Version May 2024
Growth hormone deficiency: In patients who were treated with somatropin for growth hormone deficiency (GHD) during childhood and whose epiphyses are closed, reevaluate the need for continued therapy during adulthood. Due to a high degree of interindividual variability with absorption and sensitivity, starting with low non–weight-based doses and slowly titrating is generally preferred to traditional weight-based dosing regimens (Ref).
Non–weight-based dosing:
Initial:
Patients ≤60 years of age without diabetes mellitus, glucose intolerance, or obesity: SUBQ: 0.2 to 0.4 mg/day; in patients transitioning from pediatric treatment, higher doses (eg, 50% of the dose used in childhood) may be needed (Ref).
Patients >60 years of age, or with diabetes mellitus, glucose intolerance, or obesity: SUBQ: 0.1 to 0.2 mg/day (Ref)
Dosage adjustment: May increase by 0.1 to 0.2 mg/day every 1 to 2 months based on response and/or serum IGF-1 levels (Ref).
Duration of therapy: Consider discontinuing therapy if no benefits are achieved after 12 to 18 months; may continue indefinitely in patients who benefit from therapy (Ref).
Weight-based dosing: Note: Initiating somatropin with weight-based dosing is generally not recommended due to greater risk of dose-dependent adverse effects (eg, edema), particularly in patients with obesity (Ref).
Norditropin: SUBQ: Initial: 0.004 mg/kg/day; dose may be increased up to a maximum of 0.016 mg/kg/day.
Nutropin AQ: SUBQ: Initial: ≤0.006 mg/kg/day; dose may be increased up to a maximum of 0.025 mg/kg/day in patients ≤35 years of age, or up to a maximum of 0.0125 mg/kg/day in patients >35 years of age.
Humatrope: SUBQ: Initial: 0.006 mg/kg/day; dose may be increased up to a maximum of 0.0125 mg/kg/day.
Genotropin, Omnitrope: SUBQ: Weekly dosage: ≤0.04 mg/kg/week divided into equal doses administered 6 or 7 days per week; dose may be increased at 4- to 8-week intervals to a maximum of 0.08 mg/kg/week.
Saizen: SUBQ: ≤0.005 mg/kg/day; dose may be increased up to 0.01 mg/kg/day after 4 weeks.
Zomacton: SUBQ: 0.006 mg/kg/day; dose may be increased up to a maximum of 0.0125 mg/kg/day.
HIV-associated adipose redistribution syndrome (off-label use): Serostim: SUBQ: Induction: 4 mg once daily at bedtime for 12 weeks; Maintenance: 2 mg or 4 mg every other day at bedtime for 12 to 24 weeks. Note: Every-other-day dosing during induction has also been studied. Although a greater response was seen with daily dosing, it was associated with an increased incidence of adverse events (Ref).
HIV-associated wasting, cachexia:
Serostim: SUBQ: Initial: 0.1 mg/kg once daily at bedtime (maximum: 6 mg/day); patients at risk for adverse effects (eg, glucose intolerance) may be started at 0.1 mg/kg every other day. Adjust dose (ie, reduce the total daily dose or the number of doses per week) if needed to manage adverse effects.
Daily dose based on body weight:
<35 kg: 0.1 mg/kg.
35 to 45 kg: 4 mg.
45 to 55 kg: 5 mg.
>55 kg: 6 mg.
Short-bowel syndrome: Zorbtive: SUBQ: 0.1 mg/kg once daily for 4 weeks (maximum: 8 mg/day).
Fluid retention (moderate) or arthralgias: Treat symptomatically or reduce dose to 0.05 mg/kg once daily (maximum: 4 mg/day).
Severe toxicity: Discontinue therapy for up to 5 days; when symptoms resolve, restart at 0.05 mg/kg once daily (maximum: 4 mg/day). Permanently discontinue treatment if severe toxicity recurs or does not disappear within 5 days after discontinuation.
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
There are no dosage adjustments provided in the manufacturer's labeling; decreased clearance in patients with chronic renal failure and end-stage renal disease.
There are no dosage adjustments provided in the manufacturer's labeling; reduced clearance in patients with severe hepatic impairment.
Fluid retention: Consider a dose reduction or discontinuation if clinical manifestations of fluid retention occur (eg, edema, arthralgia, carpal tunnel syndrome, myalgia, paresthesias) (Ref).
Intracranial hypertension: Discontinue therapy if papilledema occurs; may resume somatropin at a lower dose once intracranial hypertension–associated signs and symptoms have resolved.
Note: Avoid use, except as hormone replacement in patients with growth hormone deficiency due to an established etiology that is based on a rigorous diagnosis by evidence-based criteria (Ref). Consider a lower starting dose and smaller dose increments.
Growth hormone deficiency: Initial: SUBQ: 0.1 to 0.2 mg/day. Longer timer time intervals between dose titration and smaller dose changes may be needed in older patients (eg, age >60 years) (Ref).
