Vectibix

  • Name:

    Vectibix

  • Company:
    info
  • Active Ingredients:

    Panitumumab

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 01/10/19

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Summary of Product Characteristics last updated on medicines.ie: 1/10/2019

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Amgen Ireland Ltd

Amgen Ltd

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Medicine Name Mimpara tablets Active Ingredients cinacalcet hydrochloride
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Medicine Name Neulasta On Body Injector Active Ingredients Pegfilgrastim
Medicine Name Neulasta Pre-Filled Syringe Active Ingredients Pegfilgrastim
Medicine Name Neupogen 30 MU (0.3 mg/ml) solution for injection Active Ingredients Filgrastim
Medicine Name Neupogen Singleject 30 MU (0.6 mg/ml) Active Ingredients Filgrastim
Medicine Name Neupogen Singleject 48 MU (0.96 mg/ml) Active Ingredients Filgrastim
Medicine Name Nplate Active Ingredients Romiplostim
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Medicine Name Parsabiv Active Ingredients etelcalcetide
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Medicine Name Vectibix Active Ingredients Panitumumab
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1 - 0 of 25 items.Total: Infinity pages

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 1 October 2019 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.7 - Effects on ability to drive and use machines
  • 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

SPC

 New text in blue, deleted text in red

Section 2

Removal of single use

Section 3 Pharmaceutical form

Addition of PH values

Section 4.2 Posology and method of administration

The dose adjustment table from Section 4.4 has been moved to Section 4.2 under the Posology subheading.

 

Text has been moved around within Section 4.2 but not changed.

 

Section 4.4 Special Warnings and Precautions

Traceability

 

In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.

 

Dermatologic reactions and soft tissue toxicity

 

Dermatologic related reactions, a pharmacologic effect observed with epidermal growth factor receptor (EGFR) inhibitors, are experienced with nearly all patients (approximately 94%) treated with Vectibix. Severe (NCI CTC grade 3) skin reactions were reported in 3223% and life-threatening (NCI CTC grade 4) skin reactions in < 1% of patients who received Vectibix monotherapy and in combination with chemotherapy (n = 1,1722,224) (see section 4.8). If a patient develops dermatologic reactions that are grade 3 (CTCAE v 4.0) or higher, or that are considered intolerable, see the recommendation for following dose modification is recommendedin section 4.2.

 

Removal of skin tox dose adjustment table as it has been moved to section 4.2.

 

Proactive skin treatment including skin moisturiser, sun screen (SPF > 15 UVA and UVB), topical steroid cream (not stronger than 1% hydrocortisone) and an oral antibiotic (e.g. doxycycline) may be useful in the management of dermatologic reactions. Patients may be advised to apply moisturiser and sunscreen to face, hands, feet, neck, back and chest every morning during treatment, and to apply the topical steroid to face, hands, feet, neck, back and chest every night during treatment.

 

Infusion-related reactions

 

Across monotherapy and combination mCRC clinical studies (n = 2,224), infusion-related reactions (occurring within 24 hours of an infusion) were reported in approximately 5% of Vectibix-treated patients, including severe infusion-related reactions of which 1% were severe (NCI CTC grade 3 and grade 4).

 

Vectibix in combination with bevacizumab and chemotherapy regimens

 

A randomised, open-label, multicentre study of 1,053 patients evaluated the efficacy of bevacizumab and oxaliplatin- or irinotecan-containing chemotherapeutic regimens with and without Vectibix in the first-line treatment of metastatic colorectal cancer. Shortened progression-free survival time and increased deaths were observed in the patients receiving Vectibix in combination with bevacizumab and chemotherapy. A greater frequency of pulmonary embolism, infections (predominantly of dermatologic origin), diarrhoea, electrolyte imbalances, nausea, vomiting and dehydration was also observed in the treatment arms using Vectibix in combination with bevacizumab and chemotherapy. An additional analysis of efficacy data by KRAS status did not identify a subset of patients who benefited from Vectibix in combination with oxaliplatin- or irinotecan-based chemotherapy and bevacizumab. A trend towards worse survival was observed with Vectibix in the wild-type KRAS subset of the bevacizumab and oxaliplatin cohort, and a trend towards worse survival was observed with Vectibix in the bevacizumab and irinotecan cohort regardless of KRAS mutational status. Therefore, Vectibix should not be administered in combination with bevacizumab containing chemotherapy (see sections 4.5 and 5.1).

