Velcade 3.5 mg powder for solution for injection

  • Name:

    Velcade 3.5 mg powder for solution for injection

  • Company:
    info
  • Active Ingredients:

    bortezomib mannitol boronic ester

  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 25/02/19

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Summary of Product Characteristics last updated on medicines.ie: 25/2/2019

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Janssen Sciences Ireland

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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 25 February 2019 PIL

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 25 February 2019 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 medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

4.8     Undesirable effects

 

 

 

Table 7:      Adverse reactions in patients with Multiple Myeloma treated with VELCADE in clinical trials as single agent or in combination, and all post-marketing adverse reactions regardless of indication#

 

 

Blood and lymphatic system disorders

Very Common

Thrombocytopenia*, Neutropenia*, Anaemia*

Common

Leukopenia*, Lymphopenia*

Uncommon

Pancytopenia*, Febrile neutropenia, Coagulopathy*, Leukocytosis*, Lymphadenopathy, Haemolytic anaemia#

Rare

Disseminated intravascular coagulation, Thrombocytosis*, Hyperviscosity syndrome, Platelet disorder NOS, Thrombotic microangiopathy (inc Tthrombocytopenic purpura) #, Blood disorder NOS, Haemorrhagic diathesis, Lymphocytic infiltration

 

 

Eye disorders

Common

Eye swelling*, Vision abnormal*, Conjunctivitis*

Uncommon

Eye haemorrhage*, Eyelid infection*, Chalazion#, Blepharitis#, Eye inflammation*, Diplopia, Dry eye*, Eye irritation*, Eye pain, Lacrimation increased, Eye discharge

 

Updated on 17 October 2018 PIL

Reasons for updating

  • Change to section 6 - date of revision
  • Change of distributor details

Updated on 17 October 2018 SmPC

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

 

5.1     Pharmacodynamic properties

 

Median PFS by investigator assessment was 30.7 months in the VcR‑CAP group and 16.1 months in the R‑CHOP group (Hazard Ratio [HR]=0.51; p < 0.001). A statistically significant benefit (p < 0.001) in favour of the VcR‑CAP treatment group over the R‑CHOP group was observed for TTP (median 30.5 versus 16.1 months), TNT (median 44.5 versus 24.8 months) and TFI (median 40.6 versus 20.5 months). The median duration of complete response was 42.1 months in the VcR‑CAP group compared with 18 months in the R‑CHOP group. The duration of overall response was 21.4 months longer in the VcR‑CAP group (median 36.5 months versus 15.1 months in the R‑CHOP group). With a median duration of follow‑up of 40 months, median OS (56.3 months in the R‑CHOP group, and not reached in the VcR‑CAP group) favoured the VcR‑CAP group, (estimated HR=0.80; p=0.173). There was a trend towards prolonged overall survival favouring the VcR‑CAP group; the estimated 4‑year survival rate was 53.9% in the R‑CHOP group and 64.4% in the VcR‑CAP group. The final analysis for OS was performed after a median follow-up of 82 months. Median OS was 90.7 months for the VcR-CAP group compared with 55.7 months for the R-CHOP group (HR=0.66; p=0.001). The observed final median difference in the OS between the 2 treatment groups was 35 months.

Updated on 1 March 2017 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 1 March 2017 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.7 - Effects on ability to drive and use machines
  • 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 medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

4.2     Posology and method of administration

 

 

Treatment must be initiated and administered under the supervision of a physician qualified and experienced in the use of chemotherapeutic agents. VELCADE must be reconstituted by a healthcare professional.VELCADE treatment must be initiated under supervision of a physician experienced in the treatment of cancer patients, however VELCADE may be administered by a healthcare professional experienced in use of chemotherapeutic agents. VELCADE must be reconstituted by a healthcare professional (see section 6.6).

 

 

4.7     Effects on ability to drive and use machines

 

VELCADE may have a moderate influence on the ability to drive and use machines. VELCADE may be associated with fatigue very commonly, dizziness commonly, syncope uncommonly and orthostatic/postural hypotension or blurred vision commonly. Therefore, patients must be cautious when driving or using machines and should be advised not to drive or operate machinery if they experience these symptoms (see section 4.8).

 

 

6.6     Special precautions for disposal and other handling

 

General precautions

Bortezomib is a cytotoxic agent. Therefore, caution should be used during handling and preparation of VELCADE. Use of gloves and other protective clothing to prevent skin contact is recommended.

