FOSAPREPITANT DIMEGLUMINE

2 DOSAGE AND ADMINISTRATION Re c o mm ended Adult Do s age ( 2 .1 ) Fosaprepitant for injection 150 mg on Day 1 as an intravenous infusion over 20 to 30 minutes. ( 2.1 ) Complete the infusion approximately 30 minutes prior to chemotherapy. Recommended Dosage for Pediatric Patients (6 months to 17 years) Weighing at Least 6 kg ( 2.2 ) See Full Prescribing Information for pediatric dosage regimens by age. For single dose chemotherapy regimens : single dose of fosaprepitant for injection on Day 1. For single or multi-day chemotherapy regimens : 3-day fosaprepitant/aprepitant regimen of fosaprepitant for injection on Days 1,2, and 3. Aprepitant capsules or aprepitant for oral suspension may be used as an alternative on Days 2 and 3. Administer fosaprepitant for injection through a central venous catheter as an intravenous infusion over 30 minutes (12 years to 17 years) or 60 minutes (6 months to less than 12 years). Complete the infusion approximately 30 minutes prior to chemotherapy. Concomitant Antiemetics See Full Prescribing Information for additional information. ( 2.1 , 2.2 ) 2.1 Prevention of Nausea and Vomiting Associated with HEC and MEC in Adult Patients The recommended dosage of fosaprepitant for injection, dexamethasone, and a 5-HT 3 antagonist for the prevention of nausea and vomiting associated with administration of HEC or MEC in adults is shown in Table 1 or Table 2, respectively. Administer fosaprepitant for injection as an intravenous infusion on Day 1 over 20 to 30 minutes, completing the infusion approximately 30 minutes prior to chemotherapy. Table 1 Recommended Adult Dosing for the Prevention of Nausea and Vomiting Associated with HEC Day 1 Day 2 Day 3 Day 4 Fosaprepitant for Injection 150 mg intravenously over 20 to 30 minutes none none none Dexamethasone Administer dexamethasone 30 minutes prior to chemotherapy treatment on Day 1 and in the morning on Days 2 through 4. Also administer dexamethasone in the evenings on Days 3 and 4. A 50% dosage reduction of dexamethasone on Days 1 and 2 is recommended to account for a drug interaction with fosaprepitant for injection [see Clinical Pharmacology (12.3) ] . 12 mg orally 8 mg orally 8 mg orally twice daily 8 mg orally twice daily 5-HT 3 antagonist See selected 5-HT 3 antagonist prescribing information for the recommended dosage none none none Table 2 Recommended Adult Dosing for the Prevention of Nausea and Vomiting Associated with MEC Day 1 Fosaprepitant for Injection 150 mg intravenously over 20 to 30 minutes Dexamethasone Administer dexamethasone 30 minutes prior to chemotherapy treatment on Day 1. A 50% dosage reduction of dexamethasone is recommended to account for a drug interaction with fosaprepitant for injection [see Clinical Pharmacology (12.3) ] . 12 mg orally 5-HT 3 antagonist See selected 5-HT 3 antagonist prescribing information for the recommended dosage 2.2 Prevention of Nausea and Vomiting Associated with HEC and MEC in Pediatric Patients The recommended pediatric dosage regimens of fosaprepitant/aprepitant for injection, to be administered with a 5-HT 3 antagonist, with or without a corticosteroid, for the prevention of nausea and vomiting associated with administration of single or multi-day chemotherapy regimens of HEC or MEC, are shown in Tables 3 and 4. Single-day chemotherapy regimens include regimens in which HEC or MEC is administered for a single day only. Multi-day chemotherapy regimens include chemotherapy regimens in which HEC or MEC is administered for 2 or more days. Fosaprepitant/Aprepitant for Injection Dosage Regimens for Use with Single-Day Chemotherapy Regimens For pediatric patients weighing at least 6 kg receiving single-day HEC or MEC, fosaprepitant/aprepitant may be administered as: a single dose regimen of fosaprepitant for injection infused through a central venous catheter on Day 1, as shown in Table 3; or as a 3-day fosaprepitant/aprepitant regimen consisting of fosaprepitant for injection as an intravenous infusion through a central venous catheter on Days 1, 2, and 3. Aprepitant capsules or aprepitant for oral suspension may be used on Days 2 and 3, instead of fosaprepitant for injection, as shown in Table 4. Administer fosaprepitant for injection on Day 1 over 30 minutes (12 years to 17 years) or 60 minutes (6 months to less than 12 years), completing the infusion approximately 30 minutes prior to chemotherapy. Table 3 Fosaprepitant for Injection Single Dose Regimen for the Prevention of Nausea and Vomiting Associated with Single-Day Regimens of HEC or MEC in Pediatric Patients 6 Months Dosing in pediatric patients less than 6 kg is not recommended to 17 Years Drug Age Regimen Fosaprepitant for Injection 12 Years to 17 Years 150 mg intravenously over 30 minutes 2 Years to less than 12 Years 4 mg/kg (maximum dose 150 mg) intravenously over 60 minutes 6 Months to less than 2 Years 5 mg/kg (maximum dose 150 mg) intravenously over 60 minutes Dexamethasone Administer dexamethasone 30 minutes prior to chemotherapy treatment on Day 1 6 Months to 17 Years If a corticosteroid, such as dexamethasone, is co-administered, administer 50% of the recommended corticosteroid dose on Days 1 and 2. 