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Mecasermin parenteral

Updated 2 Feb 2023 | Somatomedins


Solution for injection containing mecasermin.
These products have been produced by recombinant technology using E.coli.

Drugs List

  • INCRELEX 40mg/4ml injection solution
  • mecasermin 40mg/4ml injection solution
  • Therapeutic Indications


    Growth failure due to primary IGF-1 deficiency

    Long term treatment of growth failure in patients from 2 to 18 years with severe primary insulin-like growth factor-1 deficiency (primary IGFD).
    Severe primary IGFD is manifested by:
    Height standard deviation score less than or equal to -3 and
    basal IGF-1 levels below the 2.5th percentile for age and gender and
    growth hormone (GH) sufficiency.

    Diagnosis of primary IGFD should be confirmed by an IGF-1 generation test.



    Children aged 2 to 18 years
    Dosage should be individually determined for each patient. Treatment success should be evaluated based on height velocities.

    Recommended starting dose: 0.04mg/kg twice daily.
    If the dose is well tolerated for at least one week, dose may be increased in increments of 0.04mg/kg.
    Maximum dose: 0.12mg/kg twice daily.

    If the dose is poorly tolerated, treatment with a lower dose should be considered. The lowest dose that has been associated with substantial growth increases is 0.04mg/kg twice daily.

    Additional Dosage Information

    Dosage reduction should be carried out in the event of hypoglycaemia occurring with the recommended dosage, despite adequate food intake.

    The dosage of mecasermin should never be increased to make up for missing a dose.


    For subcutaneous injection shortly before or shortly after a meal or snack.


    Children under 2 years
    Children with closed epiphyses
    Hypersensitivity to benzyl alcohol

    Precautions and Warnings

    Children under 3 years
    Predisposition to hypoglycaemia
    Diabetes mellitus

    Adjustment of hypoglycaemic therapy may be necessary in diabetes mellitus
    Treatment does not replace growth hormone therapy
    Advise patient to take precautions to avoid hypoglycaemia whilst driving
    Correct hypothyroidism before treatment
    Correct malnutrition before treatment
    Exclude growth hormone deficiency before treatment
    Exclude neoplasia before initiation of treatment
    Exclude secondary causes of IGF deficiency before commencing therapy
    Treatment to be initiated and supervised by a specialist
    Contains benzyl alcohol
    Dose should be administered just before or after food
    For subcutaneous use only
    Rotate injection sites to minimise the risk of hypertrophy
    Use only if the solution is clear and colourless
    Exclude pregnancy prior to initiation of treatment
    Funduscopic examination is recommended before + periodically during therapy
    Perform echocardiography before treatment and at treatment discontinuation
    Examine any patient with an unexplained limp
    Monitor for lymphoid tissue hypertrophy
    Perform echocardiography regularly if abnormal findings or cardiac symptoms
    Advise patient to report hip or knee pain
    Advise patient to report if allergic reaction occurs
    Increased risk of hypoglycaemia with low food intake
    Discontinue if benign intracranial hypertension develops
    Discontinue if evidence of neoplasia develops
    Discontinue if no improvement after treatment for one year
    Female: Ensure adequate contraception during treatment
    Advise patients of the warning signs of hypoglycaemia

    Patients who remain unresponsive to treatment, have unexpectedly high blood values of IGF-1 after administration or who have allergic reaction to injected IGF-1 may be experiencing an antibody response to IGF-1. Manufacturers advise further testing for the presence of antibodies in these circumstances.

    Mecasermin has insulin-like hypoglycaemic effects. This should be considered when prescribing for children with a history of hypoglycaemia or inconsistent food intake. Advise patients not to engage in high-risk activities for 2 to 3 hours after the dose has been administered, particularly in the early stage of treatment or until the optimum dose has been established. If a patient with severe hypoglycaemia is unconscious or otherwise unable to ingest food normally, an injection of glucagon may be required. At the time of starting treatment, physicians should educate parents on the signs, symptoms and treatment of hypoglycaemia, including injection of glucagon.

    Pregnancy and Lactation


    Mecasermin is contraindicated during pregnancy.

    The manufacturer states that mecasermin should not be used during pregnancy unless clearly necessary.

    No adequate studies have been performed on the use of mecasermin during human pregnancy. Information from animal studies is also insufficient. The potential risk to human pregnancy is unknown.


    Mecasermin is contraindicated during breastfeeding.

    The manufacturer states that mecasermin is not recommended during breastfeeding.

    Side Effects

    Abdominal pain
    Adenoidal hypertrophy
    Antibody formation
    Benign raised intracranial pressure
    Ear disorder
    Ear pain
    Extremity pain
    Hair disorder
    Hearing disturbances
    Hypersensitivity reactions
    Hypertrophy (injection site)
    Hypoglycaemic seizure
    Injection site reactions
    Intracranial hypertension
    Lymphoid tissue hypertrophy
    Melanocytic naevus
    Middle ear fluid
    Mitral insufficiency
    Otitis media
    Scoliosis progression
    Skin hypertrophy
    Sleep apnoea
    Slipped capital femoral epiphysis
    Thymus hypertrophy
    Tonsillar hypertrophy
    Tricuspid valve incompetence
    Ventricular hypertrophy
    Visual disturbances
    Weight gain


    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: July 2019

    Reference Sources

    Summary of Product Characteristics. Increlex 10mg/ml solution for injection. Ipsen Ltd. Revised December 2019.

    NICE Evidence Services Available at: Last accessed: 9 July 2019

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