Revlimid 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, 25 mg hard capsules

  • Name:

    Revlimid 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, 25 mg hard capsules

  • Company:
    info
  • Active Ingredients:

    Lenalidomide

  • Legal Category:

    Product subject to restricted prescription (C)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 07/01/20

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Summary of Product Characteristics last updated on medicines.ie: 7/1/2020
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

Celgene Ltd

Celgene Ltd

Company Products

Medicine NameActive Ingredients
Medicine Name Abraxane Active Ingredients Paclitaxel Albumin
Medicine Name Imnovid Active Ingredients Pomalidomide
Medicine Name Revlimid 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, 25 mg hard capsules Active Ingredients Lenalidomide
Medicine Name Thalidomide Active Ingredients Thalidomide
Medicine Name Vidaza Active Ingredients azacitidine
1 - 0 of 5 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 7 January 2020 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 4.6 - Pregnancy and lactation
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties

Legal category: Product subject to restricted prescription (C)

Free text change information supplied by the pharmaceutical company

In section 4.1 (Therapeutic indications), add a new additional indication 'Follicular lymphoma'

In section 4.2 (Posology and method of administration), add a new additional  indication 'Follicular lymphoma', new posology Tumour lysis syndrome (TLS), update to Tumour flare reaction

In section 4.4 (Special warnings and precautions for use), add a new additional indication 'Follicular lymphoma', update to Neutropenia and thrombocytopenia warning, update to Tumour flare reaction and tumour lysis syndrome warning, update Second primary malignancies in follicular lymphoma warning

In section 4.6 (Fertility, pregnancy and lactation), update to pregnancy sub-section

In section 4.8 (Undesirable effects), add a new additional indication 'Follicular lymphoma'

In section 5.1 (Pharmacodynamic properties), add a new additional indication 'Follicular lymphoma' and update to sub-sections: mechanism of action, Clinical efficacy and safety    

Updated on 7 January 2020 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 - how to take/use
  • Change to section 4 - possible side effects

Updated on 21 May 2019 PIL

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 3 - dose and frequency
  • Change to section 4 - possible side effects
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - date of revision

Updated on 21 May 2019 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 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • 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 restricted prescription (C)

Updated on 20 March 2019 PIL

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 26 November 2018 PIL

Reasons for updating

  • Change to section 6 - date of revision

Updated on 26 November 2018 SmPC

Reasons for updating

  • Change to section 10 - Date of revision of the text

Legal category: Product subject to restricted prescription (C)

Updated on 19 July 2018 SmPC

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 restricted prescription (C)

Free text change information supplied by the pharmaceutical company

Update to section 4.8 "Solid Organ Transplant Rejection"

Updated on 18 July 2018 PIL

Reasons for updating

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

Updated on 14 May 2018 SmPC

Reasons for updating

  • Correction of spelling/typing errors

Legal category: Product subject to restricted prescription (C)

Updated on 5 October 2017 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 restricted prescription (C)

Free text change information supplied by the pharmaceutical company

Update of Annex I (Sections 4.2, 4.4, 4.8), and Annex IIIB

Introduction of dose modifications in case of Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), to add a relevant warning and to include DRESS in the list of adverse reactions with a frequency unknown

Updated on 5 October 2017 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to restricted prescription (C)

Updated on 4 October 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 4 October 2017 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 31 May 2017 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

Legal category: Product subject to restricted prescription (C)

Free text change information supplied by the pharmaceutical company

 Extension of indication to add treatment of adult patients with newly diagnosed multiple myeloma (NDMM) who have undergone autologous stem cell transplantation (ASCT). Consequently SmPC sections 4.1, 4.2, 4.4, 4.8 and 5.1 have been updated with the efficacy and safety data. Furthermore, the MAH introduced 7-day pack sizes for the 10 mg and 15 mg strengths with subsequent changes to the Product Information.

All strenghs of the product are now all on 1 SPC.

