Updated on 20/07/2011 and displayed until Current
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Reasons for adding or updating:
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Change to section 5.2 - Pharmacokinetic Properties
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Change to section 7 - Marketing Authorisation Holder
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 26-May-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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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
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Updated on 07/02/2011 and displayed until 20/07/2011
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Reasons for adding or updating:
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Change to section 4.2 - Posology and method of administration
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 4.6 - Pregnancy and Lactation
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Change to section 4.8 - Undesirable Effects
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Change to section 4.9 - Overdose
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Change to section 5.1 - Pharmacodynamic Properties
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 04-Nov-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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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
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Updated on 11/05/2010 and displayed until 07/02/2011
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Reasons for adding or updating:
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 4.8 - Undesirable Effects
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| Date of revision of text on the SPC: 23-Mar-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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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.
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Updated on 12/02/2010 and displayed until 11/05/2010
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Reasons for adding or updating:
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 4.6 - Pregnancy and Lactation
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Change to section 5.1 - Pharmacodynamic Properties
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Change to section 5.3 - Preclinical Safety Data
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Change to section 6. 4 - Special Precautions for Storage
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 12-Jan-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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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.
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Updated on 08/09/2009 and displayed until 12/02/2010
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Reasons for adding or updating:
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 4.8 - Undesirable Effects
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| Date of revision of text on the SPC: 07-Aug-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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Summary of changes are as follows:
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
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Updated on 31/03/2009 and displayed until 08/09/2009
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Reasons for adding or updating:
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Change to section 4.2 - Posology and method of administration
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| Date of revision of text on the SPC: 16-Mar-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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| New Dose Adjustment Guidelines for patients with impaired renal impairment
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Updated on 02/06/2008 and displayed until 31/03/2009
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Reasons for adding or updating:
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Change to section 4.4 - Special warnings and precautions for Use
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Change to MA holder contact details
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| Date of revision of text on the SPC: 18-Mar-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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Address for Marketing Authorisation Holder has been updated from Celgene Europe Limited, 8 The Square, Stockley Park, Uxbridge, Middlesex, UB11 1FW, United Kingdom to Celgene Europe Limited, Morgan House, Madeira Walk, Windsor, Berkshire, SL4 1EP, United Kingdom.
In Section 4.4 (Special Warnings and Precautions for Use) the following changes have been made:
- under Pregnancy Testing, minimum sensitivity for pregnancy testing has been changed from 25 IU/ml to 25 mIU/ml
- under Additional Precautions, "dispensing of lenalidomide should occur within a maximum of 7 days of the prescription", has been changed to "dispensing of lenalidomide to women of childbearing potential should occur within 7 days of the prescription".
- under Other Special Warnings and Precautions for Use, a new warning has been added. Tumour Lysis Syndrome : Because lenalidomide has anti-neoplastic activity the complications of tumour lysis syndrome may occur. The patients at risk of tumour lysis syndrome are those with high tumour burden prior to treatment. These patients should be monitored closely and appropriate precautions taken.
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Updated on 21/12/2007 and displayed until 02/06/2008
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Reasons for adding or updating:
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Change to MA holder contact details
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| Date of revision of text on the SPC: 12/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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7. MARKETING AUTHORISATION HOLDER - changed to as below
Celgene Europe Limited
Morgan House
Madeira Walk
Windsor
Berkshire
SL4 1EP
United Kingdom
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Updated on 03/07/2007 and displayed until 21/12/2007
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