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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: 10 mg/2 mL (2 mL [DSC])

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)

Nutropin AQ Pen: 20 mg/2 mL (2 mL) [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)

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
  • Nutropin AQ [DSC]
  • Nutropin [DSC]
  • Omnitrope
  • Saizen
  • Saizen Click.Easy
  • 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

Absorption

IM, SubQ: Well absorbed

Distribution

Vd:Somatrem: 50 mL/kg; Somatropin: 70 mL/kg

Metabolism

Hepatic and renal (~90%)

Excretion

Urine (0.1%, as unchanged drug)

Duration of Action

Maintains supraphysiologic levels for 18 to 20 hours

Half-Life Elimination

SubQ: Somatrem: 2.3 ± 0.42 hours; Somatropin: 3.8 hours; IM: Somatropin: 4.9 hours

Special Populations: Renal Function Impairment

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

Genotropin

No studies have been conducted.

Use: Labeled Indications

Children:

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

Treatment of short stature associated with Turner syndrome (Genotropin, Humatrope, Norditropin, Nutropin, Nutropin AQ, Omnitrope)

Treatment of Prader-Willi syndrome (Genotropin, Omnitrope)

Treatment of growth failure associated with chronic renal insufficiency (CRI) 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 2-4 years of age (Humatrope, Norditropin)

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 normal adult height (Genotropin, Humatrope, Nutropin, Nutropin AQ, Omnitrope)

Treatment of short stature or growth failure associated with short stature homeobox gene (SHOX) deficiency (Humatrope)

Treatment of short stature associated with Noonan syndrome (Norditropin)

Adults:

HIV patients with wasting or cachexia with concomitant antiviral therapy (Serostim)

Replacement of endogenous growth hormone in patients with adult growth hormone deficiency who meet both of the following criteria (Genotropin, Humatrope, Norditropin, Nutropin, Nutropin AQ, Omnitrope, Saizen):

Biochemical diagnosis of adult growth hormone deficiency by means of a subnormal response to a standard growth hormone stimulation test (peak growth hormone ≤5 mcg/L). Confirmatory testing may not be required in patients with congenital/genetic growth hormone deficiency or multiple pituitary hormone deficiencies due to organic diseases.

and

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, confirmed as an adult before replacement therapy is initiated

Treatment of short-bowel syndrome (Zorbtive)

Use: Unlabeled

Pediatric HIV patients with wasting/cachexia (Serostim); HIV-associated adipose redistribution syndrome (HARS) (Serostim)

Contraindications

Hypersensitivity to growth hormone or any component of the formulation; growth promotion in pediatric patients with closed epiphyses; progression or recurrence of any underlying intracranial lesion or actively growing intracranial tumor; acute critical illness due to complications following open heart or abdominal surgery; multiple accidental trauma or acute respiratory failure; evidence of active malignancy; active proliferative or severe nonproliferative diabetic retinopathy; use in patients with Prader-Willi syndrome without growth hormone deficiency (except Genotropin) or in patients with Prader-Willi syndrome with growth hormone deficiency who are severely obese, have a history of upper airway obstruction or sleep apnea, or have severe respiratory impairment

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:

Norditropin: SubQ: Initial dose ≤0.004 mg/kg/day; after 6 weeks of therapy, may increase dose 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 of age, or up to a maximum of 0.0125 mg/kg/day in patients ≥35 years of age

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 not more than 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 (growth hormone deficiency): 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.

HIV patients with wasting or cachexia:

Serostim: SubQ: 0.1 mg/kg once daily at bedtime (maximum: 6 mg/day). Alternately, patients at risk for side effects may be started at 0.1 mg/kg every other day. Patients who continue to lose weight after 12 weeks should be re-evaluated for opportunistic infections or other clinical events; rotate injection sites to avoid lipodystrophy. Adjust dose 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

Patients ≥65 years of age may be more sensitive to the action of growth hormone and more prone to adverse effects; in general, dosing should be cautious, beginning at low end of dosing range.

Dosing: Pediatric

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

Growth hormone deficiency:

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

Tev-Tropin, Zomacton: SubQ: Up to 0.1 mg/kg/dose administered 3 days per week

Saizen: IM, 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

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

Chronic renal insufficiency (CRI): 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 CRI 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: Up to 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: Up to 0.067 mg/kg/day

Alternate dosing (small for gestational age): In older/early pubertal children or children with very short stature, consider initiating therapy at higher doses (0.067 mg/kg/day) and then consider reducing the dose (0.033 mg/kg/day) if substantial catch-up growth observed. In younger children (<4 years) with less severe short stature, consider initiating therapy with lower doses (0.033 mg/kg/day) 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: Up to 0.3 mg/kg divided into equal daily doses

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

Noonan syndrome: Norditropin: SubQ: Up to 0.066 mg/kg/day

Dosing: Renal Impairment

There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied).

