EMEND

The oral suspension should be prepared and the dose measured by healthcare professionals only. 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. 1). Recommended dose of EMEND oral suspension in paediatric patients aged 6 months to less than 12 years Day 1 Day 2 Day 3 EMEND oral suspension 25 mg/mL 3 mg/kg orally Maximum dose 125 mg 2 mg/kg orally Maximum dose 80 mg 2 mg/kg orally Maximum dose 80 mg 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. 5. Please refer to the SmPC of co-administered 5-HT3 antagonist medicinal products. 2). 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. 2). Method of administration The oral suspension may be taken with or without food. 6.

Summary of the safety profile The safety profile of aprepitant was evaluated in approximately 6,500 adults in more than 50 studies and 184 children and adolescents in 2 pivotal paediatric clinical trials. 5 %). 9 %). 0 %). Tabulated list of adverse reactions The following adverse reactions were observed in a pooled analysis of the HEC and MEC studies at a greater incidence with aprepitant than with standard therapy or in postmarketing use.

The frequency categories given in the table are based on the studies in adults; the observed frequencies in the paediatric studies were similar or lower, unless shown in the table. Some less common ADRs in the adult population were not observed in the paediatric studies.

Frequencies are defined as: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000) and very rare (< 1/10,000), not known (cannot be estimated from the available data). System organ class Adverse reaction Frequency Infection and infestations candidiasis, staphylococcal infection rare Blood and lymphatic system disorders febrile neutropenia, anaemia uncommon Immune system disorders hypersensitivity reactions including anaphylactic reactions not known decreased appetite commonMetabolism and nutrition disorders polydipsia rare anxiety uncommonPsychiatric disorders disorientation, euphoric mood rare headache common dizziness, somnolence uncommon Nervous system disorders cognitive disorder, lethargy, dysgeusia rare Eye disorders conjunctivitis rare Ear and labyrinth disorders tinnitus rare System organ class Adverse reaction Frequency palpitations uncommonCardiac disorders bradycardia, cardiovascular disorder rare Vascular disorders hot flush/flushing uncommon hiccups commonRespiratory, thoracic and mediastinal disorders oropharyngeal pain, sneezing, cough, postnasal drip, throat irritation rare constipation, dyspepsia common eructation, nausea†, vomiting†, gastroesophageal reflux disease, abdominal pain, dry mouth, flatulence uncommon Gastrointestinal disorders duodenal ulcer perforation, stomatitis, abdominal distension, faeces hard, neutropenic colitis rare rash, acne uncommon photosensitivity reaction, hyperhidrosis, seborrhoea, skin lesion, rash pruritic, Stevens-Johnson syndrome/toxic epidermal necrolysis rare Skin and subcutaneous tissue disorders pruritus, urticaria not known Musculoskeletal and connective tissue disorders muscular weakness, muscle spasms rare dysuria uncommonRenal and urinary disorders pollakiuria rare fatigue common asthenia, malaise uncommon General disorders and administration site conditions oedema, chest discomfort, gait disturbance rare ALT increased commonInvestigations AST increased, blood alkaline phosphatase increased uncommon System organ class Adverse reaction Frequency red blood cells urine positive, blood sodium decreased, weight decreased, neutrophil count decreased, glucose urine present, urine output increased rare • †Nausea and vomiting were efficacy parameters in the first 5 days of post-chemotherapy treatment and were reported as adverse reactions only thereafter.

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. 2). 5). Additionally, concomitant administration with irinotecan should be approached with particular caution as the combination might result in increased toxicity.

5). Co administration with hormonal contraceptives The efficacy of hormonal contraceptives may be reduced during and for 28 days after administration of EMEND. 5). Excipients EMEND powder for oral suspension contains sucrose and lactose.

Patients with rare hereditary problems of fructose or galactose intolerance, glucose galactose malabsorption, total lactase deficiency, or sucrase isomaltase insufficiency should not take this medicine. Sodium This medicinal product contains less than 1 mmol sodium (23 mg) per sachet, that is to say essentially ‘sodium-free’.

1. 5).