OMNITROPE

Clinical safety rating: caution

Comprehensive clinical and safety monograph for OMNITROPE (OMNITROPE).

How it works

Recombinant human growth hormone (somatropin) that binds to growth hormone receptors, activating JAK2/STAT5 signaling pathways, leading to increased IGF-1 synthesis and metabolic effects including linear growth, protein synthesis, and lipolysis.

What the body does with it

Metabolism	Metabolized primarily in the liver and kidneys via proteolytic degradation; enzymes involved include proteases.
Excretion	Renal: ~70% as intact somatropin; fecal and biliary excretion are negligible.
Half-life	IV: ~0.5 hours; subcutaneous: ~3 hours (terminal). Clinical context: Duration of growth promotion requires daily dosing due to rapid clearance.
Protein binding	~30% bound to growth hormone-binding protein (GHBP).
Volume of Distribution	~0.07 L/kg. Low Vd indicates limited extravascular distribution, primarily in blood and interstitial fluid.
Bioavailability	Subcutaneous: ~80% relative to intravenous administration.
Onset of Action	Subcutaneous: 2–4 hours (rise in IGF-1 levels). Intravenous: Immediate.
Duration of Action	Subcutaneous: Up to 24 hours (IGF-1 elevation); clinical effect requires repeated daily doses for growth.

Classification & Brands

Dosing & administration

0.005 mg/kg subcutaneously once daily initially, titrated to 0.005-0.01 mg/kg/day based on clinical response and IGF-1 levels.

Dosage form	INJECTABLE
Renal impairment	No specific dose adjustment guidelines; use caution in severe renal impairment (GFR <30 mL/min) due to potential accumulation.
Liver impairment	No specific Child-Pugh based adjustments; use with caution in hepatic failure.
Pediatric use	0.025-0.035 mg/kg subcutaneously once daily for growth hormone deficiency; doses vary by indication (e.g., Turner syndrome: 0.05 mg/kg/day).
Geriatric use	Start at lower end of dosing range (0.005 mg/kg/day) due to higher risk of adverse effects; monitor fluid balance and IGF-1 levels.

Use during pregnancy

1st trimester	Consult provider
2nd trimester	Consult provider
3rd trimester	Consult provider

Clinical note

Comprehensive clinical and safety monograph for OMNITROPE (OMNITROPE).

Breastfeeding	Not known if somatropin is excreted in human milk. No M/P ratio available. Caution advised due to potential for growth promotion in nursing infant. Consider discontinuing or avoiding breastfeeding.
Teratogenic Risk	No adequate and well-controlled studies in pregnant women. Animal studies show no evidence of teratogenicity. Somatropin is not indicated for use in pregnancy; use only if clearly needed. First trimester: unknown risk. Second and third trimesters: unknown risk; potential for fetal growth promotion if maternal IGF-1 levels are elevated.

Warnings & precautions

■ FDA Black Box Warning

Increased mortality in patients with acute critical illness due to complications following open heart surgery, abdominal surgery, multiple accidental trauma, or acute respiratory failure. Not approved for these uses.

Side Effect Profile

Serious Effects

Absolute Contraindications

["Acute critical illness (e.g., open heart surgery, abdominal surgery, multiple trauma, acute respiratory failure)","Active malignancy","Diabetic retinopathy (uncontrolled)","Hypersensitivity to somatropin or excipients","Children with Prader-Willi syndrome who are severely obese or have severe respiratory impairment (unless on respiratory support)","Growth promotion in children with closed epiphyses"]

Clinical Precautions

Precautions

["Increased risk of neoplasms (monitor for new growth or recurrence)","Intracranial hypertension (papilledema, headache; discontinue if present)","Severe hypersensitivity reactions","Fluid retention and edema","Glucose intolerance/diabetes mellitus","Slipped capital femoral epiphysis in children","Pancreatitis","Progression of scoliosis","Increased risk of second malignancy in childhood cancer survivors"]

Clinical Tips & Counseling

Drug interactions

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OMNITROPE

Clinical safety rating: caution

Comprehensive clinical and safety monograph for OMNITROPE (OMNITROPE).

How it works

What the body does with it

Metabolism	Metabolized primarily in the liver and kidneys via proteolytic degradation; enzymes involved include proteases.
Excretion	Renal: ~70% as intact somatropin; fecal and biliary excretion are negligible.
Half-life	IV: ~0.5 hours; subcutaneous: ~3 hours (terminal). Clinical context: Duration of growth promotion requires daily dosing due to rapid clearance.
Protein binding	~30% bound to growth hormone-binding protein (GHBP).
Volume of Distribution	~0.07 L/kg. Low Vd indicates limited extravascular distribution, primarily in blood and interstitial fluid.
Bioavailability	Subcutaneous: ~80% relative to intravenous administration.
Onset of Action	Subcutaneous: 2–4 hours (rise in IGF-1 levels). Intravenous: Immediate.
Duration of Action	Subcutaneous: Up to 24 hours (IGF-1 elevation); clinical effect requires repeated daily doses for growth.

Classification & Brands

Dosing & administration

0.005 mg/kg subcutaneously once daily initially, titrated to 0.005-0.01 mg/kg/day based on clinical response and IGF-1 levels.

Dosage form	INJECTABLE
Renal impairment	No specific dose adjustment guidelines; use caution in severe renal impairment (GFR <30 mL/min) due to potential accumulation.
Liver impairment	No specific Child-Pugh based adjustments; use with caution in hepatic failure.
Pediatric use	0.025-0.035 mg/kg subcutaneously once daily for growth hormone deficiency; doses vary by indication (e.g., Turner syndrome: 0.05 mg/kg/day).
Geriatric use	Start at lower end of dosing range (0.005 mg/kg/day) due to higher risk of adverse effects; monitor fluid balance and IGF-1 levels.

Use during pregnancy

1st trimester	Consult provider
2nd trimester	Consult provider
3rd trimester	Consult provider

Clinical note

Comprehensive clinical and safety monograph for OMNITROPE (OMNITROPE).

Breastfeeding	Not known if somatropin is excreted in human milk. No M/P ratio available. Caution advised due to potential for growth promotion in nursing infant. Consider discontinuing or avoiding breastfeeding.
Teratogenic Risk	No adequate and well-controlled studies in pregnant women. Animal studies show no evidence of teratogenicity. Somatropin is not indicated for use in pregnancy; use only if clearly needed. First trimester: unknown risk. Second and third trimesters: unknown risk; potential for fetal growth promotion if maternal IGF-1 levels are elevated.