Somatrogon

Generic name
Somatrogon
Brand name
ATC Code
H01AC08
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Somatrogon

Dosages
Side effects in children
Warnings & precautions in children
Contra-indications in children

Interactions
PK
Renal impairment
References

Pharmacokinetics in children

Somatrogon pharmacokinetics (PK) was assessed using a population PK approach for somatrogon in 42 paediatric patients (age range 3-15.5 years) with GHD.

Cmax=  636 ng/mL with 0,66 mg/kg/week
Tmax= 6 - 18 hours
Vd= 0,728 L/kg (central) and 0,165 L/kg (peripher)
Cl= 0,0317 L/hours/kg
T1/2= 28,2 hours
[SmPC Ngenla]

dose recommendation of formulary compared to licensed use (on-label versus off-label)

No information is present at this moment.

Available formulations

No information is present at this moment.

Dosages

Growth disorders resulting from growth hormone deficiency, neonatal hypoglycemia due to GH deficiency
  • Subcutaneous
    • ≥ 3 years
      • 0.66 mg/kg/dose once per week. Adjust dose as needed based on effect and IGF-1 serum concentration.

      • When switching from daily growth hormone treatment to weekly somatrogone treatment: administer the first dose on the day after the last daily injection.

Renal impaiment in children > 3 months

No information available on dose adjustment in renal impairment.

The complete list of all undesirable drug reactions can be found in the national Summary of Product Characteristics (SmPC) – click here

Side effects in children

Very common: headache, injection side reactions, pyrexia

Common: anaemia, eosinophilia, hypothyroidism, allergic conjunctivitis, arthralgia, pain in extremity

Uncommon: adrenal insufficiency, rash generalised

[SmPC Ngenla]

The complete list of all contra-indications can be found in the national Summary of Product Characteristics (SmPC) – click here

Contra-indications in children

  • growth promotion in children with closed epiphyses

[SmPC Ngenla]

The complete list of all warnings and precautions can be found in the national Summary of Product Characteristics (SmPC) – click here

Warnings & precautions in children

  • Somatrogon has not been studied in patients with Prader-Willi syndrome. Somatrogon is not indicated for the long-term treatment of paediatric patients who have growth failure due to genetically confirmed Prader-Willi syndrome unless they also have a diagnosis of GHD. There have been reports of sudden death after initiating therapy with growth hormone in paediatric patients with Prader-Willi syndrome who had one or more of the following risk factors: severe obesity, history of upper airway obstruction or sleep apnoea, or unidentified respiratory infection.
  • Because somatrogon increases growth rate, signs of development or progression of scoliosis should be monitored during treatment.
  • Epiphyseal disorders, including slipped capital femoral epiphysis may occur more frequently in patients with endocrine disorders or in patients undergoing rapid growth. Any paediatric patient with the onset of a limp or complaints of hip or knee pain during treatment should be carefully evaluated.

[SmPC Ngenla]

Interactions

The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here

ANTERIOR PITUITARY LOBE HORMONES AND ANALOGUES

This pages provides a list of drugs from the same ATC class for comparison. This does not necessarily mean that these drugs are interchangeable.

ACTH
H01AA02
Somatropin and somatropin agonists
H01AC09
H01AC03
H01AC07
H01AC01

References

  1. European Medicines Agency, EPAR Ngenla® (EU/1/21/1617/001), 06/2022
  2. Pfizer Europe MA EEIG, SmPC Ngenla® 24 mg/ 60 mg Injektionslösung im Fertigpen (EU/1/21/1617/001), 03/2024

Changes

Therapeutic Drug Monitoring


Overdose