 

Aseptic technique must be strictly observed throughout the handling of VELCADE, since it contains no preservative.

 

There have been fatal cases of inadvertent intrathecal administration of VELCADE. VELCADE 1 mg powder for solution for injection is for intravenous use only, while VELCADE 3.5 mg powder for solution for injection is for intravenous or subcutaneous use. VELCADE should not be administered intrathecally.

 

Instructions for reconstitution

VELCADE must be reconstituted by a healthcare professional.

 

Intravenous injection

Each 10 ml vial of VELCADE must be carefully reconstituted with 3.5 ml of sodium chloride 9 mg/ml (0.9%) solution for injection, by using a syringe of the appropriate size, without removing the vial stopper. Dissolution of the lyophilised powder is completed in less than 2 minutes.

After reconstitution, each ml solution contains 1 mg bortezomib. The reconstituted solution is clear and colourless, with a final pH of 4 to 7.

The reconstituted solution must be inspected visually for particulate matter and discolouration prior to administration. If any discolouration or particulate matter is observed, the reconstituted solution must be discarded.

 

Subcutaneous injection

Each 10 ml vial of VELCADE should must be carefully reconstituted with 1.4 ml of sodium chloride 9 mg/ml (0.9%) solution for injection, by using a syringe of the appropriate size, without removing the vial stopper. Dissolution of the lyophilised powder is completed in less than 2 minutes.

After reconstitution, each ml solution contains 2.5 mg bortezomib. The reconstituted solution is clear and colourless, with a final pH of 4 to 7. The reconstituted solution must be inspected visually for particulate matter and discolouration prior to administration. If any discolouration or particulate matter is observed, the reconstituted solution must be discarded.

Updated on 28 February 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 28 February 2017 PIL

Reasons for updating

  • Change to section 6 - date of revision
  • Change to information for healthcare professionals

Updated on 26 January 2016 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 5.1 - Pharmacodynamic properties

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Addition of paediatric data to sections 4.2 and 5.1 of SmPC.

Updated on 22 January 2016 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Table 7: Adverse reactions in patients with Multiple Myeloma treated with VELCADE as single agent or in combination

Gastrointestinal disorders

Uncommon

Pancreatitis (inc chronic)*, Haematemesis, Lip swelling*, Gastrointestinal obstruction (inc small intestinal obstruction, ileus)*, Abdominal discomfort, Oral ulceration*, Enteritis*, Gastritis*, Gingival bleeding, Gastrooesophageal reflux disease*, Colitis (inc clostridium difficile)*, Colitis ischaemic#, Gastrointestinal inflammation*, Dysphagia, Irritable bowel syndrome, Gastrointestinal disorder NOS, Tongue coated, Gastrointestinal motility disorder*, Salivary gland disorder*

Updated on 22 May 2015 SmPC

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company


5.1       Pharmacodynamic properties

VELCADE combination treatment with pegylated liposomal doxorubicin (study DOXIL‑MMY‑3001)

A Phase III randomised, parallel-group, open-label, multicentre study was conducted in 646 patients comparing the safety and efficacy of VELCADE plus pegylated liposomal doxorubicin versus VELCADE monotherapy in patients with multiple myeloma who had received at least 1 prior therapy and who did not progress while receiving anthracycline‑based therapy. The primary efficacy endpoint was TTP while the secondary efficacy endpoints were OS and ORR (CR+PR), using the European Group for Blood and Marrow Transplantation (EBMT) criteria.

A protocoldefined interim analysis (based on 249 TTP events) triggered early study termination for efficacy. This interim analysis showed a TTP risk reduction of 45% (95% CI; 2957%, p < 0.0001) for patients treated with combination therapy of VELCADE and pegylated liposomal doxorubicin. The median TTP was 6.5 months for the VELCADE monotherapy patients compared with 9.3 months for the VELCADE plus pegylated liposomal doxorubicin combination therapy patients. These results, though not mature, constituted the protocol defined final analysis.

The final analysis for OS performed after a median follow‑up of 8.6 years showed no significant difference in OS between the two treatment arms. The median OS was 30.8 months (95% CI; 25.2‑36.5 months) for the VELCADE monotherapy patients and 33.0 months (95% CI; 28.9‑37.1 months) for the VELCADE plus pegylated liposomal doxorubicin combination therapy patients.

