Somatropin parenteral
- Drugs List
- Therapeutic Indications
- Dosage
- Administration
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Injections of somatropin.
Drugs List
Therapeutic Indications
Uses
Growth disturbances in short children born small for gestational age (SGA)
Growth failure due to Noonan syndrome
Growth failure in children due to insufficient natural growth hormone
Growth hormone deficiency in adults - see manuf. lit. for criteria
Growth retardation in prepubertal children due to chronic renal impairment
Improvement of body composition and growth in Prader-Willi syndrome
Short stature homeobox-containing gene (SHOX) deficiency
Turner syndrome
Dosage
The dosage and administration schedule should be individualised. Duration of treatment will depend on maximum achievable therapeutic benefit.
Adults
Replacement therapy
Maximum dose: 1mg per day. Serum insulin-like growth factor 1 (IGF-1) can be used as guidance for dose titration.
Adult onset
Initial dose: 0.1mg to 0.3mg per day. The dosage should be increased at monthly intervals based on the patient's response.
Childhood onset
In patients continuing treatment after childhood therapy, initial dose: 0.2mg to 0.5mg per day. A lower starting dose may be required in obese patients.
The dosage should be adjusted gradually based on the patient's response. The minimum effective dose should be used and the treatment goal should be an IGF-1 concentration within 2 SDS (standard deviation score) from the age corrected mean. The accuracy of the growth hormone dose should be controlled every 6 months.
Elderly
Initial dose: 0.1mg to 0.2mg per day and gradually increased according to individual patient requirements.
Maintenance dose: Seldom exceeds 0.5mg daily.
Normal physiological production of growth hormone decreases with age so dose requirements may be reduced.
Children
Duration of treatment should be assessed individually according to patient height. Treatment should be discontinued once the epiphyses are fused (bone age greater than 14 years in girls or greater than 16 years boys) or if poor response is shown after the first year of treatment (increase in growth velocity less than 50% from baseline).
Insufficient secretion of growth hormone
Dose by bodyweight: 25micrograms/kg to 35micrograms/kg daily.
Higher doses have been used.
Dose by surface area: 0.7mg/square metre to 1mg/square metre daily.
If childhood onset growth hormone deficiency (GHD) persists into adolescence, treatment should be continued to achieve full somatic development. The attainment of a normal peak bone mass (1 SDS) from age corrected mean) should be monitored.
Turner Syndrome (Gonadal dysgenesis)
Dose by bodyweight: 45micrograms/kg to 50micrograms/kg daily.
Dose by surface area: 1.4mg/square metre daily.
Some formulations may be indicated for a maximum dose of 67micrograms/kg daily (2mg/square metre daily) - consult product literature.
For growth failure associated with chronic renal impairment
Renal function should be below 50% of normal before institution of therapy. To verify growth disturbance, growth should be followed for a year preceding institution of therapy. During this period conservative treatment for renal insufficiency (including control of acidosis, hyperparathyroidism and nutritional status) should be established and maintained during treatment. The treatment should be discontinued at renal transplantation and not restarted for at least 1 year.
Dose by bodyweight: 45micrograms/kg to 50micrograms/kg daily.
Dose by surface area: 1.4mg/square metre daily.
Higher doses may be needed if growth velocity is too low.
Dose correction may be required after six months treatment.
Prader-Willi Syndrome
Dose by bodyweight: Generally, 35micrograms/kg daily.
Dose by surface area: 1mg/square metre daily.
Maximum dose: 2.7mg daily.
Treatment should not be used in children with a growth velocity less than 1cm per year and near closure of epiphyses.
Growth disturbances in short children born small for gestational age
Dose by bodyweight: 35micrograms/kg daily until final height is reached.
Dose by surface area: 1mg/square metre daily until final height is reached.
Discontinue after one year of treatment if the height velocity SDS is below +1.
Discontinue treatment if the height velocity is less than 2cm/year and bone age is greater than 14 years (girls) or 16 years (boys) (i.e. corresponding to the closure of the epiphyseal plates).
SHOX deficiency
45micrograms/kg to 50micrograms/kg daily.
Noonan syndrome
Dose by bodyweight: 66 micrograms/kg daily. In some cases 33 microgram/kg daily may be sufficient.
Discontinue treatment at the time of epiphyseal closure.
Administration
For subcutaneous injection.
