Thalidomide

  • Name:

    Thalidomide

  • Company:
    info
  • Active Ingredients:

    Thalidomide

  • Legal Category:

    Product subject to restricted prescription (C)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 09/08/19

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Summary of Product Characteristics last updated on medicines.ie: 9/8/2019

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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
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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 9 August 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 9 August 2019 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

Legal category: Product subject to restricted prescription (C)

Updated on 21 May 2019 PIL

Reasons for updating

  • Change to section 6 - manufacturer

Updated on 5 April 2019 PIL

Reasons for updating

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

Updated on 5 April 2019 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 improve clarity and readability

Legal category: Product subject to restricted prescription (C)

Free text change information supplied by the pharmaceutical company

Minor editorial changes: section 4.4 and section 4.6

Updated on 21 August 2018 PIL

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to name of medicinal product

Updated on 21 August 2018 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 restricted prescription (C)

Free text change information supplied by the pharmaceutical company

Change the MAH name and address from Celgene Europe Limited, 1 Longwalk Road, Stockley Park, Uxbridge, UB11 1DB, United Kingdom to Celgene Europe BV, Winthontlaan 6 N, 3526 KV Utrecht, Netherlands.

Updated on 14 August 2018 PIL

Reasons for updating

  • Change to section 4 - possible side effects

Updated on 14 August 2018 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • 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 to Section 4.8 (Undesirable effects) of the SmPC to add the adverse reaction leukocytoclastic vasculitis with a frequency not known and section 9: Date of latest renewal has been updated to: 08 February 2018.

Updated on 9 March 2018 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 restricted prescription (C)

Free text change information supplied by the pharmaceutical company

Renewal of Marketing Authorisation for Thalidomide Celgene with unlimited validity AND Update to Annexes I-III

Updated on 9 March 2018 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to restricted prescription (C)

Updated on 8 March 2018 PIL

Reasons for updating

  • New PIL for new product

Updated on 8 March 2018 PIL

Reasons for updating

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

Updated on 14 February 2017 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 6.6 - Special precautions for disposal and other handling
  • 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 & 6.6

Updated on 10 February 2017 PIL

Reasons for updating

  • Change to section 3 - how to take/use

Updated on 27 July 2016 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 restricted prescription (C)

Free text change information supplied by the pharmaceutical company

Added pulmonary hypertension and viral reactivation.

Updated on 22 July 2016 PIL

Reasons for updating

  • Change to side-effects
  • Change to date of revision

Updated on 3 December 2015 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable effects

Legal category: Product subject to restricted prescription (C)

Free text change information supplied by the pharmaceutical company

·          Update to sections 4.2 and 4.8 of Annex I to add new dosing/safety information for elderly patients (>75 years) with untreated MM receiving thalidomide in combination with MP. In addition section 4.2 is updated with the recommended starting doses for melphalan and prednisone for completeness.

Updated on 2 December 2015 PIL

Reasons for updating

  • Change to dosage and administration

Updated on 11 August 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

Reporting of suspected adverse reactions: new details of the HPRA included 

Updated on 23 July 2014 PIL

Reasons for updating

  • Addition of information on reporting a side effect.

Updated on 5 August 2013 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Legal category: Product subject to restricted prescription (C)

Free text change information supplied by the pharmaceutical company

Change to section 4.8 to include Posterior reversible encephalopathy syndrome (PRES)/ Reversible posterior leukoencephalopathy syndrome (RPLS) as an adverse drug reaction

Updated on 11 April 2013 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 9 - Date of renewal of authorisation

Legal category: Product subject to restricted prescription (C)

Free text change information supplied by the pharmaceutical company

Section 4.2

·         Directly after the recommended dosing guidance, monitoring of patients for neutropenia and thrombocytopenia has been added

·         Two paragraphs from this change, two further paragraphs regarding neutropenia and thrombocytopenia have been added regarding the monitoring of counts and potential dose delay, reduction or discontinuation dependent on the NCI CTC (National Cancer Institute Common Toxicity Criteria) grade is advised where necessary

 

Section 4.4

·         Two paragraphs regarding haematological disorders have been added for neutropenia and thrombocytopenia, and include reports and increased incidence of grade 3 or 4 adverse reactions in multiple myeloma patients receiving the combination of melphalan, prednisone and thalidomide (MPT)

·         A paragraph on hepatic disorders has been added advising monitoring and review of concomitant medications


Section 4.8 

·         The headings of Table 2 have been modified to combine 'Very common' and 'Common' reactions into one heading of 'All ADRs' and the frequency is indicated within each section instead

·         The section after Table 2 concerning post-marketing experience now includes gastrointestinal haemorrhage and hepatic disorders, which were highlighted in section 4.4

·         The final paragraph of this section states that AML and MDS have been reported in clinical studies in patients with previously untreated MM receiving the combination of melphalan, prednisone and thalidomide (MPT), see section 4.4

 

