Alirocumab
ArticlesRefrigerated StorageLactation Safety InformationNew Medicines · Published , updated
30912811000001107
Articles
25 September 2020
Safety in Lactation: Drugs for hyperlipidaemias
Additional information relating to breastfeeding To be used in conjunction with individual drug entries for specific information and guidance. There is no evidence for the… Alirocumab Atorvastatin Bezafibrate Cardiovascular system disorders Ciprofibrate Colesevelam Colestipol Colestyramine Eicosapentaenoic acid + Docosahexaenoic acid Evolocumab Ezetimibe Fenofibrate Fluvastatin Gemfibrozil Obstetrics and gynaecology Paediatrics and neonates Pravastatin Rosuvastatin Safety in Breastfeeding SimvastatinRefrigerated 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