Updated on 20 May 2015 PIL

Reasons for updating

  • Change to side-effects

Updated on 9 February 2015 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 medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

 

Addition of new indication:

VELCADE in combination with rituximab, cyclophosphamide, doxorubicin and prednisone is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma who are unsuitable for haematopoietic stem cell transplantation.

 

Updated on 6 February 2015 PIL

Reasons for updating

  • Change to, or new use for medicine

Updated on 27 March 2014 PIL

Reasons for updating

  • Change to further information section

Updated on 24 January 2014 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to instructions about overdose
  • Change to side-effects
  • Change to drug interactions
  • Change to date of revision

Updated on 23 January 2014 SmPC

Reasons for 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 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 4.2:

Text repositioning. Addition of 'no data available’ under ‘Paediatric population’.

 

Section 4.3, 4.4, 4.6:

Some text reworded with no change to meaning.

 

Section 4.8:

Repositioning information under ‘Summary of the safety profile’.

Updated on 7 January 2014 PIL

Reasons for updating

  • Change to side-effects
  • Change to how the medicine works
  • Change to dosage and administration

Updated on 7 January 2014 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

4.1     Therapeutic indications

 

VELCADE as monotherapy or in combination with pegylated liposomal doxorubicin or dexamethasone is indicated for the treatment of adult patients with progressive multiple myeloma who have received at least 1 prior therapy and who have already undergone or are unsuitable for haematopoietic stem cell transplantation.

Changes through out the SmPC to reflect the approval of the new combination indication.

Updated on 7 August 2013 PIL

Reasons for updating

  • Change to, or new use for medicine
  • Change to warnings or special precautions for use
  • Change to side-effects

Updated on 7 August 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 4.3 - 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 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Approval of Velcade Induction therapy

Updated on 31 July 2013 PIL

Reasons for updating

  • Change to, or new use for medicine
  • Change to side-effects
  • Addition of information on reporting a side effect.

Updated on 30 July 2013 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company



Addition of study data to Section 5.1 regarding there being limited data concerning retreament with Velcade.

Additional monitoring statement add to Section 4.8

Updated on 19 April 2013 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use

Legal category: Product subject to medical prescription which may not be renewed (A)

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Addition of PML to section 4.4 of the SmPC

Progressive multifocal leukoencephalopathy (PML)

Very rare cases with unknown causality of John Cunningham (JC) virus infection, resulting in PML and death, have been reported in patients treated with VELCADE. Patients diagnosed with PML had prior or concurrent immunosuppressive therapy. Most cases of PML were diagnosed within 12 months of their first dose of VELCADE. Patients should be monitored at regular intervals for any new or worsening neurological symptoms or signs that may be suggestive of PML as part of the differential diagnosis of CNS problems. If a diagnosis of PML is suspected, patients should be referred to a specialist in PML and appropriate diagnostic measures for PML should be initiated. Discontinue VELCADE if PML is diagnosed.

Updated on 19 April 2013 PIL

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 27 September 2012 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to information about pregnancy or lactation
  • Change to how the medicine works
  • Change to further information section
  • Change to date of revision
  • Change to dosage and administration
  • Addition of separate PILs covering individual presentations
  • Correction of spelling/typing errors

Updated on 27 September 2012 SmPC

Reasons for 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 4.6 - 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 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

section 2 - amended to state what 1mg contains

section 4.2 posology to include subcutaneous use

section 4.2 recommendations for use for bortezomib related neuropathy

section 4.4 –  intrathecal use section elaborated and moved to prominent position

section 4.4 – inclusion of herpes zoster reactivation information and further sub-cut use information

section 4.6 – contraception statement reworded

section 4.8 – reformatting of section 4.8 with inclusion of sub-cut information

section 5.1 – amended with sub-cut information

section 6.3, 6.4 amd 6.5 – re-phrasing of statements and inclusion of intrathecal administration warning.

