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Somatropin

Pronunciation

Pronunciation

(soe ma TROE pin)

Index Terms

  • Growth Hormone, Human
  • hGH
  • Human Growth Hormone

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Solution, 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]

Norditropin NordiFlex Pen: 30 mg/3 mL (3 mL [DSC]) [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]

Nutropin AQ Pen: 10 mg/2 mL (2 mL [DSC])

Nutropin AQ Pen: 20 mg/2 mL (2 mL [DSC]) [contains phenol]

Omnitrope: 5 mg/1.5 mL (1.5 mL) [contains benzyl alcohol]

Omnitrope: 10 mg/1.5 mL (1.5 mL) [contains phenol]

Solution Reconstituted, Injection:

Humatrope: 5 mg (1 ea)

Humatrope: 6 mg (1 ea); 12 mg (1 ea); 24 mg (1 ea) [contains glycerin, metacresol]

Saizen: 5 mg (1 ea); 8.8 mg (1 ea)

Saizen Click.Easy: 8.8 mg (1 ea)

Saizenprep: 8.8 mg (1 ea) [contains metacresol]

Solution Reconstituted, Subcutaneous:

Genotropin: 5 mg (1 ea); 12 mg (1 ea) [contains metacresol]

Nutropin: 10 mg (1 ea [DSC]) [contains benzyl alcohol]

Omnitrope: 5.8 mg (1 ea)

Serostim: 4 mg (1 ea); 5 mg (1 ea); 6 mg (1 ea)

Tev-Tropin: 5 mg (1 ea [DSC])

Zomacton: 5 mg (1 ea) [contains benzyl alcohol]

Zomacton: 10 mg (1 ea) [contains metacresol]

Zorbtive: 8.8 mg (1 ea) [contains benzyl alcohol]

Solution Reconstituted, 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)

Brand Names: U.S.

  • Genotropin
  • Genotropin MiniQuick
  • Humatrope
  • Norditropin FlexPro
  • Norditropin NordiFlex Pen [DSC]
  • Nutropin AQ NuSpin 10
  • Nutropin AQ NuSpin 20
  • Nutropin AQ NuSpin 5
  • Nutropin AQ Pen [DSC]
  • Nutropin [DSC]
  • Omnitrope
  • Saizen
  • Saizen Click.Easy
  • Saizenprep
  • Serostim
  • Tev-Tropin [DSC]
  • Zomacton
  • Zorbtive

Pharmacologic Category

  • Growth Hormone

Pharmacology

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: 50 mL/kg

Metabolism

Hepatic and renal

Excretion

Urine (0.1%, as unchanged drug)

Half-Life Elimination

Genotropin: SubQ: 3 hours

Humatrope: SubQ: 3.8 hours

Norditropin: SubQ: ~7 to 10 hours

Nutropin, 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: 3.94 ± 3.44 hours

Special Populations: Renal Function Impairment

Patients with chronic renal failure and end-stage renal disease (ESRD) have decreased clearance.

Special Populations: Hepatic Function Impairment

Reduction in clearance has been noted in patients with severe hepatic impairment.

Use: Labeled Indications

Growth failure (pediatric patients):

Treatment of pediatric patients who have growth failure due to inadequate endogenous growth hormone secretion (Genotropin, Humatrope, Norditropin, Nutropin, Nutropin AQ, Omnitrope, Saizen, Tev-Tropin, Zomacton).

Treatment of pediatric patients who have growth failure or short stature associated with Turner syndrome (Genotropin, Humatrope, Norditropin, Nutropin, Nutropin AQ, Omnitrope).

Treatment of pediatric patients who have growth failure due to Prader-Willi syndrome (Genotropin, Omnitrope).

Treatment of pediatric patients who have growth failure associated with chronic kidney disease up until the time of renal transplantation (Nutropin, 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)

Treatment of pediatric patients who have 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, Nutropin, Nutropin AQ, Omnitrope).

