Home | About the eMC | Help | Mobile
eMC - trusted, up to date and comprehensive information about medicines
Link to eMC medicine guides website
eMC homepage
Advanced search
Get Medicines Compendium UK app here

Genzyme Therapeutics
4620 Kingsgate, Cascade Way, Oxford Business Park South, Oxford, Oxfordshire, OX4 2SU
Telephone: +44 (0)1865 405 200
Fax: +44 (0)1865 774 172
WWW: http://www.genzyme.co.uk
Medical Information Direct Line: +44 (0)1483 505 515
Medical Information e-mail: uk-medicalinformation@sanofi-aventis.com
Customer Care direct line: +44 (0)1865 405 200
Medical Information Fax: +44(0)1483 554 805

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?
Summary of Product Characteristics last updated on the eMC: 23/05/2011
SPC MabCampath 30mg/ml concentrate for solution for infusion

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC. For each version, we show the dates it was published on the eMC and the reasons for change.

Updated on 23/05/2011 and displayed until Current
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 5.1 - Pharmacodynamic Properties
  • Change to section 6. 3 - Shelf Life
  • Change to section 6. 5 - Nature and Contents of Container
  • Change from datasheet to SPC
Date of revision of text on the SPC:   12-May-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Changes to following sections:

4.2 Posology and method of administration
QRD changes and inclusion of subheadings.

4.4 Special warnings and precautions for use
Addition of the following sentence

The potential for an increased risk of infection-related complications may exist following treatment with multiple chemotherapeutic or biological agents.


4.6 Fertility, pregnancy and lactation
Addition subheading and the following sentence

Fertility

There are no definitive studies of MabCampath which assess its impact on fertility. It is not known if MabCampath can affect human reproductive capacity (see section 5.3).

4.8 Undesirable effects
Addition of the following paragraph

The most frequent adverse reactions with MabCampath are: infusion reactions (pyrexia, chills, hypotension, urticaria, nausea, rash, tachycardia, dyspnoea), cytopenias (neutropenia, lymphopenia, thrombocytopenia, anaemia), infections (CMV viraemia, CMV infection, other infections), gastrointestinal symptoms (nausea, emesis, abdominal pain), and neurological symptoms (insomnia, anxiety). The most frequent serious adverse reactions are cytopenias, infusion reactions, and immunosuppression/infections.

“In some cases fatal….” Has been added to this paragraph
EBV-associated lymphoproliferative disorders, in some cases fatal, have been reported

5.1 Pharmacodynamic properties
The addition of “Antineoplastic agents” has been added to the first sentence

6.3 Shelf life
Addition of “Unopen vial”: 3 years.

6.5 Nature and contents of container
Additons to this sentence Clear type I glass vial, closed with a rubber stopper, containing 1 ml of concentrate.

10. DATE OF REVISION OF THE TEXT
Updated on 01/04/2010 and displayed until 23/05/2011
Reasons for adding or updating:
  • Removal of Black Triangle
Date of revision of text on the SPC:   01-Dec-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Removal of Black Triangle
Updated on 28/10/2009 and displayed until 01/04/2010
Reasons for adding or updating:
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   01-Dec-2008
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
Change to Section 10.  Incorrect date was displayed.  Correct date is12/2008
Updated on 04/06/2009 and displayed until 28/10/2009
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • 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
Date of revision of text on the SPC:   01-May-2009
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
Changes are to bring SmPC in line with CCDS.

Section 2 (Qualative and quantative composition) - addition of word of in description.

Section 4.2 (Posology and method of administation) - rewording on dose escalation description, change of median duration of treatment from 8.0 weeks to 9.0 weeks: rewording and additional information in table.

Section 4.4 (Special warnings and precautions for use) - minor re-wording of some text; lengthening of pre-treatment levels from 6 months or longer to 12 months;addition of time scales to oral-herpes agent information.  Rewording of TAGVHD warning.

Section 4.8 (Undesirable effects) - some information has been reworded and moved regarding number of first-line patients experiencing adverse reactions from opening paragraph to 3rd paragraph.  Additional information has been inserted under the first table concerning acute infusion reactions.  Additional text has also been added concerning undesirable effects in previous treated patients.  The unknown column has been removed from the 2nd table and this information has been included in the section after 2nd table entitles - undesirable effects obeserved ....

Section 10 (Date of revsion) - this is now May 2009 
Updated on 29/01/2009 and displayed until 04/06/2009
Reasons for adding or updating:
  • 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 4.8 - Undesirable Effects
  • Change to section 4.9 - Overdose
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   05-Dec-2008
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
Sections 4.2,4.3,4.4,4.8 & 4.9 have all been updated and corrected based on new CCDS version.

Section 4.2 ( Posology and method of administration) the information on dose adjustments considering haematological values has been further clarified.
Section 4.4 ( Special warnings and precautions) has been rvised to make it clear which undesirable effects were observed during post-marketing as well as to avoid redundancies with regard to several adverse effects.
Section 10 ( Revision date) this is now 05.12.2008
Updated on 21/08/2008 and displayed until 29/01/2009
Reasons for adding or updating:
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   04-Jul-2008
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
Section 4.6 (pregnancy & lactation) the following text has been removed "MabCampath is contraindicated during breast-feeding".
Section 10 - revision date of text has been amended to 4 July 2008
Updated on 07/01/2008 and displayed until 21/08/2008
Reasons for adding or updating:
  • Change to section 4.1 - Therapeutic indications
  • Change to section 10 date of revision of the text
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
Section 4.1 - Addition of new indication - first line CLL
Section 10 - Date of revision amended to 12/2007 
Updated on 27/09/2006 and displayed until 07/01/2008
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 22/09/2006 and displayed until 27/09/2006
Reasons for adding or 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 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5 - Pharmacological Properties
  • Change to section 6.2 - Incompatibilities
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 6. 6 - Instruction for Use/Handling
  • 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 (partial) revision of the text
Date of revision of text on the SPC:   07/2006
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company

Section 2 – additional text added – each vial contains ….