(For additional information see "Recombinant human growth hormone (somatropin): Pediatric drug information")
AIDS-related wasting or cachexia: Serostim: Limited data available:
Children 6 to 8 years: SubQ: 0.04 mg/kg/day for 4 weeks.
Children ≥8 years and Adolescents: SubQ: 0.04 to 0.07 mg/kg/day for 4 weeks.
Growth failure secondary to chronic kidney disease (CKD): Children and Adolescents: Nutropin AQ: SubQ: 0.35 mg/kg weekly divided into daily injections; continue until the time of renal transplantation.
Growth hormone deficiency (GHD): Note: Therapy should be continued until growth velocity decreases to <2 to 2.5 cm/year; the decision to discontinue prior to this must be individualized (Ref).
Children and Adolescents:
Guideline recommendations: SubQ: Initial dose: 0.16 to 0.24 mg/kg weekly divided into equal doses 6 to 7 days/week. Dose should be individualized based on patient response; treat with the lowest effective dose (Ref).
Product-specific dosing:
Genotropin, Omnitrope: SubQ: 0.16 to 0.24 mg/kg weekly divided into equal doses 6 to 7 days/week.
Humatrope: SubQ: 0.18 to 0.3 mg/kg weekly divided into equal doses 6 to 7 days/week.
Norditropin: SubQ: 0.17 to 0.24 mg/kg weekly divided into equal doses 6 to 7 days/week.
Nutropin AQ: SubQ: 0.3 mg/kg weekly divided into daily doses; although the manufacturer suggests that 0.7 mg/kg weekly may be used in pubertal patients, the Pediatric Endocrine Society recommends against the use of higher doses in puberty due to increased adverse effects, long-term risk of higher dose, and increased health care costs (Ref).
Saizen: SubQ: 0.18 mg/kg weekly divided into equal doses 3, 6, or 7 days/week. Note: Pediatric Endocrine Society recommends dosing 6 to 7 days/week due to improved weight gain and height standard deviation score (HtSDS) compared to 3-times-weekly dosing (Ref).
Zomacton: SubQ: 0.18 to 0.3 mg/kg weekly divided into equal doses 3, 6, or 7 days/week. Note: Pediatric Endocrine Society recommends dosing 6 to 7 days/week due to improved weight gain and HtSDS compared to 3-times-weekly dosing (Ref).
Idiopathic short stature (ISS): Note: Guidelines recommend against the routine use of somatropin in every child with HtSDS ≤−2.25; decision to use should be made on a case-by-case basis (Ref).
Children and Adolescents:
Guideline recommendations: SubQ: Initial dose: 0.24 mg/kg weekly divided into equal doses 6 to 7 days/week. Individualize dose based on patient response; some patients may require up to 0.47 mg/kg weekly in divided doses (Ref).
Product-specific dosing:
Genotropin, Norditropin, Omnitrope: SubQ: Up to 0.47 mg/kg weekly divided into equal doses 6 to 7 days/week.
Humatrope: SubQ: Up to 0.37 mg/kg weekly divided into equal doses 6 to 7 days/week.
Nutropin AQ: SubQ: Up to 0.3 mg/kg weekly divided into daily doses.
Zomacton: SubQ: Up to 0.37 mg/kg weekly divided into equal doses 3, 6, or 7 days/week. Note: Pediatric Endocrine Society recommends dosing 6 to 7 days/week due to improved weight gain and HtSDS compared to 3-times-weekly dosing (Ref).
Noonan syndrome: Children and Adolescents: Norditropin: SubQ: Up to 0.46 mg/kg weekly divided in equal doses 6 to 7 days/week.
Prader-Willi syndrome: Children and Adolescents: Genotropin, Norditropin, Omnitrope: SubQ: 0.24 mg/kg weekly divided daily into 6 to 7 doses/week.
Small for gestational age (SGA) at birth who fail to catch-up by 2 to 4 years of age: Children:
Guideline recommendations: SubQ: 35 to 70 mcg/kg/day once daily; initiate doses at the higher end of the dosing range in patients with significant growth retardation (Ref).
Product-specific dosing:
Genotropin, Omnitrope: Up to 0.48 mg/kg weekly divided daily into 6 to 7 doses/week.
Humatrope, Norditropin: SubQ: Up to 0.47 mg/kg weekly divided into equal doses 6 to 7 days/week.
Zomacton: SubQ: Up to 0.47 mg/kg weekly divided into equal doses 3, 6, or 7 days/week. Note: Expert guidelines for other indications recommend against 3-times-weekly dosing (Ref).
Short stature homeobox gene (SHOX) deficiency: Children and Adolescents: Humatrope, Zomacton: SubQ: 0.35 mg/kg weekly divided into equal doses 6 to 7 days/week.
Turner syndrome: Children and Adolescents:
Guideline recommendations: Children ≥4 years and Adolescents: SubQ: 0.35 to 0.375 mg/kg weekly divided into equal doses 7 days/week. Higher doses may be considered in patients with poor height prognosis. Maximum dose should be based on specific product labeling (Ref).
