Lonapegsomatropin

Generic name
Lonapegsomatropin
Brand name
ATC Code
H01AC09
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Lonapegsomatropin

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]

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 up to 18 years
      • 0.24 mg/kg/dose once per week. If necessary, adjust dose according to effect and IGF serum concentrations.

      • When switching from daily growth hormone to weekly administration: inject the last dose of the daily drug the day before, or at least 8 hours before, the first weekly dose

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

Common: Secondary hypothyroidism, Arthralgia, Injection site reactions

uncommon: Anaphylactic reaction, Secondary adrenocortical insufficiency, Scoliosis, Arthritis, Growing pains, Gynaecomastia

[Skytrofa]

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]

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
H01AC03
H01AC07
H01AC08
H01AC01

Reference

  1. 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

Changes

Therapeutic Drug Monitoring


Overdose