Revlimid 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, 25 mg hard capsules | Patient Info | Celgene Ltd

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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:
Celgene Ltd
Active Ingredients:
Lenalidomide
Legal Category:
Product subject to restricted prescription (C)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 05/06/20

Summary of Product Characteristics last updated on medicines.ie: 3/7/2020

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.

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Company Products

Medicine Name	Active 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

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

Updated on 3 July 2020 SmPC

Reasons for updating

Other

Legal category: Product subject to restricted prescription (C)

Free text change information supplied by the pharmaceutical company

Print to PDF did not complete for the full document. Pages were missing.

Updated on 5 June 2020 PIL

Reasons for updating

Change to section 3 - how to take/use
Change to section 4 - possible side effects
Change to section 6 - what the product contains
Change to section 6 - what the product looks like and pack contents

Updated on 5 June 2020 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 5.1 - Pharmacodynamic properties
Change to section 6.1 - List of excipients
Change to section 6.6 - Special precautions for disposal and other handling

Legal category: Product subject to restricted prescription (C)

Free text change information supplied by the pharmaceutical company

In section 4.2 (Posology and method of administration), update to now read anaphylactic reaction.

In section 4.4 (Special warnings and precautions for use), inclusion on product handling.

In section 4.8 (Undesirable effects), update to now read anaphylactic reaction and consolidation of subsection 'Allergic reactions and severe skin reactions'

In section 5.1 (Pharmacodynamic properties), update on the cyles days for sub section 'Lenalidomide in combination with bortezomib and dexamethasone in patients who are not eligible for stem cell transplantation'.

In section 6.1 (List of excipients), inclusion of E number for Propylene glycol.

In Section 6.6 (Special precautions for disposal and other handling), inclusion on product handling.

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

New SmPC for new product

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 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 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 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 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
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
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
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
Section 5.1 (pharmacodynamic properties) - Sub-heading have been added and altered slightly
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)

Free text change information supplied by the pharmaceutical company

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)