Section 3 – description of solution added

Section 4.2 addition of text “MabCampath should be permanently discontinued if MabCampath related autoimmune anaemia or autoimmune thrombocytopenia appears”. 

Under children and adolescents – “MabCampath is not recommended for use in the paediatric age group”.

Section 4.4 –

Addition of following text: “Assessment and ongoing monitoring of cardiac function (e.g. echocardiography, heart rate and body weight) should be considered in patients previously treated with potentially cardiotoxic agents.”

“MabCampath should be permanently discontinued if MabCampath related autoimmune anaemia or autoimmune thrombocytopenia appears.”

“Medicinal products for the treatment of hypersensitivity reactions, as well as preparedness to institute emergency measures in the event of reaction during administration is necessary (see section 4.2).”

Under heading of Lactation – addition of text “If treatment is needed …”

 

Section 4.8 – extensive revision and text moved around to include addition of side effects under the following headings-

Infections and infestations – opportunistic infections, reactivation and appearance of latent infection. Other viral,  bacterial, protozoan amd fungal infections (umkown)

Neoplasms – EBV infection associated with lymphoproliferative disorder (unknown)

Blood and lymphatic system disorders – severe bleeding reactions (unkown)

Immune system disorders – severe anaphylactic and other hypersensitivity reactions (unkown), autoimmune phenomena ( unknown), Coombs test positive (unkown)

Metabolic and nutrition disorders – tumour lysis syndrome (unknown)

Nervous system disorders –intracranial haemorrhage in patients with thrombocytopenia (unknown)

Cardiac disorders – congestive heart failure, cardiomyopathy, or ejection fraction decreased in patients previously treated with cardiotoxic agents (unkown)

Vascular disorders added

Respiratory thoracic & mediastinal disorders included

Hepatobiliary disorders added

Musculoskeletal and connective tissue disorders added

Renal & urinary disorders added

General disorders – serious infusion related reactions (unknown)

 

 

New info has been inserted under the following headings:

Infusion related reactions – hypoxia, arrhythmias, acute cardiac insufficiency. Addition of text “Severe anaphylactic and other hypersensitivity reaction including anaphylactic shock and angioedema have been reported rarely following MabCampath administration”

Infections and Infestations - New information added re Progressive Multifocal Leukoencephalopathy (PML) protozoan and reactivated latent infections. Addition of text “The prolonged decrease in T-lymphocytes that can be associated with MabCampath treatment may lead to an increased risk for latent viral reactivation of Epstein Barr Virus (EBV). Evolution of EBV-infection/reactivation into EBV-associated lymphoproliferative disorder has been observed in immunocompromised patients in rare cases.”

 

 

Immune system disorders – addition of text “autoimmune phenomena have been reported uncommonly during or after treatment with MabCampath (e.g. autoimmune haemolytic anaemia, autoimmune thrombocytopenia, aplastic anemia, Guillain Barré syndrome and its chronic form, chronic inflammatory demyelinating polyradiculoneuropathy). In rare cases these can be life-threatening or fatal.

 

A positive Coombs test is also a common event.”

 

 

Metabolism and nutritional disorders – addition of text “with fatal outcome has been rarely reported”

Nervous system disorders – addition of text “in patients with thrombocytopenia with fatal outcome”

 

 

Section 5 – Additional text re authorisation of this product “Under Exceptional Circumstances”

 

Section 6.2 – addition of text re mixing product with other medicinal products

 

Section 6.4 – addition of “In order to protect from light, store in the original package.

and “For storage conditions of the reconstituted medicinal product, see section 6.”.

 

Section 6.5 -  Text regarding 1ml concentrate content has been re-worded

 

Section 6.6 – Strength of sodium chloride solution ( 9mg/ml) has been added

 

Sections 9 and 10 – revision dates changed

 

 

 
Updated on 21/09/2005 and displayed until 22/09/2006
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 10 (date of (partial) revision of the text
Updated on 11/05/2005 and displayed until 21/09/2005
Reasons for adding or updating:
  • Change to section 1 - trade name
  • Change to section 2 - qualitative and quantitative composition
  • Change to section 6. 3 - Shelf Life
  • Change to section 10 (date of (partial) revision of the text
Updated on 16/02/2004 and displayed until 11/05/2005
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 4.8 - Undesirable Effects
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 6. 3 - Shelf Life
  • Change to section 6. 6 - Instruction for Use/Handling
  • Change to section 10 (date of (partial) revision of the text
Updated on 30/09/2003 and displayed until 16/02/2004
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 30/09/2003 and displayed until 30/09/2003
Reasons for adding or updating:
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 10 (date of (partial) revision of the text
Updated on 26/11/2002 and displayed until 30/09/2003
Reasons for adding or updating:
  • Improved Electronic Presentation
Updated on 04/10/2002 and displayed until 26/11/2002
Reasons for adding or updating:
  • Change to section 4.2 - Posology and Method of Administration
  • Change to section 10 (date of (partial) revision of the text
Updated on 31/08/2001 and displayed until 04/10/2002
Reasons for adding or updating:
  • New SPC for new product

Active Ingredients/Generics

 
  alemtuzumab