- Drugs List
- Therapeutic Indications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
Solution for injection containing mecasermin.
These products have been produced by recombinant technology using E.coli.
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
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.
Benign raised intracranial pressure
Hypertrophy (injection site)
Injection site reactions
Lymphoid tissue hypertrophy
Middle ear fluid
Slipped capital femoral epiphysis
Tricuspid valve incompetence
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 ).
Last Full Review Date: July 2019
Summary of Product Characteristics. Increlex 10mg/ml solution for injection. Ipsen Ltd. Revised December 2019.
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 9 July 2019
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Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
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.