View by Tumor Type
Lung Cancer Colorectal Cancer
Home › All Therapies › Lumakras

Lumakras

sotorasib
KRAS G12C Inhibitor FDA Approved 2021 Amgen
Route
Oral
Half-Life
5.5 hrs
FDA Approved
2021
Manufacturer
Amgen
Navigation -->
1. Indications and Usage

NSCLC: KRAS G12C-mutated NSCLC after ≥1 prior systemic therapy.

2. Dosage and Administration

960 mg orally once daily.

3. Dosage Forms and Strengths

Tablets: 120 mg

4. Contraindications

None listed.

5. Warnings and Precautions
  • Hepatotoxicity: Monitor LFTs.
  • ILD/Pneumonitis: Fatal cases. Permanently discontinue.
  • Embryo-Fetal Toxicity: Can cause fetal harm.
6. Adverse Reactions
Most Common Adverse Reactions

Diarrhea (37%), Musculoskeletal Pain (30%), Nausea (28%), Fatigue (26%), Hepatotoxicity (25%), Cough (20%), Decreased Appetite (13%), Constipation (12%)

Diarrhea
37%
Musculoskeletal Pain
30%
Nausea
28%
Fatigue
26%
Hepatotoxicity
25%
Cough
20%
Decreased Appetite
13%
Constipation
12%

Consult the complete prescribing information for a comprehensive list of adverse reactions and their frequencies.

7. Drug Interactions

PPIs: Avoid.
CYP3A4 Substrates: Moderate inducer.

8. Use in Specific Populations
Pregnancy

Consult the full prescribing information for pregnancy-related considerations.

Lactation

Refer to prescribing information for lactation guidance.

Pediatric Use

Pediatric safety and efficacy information is detailed in the full label.

Hepatic/Renal Impairment

Dose modifications for organ impairment are specified in the complete prescribing information.

12. Clinical Pharmacology
Mechanism of Action

Selective irreversible KRAS G12C inhibitor locking KRAS in inactive GDP-bound state.

Pharmacokinetics

Tmax: 1h. t½: 5h. Feces 74%.

14. Clinical Studies

Clinical efficacy and safety data supporting the approval are available in the full prescribing information and from the clinical trials listed below.

Pivotal Clinical Trials
Additional Resources
📋 All Lumakras Trials on ClinicalTrials.gov ↗ 📚 PubMed: Lumakras Clinical Trials ↗
FDA-Approved Tumor Types

Lumakras has FDA-approved indications across the following cancer types covered on CancerDrugEvidence:

Non-Small Cell Lung Cancer
External Resources
📋 DailyMed Label ↗ 🏛️ FDA Drugs@FDA ↗ 🔬 ClinicalTrials.gov ↗ 📚 PubMed Pivotal Trials ↗
Important Notice: This page is intended as a navigational reference to the FDA-approved prescribing information for Lumakras. It does not replace the full prescribing information. Healthcare professionals should consult the complete package insert available at DailyMed before making prescribing decisions. Patient-specific factors should always guide clinical decision-making.

Frequently Asked Questions

What is Lumakras (sotorasib) approved for?

Lumakras (sotorasib) is an FDA-approved oncology agent. Refer to the full prescribing information for complete indication details.

How is Lumakras (sotorasib) administered?

Refer to the full prescribing information for dosing schedules, administration instructions, and dose modifications.

How does Lumakras (sotorasib) work?

Selective irreversible KRAS G12C inhibitor locking KRAS in inactive GDP-bound state.

What are the most common side effects?

Diarrhea (37%), Musculoskeletal Pain (30%), Nausea (28%), Fatigue (26%), Hepatotoxicity (25%), Cough (20%), Decreased Appetite (13%), Constipation (12%) Diarrhea 37% Musculoskeletal Pain 30% Nausea 28% Fatigue 26% Hepatotoxicity 25% Cough 20% Decreased Appetite 13% Constipation 12%

← All Therapies Full Prescribing Information ↗