Product-specific dosing:
Genotropin; Omnitrope: SubQ: 0.33 mg/kg weekly divided into equal doses 6 to 7 days/week.
Humatrope: SubQ: 0.375 mg/kg weekly divided into equal doses 6 to 7 days/week.
Norditropin: SubQ: Up to 0.47 mg/kg weekly divided into equal doses 6 to 7 days/week.
Nutropin AQ: SubQ: Up to 0.375 mg/kg weekly divided into equal doses 6 to 7 days/week.
Zomacton: SubQ: Up to 0.375 mg/kg weekly divided into equal doses 3, 6, or 7 days/week. Note: Expert guidelines for other indications recommend against 3-times-weekly dosing (Ref).
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
There are no dosage adjustments provided in the manufacturer's labeling; patients with chronic renal failure and end-stage renal disease tend to have decreased clearance.
There are no dosage adjustments provided in the manufacturer's labeling; clearance may be reduced in patients with severe hepatic impairment.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
>10%:
Cardiovascular: Edema (≤41%; including peripheral edema; dependent edema [1% to 5%])
Endocrine & metabolic: Hypothyroidism (25%)
Hypersensitivity: Hypersensitivity reaction (11%)
Nervous system: Headache (10% to 11%)
Neuromuscular & skeletal: Arthralgia (6% to 36%), arthropathy (8% to 11%), limb pain (15%), myalgia (5% to 30%)
Respiratory: Pharyngitis (12%), upper respiratory tract infection (16% to 32%)
Miscellaneous: Fever (16%)
1% to 10%:
Cardiovascular: Cardiac disorder (1%)
Dermatologic: Maculopapular rash (6%)
Endocrine & metabolic: Decreased T4 (9%), hyperglycemia (1% to 5%), gynecomastia (4% to 6%), hypertriglyceridemia (1% to 5%), thyroid dysfunction (1%)
Gastrointestinal: Abdominal pain (7%), diarrhea (5%), nausea (9%)
Hematologic & oncologic: Anemia (6%), neoplasm (≤2%), tumor growth (≤2%)
Immunologic: Antibody development (2%)
Local: Injection-site reaction (≤4%; including bleeding at injection site, burning sensation at injection site, discomfort at injection site, erythema at injection site, fibrosis at injection site, injection-site nodule, injection-site numbness, lipoatrophy at injection site, pain at injection site, rash at injection site, skin discoloration at injection site, swelling at injection site)
Nervous system: Carpal tunnel syndrome (1% to 5%), fatigue (6%), hypoesthesia (5%), pain (5%), paresthesia (7% to 10%)
Neuromuscular & skeletal: Bone disease (4%; including abnormal bone growth, avascular necrosis of bones [Legg-Calve-Perthes disease], bone fracture, disproportional growth of lower jaw, osteonecrosis, and slipped capital femoral epiphysis), stiffness (8%)
Ophthalmic: Periorbital edema (1% to 5%)
Respiratory: Cough (9%), rhinitis (5%)
<1%: Endocrine & metabolic: Diabetes mellitus (including diabetic coma, diabetic ketoacidosis, diabetic retinopathy, exacerbation of diabetes mellitus, impaired glucose intolerance)
Frequency not defined:
Dermatologic: Alopecia
Endocrine & metabolic: Hyperlipidemia, precocious puberty
Genitourinary: Hematuria
Hematologic & oncologic: Hematoma, meningioma
Nervous system: Aggressive behavior, seizure
Neuromuscular & skeletal: Back pain
Postmarketing:
Cardiovascular: Hypertension, lower extremity edema (Gharb 2003)
Dermatologic: Exacerbation of psoriasis (Mehta 2018), increased growth of preexisting nevi, lichenoid eruption (including lichen planus) (Mehta 2018), psoriasiform eruption (Mehta 2018), skin rash (including exacerbation of atopic dermatitis and pruritic rash) (Mann 2022, Mehta 2018)
Endocrine & metabolic: Fluid retention (Gharib 2003)
Gastrointestinal: Pancreatitis (Gharib 2003)
Hematologic & oncologic: Benign neoplasm (new onset or recurring), eosinophilia (Mehta 2018), leukemia (Gharib 2003), malignant neoplasm (new onset or recurring) (Cook 2009)
Hepatic: Increased serum alkaline phosphatase
Hypersensitivity: Anaphylaxis, angioedema, type 1 hypersensitivity reaction (Mehta 2018), type III hypersensitivity reaction (Mehta 2018), type IV hypersensitivity reaction (Mann 2022)
Nervous system: Intracranial hypertension (Obinata 2010)
Neuromuscular & skeletal: Arthritis, joint stiffness (Molitch 2011), ostealgia (including arthralgia of hip and knee pain) (Deal 2013), scoliosis (including scoliosis progression) (Wilson 2003)
Ophthalmic: Papilledema (Kanner 2018)
Respiratory: Dyspnea, sleep apnea (Deal 2013)
Hypersensitivity to somatropin or any component of the formulation; growth promotion in pediatric patients with closed epiphyses; acute critical illness due to increased complications/mortality following open heart or abdominal surgery, multiple accidental trauma, or acute respiratory failure; active malignancy; active proliferative or severe nonproliferative diabetic retinopathy.
