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Fruzaqla

FRUQUINTINIB

Manufacturer: Takeda Pharmaceuticals America, Inc.

Score: 141.0

Quick Summary

Fruzaqla (Fruquintinib) is a kinase inhibitor used 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, an anti-EGFR therapy. The recommended dose is 5 mg orally once daily for the first 21 days of each 28-day cycle. Important safety information includes warnings for hypertension, hemorrhagic events, infections, gastrointestinal perforation, hepatotoxicity, proteinuria, palmar-plantar erythrodysesthesia, and posterior reversible encephalopathy syndrome. Contraindications are none. Special population considerations include use in pregnancy, pediatric use, and geriatric use.

Key Clinical Findings and Indications

  • 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, an anti-EGFR therapy
  • Fruquintinib is a small molecule kinase inhibitor of vascular endothelial growth factor receptors (VEGFR)-1, -2, and -3

Important Safety Information

Warning

Hypertension, hemorrhagic events, infections, gastrointestinal perforation, hepatotoxicity, proteinuria, palmar-plantar erythrodysesthesia, and posterior reversible encephalopathy syndrome

Contraindications

  • None

Adverse Reactions

  • Hypertension, palmar-plantar erythrodysesthesia, proteinuria, dysphonia, abdominal pain, diarrhea, asthenia

Dosing Recommendations

General Guidance

Dose reductions for adverse reactions are recommended, with permanent discontinuation for certain adverse reactions

Metastatic colorectal cancer (mCRC)

Adult Dose

5 mg orally once daily for the first 21 days of each 28-day cycle

Pediatric Dose

Not established

Special Population Considerations

Pregnancy

  • Fruzaqla can cause fetal harm when administered to a pregnant woman
  • Advise pregnant women of the potential risk to a fetus

Nursing Mothers

  • Not specified

Pediatric Use

  • The safety and efficacy of Fruzaqla in patients younger than 18 years of age have not been established

Geriatric Use

  • No observed overall differences in safety and effectiveness of Fruzaqla in geriatric compared to younger patients