IVEMEND Powder for solution for infusion Ref.[8361] Active ingredients: Fosaprepitant

Posology

Adults

The recommended dose is 150 mg administered as an infusion over 20-30 minutes on Day 1, initiated approximately 30 minutes prior to chemotherapy (see section 6.6). IVEMEND should be administered in conjunction with a corticosteroid and a 5-HT₃ antagonist as specified in the tables below.

The following regimens are recommended for the prevention of nausea and vomiting associated with emetogenic cancer chemotherapy.

Table 1. Recommended dosing for the prevention of nausea and vomiting associated with highly emetogenic chemotherapy regimen in adults:

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

Table 2. Recommended dosing for the prevention of nausea and vomiting associated with moderately emetogenic chemotherapy regimen in adults:

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

Paediatric population

Paediatric patients aged 6 months and older, and not less than 6 kg

The recommended dose regimen of IVEMEND, 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 Highly Emetogenic Chemotherapy (HEC) or Moderately Emetogenic Chemotherapy (MEC), is shown in Table 3. 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.

An alternative dose regimen that may be used with single-day chemotherapy regimens is shown in Table 4.

Dosing for Single or Multi-Day Chemotherapy Regimens

For paediatric patients receiving single or multi-day regimens of HEC or MEC, administer IVEMEND as an intravenous infusion through a central venous catheter on Days 1, 2, and 3. EMEND capsules or EMEND for oral suspension may be used on Days 2 and 3 instead of IVEMEND, as shown in Table 3. See the Summary of Product Characteristics (SmPC) for EMEND capsules or EMEND for oral suspension for appropriate dosing instructions.

Table 3. Recommended dosing for the prevention of nausea and vomiting associated with single or multi-day regimens of HEC or MEC in paediatric patients:

* For paediatric patients 12 years and older, administer IVEMEND intravenously over 30 minutes, completing the infusion approximately 30 minutes prior to chemotherapy. For paediatric patients less than 12 years, administer IVEMEND intravenously over 60 minutes, completing the infusion approximately 30 minutes prior to chemotherapy.
** Dexamethasone should be administered 30 minutes prior to chemotherapy treatment on Day 1.

Alternative Dosing for Single Day Chemotherapy Regimens

For paediatric patients receiving single day HEC or MEC, IVEMEND may be administered as an intravenous infusion through a central venous catheter on Day 1.

Table 4. Alternative dosing for the prevention of nausea and vomiting associated with single day regimens of HEC or MEC in paediatric patients:

* For paediatric patients 12 years and older, administer IVEMEND intravenously over 30 minutes, completing the infusion approximately 30 minutes prior to chemotherapy. For paediatric patients less than 12 years, administer IVEMEND intravenously over 60 minutes, completing the infusion approximately 30 minutes prior to chemotherapy.
** Dexamethasone should be administered 30 minutes prior to chemotherapy treatment on Day 1.

The safety and efficacy of IVEMEND in infants below 6 months of age have not been established. No data are available.

General

Efficacy data in combination with other corticosteroids and 5-HT₃ antagonists are limited. For additional information on the co-administration with corticosteroids, see section 4.5.

Refer to the Summary of Product Characteristics of co-administered 5-HT₃ antagonist medicinal products.

Special populations

Elderly (≥65 years)

No dose adjustment is necessary for the elderly (see section 5.2).

Gender

No dose adjustment is necessary based on gender (see section 5.2).

Renal impairment

No dose adjustment is necessary for patients with renal impairment or for patients with end stage renal disease undergoing haemodialysis (see section 5.2).

Hepatic impairment

No dose adjustment is necessary for patients with mild hepatic impairment. There are limited data in patients with moderate hepatic impairment and no data in patients with severe hepatic impairment. IVEMEND should be used with caution in these patients (see sections 4.4 and 5.2).

Method of administration

IVEMEND 150 mg should be administered intravenously and should not be given by the intramuscular or subcutaneous route. Intravenous administration in adults occurs preferably through a running intravenous infusion over 20-30 minutes. Intravenous administration in paediatric patients aged 6 months and older is recommended through a central venous catheter and should be administered over 30 minutes in patients aged 12 years and older or over 60 minutes in patients less than 12 years of age (See section 6.6). Do not administer IVEMEND as a bolus injection or undiluted solution.

For instructions on reconstitution and dilution of the medicinal product before administration, see section 6.6.

In the event of overdose, fosaprepitant should be discontinued and general supportive treatment and monitoring should be provided. Because of the antiemetic activity of aprepitant, emesis induced by a medicinal product may not be effective.

Aprepitant cannot be removed by haemodialysis.

2 years.

After reconstitution and dilution, chemical and physical in-use stability has been demonstrated for 24 hours at 25°C.

From a microbiological point of view, the medicinal product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C.

Store in a refrigerator (2°C-8°C).

For storage conditions after reconstitution and dilution of the medicinal product, see section 6.3.

10 ml Type I clear glass vial with a chlorobutyl or bromobutyl rubber stopper and an aluminum seal with a grey plastic flip off cap.

Pack sizes: 1 or 10 vials.

Not all pack sizes may be marketed.

IVEMEND must be reconstituted and then diluted prior to administration.

Preparation of IVEMEND 150 mg for intravenous administration:

1. 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.
2. 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).
3. 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.
4. Determine the volume to be administered from this prepared infusion bag, based on the recommended dose (see section 4.2).

Adults:

The entire volume of the prepared infusion bag (150 ml) should be administered.

Paediatrics:

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) x weight (kg)

Note: Do not exceed maximum doses (see section 4.2).

5. 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 section 6.2).