Updated on 18 May 2017 PIL

Reasons for updating

  • Change to Section 1 - what the product is
  • Change to section 1 - what the product is used for
  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - use in children and adolescents
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 2 - driving and using machines
  • Change to section 2 - excipient warnings
  • Change to section 3 - dose and frequency
  • Change to section 3 - use in children/adolescents
  • Change to section 3 - how to take/use
  • Change to section 3 - duration of treatment
  • Change to section 3 - overdose, missed or forgotten doses
  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect
  • Change to section 5 - how to store or dispose
  • Change to section 6 - what the product contains
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - marketing authorisation number
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 16 February 2017 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 3 - how to take/use
  • Change to section 4 - possible side effects
  • Change to section 5 - how to store or dispose

Updated on 16 February 2017 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 6.6 - Special precautions for disposal and other handling
  • Change to section 9 - Date of first authorisation/renewal of the authorisation
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to restricted prescription (C)

Free text change information supplied by the pharmaceutical company

  • Update of Annex I and Annex III-B and Annex III-B

o    section 4.4 and 4.8 of the SmPC and the corresponding sections of the PIL to implement the wording agreed by the PRAC/CHMP regarding the risk of viral reactivation.

o    Update to sections 6.6 of the SmPC and corresponding section of the PIL with additional guidance on product handling.

              o    Update according to the latest QRD template (v 10.0) and some other minor editorial changes

Updated on 17 October 2016 SmPC

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 restricted prescription (C)

Free text change information supplied by the pharmaceutical company

Update to sections 4.8 and 10.

Updated on 23 September 2016 PIL

Reasons for updating

  • Change to date of revision

Updated on 14 September 2016 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 26 August 2016 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to restricted prescription (C)

Free text change information supplied by the pharmaceutical company

Update to sections 4.2 and 10.

Updated on 12 August 2016 PIL

Reasons for updating

  • Change to date of revision
  • Change to dosage and administration

Updated on 27 July 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 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • 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 10 - Date of revision of the text

Legal category: Product subject to restricted prescription (C)

Free text change information supplied by the pharmaceutical company

Updates to sections 4.1, 4.2, 4.4, 4.7, 4.8, 5.1, 5.2 and 10. To reflect new indication.

Updated on 19 July 2016 PIL

Reasons for updating

  • Change to improve clarity and readability

Updated on 7 August 2015 SmPC

Reasons for updating

  • Change to section 5.2 - Pharmacokinetic properties

Legal category: Product subject to restricted prescription (C)

Free text change information supplied by the pharmaceutical company

Update of section 5.2 “Pharmacokinetic properties” of the SmPC with the results from an in vitro study (CC-5013-DMPK-1895) on the inhibitory effect of lenalidomide on various human efflux and uptake transporters and to implement minor editorial corrections in the SmPC

Updated on 2 April 2015 SmPC

Reasons for updating

  • Addition of black triangle

Legal category: Product subject to restricted prescription (C)

Free text change information supplied by the pharmaceutical company

Addition of Black Triangle

Updated on 27 March 2015 PIL

Reasons for updating

  • Addition of black triangle

Updated on 11 March 2015 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • 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 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • 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 9 - Date of renewal of authorisation

Legal category: Product subject to restricted prescription (C)

Free text change information supplied by the pharmaceutical company

Section 2 – wording updated

 

Section 3 – description of capsule updated

 

Section 4.1 –indications updated

 

Section 4.2 –new section included for new indication

 

Section 4.2 – existing indication updated

 

Section 4.3 - order of contraindications updated

 

Section 4.4 – wording updated and new information for new indication added

 

Section 4.5 – Wording updated

 

Section 4.8 – new sections included for added new indication

 

Section 4.8 – undesirable effects updated

 

Section 5.1 – new sections included for added new indication

 

Section 5.2 – Wording updated

 

Section 6.5 – Description updated

 

Section 6.6 – wording updated

 

Section 9 – wording updated

Updated on 5 March 2015 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 26 November 2014 SmPC

Reasons for updating

  • Change to separate SPCs covering individual presentations

Legal category: Product subject to restricted prescription (C)

Free text change information supplied by the pharmaceutical company

Individual SmPC from previous combined strengths one

Updated on 17 October 2014 SmPC

Reasons for updating

  • 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 5.2 - Pharmacokinetic properties

Legal category: Product subject to restricted prescription (C)

Free text change information supplied by the pharmaceutical company

SPC has been amended to address changes required in the following regulatory procedure:

 

