Fruquintinib

FDA label, Takeda Pharmaceuticals America, Inc., oral, effective 2026-07-31. Full label on DailyMed

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Quoted from the FDA label. Product labels differ by manufacturer and change over time; confirm against the label for the product you are using.

Dosing in kidney impairment

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Drug interactions

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Label text (2 paragraphs)

7. DRUG INTERACTIONS Strong or Moderate CYP3A Inducers: Avoid concomitant use. ( 7.1 ) 7.1. Effects of Other Drugs on FRUZAQLA Strong CYP3A Inducers Avoid concomitant use of drugs that are strong CYP3A inducers with FRUZAQLA. Concomitant use with a strong CYP3A inducer may decrease fruquintinib C max and AUC [see Clinical Pharmacology (12.3) ] , which may reduce the efficacy of FRUZAQLA. Moderate CYP3A Inducers If possible, avoid concomitant use of drugs that are moderate CYP3A inducers with FRUZAQLA. If it is not possible to avoid concomitant use of a moderate CYP3A inducer and fruquintinib, continue to administer FRUZAQLA at the recommended dosage.

Concomitant use with a moderate CYP3A inducer may decrease fruquintinib C max and AUC [see Clinical Pharmacology (12.3) ] , which may reduce the efficacy of FRUZAQLA.

Contraindications

4. CONTRAINDICATIONS None. None. ( 4 )

Safety data

Reported adverse events (FAERS)

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Source: FDA Adverse Event Reporting System via openFDA

Liver injury (LiverTox)

E*

Likelihood score E*: Unproven but suspected rare cause of clinically apparent liver injury.

Fruquintinib is a small molecule inhibitor of vascular endothelial growth factor (VEGF) receptors that is used in adults with metastatic, heavily pretreated colorectal cancer. Fruquintinib is associated with transient elevations in serum aminotransferase during therapy and is likely to result in clinically apparent liver injury in a proportion of patients.

ABCDEA: well known cause; E: unlikely cause. [HD]: high doses only.

Source: LiverTox: Fruquintinib (NIDDK, public domain)Chapter updated Mar 23, 2025

Pregnancy and lactation

Pregnancy

8.1. Pregnancy Risk Summary Based on findings in animal studies and its mechanism of action, FRUZAQLA can cause fetal harm when administered to a pregnant woman. In an embryo-fetal developmental study in pregnant rats, oral administration of fruquintinib during the period of organogenesis resulted in teratogenicity and embryo lethality at exposures below the clinical exposure (see Data ) . There are no data on the use of FRUZAQLA in pregnant women. Advise pregnant women of the potential risk to a fetus. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

Data Animal Data In an embryo-fetal developmental study in pregnant rats, daily oral administration of fruquintinib at doses ≥0.1 mg/kg [approximately 0.2 times the recommended clinical dose of 5 mg based on body surface area (BSA)] during the period of organogenesis resulted in fetal external (edema and head and tail abnormalities), visceral, and skeletal malformations. At doses of 0.25 mg/kg (approximately 0.5 times the recommended clinical dose of 5 mg based on BSA), an increase in post-implantation loss and reduction in live fetuses was observed.

Breastfeeding (LactMed)

No information is available on the clinical use of fruquintinib during breastfeeding. Because fruquintinib is 95% bound to plasma proteins, the amount in milk is likely to be low. However, the manufacturer recommends that breastfeeding be discontinued during fruquintinib therapy and for 2 weeks after the last dose.

Source: LactMed: Fruquintinib (NICHD, public domain)Revised Nov 15, 2023

Supply and cost

Drug shortage status

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Recalls (last 24 months)

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Therapeutic equivalence (Orange Book)

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