Lenvima (lenvatinib)
*Company:
Eisai LtdStatus:
UpdatedLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 01 November 2024
File name
ROI Lenvima SmPC Oct 2024.pdf
Reasons for updating
- 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)
Updated on 03 April 2024
File name
ROI Lenvima SmPC March 2024.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- 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 14 December 2023
File name
ROI Lenvima PIL Nov 2023.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 14 December 2023
File name
ROI Lenvima SmPC Nov 2023.pdf
Reasons for updating
- 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 24 November 2023
File name
ROI Lenvima PIL Nov 2023.pdf
Reasons for updating
- Change to section 2 - use in children and adolescents
- Change to section 6 - date of revision
Updated on 24 November 2023
File name
ROI Lenvima SmPC Nov 2023.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- 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 24 November 2023
File name
ROI Lenvima SmPC Nov 2023.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- 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 07 August 2023
File name
ROI Lenvima PIL July 2023.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 07 August 2023
File name
ROI Lenvima SmPC July 2023.pdf
Reasons for updating
- 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 22 March 2023
File name
ROI Lenvima SmPC March 2023.pdf
Reasons for updating
- 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)
Updated on 10 March 2023
File name
ROI Lenvima 4mg & 10mg capsules SmPC Feb 2023.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 6.6 - Special precautions for disposal and other handling
- 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 10 March 2023
File name
ROI Lenvima 4mg & 10mg capsules PIL Feb 2023.pdf
Reasons for updating
- Change to section 3 - how to take/use
- Change to section 6 - date of revision
Updated on 19 January 2023
File name
ROI Lenvima 4mg and 10mg SmPC 07.04.2022.pdf
Reasons for updating
- Document format updated
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 05 May 2022
File name
ROI Lenvima 4mg and 10mg SmPC 07.04.2022.pdf
Reasons for updating
- 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
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Documented changes |
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Sections of the SmPC |
Changes/updates |
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Section 4.8: Undesirable effects |
Following a PRAC signal assessment, ‘colitis’ has been added as an adverse event with frequency uncommon for lenvatinib monotherapy and common for combination with pembrolizumab |
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Section 10: Date of revision of the text |
Updated to 04/2022 |
Updated on 05 May 2022
File name
ROI Lenvima 4mg and 10mg PIL.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
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Documented changes |
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Sections of the PIL |
Changes/updates |
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Section 4: Possible side effects |
Addition of ‘inflammation of the colon (colitis)’ with frequency uncommon under the heading ‘The following side effects may happen with this medicine when given alone’ |
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Section 4: Possible side effects |
Addition of ‘inflammation of the colon (colitis)’ with frequency common under the heading ‘The following side effects may happen with this medicine when given in combination with pembrolizumab’ |
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Section 6: Contents of the pack and other information |
This leaflet was last revised in April 2022 |
Updated on 05 May 2022
File name
ROI Lenvima 4mg and 10mg SmPC 07.04.2022.pdf
Reasons for updating
- 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 03 December 2021
File name
ROI Lenvima SmPC clean - Nov 21.pdf
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 4.8 - 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
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Documented changes |
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Sections of the SmPC |
Changes/updates |
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Section 4.1 |
Addition of endometrial cancer (EC) indication |
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Section 4.2 |
Addition of dosages and dose adjustments for EC |
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Section 4.4 |
Addition of liver-related adverse reactions for EC |
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Section 4.8 |
Addition of EC undesirable effects. |
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Section 5.1 |
Addition of EC pivotal trial data |
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Section 5.2 |
Update to age, sex, weight, race within section 5.2 |
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Section 10 |
The date of revision of text has been changed to 29/11/2021 |
Updated on 03 December 2021
File name
ROI Lenvima PIl- Nov 21.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 3 - how to take/use
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
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Documented changes |
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Sections of the PIL |
Changes/updates |
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Section 1 |
Addition of endometrial cancer (EC) indication |
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Section 3 |
Addition of dosages for uterine cancer |
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Section 4 |
Addition of EC side effects |
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Section 6 |
The date of revision of text has been changed to November 2021 |
Updated on 25 March 2021
File name
ROI Lenvima SmPC 4mg and 10mg 17 Mar 2021.pdf
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 25 March 2021