  • II/070 - update of sections 4.2, 4.5 and 5.2 of the EU SmPC following the availability of new clinical pharmacology data including; the drug interaction potential of lenalidomide

Updated on 15 October 2014 SmPC

Reasons for updating

  • 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 - how to report a side effect
  • Change to section 5.2 - Pharmacokinetic properties

Legal category: Product subject to restricted prescription (C)

Free text change information supplied by the pharmaceutical company

 

 

 

 

 

 

 

·         Section 4.2 Posology and method of administration – Amendment of the paragraph for older people, stating PK data is in section 5.2

·         Section 4.5 Interaction with other medicinal products and other forms of interaction – Addition of a paragraph for interations with dexamethasone; amendment to the paragraph for interaction with P-glycoprotein inhibitors

·         Section 4.8 Undesirable effects – Addition of a final paragraph regarding adverse event reporting

·         Section 5.2 Pharmacokinetic properties –

o   Addition of a final paragraph regarding the oral absorption rate for MM and MDS patients

o   Amendment to the paragraph on biotransformation and elimination

o   Addition of a paragraph on older people

o   Addition of a paragraph on hepatic impairment

o   Addition of a paragraph outlining other intrinsic factors (e.g. weight, gender etc.)

 

Updated on 30 July 2014 SmPC

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect

Legal category: Product subject to restricted prescription (C)

Free text change information supplied by the pharmaceutical company

$0HPRA details added$0

Updated on 13 June 2014 SmPC

Reasons for updating

  • Correction of spelling/typing errors

Legal category: Product subject to restricted prescription (C)

Free text change information supplied by the pharmaceutical company

Previous version was incorrect with unecessary asterisk

Updated on 14 April 2014 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 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties

Legal category: Product subject to restricted prescription (C)

Free text change information supplied by the pharmaceutical company

·   Update of sections 4.4 and 4.8 with the adverse drug reaction “hyperthyroidism” and “leucocytoclastic vasculitis“

·   Update of section 4.8 with the adverse drug reaction “weight decreased” applicable to 2.5mg, 5mg and10mg strengths only.

·   Revisions to section 4.4, 4.5, 4.6, 4.8 and 5.1 with grammatical amends

Updated on 6 December 2013 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

Legal category: Product subject to restricted prescription (C)

Free text change information supplied by the pharmaceutical company

Section 4.5:
Interraction between lenalidomide and statins reported

Section 4.8:
Rhabdomyolysis included as a rare side efect reported with the use of lenaldiomide and statins

Updated on 28 June 2013 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 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties

Legal category: Product subject to restricted prescription (C)

Free text change information supplied by the pharmaceutical company

Section 4.1
Addition of myelodysplastic syndromes (MDS) to therapeutic indication

Section 4.2
Addition of MDS to posolgy and method of administration

Section 4.4
Additional information for female patients regarding amenorrhoea and lactation and male patients and contraception
Updates to educational materials
Updated information for venous thromboembolism for MDS patients
Updated information for Neutropenia and thrombocytopenia for MM patients
Progression to AML and TP53 status for MDS patients

Section 4.8
Addition of undesirable effects for MDS indication

Section 4.9
Overdose section has been generalized to include both indications

Section 5.1
Addition of MDS data

Section 5.2
Addition of MDS data

Updated on 12 February 2013 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • 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 6.1 - List of excipients

Legal category: Product subject to restricted prescription (C)

Free text change information supplied by the pharmaceutical company

Section 1- Addition of 2.5 mg and 7.5 mg strengths
Section 2- Addition of 2.5 mg and 7.5 mg strengths and description of excipient for both strengths
Section 3- Addition of the following: 

Pale yellow/white capsules marked “REV 7.5 mg”.

Blue-green/white capsules marked “REV 2.5 mg”.

Section 4.2- Changes to renal table which includes 7.5 mg dose as an option for severe renal impairment in countries where it is available
Section 6.1- Description of excipients within the capsule contents, shell and printing ink for both 2.5 mg and 7.5 mg strengths

Updated on 13 December 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 4.8 - Undesirable effects

Legal category: Product subject to restricted prescription (C)

Free text change information supplied by the pharmaceutical company

4.4     Special warnings and precautions for use - Additional two paragraphs added to the end of the section entitled 'Hepatic Disorders', cautioning usage in patients with impaired hepatic function and suggestions for monitoring/dose interruption.

