NGENLA (somatrogon-ghla)
- growth hormone deficiency dwarfism
24 mg/1.2 mL (20 mg/mL) subcutaneous pen injector
- Dosage information is not available
60 mg/1.2 mL (50 mg/mL) subcutaneous pen injector
- Dosage information is not available
- None
Contraindicated
- None
Severe
Moderate
- None
- Invasive surgical procedure
- Major traumatic injury
- Malignancy
- Premature epiphyseal closure
Contraindicated
- Intracranial hypertension
- Respiratory depression
Severe
Moderate
- Hypothyroidism
NGENLA (somatrogon-ghla)
- growth hormone deficiency dwarfism
- None
- Acute abdominal pain
- Anemia
- Cough
- Fever
- Headache disorder
- Hypothyroidism
- Injection site sequelae
- Pain in oropharynx
- Skin rash
- Vomiting
More Frequent
Severe
Less Severe
- Anaphylaxis
- Angioedema
- Intracranial hypertension
- Malignancy
- Pancreatitis
- Adrenocortical insufficiency
- Body fluid retention
- Bronchitis
- Eosinophilia
- Slipped capital epiphyses
- Tonsillitis
Less Frequent
Severe
Less Severe
Rare / Very Rare
Severe
- None
Less Severe
- None
Contraindicated
None
Severe Precaution
None
Management or Monitoring Precaution
Somatrogon
Safety and effectiveness not established age < 3 years. Risk of pancreatitis, scoliosis progression, slipped femoral epiphysis, fluid retention, glucose intolerance, tumor progression/recurrence. Contraindicated for closed epiphyses. Risk of sudden death in Prader-Willi patient with severe obesity and upper airway obstruction, sleep apnea or severe respiratory impairment.
Risk of pancreatitis, scoliosis progression, slipped femoral epiphysis, fluid retention, glucose intolerance, tumor progression/recurrence. Contraindicated for closed epiphyses. Risk of sudden death in Prader-Willi patient with severe obesity and upper airway obstruction, sleep apnea or severe respiratory impairment. Limited safety and efficacy data for use in pediatrics age >12 years.
- 1 Day – 3 Years
- Safety and effectiveness not established age < 3 years. Risk of pancreatitis, scoliosis progression, slipped femoral epiphysis, fluid retention, glucose intolerance, tumor progression/recurrence. Contraindicated for closed epiphyses. Risk of sudden death in Prader-Willi patient with severe obesity and upper airway obstruction, sleep apnea or severe respiratory impairment.
- Risk of pancreatitis, scoliosis progression, slipped femoral epiphysis, fluid retention, glucose intolerance, tumor progression/recurrence. Contraindicated for closed epiphyses. Risk of sudden death in Prader-Willi patient with severe obesity and upper airway obstruction, sleep apnea or severe respiratory impairment. Limited safety and efficacy data for use in pediatrics age >12 years.
- 3 Years – 18 Years
- Safety and effectiveness not established age < 3 years. Risk of pancreatitis, scoliosis progression, slipped femoral epiphysis, fluid retention, glucose intolerance, tumor progression/recurrence. Contraindicated for closed epiphyses. Risk of sudden death in Prader-Willi patient with severe obesity and upper airway obstruction, sleep apnea or severe respiratory impairment.
- Risk of pancreatitis, scoliosis progression, slipped femoral epiphysis, fluid retention, glucose intolerance, tumor progression/recurrence. Contraindicated for closed epiphyses. Risk of sudden death in Prader-Willi patient with severe obesity and upper airway obstruction, sleep apnea or severe respiratory impairment. Limited safety and efficacy data for use in pediatrics age >12 years.
Somatrogon
- Severity Level:
2
- Additional Notes: Insufficient data available; weigh maternal benefit vs potential fetal risk
Contraindicated
None
General | Excretion Potential | Effect on Infant | Notes |
None |
Precaution Exists
Somatrogon
Insufficient data available.
General | Excretion Potential | Effect on Infant | Notes |
Evaluate use carefully | Unknown | Not known; no or inclusive data | Insufficient data available. |
No Known Risk
None
General | Excretion Potential | Effect on Infant | Notes |
None |
Contraindicated
None
Precaution Exists
None
No Known Risk
None
- None
Pituitary dwarfism | |
E23.0 | Hypopituitarism |
0-9 | A-Z |
---|---|
E23.0 | Hypopituitarism |