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Safety in Lactation: Subfoveal choroidal neovascularisation

21 September 2020VEGF inhibitors are used for age-related macular degeneration, administered by intravitreal injection. They are also large molecules with a high molecular weight. These factors will…
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Refrigerated Storage

EyleaBayer PLC

Bayer PLC
Eylea
Solution for injection in a vial (40mg/mL)

In the event of an inadvertent temperature excursion the following data may be used:
The product literature states that prior to usage, the unopened vial may be kept at room temperature (below 25°C) for up to 24 hours. The manufacturer is unable to provide any further stability data outside of the product licence.

Please also refer to the manufacturer’s product literature for recommended storage information at https://www.medicines.org.uk

24 hours
No
19 March 2021
London Medicines Information Service

ZaltrapSanofi

Sanofi
Zaltrap
25mg/mL concentrate for solution for infusion

Contact Sanofi in all cases where a deviation from the recommended storage conditions has occurred. Refer to the current BNF for company contact details.

Storage at ambient temperature Information is not provided by the manufacturer.

Store in the original package in order to protect from light.

12 October 2020
London MI Service

Lactation Safety Information

Yes
No published evidence of safety
Negligible levels anticipated in milk due to the drug’s properties
17 September 2020

New Medicines

EyleaRetinopathy of prematurity (ROP)

Information

Eylea
Licence extension / variation
Bayer
Regeneron

Development and Regulatory status

Phase III Clinical Trials
Phase III Clinical Trials
Phase III Clinical Trials

Category

Fully humanised fusion protein binding all forms of VEGF-A and PIGF
ROP develops in 16% of all premature births, the figure rising to around 60% of infants weighing less than 1500 g at birth and 65% for infants less than 1250 g; however, severe ROP is uncommon. A review in the USA in 2008 looked at 4.67 million live births. The total incidence of ROP was 0.12% overall and 7.35% for premature infants with hospital stay greater than 14 days [1].
Retinopathy of prematurity (ROP)
Intravitreal

Information

Eylea
New formulation
Bayer
Bayer

Development and Regulatory status

Phase III Clinical Trials
Phase III Clinical Trials
Phase III Clinical Trials

Category

VEGF inhibitor. 8mg formulation dosed 12 or 16 weekly.
The estimated prevalence of AMD in the UK is 4.8% of those over 65 years of age and 12.2% of those aged 80 years or more and there are around 70,000 new diagnoses in the UK each year [2].
Wet age-related macular degeneration (AMD) and diabetic macular oedema - 8mg formulation
Intravitreal

Information

aflibercept biosimilar (ABP 938)
Biosimilar
Amgen
Amgen

Development and Regulatory status

Phase III Clinical Trials
Phase III Clinical Trials
Phase III Clinical Trials

Category

Vascular endothelial growth factor (VEGF) inhibitor
The estimated prevalence of AMD in the UK is 4.8% of those over 65 years of age and 12.2% of those aged 80 years or more, though 90% of this is the dry type [2].
Wet age-related macular degeneration (AMD), macular oedema following retinal vein occlusion, diabetic macular oedema and diabetic retinopathy in patients with diabetic macular oedema
Intravitreal

Information

aflibercept biosimilar (M710)
Biosimilar
Momenta & Mylan
Momenta & Mylan

Development and Regulatory status

Phase III Clinical Trials
Phase III Clinical Trials
Phase III Clinical Trials

Category

Fully humanised fusion protein binding all forms of VEGF-A and PIGF
AMD is the most common cause of severe visual impairment in older adults in the developed world and responsible for two thirds of registrations of visual impairment in the UK. The estimated prevalence of AMD in the UK is 4.8% of those over 65 years of age and 12.2% of those aged 80 years or more; there are around 70,000 new diagnoses in the UK each year [2].
Wet age-related macular degeneration (AMD)
Intravitreal

Information

aflibercept biosimilar (FYB203)
Biosimilar
Bioeq
Bioeq

Development and Regulatory status

None
Phase III Clinical Trials
None

Category

vascular endothelial growth factor (VEGF) inhibitor
Most common cause of severe visual impairment in older adults, the estimated prevalence of AMD in the UK is 4.8% of those over 65 years of age and 12.2% of those aged 80 years or more [12].
Wet age-related macular degeneration (AMD)
Intravitreal

Information

aflibercept biosimilar (SB15)
Biosimilar
Biogen
Biogen

Development and Regulatory status

None
Phase III Clinical Trials
Phase III Clinical Trials

Category

Vascular endothelial growth factor (VEGF) inhibitor
The estimated prevalence of AMD in the UK is 4.8% of those over 65 years of age and 12.2% of those aged 80 years or more. There are around 70,000 new diagnoses in the UK each year [2].
Wet age-related macular degeneration (AMD)
Intravitreal

aflibercept biosimilar (CT-P42) Diabetic macular oedema

Information

aflibercept biosimilar (CT-P42)
Biosimilar
Celltrion
Celltrion

Development and Regulatory status

None
Phase III Clinical Trials
None

Category

Vascular endothelial growth factor (VEGF) inhibitor
Diabetes is the most common cause of severe sight impairment in working-age people in England, Wales and Scotland. One study found that macular oedema (MO) is present in 9% of the population with diabetes. In type 2 diabetes, changes may be found at diagnosis because subclinical hyperglycaemia may have been present for a prolonged preceding period. Over 25 years, cumulative rate of progression to diabetic retinopathy is 83%, to DMO is 29% & to clinically significant MO 17% [1].
Diabetic macular oedema
Intravitreal

Information

aflibercept biosimilar (SOK583A1)
Biosimilar
Sandoz
Sandoz

Development and Regulatory status

None
Phase III Clinical Trials
Phase III Clinical Trials

Category

Binds and inhibits ocular vascular endothelial growth factor (VEGF-A)
AMD is responsible for two thirds of registrations of visual impairment in the UK. There are around 70,000 new diagnoses in the UK each year [2].
Age related macular degeneration (neovascular, wet type)
Intravitreal