Treatment of pediatric patients who have short stature or growth failure associated with short stature homeobox gene (SHOX) deficiency (Humatrope).

Treatment of pediatric patients who have 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, Nutropin AQ, Omnitrope, Saizen):

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 were growth hormone deficient during childhood as a result of congenital, genetic, acquired, or idiopathic causes, confirmed as an adult before replacement therapy is initiated

HIV-associated wasting, cachexia: Treatment of HIV patients with wasting or cachexia (Serostim).

Short bowel syndrome: Treatment of short-bowel syndrome in patients receiving specialized nutritional support (Zorbtive).

Off Label Uses

HIV-associated adipose redistribution syndrome (HARS) (Serostim)

Data from a randomized, double-blind, placebo-controlled, multicenter study supports the use of somatropin (Serostim) in the treatment of HIV-associated adipose redistribution syndrome (HARS) [Grunfeld 2007]. Somatropin produced greater relative loss of visceral adipose tissue and trunk fat. In another double-blind, randomized, placebo-controlled study somatropin (Serostim) was also found to decrease visceral adipose tissue in patient with HIV-associated adipose redistribution syndrome (HARS) [Kotler 2004].

Additional Off-Label Uses

Pediatric HIV patients with wasting/cachexia (Serostim)

Contraindications

Hypersensitivity to somatropin or any component of the formulation; growth promotion in pediatric patients with closed epiphyses; acute critical illness due to complications following open heart or abdominal surgery, multiple accidental trauma, or acute respiratory failure; active malignancy.

Additional product-specific contraindications:

Active proliferative or severe nonproliferative diabetic retinopathy (Genotropin, Humatrope, Norditropin, Nutropin, Nutropin AQ, Omnitrope, Saizen, Serostim, Zomacton).

Pediatric patients with Prader-Willi syndrome who are severely obese or have severe respiratory impairment (Genotropin, Humatrope, Norditropin, Nutropin, 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, Nutropin AQ, Omnitrope).

Dosing: Adult

Note: Nutropin (lyophilized powder) has been discontinued in the US for more than 1 year.

Growth hormone deficiency: Adjust dose based on individual requirements: To minimize adverse events in older or overweight patients, reduced dosages may be necessary. During therapy, dosage should be decreased if required by the occurrence of side effects or excessive IGF-I levels.

Weight-based dosing: Note: Obese patients are more likely to experience adverse effects when treated with a weight-based regimen.

Norditropin: SubQ: Initial dose ≤0.004 mg/kg/day; after ~6 weeks, may increase up to 0.016 mg/kg/day

Nutropin, Nutropin AQ: SubQ: ≤0.006 mg/kg/day; dose may be increased up to a maximum of 0.025 mg/kg/day in patients ≤35 years, or up to a maximum of 0.0125 mg/kg/day in patients >35 years

Humatrope: SubQ: ≤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 divided into equal doses 6 to 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 to ≤0.01 mg/kg/day after 4 weeks.

Non–weight-based dosing: SubQ: Initial: ~0.2 mg/day (range: 0.15 to 0.3 mg/day); may increase every 1 to 2 months by 0.1 to 0.2 mg/day based on response and/or serum IGF-I levels.

Dosage adjustment with estrogen supplementation: Larger doses of somatropin may be needed for women taking oral estrogen replacement products; dosing not affected by topical products

HIV-associated adipose redistribution syndrome (HARS) (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 (Grunfeld 2007; Kotler 2004).

HIV-associated wasting, cachexia:

Serostim: SubQ: Initial: 0.1 mg/kg once daily at bedtime (maximum: 6 mg/day); patients at risk for side 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 side 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 by 50%

Severe toxicity: Discontinue therapy for up to 5 days; when symptoms resolve, restart at 50% of dose. If severe toxicity recurs or does not disappear within 5 days after discontinuation, permanently discontinue treatment.