Dosing: Hepatic Impairment

There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied).

Reconstitution

Genotropin: Reconstitute with diluent provided.

Genotropin 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: 5 mg: Reconstitute with 1.5 to 5 mL diluent provided. Swirl gently; do not shake.

Nutropin: Vial:

5 mg: Reconstitute with 1 to 5 mL bacteriostatic water for injection. Swirl gently, do not shake.

10 mg: Reconstitute with 1 to 10 mL bacteriostatic water for injection. Swirl gently, do not shake.

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

Saizen: Vial:

5 mg: Reconstitute with 1 to 3 mL bacteriostatic water for injection or sterile water for injection. Gently swirl; do not shake.

8.8 mg: Reconstitute with 2 to 3 mL bacteriostatic water for injection or sterile water for injection. Gently swirl; do not shake.

Serostim: 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.

5 mg vial: Reconstitute with 1 to 5 mL of provided diluent (bacteriostatic 0.9% sodium chloride for injection [benzyl alcohol preserved]). Swirl gently; do not shake. Use preservative-free NS for injection for use in newborns. When reconstituting with NS for injection, use only one dose per vial; discard unused portion.

10 mg vial: Reconstitute with 1 mL of provided diluent (bacteriostatic water for injection [metacresol 0.33% preserved]). Use the 25-gauge mixing needle provided. Swirl gently; do not shake.

Zorbtive: 8.8 mg vial: Reconstitute with 1 to 2 mL bacteriostatic water for injection. Swirl gently.

Administration

Do not shake; administer SubQ or IM (not all products are approved for IM administration). Rotate administration sites to avoid tissue atrophy. When administering to newborns, do not reconstitute with a diluent that contains benzyl alcohol; sterile water for injection may be used as an alternative.

Norditropin cartridge must be administered using the corresponding color-coded NordiPen injection pen.

Omnitrope: Solution in the cartridges must be administered using the Omnitrope pen; when installing a new cartridge, prime pen prior to first use.

Humatrope: When administering for growth hormone deficiency, SubQ route is preferred

Tev-Tropin, Zomacton: Administer SubQ injections with standard sterile disposable needle or Tjet Needle-Free (Tev-Tropin) or ZOMA-Jet Needle-Free (Zomacton) injection device.

Dietary Considerations

Prader-Willi syndrome: All patients should have effective weight control (use is contraindicated in severely-obese patients).

Short-bowel syndrome: Intravenous parenteral nutrition requirements may need reassessment as gastrointestinal absorption improves.

Storage

Genotropin: Store at 2°C to 8°C (36°F to 46°F); do not freeze. Protect from light. Following reconstitution of 5.8 mg and 13.8 mg cartridge, store under refrigeration and use within 28 days.

Genotropin Miniquick: Store in refrigerator prior to dispensing, but may be stored ≤25°C (77°F) for up to 3 months after dispensing. Once reconstituted, solution must be refrigerated and used within 24 hours. Discard unused portion.

Humatrope:

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, use within 14 days. When reconstituted with sterile water for injection, use within 24 hours and discard unused portion.

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.

Norditropin: Store at 2°C to 8°C (36°F to 46°F); do not freeze. Avoid direct light. When refrigerated, prefilled pen must be used within 4 weeks after initial injection. Orange and blue prefilled pens may also be stored up to 3 weeks at ≤25°C (77°F).

Nutropin: Before and after reconstitution, store at 2°C to 8°C (36°F to 46°F); do not freeze.

Nutropin vial: Use reconstituted vials within 14 days. When reconstituted with sterile water for injection, use immediately and discard unused portion.

Nutropin AQ formulations: Use within 28 days following initial use.

Omnitrope:

Powder for injection: Prior to reconstitution, store under refrigeration at 2°C to 8°C (36°F to 46°F); do not freeze. Protect from light. Reconstitute with provided diluent. Swirl gently; do not shake. Following reconstitution with the provided diluents, the 5.8 mg vial may be stored under refrigeration for up to 3 weeks. Store vial in carton to protect from light.

Solution: Prior to use, store under refrigeration at 2°C to 8°C (36°F to 46°F). Once the cartridge is loaded into the pen delivery system, store under refrigeration for up to 28 days after first use.

Saizen: Prior to reconstitution, store at room temperature 15°C to 30°C (59°F to 86°F). Following reconstitution with bacteriostatic water for injection, reconstituted solution should be refrigerated and used within 14 days. When reconstituted with sterile water for injection, use immediately and discard unused portion. The Saizen easy click cartridge, when reconstituted with the provided bacteriostatic water, should be stored under refrigeration and used within 21 days.

Serostim: Prior to reconstitution, store at room temperature 15°C to 30°C (59°F to 86°F). When reconstituted with sterile water for injection, use immediately and discard unused portion.

