SEROSTIM LQ

Clinical safety rating: caution

Comprehensive clinical and safety monograph for SEROSTIM LQ (SEROSTIM LQ).

How it works

Recombinant human growth hormone (somatropin) that binds to growth hormone receptors, activating JAK-STAT signaling pathways, leading to increased insulin-like growth factor-1 (IGF-1) production, which promotes linear growth and anabolic effects.

What the body does with it

Metabolism	Primarily hepatic via proteolytic degradation; excreted in urine and bile.
Excretion	Renal: >90% of somatropin is metabolized in the liver and kidneys; less than 1% of the administered dose is excreted unchanged in urine.
Half-life	2.6 hours (subcutaneous administration); terminal half-life is approximately 2-3 hours, requiring daily dosing for growth hormone deficiency.
Protein binding	Approximately 30% bound to growth hormone binding protein (GHBP) in plasma.
Volume of Distribution	Central Vd: approximately 0.07 L/kg; reflects distribution primarily into extracellular fluid.
Bioavailability	Subcutaneous: approximately 80% (range 70-90%) compared to intravenous administration.
Onset of Action	Subcutaneous: Rapid; measurable increases in IGF-1 levels within 4-6 hours after first dose.
Duration of Action	Subcutaneous: 24 hours; supports once-daily dosing regimen for growth hormone replacement therapy.

Classification & Brands

Dosing & administration

0.2 mg/kg subcutaneously once daily for 4 weeks in HIV-associated wasting; for growth hormone deficiency, 0.005 mg/kg subcutaneously once daily initially, titrated to 0.01 mg/kg once daily.

Dosage form	INJECTABLE
Renal impairment	eGFR < 30 mL/min/1.73 m2: Adhere to standard dosing for HIV-associated wasting; for GHD, consider dose reduction by 50% due to decreased clearance. eGFR 30-59 mL/min/1.73 m2: No adjustment necessary for HIV wasting; for GHD, monitor closely.
Liver impairment	Child-Pugh Class A: No adjustment. Child-Pugh Class B: Use with caution; consider 25% dose reduction. Child-Pugh Class C: Avoid use or reduce dose by 50%.
Pediatric use	For growth hormone deficiency: 0.025-0.05 mg/kg subcutaneously once daily; for HIV-associated wasting: 0.1 mg/kg subcutaneously once daily (maximum 6 mg/day) for 4 weeks.
Geriatric use	Initiate at lowest adult dose; monitor for fluid retention and glucose tolerance. Consider dose reduction if impaired renal function (eGFR <60 mL/min/1.73 m2).

Use during pregnancy

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

Clinical note

Comprehensive clinical and safety monograph for SEROSTIM LQ (SEROSTIM LQ).

Breastfeeding	No data on presence in human milk; risk to infant cannot be excluded. Caution advised; consider developmental benefits of breastfeeding versus maternal need for drug.
Teratogenic Risk	Pregnancy Category C. Animal studies show no evidence of teratogenicity but no adequate human studies. Use only if potential benefit justifies potential risk.
Fetal Monitoring

Warnings & precautions

■ FDA Black Box Warning

Increased risk of mortality in patients with acute critical illness due to complications following open heart surgery, abdominal surgery, multiple accidental trauma, or acute respiratory failure. Serostim is contraindicated in pediatric patients with closed epiphyses and in patients with active neoplasia.

Side Effect Profile

Serious Effects

Absolute Contraindications

Hypersensitivity to somatropin or excipients; active malignancy; acute critical illness; children with closed epiphyses; retinopathy (proliferative or preproliferative) in patients with growth failure due to Prader-Willi syndrome.

Clinical Precautions

Precautions

Risk of neoplasia (monitor for new or recurrent tumors); increased risk of secondary intracranial hypertension with papilledema; fluid retention (peripheral edema, arthralgia, carpal tunnel syndrome); impaired glucose tolerance and diabetes mellitus; slipped capital femoral epiphysis in pediatric patients; pancreatitis; hypersensitivity reactions.

Clinical Tips & Counseling

Drug interactions

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SEROSTIM LQ

Clinical safety rating: caution

Comprehensive clinical and safety monograph for SEROSTIM LQ (SEROSTIM LQ).

How it works

What the body does with it

Metabolism	Primarily hepatic via proteolytic degradation; excreted in urine and bile.
Excretion	Renal: >90% of somatropin is metabolized in the liver and kidneys; less than 1% of the administered dose is excreted unchanged in urine.
Half-life	2.6 hours (subcutaneous administration); terminal half-life is approximately 2-3 hours, requiring daily dosing for growth hormone deficiency.
Protein binding	Approximately 30% bound to growth hormone binding protein (GHBP) in plasma.
Volume of Distribution	Central Vd: approximately 0.07 L/kg; reflects distribution primarily into extracellular fluid.
Bioavailability	Subcutaneous: approximately 80% (range 70-90%) compared to intravenous administration.
Onset of Action	Subcutaneous: Rapid; measurable increases in IGF-1 levels within 4-6 hours after first dose.
Duration of Action	Subcutaneous: 24 hours; supports once-daily dosing regimen for growth hormone replacement therapy.

Classification & Brands

Dosing & administration

0.2 mg/kg subcutaneously once daily for 4 weeks in HIV-associated wasting; for growth hormone deficiency, 0.005 mg/kg subcutaneously once daily initially, titrated to 0.01 mg/kg once daily.

Dosage form	INJECTABLE
Renal impairment	eGFR < 30 mL/min/1.73 m2: Adhere to standard dosing for HIV-associated wasting; for GHD, consider dose reduction by 50% due to decreased clearance. eGFR 30-59 mL/min/1.73 m2: No adjustment necessary for HIV wasting; for GHD, monitor closely.
Liver impairment	Child-Pugh Class A: No adjustment. Child-Pugh Class B: Use with caution; consider 25% dose reduction. Child-Pugh Class C: Avoid use or reduce dose by 50%.
Pediatric use	For growth hormone deficiency: 0.025-0.05 mg/kg subcutaneously once daily; for HIV-associated wasting: 0.1 mg/kg subcutaneously once daily (maximum 6 mg/day) for 4 weeks.
Geriatric use	Initiate at lowest adult dose; monitor for fluid retention and glucose tolerance. Consider dose reduction if impaired renal function (eGFR <60 mL/min/1.73 m2).

Use during pregnancy

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

Clinical note

Comprehensive clinical and safety monograph for SEROSTIM LQ (SEROSTIM LQ).

Breastfeeding	No data on presence in human milk; risk to infant cannot be excluded. Caution advised; consider developmental benefits of breastfeeding versus maternal need for drug.
Teratogenic Risk	Pregnancy Category C. Animal studies show no evidence of teratogenicity but no adequate human studies. Use only if potential benefit justifies potential risk.
Fetal Monitoring