Beovu 120 mg/ml solution for injection in pre-filled syringe

*
Pharmacy Only: Prescription
  • Company:

    Novartis Ireland Limited
  • Status:

    No Recent Update
  • 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 17 August 2023

File name

Beovu PFS REG PIL PF22-178 and 23-069 June 2023 clean.pdf

Reasons for updating

  • Improved presentation of PIL

Free text change information supplied by the pharmaceutical company

Improve readability of figures in dosing section

Updated on 12 July 2023

File name

Beovu PFS REG PIL PF22-178 and 23-069 June 2023_IPHA.pdf

Reasons for updating

  • Change to section 3 - dose and frequency
  • Change to section 4 - possible side effects

Free text change information supplied by the pharmaceutical company

Alternative dosing/maintenance regimen for DME and wAMD

Change in frequency of some side effects

Updated on 12 July 2023

File name

Beovu REG SPC PF22-178 & 23-069 June 2023_IPHA.pdf

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 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

nAMD label update based on Modelling & Simulation, alternative posology:

·      Section 4.2: Updated the posology for wAMD to include the following alternative loading regimen: ‘Alternatively, 6 mg brolucizumab (0.05 ml solution) may be administered every 6 weeks for the first 2 doses. A disease activity assessment is suggested 12 weeks (3 months) after treatment start. A third dose may be administered based on disease activity as assessed by visual acuity and/or anatomical parameters at week 12.’

·      Section 5.1: Updated to include the results of the PK/PD model simulation study

 

DME posology & 100-week KESTREL/KITE variation:

  • Section 4.2: Updated the posology for DME based on the KITE study to include 16 week or 4 months extension during maintenance phase for the DME dosing: ‘. After 12 months of treatment, in patients without disease activity, treatment intervals up to 16 weeks (4 months) could be considered’
  • Section 4.8: Two sentences were added above the ADR Table 1 regarding iridocyclitis, retinal vascular occlusion and vitreous haemorrhage since these were observed at a higher frequency (category of common) in the pooled DME Phase III studies. The immunogenicity sub-section for DME was updated with the KESTREL and KITE 2-year data.
  • Section 5.1: Updated to provide the updated (Week 100) safety and efficacy data from the KESTREL and KITE DME studies


EDM Updated on 28 November 2022

File name

Your Guide to Therapy with Beovu - Audio - Aug 2022.mp3

Reasons for updating

  • Add New Audio

EDM Updated on 28 November 2022

File name

IE203173_Beovu_Patient_Therapy_Guide_Booklet_Aug2022.pdf

Reasons for updating

  • Add New Doc

Free text change information supplied by the pharmaceutical company

First upload to medicines.ie

Updated on 05 April 2022

File name

Beovu PFS_REG PIL_PF21-060_March 2022 IPHA.pdf

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 2 - use in children and adolescents
  • Change to section 3 - dose and frequency
  • Change to section 3 - duration of treatment

Free text change information supplied by the pharmaceutical company

Updated due to new DME indication

Updated on 05 April 2022

File name

Beovu_REG SPC_PF21-060 March 2022_IPHA.pdf

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 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.3 - Preclinical safety data

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

Free text change information supplied by the pharmaceutical company

New DME indication

Information on (limited) experience in diabetic patients added to Section 4.4 'Special warnings and precautions for use' 

Results from study in pregnant cynomolgus monkeys added to Section 4.6 'Fertility, pregnancy & lactation' and Section 5.3 'Preclinical safety data'

Updated on 14 December 2021

File name

Beovu REG PIL PF21-241 November 2021 IPHA.pdf

Reasons for updating

  • Correction of spelling/typing errors

Free text change information supplied by the pharmaceutical company

Last sentence in the "Commonly asked Q&A section" was omitted in error

Updated on 30 November 2021

File name

Beovu PFS_REG PIL_PF21-241 TBI 03 March 2021 (expedited)_clean.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 3 - dose and frequency

Updated on 30 November 2021

File name

Beovu REG SPC PF21-241 November 2021_IPHA.pdf

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 medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Update Section 4.2 to remove "The physician may further individualise treatment intervals based on disease activity" from the posology

Update Section 4.4 warning on intraocular inflammation, including retinal vasculitis and/or retinal vascular occlusion and instructions that the interval between two Beovu doses during maintenance treatment should not be less than 8 weeks.

Update adverse drug reactions in Section 4.8 to remove "retinal artery occlusion" and to include "retinal vasculitis" and "retinal vascular occlusion" with frequency "unknown"

Updated on 13 April 2021

File name

Beovu REG PIL PF21-047 TBI 01.11.2021 IPHA.pdf

Reasons for updating

  • Change to information for healthcare professionals

Free text change information supplied by the pharmaceutical company

Figure 5 changed to a clearer picture

Updated on 19 November 2020

File name

Beovu REG PIL PF20-0096 TBI20.1.2021.pdf

Reasons for updating

  • New PIL for new product

Updated on 19 November 2020

File name

Beovu REG SmPC 120mg-ml_Soln_Inj_14-Oct-20_PF20-0096 Sept 2020clean.pdf

Reasons for updating

  • New SPC for new product

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