Nucleoside Metabolic Inhibitor

Favlyxa

Approved 20 Feb 2026IntravenousSolution

Indications

FAVLYXA is indicated for the treatment of patients with: FAVLYXA is a nucleoside metabolic inhibitor indicated for the treatment of patients with: Adenocarcinoma of the Colon and Rectum ( 1.1 ) Adenocarcinoma of the Breast ( 1.2 ) Gastric Adenocarcinoma ( 1.3 ) Pancreatic Adenocarcinoma ( 1.4 )

1.1 Adenocarcinoma of the Colon and Rectum

1.2 Adenocarcinoma of the Breast

1.3 Gastric Adenocarcinoma

1.4 Pancreatic Adenocarcinoma

Contraindications

None. None. ( 4 )

Warnings and precautions

Cardiotoxicity: FAVLYXA can cause cardiotoxicity, including angina, myocardial infarction/ischemia, arrhythmia, and heart failure. Withhold FAVLYXA for cardiac toxicity. ( 5.2 ) Hyperammonemic Encephalopathy: Altered mental status, confusion, disorientation, coma, or ataxia with elevated serum ammonia level can occur within 72 hours of initiation of FAVLYXA. Withhold FAVLYXA and initiate ammonia-lowering therapy. ( 5.3 ) Neurologic Toxicity: FAVLYXA can cause acute cerebellar syndrome, confusion, disorientation, ataxia, or visual disturbances.

Withhold FAVLYXA for neurologic toxicity. ( 5.4 ) Diarrhea: FAVLYXA can cause severe diarrhea. Withhold FAVLYXA for severe diarrhea until resolved. ( 5.5 ) Palmar-Plantar Erythrodysesthesia Syndrome: Based on severity, withhold FAVLYXA until resolved or decreased to Grade 1, then resume at a reduced dose. ( 5.6 ) Myelosuppression: FAVLYXA can cause severe and fatal myelosuppression. Withhold FAVLYXA until severe myelosuppression resolves, then resume at a reduced dose.

( 5.7 ) Mucositis: FAVLYXA can cause severe mucositis. Withhold FAVLYXA until resolved or decreased to Grade 1, then resume at a reduced dose. ( 5.8 ) Increased Risk of Bleeding with Concomitant Use of Warfarin: Concurrent administration with warfarin can result in clinically significant increases in coagulation parameters: Closely monitor INR and prothrombin time. ( 5.9 ) Embryofetal Toxicity: Can cause fetal harm. Advise females and males of reproductive potential of the potential risk to a fetus and to use effective contraception.

( 5.10 , 8.1 , 8.3 )

At a glance

Brand name: Favlyxa
Active substance: fluorouracil
Pharmacologic class: Nucleoside Metabolic Inhibitor
Route: Intravenous
Dosage form: Solution
Applicant: Avyxa Holdings
Status: Prescription
FDA approval: 20 Feb 2026
Application: NDA220201-001

Indications

1.1 Adenocarcinoma of the Colon and Rectum

1.2 Adenocarcinoma of the Breast

1.3 Gastric Adenocarcinoma

1.4 Pancreatic Adenocarcinoma

Warnings and precautions

( 5.10 , 8.1 , 8.3 )

Pregnancy and breastfeeding

8.1Pregnancy Risk Summary Based

on mechanism of action and animal reproduction studies, FAVLYXA can cause fetal harm when administered during pregnancy [see Clinical Pharmacology (12.1) ]. Available data from observational studies with intravenous administration of fluorouracil during pregnancy are insufficient to identify a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Administration of fluorouracil to rats and mice during selected periods of organogenesis, at doses lower than a human dose of 12 mg/kg, caused embryolethality and teratogenicity.

Malformations included cleft palate and skeletal defects. In monkeys, maternal doses of fluorouracil higher than an approximate human dose of 12 mg/kg resulted in abortion (see Data). In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2–4% and 15–20%, respectively. Data Animal Data Malformations including cleft palate, skeletal defects and deformed appendages (paws and tails) were observed when fluorouracil was administered by intraperitoneal injection to mice at doses at or above 10 mg/kg (approximately 0.06 times a human dose of 12 mg/kg on a mg/m 2 basis) for 4 days during the period of organogenesis.

Similar results were observed in hamsters administered fluorouracil intramuscularly at doses lower than those administered in commonly used clinical treatment regimens. In rats, administration of fluorouracil by intraperitoneal injection at doses greater than 15 mg/kg (approximately 0.2 times a human dose of 12 mg/kg on a mg/m 2 basis) for a single day during organogenesis resulted in delays in growth and malformations including micro-anophthalmos.

In monkeys, administration of fluorouracil during organogenesis at doses approximately equal to a human dose of 12 mg/kg on a mg/m 2 basis resulted in abortion; at a 50% lower dose, resorptions and decreased fetal body weights were reported.

Favlyxa

Indications

Contraindications

Warnings and precautions

At a glance

Two medicines in one question?

Favlyxa

Indications

Contraindications

Warnings and precautions

At a glance

Two medicines in one question?

5.1Serious Adverse Reactions or Death from Dihydropyrimidine Dehydrogenase (DPD) Deficiency Patients

5.2Cardiotoxicity

5.3Hyperammonemic Encephalopathy

5.4Neurologic Toxicity

5.5Diarrhea

5.6Palmar-Plantar Erythrodysesthesia (Hand-Foot Syndrome)

5.7Myelosuppression

5.8Mucositis

5.9Increased Risk of Bleeding with Concomitant Use of Warfarin

5.10Embryofetal Toxicity Based

Interactions

7.1Effect of

Pregnancy and breastfeeding

8.1Pregnancy Risk Summary Based

Adverse reactions

6.2Postmarketing Experience

Composition

Official product information