Drug Detail:Emend for injection (Fosaprepitant [ fos-a-prep-i-tan-t ])
Generic Name: FOSAPREPITANT DIMEGLUMINE 150mg in 5mL
Dosage Form: injection, powder, lyophilized, for solution
Drug Class: NK1 receptor antagonists
Prevention of Nausea and Vomiting Associated with HEC and MEC in Adult Patients
The recommended dosage of EMEND for injection, dexamethasone, and a 5-HT3 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 EMEND for injection as an intravenous infusion on Day 1 over 20 to 30 minutes, completing the infusion approximately 30 minutes prior to chemotherapy.
| Day 1 | Day 2 | Day 3 | Day 4 | |
|---|---|---|---|---|
|
||||
| EMEND for injection | 150 mg intravenously over 20 to 30 minutes | none | none | none |
| Dexamethasone* | 12 mg orally | 8 mg orally | 8 mg orally twice daily | 8 mg orally twice daily |
| 5-HT3 antagonist | See selected 5-HT3 antagonist prescribing information for the recommended dosage | none | none | none |
| Day 1 | |
|---|---|
|
|
| EMEND for injection | 150 mg intravenously over 20 to 30 minutes |
| Dexamethasone* | 12 mg orally |
| 5-HT3 antagonist | See selected 5-HT3 antagonist prescribing information for the recommended dosage |
Prevention of Nausea and Vomiting Associated with HEC and MEC in Pediatric Patients
The recommended pediatric dose regimens of EMEND, to be administered with a 5-HT3 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 those 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.
EMEND Dosage Regimens for Use with Single-Day Chemotherapy Regimens
For pediatric patients weighing at least 6 kg receiving single-day HEC or MEC, EMEND may be administered as:
- a single dose regimen of EMEND for injection infused through a central venous catheter on Day 1, as shown in Table 3; or
- as a 3-day EMEND regimen consisting of EMEND for injection as an intravenous infusion through a central venous catheter on Day 1 and EMEND capsules or EMEND for oral suspension on Days 2 and 3, as shown in Table 4.
Administer EMEND 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.
| Drug | Age | Regimen |
|---|---|---|
|
||
| EMEND 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† | 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-HT3 antagonist | 6 Months to 17 Years | See selected 5-HT3 antagonist prescribing information for the recommended dosage |
EMEND 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 EMEND on Days 1, 2, and 3. Administer EMEND for injection as an intravenous infusion through a central venous catheter on Day 1 and EMEND capsules or EMEND for oral suspension on Days 2 and 3, as shown in Table 4.
Administer EMEND 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.
| Age Group | Drug | Day 1 | Day 2 | Day 3 |
|---|---|---|---|---|
|
||||
| 12 Years to 17 Years | EMEND for injection | 115 mg intravenously over 30 minutes | -- | -- |
| EMEND capsules† | -- | 80 mg orally | 80 mg orally | |
| 6 Months to Less than 12 Years | EMEND for injection | 3 mg/kg (maximum dose 115 mg) intravenously over 60 minutes | -- | -- |
| EMEND for oral suspension | -- | 2 mg/kg orally (maximum 80 mg) | 2 mg/kg orally (maximum 80 mg) | |
| 6 Months to 17 Years | Dexamethasone‡ | If a corticosteroid, such as dexamethasone, is co-administered, administer 50% of the recommended corticosteroid dose on Days 1 through 4 | ||
| 6 Months to 17 Years | 5-HT3 antagonist | See selected 5-HT3 antagonist prescribing information for the recommended dosage | ||
Preparation of EMEND for injection
| The recommended dose of EMEND 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:
|
| 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 EMEND for injection with solutions for which physical and chemical compatibility have not been established. EMEND for injection is incompatible with any solutions containing divalent cations (e.g., Ca2+, Mg2+), including Lactated Ringer's Solution and Hartmann's Solution.
