Alirocumab

ArticlesRefrigerated StorageLactation Safety InformationNew Medicines ·
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Articles

Refrigerated Storage

PraluentSanofi

Sanofi
Praluent
75mg and 150mg Solution for Injection in pre-filled disposable pen or syringe

In the event of an inadvertent temperature excursion the following data may be used
Praluent can be stored outside the refrigerator (below 25°C) protected from light for a single period not exceeding 30 days. After removal from the refrigerator, the medicinal product must be used within 30 days or discarded. Once the medication has gone above 8°C it can be stored in the refrigerator or outside of the refrigerator below 25 degrees, however, the reduced shelf life must be adhered to.
Please also refer to the manufacturer’s product literature for recommended storage information at https://www.medicines.org.uk

if exposed to temperatures described above, reduce the expiry date to 30 days
if exposed to temperatures described above, it can be returned to the fridge or kept at temperatures below 25°C
12 October 2020
London MI Service

Lactation Safety Information

Bile acid sequestrants (if appropriate)
No published evidence of safety
Low levels anticipated in milk due to the drug’s properties and likely to be degraded in infant’s GI tract
Although large protein molecules may appear in colostrum, risk to preterm infants and neonates is considered to be small and unproven
Possible impact on neonatal development
18 March 2017

New Medicines

PraluentHomozygous familial hypercholesterolaemia (hoFH) in adults and children - adjunctive therapy

Information

Praluent
Licence extension / variation
Sanofi
Regeneron

Development and Regulatory status

None
Phase III Clinical Trials
Phase III Clinical Trials
Yes

Category

PCSK9 inhibitor - PCSK9 is a naturally occurring molecule involved in the regulation of cholesterol levels by modulating low-density lipoprotein cholesterol receptors
Homozygous familial hypercholesterolaemia is rare, presents in children and is associated with early death from cardiovascular disease. Homozygous FH has an incidence of approximately one case per million [1].
Homozygous familial hypercholesterolaemia (hoFH) in adults and children - adjunctive therapy
Subcutaneous injection

PraluentHeterozygous familial hypercholesterolaemia (HeFH) in children aged 8 to 17 years

Information

Praluent
Licence extension / variation
Sanofi
Regeneron

Development and Regulatory status

None
Phase III Clinical Trials
Phase III Clinical Trials

Category

PCSK9 inhibitor - PCSK9 is a naturally occurring molecule involved in the regulation of cholesterol levels by modulating low-density lipoprotein cholesterol receptors
There are potentially 4.5 million individuals in Europe with HeFH and probably 35 million worldwide, of whom 20–25% are children and adolescents. Given that there are 255 worldwide births per minute, one baby is born with FH every minute [1].
Heterozygous familial hypercholesterolaemia (HeFH) in children aged 8 to 17 years
Subcutaneous injection