EMEND IV Fosaprepitant for injection Ref.[27979] Active ingredients: Fosaprepitant

Dosing Consideration

EMEND IV is available as a 150 mg for IV infusion.

EMEND IV has not been demonstrated to be effective as a single anti-emetic agent and must be administered with other anti-emetic agents.

Recommended Dose and Dosage Adjustment

EMEND IV 150 mg is administered on Day 1 only as an infusion over 20-30 minutes initiated approximately 30 minutes prior to chemotherapy. EMEND IV should be administered in conjunction with a corticosteroid and a 5-HT₃ antagonist as specified in the tables below. The package insert for the coadministered 5-HT₃ antagonist must be consulted prior to initiation of treatment with EMEND IV 150 mg.

Table 3. Recommended dosing for the prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy:

^* Dexamethasone should be administered 30 minutes prior to chemotherapy treatment on Day 1 and in the morning on Days 2 through 4. Dexamethasone should also be administered in the evenings on Days 3 and 4. The dose of dexamethasone accounts for drug interactions.

Table 4. Recommended dosing for the prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy:

^* Dexamethasone should be administered 30 minutes prior to chemotherapy treatment on Day 1. The dose of dexamethasone accounts for drug interactions.

For highly emetogenic chemotherapy, there is only limited efficacy data with EMEND or EMEND IV in combination with oral ondansetron or other 5-HT₃ antagonist class of antiemetics and dexamethasone. In the highly emetogenic chemotherapy clinical trials, the 5-HT₃ antagonist studied was ondansetron administered by intravenous route. However, the dose was 32 mg and is no longer a recommended dose due to the dose-dependent risk of QTc prolongation (see the package insert for ondansetron for additional details).

For moderately emetogenic chemotherapy, there is only limited efficacy data with EMEND and EMEND IV in combination with other 5-HT₃ antagonist class of antiemetics and dexamethasone. In the moderately emetogenic trials, the 5-HT₃ antagonist studied was ondansetron administered by the oral route.

Dosage Adjustment

See DRUG INTERACTIONS for additional information on the administration of fosaprepitant or aprepitant with corticosteroids.

Refer to each product’s respective Product Monograph for additional information on coadministered antiemetic agents.

No dosage adjustment is necessary based on age, gender, race or Body Mass Index (BMI).

No dosage adjustment is necessary for patients with severe renal insufficiency (creatinine clearance <30 mL/min) or for patients with end stage renal disease undergoing hemodialysis.

No dosage adjustment is necessary for patients with mild to moderate hepatic insufficiency (Child-Pugh score 5 to 9). There are no clinical data in patients with severe hepatic insufficiency (Child-Pugh score >9).

Administration

EMEND IV is for IV infusion only, upon reconstitution and dilution and for single use only.

Instructions for reconstitution and dilution

1. Aseptically inject 5 mL 0.9% Sodium Chloride for injection (saline) into the vial. Assure that saline is added to the vial along the vial wall in order to prevent foaming. Swirl the vial gently. Avoid shaking and jetting saline into the vial.
2. Aseptically prepare an infusion bag filled with 145 mL 0.9% NaCl for injection
3. Aseptically withdraw the entire volume from the vial and transfer it into an infusion bag containing 145 mL of saline to yield a total volume of 150 mL and a final concentration of approximately 1 mg fosaprepitant/mL. Gently invert the bag 2–3 times.

The reconstituted and diluted solutions should be used immediately; however, after reconstitution and dilution the final drug solution is stable for 24 hours at ambient room temperature (at or below 25°C).

Reconstituted and diluted solutions should be inspected for discoloration, cloudiness and particulate matter before administration whenever solution and container permit. Discard unused portion.

EMEND IV is incompatible with any solutions containing divalent cations (e.g., Ca²⁺, Mg²⁺), including Hartman’s and Lactated Ringer’s Solution. EMEND IV must not be reconstituted or mixed with solutions for which physical and chemical compatibility have not been established.

For management of a suspected drug overdose, contact your regional Poison Control Centre.

No specific information is available on the treatment of overdosage. Single doses up to 200 mg of fosaprepitant IV and 600 mg of aprepitant were generally well tolerated in healthy subjects. Three out of 33 subjects receiving 200 mg of fosaprepitant experienced mild injection site thrombosis. Aprepitant was generally well tolerated when administered as 375 mg once daily for up to 42 days to patients in non-CINV studies. In 33 cancer patients, administration of a single 375 mg dose of aprepitant on Day 1 and 250 mg once daily on Days 2 to 5 was generally well tolerated.

Drowsiness and headache were reported in one patient who ingested 1440 mg of aprepitant.

In the event of overdose, EMEND IV should be discontinued and general supportive treatment and monitoring should be provided. Because of the antiemetic activity of aprepitant, drug-induced emesis may not be effective.

Aprepitant cannot be removed by hemodialysis.

Vials: store at 2-8°C.