File name
ROI Lenvima SmPC 4mg and 10mg 17 Mar 2021.pdf
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 10 March 2021
File name
ROI Lenvima PIL 4mg and 10mg 04 Mar 2021.pdf
Reasons for updating
- XPIL Created
Updated on 09 March 2021
File name
ROI Lenvima PIL 4mg and 10mg 04 Mar 2021.pdf
Reasons for updating
- Change to section 6 - manufacturer
Updated on 18 December 2020
File name
ROI Lenvima SmPC 10 Dec 2020.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
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Documented changes |
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Sections of the SmPC |
Changes/updates |
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Section 4.8 Undesirable effects |
The following information on ethnic groups has been expanded:
Ethnic origin
DTC
Asian patients had a higher (≥ 10% difference) incidence than Caucasian patients of peripheral oedema, hypertension, fatigue, PPE, proteinuria, stomatitis, thrombocytopenia, and myalgia; while Caucasian patients had a higher incidence of diarrhoea, weight decreased, nausea, vomiting, constipation, asthenia, abdominal pain, pain in extremity, and dry mouth. A larger proportion of Asian patients had a lenvatinib dose reduction compared to Caucasian patients. the median time to first dose reduction and the average daily dose taken were lower in Asian than in Caucasian patients. |
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Section 10 Date of Revision of the Text |
Date of revision of text has been updated to 12/2020 |
Updated on 25 November 2020
File name
UK Lenvima PIL 18 Nov 2020.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
- Removal of Black Inverted Triangle
Free text change information supplied by the pharmaceutical company
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Removal of the black triangle and associated text |
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Inclusion of osteonecrosis of the jaw |
Updated on 25 November 2020
File name
ROI Lenvima PIL 26 May 2020.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
- Removal of Black Inverted Triangle
Free text change information supplied by the pharmaceutical company
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Removal of the black triangle and associated text |
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Section 4 Inclusion of Osteonecrosis of the jaw (ONJ) |
Updated on 25 November 2020
File name
UK Lenvima SmPC 18 Nov 2020.pdf
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
- Removal of Black Inverted Triangle
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
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Removal of the black triangle and associated text |
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Section 4.4: Osteonecrosis of the jaw (ONJ) Cases of ONJ have been reported in patients treated with lenvatinib. Some cases were reported in patients who had received prior or concomitant treatment with antiresorptive bone therapy, and/or other angiogenesis inhibitors, e.g. bevacizumab, TKI, mTOR inhibitors. Caution should therefore be exercised when lenvatinib is used either simultaneously or sequentially with antiresorptive therapy and/or other angiogenesis inhibitors. Invasive dental procedures are an identified risk factor. Prior to treatment with lenvatinib, a dental examination and appropriate preventive dentistry should be considered. In patients who have previously received or are receiving intravenous bisphosphonates, invasive dental procedures should be avoided if possible (see section 4.8). |
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Section 4.8: Inclusion of osteonecrosis of the jaw as an uncommon adverse effect |
Updated on 01 July 2020
File name
ROI Lenvima SmPC 26 May 2020.pdf
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
This update was to change the MAH and manufacturer to:
Eisai GmbH
Edmund-Rumpler-Straße 3
60549 Frankfurt am Main
Germany
The date of revision has been updated in line with EMA guidance to the date of implementation by the MAH, rather than the date of approval
Updated on 01 July 2020
File name
ROI Lenvima PIL 26 May 2020.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
This update was to change the MAH and manufacturer to:
Eisai GmbH
Edmund-Rumpler-Straße 3
60549 Frankfurt am Main
Germany
The date of revision has been updated in line with EMA guidance to the date of implementation by the MAH, rather than the date of approval
Updated on 01 July 2020
File name
UK Lenvima PIL 26 May 2020.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
This update was to change the MAH and manufacturer to:
Eisai GmbH
Edmund-Rumpler-Straße 3
60549 Frankfurt am Main
Germany
The date of revision has been updated in line with EMA guidance to the date of implementation by the MAH, rather than the date of approval
Updated on 29 June 2020
File name
ROI Lenvima PIL June 2020.pdf
Reasons for updating
- Change to section 6 - manufacturer
Free text change information supplied by the pharmaceutical company
Eisai GmbH
Lyoner Straße 36
60528 Frankfurt am Main
Germany
Has changed to:
Eisai GmbH
Edmund-Rumpler-Straße 3
60549 Frankfurt am Main
Germany
Updated on 29 June 2020
File name
ROI Lenvima SmPC Jun 2020.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Eisai GmbH
Lyoner Straße 36
60528 Frankfurt am Main
Germany
Has changed to:
Eisai GmbH
Edmund-Rumpler-Straße 3
60549 Frankfurt am Main
Germany
Updated on 29 May 2020
File name
ROI Lenvima PIL May 2020.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - what the product contains
Free text change information supplied by the pharmaceutical company
Hand foot syndrome has been changed to palmar-plantar erythrodysesthesia
Lenvatinib (as mesylate) has been changed to lenvatinib (as mesilate)
Updated on 29 May 2020
File name
ROI Lenvima PIL May 2020.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - what the product contains
Free text change information supplied by the pharmaceutical company
Hand foot syndrome has been changed to palmar-plantar erythrodysesthesia.
