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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

Mises en garde et précautions d’emploi

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.

Indications

1.1 Adenocarcinoma of the Colon and Rectum

1.2 Adenocarcinoma of the Breast

1.3 Gastric Adenocarcinoma

1.4 Pancreatic Adenocarcinoma

Mises en garde et précautions d’emploi

Grossesse et allaitement

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

Contre-indications

Mises en garde et précautions d’emploi

Deux médicaments dans une même question ?

Favlyxa

Indications

Contre-indications

Mises en garde et précautions d’emploi

Deux médicaments dans une même 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

Grossesse et allaitement

8.1Pregnancy Risk Summary Based

Effets indésirables

6.2Postmarketing Experience

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