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SEROSTIM (SOMATROPIN)
- Cachexia due to HIV
- Idiopathic short stature
- Adult growth hormone deficiency
- Growth failure associated with turner's syndrome
- Growth failure due to prader-willi syndrome
- Growth failure in child with SHOX deficiency
- Growth failure secondary to chronic renal failure
- Pituitary dwarfism
- Short bowel syndrome
- Short stature associated with noonan syndrome
- Short stature, born small for gestational age
4 mg subcutaneous solution
- Inject 0.1 mg/kg up to a maximum of 8 mg by subcutaneous route once daily
5 mg subcutaneous solution
- Inject 0.1 mg/kg up to a maximum of 8 mg by subcutaneous route once daily
6 mg subcutaneous solution
- Inject 0.1 mg/kg up to a maximum of 8 mg by subcutaneous route once daily
5 mg subcutaneous solution
- Inject 0.1 mg/kg up to a maximum of 8 mg by subcutaneous route once daily
8.8 mg subcutaneous solution
- Inject 0.01 mg/kg by subcutaneous route once daily
Adult growth hormone deficiency
- Inject 0.025 mg/kg by subcutaneous route once daily
- Inject 0.0125 mg/kg by subcutaneous route once daily
- Inject 0.004 mg/kg by subcutaneous route once daily
- Inject 0.016 mg/kg by subcutaneous route once daily
Cachexia due to HIV
- Inject 6 mg by subcutaneous route once daily at bedtime
- Inject 5 mg by subcutaneous route once daily at bedtime
- Inject 4 mg by subcutaneous route once daily at bedtime
- Inject 0.1 mg/kg up to a maximum of 6Mg by subcutaneous route once daily at bedtime
- Inject 0.1 mg/kg up to a maximum of 6Mg by subcutaneous route every other day at bedtime
Short bowel syndrome
- Inject 0.1 mg/kg up to a maximum of 8 mg by subcutaneous route once daily
- Inject 0.1 mg/kg up to a maximum of 8 mg by subcutaneous route once daily for 28 days
- None
Contraindicated
- None
Severe
Moderate
- None
- Acute respiratory insufficiency
- Diabetic retinopathy
- Major traumatic injury
- Morbid obesity
- Sleep apnea
Contraindicated
- Adrenal cortical insufficiency
- Idiopathic intracranial hypertension
- Malignancy
- Pancreatitis
- Slipped capital epiphyses
- Snoring
- Untreated hypopituitarism
- Untreated hypothyroidism
Severe
Moderate
- Carpal tunnel syndrome
- Diabetes mellitus
- Edema
- Hypertension
- Progression of nevus
- Scoliosis
SEROSTIM (SOMATROPIN)
- Cachexia due to HIV
- Idiopathic short stature
- Adult growth hormone deficiency
- Growth failure associated with turner's syndrome
- Growth failure due to prader-willi syndrome
- Growth failure in child with SHOX deficiency
- Growth failure secondary to chronic renal failure
- Pituitary dwarfism
- Short bowel syndrome
- Short stature associated with noonan syndrome
- Short stature, born small for gestational age
- None
- Acute abdominal pain
- Arthralgias
- Carpal tunnel syndrome
- Edema
- Headache disorder
- Hematoma
- Injection site sequelae
- Muscle rigidity
- Myalgias
- Peripheral edema
More Frequent
Severe
Less Severe
- Dyspnea
- Hypertension
- Hypothyroidism
- Increased alanine transaminase
- Increased aspartate transaminase
- Acne vulgaris
- Back pain
- Hypesthesia
- Nausea
- Paresthesia
- Skin atrophy
- Upper respiratory infection
- Vomiting
Less Frequent
Severe
Less Severe
Rare / Very Rare
Severe
- Acute pancreatitis
- Adrenal cortical insufficiency
- Anaphylaxis
- Angioedema
- Diabetes mellitus
- Diabetic retinopathy
- Fracture
- Gastroenteritis
- Hyperglycemia
- Hyperparathyroidism
- Intracranial hypertension
- Leukemia
- Neoplasm
- Papilledema
- Pituitary insufficiency
- Retinal disorder
- Sleep apnea
- Slipped capital epiphyses
Less Severe
- Abnormal glucose tolerance
- Acute bacterial otitis media
- Alopecia
- Body fluid retention
- Fatigue
- Fever
- Gynecomastia
- Hematuria
- Increased appetite
- Mood changes
- Pharyngitis
- Progression of nevus
- Skin rash
- Tonsillitis
- Urinary tract infection
Contraindicated
None
Severe Precaution
None
Management or Monitoring Precaution
Somatropin
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 – 18 Years
- 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.