Dosing: Geriatric

Consider a lower starting dose and smaller dose increments.

Dosing: Pediatric

Note: Nutropin (lyophilized powder) has been discontinued in the US for more than 1 year.

Growth hormone defieciency:

Genotropin, Omnitrope: SubQ: Weekly dosage: 0.16 to 0.24 mg/kg divided into equal doses 6 to 7 days per week.

Humatrope: SubQ: Weekly dosage: 0.18 to 0.3 mg/kg divided into equal doses 6 to 7 days per week.

Norditropin: SubQ: 0.024 to 0.034 mg/kg/day, 6 to 7 days per week.

Nutropin, Nutropin AQ: SubQ: Weekly dosage: 0.3 mg/kg divided into equal daily doses; pubertal patients: ≤0.7 mg/kg divided into equal daily doses.

Saizen: SubQ: Weekly dosage: 0.18 mg/kg divided into equal daily doses or as 0.06 mg/kg/dose administered 3 days per week or as 0.03 mg/kg/dose administered 6 days per week.

Tev-Tropin, Zomacton: SubQ: ≤0.1 mg/kg/dose 3 days per week.

Note: Therapy should be discontinued when patient has reached satisfactory adult height, when epiphyses have fused, or when the patient ceases to respond. Growth of 5 cm/year or more is expected, if growth rate does not exceed 2.5 cm in a 6-month period, double the dose for the next 6 months; if there is still no satisfactory response, discontinue therapy

Growth failure secondary to chronic kidney disease (CKD): Nutropin, Nutropin AQ: SubQ: Weekly dosage: ≤0.35 mg/kg divided into daily injections; continue until the time of renal transplantation.

Dosage recommendations in patients treated for CKD who require dialysis:

Hemodialysis: Administer dose at night prior to bedtime or at least 3 to 4 hours after hemodialysis to prevent hematoma formation from heparin.

CCPD: Administer dose in the morning following dialysis.

CAPD: Administer dose in the evening at the time of overnight exchange.

Turner syndrome:

Genotropin, Omnitrope: SubQ: Weekly dosage: 0.33 mg/kg divided into equal doses 6 to 7 days per week.

Humatrope: SubQ: Weekly dosage: ≤0.375 mg/kg divided into equal doses 6 to 7 days per week.

Norditropin: SubQ: ≤0.067 mg/kg/day

Nutropin, Nutropin AQ: SubQ: Weekly dosage: ≤0.375 mg/kg divided into equal doses 3 to 7 days per week.

Prader-Willi syndrome: Genotropin, Omnitrope: SubQ: Weekly dosage: 0.24 mg/kg divided into equal doses 6 to 7 days per week

Small for gestational age:

Genotropin, Omnitrope: SubQ: Weekly dosage: ≤0.48 mg/kg divided into equal doses 6 to 7 days per week.

Humatrope: SubQ: Weekly dosage: ≤0.47 mg/kg divided into equal doses 6 to 7 days per week.

Norditropin: SubQ: ≤0.067 mg/kg/day

Alternate dosing (small for gestational age): In older/pubertal children or children with very short stature (ie, height SDS <–3), consider initiating therapy at higher doses (eg, 0.067 mg/kg/day [0.48 mg/kg/week]) and then consider reducing the dose (eg, gradually towards 0.033 mg/kg/day [0.24 mg/kg/week]) if substantial catch-up growth observed during the first few years of therapy. In younger children (~<4 years) with less severe short stature (ie, baseline height SDS values between -2 and -3), consider initiating therapy with lower doses (eg, 0.033 mg/kg/day [0.24 mg/kg/week]) and then titrating the dose upwards as needed.

