EMEND 80 mg hard capsules
- Name:
EMEND 80 mg hard capsules
- Company:
MSD Ireland (Human Health) Limited
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may not be renewed (A)
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MSD Ireland (Human Health) Limited
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Updated on 18 June 2019 SmPC
Reasons for updating
- Improved presentation of SmPC
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Converted the SPC from word document to pdf file format
Updated on 13 June 2018 SmPC
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may not be renewed (A)
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Change to section 7 - Marketing authorisation holder
|
Present |
Proposed |
|
Merck Sharp & Dohme Ltd. |
Merck Sharp & Dohme B.V. |
Updated on 13 June 2018 PIL
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 12 May 2018 SmPC
Reasons for updating
- New SmPC for new product
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 15 April 2016 SmPC
Reasons for updating
- Change to section 8 - MA number
- Change to section 10 - Date of revision of the text
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Updated on 15 April 2016 SmPC
Reasons for updating
- New SmPC for new product
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 14 April 2016 PIL
Reasons for updating
- New PIL for new product
Updated on 14 April 2016 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change to date of revision
Updated on 4 January 2016 SmPC
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 5.3 - Preclinical safety data
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may not be renewed (A)
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Updated on 23 December 2015 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to information about driving or using machinery
- Change to date of revision
Updated on 26 March 2015 PIL
Reasons for updating
- Change to further information section
Updated on 28 February 2014 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change to further information section
- Addition of information on reporting a side effect.
Updated on 15 January 2014 SmPC
Reasons for updating
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may not be renewed (A)
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Which SPC sections have changed: 4.5, 4.8, 10
Detailed SPC change information: Updated Post-marketing events (neurotoxicity with aprepitant and ifosfamide); added details for reporting suspected adverse reactions
Updated on 23 August 2013 PIL
Reasons for updating
- New individual PIL (was previously included in a combined PIL)
Updated on 29 April 2013 SmPC
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may not be renewed (A)
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Updated on 21 December 2012 SmPC
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may not be renewed (A)
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Amended text for posology
Updated on 9 January 2012 SmPC
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.7 - Effects on ability to drive and use machines
- Change to section 4.8 - Undesirable effects
- Change to section 6.1 - List of excipients
- Change to section 10 - Date of revision of the text
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.3 - Contraindications
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Sections 2, 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 6.1, 10 - update to side effects.
Updated on 9 November 2011 SmPC
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
Legal category: Product subject to medical prescription which may not be renewed (A)
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Update to Sections: 4.2, 4.4, 4.5, 4.6, 4.8, 5.1
Updated on 11 February 2010 SmPC
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
Legal category: Product subject to medical prescription which may not be renewed (A)
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PSUR updates
4.8 Undesirable effects
4.8 Undesirable effectsThe safety profile of aprepitant was evaluated in approximately 4,900
5,300 individuals.
Adverse reactions considered as drug-related by the investigator were reported in approximately 17 % of patients treated with the aprepitant regimen compared with approximately 13 % of patients treated with standard therapy in patients receiving highly emetogenic chemotherapy
(HEC). Aprepitant was discontinued due to adverse reactions in 0.6 % of patients treated with the aprepitant regimen compared with 0.4 % of patients treated with standard therapy. In a combined analysis of 2 clinical studyies of patients receiving moderately emetogenic chemotherapy (MEC), clinical adverse reactions were reported in approximately 2114 % of patients treated with the aprepitant regimen compared with approximately 2015 % of patients treated with standard therapy. Aprepitant was discontinued due to adverse reactions in 1.10.7 % of patients treated with the aprepitant regimen compared with 0.50.2 % of patients treated with standard therapy.
The most common adverse reactions reported at a greater incidence in patients treated with the aprepitant regimen than with standard therapy in patients receiving highly emetogenic chemotherapy were: hiccups (4.6 % versus 2.9 %), asthenia/fatigue (2.9 % versus 1.6 %), alanine aminotransferase (ALT) increased (2.8 % versus 1.5 %), constipation (2.2 % versus 2.0 %), headache (2.2 % versus 1.8 %), and anorexia (2.0 % versus 0.5 %). The most common adverse reaction reported at a greater incidence in patients treated with the aprepitant regimen than with standard therapy in patients receiving moderately emetogenic chemotherapy was fatigue (2.5
1.4 % versus 1.60.9 %).