Lenvatinib (as mesylate) has been changed to lenvatinib (as mesilate)
Updated on 29 May 2020
File name
ROI Lenvima SmPC May 2020.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- 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 - how to report a side effect
- Change to section 5.2 - Pharmacokinetic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
The update is required for the five year renewal of the marketing authorisation for Lenvima. The sections outlined have been updated with editorial changes to ensure consistency. No additional data have been added to these sections
Updated on 17 October 2019
File name
ROI Lenvima PIL October 2019.pdf
Reasons for updating
- Change to section 6 - what the product contains
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
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Documented changes |
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Sections of the PIL |
Changes/updates |
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Section 6 Contents of the pack and other information |
Lenvatinib (as mesilate) has been changed to lenvatinib (as mesylate)
The following pack sizes have been added: The capsules come in blisters of polyamide/aluminium/PVC with a push through aluminium foil lidding in cartons of 30,60 or 90 hard capsules. Not all pack sizes may be marketed
The date of revision of text has been updated to 10/2019 |
Updated on 17 October 2019
File name
ROI Lenvima SmPC October 2019.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 6.5 - Nature and contents of container
- 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
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Documented changes |
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Sections of the SmPC |
Changes/updates |
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Section 2 Qualitative and quantitative composition |
Mesilate has changed to mesylate |
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Section 6.5 Nature and contents of container |
The wording has changed to include the following: Polyamide/Aluminium/PVC/Aluminium blisters containing 10 capsules. Each carton contains 30 ,60,or 90 hard capsules.
Not all pack sizes may be marketed.
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Section 8 Marketing authorisation number(s) |
The wording has changed to include the following: Lenvima 4mg hard capsules EU/1/15/1002/001 EU/1/15/1002/003 EU/1/15/1002/004
Lenvima 10 mg hard capsules EU/1/15/1002/002 EU/1/15/1002/005 EU/1/15/1002/006 |
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Section 10 Date of Revision of the Text |
Date of revision of text has been updated to October 2019 |
Updated on 29 September 2019
File name
Irish Lenvima PIL Sept 2019.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
Updated on 29 September 2019
File name
Irish Lenvima SmPC September 2019.pdf
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)
Updated on 21 August 2019
File name
Irish Lenvima SmPC June 2019 .pdf
Reasons for updating
- Change to section 5.2 - Pharmacokinetic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 5.2 Pharmacokinetic properties
The following text has been added to Special Populations Hepatic Impairment:
It has been determined that plasma protein binding in plasma from hepatically impaired subjects was similar to the respective matched healthy subjects and no concentration dependency was observed. See section 4.2 for dosing recommendation.
The following text has been added to Special Populations Renal Impairment:
It has been determined that plasma protein binding in plasma from renally impaired subjects was similar to the respective matched healthy subjects and no concentration dependency was observed. See section 4.2 for dosing recommendation
Section 10 Date of Revision of the Text
The date of revision of text has been updated to 06/2019
Updated on 20 February 2019
File name
Irish Lenvima PIL February 2019.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 20 February 2019
File name
Irish Lenvima SmPC February 2019 .pdf
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
A new Marketing Authorisation Holder address has been added:
Eisai GmbH
Lyoner Straße 36
60528 Frankfurt am Main
Germany
E-mail: medinfo_de@eisai.net
Updated on 18 December 2018
File name
Irish Lenvima PIL October 2018.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 18 December 2018
File name
Irish Lenvima SmPC October 2018 .pdf
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
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Section 4.4 |
Updated to amend the existing warnings on proteinuria and non-gastro-intestinal fistula |
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Section 4.8 |
Pneumothorax and nephrotic syndrome added as new adverse drug reactions (ADRs) with uncommon frequency |
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Section 10 |
The date of revision of text has been updated to 10/2018 |
Updated on 20 November 2018
File name
Irish Lenvima PIL September 2018.pdf
Reasons for updating
- Change to section 4 - possible side effects
Updated on 16 November 2018
File name
Irish Lenvima PIL September 2018.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 15 November 2018
File name
Irish Lenvima SmPC September 2018 .pdf
Reasons for updating
- 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
In section 4.5 (Interactions with other medicinal products and other forms of interaction), the potential for an interaction with CY3A4/Pgp substrates has been removed following a clinical drug-drug interaction (DDI) study in cancer patients which showed that plasma concentrations of midazolam (a sensitive CYP3A and Pgp substrate) were not altered in the presence of lenvatinib. No significant drug-drug interaction is therefore expected between lenvatinib and other CYP3A4/Pgp substrates.
