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SKYTROFA (lonapegsomatropin-tcgd)
- growth hormone deficiency dwarfism
11 mg subcutaneous cartridge
- Dosage information is not available
13.3 mg subcutaneous cartridge
- Dosage information is not available
3 mg subcutaneous cartridge
- Dosage information is not available
3.6 mg subcutaneous cartridge
- Dosage information is not available
4.3 mg subcutaneous cartridge
- Dosage information is not available
5.2 mg subcutaneous cartridge
- Dosage information is not available
6.3 mg subcutaneous cartridge
- Dosage information is not available
7.6 mg subcutaneous cartridge
- Dosage information is not available
9.1 mg subcutaneous cartridge
- Dosage information is not available
- None
Contraindicated
- None
Severe
Moderate
- None
- Acute respiratory failure
- Diabetic retinopathy
- Major traumatic injury
- Morbid obesity
- Sleep apnea
Contraindicated
- Adrenocortical insufficiency
- Idiopathic intracranial hypertension
- Malignancy
- Pancreatitis
- Slipped capital epiphyses
- Untreated hypothyroidism
Severe
Moderate
- Carpal tunnel syndrome
- Diabetes mellitus
- Edema
- Progression of nevus
- Scoliosis
SKYTROFA (lonapegsomatropin-tcgd)
- growth hormone deficiency dwarfism
- Hemorrhage
- Acute abdominal pain
- Arthralgia
- Arthritis
- Cough
- Diarrhea
- Fever
- Nausea
- Viral infection
- Vomiting
More Frequent
Severe
Less Severe
- None
- Body fluid retention
- Hyperglycemia
Less Frequent
Severe
Less Severe
Rare / Very Rare
Severe
- Adrenocortical insufficiency
- Anaphylaxis
- Angioedema
- Hypersensitivity drug reaction
- Hypothyroidism
- Intracranial hypertension
- Malignancy
- Pancreatitis
- Slipped capital epiphyses
Less Severe
- None
Contraindicated
None
Severe Precaution
None
Management or Monitoring Precaution
Lonapegsomatropin-tcgd
Safety and effectiveness not established in age < 1 year and weight < 11.5 kg. May cause pancreatitis, scoliosis progression, slipped femoral epiphysis, fluid retention, glucose intolerance, tumor progression/recurrence [if applicable]. Contraindicated if epiphyses are closed. Do not use in Prader-Willi patients who are severely obese, have upper airway obstruction, sleep apnea or severe respiratory impairment; use contraindicated due to risk of sudden death.
Monitor for: pancreatitis, scoliosis progression, slipped femoral epiphysis, fluid retention, glucose intolerance, tumor progression/recurrence [if applicable]. Contraindicated if epiphyses are closed. Do not use in Prader-Willi patients who are severely obese, have upper airway obstruction, sleep apnea or severe respiratory impairment; use contraindicated due to risk of sudden death.
- 1 Day – 364 Days
- Safety and effectiveness not established in age < 1 year and weight < 11.5 kg. May cause pancreatitis, scoliosis progression, slipped femoral epiphysis, fluid retention, glucose intolerance, tumor progression/recurrence [if applicable]. Contraindicated if epiphyses are closed. Do not use in Prader-Willi patients who are severely obese, have upper airway obstruction, sleep apnea or severe respiratory impairment; use contraindicated due to risk of sudden death.
- Monitor for: pancreatitis, scoliosis progression, slipped femoral epiphysis, fluid retention, glucose intolerance, tumor progression/recurrence [if applicable]. Contraindicated if epiphyses are closed. Do not use in Prader-Willi patients who are severely obese, have upper airway obstruction, sleep apnea or severe respiratory impairment; use contraindicated due to risk of sudden death.
- 1 Years – 18 Years
- Safety and effectiveness not established in age < 1 year and weight < 11.5 kg. May cause pancreatitis, scoliosis progression, slipped femoral epiphysis, fluid retention, glucose intolerance, tumor progression/recurrence [if applicable]. Contraindicated if epiphyses are closed. Do not use in Prader-Willi patients who are severely obese, have upper airway obstruction, sleep apnea or severe respiratory impairment; use contraindicated due to risk of sudden death.
- Monitor for: pancreatitis, scoliosis progression, slipped femoral epiphysis, fluid retention, glucose intolerance, tumor progression/recurrence [if applicable]. Contraindicated if epiphyses are closed. Do not use in Prader-Willi patients who are severely obese, have upper airway obstruction, sleep apnea or severe respiratory impairment; use contraindicated due to risk of sudden death.
Lonapegsomatropin-tcgd
- Severity Level:
2
- Additional Notes: Insufficient human data avail; consider maternal benefit vs fetal risk
Contraindicated
None
| General | Excretion Potential | Effect on Infant | Notes |
| None |
Precaution Exists
Lonapegsomatropin-tcgd
Insufficient human data available
| General | Excretion Potential | Effect on Infant | Notes |
| Evaluate use carefully | Unknown | Not known; no or inclusive data | Insufficient human 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 |
Formulary Reference Tool