablets) orally once daily, at the same time each day with or without food, until disease progression or unacceptable toxicity. Swallow tablets whole - do not chew, crush or split. Dose adjustments: Maximum of two dose reductions: first reduction 480 mg once daily, second reduction 240 mg once daily; discontinue if unable to tolerate 240 mg once daily. For AST/ALT >3-5x ULN with symptoms or >5x ULN: withhold until recovery and resume at the next lower dose; for AST/ALT >3x ULN with total bilirubin >2x ULN: permanently discontinue unless another cause is identified. Confirmed ILD/pneumonitis: permanently discontinue. Avoid concomitant PPIs and H2-receptor antagonists; if an acid-reducing agent is needed, take sotorasib 4 hours before or 10 hours after a local antacid.

Sotorasib is approved for: As a single agent: adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), determined by an FDA-approved test, who have received at least one prior systemic therapy (accelerated approval, first approved 28 May 2021); In combination with panitumumab: adult patients with KRAS G12C-mutated metastatic colorectal cancer (mCRC) who have received prior fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy (approved Jan 2025). It is a sotorasib (Oral KRAS G12C inhibitor), originally marketed as Lumakras (US); Lumykras (EU) by Amgen.

The most frequently reported side effects of sotorasib are diarrhoea (42%, grade 3-4 in 5%), musculoskeletal pain, nausea (26%), fatigue, hepatotoxicity (27% of the pooled nsclc population, 16% grade >=3; grade 3-4 alt/ast increase in 9%), cough, vomiting (17%). Serious but less common reactions include hepatotoxicity (27% of the pooled nsclc population, 16% grade >=3; grade 3-4 alt/ast increase in 9%), interstitial lung disease / pneumonitis (2. 2%, one fatal case; median onset 8. 6 weeks). Routine monitoring: Liver function tests (ALT, AST, alkaline phosphatase and total bilirubin) before starting, every 3 weeks for the first 3 months, then once a month or as clinically indicated; Pulmonary symptoms for ILD/pneumonitis (dyspnoea, cough, fever); Monitor patients with hepatic impairment more frequently. Report any new or worsening symptom to your treating physician — most adverse effects are managed by dose reduction rather than stopping treatment.

Sotorasib (Oral KRAS G12C inhibitor (small molecule, inhibitor of the RAS GTPase family), originally Lumakras (US); Lumykras (EU) by Amgen) Sotorasib locks onto the mutant KRAS G12C protein and switches it off. That protein normally keeps tumour cells dividing; blocking it slows or stops tumour growth. It does not act on normal (wild-type) KRAS. 960 mg (three 320 mg tablets or four 240 mg tablets or eight 120 mg tablets) orally once daily, at the same time each day with or without food, until disease progression or unacceptable toxicity. Swallow tablets whole - do not chew, crush or split.

Elimination half-life: Mean terminal elimination half-life 5 hours (standard deviation 2); steady-state apparent clearance 26. 2 L/h (CV 76%) at 960 mg once daily. Dosing intervals are designed around this, which is why most regimens are once or twice daily.

No FDA- or EMA-approved generic sotorasib was identified. Lao copies (LuciSot by Lucius; Sotoraib by TLPH) are nationally registered in Laos and are not FDA/EMA-approved. No published bioequivalence study against Lumakras was found in this search. Lumakras remains under accelerated approval in NSCLC pending a confirmatory study (FDA requested completion by February 2028), which is relevant to how 'fully approved' comparisons should be framed. Manufacturers supplying sotorasib generic versions include Lao ASEAN Pharmaceutical & Food Co. , Ltd - TLPH, Lucius Pharmaceuticals. Brands registered in Bangladesh include Sotoras, Sotoxen.

Sotorasib (Oral KRAS G12C inhibitor (small molecule, inhibitor of the RAS GTPase family), originally Lumakras (US); Lumykras (EU) by Amgen) Sotorasib locks onto the mutant KRAS G12C protein and switches it off. That protein normally keeps tumour cells dividing; blocking it slows or stops tumour growth. It does not act on normal (wild-type) KRAS. 960 mg (three 320 mg tablets or four 240 mg tablets or eight 120 mg tablets) orally once daily, at the same time each day with or without food, until disease progression or unacceptable toxicity. Swallow tablets whole - do not chew, crush or split.

Storage: Store at 20-25 C (68-77 F); excursions permitted from 15 to 30 C (59-86 F) Keep the product in its original packaging and check the expiry date printed on the pack.