4.5     Interaction with other medicinal products and other forms of interaction - Additional paragraph: 'Interactions with other medicines'

4.8     Undesirable effects: 
        - Table 1 contains more adverse drug reactions (all and Grade 3-4) for Hepatobiliary Disorders

        - Additional paragraph at the end of the section 'Hepatic Disorders' reporting the frequency of hepatic related conditions

Updated on 20 September 2012 SmPC

Reasons for updating

  • Change to improve clarity and readability

Legal category: Product subject to restricted prescription (C)

Free text change information supplied by the pharmaceutical company

Slight change to some text and sub-headings

Updated on 2 May 2012 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 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.5 - Nature and contents of container
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to restricted prescription (C)

Free text change information supplied by the pharmaceutical company

  • Section 2 (qualitative and quantitative composition) - excipients with known effect are listed only here
  • Section 4.1  (therapeutic indications) - specified that revlimid is indicated in adults
  • Section 4.2 (posology and method of administration) - administration section has moved from second paragraph to the end of the section
                  • Special populations are titled together
                  • Wording has changed from patients to populations for all of these groups
                  • Safety and efficacy in 0-17yr olds has been altered to say 'no data available' rather than 'do not use'
  • Section 4.3 (contraindications) - highlights that excipients are listed in section 6.1
  • Section 4.4 (special warnings and precautions for use) - wording in counselling section has changed: contraceptive measure rather than treatment
                  • The word substance is used rather than drug
  • Section 4.5 (interaction with other medicinal products and other forms of interaction) - Final section of Oral contraceptives regarding metabolic studies has been moved to the end of this section
  • Section 4.6 (fertility, pregnancy and lactation) - Two paragraphs, regarding women of childbearing potential and revlimid levels in semen, originally under the pregnancy sub-heading are now at the start of the section
                  • Fertility studies in rats showing no genetic toxicity has been included
  • Section 4.7 (effects on ability to drive and use machines) - No longer states that no studies have been performed, but still provides a cautionary note
  • Section 4.8 (undesirable effects) - does not specify safety in multiple myeloma patients anymore
                  • Removed the paragraph outlining the efficacy & safety data for the two major registration trials MM-09 & MM-10 (already contained in section 5.1)
                  • Updated the statistics of most frequently observed adverse event section
                  • Removed text regarding rairy and isolated reports
                  • Includes post-marketing data in the title of Table 1, rather than at the bottom
                  • Tumour lysis syndrome, interstitial pneumonitis, pancreatitis, angioedema, Stevens-Johnson Syndrome, toxic epidermal necrolysis have been added
                  • Table 2 containing post-marketing data has been removed an incorporated into Table
  •  Section 5.1 (pharmacodynamic properties) - Sub-heading have been added and altered slightly    
                • Statement that the EMA has waived the obligation to perform pediatric studies in multiple myeloma            
                • The word substance is used rather than drug 
  • Section 6.5 (nature and contents of container) - Wording has altered but the content is the same regarding technical particulars
  • Section 9 (date of the first authorisation/renewal of the authorisation) - Wording added
  • Section 10 (date of revision of the text) - 13th April 2012

Updated on 12 March 2012 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

Legal category: Product subject to restricted prescription (C)

Free text change information supplied by the pharmaceutical company

Section 4.4 Special warnings and precautions for use
Paragraph added regarding the incidence of second primary malignancies, and the risk of occurence of SPM should be taken into account pior to initiating treatment with lenalidomide

Section 4.8 Undesirable effects
Squamous skin cancer added into Table 1.
Small section on second primary malignancies and basal cell or squamous cell skin cancers.

Updated on 21 July 2011 SmPC

Reasons for updating

  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to restricted prescription (C)

Free text change information supplied by the pharmaceutical company

Section 5.2 - Minor alterations to first paragraph in the absorption section and an addition of a second paragraph regarding administration with or without food.

Distribution section - Alteration of figures to 
23% and 29% from 22.7% and 29.2% with respect to plasma protein binding.

Metabolism and excretion section - Deletion of final sentence in first paragraph and addition of faecal excretion percentage. Additional paragraph entered regarding metabolism of lenalidomide. Final paragraph removed.

