APRITANT IV POWDER FOR SOLUTION FOR INJECTION 150MG/VIAL [SIN16996P]

Product Info

APRITANT IV POWDER FOR SOLUTION FOR INJECTION 150MG/VIAL

[SIN16996P]

4.1 Therapeutic indications

Fosaprepitant for injection is indicated for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of:

• highly emetogenic cancer chemotherapy

• moderately emetogenic cancer chemotherapy.

Fosaprepitant for injection should be given in combination with a corticosteroid and a 5-HT₃ antagonist.

4.2 Posology and method of administration

Apritant IV for intravenous administration is a lyophilized prodrug of aprepitant containing polysorbate 80 (PS80).

Apritant IV is administered on Day 1 as an infusion over 20 – 30 minutes initiated approximately 30 minutes prior to chemotherapy. Apritant 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 co-administered 5-HT₃ antagonist must be consulted prior to initiation of treatment with Apritant IV.

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

Method of administration
APRITANT IV powder for solution for injection 150mg/vial should be administered intravenously.
Preparation of Apritant IV for Injection 150 mg

1. Aseptically inject 5 ml 0.9% 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 of saline.

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. Gently invert the bag 2–3 times.

The reconstituted solution should be used immediately; although the reconstituted final drug solution is stable for 24 hours at ambient room temperature (at or below 25°C).
Parenteral drug products should be inspected visually for particulate matter and discoloration before administration whenever solution and container permit.
Apritant IV is incompatible with any solutions containing divalent cations (e.g., Ca²⁺, Mg²⁺), including Hartman’s and Lactated Ringer’s Solution. Apritant IV must not be reconstituted or mixed with solutions for which physical and chemical compatibility have not been established.

GENERAL INFORMATION

See Interaction with other medicinal products and other forms of interaction for additional information on the administration of Apritant IV with corticosteroids – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.
Refer to the full prescribing information for 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 <30ml/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).

4.3 Contraindications

Apritant IV is contraindicated in patients who are hypersensitive to APRITANT IV powder for solution for injection 150mg/vial, aprepitant, polysorbate 80 or any other components of the product.
Apritant IV should not be used concurrently with pimozide, terfenadine, astemizole, or cisapride. Inhibition of cytochrome P450 isoenzyme 3A4 (CYP3A4) by aprepitant could result in elevated plasma concentrations of these drugs, potentially causing serious or life-threatening reactions (see Interaction with other medicinal products and other forms of interaction – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).