5-HT 3 antagonist 6 Months to 17 Years See selected 5-HT 3 antagonist prescribing information for the recommended dosage Fosaprepitant/aprepitant Dosage Regimen for Use with Multi-Day Chemotherapy Regimens For pediatric patients weighing at least 6 kg receiving multi-day regimens of HEC or MEC, administer fosaprepitant for injection/aprepitant on Days 1, 2, and 3. Administer fosaprepitant for injection as an intravenous infusion through a central venous catheter on Days 1, 2, and 3. Aprepitant capsules or aprepitant for oral suspension may be used on Days 2 and 3 instead of fosaprepitant for injection, as shown in Table 4. Administer fosaprepitant for injection over 30 minutes (12 years to 17 years) or 60 minutes (6 months to less than 12 years), completing the infusion approximately 30 minutes prior to chemotherapy. Table 4 3-Day Fosaprepitant/Aprepitant Dosage Regimen for Prevention of Nausea and Vomiting Associated with Single or Multi-day Regimens of HEC or MEC in Pediatric Patients 6 Months Dosing in pediatric patients less than 6 kg is not recommended. to 17 Years Age of Pediatric Population Day 1 Day 2 Day 3 Fosaprepitant for Injection 12 Years to 17 Years 115 mg intravenously over 30 minutes 80 mg intravenously over 30 minutes OR 80 mg orally (aprepitant capsules) For patients 12 years to 17 years unable to swallow oral capsules, aprepitant for oral suspension can be used instead on Days 2 and 3. 80 mg intravenously over 30 minutes OR 80 mg orally (aprepitant capsules) 6 months to less than 12 years 3 mg/kg intravenously over 60 minutes (maximum dose 115 mg) 2 mg/kg intravenously over 60 minutes OR 2 mg/kg orally (aprepitant for oral suspension) For patients less than 12 years of age who weigh at least 40 kg and who are able to swallow oral capsules, aprepitant capsules can be used instead on Days 2 and 3. (maximum dose 80 mg) 2 mg/kg intravenously over 60 minutes OR 2 mg/kg orally (aprepitant for oral suspension) (maximum dose 80 mg) Dexamethasone Administer dexamethasone 30 minutes prior to chemotherapy treatment on Day 1. 6 Months to 17 Years If a corticosteroid, such as dexamethasone, is co-administered, administer 50% of the recommended corticosteroid dose on Days 1 through 4. 5-HT 3 antagonist 6 Months to 17 Years See selected 5-HT 3 antagonist prescribing information for the recommended dosage. 2.3 Preparation of Fosaprepitant for Injection Table 5 Preparation Instructions for Fosaprepitant for Injection (150 mg) The recommended dose of fosaprepitant for injection is based on the patient's age and weight. Step 1 Aseptically inject 5 mL 0.9% Sodium Chloride Injection, USP into the vial. Assure that 0.9% Sodium Chloride Injection, USP is added to the vial along the vial wall in order to prevent foaming. Swirl the vial gently. Avoid shaking and jetting 0.9% Sodium Chloride Injection, USP into the vial. Step 2 Aseptically prepare an infusion bag filled with 145 mL of 0.9% Sodium Chloride Injection, USP. Step 3 Aseptically withdraw the entire volume from the vial and transfer it into the infusion bag containing 145 mL of 0.9% Sodium Chloride Injection, USP to yield a total volume of 150 mL and a final concentration of 1 mg/mL . Step 4 Gently invert the bag 2 to 3 times. Step 5 Determine the volume to be administered from this prepared infusion bag, based on the recommended dose [see Dosage and Administration (2.1 , 2.2) ] . Adults The entire volume of the prepared infusion bag (150 mL) should be administered. Pediatrics In patients 12 years and older, the volume to be administered is calculated as follows: Volume to administer (mL) equals the recommended dose (mg) In patients 6 months to less than 12 years, the volume to be administered is calculated as follows: Volume to administer (mL) = recommended dose (mg/kg) × weight (kg) Note: Do not exceed the maximum dose [see Dosage and Administration (2.2) ] In pediatric patients, the entire volume in the infusion bag may not be required. Step 6 If necessary, for volumes less than 150 mL, the calculated volume can be transferred to an appropriate size bag or syringe prior to administration by infusion. Step 7 Before administration, inspect the bag for particulate matter and discoloration. Discard the bag if particulate and/or discoloration are observed. Caution: Do not mix or reconstitute fosaprepitant for injection with solutions for which physical and chemical compatibility have not been established. Fosaprepitant for Injection is incompatible with any solutions containing divalent cations (e.g., Ca 2+ , Mg 2+ ), including Lactated Ringer's Solution and Hartmann's Solution. Storage The reconstituted final drug solution is stable for 24 hours at ambient room temperature [at or below 25°C (77°F)]. Discard unused portion.

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1 INDICATIONS AND USAGE Fosaprepitant for Injection, in combination with other antiemetic agents, is indicated in adults and pediatric patients 6 months of age and older for the prevention of: acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin.