FAVLYXA

2 DOSAGE AND ADMINISTRATION FAVLYXA is recommended for administration either as an intravenous bolus or as an intravenous infusion. ( 2.1 ) Adenocarcinoma of the Colon and Rectum In combination with leucovorin or as a component of a multidrug chemotherapy regimen that includes leucovorin (infusional regimen): 400 mg/m 2 for one dose, followed by 2,400 mg/m 2 to 3,000 mg/m 2 over 46 hours on day 1 of each 2-week cycle or In combination with leucovorin (bolus regimen): 500 mg/m 2 on days 1, 8, 15, 22, 29 and 36 of each 8-week cycle. ( 2.2 ) Adenocarcinoma of the Breast in combination with a cyclophosphamide-based multidrug regimen: 500 mg/m 2 or 600 mg/m 2 on days 1 and 8 of each 28-day cycle (bolus regimen). ( 2.2 ) Gastric Adenocarcinoma in combination with a platinum-containing multidrug regimen: 200 mg/m 2 to 1,000 mg/m 2 over 24 hours (infusional regimen). ( 2.2 ) Pancreatic Adenocarcinoma in combination with leucovorin or as a component of a multidrug chemotherapy regimen that includes leucovorin: 400 mg/m 2 on day 1, followed by 2,400 mg/m 2 over 46 hours every 2 weeks (infusional regimen). ( 2.2 ) Refer to Section 2.3 for dosage modifications due to adverse reactions. 2.1 Evaluation and Testing for DPD Deficiency Before Initiating FAVLYXA Prior to initiating FAVLYXA, test patients for genetic variants of the DPYD gene unless immediate treatment is necessary. An FDA-authorized test for the detection of the DPYD gene to identify patients at risk of serious adverse reactions with FAVLYXA is not currently available. Currently available tests used to identify DPYD variants may vary in accuracy and design (e.g., which DPYD variant(s) they identify). Avoid use of FAVLYXA in patients known to have certain homozygous or compound heterozygous DPYD variants that result in complete DPD deficiency . No FAVLYXA dose has been proven safe for patients with complete DPD deficiency. For patients with partial DPD deficiency, individualize the dosage and modify based on tolerability and intent of treatment [see Warnings and Precautions (5.1) ] . 2.2 Recommended Dosage FAVLYXA is recommended for administration either as an intravenous bolus or as an intravenous infusion. Dosage recommendations are in Table 1. Table 1: Recommended dosage of FAVLYXA Indication Recommended Dosage Duration of Treatment Adenocarcinoma of the Colon and Rectum In combination with leucovorin or as a component of a multidrug chemotherapy regimen that includes leucovorin 400 mg/m 2 for one dose, followed by 2,400 mg/m 2 to 3,000 mg/m 2 over 46 hours on day 1 of each 2-week cycle Until disease progression or unacceptable toxicity. In combination with leucovorin alone (bolus regimen) 500 mg/m 2 on days 1, 8, 15, 22, 29 and 36 of each 8-week cycle Until disease progression or unacceptable toxicity. Adenocarcinoma of the Breast In combination with cyclophosphamide-based multidrug regimen (bolus regimen) 500 mg/m 2 or 600 mg/m 2 on days 1 and 8 of each 28-day cycle Until disease progression or unacceptable toxicity or 6 cycles Gastric Adenocarcinoma In combination with a platinum-containing multidrug regimen 200 mg/m 2 to 1,000 mg/m 2 over 24 hours Frequency in each cycle and length of each cycle depend on dose of FAVLYXA and specific regimen Pancreatic Adenocarcinoma In combination with leucovorin or as a component of a multidrug chemotherapy regimen that includes leucovorin 400 mg/m 2 on day 1, followed by 2,400 mg/m 2 over 46 hours every 2 weeks Until disease progression or unacceptable toxicity. 2.3 Dosage Modifications for Adverse Reactions Withhold FAVLYXA for the following adverse reactions. Depending on the severity of the adverse reaction, either discontinue or resume FAVLYXA at a reduced dosage upon resolution or improvement to Grade 1: Grade 3 or 4 diarrhea [see Warnings and Precautions (5.5) ] Grade 2 or 3 palmar-plantar erythrodysesthesia (hand-foot syndrome) [see Warnings and Precautions (5.6) ] Grade 3 or 4 mucositis [see Warnings and Precautions (5.8) ] Grade 4 myelosuppression [see Warnings and Precautions (5.7) ] There is no recommended dose for resumption of FAVLYXA administration following development of any of the following adverse reactions; consider permanent discontinuation of FAVLYXA following: Development of angina, myocardial infarction/ischemia, arrhythmia, or heart failure in patients with no history of coronary artery disease or myocardial dysfunction [see Warnings and Precautions (5.2) ] Hyperammonemic encephalopathy [see Warnings and Precautions (5.3) ] Neurologic toxicity including acute cerebellar syndrome [see Warnings and Precautions (5.4) ] 2.4 Preparation and Administration FAVLYXA is a hazardous drug. Follow applicable special handling and disposal procedures 1 . Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. For Direct Intravenous Bolus Injection Preparation Select the appropriate number of vial(s) based on the prescribed dose. Withdraw the calculated dose into a sterile syringe. Discard partially used or empty vials of FAVLYXA. Administration Administer FAVLYXA as an intravenous bolus through an established intravenous line over 2 to 5 minutes. Do not administer in the same intravenous line concomitantly with other medicinal products. Storage If the dose is not administered, attach a tip cap to the syringe prior to storage. The syringe can be stored at room temperature 20°C to 25°C (68°F to 77°F) for up to 4 hours. For Intravenous Infusion Preparation Select the appropriate number of vial(s) based on the prescribed dose. Withdraw the calculated dose into a sterile syringe. Dilute the calculated dose in an appropriate amount of 0.9% Sodium Chloride Injection, or 5% Dextrose Injection, to prepare an infusion solution with a final concentration ranging from 1.5 mg/mL to 10 mg/mL. Administration Do not administer in the same intravenous line concomitantly with other medicinal products. For intravenous infusion regimens, administer through a central venous line using an infusion pump. Storage If not used immediately, the diluted FAVLYXA can be stored at room temperature 20°C to 25°C (68°F to 77°F) for up to 24 hours.

See official label

1 INDICATIONS AND USAGE 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