Updated on 29 March 2012 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 4.5 - 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 5.3 - Preclinical safety data
  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Change to section 4.1: Editorial changes
Change to section 4.2: Editorial changes
Change to section 4.4: Editorial changes
Change to section 4.5: Editorial changes
Change to section 4.8: Additional rare ADRs – optic neuropathy &different degrees of visual impairment (up to blindness)
Change to section 5.1: Editorial changes
Change to section 5.2: Editorial changes
Change to section 5.3: Editorial changes
Change to section 6.5: Editorial change
Change to section 10: 21/03/2012

Updated on 27 March 2012 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 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Change to section 4.2:  Editorial change
 
Change to section 4.4: Editorial change

Change to section 4.6: Editorial change

Change to section 4.8: Editorial change

Change to section 5.1: Additional clinical study data

Change to section 5.2: Editorial change

Change to section 5.3: Editorial change

Change to section 7:  
Editorial change

Change to section 10: 19/03/2012

Updated on 27 March 2012 PIL

Reasons for updating

  • Change to side-effects
  • Change to improve clarity and readability

Updated on 23 March 2012 PIL

Reasons for updating

  • Change to further information section
  • Change to date of revision

Updated on 26 September 2011 SmPC

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 4.5 - Addition of

A drug-drug interaction study assessing the effect of rifampicin, a potent CYP3A4 inducer, showed a mean bortezomib AUC reduction of 45% based on data from 6 patients. Therefore, the concomitant use of bortezomib with strong CYP3A4 inducers (e.g., rifampicin, carbamazepine, phenytoin, phenobarbital and St. John’s Wort), is not recommended, as efficacy may be reduced.

In the same drug-drug interaction study assessing the effect of dexamethasone, a weaker CYP3A4 inducer, there was no significant effect on the pharmacokinetics bortezomib based on data from 7 patients.

Updated on 22 September 2011 PIL

Reasons for updating

  • Change to drug interactions

Updated on 11 August 2011 SmPC

Reasons for 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 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 medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 4.2

Change to information for patients with hepatic impairment and table number change

Section 4.3

Removal of severe hepatic impairment as a contraindication

Section 4.4

Change to information for patients with hepatic impairment

Section 4.8

Table numbers updated

Section 5.1

Table numbers updated

Section 5.2

Change to information for hepatic impairment

Updated on 9 August 2011 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications

Updated on 25 January 2011 PIL

Reasons for updating

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

Updated on 25 January 2011 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 4.2 - Update to Neuropathic pain and/or peripheral neuropathy text and Special Populations information re-ordered.

Section 4.8 - Adverse events table updated to include postmarketing data as well as clinical trial data

Section 5.1 - Table numbers updated to reflect deletion of previous table

Updated on 15 July 2010 SmPC

Reasons for 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 4.6 - Pregnancy and lactation
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Change to section 2

Updated in-line with new QRD template

Change to section 4.2

Updated in-line with new QRD template

Change to section 4.4

Deletion of amyloidosis text.

Change to section 4.6

Updated in-line with new QRD template

Change to section 5.1

Addition of information on patients with previously treated light-chain (AL) amyloidosis

Change to section 6.5

Updated in-line with new QRD template

Change to section 10

Changed to 2nd July 2010

 

Updated on 13 July 2010 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to date of revision

Updated on 16 June 2010 SmPC

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Change to section 5.1 - Addition of VISTA Survival Data following interim analysis.
Change to section 10 - Changed to 2nd June 2010.

Updated on 8 June 2010 PIL

Reasons for updating

  • Change to drug interactions
  • Change to date of revision

Updated on 11 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 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company



4.4 - Special Warnings and Precautions for Use

Addition of: Reversible Posterior Leukoencephalopathy Syndrome (RPLS).

 

4.8 - Undesirable effects

Addition of:

Reversible Posterior Leukoencephalopathy Syndrome (RPLS)

Acute febrile neutrophilic dermatosis (Sweet’s syndrome)

Vasculitic rash (including leukocytoclastic vasculitis)

 

10 - DATE OF REVISION OF THE TEXT

Changed to 27/04/2010

 

Updated on 29 April 2010 PIL

Reasons for updating

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

Updated on 9 December 2009 SmPC

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Interaction with other medicinal products and other forms of interaction

Deletion of: Patients should be closely monitored when given bortezomib in combination with CYP2C19-inhibitors (e.g. fluoxetine).

 

DATE OF REVISION OF THE TEXT

 

Changed to 30th November 2009

 

Updated on 25 November 2009 SmPC

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

5.1

Pharmacodynamic properties

Data from in vitro, ex-vivo, and animal models with bortezomib suggest that it increases osteoblast differentiation and activity and inhibits osteoclast function. These effects have been observed in patients with multiple myeloma affected by an advanced osteolytic disease and treated with bortezomib.

 

10.