Idiopathic short stature:

Genotropin, Omnitrope: SubQ: Weekly dosage: ≤0.47 mg/kg divided into equal doses 6 to 7 days per week

Humatrope: SubQ: Weekly dosage: ≤0.37 mg/kg divided into equal doses 6 to 7 days per week

Nutropin, Nutropin AQ: SubQ: Weekly dosage: ≤0.3 mg/kg divided into equal daily doses

Short stature associated with Noonan syndrome: Norditropin: SubQ: ≤0.066 mg/kg/day

SHOX deficiency: Humatrope: SubQ: Weekly dosage: 0.35 mg/kg divided into equal doses 6 to 7 days per week

HIV patients with wasting or cachexia (off-label use): Serostim: SubQ: Limited data; doses of 0.04 mg/kg/day were reported in five children, 6 to 17 years of age; doses of 0.07 mg/kg/day were reported in six children, 8 to 14 years of age

Dosing: Renal Impairment

There are no dosage adjustments provided in the manufacturer's labeling; decreased clearance in patients with chronic renal failure and end-stage renal disease.

Dosing: Hepatic Impairment

There are no dosage adjustments provided in the manufacturer's labeling; reduced clearance in patients with severe hepatic impairment.

Reconstitution

Genotropin:

Cartridge: Reconstitute with diluent provided.

MiniQuick: Reconstitute with diluent provided. Consult the instructions provided with the reconstitution device.

Humatrope:

Cartridge: Consult HumatroPen User Guide for complete instructions for reconstitution. Dilute with solution provided with cartridges ONLY; do not use diluent provided with vials.

Vial: Reconstitute with 1.5 to 5 mL diluent provided. Swirl gently; do not shake. If sensitivity to the diluent occurs, reconstitute with bacteriostatic water for injection (benzyl alcohol preserved) or sterile water for injection. Reconstitute with sterile water for injection for use in newborns.

Nutropin: Reconstitute each vial with 1 to 10 mL bacteriostatic water for injection (benzyl alcohol preserved). Swirl gently, do not shake. If sensitivity to the diluent occurs or for use in newborns, reconstitute with sterile water for injection.

Nutropin AQ: Allow device to come to room temperature and gently swirl; if solution is cloudy, do not use.

Omnitrope vial: Reconstitute with provided diluent. Swirl gently; do not shake.

Saizen:

Cartridge: Consult instructions provided with reconstitution device.

Vial: Reconstitute 5 mg vial with 1 to 3 mL and 8.8 mg vial with 2 to 3 mL bacteriostatic water for injection (benzyl alcohol preserved). If sensitivity to the diluent occurs, reconstitute with sterile water for injection. Gently swirl; do not shake.

Serostim:

4 mg vial: Reconstitute with 0.5 to 1 mL bacteriostatic water for injection (benzyl alcohol preserved). For patients sensitive to benzyl alcohol, reconstitute with sterile water for injection.

5 or 6 mg vial: Reconstitute with 0.5 to 1 mL sterile water for injection.

Tev-Tropin, Zomacton: Note: Only use the provided diluent for the 5 mg and 10 mg vial; diluents differ, do not interchange. Some cloudiness may occur; do not use if cloudiness persists after warming to room temperature.

5 mg vial: Reconstitute with 1 to 5 mL of provided diluent. Swirl gently; do not shake. If sensitivity to the diluent occurs or for use in newborns, reconstitute with sterile water for injection.

10 mg vial: Reconstitute with 1 mL of provided diluent. Use the 25-gauge mixing needle provided. Swirl gently; do not shake.

Zorbtive: Reconstitute with 1 to 2 mL bacteriostatic water for injection (benzyl alcohol preserved). Swirl gently; do not shake. Allow refrigerated solution to come to room temperature prior to administration.

Administration

Do not shake. Administer SubQ; do not inject IV. Rotate administration sites to avoid tissue atrophy.

Storage

Genotropin:

Cartridge: Store at 2°C to 8°C (36°F to 46°F); do not freeze. Protect from light. Following reconstitution, may store under refrigeration for up to 28 days.