Additional product-specific contraindications:
Pediatric patients with Prader-Willi syndrome who have severe obesity or severe respiratory impairment (Genotropin, Humatrope, Norditropin, Nutropin AQ, Omnitrope, Saizen, Zomacton).
Patients with Prader-Willi syndrome who have a history of upper airway obstruction or sleep apnea (Genotropin, Humatrope, Norditropin, Nutropin AQ, Omnitrope, Zomacton).
Canadian labeling: Additional contraindications (not in US labeling): Note: Product-specific contraindications may vary; refer to manufacturer's labeling.
Active intracranial tumor; critically ill patients; pregnancy and lactation; renal transplant; diabetes mellitus (Serostim only).
Patients with Prader-Willi syndrome who have uncontrolled diabetes, active psychosis (Genotropin only).
Concerns related to adverse effects:
• Fluid retention: Fluid retention may occur in adults; manifestations of fluid retention (eg, edema, arthralgia, myalgia, nerve compression syndromes [including carpal tunnel syndrome]/paresthesias) are generally transient and dose dependent.
• Glucose tolerance: Somatropin may decrease insulin sensitivity. Previously undiagnosed impaired glucose tolerance or diabetes mellitus may be detected; new-onset type 2 diabetes mellitus and exacerbation of preexisting diabetes mellitus may occur. Diabetic ketoacidosis and hyperosmolar hyperglycemic state have been reported in some patients. Discontinuing somatropin may improve glucose tolerance in some patients. Adjustment of antidiabetic medications may be necessary.
• Hypersensitivity: Serious systemic hypersensitivity reactions, including anaphylactic reactions and angioedema, have been reported.
• Intracranial hypertension: Intracranial hypertension with headache, nausea, papilledema, visual changes, and/or vomiting has been reported; symptoms usually occur within the first 8 weeks of therapy and signs and symptoms of intracranial hypertension may rapidly resolve after discontinuation or reduction of dose. Funduscopic examination prior to initiation of therapy and periodically thereafter is recommended. Patients with Turner syndrome, chronic renal impairment and Prader-Willi syndrome may be at increased risk for intracranial hypertension.
• Lipoatrophy: Lipoatrophy has been reported at injection sites when used at the same site for a prolonged period. Ensure proper injection technique and rotate injection sites.
• Neoplasm: Increased risk of malignancy progression in patients with active malignancy; any preexisting malignancy should be inactive and treatment complete prior to initiating therapy. An increased risk of second neoplasm has been reported in childhood cancer survivors treated with somatropin; the most common second neoplasms were meningiomas in patients treated with radiation to the head for their first neoplasm. Patients with HIV and pediatric patients with short stature (genetic cause) have increased baseline risk of developing malignancies; consider risk/benefits prior to initiation of therapy and monitor these patients carefully. Rule out pituitary tumor (or other brain tumors) prior to initiation of treatment because growth hormone deficiency may be an early sign of the presence of these tumors.
• Pancreatitis: Has been rarely reported; incidence in children with Turner syndrome may be greater than adults.
• Slipped capital femoral epiphyses: Patients with endocrine disorders (including growth hormone deficiency and Turner syndrome) or in patients undergoing rapid growth may develop slipped capital femoral epiphyses more frequently; evaluate any child with new onset of a limp or with complaints of hip or knee pain.
Disease-related concerns:
• Adrenal insufficiency: Patients who have or are at risk for pituitary hormone deficiency(ies) may be at risk for reduced serum cortisol levels and/or unmasking of central (secondary) adrenal insufficiency with somatropin therapy; patients with previously diagnosed adrenal insufficiency may require increased glucocorticoid doses. Excessive glucocorticoid therapy may inhibit the growth-promoting effects of somatropin in children.
• Chronic kidney disease: Slipped capital femoral epiphysis or avascular necrosis of the femoral head may be seen in children with advanced renal osteodystrophy. Obtain x-rays of the hip prior to initiating somatropin in chronic kidney disease patients; be alert to the development of a limp or complaints of hip or knee pain.
• Hypothyroidism: Patients who have or are at risk for pituitary hormone deficiency(ies) may be at risk for central (secondary) hypothyroidism; patients with Turner syndrome have an increased risk of developing autoimmune thyroid disease and primary hypothyroidism. Untreated/undiagnosed hypothyroidism may decrease response to somatropin therapy, particularly the growth response in children.
• Noonan syndrome: Safety has not been established for the treatment of Noonan syndrome in children with significant cardiac disease.