 

Vectibix in combination with oxaliplatin-based chemotherapy in patients with mutant RAS mCRC or for whom RAS tumour status is unknown

 

The combination of Vectibix with oxaliplatin-containing chemotherapy is contraindicated for patients with mutant RAS mCRC or for whom RAS mCRC status is unknown (see sections 4.3 and 5.1).

 

In the primary analysis of a study (n = 1,183, 656 patients with wild-type KRAS (exon 2) and 440 patients with mutant KRAS tumours) evaluating panitumumab in combination with infusional 5 fluorouracil, leucovorin, and oxaliplatin (FOLFOX) compared to FOLFOX alone as first-line therapy for mCRC, aA shortened progression-free survival (PFS) and overall survival (OS) time were observed in patients with mutant KRAS (exon 2) tumours and additional RAS mutations (KRAS [exons 3 and 4] or NRAS [exons 2, 3, 4]) who received panitumumab in combination with infusional 5 fluorouracil, leucovorin, and oxaliplatin and (FOLFOX) (n = 221) versus FOLFOX alone (n = 219see section 5.1).

 

A predefined retrospective subset analysis of 641 patients of the 656 patients with wild-type KRAS (exon 2) tumours from this study identified additional RAS (KRAS [exons 3 and 4] or NRAS [exons 2, 3, 4]) mutations in 16% (n = 108) of patients. A shortening of PFS and OS was observed in patients with mutant RAS tumours who received panitumumab and FOLFOX (n = 51) versus FOLFOX alone (n = 57).RAS mutational status should be determined using a validated test method by an experienced laboratory (see section 4.2). If Vectibix is to be used in combination with FOLFOX then it is recommended that mutational status be determined by a laboratory that participates in a RAS External Quality Assurance programme or wild-type status be confirmed in a duplicate test.

 

Warnings for excipients

Other precautions

This medicinal product contains 3.45 mg sodium per mL, equivalent to 0.017% of the WHO recommended maximum daily intake of 2 g sodium for an adult.

This medicinal product contains 0.150 mmol sodium (which is 3.45 mg sodium) per mL of concentrate. To be taken into consideration by patients on a controlled sodium diet.

 

Section 4.7 Effects on ability to drive and use machines

Vectibix may have a minor influence on the ability to drive and use machines. If patients experience treatment-related symptoms affecting their vision and/or ability to concentrate and react, it is recommended that they do not drive or use machines until the effect subsides.

Section 4.8 Undesirable Effects

Skin and subcutaneous tissue disorders

Across all clinical trials, skin reactions occurred in approximately 94% of patients receiving Vectibix as monotherapy or in combination with chemotherapy (n = 2,224). These events consisted predominantly of rash and dermatitis acneiform and were mostly mild to moderate in severity. Severe (NCI CTC grade 3) skin reactions were reported in 3223% and life-threatening (NCI CTC grade 4) skin reactions in < 1% of patients who received Vectibix in combination with chemotherapy (n = 1,172). Life threatening and fatal infectious complications including necrotising fasciitis and sepsis have been observed in patients treated with Vectibix (see section 4.4).

Section 10 Date of revision of the text

September 2019

Updated on 1 October 2019 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 6 - date of revision

Updated on 22 August 2019 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 6 - date of revision

Updated on 22 August 2019 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 4.8 - 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)

Updated on 3 August 2018

Updated on 27 February 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 27 February 2018 PIL

Reasons for updating

  • New PIL for new product

Updated on 27 February 2018 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • 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

Section 4.4
Change to % of dermatologic reactions and soft tissue toxicity and infusion-related reactions experienced in patients.

