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EMEND 125 mg hard capsules

  • Name:

    EMEND 125 mg hard capsules

  • Company:
    info
  • Active Ingredients:

    Aprepitant

  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 13/06/18

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Summary of Product Characteristics last updated on medicines.ie: 18/6/2019

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MSD Ireland (Human Health) Limited

MSD Ireland (Human Health) Limited

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When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 18 June 2019 SmPC

Reasons for updating

  • Improved presentation of SmPC

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

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)

Free text change information supplied by the pharmaceutical company

Change to section 7 - Marketing authorisation holder

Present

Proposed

Merck Sharp & Dohme Ltd.
Hertford Road
Hoddesdon
Hertfordshire
EN11 9BU
United Kingdom

Merck Sharp & Dohme B.V.
Waarderweg 39
2031 BN Haarlem
The Netherlands

 

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

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

SPC Change Details e.g. “In section 8 (MA number), the list of strengths applicable to each EU number has been removed

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)

Free text change information supplied by the pharmaceutical company

Added info on paediatric population; added flushing side effect (uncommon)

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)

Free text change information supplied by the pharmaceutical company

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)

Free text change information supplied by the pharmaceutical company

Update to Sections: 4.2, 5.1,10

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)

Free text change information supplied by the pharmaceutical company

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

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

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)

Free text change information supplied by the pharmaceutical company

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)

Free text change information supplied by the pharmaceutical company

PSUR updates

4.8 Undesirable effects

4.8 Undesirable effects

The 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).

System Organ Class

 

Adverse reaction

 

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

 

febrile neutropenia, anaemia

 

uncommon

 

Nervous system disorders

 

headache, dizziness

dream abnormality, cognitive disorder

, lethargy, somnolence

common

 

uncommon

 

Eye disorders

 

conjunctivitis

 

uncommon

 

Ear and labyrinth disorders

 

tinnitus

 

uncommon

 

Respiratory, thoracic and mediastinal disorders

 

 

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

 

polyuria, dysuria, pollakiuria

 

uncommon

 

Skin and subcutaneous tissue disorders

 

rash, acne, photosensitivity, hyperhidrosis, oily skin, pruritus, skin lesion

, rash pruritic

uncommon

 

Musculoskeletal and connective tissue disorders

 

muscle cramp, myalgia

, muscular weakness

uncommon

 

Metabolism and nutrition disorders

 

anorexia

weight gain, polydipsia

 

common

 

uncommon

 

Infection and infestations

 

candidiasis, staphylococcal infection

 

uncommon

 

Vascular disorders

 

flushing/hot flush

 

uncommon

 

General disorders and administration site conditions

 

asthaenia/fatigue

oedema, chest discomfort, lethargy,

malaise, thirst, chills, gait disturbance

common

 

uncommon

 

Psychiatric disorders

 

disorientation, euphoria, anxiety

 

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)

 

%

 

 

 

Differences*

 

 

% (95 % CI)

 

 

 
         

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 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

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

6.5- Pack sizes omitted in error

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)

Free text change information supplied by the pharmaceutical company

Update section 4.4: CYP3A4  with narrow therapeutic range.
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

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Change to SPC to include text to section 6.5

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)

Free text change information supplied by the pharmaceutical company

Changes to SPC following adoption of Type II variation by the commission.

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)