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Celgene Ltd
1 Longwalk Road, Stockley Park, Uxbridge, UB11 1DB, UK
Telephone: +44 (0)208 831 8300
Fax: +44 1753 861 484
Medical Information Direct Line: +353 1800 333 111
Medical Information e-mail: medinfo.uk.ire@celgene.com
Medical Information Facsimile: +353 1800 333 112
Summary of Product Characteristics last updated on medicines.ie: 21/07/2011
SPC Revlimid

When a pharmaceutical company changes an SPC or PIL, 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 21/07/2011 and displayed until Current
Reasons for adding or 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
Date of revision of text on the SPC:   26-May-2011
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 08/02/2011 and displayed until 21/07/2011
Reasons for adding or 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
Date of revision of text on the SPC:   04-Nov-2010
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 10/05/2010 and displayed until 08/02/2011
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   23-Mar-2010
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 15/02/2010 and displayed until 10/05/2010
Reasons for adding or 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
Date of revision of text on the SPC:   12-Jan-2010
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 02/12/2009 and displayed until 15/02/2010
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   07-Aug-2009
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 31/03/2009 and displayed until 02/12/2009
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
Date of revision of text on the SPC:   03/2009
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
Section 4.2 New dosing in renal impairment guidelines
Updated on 28/10/2008 and displayed until 31/03/2009
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
Date of revision of text on the SPC:   08/2008
Legal Category:   prescription only

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 11/08/2008 and displayed until 28/10/2008
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
  Lenalidomide