Miniquick: Store at 2°C to 8°C (36°F to 46°F) prior to dispensing; may be stored ≤25°C (77°F) for up to 3 months after dispensing. Store in original carton to protect from light; do not freeze. Once reconstituted, solution must be refrigerated and used within 24 hours. Discard unused portion.

Humatrope:

Cartridge: Before and after reconstitution, store at 2°C to 8°C (36°F to 46°F); do not freeze. Following reconstitution with provided diluent, stable for 28 days under refrigeration.

Vial: Before and after reconstitution, store at 2°C to 8°C (36°F to 46°F); do not freeze. When reconstituted with provided diluent or bacteriostatic water for injection (benzyl alcohol preserved), use within 14 days. When reconstituted with sterile water for injection, use within 24 hours and discard unused portion.

Norditropin: Store at 2°C to 8°C (36°F to 46°F); do not freeze. Avoid direct light. Pens in use may be stored in refrigerator and used within 4 weeks after initial injection or may be stored up to 3 weeks at ≤25°C (77°F). Discard unused portion.

Nutropin: Before and after reconstitution, store at 2°C to 8°C (36°F to 46°F); do not freeze. Use vials reconstituted with bacteriostatic water for injection (benzyl alcohol preserved) within 14 days; when reconstituted with sterile water for injection, use immediately and discard unused portion.

Nutropin AQ: Before and after reconstitution, store at 2°C to 8°C (36°F to 46°F); do not freeze. Use within 28 days following initial use. Protect from light.

Omnitrope:

Cartridge: Store at 2°C to 8°C (36°F to 46°F); do not freeze. Protect from light. Once the cartridge is loaded into the pen delivery system, store under refrigeration for up to 28 days after first use.

Vial: Store intact vials at 2°C to 8°C (36°F to 46°F); do not freeze. Protect from light. Following reconstitution, store under refrigeration for up to 3 weeks. Store vial in carton to protect from light.

Saizen:

Cartridge: Store at 15°C to 30°C (59°F to 86°F). Following reconstitution with the provided diluent, store under refrigeration for up to 21 days. Avoid freezing.

Vial: Store at 15°C to 30°C (59°F to 86°F). Following reconstitution with bacteriostatic water for injection (benzyl alcohol preserved), store under refrigeration for up to 14 days. Following reconstitution with sterile water for injection, use immediately and discard unused portion. Avoid freezing.

Serostim: Prior to reconstitution, store at 15°C to 30°C (59°F to 86°F). Following reconstitution with sterile water for injection, use immediately and discard unused portion. Following reconstitution with bacteriostatic water for injection (benzyl alcohol preserved), store under refrigeration for up to 14 days; avoid freezing.

Tev-Tropin, Zomacton: Prior to reconstitution, store at 2°C to 8°C (36°F to 46°F). Following reconstitution with the provided diluent, store under refrigeration and use within 14 days (5 mg vial) or 28 days (10 mg vial); do not freeze.

Zorbtive: Store intact vials and diluent at 15°C to 30°C (59°F to 86°F). Following reconstitution with the provided diluent, store under refrigeration at 2°C to 8°C (36°F to 46°F) for up to 14 days; do not freeze.

Drug Interactions

Antidiabetic Agents: Hyperglycemia-Associated Agents may diminish the therapeutic effect of Antidiabetic Agents. Monitor therapy

Cortisone: Somatropin may diminish the therapeutic effect of Cortisone. Growth hormone may reduce the conversion of cortisone to the active cortisol metabolite. Consider therapy modification

Estrogen Derivatives: May diminish the therapeutic effect of Somatropin. Shown to be a concern with oral hormone replacement therapy in postmenopausal women. Management: Monitor for reduced growth hormone efficacy. A larger somatropin dose may be required to reach treatment goal. This interaction does not appear to apply to non-orally administered estrogens (e.g., transdermal, vaginal ring). Exceptions: Ethinyl Estradiol; Mestranol. Consider therapy modification