• Prader-Willi syndrome: Sudden death has been reported in pediatric patients with Prader-Willi syndrome following the use of growth hormone. The reported fatalities occurred in patients with one or more risk factors, including severe obesity, history of upper airway obstruction or sleep apnea, respiratory impairment, or unidentified respiratory infection; male patients may be at greater risk. Treatment interruption is recommended in patients who show signs of upper airway obstruction, including the onset of, or increased, snoring and/or new-onset sleep apnea. Unless patients with Prader-Willi syndrome also have a diagnosis of growth hormone deficiency, use is not indicated for the long-term treatment of pediatric patients who have growth failure due to Prader-Willi syndrome.
• Scoliosis: Progression of scoliosis may occur in children experiencing rapid growth.
• Turner syndrome: Patients with Turner syndrome are at increased risk for otitis media and other ear/hearing disorders, autoimmune thyroid disease, primary hypothyroidism, and cardiovascular disorders (eg, hypertension, aortic aneurysm/dissection, stroke).
Special populations:
• Older adults: Older adult patients may be more sensitive to the actions of somatropin; consider lower starting doses and smaller dose increments.
• Pediatric: Failure to increase growth rate, particularly during the first year of therapy, indicates need for close assessment of adherence and evaluation for other causes of growth failure, such as hypothyroidism, undernutrition, advanced bone age, and antibodies to recombinant human growth hormone.
• Renal transplant recipients: No studies have been completed evaluating Nutropin AQ in patients with renal transplant; use of Nutropin AQ is not indicated in patients with functioning renal allografts.
Dosage form specific issues:
• Benzyl alcohol and derivatives: Diluent may contain benzyl alcohol; large amounts of benzyl alcohol (≥99 mg/kg/day) have been associated with a potentially fatal toxicity (“gasping syndrome”) in neonates; the “gasping syndrome” consists of metabolic acidosis, respiratory distress, gasping respirations, CNS dysfunction (including convulsions, intracranial hemorrhage), hypotension, and cardiovascular collapse (AAP ["Inactive" 1997]; CDC 1982); some data suggests that benzoate displaces bilirubin from protein binding sites (Ahlfors 2001); avoid or use dosage forms containing benzyl alcohol with caution in neonates. See manufacturer's labeling.
• M-cresol: Some products may contain m-cresol as a preservative.
• Multiple-dose injection pens: According to the Centers for Disease Control and Prevention (CDC), pen-shaped injection devices should never be used for more than one person (even when the needle is changed) because of the risk of infection. The injection device should be clearly labeled with individual patient information to ensure that the correct pen is used (CDC 2012).
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Cartridge, Injection:
Humatrope: 6 mg (1 ea); 12 mg (1 ea); 24 mg (1 ea) [contains glycerin, metacresol]
Cartridge, Subcutaneous:
Genotropin: 5 mg (1 ea); 12 mg (1 ea) [contains metacresol]
Prefilled Syringe, Subcutaneous [preservative free]:
Genotropin MiniQuick: 0.2 mg (1 ea); 0.4 mg (1 ea); 0.6 mg (1 ea); 0.8 mg (1 ea); 1 mg (1 ea); 1.2 mg (1 ea); 1.4 mg (1 ea); 1.6 mg (1 ea); 1.8 mg (1 ea); 2 mg (1 ea)
Solution Cartridge, Subcutaneous:
Omnitrope: 5 mg/1.5 mL (1.5 mL) [contains benzyl alcohol]
Omnitrope: 10 mg/1.5 mL (1.5 mL) [contains phenol]
Solution Pen-injector, Subcutaneous:
Norditropin FlexPro: 5 mg/1.5 mL (1.5 mL); 10 mg/1.5 mL (1.5 mL); 15 mg/1.5 mL (1.5 mL); 30 mg/3 mL (3 mL) [contains phenol]
Nutropin AQ NuSpin 5: 5 mg/2 mL (2 mL) [contains phenol]
Nutropin AQ NuSpin 10: 10 mg/2 mL (2 mL) [contains phenol]
