Oncology Drug Reference Sheet: Fruquintinib
In two clinical trials, patients who received fruquintinib (Fruzaqla™) had an overall survival (https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/217564s000lbl.pdf) of 7.4 and 9.3 months compared to 4.8 and 6.6 months with placebo, leading to the drug’s November 2023 U.S. Food and Drug Administration (FDA) approval for adults with metastatic colorectal cancer who previously received standard chemotherapy and experienced disease progression.
Category/Class
Targeted therapy/tyrosine kinase inhibitor
Mechanism of Action
Prevents VEGF-mediated cell proliferation, which inhibits vascular growth
Indication
Adult patients with metastatic colorectal cancer who received (https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/217564s000lbl.pdf) previous standard chemotherapy, including fluoropyrimidine, oxaliplatin, and irinotecan
Dosing
Available in 1 mg and 5 mg capsules, fruquintinib’s recommended dose (https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/217564s000lbl.pdf) is 5 mg once daily for 21 days during each 28-day cycle. Dose reductions or discontinuation are recommended for unacceptable adverse reactions.
- First dose reduction: 4 mg orally once daily
- Second dose reduction: 3 mg orally once daily
Refer to the package insert (https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/217564s000lbl.pdf) for individualized dose reduction recommendations.
Administration
Take orally once daily (https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/217564s000lbl.pdf) with or without food. Swallow the capsule whole with water at the same time each day. Missed doses can be taken within 12 hours; if more than 12 hours have passed, skip the dose and resume at the normal dosage time the next day. Do not take two doses to make up for the missed dose.
Adverse Reactions
More than 20% of patients in the clinical trials experienced (https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/217564s000lbl.pdf) hypertension, hemorrhage, infection, gastrointestinal perforation, hepatotoxicity, proteinuria, hand-foot syndrome, posterior reversible encephalopathy syndrome, and embryo-fetal toxicity.
Nursing Considerations
Complete an oral adherence assessment and assess patients’ ability to safely take the drug. Closely monitor patients’ laboratory values (liver and kidney function, hematology), risks for infection, bowel and bladder function, neurologic status, and skin conditions.
Patient Education
Focus on proper administration, oral adherence, and preventing and managing side effects. Educate patients about the common side effects, as well as signs and symptoms of high blood pressure, bleeding, infection, gastrointestinal perforation, liver failure, and kidney dysfunction. Discuss the need for surveillance for hand-foot syndrome and neurologic changes. Advise patients about the risk for embryo-fetal toxicity and instruct them to use effective contraception during treatment and for two weeks after the final dose.
Special Considerations
Fruquintinib’s safety has not been tested (https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/217564s000lbl.pdf) in patients younger than 18 years. Its safety for patients with moderate liver impairment has not been established. It is not advised for patients with severe liver dysfunction.
Safe Handling
Store at room temperature, secured away from children, and dispose of according to local requirements.
Patient Assistance
Visit Here2Assist.com (https://www.here2assist.com/) or call 844-817-6468.