PredniSONE: Somatropin may diminish the therapeutic effect of PredniSONE. Growth hormone may reduce the conversion of prednisone to the active prednisolone metabolite. Consider therapy modification

Adverse Reactions

>10%:

Cardiovascular: Peripheral edema (short bowel syndrome: 69% to 81%; HARS: 19% to 45%; HIV with wasting/cachexia: 26%), facial edema (short bowel syndrome: 44% to 50%), chest pain (short bowel syndrome: ≤19%), edema (≤13%)

Central nervous system: Pain (short bowel syndrome: 6% to 19%), hypoesthesia (HARS: 9% to 15%; HIV with wasting/cachexia: 5%), headache (≤14%), malaise (short bowel syndrome: ≤13%), paresthesia (8% to 13%), dizziness (short bowel syndrome: 6% to 13%)

Dermatologic: Diaphoresis (short bowel syndrome: ≤13%), skin rash (short bowel syndrome: 6% to 13%)

Endocrine & metabolic: Dehydration (short bowel syndrome: ≤19%)

Gastrointestinal: Nausea (short bowel syndrome: 13% to 31%; HIV with wasting/cachexia: 9%), flatulence (short bowel syndrome: 25%), abdominal pain (short bowel syndrome: 13% to 25%), vomiting (short bowel syndrome: 19%)

Infection: Infection (short bowel syndrome: ≤19%), candidiasis (short bowel syndrome: ≤13%)

Local: Pain at injection site (short bowel syndrome: ≤31%), injection site reaction (short bowel syndrome: 19% to 25%, idiopathic short stature: <1%)

Neuromuscular & skeletal: Arthralgia (HIV with wasting/cachexia: ≤78%; HARS, short bowel syndrome: 28% to 44%; idiopathic short stature, SHOX deficiency: 11%), arthropathy (HIV with wasting/cachexia: ≤78%; idiopathic short stature: 11%), myalgia (HIV with wasting/cachexia: ≤78%, idiopathic short stature: 24%; HARS, short bowel syndrome: ≤13%), scoliosis (idiopathic short stature: 19%; SHOX deficiency: 4%), limb pain (HARS: 5% to 19%)

Otic: Otitis media (Turner syndrome: 43%; idiopathic short stature: 16%), ear disease (Turner syndrome: 18%), auditory disturbance (short bowel syndrome: 13%)

Respiratory: Rhinitis (short bowel syndrome: ≤19%)

Miscellaneous: Surgery (Turner syndrome: 45%)

1% to 10%:

Cardiovascular: Hypertension (idiopathic short stature: 3%)

Dermatologic: Nevus (excessive; SHOX deficiency: 7%)

Endocrine & metabolic: Hyperlipidemia (idiopathic short stature: 8%), gynecomastia (≤8%)

Neuromuscular & skeletal: Hip pain (idiopathic short stature: 3%)

Frequency not defined:

Cardiovascular: Lower extremity edema (adults; growth hormone deficiency)

Central nervous system: Depression (adults; growth hormone deficiency), fatigue (adults; growth hormone deficiency), insomnia (adults; growth hormone deficiency), seizure (children; growth hormone deficiency)

Dermatologic: Acne vulgaris (adults; growth hormone deficiency), exacerbation of psoriasis (children; growth hormone deficiency)

Endocrine & metabolic: Decreased glucose tolerance (adults; growth hormone deficiency), glycosuria (growth hormone deficiency), hyperglycemia (mild; growth hormone deficiency, small for gestational age), hypertriglyceridemia (children; growth hormone deficiency), hypoglycemia (children; growth hormone deficiency), hypothyroidism (growth hormone deficiency), insulin resistance (adults; growth hormone deficiency)

Gastrointestinal: Gastritis (adults; growth hormone deficiency)