DATE OF REVISION OF THE TEXT

 

Changed to 28th October 2009

 

Updated on 26 June 2009 SmPC

Reasons for updating

  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • 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
  • 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 10 - Date of revision of the text
  • Change to section 4.8 - Undesirable effects

Legal category: Product subject to medical prescription which may not be renewed (A)

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Change to section 4.2 – Posology and |Method of Administration

Renewal Approved

Change to section 4.3 – Contra-indications

Renewal Approved

Change to section 4.4 – Special Warnings and Precautions for Use

Renewal Approved

Change to section 4.5 –Interaction with other medicinal products and other forms of interaction

Renewal Approved

Change to section 4.6 – Pregnancy and Lactation

Renewal Approved

Change to section 4.7 - Effects on Ability to Drive and Use Machines

Renewal Approved

Change to section 4.8 – Undesirable effects

recommendation to consider the use of antiviral prophylaxis therapy in patients treated with Velcade and to include Steven Johnson Syndrome and Toxic Epidermal Necrolysis as very rare ADR’s in the postmarketing section

Change to section 4.9 - Overdose

Renewal Approved

Change to section 5.1 - Pharmacodynamic properties

Renewal Approved

Change to section 5.2 - Pharmacokinetic properties

Renewal Approved

Change to section 5.3 - Preclinical Safety Data

Renewal Approved

Change to section 6.3 – Shelf Life

Renewal Approved

Change to section 6.4 – Special Precautions for Storage

Renewal Approved

Change to section 6.5 – Nature and Contents of Container*

Renewal Approved

Change to section 6.6 –  Instructions for use, handling and disposal*

Renewal Approved

Change to section 9 – Date of Renewal of Authorisation

Changed to 26/04/2009

Change to section 10 – Date of revision of the text

Changed to 29th May 2009

Updated on 17 June 2009 PIL

Reasons for updating

  • Change to information about pregnancy or lactation
  • Change to dosage and administration
  • Change to, or new use for medicine
  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to side-effects

Updated on 18 September 2008 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.5 - 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 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

4.

CLINICAL PARTICULARS

 

4.1

Therapeutic Indications

Velcade can now be used in combination with melphalan and prednisone for the treatment of patients with previously untreated multiple myeloma who are not eligible for high-dose chemotherapy with bone marrow transplant.

4.2

Posology and method of administration

Details of usage in Monotherapy and Combination therapy

4.5

Interaction with other medicinal products and other forms of interaction

Information on a drug-drug interaction study assessing the effect of melphalan-prednisone on VELCADE.

4.8

Undesirable effects

Summary of safety data in patients with previously untreated multiple myeloma

 

5.

PHARMACOLOGICAL PROPERTIES

 

5.1

Pharmacodynamic properties

Information on a Randomized, Open-Label Clinical Study in Patients with Previously Untreated Multiple Myeloma

 

 

10.

DATE OF REVISION OF THE TEXT

 

29th August 2008

 

Updated on 17 September 2008 PIL

Reasons for updating

  • Change to, or new use for medicine
  • Change to dosage and administration

Updated on 7 August 2008 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 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

4.2

Posology and method of administration

Additional information on use in patients with renal impairment

4.4

Special Warnings and Precautions for Use

Additional information on use in patients with renal impairment

5.2

Pharmacokinetic properties

Additional information on use in patients with renal impairment

10.

DATE OF REVISION OF THE TEXT

 

Changed to July 2008

 

Updated on 6 August 2008 PIL

Reasons for updating

  • Change to marketing authorisation holder

Updated on 8 May 2008 SmPC

Reasons for updating

  • 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 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

4.3

Contraindications

Addition of - Acute diffuse infiltrative pulmonary and pericardial disease.

4.4

Special Warnings and Precautions for Use

Pulmonary Disorders addition of - A pretreatment chest radiograph is recommended to determine if any additional diagnostic measures are necessary and to serve as a baseline for potential post-treatment pulmonary changes.

 

In the event of new or worsening pulmonary symptoms - The benefit/risk ratio should be considered prior to continuing VELCADE therapy.

4.8

Undesirable effects

Cardiac disorders addition of - pericarditis, cardiac and cardiopulmonary arrest, ventricular arrhythmias, atrio-ventricular block complete, atrial fibrillation, tachycardia, sinus and ventricular tachycardia

 

Respiratory, thoracic and mediastinal disorders addition of – pneumonia, acute diffuse infiltrative pulmonary disease, pulmonary hypertension, respiratory failure, pulmonary alveolar haemorrhage, acute pulmonary oedema, pulmonary oedema, pulmonary embolism, peripheral embolism

 

6.5

Nature and contents of container

Addition of - The cap colour of the 10 ml vial is royal blue.

