- Dosages
- Side effects in children
- Warnings & precautions in children
- Contra-indications in children
-
Interactions - PK
- Renal impairment
- References
Pharmacokinetics in children
In paediatric GHD patients:
Cmax(Lonapegsomatropin): 1230 ng Somatropin/mL
median Tmax(Lonapegsomatropin): 25 hours
Vd(Lonapegsomatropin) after 0.24 mg somatropin/kg/week: 0.13 L/kg
Cl(Lonapegsomatropin) after 0.24 mg somatropin/kg/week: 3.2 mL/h/kg
mean T1/2: 30.7 (± 12.7) hours
released Somatropin:
Cmax: 15.2 ng/mL
T1/2: 25 hours
[SmPC Skytrofa]
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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
Common: Secondary hypothyroidism, Arthralgia, Injection site reactions
uncommon: Anaphylactic reaction, Secondary adrenocortical insufficiency, Scoliosis, Arthritis, Growing pains, Gynaecomastia
[Skytrofa]
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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
- evidence of tumour activity
- Patients with acute critical illness suffering complications following open heart surgery, abdominal surgery, multiple accidental trauma, acute respiratory failure or similar conditions
- growth promotion in children with closed epiphyses
[SmPC Skytrofa]
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
- Scoliosis may progress in any child during rapid growth. Because growth hormone treatment increases growth rate, signs and progression of scoliosis should be monitored during treatment.
- Although rare, pancreatitis should be considered in growth hormone treated children who develop unexplained abdominal pain.
- Lonapegsomatropin 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 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.
[SmPC Skytrofa]
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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 | ||
|---|---|---|
| H01AC03 | ||
| H01AC07 | ||
| H01AC08 | ||
| H01AC01 | ||
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Reference
- Ascendis Pharma Endocrinology Division A/S, SmPC Skytrofa Pulver und Lösungsmittel zur Herstellung einer Injektionslösung in einer Patrone (EU/1/21/1607/001), 01/2023
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Changes
Changes