Genitourinary: Hematuria (children; growth hormone deficiency), precocious puberty (small for gestational age), urinary tract infection (Turner syndrome)

Hematologic & oncologic: Elevated glycosylated hemoglobin (children; growth hormone deficiency), eosinophilia (children; growth hormone deficiency), hematoma (children; growth hormone deficiency), leukemia (children; growth hormone deficiency), meningioma (children, growth hormone deficiency), neoplasm (intracranial; children; growth hormone deficiency)

Hepatic: Increased serum ALT (adults; growth hormone deficiency), increased serum AST (adults; growth hormone deficiency)

Immunologic: Antibody development (children; growth hormone deficiency)

Neuromuscular & skeletal: Back pain (adults; growth hormone deficiency), leg pain (children; growth hormone deficiency), lipoatrophy (children; growth hormone deficiency), muscle rigidity (adults; growth hormone deficiency), skeletal pain (adults; growth hormone deficiency), slipped capital femoral epiphysis (small for gestational age; children, growth hormone deficiency), weakness (growth hormone deficiency)

Ophthalmic: Papilledema (children; growth hormone deficiency), retinopathy (adults; growth hormone deficiency)

Respiratory: Bronchitis (adults; growth hormone deficiency), cough (adults; growth hormone deficiency), flu-like symptoms (adults; growth hormone deficiency), pharyngitis (adults, growth hormone deficiency), respiratory tract disease (Turner syndrome), upper respiratory tract infection (adults, growth hormone deficiency)

<1%, postmarketing, and/or case reports: Aggressive behavior (idiopathic short stature), alopecia (idiopathic short stature), carpal tunnel syndrome (small for gestational age), diabetes mellitus (idiopathic short stature, small for gestational age), enlargement of facial features (jaw prominence; small for gestational age), increased growth of pre-existing nevi (growth hormone deficiency, small for gestational age), pancreatitis (growth hormone deficiency), pseudotumor cerebri, scoliosis progression (small for gestational age)

Warnings/Precautions

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. If symptoms of carpal tunnel syndrome do not resolve by decreasing the dose or frequency of somatropin, discontinue therapy.

• Glucose tolerance: Unmasked impaired glucose tolerance and overt diabetes mellitus, new-onset type 2 diabetes mellitus, and exacerbation of preexisting diabetes mellitus have been reported; diabetic ketoacidosis and diabetic coma have occurred. In some patients, these conditions improved when somatropin was discontinued, while in others the glucose intolerance persisted. 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. Treatment should be discontinued in patients who develop papilledema; resuming treatment at a lower dose may be considered once IH-associated signs and symptoms have resolved. Patients with Turner syndrome, chronic renal impairment and Prader-Willi syndrome may be at increased risk for intracranial hypertension.

• Neoplasm: Any preexisting malignancy should be inactive and treatment complete prior to initiating therapy; discontinue therapy with evidence of recurrence or progression. Monitor patients with preexisting tumors or growth hormone deficiency secondary to an intracranial lesion for recurrence or progression of underlying disease. 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. Monitor all patients for any malignant transformation of skin lesions. 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 (especially girls) 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:

• Acute critical illness: Initiation of somatropin is contraindicated with acute critical illness due to complications following open heart or abdominal surgery, multiple accidental trauma, or acute respiratory failure; mortality may be increased. The safety of continuing somatropin in patients who develop these illnesses during therapy has not been established; use with caution.

• Childhood-onset adult growth hormone deficiency: Patients who were treated with somatropin for growth hormone deficiency in childhood and whose epiphyses are closed should be reevaluated before continuation of somatropin for growth hormone deficiency in adults.

• Chronic kidney disease: Periodically monitor children with growth failure secondary to chronic kidney disease (CKD) for evidence of progression of renal osteodystrophy. 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 CKD patients; be alert to the development of a limp or complaints of hip or knee pain.