The following adverse reactions were observed
in either HEC or MEC studies in patients treated with the aprepitant regimen and at a greater incidence than with standard therapy:
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).
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System Organ Class
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Adverse reaction
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Frequency
|
|
Investigations
|
ALT increased, AST increased alkaline phosphatase increased, hyperglycaemia, microscopic haematuria, hyponatraemia, weight decreased , neutrophil count decreased |
common
uncommon
|
|
Cardiac disorders
|
b
Bradycardia, palpitations, cardiovascular disorder |
uncommon
|
|
Blood and lymphatic system disorders
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febrile neutropenia, anaemia
|
uncommon
|
|
Nervous system disorders
|
headache, dizziness dream abnormality, cognitive disorder , lethargy, somnolence |
common
uncommon
|
|
Eye disorders
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conjunctivitis
|
uncommon
|
|
Ear and labyrinth disorders
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tinnitus
|
uncommon
|
|
Respiratory, thoracic and mediastinal disorders
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hiccups pharyngitis, sneezing, cough, postnasal drip, throat irritation
|
common
uncommon
|
|
Gastrointestinal disorders |
constipation, diarrhoea, dyspepsia, eructation perforating duodenal ulcer, nausea*, vomiting*, acid reflux, dysgeusia, epigastric discomfort, obstipation, gastroesophageal reflux disease, abdominal pain, dry mouth, enterocolitis, flatulence, stomatitis , abdominal distension, faeces hard, neutropenic colitis |
common
uncommon
|
|
Renal and urinary disorders
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polyuria, dysuria, pollakiuria
|
uncommon
|
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Skin and subcutaneous tissue disorders
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rash, acne, photosensitivity, hyperhidrosis, oily skin, pruritus, skin lesion , rash pruritic |
uncommon
|
|
Musculoskeletal and connective tissue disorders
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muscle cramp, myalgia , muscular weakness |
uncommon
|
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Metabolism and nutrition disorders
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anorexia weight gain, polydipsia
|
common
uncommon
|
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Infection and infestations
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candidiasis, staphylococcal infection
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uncommon
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Vascular disorders
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flushing/hot flush
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uncommon
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General disorders and administration site conditions
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asthaenia/fatigue oedema, chest discomfort, lethargy, malaise, thirst, chills, gait disturbance |
common
uncommon
|
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Psychiatric disorders
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disorientation, euphoria, anxiety
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uncommon
|
*Nausea and vomiting were efficacy parameters in the first 5 days of post-chemotherapy treatment and were reported as adverse reactions only thereafter.
The adverse reactions profiles in the Multiple-Cycle extension
of HEC and MEC studies for up to 56 additional cycles of chemotherapy were generally similar to those observed in Cycle 1
5.1 Pharmacodynamic properties
The estimated time to first emesis in the study is depicted by the Kaplan-Meier plot in Figure 2.
Figure 2
Percent of Patients Receiving Moderately Emetogenic Chemotherapy
Who Remain Emesis Free Over Time – Cycle 1
In the same clinical study, 744 patients continued into the Multiple-Cycle extension for up to 3 additional cycles of chemotherapy. The efficacy of the aprepitant regimen was apparently maintained during all cycles.
In a second multicenter, randomized, double-blind, parallel-group, clinical study, the aprepitant regimen was compared with standard therapy in 848 patients (652 females, 196 males) receiving a chemotherapy regimen that included any IV dose of oxaliplatin, carboplatin, epirubicin, idarubicin, ifosfamide, irinotecan, daunorubicin, doxorubicin; cyclophosphamide IV (<1500 mg/m2); or cytarabine IV (>1 g/m2). Patients receiving the aprepitant regimen were receiving chemotherapy for a variety of tumor types including 52 % with breast cancer, 21 % with gastrointestinal cancers including colorectal cancer, 13 % with lung cancer and 6 % with gynecological cancers. The aprepitant regimen in combination with an ondansetron/dexamethasone regimen (see section 4.2) was compared with standard therapy (placebo in combination with ondansetron 8 mg orally (twice on Day 1, and every 12 hours on Days 2 and 3) plus dexamethasone 20 mg orally on Day 1).