Section 7.0 - Change of address of MA holder to 

Celgene Europe Limited

1 Longwalk Road

Stockley Park

Uxbridge

UB11 1DB

Section 10 - change of date of revision of text to 26/05/11

Updated on 8 February 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 4.6 - 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 restricted prescription (C)

Free text change information supplied by the pharmaceutical company

Section 4.2 : Now states "Prescribing physicians should carefully evaluate which dose of dexamethasone to use, taking into account the condition and disease status of the patient." at the end of the Recommended Dose section.

Section 4.4: Additional information added under sections "Cardiovascular disorders", regarding Myocardial Infarction and Venous and Arterial Thromboembolic Events.

Section 4.6: Title altered to "Fertility, Pregnancy and Lactation"

Section 4.8: Adverse Events put into a tabular format. Table 2 regarding adverse reactions noted from post marketing data has been added. Description of selected adverse reactions has been added.

Section 4.9: 50mg changed to 150mg. Addition to first sentence stating: "and in single-dose studies, some patients were exposed to up to 400 mg."

Section 5.1: Exploratory study added

Section 10: Date or Revision updated to 04/11/2010

Updated on 10 May 2010 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

Legal category: Product subject to restricted prescription (C)

Free text change information supplied by the pharmaceutical company

Section 4.4 - Cardiovascular Disorders and Mycardial Infarction have been added.
Section 4.8 - Myocardial Infarction added as a common side effect to Cardiovascular Disorders. Interstitial pneumonitis (frequency unknown) added to Respiratory, thoracic and mediastinal disorders. Pancreatitis (frequency unknown) added to Gastrointestinal disorders.

Updated on 15 February 2010 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 5.1 - Pharmacodynamic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.4 - Special precautions for storage
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to restricted prescription (C)

Free text change information supplied by the pharmaceutical company

In section 4.4 (Special warnings and precautions for use), new data on the presence of lenalidomide in human semen "at extremely low levels" has been added, and "no clinical data available of the presence of lenalidomide in human semen" has been removed. In the section entitled: Additional precautions, the precaution regarding semen donation during or 1 week following discontinuation of therapy has been removed, however the precaution regarding blood donation remains.

In section 4.6 (Preganancy and lactation) this same information has been added (above).

In section 5.1 (Pharmacodynamic properties) extended follow up data has been added regarding the MM 009 and MM 010 studies.

In section 5.3 (Preclinical safety data) more detail regarding the findings of an embryofoetal malformation study conducted in monkeys has been added. Preliminary findings have been removed.

In section 6.4 (Special precautions for storage): This has changed to "no special storage conditions" being required and the original precaution of "Do not store above 25C" has been removed.

Section 10: date of revision of text updated to 12/01/2010.

Updated on 2 December 2009 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

Legal category: Product subject to restricted prescription (C)

Free text change information supplied by the pharmaceutical company

Summary of changes include:

Section 4.4 Special Warnings and Precautions

Under special warning for venous thromboembolism – the threshold for haemoglobin concentration above which erythropoietic agents must be discontinued has changed from 13 to 12 g/dl.

Special warnings added for Allergic Reactions and Severe skin reactions.

Section 4.8 Undesirable Effects

Tumour lysis syndrome and Hypersensitivity reactions are added as rare events

Updated on 31 March 2009 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration

Legal category: Product subject to restricted prescription (C)

Free text change information supplied by the pharmaceutical company

Section 4.2 New dosing in renal impairment guidelines

Updated on 28 October 2008 SmPC

Reasons for updating

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

Legal category: Product subject to restricted prescription (C)

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Section 4.4 Pregnancy Warnings
Lenalidomide induced in monkeys malformations similiar to those described with thalidomide (serctions 4.6 and 5.3). If lenalidomide is taken during pregnancy, a teratogenic effect of lenalidomide in humans is expected.
 
Section 4.6 Pregnancy and Lactation
Lenalidomide induced in monkeys malformations similiar to those described with thalidomide (see section 5.3). Therefore, a teratogenic effect of lenalidomide is expected and lenalidomide is contraindicated during pregnancy (section 4.3).

Updated on 11 August 2008 SmPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Product subject to restricted prescription (C)