Somatropin
- Severity Level:
2
- Additional Notes: Insuff data avail; consider maternal benefit vs. fetal risk
Contraindicated
None
| General | Excretion Potential | Effect on Infant | Notes |
| None |
Precaution Exists
Somatropin
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
Somatropin
Endocrine-Somatropin decreases sensitivity to insulin and may result in hyperglycemia in susceptible elderly, particularly with risk factors for diabetes mellitus. General-Associated with edema, arthralgia, carpal tunnel syndrome and gynecomastia. Lower starting doses are generally recommended in the elderly due to increased susceptibility to adverse effects.
| Organ / System | HEP | REN | CARD | ENDO | NEURO / PSYCH | PULM |
| Increased Risk / Adverse Effects | N | N | N | N | N | Y |
BEERS: Y HEDIS: N STOPP: N
No Known Risk
None
- None
| Adult growth hormone deficiency | |
| E23.0 | Hypopituitarism |
| E23.1 | Drug-induced hypopituitarism |
| E89.3 | Postprocedural hypopituitarism |
| Cachexia due to HIV | |
| R64 | Cachexia |
| Growth failure associated with turner's syndrome | |
| Q96 | Turner's syndrome |
| Q96.0 | Karyotype 45, X |
| Q96.1 | Karyotype 46, X iso (xq) |
| Q96.2 | Karyotype 46, X with abnormal sex chromosome, except iso (xq) |
| Q96.3 | Mosaicism, 45, x/46, XX or XY |
| Q96.4 | Mosaicism, 45, x/other cell line(s) with abnormal sex chromosome |
| Q96.8 | Other variants of turner's syndrome |
| Q96.9 | Turner's syndrome, unspecified |
| R62.52 | Short stature (child) |
| Growth failure due to prader-willi syndrome | |
| Q87.11 | Prader-willi syndrome |
| R62.52 | Short stature (child) |
| Growth failure in child with SHOX deficiency | |
| Q87.1 | Congenital malformation syndromes predominantly associated with short stature |
| Q87.19 | Other congenital malformation syndromes predominantly associated with short stature |
| R62.52 | Short stature (child) |
| Growth failure secondary to chronic renal failure | |
| R62.52 | Short stature (child) |
| Idiopathic short stature | |
| R62.52 | Short stature (child) |
| Pituitary dwarfism | |
| E23.0 | Hypopituitarism |
| Short bowel syndrome | |
| K91.2 | Postsurgical malabsorption, not elsewhere classified |
| Short stature associated with noonan syndrome | |
| Q87.1 | Congenital malformation syndromes predominantly associated with short stature |
| Q87.19 | Other congenital malformation syndromes predominantly associated with short stature |
| R62.52 | Short stature (child) |
| Short stature, born small for gestational age | |
| R62.52 | Short stature (child) |
| 0-9 | A-Z |
|---|---|
| E23.0 | Hypopituitarism |
| E23.0 | Hypopituitarism |
| E23.1 | Drug-induced hypopituitarism |
| E89.3 | Postprocedural hypopituitarism |
| K91.2 | Postsurgical malabsorption, not elsewhere classified |
| Q87.1 | Congenital malformation syndromes predominantly associated with short stature |
| Q87.1 | Congenital malformation syndromes predominantly associated with short stature |
| Q87.11 | Prader-willi syndrome |
| Q87.19 | Other congenital malformation syndromes predominantly associated with short stature |
| Q87.19 | Other congenital malformation syndromes predominantly associated with short stature |
| Q96 | Turner's syndrome |
| Q96.0 | Karyotype 45, X |
| Q96.1 | Karyotype 46, X iso (xq) |
| Q96.2 | Karyotype 46, X with abnormal sex chromosome, except iso (xq) |
| Q96.3 | Mosaicism, 45, x/46, XX or XY |
| Q96.4 | Mosaicism, 45, x/other cell line(s) with abnormal sex chromosome |
| Q96.8 | Other variants of turner's syndrome |
| Q96.9 | Turner's syndrome, unspecified |
| R62.52 | Short stature (child) |
| R62.52 | Short stature (child) |
| R62.52 | Short stature (child) |
| R62.52 | Short stature (child) |
| R62.52 | Short stature (child) |
| R62.52 | Short stature (child) |
| R62.52 | Short stature (child) |
| R64 | Cachexia |
Formulary Reference Tool