Updated on 28 August 2018
File name
Irish Lenvima PIL August 2018 .pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 3 - dose and frequency
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 28 August 2018
File name
Irish Lenvima SmPC August 2018 .pdf
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 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- 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 02 August 2018
File name
Irish Lenvima PIL July 2018 .pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 02 August 2018
File name
Irish Lenvima SmPC July 2018 .pdf
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)
Updated on 01 August 2018
File name
PIL_16570_77.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
Updated on 08 June 2017
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 08 June 2017
Reasons for updating
- 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
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Documented changes |
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Sections of the SmPC |
Changes/updates |
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Section 6.3 |
Shelf-life has been extended from 3 to 4 years. |
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Section 10 |
The Date of revision of text has been updated |
Updated on 08 June 2017
Reasons for updating
- Change to section 6.3 - Shelf life
- Change to section 10 - Date of revision of the text
Free text change information supplied by the pharmaceutical company
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Documented changes |
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Sections of the SmPC |
Changes/updates |
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Section 6.3 |
Shelf-life has been extended from 3 to 4 years. |
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Section 10 |
The Date of revision of text has been updated |
Updated on 05 May 2017
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 5.2 - Pharmacokinetic 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
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Documented changes |
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Sections of the SmPC |
Changes/updates |
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Section 4.8 |
Updated to add the adverse events “cholecystitis” with a frequency of common, and the adverse events “pancreatitis”, “amylase increased” and “lipase increased” with a frequency of uncommon, common and common respectively.
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Section 5.2 |
A correction has been done to ‘Biotransformation’ subsection as below:
“The main metabolic pathways in humans were identified as oxidation by aldehyde oxidase, demethylation via CYP3A4, glutathione conjugation with elimination of the O-aryl group (chlorophenyl moiety), and combinations of these pathways followed by further biotransformations (e.g., glucuronidation, hydrolysis of the glutathione moiety, degradation of the cysteine moiety, and intramolecular rearrangement of the cysteinylglycine and cysteine conjugates with subsequent dimerisation).” |
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Section 10 |
The Date of revision of text has been updated |
Updated on 05 May 2017
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 10 - Date of revision of the text
Free text change information supplied by the pharmaceutical company
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Documented changes |
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Sections of the SmPC |
Changes/updates |
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Section 4.8 |
Updated to add the adverse events “cholecystitis” with a frequency of common, and the adverse events “pancreatitis”, “amylase increased” and “lipase increased” with a frequency of uncommon, common and common respectively.
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Section 5.2 |
A correction has been done to ‘Biotransformation’ subsection as below:
“The main metabolic pathways in humans were identified as oxidation by aldehyde oxidase, demethylation via CYP3A4, glutathione conjugation with elimination of the O-aryl group (chlorophenyl moiety), and combinations of these pathways followed by further biotransformations (e.g., glucuronidation, hydrolysis of the glutathione moiety, degradation of the cysteine moiety, and intramolecular rearrangement of the cysteinylglycine and cysteine conjugates with subsequent dimerisation).” |
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Section 10 |
The Date of revision of text has been updated |
Updated on 04 May 2017
File name
PIL_16570_77.pdf
Reasons for updating
- New PIL for new product
Updated on 26 October 2016
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 5.2 - Pharmacokinetic properties
- Change to section 9 - Date of first authorisation/renewal of the authorisation
- Change to section 10 - Date of revision of the text
- 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
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Documented changes |
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Sections of the SPC |
Changes/updates |
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Section 4.2 |
For lenvatinib related toxicities, “Adverse reactions requiring dose modification of lenvatinib” has been added as Table 1. |
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Section 4.4 |
Section 4.4 has been updated to include special warnings/precautions on non-gastrointestinal fistula and diarrhoea.
