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Somatrogon parenteral

Presentation

Injection of somatrogon.

Drugs List

  • NGENLA 24mg/1.2ml solution for injection pre-filled pen
  • NGENLA 60mg/1.2ml solution for injection pre-filled pen
  • somatrogon 24mg/1.2ml solution for injection pre-filled device
  • somatrogon 60mg/1.2ml solution for injection pre-filled device
  • Therapeutic Indications

    Uses

    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.

    Dosage

    Children

    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.

    Missed dose
    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.

    Administration

    For subcutaneous injection into the abdomen, thighs, buttocks or upper arms. Rotate the site of each injection.

    Contraindications

    Acute critical complications of major surgery, trauma or serious disease
    Children under 3 years
    Children with closed epiphyses
    Breastfeeding
    Intracranial neoplasm
    Neoplasia
    Pregnancy

    Precautions and Warnings

    Prader-Willi syndrome
    Adrenal insufficiency
    Diabetes mellitus
    History of neoplasm
    Hypothyroidism

    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
    Contains metacresol
    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

    Pregnancy

    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.

    Lactation

    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.

    Side Effects

    Adrenal insufficiency
    Allergic conjunctivitis
    Anaemia
    Arthralgia
    Eosinophilia
    Headache
    Hypothyroidism
    Injection site reactions
    Painful extremities
    Pyrexia
    Rash

    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 2022

    Reference Sources

    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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