EMEND® 125 mg powder for oral suspension
Each sachet contains 125 mg of aprepitant. After reconstitution, 1 mL oral suspension contains 25 mg of aprepitant.
Excipients with known effect
Each sachet contains approximately 125 mg of sucrose and 468.7 mg lactose (as anhydrous).
For the full list of excipients, see section 6.1.
Powder for oral suspension.
Pink to light pink powder.
Prevention of nausea and vomiting associated with highly and moderately emetogenic cancer chemotherapy in children, toddlers and infants from the age of 6 months to less than 12 years.
EMEND powder for oral suspension is given as part of combination therapy (see section 4.2).
Posology
Paediatric population
Infants, toddlers and children (aged 6 months to less than 12 years, and not less than 6 kg)
EMEND is given for 3 days as part of a regimen that includes a 5-HT3 antagonist. The recommended dose of EMEND powder for oral suspension is based on weight, as specified in the table below. EMEND is administered orally 1 hour prior to chemotherapy on Days 1, 2 and 3. If no chemotherapy is given on Days 2 and 3, EMEND should be administered in the morning. See the Summary of Product Characteristics (SmPC) for the selected 5-HT3 antagonist for appropriate dosing information. If a corticosteroid, such as dexamethasone, is co-administered with EMEND, the dose of the corticosteroid should be administered at 50 % of the usual dose (see sections 4.5 and 5.1).
Recommended dose and volume of EMEND oral suspension in paediatric patients aged 6 months to less than 12 years
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Body weight
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Dose volume of suspension to be administered orally
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Day 1
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Day 2
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Day 3
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less than 6 kg
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Not recommended
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6 kg to less than 8 kg
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1 mL
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(25 mg)
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0.6 mL
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(15 mg)
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0.6 mL
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(15 mg)
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8 kg to less than 10 kg
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1.2 mL
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(30 mg)
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0.8 mL
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(20 mg)
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0.8 mL
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(20 mg)
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10 kg to less than 12 kg
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1.4 mL
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(35 mg)
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1 mL
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(25 mg)
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1 mL
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(25 mg)
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12 kg to less than 15 kg
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1.8 mL
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(45 mg)
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1.2 mL
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(30 mg)
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1.2 mL
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(30 mg)
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15 kg to less than 20 kg
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2.4 mL
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(60 mg)
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1.6 mL
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(40 mg)
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1.6 mL
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(40 mg)
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20 kg to less than 25 kg
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3 mL
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(75 mg)
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2 mL
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(50 mg)
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2 mL
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(50 mg)
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25 kg to less than 30 kg
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3.6 mL
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(90 mg)
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2.4 mL
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(60 mg)
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2.4 mL
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(60 mg)
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30 kg and above
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Withdraw all of the contents from the mixing cup into the oral dispenser (~5 mL)
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(125 mg)
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3.2 mL
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(80 mg)
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3.2 mL
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(80 mg)
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The efficacy of the 125 mg powder for oral suspension has not been established in children 12 years of age and older. For adolescents aged 12-17 years, EMEND is available as capsules containing 80 mg, or 125 mg of aprepitant.
The safety and efficacy of EMEND powder for oral suspension in infants below 6 months of age or weighing less than 6 kg has 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. Please refer to the SmPC of co-administered 5-HT3 antagonist medicinal products.
Special populations
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. Aprepitant should be used with caution in these patients (see sections 4.4 and 5.2).
Method of administration
The oral suspension may be taken with or without food.
For details on preparation and administration of the suspension, see section 6.6.
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Co-administration with pimozide, terfenadine, astemizole or cisapride (see section 4.5).
Patients with moderate to severe hepatic impairment
There are limited data in patients with moderate hepatic impairment and no data in patients with severe hepatic impairment. EMEND should be used with caution in these patients (see section 5.2).
CYP3A4 interactions
EMEND should be used with caution in patients receiving concomitant orally administered active substances that are metabolised primarily through CYP3A4 and with a narrow therapeutic range, such as cyclosporine, tacrolimus, sirolimus, everolimus, alfentanil, ergot alkaloid derivatives, fentanyl, and quinidine (see section 4.5). Additionally, concomitant administration with irinotecan should be approached with particular caution as the combination might result in increased toxicity.
Co-administration with warfarin (a CYP2C9 substrate)