Nutropin AQ NuSpin 20: 20 mg/2 mL (2 mL) [contains phenol]
Solution Reconstituted, Injection:
Humatrope: 5 mg (1 ea [DSC])
Saizen: 5 mg (1 ea); 8.8 mg (1 ea)
Saizenprep: 8.8 mg (1 ea [DSC]) [contains metacresol]
Solution Reconstituted, Subcutaneous:
Omnitrope: 5.8 mg (1 ea)
Serostim: 4 mg (1 ea) [contains benzyl alcohol]
Serostim: 5 mg (1 ea); 6 mg (1 ea)
Zomacton: 5 mg (1 ea) [contains benzyl alcohol]
Zomacton: 10 mg (1 ea) [contains metacresol]
Zomacton (for Zoma-Jet 10): 10 mg (1 ea [DSC]) [contains metacresol]
Zorbtive: 8.8 mg (1 ea [DSC]) [contains benzyl alcohol]
No
Cartridge (Genotropin Subcutaneous)
5 mg (per each): $886.52
12 mg (per each): $2,127.68
Cartridge (Humatrope Injection)
6 mg (per each): $1,116.72
12 mg (per each): $2,233.44
24 mg (per each): $4,466.88
Prefilled Syringe (Genotropin MiniQuick Subcutaneous)
0.2 mg (per each): $36.43
0.4 mg (per each): $72.87
0.6 mg (per each): $109.30
0.8 mg (per each): $145.73
1 mg (per each): $182.17
1.2 mg (per each): $218.60
1.4 mg (per each): $255.03
1.6 mg (per each): $291.45
1.8 mg (per each): $327.90
2 mg (per each): $364.32
Solution (reconstituted) (Omnitrope Subcutaneous)
5.8 mg (per each): $396.96
Solution (reconstituted) (Saizen Injection)
5 mg (per each): $862.24
8.8 mg (per each): $1,379.57
Solution (reconstituted) (Serostim Subcutaneous)
4 mg (per each): $553.49
5 mg (per each): $691.86
6 mg (per each): $830.23
Solution (reconstituted) (Zomacton Subcutaneous)
5 mg (per each): $348.00
10 mg (per each): $696.00
Solution Cartridge (Omnitrope Subcutaneous)
5 mg/1.5 mL (per mL): $441.08
10 mg/1.5 mL (per mL): $882.15
Solution Pen-injector (Norditropin FlexPro Subcutaneous)
5 mg/1.5 mL (per mL): $644.36
10 mg/1.5 mL (per mL): $1,288.72
15 mg/1.5 mL (per mL): $1,933.08
30 mg/3 mL (per mL): $1,933.08
Solution Pen-injector (Nutropin AQ NuSpin 10 Subcutaneous)
10 mg/2 mL (per mL): $754.41
Solution Pen-injector (Nutropin AQ NuSpin 20 Subcutaneous)
20 mg/2 mL (per mL): $1,508.81
Solution Pen-injector (Nutropin AQ NuSpin 5 Subcutaneous)
5 mg/2 mL (per mL): $377.20
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Pen-injector, Subcutaneous:
Genotropin GoQuick: 5 mg (1 ea); 5.3 mg (1 ea); 12 mg (1 ea) [contains metacresol]
Prefilled Syringe, Subcutaneous:
Genotropin MiniQuick: 0.2 mg (1 ea); 0.4 mg (1 ea); 0.6 mg (1 ea); 0.8 mg (1 ea); 1 mg (1 ea); 1.2 mg (1 ea); 1.4 mg (1 ea); 1.6 mg (1 ea); 1.8 mg (1 ea); 2 mg (1 ea)
Solution Cartridge, Subcutaneous:
Omnitrope: 5 mg/1.5 mL (1.5 mL) [contains benzyl alcohol]
Omnitrope: 10 mg/1.5 mL (1.5 mL); 15 mg/1.5 mL (1.5 mL) [contains phenol]
Saizen: 6 mg/1.03 mL (1.03 mL); 12 mg/1.5 mL (1.5 mL); 20 mg/2.5 mL (2.5 mL) [contains phenol]
Solution Pen-injector, Subcutaneous:
Norditropin FlexPro: 5 mg/1.5 mL (1.5 mL); 10 mg/1.5 mL (1.5 mL); 15 mg/1.5 mL (1.5 mL) [contains phenol]
Norditropin NordiFlex Pen: 5 mg/1.5 mL (1.5 mL); 10 mg/1.5 mL (1.5 mL); 15 mg/1.5 mL (1.5 mL) [contains phenol]
Nutropin AQ NuSpin 5: 5 mg/2 mL (2 mL) [contains phenol]
Nutropin AQ NuSpin 10: 10 mg/2 mL (2 mL) [contains phenol]
Nutropin AQ NuSpin 20: 20 mg/2 mL (2 mL) [contains phenol]
Solution Reconstituted, Injection:
Humatrope: 6 mg (1 ea); 12 mg (1 ea) [contains metacresol]
Humatrope: 24 mg (1 ea) [contains glycerin, metacresol]
Saizen: 5 mg (1 ea)
Solution Reconstituted, Subcutaneous:
Humatrope: 5 mg ([DSC]) [contains metacresol]
Saizen: 8.8 mg ([DSC]) [contains benzyl alcohol]
Serostim: 5 mg (1 ea)
Serostim: 8.8 mg ([DSC]) [contains benzyl alcohol]
SUBQ: Do not shake. Administer SUBQ; do not inject IV. Rotate administration sites (back of upper arm, abdomen, buttock, or thigh) to avoid tissue atrophy.
Parenteral: SubQ: Administer by SubQ injection only; not for IV injection; do not shake. Administer into the back of the upper arm, thigh, buttock, or abdomen; rotate administration sites to avoid tissue atrophy.
