Ivemend

6). IVEMEND should be administered in conjunction with a corticosteroid and a 5-HT3 antagonist as specified in the tables below. 3 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 Day 1 Day 2 Day 3 Day 4 IVEMEND 150 mg intravenously none none none Dexamethasone 12 mg orally 8 mg orally 8 mg orally twice daily 8 mg orally twice daily 5-HT3 antagonists Standard dose of 5-HT3 antagonists.

See the product information for the selected 5-HT3 antagonist for appropriate dosing information none none none 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 Day 1 IVEMEND 150 mg intravenously Dexamethasone 12 mg orally 5-HT3 antagonists Standard dose of 5-HT3 antagonists.

See the product information for the selected 5-HT3 antagonist for appropriate dosing information 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.

Summary of the safety profile In clinical studies, various formulations of fosaprepitant have been administered to a total of 2,687 adults including 371 healthy subjects and 2,084 patients, and 299 children and adolescents with chemotherapy induced nausea and vomiting (CINV).

Since fosaprepitant is converted to aprepitant, those adverse reactions associated with aprepitant are expected to occur with fosaprepitant. The safety profile of aprepitant was evaluated in approximately 6,500 adults and 184 children and adolescents.

5 %). 9 %). 0 %). Tabulated list of adverse reactions - aprepitant The following adverse reactions were observed in a pooled analysis of the HEC and MEC studies at a greater incidence with oral aprepitant than with standard therapy in adults or paediatric patients or in post-marketing 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).

Table 5:

Tabulated list of adverse reactions – aprepitant 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 Metabolism and nutrition disorders decreased appetite common polydipsia rare Psychiatric disorders anxiety uncommon disorientation, euphoric mood rare Nervous system disorders headache common dizziness, somnolence uncommon cognitive disorder, lethargy, dysgeusia rare Eye disorders conjunctivitis rare Ear and labyrinth disorders tinnitus rare 11 System organ class Adverse reaction Frequency Cardiac disorders palpitations uncommon bradycardia, cardiovascular disorder rare Vascular disorders hot flush/flushing uncommon Respiratory, thoracic and mediastinal disorders hiccups common oropharyngeal pain, sneezing, cough, postnasal drip, throat irritation rare Gastrointestinal disorders constipation, dyspepsia common eructation, nausea*, vomiting*, gastroesophageal reflux disease, abdominal pain, dry mouth, flatulence uncommon duodenal ulcer perforation, stomatitis, abdominal distension, faeces hard, neutropenic colitis rare Skin and subcutaneous tissue disorders rash, acne uncommon photosensitivity reaction, hyperhidrosis, seborrhoea, skin lesion, rash pruritic, Stevens-Johnson syndrome/toxic epidermal necrolysis rare pruritus, urticaria not known Musculoskeletal and connective tissue disorders muscular weakness, muscle spasms rare Renal and urinary disorders dysuria uncommon pollakisuria rare General disorders and administration site conditions fatigue common asthenia, malaise uncommon oedema, chest discomfort, gait disturbance rare Investigations ALT increased common AST increased, blood alkaline phosphatase increased uncommon 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 fosaprepitant. 5). Hypersensitivity reactions Immediate hypersensitivity reactions including flushing, erythema, dyspnoea, and anaphylaxis/anaphylactic shock have occurred during or soon after infusion of fosaprepitant.

These hypersensitivity reactions have generally responded to discontinuation of the infusion and administration of appropriate therapy. It is not recommended to reinitiate the infusion in patients who experience hypersensitivity reactions.

8). , anthracycline-based) chemotherapy administration, particularly when associated with extravasation. Necrosis was also reported in some patients with concomitant vesicant chemotherapy. Mild injection site thrombosis has been observed at higher doses without concomitant vesicant chemotherapy.

2). 3). If signs or symptoms of local irritation occur, the injection or infusion should be terminated and restarted in another vein. 7 Sodium This medicinal product contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’.

1. 5).