In addition, hypertension, haemorrhage, QT interval prolongation and Impairment of thyroid stimulating hormone suppression/Thyroid dysfunction subheading have been updated with new information.
Following wording regarding hypertension has been removed from the SmPC: “For patients with hypertension and proteinuria, treatment with an angiotensin-converting enzyme inhibitor or angiotensin-II receptor antagonist is preferred.”
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Section 4.8 |
“Arterial thromboembolism (3.9%)” has been added to the most important serious adverse reactions.
New adverse reaction frequency has been added to the SmPC as “Not known (cannot be estimated from available data)”.
The table of adverse reactions has been updated to include “Non-Gastrointestinal fistulak ” as a general disorder and administration site AE under “Not known” frequency. k: Non-gastrointestinal fistula includes cases of fistula occurring outside of the stomach and intestines such as tracheal, tracheo-oesophageal, oesophageal, female genital tract fistula, and cutaneous fistula. New adverse reaction descriptions have been added for: · Gastrointestinal perforation and fistula formation · Non-Gastrointestinal fistulae · QT interval prolongation · Diarrhoea
Description of following adverse reactions have been updated: · Renal failure and impairment · Cardiac dysfunction · Posterior reversible encephalopathy syndrome (PRES) / Reversible posterior leucoencephalopathy syndrome (RPLS) · Hepatotoxicity · Arterial thromboembolisms · Haemorrhage
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Section 5.2 |
Change of wording from severe hepatic impairment to severe renal impairment (see below):
Lenvatinib exposure, based on AUC0-inf data, was 101%, 90%, and 122% of normal for subjects with mild, moderate, and severe renal impairment, respectively. It is unknown whether there is a change in the plasma protein binding in renally impaired subjects. See section 4.2 for dosing recommendation.
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Section 10 |
The Date of revision of text has been updated |
Updated on 26 October 2016
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 5.2 - Pharmacokinetic properties
- Change to section 9 - Date of first authorisation/renewal of the authorisation
- Change to section 10 - Date of revision of the text
- Correction of spelling/typing errors
Free text change information supplied by the pharmaceutical company
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Documented changes |
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Sections of the SPC |
Changes/updates |
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Section 4.2 |
For lenvatinib related toxicities, “Adverse reactions requiring dose modification of lenvatinib” has been added as Table 1. |
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Section 4.4 |
Section 4.4 has been updated to include special warnings/precautions on non-gastrointestinal fistula and diarrhoea.
In addition, hypertension, haemorrhage, QT interval prolongation and Impairment of thyroid stimulating hormone suppression/Thyroid dysfunction subheading have been updated with new information.
Following wording regarding hypertension has been removed from the SmPC: “For patients with hypertension and proteinuria, treatment with an angiotensin-converting enzyme inhibitor or angiotensin-II receptor antagonist is preferred.”
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Section 4.8 |
“Arterial thromboembolism (3.9%)” has been added to the most important serious adverse reactions.
New adverse reaction frequency has been added to the SmPC as “Not known (cannot be estimated from available data)”.
The table of adverse reactions has been updated to include “Non-Gastrointestinal fistulak ” as a general disorder and administration site AE under “Not known” frequency. k: Non-gastrointestinal fistula includes cases of fistula occurring outside of the stomach and intestines such as tracheal, tracheo-oesophageal, oesophageal, female genital tract fistula, and cutaneous fistula. New adverse reaction descriptions have been added for: · Gastrointestinal perforation and fistula formation · Non-Gastrointestinal fistulae · QT interval prolongation · Diarrhoea
Description of following adverse reactions have been updated: · Renal failure and impairment · Cardiac dysfunction · Posterior reversible encephalopathy syndrome (PRES) / Reversible posterior leucoencephalopathy syndrome (RPLS) · Hepatotoxicity · Arterial thromboembolisms · Haemorrhage
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Section 5.2 |
Change of wording from severe hepatic impairment to severe renal impairment (see below):
Lenvatinib exposure, based on AUC0-inf data, was 101%, 90%, and 122% of normal for subjects with mild, moderate, and severe renal impairment, respectively. It is unknown whether there is a change in the plasma protein binding in renally impaired subjects. See section 4.2 for dosing recommendation.
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Section 10 |
The Date of revision of text has been updated |
Updated on 31 December 2015
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 31 December 2015
Reasons for updating
- New SPC for new product