 

10.

DATE OF REVISION OF THE TEXT

 

Updated to 21st April 2008

 

 

 

Updated on 6 May 2008 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to date of revision
  • Addition of separate PILs covering individual presentations

Updated on 4 February 2008 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 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Change to section 4.4 – Special Warnings and Precautions for Use

Administrative change

Change to section 4.5 –Interaction with other medicinal products and other forms of interaction

Change to PK wording following the omeprazole and ketoconazole interaction studies

Change to section 10 – Date of revision of text

Changed to 14/12/2007

Updated on 11 September 2007 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 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Change to section 4.2 – Posology and Method of Administration

Change to content of Table 1

Change to section 4.4 – Special Warnings and Precautions for Use

Update to text on Peripheral Neuropathy, Hypotension and Pulmonary Disorders

Change to section 4.8 – Undesirable effects

Update to entire section

Change to section 5.2 - Pharmacokinetic properties

Update to entire section

Change to section 10 – Date of revision of the text

Changed to 30/07/2007

Updated on 11 September 2007 PIL

Reasons for updating

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

Updated on 26 April 2007 SmPC

Reasons for updating

  • Change to section 6.3 - Shelf life
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 6.3 - Change of shelf life.
Section 10  -  Change of date of revision of text.

Updated on 4 April 2007 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

4.8 Undesirable effects - Position of sections headed Endocrine disorders and Reproductive system and breast disorders moved.

 

5.1 Pharmacodynamic properties - Additional statement:

This medicinal product has been authorised under “Exceptional Circumstances.” This means that for scientific reasons it has not been possible to obtain complete information on this medicinal product. The European Medicines Agency (EMEA) will review any new information which may become available each year and this SPC will be updated as necessary.

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Add:

Renewal of the authorisation: 03/01/2007

 

10. DATE OF REVISION OF THE TEXT - 03/01/2007

 

Updated on 5 September 2006 PIL

Reasons for updating

  • Change to further information section
  • Change to date of revision

Updated on 31 August 2006 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 medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

4.4

Special Warnings and Precautions for Use

Addition of text:

 

Pulmonary Disorders

There have been rare reports of acute diffuse infiltrative pulmonary disease of unknown aetiology such as pneumonitis, interstitial pneumonia, lung infiltration, and Acute Respiratory Distress Syndrome (ARDS) in patients receiving VELCADE (see section 4.8). Some of these events have been fatal.  A higher proportion of these events have been reported in Japan.  In the event of new or worsening pulmonary symptoms (e.g. cough, dyspnoea), a prompt diagnostic evaluation should be performed and patients treated appropriately.

 

4.8

Undesirable effects

Change to text:

 

Post Marketing Experience

Clinically significant adverse reactions are listed if they have been reported during post approval use of VELCADE and have not been reported in clinical trials. Their frequency is not known.

 

Nervous system disorders

Encephalopathy

 

Cardiac disorders

Cardiac tamponade

 

Respiratory, thoracic and mediastinal disorders (see section 4.4)

Pneumonitis, interstitial pneumonia, Acute Respiratory Distress Syndrome (ARDS)

 

Gastrointestinal disorders

Ischemic colitis

 

Hepatobiliary disorders

Liver failure

 

 

10.

DATE OF REVISION OF THE TEXT

Changed to 28/07/2006

Updated on 28 November 2005 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 medical prescription which may not be renewed (A)

Updated on 11 August 2005 PIL

Reasons for updating

  • Change to further information section

Updated on 9 August 2005 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 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.3 - Preclinical safety data

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 24 June 2005 PIL

Reasons for updating

  • Correction of spelling/typing errors

Updated on 22 June 2005 SmPC

Reasons for updating

  • Correction of spelling/typing errors

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 10 May 2005 PIL

Reasons for updating

  • Change to, or new use for medicine
  • Change to side-effects

Updated on 5 May 2005 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 medical prescription which may not be renewed (A)

Updated on 18 November 2004 PIL

Reasons for updating

  • Change to storage instructions
  • Change to date of revision

Updated on 17 November 2004 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 17 November 2004 SmPC

Reasons for updating

  • Change to section 6.4 - Special precautions for storage
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 26 October 2004 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 29 September 2004 SmPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Product subject to medical prescription which may not be renewed (A)