 

“Dermatologic reactions and soft tissue toxicity

Dermatologic related reactions, a pharmacologic effect observed with epidermal growth factor receptor (EGFR) inhibitors, are experienced with nearly all patients (approximately 9490%) treated with Vectibix. Severe (NCI-CTC grade 3) skin reactions were reported in 3234% and life-threatening (NCI-CTC grade 4) skin reactions in < 1% of patients who received Vectibix in combination with chemotherapy (n = 1,1721536) (see section 4.8).”

 

“Infusion- related reactions

Across monotherapy and combination mCRC clinical studies (n = 2,2242,588), infusion-related reactions (occurring within 24 hours of an infusion) were reported in approximately 54% of Vectibix treated patients, of which < 1% were severe (NCI-CTC grade 3 and grade 4).”

Section 4.8
Update to summary of safety profile

“Summary of safety profile

Based on an analysis of all mCRC clinical trial patients receiving Vectibix monotherapy and in combination with chemotherapy (n = 2,2242,588), the most commonly reported adverse reactions are

skin reactions occurring in approximately 94%93% of patients. These reactions are related to the pharmacologic effects of Vectibix, and the majority are mild to moderate in nature with 2325% severe (grade 3 NCI-CTC) and < 1% life -threatening (grade 4 NCI-CTC). For clinical management of skin reactions, including dose modification recommendations, see section 4.4.

Very commonly reported adverse reactions occurring in ≥ 20% of patients were gastrointestinal disorders [diarrhoea (4650%), nausea (3941%), vomiting (2627%), constipation (23%) and abdominal pain (23%)]; general disorders [fatigue (3537%), pyrexia (2120%)]; metabolism and nutrition disorders [anorexia decreased appetite (3027%)]; infections and infestations [paronychia (20%)]; and skin and subcutaneous disorders [rash (4745%), dermatitis acneiform (39%), pruritus (3635%), erythema (3330%) and dry skin (2122%)].”

 

Update to AE table to better present the safety profile of Vectibix.

Section 10 date of revision to January 2018

Updated on 27 February 2018 PIL

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 31 March 2017 PIL

Reasons for updating

  • Change to section 6 - manufacturer

Updated on 22 November 2016 SmPC

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation
  • 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

Removal of PSP/LSP wording
Updated date of revision

Updated on 17 November 2016 PIL

Reasons for updating

  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 6 - date of revision

Updated on 19 October 2016 PIL

Reasons for updating

  • Deletion of a pack size
  • Change to further information section
  • Change to date of revision

Updated on 19 October 2016 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 8 - Marketing authorisation number(s)
  • 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

Removal of the 10ml vial and MA number related to that presentation.
Further clarity on the presentation of Vectibix and single-use vial.

Updated on 13 April 2015 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 9 - Date of renewal of authorisation
  • 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

Section 4.1 – Extenstion of first line indication with FOLFIRI

Section 5.1 - Addition of data around efficacy of Vectibix in first line indication with FOLFIRI

Section 9 – Date of latest renewal of the text updated to 15 January 15

 Section 10 – Date of revision of the text updated to March 2015

Updated on 27 January 2015 SmPC

Reasons for updating

  • Removal of black triangle
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • 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

Header

Removal of inverted black triangle and additional monitoring statement

Section 4.4

Change of the word “Hold” to “Withhold” in the table for occurrence of skin reactions

Section 4.8

Addition of 3 new common adverse event reactions (Urinary tract infection, Hyperhidrosis, Dermatitis) and 1 uncommon (dry Lips)  

Section 5.1

Add efficacy data from a predefined retrospective analysis by RAS and RAS/BRAF status and removal of KRAS (exon 2) information across all treatment lines. Results of Study 20080763 (KRAS exon 2) remain.