Section 9

·         The date of latest renewal has been updated to 16 April 2013

Updated on 5 April 2013 PIL

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 11 February 2013 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.4 - Special warnings and precautions for use
  • 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 6.1 - List of excipients
  • Change to section 6.3 - Shelf life
  • Change to section 6.5 - Nature and contents of container
  • 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: Excipents removed
Section 3: The word 'hard' removed
Section 4.4: Lactose intolerance section removed
Section 4.6: Fertility section revised 
Section 4.7: Punctuation change
Section 4.8: Grammatical changes
Section 5.1:  Grammatical changes
Section 6.1: Capsule content change 
Section 6.3: Shelf life is no longer 3 years 
Section 6.5: Material change to container
Section 9: Format changes 

Updated on 6 February 2013 PIL

Reasons for updating

  • Change of inactive ingredient
  • Change to improve clarity and readability

Updated on 15 January 2013 SmPC

Reasons for updating

  • 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 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 6.1 - List of excipients
  • 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- Grammatical changes
Section 3- Added the word 'hard'
Section 4.2-

  • Formatting changes
  • Added full abbreviation for NCI CTC (National Cancer Institute Common Toxicity Criteria)
  • Paediatric population- There is no relevant use of Thalidomide Celgene in the paediatric population in the indication of multiple myeloma 

Section 4.3- Added that excipients are listed in section 6.1
Section 4.4- Grammatical and formatting changes
Section 4.5- Italicized words added.
Thalidomide is a poor substrate for cytochrome P450 isoenzymes and therefore clinically important interactions with medicinal products t
hat are inhibitors and/or inducers of this enzyme system are unlikely. Non-enzymatic hydrolysis of thalidomide, being the primary clearance mechanism, suggests that the potential for drug-drug interactions with thalidomide is low.

Section 4.6- 

  • Grammatical and formatting changes
  • Fertility section added

Section 4.7-
Thalidomide Celgene has minor or moderate influence on the ability to drive and use machines. Thalidomide may cause fatigue, dizziness; somnolence and blurred vision (see section 4.8).
Section 4.8- Grammatical and formatting changes
Section 5.1-

  • Pharmacotherapeutic group changed to: immunosuppressants, other immunosuppressants.
  • Paediatric population added.

Section 5.2-

  • Metabolism changed to biotransformation
  • Linearity/ non linearity added
  • insufficiency changed to impairment

Section 6.1- Formatting changes
Section 9- Formatting changes
Section 10- Formatting changes

Updated on 20 September 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

4.4 Addition of paragraph regarding allergic reactions
4.8 Additional information regarding allergic reactions

Updated on 12 August 2011 PIL

Reasons for updating

  • Change to MA holder contact details
  • Change to name of manufacturer

Updated on 11 August 2011 SmPC

Reasons for updating

  • Change to section 10 - Date of revision of the text
  • Change to MA holder contact details

Legal category: Product subject to restricted prescription (C)

Free text change information supplied by the pharmaceutical company

Section 7 - The address of the MA holder has been updated
Section 10 - The date of the revision of the text has been amended

Updated on 25 May 2011 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
  • 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

Section 4.4 - Changes to Cardiovascular disorders section. Addition of section regarding MI and alteration to section regarding VTE. Addition to section regarding patients with renal/hepatic impairment.

Section 4.5 - "
Non-enzymatic hydrolysis suggests that the potential for drug-drug interactions with thalidomide is low." added to first paragraph.

Section 4.6 - title altered to "Fertility, pregnancy and lactation". Addition of "hypersensitivity, hearing impaired or deafness, renal failure, myocardial infarction and worsening of Parkinson’s disease symptoms" to adverse reaction experienced in post marketing surveillance.

Section 4.8 - Pancytopenia also added. Venous and arterial thromboembolic events section altered: "An increased risk of venous thromboembolism (such as deep vein thrombosis and pulmonary embolism) and arterial thromboembolism (such as myocardial infarction and cerebrovascular event) has been reported in patients treated with thalidomide (see section 4.4)."

5.1 - ATC code: L04AX 02. Previously read: LO4AX

5.2 - Sentence added: "Thalidomide is metabolised almost exclusively by non-enzymatic hydrolysis." Second paragraph added under Elimination. Additional information added to Hepatic and Renal insufficiency section.

10 – Date of revision 04/05/2011

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
  • Change to section 5.2 - Pharmacokinetic properties

Legal category: Product subject to restricted prescription (C)

Free text change information supplied by the pharmaceutical company

4.4 - Tumour Lysis Syndrome added
4.8 - Tumour Lysis Syndrome added. Febrile neutropenia added as an additional AE from post marketing experience.
5.2 - Additional information added in the Metabolism, Elimination and Hepatic and Renal Insufficiency sections.

Updated on 30 April 2010 PIL

Reasons for updating

  • Change to side-effects

Updated on 5 February 2010 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 7 December 2009 SmPC

Reasons for updating

  • Change to product name

Legal category: Product subject to restricted prescription (C)

Free text change information supplied by the pharmaceutical company

Name change from Thlaidomide Pharmion to Thalidomide Celgene

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 Peripheral Neuropathy Guidelines ammendment

Updated on 12 August 2008 SmPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Product subject to restricted prescription (C)