Efficacy was based on the evaluation of the following primary and key secondary endpoints: No Vomiting in the overall period (0 to 120 hours post-chemotherapy), E
evaluation of safety and tolerability of the aprepitant regimen for CINV, and complete response (defined as no vomiting and no use of rescue therapy) in the overall period (0 to 120 hours post-chemotherapy). Additionally, No Significant Nausea in the overall period (0 to 120 hours post-chemotherapy) was evaluated as an exploratory endpoint, and in the acute and delayed phases as a post-hoc analysis.
A summary of the key study results is shown in Table 3.
Table 3
Percent of Patients Responding by TreatmentGroup and Phase for Study 2 – Cycle 1
Moderately Emetogenic Chemotherapy
|
|
Aprepitant Regimen (N=
425) †
%
|
Standard Therapy (N=
406)
%
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Differences*
% (95 % CI)
|
|
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Complete Response (no emesis and no rescue therapy)
|
||||
Overall (0-120 hours) 0-24 hours 25-120 hours |
68.7 89.2 70.8
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56.3 80.3 60.9
|
12.4 8.9 9.9
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(5.9, 18.9) (4.0, 13.8) (3.5, 16.3)
|
|
No Emesis (no emetic episodes regardless of use of rescue therapy)
|
||||
Overall (0-120 hours) 0-24 hours 25-120 hours |
76.2 92.0 77.9
|
62.1 83.7 66.8
|
14.1 8.3 11.1
|
(7.9, 20.3) (3.9, 12.7) (5.1, 17.1)
|
|
Complete Response (no emesis and no rescue therapy)
|
||||
Overall (0-120 hours) 0-24 hours 25-120 hours |
68.7 89.2 70.8
|
56.3 80.3 60.9
|
12.4 8.9 9.9
|
(5.9, 18.9) (4.0, 13.8) (3.5, 16.3)
|
|
No Significant Nausea (maximum VAS <25 mm on a scale of 0-100 mm)
|
||||
Overall (0-120 hours) 0-24 hours 25-120 hours |
73.6 90.9 74.9
|
66.4 86.3 69.5
|
7.2 4.6 5.4
|
(1.0, 13.4) (0.2, 9.0) (-0.7, 11.5)
|
*
The confidence intervals were calculated with no adjustment for gender and region, which were included in the primary analysis using logistic models.
The benefit of aprepitant combination therapy in the full study population was mainly driven by the results observed in patients with poor control with the standard regimen such as in women, even though the results were numerically better regardless of age, tumour type or gender. Complete response to the aprepitant regimen and standard therapy, respectively, was reached in 209/324 (65 %) and 161/320 (50 %) in women and 83/101 (82 %) and 68/87 (78 %) of men.
The estimated time to first vomiting in this study is depicted by the Kaplan-Meier plot in Figure 3.
Figure 3:
Percent of Patients Receiving Moderately Emetogenic Chemotherapy
Who Remain Emesis Free Over Time – Cycle 1
0
12
24
36
48
60
72
84
96
108
120
Percent of Patients
0
20
40
60
80
100
Time(hours) Since the First Chemotherapy Administration
Aprepitant Regimen(N=425)
Standard Regimen(N=407)
Updated on 20 November 2009 SmPC
Reasons for updating
- Correction of spelling/typing errors
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Updated on 30 September 2009 SmPC
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
Legal category: Product subject to medical prescription which may not be renewed (A)
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Update section 4.5: Add immunosuppresants and induction details, update CYP3A4 with narrow therapeutic range.
Updated on 16 October 2008 SmPC
Reasons for updating
- Improved electronic presentation
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 22 March 2007 SmPC
Reasons for updating
- Change to section 6.5 - Nature and contents of container
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Updated on 21 March 2007 SmPC
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.4 - Special warnings and precautions for use
Legal category: Product subject to medical prescription which may not be renewed (A)
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Updated on 27 January 2006 SmPC
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 17 May 2005 SmPC
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 6.3 - Shelf life
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 23 December 2004 SmPC
Reasons for updating
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 5.1 - Pharmacodynamic properties
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 5 August 2004 SmPC
Reasons for updating
- Change to section 6.3 - Shelf life
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 26 July 2004 SmPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may not be renewed (A)