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Safety in Lactation: Drugs for hyperlipidaemias

25 September 2020Additional information relating to breastfeeding To be used in conjunction with individual drug entries for specific information and guidance. There is no evidence for the…
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Refrigerated Storage

Repatha SureClickAmgen Ltd

Amgen Ltd
Repatha SureClick
SureClick (solution for injection in pre-filled syringe/pen/cartridge)

In the event of an inadvertent temperature excursion the following data may be used:
Repatha may be stored at room temperature (up to 25°C) in the original carton for 1 month.
Once removed from the refrigerator it must either be used within 1 month or disposed of.
Please also refer to the manufacturer’s product literature for recommended storage information at https://www.medicines.org.uk

Contact Amgen Ltd in cases where additional stability data is required. Refer to the current BNF for company contact details.

1 month.
No
15 March 2021
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

Repatha SureClick Heterozygous familial hypercholesterolaemia (HeFH) in children aged 10 to 17 years and homozygous familial hypercholesterolaemia (HoFH) in children aged 10 to 12 years

Information

Repatha SureClick
Licence extension / variation
Amgen
Amgen

Development and Regulatory status

Launched
Launched
Launched
Mar 22Licence extension approved in UK. The newly approved indication is use in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, and in paediatric patients aged 10 years and over with heterozygous familial hypercholesterolaemia, as an adjunct to diet in combination with a statin or statin with other lipid-lowering therapies in patients unable to reach LDL-C goals with the maximum tolerated dose of a statin or, alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated. Also use in adults and paediatric patients aged 10 years and over with homozygous familial hypercholesterolaemia in combination with other lipid-lowering therapies [7].
Jan 22Approved in EU [6].
Oct 21CHMP recommends a change to the indications for Repatha to permit use in children aged 10 years and older with HoFH (previously only licensed from the age of 12) and for use to treat HeFH (previously only licensed for use in adults). The proposed revised indications are use in adults with primary hypercholesterolaemia (heterozygous familial and non‑familial) or mixed dyslipidaemia, and in paediatric patients aged 10 years and over with heterozygous familial hypercholesterolaemia, as an adjunct to diet in combination with a statin or statin with other lipid-lowering therapies in patients unable to reach LDL‑C goals with the maximum tolerated dose of a statin or, alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated. Also use in adults and adolescents paediatric patients aged 10 years and over with homozygous familial hypercholesterolaemia in combination with other lipid-lowering therapies [5].
Sep 20PIII HAUSER-RCT (NCT02392559; n=157) is published. At week 24, the mean percent change from baseline in LDL cholesterol level was −44.5% in the evolocumab group and −6.2% in the placebo group, for a difference of −38.3 percentage points (P<0.001). The absolute change in the LDL cholesterol level was −77.5 mg per deciliter (−2.0 mmol per liter) in the evolocumab group and −9.0 mg per deciliter (−0.2 mmol per liter) in the placebo group, for a difference of −68.6 mg per deciliter (−1.8 mmol per liter) (P<0.001) [8].
Nov 19PIII HAUSER-RCT study completes [2].
Feb 16PIII HAUSER-RCT study to assess safety and efficacy of evolocumab (AMG-145) in paediatric subjects aged 10-17 years diagnosed with heterozygous familial hypercholesterolemia starts. 159 children will be recruited from sites around the world, including US, EU & UK [2].

Category

Fully human monoclonal antibody to Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9), a negative regulator of the LDL receptor.
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 10 to 17 years and homozygous familial hypercholesterolaemia (HoFH) in children aged 10 to 12 years
Subcutaneous injection

Evidence based evaluations