Alirocumab parenteral
- Drugs List
- Therapeutic Indications
- Dosage
- Administration
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Parenteral formulations of alirocumab.
Drugs List
Therapeutic Indications
Uses
Atherosclerotic cardiovascular disease
Mixed dyslipidaemia (type IIb) - adjunct to diet
Treatment of primary hypercholesterolaemia resistant to diet
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 low density lipoprotein cholesterol (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.
Established atherosclerotic cardiovascular disease to reduce cardiovascular risk by lowering LDL-C levels, as an adjunct to correction of other risk factors:
In combination with 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
Initial dose: 75mg once every 2 weeks.
Patients requiring larger LDL-C reduction (greater than 60%) may be started on 150mg once every 2 weeks, or 300mg once every 4 weeks.
The maximum dose for all patients is 150mg once every 2 weeks.
The dose of alirocumab can be individualised based on patient characteristics such as baseline LDL-C level, goal of therapy, and response. Lipid levels can be assessed 4 to 8 weeks after treatment initiation or titration, when steady state LDL-C is usually achieved, and dose adjusted accordingly (up-titration or down-titration). If additional LDL-C reduction is needed in patients treated with 75mg once every 2 weeks or 300mg once every 4 weeks, the dosage may be adjusted to 150mg once every 2 weeks.
Additional Dosage Information
If a dose is missed, the patient should administer the injection as soon as possible and thereafter resume treatment on the original schedule.
Administration
For subcutaneous injection.
For patients receiving the 300mg dose, either administer one 300mg injection or two 150mg injections consecutively at different injection sites.
Contraindications
Children under 18 years
Breastfeeding
Precautions and Warnings
Pregnancy
Renal impairment - eGFR below 30ml/minute/1.73m sq
Severe hepatic impairment
Administration of live vaccines is not recommended
Exclude/correct secondary causes of dyslipidaemia prior to treatment
Avoid injection into areas of active skin disease
Do not mix with other drugs or substances
Do not use if solution is discoloured or particulates are apparent
Record name and batch number of administered product
Vary injection site during prolonged therapy
Warm to room temperature prior to use
Monitor serum lipids 4 to 8 weeks after initiation or titration
Discontinue if allergic reaction occurs
Pregnancy and Lactation
Pregnancy
Use alirocumab with caution during pregnancy.
At the time of writing there is limited data from the use of alirocumab in pregnant women. Alirocumab is a recombinant IgG1 antibody, therefore it is expected to cross the placental barrier. Animal studies do not indicate direct or indirect harmful effects with respect to maintenance of pregnancy or embryo-foetal development. Maternal toxicity was noted in rats, but not in monkeys at doses in excess of the human dose, and a weaker secondary immune response to antigen challenge was observed in the offspring of monkeys. The use of alirocumab is not recommended during pregnancy unless the clinical condition of the woman requires treatment with alirocumab.
Lactation
Alirocumab is contraindicated during breastfeeding.
It is not known whether alirocumab is excreted in human milk. As it is a large protein molecule with a molecular weight of about 146,000, the amount secreted into milk is likely to be low. Absorption by the infant is unlikely because it is probably destroyed in the infant's gastrointestinal tract. Human immunoglobulin (IgG) is excreted in human milk, in particular in colostrum; the manufacturer advises use of alirocumab is not recommended in breastfeeding women during this period. For the remaining duration of breastfeeding, exposure is expected to be low. Since the effects of alirocumab on the breast fed infant are unknown, a decision should be made whether to discontinue nursing or to discontinue alirocumab during this period.
Side Effects
Angioedema
Erythema at injection site
Hypersensitivity reactions
Influenza-like syndrome
Injection site reactions
Itching (injection site)
Local pain (injection site)
Nummular eczema
Oropharyngeal pain
Pruritus
Rhinorrhoea
Sneezing
Swelling (injection site)
Tenderness (injection site)
Upper respiratory symptoms
Urticaria
Vasculitis (allergic)
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: April 2019
Reference Sources
Summary of Product Characteristics: Praluent 75mg, 150mg solution for injection in pre-filled pen. Sanofi. Revised December 2020.
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 13 April 2021.
US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
Alirocumab Last revised: 03 December 2018.
Last accessed: 03 April 2019.
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