Fosemred Dosage/Direction for Use

FOSEMRED is administered on Day 1 as an infusion over 20-30 minutes initiated approximately 30 minutes prior to chemotherapy. FOSEMRED should be administered in conjunction with a corticosteroid and a 5-HT3 antagonist as specified in the tables as follows. The package insert for the co-administered 5- HT3 antagonist must be consulted prior to initiation of treatment with FOSEMRED.
Recommended dosing for the prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy: See Table 1.

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Recommended dosing for the prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy: See Table 2.

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Preparation of FOSEMRED 150 mg for intravenous administration: Inject 5 ml sodium chloride 9 mg/ml (0.9%) solution for injection into the vial. Assure that sodium chloride 9 mg/ml (0.9%) solution for injection is added to the vial along the vial wall in order to prevent foaming. Swirl the vial gently. Avoid shaking and jetting sodium chloride 9 mg/ml (0.9%) solution for injection into the vial.
Prepare an infusion bag filled with 145 ml of sodium chloride 9 mg/ml (0.9%) solution for injection (for example, by removing 105 ml of sodium chloride 9 mg/ml (0.9%) solution for injection from a 250 ml sodium chloride 9 mg/ml (0.9%) solution for injection infusion bag).
Withdraw the entire volume from the vial and transfer it into an infusion bag containing 145 ml of sodium chloride 9 mg/ml (0.9%) solution for injection to yield a total volume of 150 ml and final concentration of 1 mg/ml. Gently invert the bag 2-3 times.
Determine the volume to be administered from this prepared infusion bag, based on the recommended dose (see previously mentioned Tables 1 and 2).
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.
FOSEMRED is incompatible with any solutions containing divalent cations (e.g., Ca2+, Mg2+), including Hartman's and Lactated Ringer's Solution. FOSEMRED must not be reconstituted or mixed with solutions for which physical and chemical compatibility have not been established.
General Information: See Interactions for additional information on the administration of FOSEMRED with corticosteroids.
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 <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).
Instructions for Use: Physicians should instruct their patients to read the patient package insert before starting therapy with FOSEMRED and to reread it each time the prescription is renewed.
Patients should follow the physician's instructions for the FOSEMRED regimen. For the prevention of CINV, patients can be given a single dose of FOSEMRED 150 mg as an infusion over 20-30 minutes, 30 minutes prior to chemotherapy on Day 1.
Advise patients to seek medical attention if they experience new or worsening signs or symptoms of an infusion site reaction, such as erythema, edema, pain, necrosis, vasculitis, or thrombophlebitis at or near the infusion site (see Precautions).
FOSEMRED may interact with some drugs; therefore, patients should be advised to report to their doctor the use of any other prescription, non-prescription medication or herbal products.
Patients on chronic warfarin therapy should be instructed to have their clotting status closely monitored in the 2-week period, particularly at 7 to 10 days, following initiation of fosaprepitant with each chemotherapy cycle.
Concomitant administration of FOSEMRED may reduce the efficacy of hormonal contraceptives. Patients should be advised to use alternative or back-up methods of contraception during treatment with and for 1 month following administration of FOSEMRED.
Incompatibilities: FOSEMRED is incompatible with any solutions containing divalent cations (e.g., Ca2+, Mg2+), including Hartman's and lactated Ringer's solutions.
FOSEMRED must be reconstituted and then diluted prior to administration.
Adults: The entire volume of the prepared infusion bag (150 ml) should be administered.
Children: In patients 12 years and older, the volume to be administered is calculated as follows: Volume to administer (ml) equals the recommended dose (mg): 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.
The appearance of the reconstituted solution is the same as the appearance of the diluent.
The reconstituted and diluted medicinal product should be inspected visually for particulate matter and discoloration before administration.
Discard any remaining solution and waste material. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
The medicinal product must not be reconstituted or mixed with solutions for which physical and chemical compatibility has not been established (see previously mentioned Incompatibilities).
Method of administration: FOSEMRED should be administered intravenously.