Fulzerasib is a selective, orally active KRAS G12C inhibitor developed for the treatment of solid tumors harboring the KRAS G12C mutation, particularly non-small cell lung cancer (NSCLC).
Fulzerasib
Generic Name/API:Fulzerasib
Packaging:Available in bottles containing 112 tablets.
Storage:Store in a sealed container at temperatures not exceeding 30°C. Keep out of reach of children.
Dosage:For dosage information, please visit the General Information section.
Strength:Commercially available in 150 mg tablets.
Indication:Fulzerasib is being developed for the treatment for adult patients with advanced Non-Small Cell Lung Cancer (NSCLC) harboring the KRAS G12C mutation who have received at least one prior line of systemic therapy.
Fulzerasib is an orally active small molecule inhibitor of the KRAS G12C mutant protein, and has demonstrated promising anti-tumour activity in patients with solid tumours. It is being developed for the treatment for adult patients with advanced Non-Small Cell Lung Cancer (NSCLC) harboring the KRAS G12C mutation who have received at least one prior line of systemic therapy.
STRENGTH:
Commercially available in 150 mg tablets.
DOSAGE:
Fulzerasib is administered at an oral recommended dosage of 600 mg twice daily.
ADVERSE REACTIONS:
Common adverse reactions (≥20%) include anemia (47.5%), elevated alanine aminotransferase (28.2%), elevated aspartate aminotransferase (27.6%), increased blood bilirubin (25.2%), proteinuria (24.6%), fatigue (24.3%), hypoproteinemia (23.9%), pruritus (23.3%), edema (22.9%), and elevated gamma-glutamyl transferase (20.3%). Serious adverse reactions (≥3%) include anemia (9.0%), elevated gamma-glutamyl transferase (8.0%), fatigue (4.0%), liver function abnormalities (4.0%), elevated alkaline phosphatase (3.7%), and decreased lymphocyte count (3.7%)
STORAGE:
Store in a sealed container at temperatures not exceeding 30°C. Keep out of reach of children.
Fulzerasib (a targeted KRAS G12C inhibitor) requires specific warnings regarding myelosuppression, liver function, and gastrointestinal issues. Patients should immediately report severe fatigue, signs of anemia (dizziness, shortness of breath), skin rashes, or symptoms of liver damage like yellowing eyes or dark urine.
- Hepatotoxicity: Monitor liver function tests before starting treatment, every three weeks for the first three months, and monthly thereafter. Adjust dosage or discontinue use if liver function abnormalities occur.
- Anemia: Monitor complete blood counts before starting treatment, every three weeks for the first three months, and monthly thereafter. Manage anemia appropriately, including dose adjustments or discontinuation if necessary.
- Drug Interactions: Caution is advised when co-administering fulzerasib with sensitive CYP2D6 substrates or those with a narrow therapeutic index, as it may increase their plasma concentrations. Avoid concomitant use with strong P-glycoprotein (P-gp) inhibitors. Concurrent use with proton pump inhibitors should also be avoided.
FAQ
What type of drug is Fulzerasib?
Fulzerasib is a targeted therapy and belongs to the class of KRAS G12C inhibitors.
Is Fulzerasib administered orally or intravenously?
Fulzerasib is an oral targeted therapy that is administered by mouth.
Has Fulzerasib received regulatory approval?
Fulzerasib received approval in China in 2024 for certain patients with KRAS G12C-mutated NSCLC who had previously received systemic therapy.
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