• Hypoadrenalism: Patients who have or are at risk for pituitary hormone deficiency(s) may be at risk for reduced serum cortisol levels and/or unmasking of central (secondary) hypoadrenalism with somatropin therapy; patients with previously diagnosed hypoadrenalism may require increased dosages of glucocorticoids due to the effects of somatropin. Excessive glucocorticoid therapy may inhibit the growth-promoting effects of somatropin in children; monitor and adjust glucocorticoids carefully.

• Hypothyroidism: Untreated/undiagnosed hypothyroidism may decrease response to therapy, particularly the growth response in children. Monitor thyroid function periodically and initiate/adjust thyroid replacement therapy as needed.

• Noonan syndrome: Safety has not been established for the treatment of Noonan syndrome in children with significant cardiac disease.

• Prader-Willi syndrome: Fatalities have 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. Monitor for sleep apnea, upper airway obstruction, and respiratory infections prior to initiation of therapy and periodically thereafter. 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. All patients with Prader-Willi syndrome should have effective weight control. 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 genetically confirmed Prader-Willi syndrome.

• Scoliosis: Progression of scoliosis may occur in children experiencing rapid growth; monitor.

• 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). Monitor patients with Turner syndrome for these conditions.

Concurrent drug therapy issues:

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

Special populations:

• Elderly: Elderly patients may be more sensitive to the actions of somatropin; consider lower starting doses and smaller dose increments.

• HIV patients: Patients with HIV infection should be maintained on antiretroviral therapy to prevent the potential increase in viral replication.

• Pediatric: Failure to increase growth rate, particularly during the first year of therapy, indicates need for close assessment of compliance and evaluation for other causes of growth failure, such as hypothyroidism, undernutrition, advanced bone age, and antibodies to recombinant human GH.

• Renal transplant recipients: No studies have been completed evaluating Nutropin or Nutropin AQ in patients with renal transplant. Use 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).

Monitoring Parameters

Growth curve; periodic thyroid function tests; bone age (annually); periodic glucose, somatomedin C levels; funduscopic examinations at initiation of therapy and periodically during treatment; progression of scoliosis; clinical evidence of slipped capital femoral epiphysis, such as a limp or hip or knee pain; progression or recurrence of pre-existing tumors or malignant transformation of skin lesions. If growth deceleration is observed in children treated for growth hormone deficiency, and not due to other causes, evaluate for presence of antibody formation. Note: Practice guidelines recommend monitoring for efficacy and adverse effects every 1 to 2 months during dose titration and semiannually, thereafter (TES 2006).

Chronic kidney disease: Progression of renal osteodystrophy.

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.

Pregnancy Risk Factor

B/C (depending upon manufacturer)

Pregnancy Considerations

Adverse events have not been observed in animal reproduction studies, however, reproduction studies have not been conducted with all agents. During normal pregnancy, maternal production of endogenous growth hormone decreases as placental growth hormone production increases. Data with somatropin use during pregnancy is limited.

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience headache, loss of strength and energy, muscle rigidity, insomnia, or nausea. Have patient report immediately to prescriber signs of high blood sugar (confusion, fatigue, increased thirst, increased hunger, polyuria, flushing, fast breathing, or breath that smells like fruit), signs of pancreatitis (severe abdominal pain, severe back pain, severe nausea, or vomiting), signs of adrenal gland problems (severe nausea, vomiting, severe dizziness, passing out, muscle weakness, severe fatigue, mood changes, lack of appetite, or weight loss), signs of severe cerebrovascular disease (change in strength on one side is greater than the other, difficulty speaking or thinking, change in balance, or vision changes), shortness of breath, mood changes, depression, vision changes, angina, numbness or tingling of hands or feet, swelling of arms or legs, bone pain, severe muscle pain, severe joint pain, mole changes, hematuria, injection site redness or edema, skin thinning, injection site skin breakdown, or signs of increased intracranial pressure (vision changes, severe headache, nausea, or vomiting) (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

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