Lenvima (lenvatinib)

  • Name:

    Lenvima (lenvatinib)

  • Company:
    info
  • Active Ingredients:

    Lenvatinib mesilate

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 29/05/20

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XPIL

Summary of Product Characteristics last updated on medicines.ie: 29/5/2020
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions.

Click on this link to Download PDF directly

Eisai Ltd

Eisai Ltd

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1 - 0 of 12 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 29 May 2020 PIL

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 PIL

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 SmPC

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 PIL

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

Documented changes

Sections of the PIL

Changes/updates

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 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 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

Documented changes

Sections of the SmPC

Changes/updates

Section 2 Qualitative and quantitative composition

Mesilate has changed to mesylate

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.

 

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

Section 10 Date of Revision of the Text

Date of revision of text has been updated to October 2019

Updated on 29 September 2019 PIL

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 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)

Updated on 21 August 2019 SmPC

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 PIL

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 20 February 2019 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

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 PIL

Reasons for updating

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

Updated on 18 December 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

Updated to amend the existing warnings on proteinuria and non-gastro-intestinal fistula

Section 4.8

Pneumothorax and nephrotic syndrome added as new adverse drug reactions (ADRs) with uncommon frequency

 

Section 10

 

The date of revision of text has been updated to 10/2018

Updated on 20 November 2018 PIL

Reasons for updating

  • Change to section 4 - possible side effects

Updated on 16 November 2018 PIL

Reasons for updating

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

Updated on 15 November 2018 SmPC

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 PIL

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 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 4.8 - 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 2 August 2018 PIL

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 2 August 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)

Updated on 1 August 2018 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions

Updated on 8 June 2017 PIL

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

Documented changes

Sections of the SmPC

Changes/updates

Section 6.3

 Shelf-life has been extended from 3 to 4 years.

Section 10

The Date of revision of text has been updated

Updated on 8 June 2017 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 8 June 2017 SmPC

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

Documented changes

Sections of the SmPC

Changes/updates

Section 6.3

 Shelf-life has been extended from 3 to 4 years.

Section 10

The Date of revision of text has been updated

Updated on 5 May 2017 SmPC

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

Documented changes

Sections of the SmPC

Changes/updates

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.

 

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).”  

Section 10

The Date of revision of text has been updated

Updated on 5 May 2017 PIL

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

Documented changes

Sections of the SmPC

Changes/updates

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.

 

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).”  

Section 10

The Date of revision of text has been updated

Updated on 4 May 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 26 October 2016 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 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

Documented changes

Sections of the SPC

Changes/updates

Section 4.2

 For lenvatinib related toxicities, “Adverse reactions requiring dose modification of lenvatinib” has been added as Table 1.

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.”

 

 

 

 

 

 

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

 

 

 

 

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.

 

 

 

 

Section 10

The Date of revision of text has been updated

Updated on 26 October 2016 PIL

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

Documented changes

Sections of the SPC

Changes/updates

Section 4.2

 For lenvatinib related toxicities, “Adverse reactions requiring dose modification of lenvatinib” has been added as Table 1.

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.”

 

 

 

 

 

 

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

 

 

 

 

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.

 

 

 

 

Section 10

The Date of revision of text has been updated

Updated on 31 December 2015 SmPC

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

None provided

Updated on 31 December 2015 PIL

Reasons for updating

  • New SPC for new product

Free text change information supplied by the pharmaceutical company

None provided