Removal of statement around conditional approval

Section 10

Date of revision of the text has been updated to January 2015

Updated on 27 January 2015 PIL

Reasons for updating

  • Change to side-effects
  • Change to date of revision
  • Removal of black triangle

Updated on 28 May 2014 PIL

Reasons for updating

  • Change to side-effects
  • Change to date of revision

Updated on 28 May 2014 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 9 - Date of renewal of authorisation
  • 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

Section 4.4

-Addition of text around rare cases of Stevens-Johnson syndrome and toxic epidermal necrolysis reported in the post-marketing setting

Section 4.8

-Addition of Stevens-Johnson syndrome and toxic epidermal necrolysis to the list of rare adverse reactions

-Addition of text around rare cases of Stevens-Johnson syndrome and toxic epidermal necrolysis reported in the post-marketing

Section 9

-Date of latest renewal has been updated to 18 March 2014

Section 10

-Date of revision of the text has been updated to April 2014

Updated on 5 March 2014 PIL

Reasons for updating

  • Change to date of revision
  • Change to improve clarity and readability

Updated on 5 March 2014 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • 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

Section 4.4
-
Minor text amendment from KRAS to RAS in the following sentence: “If Vectibix is to be used in combination with FOLFOX then it is recommended that mutational status be determined by a laboratory that participates in a RAS External Quality Assurance program or wild-type status be confirmed in a duplicate test”.

Section 5.1
-Inclusion of text around new data from a randomised controlled trial of Vectibix monotherapy versus cetuximab
-Minor amendments to reflect change to RAS

Section 10
-
Date of Revision of the text updated to February 2014

Updated on 15 August 2013 PIL

Reasons for updating

  • Change to further information section
  • Addition of information on reporting a side effect.
  • Addition of black triangle

Updated on 15 August 2013 SmPC

Reasons for updating

  • Addition of black triangle
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.3 - Shelf life
  • 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

Header 
Addition of inverted black triangle and statement on additional monitoring

                                                                                                                               

Section 4.1

Updated text around refined indication for adult patients with wild type RAS metastatic colorectal cancer (mCRC)

 

Section 4.2

Revised text around wild-type RAS status and method of determination of mutational status

Revised text around paediatric population

 

Section 4.3

Revised text around expanded contraindication to mutant RAS mCRC or unknown RAS mCRC status

 

Section 4.4

Addition of text around results in patients with mutant RAS tumour status who received Panitumumab and FOLFOX

 

Section 4.8

Addition of text around reporting of suspected Adverse Reactions

 

Section 5.1

Addition of text around new analysis

 

Section 6.3

Minor text changes

 

Section 10

Updated to 25 July 2013

Updated on 4 February 2013 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to date of revision
  • Change to improve clarity and readability

Updated on 1 February 2013 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • 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

Section 4.4  Special warnings and precautions for use
Addition of wording around soft tissue toxicity

Section 4.8  Undesirable effects
Order of System Organ Classes revised to comply with the latest MedDRA version

Section 10. Date of revision
Updated to 14 January 2013

Minor changes and clarifications made throughout the SmPC.

Updated on 17 August 2012 PIL

Reasons for updating

  • Addition of manufacturer

Updated on 9 July 2012 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • 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

In section 4.4 - Addition of the NCI-CTC grades and text on necrotising fasciitis and sepsis
In section 4.6 - Change in timeframe for contraception use and breastfeeding to 2 months after Vectibix use
In section 4.8 - Addition of necrotising fasciitis and sepsis
In section 10 - Revision of date

Updated on 9 July 2012 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to information about pregnancy or lactation

Updated on 29 February 2012 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to side-effects
  • Change to drug interactions
  • Change to information about pregnancy or lactation
  • Change to information about driving or using machinery
  • Change to date of revision
  • Change to improve clarity and readability

Updated on 29 February 2012 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • 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

In Section 4.4 - Updates to pulmonary complications and electrolyte disturbances.
In Section 4.6 - Updates text with Amgen Surveillance program
In Section 4.8 - Updates to infusion related reactions, Ocular toxicities and AE's including ILD
In Section 5.1 - Updates to PD effects and clinical efficacy data