Contraindications
Acute critical complications of major surgery, trauma or serious disease
Children with closed epiphyses
History of respiratory impairment - if treating Prader-Willi syndrome
Prader-Willi patients with severe obesity
Severe respiratory impairment - if treating Prader-Willi syndrome
Intracranial neoplasm
Kidney transplantation
Neoplasia
Pregnancy
Sleep apnoea - if treating Prader-Willi Syndrome
Precautions and Warnings
Adrenal insufficiency
Breastfeeding
Diabetes mellitus
History of neoplasm
Hypothyroidism
Adrenal insufficiency: Corticoid dose increase may be required
Calorie-restricted diet recommended in patients with Prader-Willi Syndrome
Undiagnosed hypoadrenalism may be unmasked and corticoid therapy required
Not all available brands are licensed for all indications
Re-evaluate previously treated children before restarting as adult therapy
Treatment to be initiated and supervised by a specialist
Some formulations contain metacresol
Some presentations may contain benzyl alcohol
Record name and batch number of administered product
Rotate injection sites to minimise the risk of lipoatrophy
Perform hip x-ray prior to initiating therapy
SGA: Measure fasting insulin and glycaemia at initiation and then annually
Examine any patient with an unexplained limp
Examine patients with chronic renal failure for evidence of osteodystrophy
Investigate occurrences of nausea and/or vomiting
Monitor for relapse in patients with resolved intracranial hypertension
Monitor for signs and symptoms of glucose intolerance
Monitor for signs of scoliosis during treatment
Monitor growth response and endocrine status regularly
Monitor levels of IGF-1
Monitor patients with existing or tendency towards diabetes mellitus
Monitor patients with renal impairment
Monitor thyroid function regularly
Observe for signs of relapse in pre-existing malignant disease
Prader-Willi: Assess for respiratory obstruction/infection + sleep apnoea
Turner syndrome: Consider dose reduction if hands and feet growth increases
Advise patient to report hip or knee pain
Consider dose reduction if persistent oedema or severe paraesthesia occur
Consider pancreatitis in children with abdominal pain
Investigate occurrence of visual disturbance or severe headache
Neutralising antibodies may develop that decrease clinical efficacy
Discontinue if benign intracranial hypertension develops
Men may require lower doses than women
Female: Ensure adequate contraception during treatment
Acute critically ill patients experiencing complications following cardiac surgery, abdominal surgery, respiratory failure, accidental trauma or similar conditions should not use somatropin. In all patients developing acute critical illness, the benefit of treatment must be weighed against the potential risk.
Pregnancy and Lactation
Pregnancy
Somatropin is contraindicated during pregnancy.
Manufacturers recommend not using somatropin during pregnancy. At the time of writing there is limited published information regarding the use of somatropin during pregnancy. Potential risks are unknown.
Lactation
Use somatropin with caution during breastfeeding.
Manufacturers advises caution if somatropin is used when breastfeeding. The presence of somatropin in human breast milk is unknown but absorption into the gastrointestinal tract is not expected.
Side Effects
Abdominal pain
Anaemia
Arthralgia
Asthenia
Benign intracranial hypertension
Bone pain
Carpal tunnel syndrome
Dermatitis
Diabetes mellitus
Diplopia
Epiphysiolysis at the site of the hip joint
Exfoliative dermatitis
Flatulence
Fluid retention
Gynaecomastia
Headache
Hirsutism
Hypersensitivity reactions
Hypertonia
Hypoglycaemia
Hypothyroidism
Insomnia
Insulin resistance
Leukaemia
Lipodystrophy
Local reaction at injection site
Musculoskeletal disturbances
Myalgia
Nausea
Neoplasms
Neuropathy
Nystagmus
Oedema
Pancreatitis
Papilloedema
Paraesthesia
Peripheral oedema
Personality change
Pollakiuria
Polyuria
Raised intracranial pressure
Rash
Reduction in serum cortisol levels
Skin atrophy
Somnolence
Stiffness in extremities
Tachycardia
Urinary incontinence
Urine abnormality
Urticaria
Vertigo
Vomiting
Weakness
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 2020
Reference Sources
Summary of Product Characteristics: Genotropin (0.2mg to 2mg) MiniQuick. Pfizer Ltd. Revised June 2018.
Summary of Product Characteristics: Genotropin 12mg powder and solvent. Pfizer Ltd. Revised June 2018.
Summary of Product Characteristics: Genotropin 5.3mg powder and solvent. Pfizer Ltd. Revised June 2018.
Summary of Product Characteristics: Humatrope 6mg, 12mg or 24mg powder and solvent for solution for injection. Eli Lilly and Company. Revised March 2019.
Summary of Product Characteristics: Norditropin Flexpro 5mg/1.5ml, 10mg/1.5ml, 15mg/1.5ml. Novo Nordisk Ltd. Revised December 2019.
Summary of Product Characteristics: Norditropin SimpleXx 5 mg/1.5ml, 10 mg/1.5ml, 15 mg/1.5ml; Norditropin NordiFlex 5 mg/1.5ml, 10 mg/1.5ml, 15 mg/1.5ml. Novo Nordisk Ltd. Revised February 2020.
Summary of Product Characteristics: NutropinAq 10mg/2mL. Ispen Ltd. Revised February 2021.
Summary of Product Characteristics: Omnitrope Pen 5 5mg/1.5ml solution for injection cartridges. Sandoz Ltd. Revised March 2018.
Summary of Product Characteristics: Omnitrope Pen 10 10mg/1.5ml solution for injection cartridges. Sandoz Ltd. Revised March 2018.
Summary of Product Characteristics: Omnitrope SurePal 5 5mg/1.5ml solution for injection cartridges. Sandoz Ltd. Revised February 2021.
Summary of Product Characteristics: Omnitrope SurePal 10 10mg/1.5ml solution for injection cartridges. Sandoz Ltd. Revised February 2021.
Summary of Product Characteristics: Omnitrope SurePal 15 15mg/1.5ml solution for injection cartridges. Sandoz Ltd. Revised February 2021.
Summary of Product Characteristics: Saizen 8 mg/ml solution for injection. Merck Serono. Revised July 2018.
Summary of Product Characteristics: Zomacton 4mg injection. Ferring Pharmaceuticals Ltd. Revised. June 2013.
Summary of Product Characteristics: Zomacton 10mg injection. Ferring Pharmaceuticals Ltd. Revised December 2014.
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 15 July 2020
US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
Somatropin. Last revised: 31 October 2018
Last accessed: 15 July 2020
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
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