Product-specific information:
Omnitrope: Solution in the Omnitrope cartridges must be administered using the Omnitrope pen; see product labeling for details on correct installation of cartridge; prime pen prior to first use.
Zomacton: When administering Zomacton, use a standard sterile disposable needle or ZOMA-Jet Needle-Free injection device for SubQ injection; see product labeling for proper use of the injection device.
Timing of administration for treatment of growth failure due to chronic kidney disease:
Hemodialysis (HD): Administer at night just prior to sleeping and at least 3 to 4 hours after dialysis.
Peritoneal dialysis (PD):
Chronic cycling peritoneal dialysis: Administer in the morning after dialysis.
Continuous ambulatory peritoneal dialysis (CAPD): Administer in the evening at the time of the overnight exchange.
Growth failure (pediatric patients):
Treatment of growth failure due to inadequate endogenous growth hormone secretion (Genotropin, Humatrope, Norditropin, Nutropin AQ, Omnitrope, Saizen, Tev-Tropin, Zomacton).
Treatment of short stature associated with Turner syndrome (Genotropin, Humatrope, Norditropin, Nutropin AQ, Omnitrope, Zomacton).
Treatment of Prader-Willi syndrome (Genotropin, Norditropin, Omnitrope).
Treatment of growth failure associated with chronic kidney disease up until the time of renal transplantation (Nutropin AQ).
Treatment of growth failure in children born small for gestational age who fail to manifest catch-up growth by 2 years of age (Genotropin, Omnitrope) or by 2 to 4 years of age (Humatrope, Norditropin, Zomacton)
Treatment of idiopathic short stature (nongrowth hormone-deficient short stature), defined by height standard deviation score (SDS) ≤-2.25 and growth rate not likely to attain adult height in the normal range, in pediatric patients whose epiphyses are not closed and for whom other causes associated with short stature have been excluded (Genotropin, Humatrope, Norditropin, Nutropin AQ, Omnitrope, Zomacton).
Treatment of short stature or growth failure associated with short stature homeobox gene (SHOX) deficiency (Humatrope, Zomacton).
Treatment of short stature associated with Noonan syndrome (Norditropin).
Growth hormone deficiency (adults): Replacement of endogenous growth hormone in adults with growth hormone deficiency who meet either of the following criteria (Genotropin, Humatrope, Norditropin, Nutropin AQ, Omnitrope, Saizen, Zomacton):
Adult-onset: Patients who have adult growth hormone deficiency whether alone or with multiple hormone deficiencies (hypopituitarism) as a result of pituitary disease, hypothalamic disease, surgery, radiation therapy, or trauma
or
Childhood-onset: Patients who had growth hormone deficiency during childhood as a result of congenital, genetic, acquired, or idiopathic causes.
HIV-associated wasting, cachexia: Treatment of patients with HIV-associated wasting or cachexia (Serostim).
Short bowel syndrome: Treatment of short-bowel syndrome in patients receiving specialized nutritional support (Zorbtive).
HIV-associated adipose redistribution syndrome (HARS) (Serostim)
Humatrope may be confused with homatropine
Somatrem may be confused with somatropin
Somatropin may be confused with homatropine, sumatriptan
Beers Criteria: Growth hormone is identified in the Beers Criteria as a potentially inappropriate medication to be avoided in patients 65 years and older except as hormone replacement in patients with growth hormone deficiency due to an established etiology that is based on a rigorous diagnosis by evidence-based criteria due to its minimal impact on body composition and its association with causing edema, arthralgia, carpal tunnel syndrome, gynecomastia, and impaired fasting glucose (Beers Criteria [AGS 2023]).
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Antidiabetic Agents: Hyperglycemia-Associated Agents may diminish the therapeutic effect of Antidiabetic Agents. Risk C: Monitor therapy
Corticosteroids (Systemic): May diminish the therapeutic effect of Growth Hormone Analogs. Growth Hormone Analogs may decrease serum concentrations of the active metabolite(s) of Corticosteroids (Systemic). Risk C: Monitor therapy
Cortisone: May diminish the therapeutic effect of Growth Hormone Analogs. Growth Hormone Analogs may decrease serum concentrations of the active metabolite(s) of Cortisone. Risk C: Monitor therapy
Estrogen Derivatives: May diminish the therapeutic effect of Growth Hormone Analogs. Management: Initiate somapacitan at 2 mg once weekly in patients receiving oral estrogens. Monitor for reduced efficacy of growth hormone analogs; increased doses may be required. Risk D: Consider therapy modification
Macimorelin: Products that Affect Growth Hormone may diminish the diagnostic effect of Macimorelin. Risk X: Avoid combination
PredniSONE: May diminish the therapeutic effect of Growth Hormone Analogs. Growth Hormone Analogs may decrease serum concentrations of the active metabolite(s) of PredniSONE. Risk C: Monitor therapy
Thyroid Products: Somatropin may diminish the therapeutic effect of Thyroid Products. Risk C: Monitor therapy
Adequate somatropin use prior to conception may improve fertility in females with hypopituitarism (Vila 2019).
