MVASI *
Pharmacy Only: Prescription

  • Company:

    Amgen Ireland Ltd
  • Status:

    Updated
  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)
  • Active Ingredient(s):

    This medicinal product is subject to additional monitoring.

    *Additional information is available within the SPC or upon request to the company

Updated on 30 September 2022

File name

633698c2c1b90.pdf

Reasons for updating

  • Change to section 6 - date of revision
  • Removal of Black Inverted Triangle

Updated on 30 September 2022

File name

63369825e6b0f.pdf

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 10 - Date of revision of the text
  • Removal of Black Inverted Triangle
  • Other

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

Updated on 18 July 2022

File name

62d54e62796c8.pdf

Reasons for updating

  • Change to section 3 - how to take/use
  • Change to section 6 - date of revision

Updated on 18 July 2022

File name

62d54e0bc5d50.pdf

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 medical prescription which may not be renewed (A)

Updated on 14 July 2021

File name

en_mvasi_approved_spc_v23_ie_1626252143.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.6 - Special precautions for disposal and other handling

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

Free text change information supplied by the pharmaceutical company

Originator alignment:

4.4     Special warnings and precautions for use

Traceability

In order to improve the traceability of biological medicinal products, the tradename and the batch number of the administered product should be clearly recorded (or stated) in the patient file.

 

5.1     Pharmacodynamic properties

Paediatric population

Soft tissue sarcoma

In a randomised phase II study (BO20924) a total of 154 patients aged ≥ 6 months to < 18 years with newly diagnosed metastatic rhabdomyosarcoma and non-rhabdomyosarcoma soft tissue sarcoma were treated with standard of care (Induction IVADO/IVA+/- local therapy followed by maintenance vinorelbine and cyclophosphamide) with or without bevacizumab (2.5 mg/kg/week) for a total duration of treatment of approximately 18 months. At the time of the final primary analysis, the primary endpoint of EFS by independent central review did not show a statistically significant difference between the two treatment arms, with HR of 0.93 (95% CI: 0.61, 1.41; p-value = 0.72). The difference in ORR per independent central review was 18% (CI: 0.6%, 35.3%) between the two treatment arms in the few patients who had evaluable tumour at baseline and had a confirmed response prior to receiving any local therapy: 27/75 patients (36.0%, 95% CI: 25.2%, 47.9%) in the chemo arm and 34/63 patients (54.0%, 95% CI: 40.9%, 66.6%) in the BV + chemo arm. The secondary endpoint of overall survival was not mature. Until mature OS results and safety data are available no definitive conclusion can be drawn on the benefit/risk balance. The final overall survival (OS) analyses showed no significant clinical benefit from addition of bevacizumab to chemotherapy in this patient population.

 

6.6     Special precautions for disposal and other handling

MVASI should be prepared by a healthcare professional using aseptic technique to ensure the sterility of the prepared solution. A sterile needle and syringe should be used to prepare MVASI.

 

Updated on 14 July 2021

File name

en_mvasi_approved_pil_v23_ie_1626252050.pdf

Reasons for updating

  • Change to section 6 - date of revision
  • Change to improve clarity and readability

Updated on 04 March 2021

File name

en_mvasi_approved_pil_v19_ie_1614875768.pdf

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 2 - excipient warnings
  • Change to section 6 - date of revision

Updated on 04 March 2021

File name

en_mvasi_approved_spc_v19_ie_1614875716.pdf

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • 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 10 - Date of revision of the text

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

Updated on 01 September 2020

File name

en_mvasi_approved_pil_v16_1598258716.pdf

Reasons for updating

  • New PIL for medicines.ie

Updated on 24 August 2020

File name

en_mvasi_approved_spc_v16_1598259937.pdf

Reasons for updating

  • New SPC for new product

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

Updated on 24 August 2020

File name

en_mvasi_approved_pil_v16_1598258716.pdf

Reasons for updating

  • New PIL for new product