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Metreleptin parenteral

Updated 2 Feb 2023 | Lipodystrophy


Parenteral formulations of metreleptin.

Drugs List

  • metreleptin 11.3mg powder for solution for injection vial
  • metreleptin 3mg powder for solution for injection vial
  • metreleptin 5.8mg powder for solution for injection vial
  • MYALEPTA 11.3mg powder for solution for injection vial
  • MYALEPTA 3mg powder for solution for injection vial
  • MYALEPTA 5.8mg powder for solution for injection vial
  • Therapeutic Indications


    Lipodystrophy: Adjunct to diet

    Adults and children over the age of 2 years with generalised lipodystrophy (Berardinelli-Seip syndrome and Lawrence syndrome).
    Adults and children over the age of 12 years with partial lipodystrophy (including Barraquer-Simons syndrome), when standard treatments have failed.



    The recommended daily dose depends on the patient�s bodyweight and is adjusted based on the patient�s response to treatment. Clinical response is measured by triglyceride levels, HbA1c value and insulin requirements. Dose increases should not be made more frequently than every 4 weeks. Dose decreases based on weight loss may be made weekly.

    The appropriate dose should be prescribed in both milligrams and volume in millilitres by the prescriber in order to ensure that patient and carers understand the correct dose to be injected.

    Male and Female 40kg and less
    Initial dose 0.06mg/kg (0.012ml/kg) daily.

    Dose adjustments in increments of 0.02mg/kg (0.004ml/kg) up to a maximum daily dose of 0.13mg/kg (0.026ml/kg).

    Male over 40kg
    Initial dose 2.5mg (0.5ml) daily.

    Dose adjustments in increments of 1.25mg (0.25ml) to 2.5mg (0.5ml) up to a maximum daily dose of 10mg (2ml).

    Female over 40kg
    Initial dose 5mg (1ml) daily.

    Dose adjustments in increments of 1.25mg (0.25ml) to 2.5mg (0.5ml) up to a maximum daily dose of 10mg (2ml).


    Over 2 years
    (See Dosage; Adult)

    Under 2 years

    Additional Dosage Information

    If after 6 months a clinical response is not seen then it is important to ensure that the patient is compliant with the administration technique, is receiving the correct dose and is adhering to the diet. Before stopping treatment, consider a dose increase.

    Dose increases based on incomplete clinical response in adults and children can be considered after a minimum of 6 months of treatment, allowing for lowering concomitant insulin, oral anti-diabetic and/or lipid lowering medication.


    For subcutaneous injection at the same time each day.

    The reconstituted solution should be injected into the abdomen, thigh or upper arm.


    Children under 2 years
    Positive HIV status

    Precautions and Warnings

    Autoimmune disease
    Children aged 2 to 12 years
    Patients over 65 years
    Severe infection
    Diabetes mellitus
    Haematological disorder
    Hepatic impairment
    Renal impairment

    Advise ability to drive/operate machinery may be affected by side effects
    Treatment to be initiated and supervised by a specialist
    Rotate injection site each day when injecting the same region
    Diabetic control may need adjustment
    Monitor blood glucose closely in patients with diabetes mellitus
    Monitor for autoimmune disorder flares
    Review self injection technique every 6 months
    Advise patient to report symptoms of infection immediately
    Gradually withdraw over 2 weeks
    Discontinue if serious allergic or anaphylactic reaction occurs
    Female: Ensure adequate contraception during treatment
    Female: Non-hormonal contraception advised in addition to hormonal
    Advise patients with diabetes of the increased risk of hypoglycaemia

    If while being treated with metreleptin a patient develops pancreatitis, it is advisable that metreleptin is continued uninterrupted, as stopping treatment abruptly may exacerbate the condition.

    When discontinuing metreleptin in patients with risk factors for pancreatitis, during the 2 week tapering period, monitor triglyceride levels and consider initiating or adjusting the dose of lipid-lowering medicines as needed. Signs or symptoms of pancreatitis should be evaluated.

    There is no data to support the safety and efficacy of metreleptin in patients with HIV-related lipodystrophy.

    Pregnancy and Lactation


    Metreleptin is contraindicated during pregnancy.

    The manufacturer recommends metreleptin is not used in pregnancy and in women of childbearing potential not using contraception. As the efficacy of hormonal contraceptives may be reduced if co-administered with metreleptin an additional non-hormonal contraceptive method should be considered during treatment. Animal studies have shown some reproductive toxicity. At the time of writing there is limited human data available. Abortions, stillbirths and preterm deliveries have been reported in women exposed to metreleptin during pregnancy. Risks are unknown.


    Metreleptin is contraindicated during breastfeeding.

    The manufacturer advises that a decision must be made whether to discontinue breastfeeding or to discontinue or abstain from metreleptin therapy, taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman. The presence of metreleptin in human breast milk is unknown. Endogenous leptin is present in human milk. Effects on exposed infants are unknown.


    Administer at the same time every day.

    Advise patient that they should use a different injection site each day when injecting in the same region.

    Advise patient to report symptoms of infection immediately.

    Advise patient to report any symptoms of an allergic reaction.

    Advise women that metreleptin may increase their fertility due to the restoration of luteinising hormone (LH) release and that they should ensure adequate contraception during treatment.

    Advise patient that dizziness and fatigue may affect ability to drive or operate machinery.

    Side Effects

    Abdominal pain
    Acute appendicitis
    Anaphylactic reaction
    Antibody formation
    Blood glucose disturbances
    Bruising at injection site
    Decreased appetite
    Deep vein thrombosis (DVT)
    Development of neutralising antibodies
    Diabetes mellitus
    Ear infection
    Elevated triglyceride levels
    Erythema at injection site
    Fat tissue increased
    Haemorrhage (injection site)
    Increased glycated haemoglobin (HbA1c) levels
    Injection site reactions
    Insulin resistance
    Local pain (injection site)
    Peripheral oedema
    Pleural effusion
    Swelling (injection site)
    Weight gain
    Weight loss
    Worsening hypertension


    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: March 2021

    Reference Sources

    Summary of Product Characteristics: Myalepta 3mg powder for solution for injection, Myalepta 5.8mg powder for solution for injection, Myalepta 11.3mg powder for solution for injection. Amryt Pharmaceuticals DAC. Revised November 2020.

    NICE Evidence Services Available at: Last accessed: 21 May 2021

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    Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content

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    FDB Disclaimer : FDB Multilex is intended for the use of healthcare professionals and is provided on the basis that the healthcare professionals will retain FULL and SOLE responsibility for deciding what treatment to prescribe or dispense for any particular patient or circumstance.