During normal pregnancy, maternal production of endogenous growth hormone decreases as placental growth hormone production increases. Data with somatropin use during pregnancy in females with hypopituitarism is limited; however, adequate replacement prior to conception may improve fertility (Vila 2019). The Endocrine Society guidelines for hormonal replacement in hypopituitarism suggest discontinuation of somatropin during pregnancy (ES [Fleseriu 2016]).
It is not known if somatropin is present in breast milk.
Endogenous growth hormone is involved in the establishment of lactogenesis and use of recombinant growth hormone has been evaluated as a galactogogue. Although use may be considered in some patients, somatropin is not currently used in most countries; nonpharmacologic measures should be used prior to the start of medications (ABM [Brodribb 2018]). Adverse events have not been reported in breastfed infants following maternal use (limited data). According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and benefits of treatment to the mother.
General monitoring: Monitor for progression or recurrence of tumor in patients treated for growth deficiency secondary to a tumor or tumor development in at-risk patients; progression of preexisting nevi; malignant transformation of skin lesions. Perform fundoscopic examination prior to treatment.
Indication-specific monitoring:
Treatment of growth hormone deficiency (children): Growth response; progression of scoliosis in patients with a history of scoliosis; clinical evidence of slipped capital femoral epiphysis, such as a limp or hip or knee pain; thyroid function; glucose in patients with risk factors for glucose intolerance. In addition, guidelines recommend a physical exam at every visit; monitoring serum IGF-1; adrenal and thyroid function in patients with growth hormone deficiency due to multiple pituitary hormone deficiencies; funduscopic exam if symptoms of intracranial hypertension occur (Grimberg [PES 2016]).
Chronic kidney disease: Progression of renal osteodystrophy.
Idiopathic short stature: Height, weight, pubertal development and adverse events every 3 to 6 months (Cohen 2008).
Prader-Willi syndrome: Signs of upper airway obstruction (including onset of or increased snoring), sleep apnea, respiratory infections; effective weight control.
Turner syndrome: Ear disorders including otitis media; cardiovascular disorders (eg, stroke, aortic aneurysm/dissection, hypertension).
Noonan syndrome: Prior to use, verify short stature syndrome.
Treatment of growth hormone deficiency (adults): Monitor clinical response, serum IGF-1, and adverse effects every 1 to 2 months during dose titration. Once at maintenance dose, monitor serum IGF-1, fasting glucose, hemoglobin A1c, BMI, waist circumference/waist to hip ratio, thyroid function (free T4), adrenal function, lipid profile, BP, heart rate, clinical response, and adverse effects every 6 to 12 months. In patients with a pituitary adenoma lesion, obtain MRI at baseline and periodically thereafter. Evaluate bone mineral density prior to therapy initiation; repeat DXA scan every 1.5 to 3 years if initial bone scan is abnormal (AACE/ACE [Yuen 2019]; ES [Fleseriu 2016]; ES [Molitch 2011]).
Short bowel syndrome: Optimize diet prior to therapy and monitor nutritional status during treatment; colonoscopy prior to therapy (in patients with residual colon) especially if risk factors for colon cancer are present (Steiger 2006). In addition, monitor glucose in patients with risk factors for glucose intolerance; thyroid function prior to and 4 weeks after treatment initiation in patients with suspected or diagnosed hypopituitarism.
Somatropin is a purified polypeptide hormones of recombinant DNA origin; somatropin contains the identical sequence of amino acids found in human growth hormone; human growth hormone assists growth of linear bone, skeletal muscle, and organs by stimulating chondrocyte proliferation and differentiation, lipolysis, protein synthesis, and hepatic glucose output; stimulates erythropoietin which increases red blood cell mass; exerts both insulin-like and diabetogenic effects; enhances the transmucosal transport of water, electrolytes, and nutrients across the gut
Distribution: Vd: Nutropin AQ: 50 mL/kg; Norditropin: 43.9 ± 14.9 L; Zorbtive: 12 ± 1 L.
Metabolism: Hepatic and renal.
Bioavailability: SubQ: Nutropin AQ; Saizen; Serostim; Zorbtive: 70% to 90%.
Half-life elimination:
Genotropin: SubQ: 3 hours.
Humatrope: SubQ: 3.8 hours.
Norditropin: SubQ: ~7 to 10 hours.
Nutropin AQ: SubQ: 2.1 ± 0.43 hours.
Omnitrope: SubQ: 2.5 to 2.8 hours.
Saizen: SubQ: ~2 hours.
Serostim: SubQ: 4.28 ± 2.15 hours.
Zomacton: SubQ: ~2.7 hours.
Zorbtive: SubQ: 4 ± 2 hours.
Excretion: Urine.
Altered kidney function: Patients with chronic renal failure and ESRD have decreased clearance.
Hepatic function impairment: Reduction in clearance has been noted in patients with severe hepatic impairment.
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