Evolocumab parenteral
- Drugs List
- Therapeutic Indications
- Dosage
- Administration
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
All formulations of evolocumab.
These products have been produced by recombinant technology using Chinese Hamster Ovary (CHO) cell lines.
Drugs List
Therapeutic Indications
Uses
Atherosclerotic cardiovascular disease
Homozygous familial hypercholesterolaemia: adjunctive treatment
Mixed dyslipidaemia (type IIb) - adjunct to diet
Treatment of primary hypercholesterolaemia resistant to diet
Hypercholesterolaemia and mixed dyslipidaemia
Evolocumab is indicated in patients 10 years and over with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, 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.
Homozygous familial hypercholesterolaemia
Evolocumab is indicated in patients 10 years and over with homozygous familial hypercholesterolaemia in combination with other lipid-lowing therapies.
Established atherosclerotic cardiovascular disease
Evolocumab is indicated in patients with established cardiovascular disease to reduce cardiovascular risk by lowering low density lipoprotein cholesterol levels, as an adjunct to correction of other risk factors:
In combination with the maximum tolerated dose of statin with or without other lipid-lowering therapies or;
Alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated.
Dosage
Adults
Primary hypercholesterolaemia and mixed dyslipidaemia
140mg every two weeks or 420mg once monthly.
Established atherosclerotic cardiovascular disease
The recommended dose of evolocumab is either 140mg every two weeks or 420mg once monthly.
Children
Children aged 10 to 18 years
Primary hypercholesterolaemia and mixed dyslipidaemia
140mg every two weeks or 420mg once monthly.
Homozygous familial hypercholesterolaemia
The initial recommended dose is 420mg once monthly. After 12 weeks of treatment, dose frequency can be up-titrated to 420mg once every 2 weeks if a clinically meaningful response is not achieved.
Patients on apheresis may initiate treatment with 420mg every two weeks to correspond with their apheresis schedule.
Administration
For subcutaneous administration.
Evolocumab is for subcutaneous injection into the abdomen, thigh or upper arm region. Injection sites should be rotated and injections should not be given into areas where the skin is tender, bruised, red or hard.
Evolocumab is intended for patient self-administration after proper training.
Contraindications
Children under 10 years
Breastfeeding
Precautions and Warnings
Children aged 10 to 18 years
Moderate hepatic impairment
Pregnancy
Exclude/correct secondary causes of dyslipidaemia prior to treatment
Contains polysorbate
Needle cover contains a derivative of latex
Do not mix with other drugs or substances
Do not use if solution is discoloured or particulates are apparent
Rotate injection sites to minimise the risk of hypertrophy
Warm to room temperature prior to use
Monitor patients with hepatic impairment
Not licensed for all indications in all age groups
Pregnancy and Lactation
Pregnancy
Use evolocumab with caution during pregnancy.
The manufacturer does not recommend using evolocumab during pregnancy unless essential. At the time of writing there is limited published information regarding the use of evolocumab during pregnancy. Potential risks are unknown.
Lactation
Evolocumab is contraindicated during breastfeeding.
The manufacturer advises that the patient either discontinues evolocumab or discontinues breastfeeding. The presence of evolocumab in human breast milk is unknown but due to its large molecular weight, transfer is not expected. Effects on exposed infants are unknown.
Side Effects
Angioedema
Arthralgia
Back pain
Bruising at injection site
Erythema at injection site
Haemorrhage (injection site)
Hypersensitivity reactions
Increased susceptibility to infection
Influenza
Injection site reactions
Local pain (injection site)
Nasopharyngitis
Nausea
Rash
Swelling (injection site)
Upper respiratory tract infection
Urticaria
Overdosage
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Further Information
Last Full Review Date: August 2019
Reference Sources
Summary of Product Characteristics: Repatha SureClick. Amgen Ltd. Revised September 2022.
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 12 July 2019
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
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