Updated on 22 February 2012 SmPC

Reasons for updating

  • 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

In Section 4.4 - Addition of text to Pulmonary Complications and Electrolyte Disturbances.  Addition of Skin Necrosis and Interstitial Lung Disease to list of Adverse Reactions

In Section 10 - Updated date of revision

Updated on 22 February 2012 PIL

Reasons for updating

  • Change to side-effects

Updated on 21 November 2011 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • 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 4.9 - Overdose
  • 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

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • 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 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 10 - Date of revision of the text

Updated on 21 November 2011 PIL

Reasons for updating

  • Change to side-effects
  • Change to information about pregnancy or lactation
  • Change to how the medicine works
  • Change to date of revision
  • Change due to user-testing of patient information

Updated on 3 June 2011 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • 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

Section 4.4 (special warnings and precautions for use) 

Addition of a paragraph regarding ocular toxicities (including cases of keratitis and ulcerative keratitis)

 

Section 4.8 (undesirable effects)

Inclusion of the adverse reactions keratitis (uncommon) and ulcerative keratitis (rare).   

Addition of a paragraph regarding ocular toxicities (including cases of keratitis and ulcerative keratitis)

 

Section 10 (date of revision of the text)

Date changed to 23 May 2011

Updated on 3 June 2011 PIL

Reasons for updating

  • Change to side-effects
  • Change to date of revision
  • Change to warnings or special precautions for use

Updated on 1 June 2010 SmPC

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • Change to section 4 - Clinical particulars
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • 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 5.2 - Pharmacokinetic properties
  • Change to section 6.3 - Shelf life
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 9 - Date of renewal of authorisation
  • 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

Section 4.4 addition of warnings concerning cellulitis and also infusion related reactions. The background to the warning on cellulitis is provided. In addition, a warning has been included that Vectibix should not be administered to mCRC patients with mutant KRAS tumours or for whom KRAS status is unknown in combination with oxaliplatin-containing chemotherapy based on the results of a recent trial (also included in Section 4.5).
Section 4.8, amendment of table of adverse reactions, increased information concerning dermatological reactions, infusion-related reactions, cellulitis. angioedema.
Other indicated sections have minor amendments.

Updated on 26 May 2010 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects

Updated on 12 May 2010 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to side-effects

Updated on 27 April 2009 SmPC

Reasons for updating

  • 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
  • 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

In section 4.4 (Special Warnings and Precautions for Use), revised wording concerning infusion related reactions, and hypersensitivity and inclusion of warning about late onset reactions.
Strengthened warning about use in combination with bevacizumab containing chemotherapy. New warning about acute renal failure.
In section 4.5 (Interaction), strengthened warning about use in combination with chemotherapy and IFL or bevacizumab.
Section 4.8 (undesirable effects), new warnings concerning dermatitis acneiform, acute renal failure, infusion related reactions and fatal angioedema, revisions in line with new data.
Section 5.1 (Pharmacodynamic Properties), revised text in line with the latest data concerning hazard ratios and survival in the different treatment groups of the PACCE study.

Updated on 23 April 2009 PIL

Reasons for updating

  • Change to side-effects

Updated on 21 January 2009 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 6.3 - Shelf life

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

Free text change information supplied by the pharmaceutical company

In section 4.4, warning concerning hypomagnesaemia has been extended to include reference to hypocalcaemia and hypokalaemia and the details concerning frequency of monitoring these electrolyte disturbances has been modified.
In section 6.3, the precautions to be taken after dilution of the product have been strengthened.

Updated on 21 January 2009 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to date of revision

Updated on 28 August 2008 PIL

Reasons for updating

  • Change to side-effects

Updated on 26 August 2008 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 6.3 - Shelf life

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

Free text change information supplied by the pharmaceutical company

Section 4.8 (undesirable effects) vascular disorders: pulmonary embolism has been added to table in this section as a common side effect.
 
section 6.3 the shelf life has been changed from 2 years to 3 years.

Updated on 3 July 2008 SmPC

Reasons for updating

  • New SPC for new product

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

Updated on 1 July 2008 PIL

Reasons for updating

  • New PIL for new product