Drugs List

Therapeutic Indications

Uses

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.

Administration

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

Contraindications

Children under 2 years
Children with closed epiphyses
Hypersensitivity to benzyl alcohol
Breastfeeding
Neoplasia
Pregnancy

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

Pregnancy

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.

Lactation

Mecasermin is contraindicated during breastfeeding.

The manufacturer states that mecasermin is not recommended during breastfeeding.

Side Effects

Abdominal pain
Adenoidal hypertrophy
Alopecia
Anaphylaxis
Angioedema
Antibody formation
Arrhythmias
Arthralgia
Benign raised intracranial pressure
Cardiomegaly
Convulsions
Depression
Dizziness
Dyspnoea
Ear disorder
Ear pain
Extremity pain
Gynaecomastia
Hair disorder
Headache
Hearing disturbances
Hyperglycaemia
Hypersensitivity reactions
Hypertrophy (injection site)
Hypoacusis
Hypoglycaemia
Hypoglycaemic seizure
Injection site reactions
Intracranial hypertension
Lymphoid tissue hypertrophy
Melanocytic naevus
Middle ear fluid
Mitral insufficiency
Myalgia
Nausea
Nervousness
Otitis media
Papilloedema
Pruritus
Scoliosis progression
Skin hypertrophy
Sleep apnoea
Slipped capital femoral epiphysis
Snoring
Thymus hypertrophy
Tonsillar hypertrophy
Tremor
Tricuspid valve incompetence
Urticaria
Ventricular hypertrophy
Visual disturbances
Vomiting
Weight gain

Presentation

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

Drugs List

Therapeutic Indications

Uses

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.

Dosage

Children

Additional Dosage Information

Administration

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

Contraindications

Children under 2 years
Children with closed epiphyses
Hypersensitivity to benzyl alcohol
Breastfeeding
Neoplasia
Pregnancy

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

Pregnancy

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.

Lactation

Mecasermin is contraindicated during breastfeeding.

The manufacturer states that mecasermin is not recommended during breastfeeding.

Side Effects

Abdominal pain
Adenoidal hypertrophy
Alopecia
Anaphylaxis
Angioedema
Antibody formation
Arrhythmias
Arthralgia
Benign raised intracranial pressure
Cardiomegaly
Convulsions
Depression
Dizziness
Dyspnoea
Ear disorder
Ear pain
Extremity pain
Gynaecomastia
Hair disorder
Headache
Hearing disturbances
Hyperglycaemia
Hypersensitivity reactions
Hypertrophy (injection site)
Hypoacusis
Hypoglycaemia
Hypoglycaemic seizure
Injection site reactions
Intracranial hypertension
Lymphoid tissue hypertrophy
Melanocytic naevus
Middle ear fluid
Mitral insufficiency
Myalgia
Nausea
Nervousness
Otitis media
Papilloedema
Pruritus
Scoliosis progression
Skin hypertrophy
Sleep apnoea
Slipped capital femoral epiphysis
Snoring
Thymus hypertrophy
Tonsillar hypertrophy
Tremor
Tricuspid valve incompetence
Urticaria
Ventricular hypertrophy
Visual disturbances
Vomiting
Weight gain

Overdosage

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 ).

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: www.nice.org.uk Last accessed: 9 July 2019