- Drugs List
- Therapeutic Indications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
Injection of somatrogon.
Growth failure in children due to insufficient natural growth hormone
Treatment of children and adolescents from 3 years of age with growth disturbance due to insufficient secretion of growth hormone.
Recommended dose: 0.66mg/kg once weekly.
Doses higher than 30mg (bodyweight above 45kg) are administered as two injections.
Dose adjustments should aim to achieve average IGF-1 standard deviation score (SDS) of 0 or within the normal range of -2 and +2 .
Patients with serum IGF-1 concentrations that exceed the mean reference value for their age and sex by more than 2 SDS, reduce somatrogon dose by 15%.
Additional Dosage Information
Patients switching from daily growth hormone
Patient can initiate Somatrogon dose at 0.66mg/kg/week on the day following the last daily injection.
If less than 3 days have passed
Administer the missed dose as soon as possible, the usual once weekly dose should then be resumed.
If more than 3 days have passed
Skip the missed dose and the next dose should be administered at the expected scheduled day.
Changing the dosing day
The day of administration can be changed as long as the time between two doses are at least 3 days apart. The once weekly dose should then be resumed after the new dosing day.
For subcutaneous injection into the abdomen, thighs, buttocks or upper arms. Rotate the site of each injection.
Acute critical complications of major surgery, trauma or serious disease
Children under 3 years
Children with closed epiphyses
Precautions and Warnings
History of neoplasm
Adrenal insufficiency: Corticoid dose increase may be required
Undiagnosed hypoadrenalism may be unmasked and corticoid therapy required
Correct hypothyroidism before treatment
Treatment to be initiated and supervised by a specialist
Record name and batch number of administered product
Rotate the injection site
Funduscopic examination is recommended before + periodically during therapy
Examine any patient with an unexplained limp
IGF-1 monitoring: Obtain samples 4 days after previous dose
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 thyroid function regularly
Observe for signs of relapse in pre-existing malignant disease
Advise patient to report hip or knee pain
Consider pancreatitis in patients with unexplained abdominal pain
Discontinue if benign intracranial hypertension develops
Discontinue if severe hypersensitivity reactions occur
Treatment should be evaluated at approximately 6 to 12 month intervals, evaluations should include auxological parameters, biochemistry (IGF-1, hormones, glucose levels) and pubertal status.
Acute critically ill patients experiencing complications following cardiac surgery, abdominal surgery, respiratory failure, accidental trauma or similar conditions should not use somatrogon. In all patients developing acute critical illness, the benefit of treatment must be weighed against the potential risk.
Discontinue treatment if the height velocity is less than 2cm/year and bone age is greater than 14 years (girls) or 16 years (boys).
Reports of sudden death has been observed after initiating therapy with growth hormones in paediatric patients with Prader-Willi syndrome with one or more of the following risk factors: severe obesity, history of upper airway obstruction or sleep apnoea or unidentified respiratory infection.
Pregnancy and Lactation
Somatrogon is contraindicated during pregnancy.
The manufacturer advises that somatrogon is not recommended during pregnancy and in women of childbearing potential not using contraception. Animal studies do not indicate an effect on reproductive toxicity.
Somatrogon is contraindicated during breastfeeding.
The manufacturer advises that a decision has to be made on whether to stop breastfeeding or discontinue somatrogon based on the benefit of breastfeeding for the child and the benefit of the therapy for the mother. It is unknown whether somatrogon is excreted in human milk.
Injection site reactions
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 2022
Summary of Product Characteristics: Ngenla 24 mg solution for injection in pre-filled pen. Pfizer Limited. Revised April 2022.
Summary of Product Characteristics: Ngenla 60 mg solution for injection in pre-filled pen. Pfizer Limited. Revised April 2022.
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 20 July 2022
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