- 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]
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dose recommendation of formulary compared to licensed use (on-label versus off-label)
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Available formulations
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Dosages
| Growth disorders resulting from growth hormone deficiency, neonatal hypoglycemia due to GH deficiency |
|---|
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Renal impaiment in children > 3 months
No information available on dose adjustment in renal impairment.
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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]
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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]
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Interactions
The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here
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| ACTH | ||
|---|---|---|
| H01AA02 | ||
| Somatropin and somatropin agonists | ||
|---|---|---|
| H01AC09 | ||
| H01AC03 | ||
| H01AC07 | ||
| H01AC01 | ||
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References
- European Medicines Agency, EPAR Ngenla® (EU/1/21/1617/001), 06/2022
- Pfizer Europe MA EEIG, SmPC Ngenla® 24 mg/ 60 mg Injektionslösung im Fertigpen (EU/1/21/1617/001), 03/2024
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Changes
Changes
