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Laronidase parenteral

Updated 2 Feb 2023 | Mucopolysaccharidosis


Concentrate for solution for infusion containing 500 units laronidase in 5ml (approximately 2.9 mg/5 ml)

One unit is defined as activity required to hydrolyse one micromole of substrate (4-MUI) per minute.

Laronidase is produced by recombinant DNA technology using mammalian Chinese Hamster Ovary cell lines.

Drugs List

  • ALDURAZYME 500unit/5ml concentrate for solution for infusion
  • laronidase 500unit/5ml concentrate for solution for infusion
  • Therapeutic Indications


    Mucopolysaccharidosis I - long term enzyme replacement therapy



    The recommended dosage is 100 units/kg body weight administered once weekly.


    Safety and efficacy of laronidase in patients over 65 years of age has not been established. No dosage regimen can be recommended in these patients.


    Children aged 1 month to 18 years
    The recommended dosage is 100 units/kg body weight administered once weekly.

    Patients with Renal Impairment

    Safety and efficacy of laronidase in patients with renal impairment has not been established. No dosage regimen can be recommended in these patients.

    Renal elimination is considered to be a minor route of elimination.

    Patients with Hepatic Impairment

    Safety and efficacy of laronidase in patients with hepatic impairment has not been established. No dosage regimen can be recommended in these patients.

    Impairment of hepatic function is not expected to affect the pharmacokinetics of laronidase to a clinically significant extent. Laronidase is metabolised by peptide hydrolysis.


    To be administered as an intravenous infusion.

    The initial infusion rate of 2 units/kg/hour may be incrementally increased every fifteen minutes, if tolerated, to a maximum of 43 units/kg/hour.

    The total volume of the administration should be delivered in approximately 3 to 4 hours.



    Precautions and Warnings

    Restricted sodium intake
    Hepatic impairment
    Renal impairment
    Severe respiratory impairment

    Sodium content of formulation may be significant
    Consider pre-medication with antihistamines and/or antipyretics
    Treatment to be initiated and supervised by a specialist
    Resuscitation facilities must be immediately available
    Monitor patient for infusion-associated reactions (IARs)
    Monitor periodically for IgG antibody formation
    Discontinue if severe hypersensitivity reactions occur
    Interrupt treatment if severe infusion reaction occurs

    Greater risk of IARs in patients with an acute underlying illness at the time of treatment.

    Pre-treatment with antihistamine and/or antipyretics may be considered in patients with a history of laronidase IARs or in initial treatment and should be administered approximately 60 minutes prior to infusion. Infusion rates can be reduced by one half of that at which the reaction occurred or up to one quarter in the case of severe IAR.

    Based on clinical trial data, almost all patients are expected to develop IgG antibodies to laronidase (mostly within three months of the start of therapy). Re-administer laronidase with caution to patients who have previously developed antibodies or symptoms of IAR.

    There is little experience in resuming therapy after prolonged interruption. Re-starting therapy should be approached with caution due to a theoretical increased risk of hypersensitivity reaction after prolonged interruption.

    Pregnancy and Lactation


    Laronidase should be used with caution during pregnancy.

    There is inadequate data available on the use of laronidase in pregnant women. Animal studies do not indicate direct or indirect harmful effects on pregnancy, embryonal/foetal development, parturition or postnatal development.

    The potential risk for humans is unknown. However the benefits of the treatment with laronidase to a pregnant woman with mucopolysaccharidosis appear to outweigh the unknown risks to the embryo and/or foetus.

    The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( ) or if this is unavailable at the backup site ( ).


    Laronidase should not be used during breastfeeding.

    Laronidase may be excreted in milk. There are no data available in neonates exposed to laronidase via breast milk and as such it is recommended that breastfeeding should be stopped during laronidase therapy.

    Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
    Specialist advice is available from the UK Drugs in Lactation Advisory Service at

    Side Effects

    Abdominal pain
    Anaphylactic reaction
    Antibody formation
    Back pain
    Cold sweat
    Facial oedema
    Feeling hot
    Influenza-like symptoms
    Injection site reactions
    Laryngeal oedema
    Musculoskeletal pain
    Oxygen saturation decreased
    Painful extremities
    Peripheral coldness
    Peripheral oedema
    Respiratory arrest
    Respiratory distress
    Rise in body temperature
    Sensation of cold


    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: May 2015.

    Reference Sources

    Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 9th edition (2011) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia.

    Joint Formulary Committee. British National Formulary (online) London: BMJ Group and Pharmaceutical Press. Accessed on 13 May 2015.

    Paediatric Formulary Committee. BNF for Children (online) London: BMJ Group, Pharmaceutical Press, and RCPCH Publications. Accessed on 13 May 2015.

    Summary of Product Characteristics: Aldurazyme 100 U/ml concentrate for solution for infusion. Genzyme Therapeutics. Revised November 2014.

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