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Alirocumab parenteral

Updated 2 Feb 2023 | Other lipid-regulating drugs


Parenteral formulations of alirocumab.

Drugs List

  • alirocumab 300mg/2ml solution for injection pre-filled pen
  • alirocumab pre-filled pen 150mg/1ml injection
  • alirocumab pre-filled pen 75mg/1ml injection
  • PRALUENT 300mg/2ml solution for injection pre-filled pen
  • PRALUENT PRE-FILLED PEN 150mg/1ml injection
  • PRALUENT PRE-FILLED PEN 75mg/1ml injection
  • Therapeutic Indications


    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.



    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.


    For subcutaneous injection.

    For patients receiving the 300mg dose, either administer one 300mg injection or two 150mg injections consecutively at different injection sites.


    Children under 18 years

    Precautions and Warnings

    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


    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.


    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

    Erythema at injection site
    Hypersensitivity reactions
    Influenza-like syndrome
    Injection site reactions
    Itching (injection site)
    Local pain (injection site)
    Nummular eczema
    Oropharyngeal pain
    Swelling (injection site)
    Tenderness (injection site)
    Upper respiratory symptoms
    Vasculitis (allergic)


    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 ( ) or if this is unavailable at the backup site ( ).

    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: Last accessed: 13 April 2021.

    US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
    Available at:
    Alirocumab Last revised: 03 December 2018.
    Last accessed: 03 April 2019.

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