FRUQUINTINIB

Other

Brand names: Fruzaqla

Oral

Mechanism of Action

12.1. Mechanism of Action Fruquintinib is a small molecule kinase inhibitor of vascular endothelial growth factor receptors (VEGFR)-1, -2, and -3 with IC 50 values of 33, 35, and 0.5 nM, respectively. In vitro studies showed fruquintinib inhibited VEGF-mediated endothelial cell proliferation and tubular formation. In vitro and in vivo studies showed fruquintinib inhibited VEGF-induced VEGFR-2 phosphorylation. In vivo studies showed fruquintinib inhibited tumor growth in a tumor xenograft mouse model of colon cancer.

Indications

1. INDICATIONS AND USAGE FRUZAQLA is indicated for the treatment of adult patients with metastatic colorectal cancer (mCRC) who have been previously treated with fluoropyrimidine‑

oxaliplatin‑

and irinotecan‑based chemotherapy

an anti‑VEGF therapy

and

if RAS wild‑type and medically appropriate

Contraindications

• 4. CONTRAINDICATIONS None. None. ( 4 )

FDA Warnings

WARNINGS AND PRECAUTIONS Hypertension: Control blood pressure prior to treatment and monitor during treatment
1 ) Hemorrhagic Events: Closely monitor patients who are at risk for bleeding
Advise patients of reproductive potential of the potential risk to the fetus and to use effective contraception
Hemorrhagic Events FRUZAQLA can cause serious hemorrhagic events, which may be fatal

Known Side Effects

6 documented side effects by frequency

Fatigue

>10%

Diarrhea

1-10%

Weakness

1-10%

Decreased Appetite

1-10%

Nausea

0.1-1%

High Blood Pressure

0.1-1%

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Formulations

Dosage Forms

Tablet

Route

Oral