Tev-Tropin, Zomacton: Prior to reconstitution, store at 2°C to 8°C (36°F to 46°F). Following reconstitution with the provided diluents, should be refrigerated and used within 14 days (5 mg vial) or 28 days (10 mg vial); do not freeze. Some cloudiness may occur; do not use if cloudiness persists after warming to room temperature.

Zorbtive: Store unopened vials and diluent at room temperature of 15°C to 30°C (59°F to 86°F). Store reconstituted vial 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

Growth hormone deficiency: Adverse reactions reported with growth hormone deficiency vary greatly by age. Generally, percentages are less in pediatric patients than adults, and many of the reactions reported in adults are dose related. Percentages reported also vary by product. Below is a listing by age group; events reported more commonly overall are noted with an asterisk (*).

Children: Antibodies development, arthralgia, benign intracranial hypertension, edema, eosinophilia, glycosuria, Hb A1c increased, headache, hematoma, hematuria, hyperglycemia (mild), hypertriglyceridemia, hypoglycemia, hypothyroidism, injection site reaction, intracranial tumor, leg pain, lipoatrophy, leukemia, meningioma, muscle pain, papilledema, pseudotumor cerebri, psoriasis exacerbation, rash, scoliosis progression, seizure, slipped capital femoral epiphysis, weakness

Adults: Acne, ALT increased, AST increased, arthralgia*, back pain, bronchitis, carpal tunnel syndrome, chest pain, cough, depression, diabetes mellitus (type 2), diaphoresis, dizziness, edema*, fatigue, flu-like syndrome*, gastritis, glucose intolerance, glucosuria, headache*, hyperglycemia (mild), hypertension, hypoesthesia, hypothyroidism, infection, insomnia, insulin resistance, joint disorder, leg edema, muscle pain, myalgia*, nausea, pain in extremities, paresthesia*, peripheral edema*, pharyngitis, retinopathy, rhinitis, skeletal pain*, stiffness in extremities, surgical procedure, upper respiratory tract infection, weakness

Additional/postmarketing reactions observed with growth hormone deficiency: Gynecomastia, increased growth of pre-existing nevi, pancreatitis

HARS: Serostim®: Limited to >10%: Edema (peripheral) (19% to 45%), arthralgia (28% to 37%), pain (extremity) (5% to 19%), hypoesthesia (9% to 15%), headache (4% to 14%), blood glucose increased (4% to 14%), paresthesia (11% to 13%), myalgia (3% to 13%)

Idiopathic short stature: Percentages reported using Humatrope® versus placebo: Myalgia (24%), scoliosis (19%), otitis media (16%), arthralgia (11%), arthrosis (11%), hyperlipidemia (8%), gynecomastia (5%), hip pain (3%), hypertension (3%). Additional adverse reactions listed as reported using other products from ISS NCGS Cohort (frequencies <1%): Aggressiveness, benign intracranial hypertension, diabetes, edema, hair loss, headache, injection site reaction

Prader-Willi syndrome: Genotropin® (frequency not defined): Aggressiveness, arthralgia, edema, hair loss, headache, benign intracranial hypertension, myalgia; fatalities associated with use in this population have been reported

Turner syndrome: Percentages reported using Humatrope® compared to untreated patients. Additional adverse reactions reported from other products, frequency not specified: Surgical procedures (45%), otitis media (43%), ear disorders (18%), joint pain, respiratory illness, urinary tract infection

HIV patients with wasting or cachexia: Serostim® (limited to ≥5%): Musculoskeletal disorders (arthralgia, arthrosis, myalgia: 78%), peripheral edema (26%), headache (13%), nausea (9%), paresthesia (8%), edema (6%), gynecomastia (6%), hypoesthesia (5%)

Short-bowel syndrome: Zorbtive® (limited to >10%): Peripheral edema (69% to 81%), facial edema (44% to 50%), arthralgia (31% to 44%), nausea (13% to 31%), injection site pain (up to 31%), flatulence (25%), injection site reaction (19% to 25%), abdominal pain (13% to 25%), vomiting (19%), pain (6% to 19%), chest pain (up to 19%), dehydration (up to 19%), infection (up to 19%), rhinitis (up to 19%), hearing symptoms (13%), dizziness (6% to 13%), rash (6% to 13%), diaphoresis (up to 13%), generalized edema (up to 13%), malaise (up to 13%), moniliasis (up to 13%), myalgia (up to 13%)

SHOX deficiency: Humatrope®: Arthralgia (11%), gynecomastia (8%), excessive cutaneous nevi (7%), scoliosis (4%)

Small for gestational age: Genotropin®, Humatrope® (frequency not defined): Mild, transient hyperglycemia; benign intracranial hypertension (rare); central precocious puberty; jaw prominence (rare); aggravation of pre-existing scoliosis (rare); injection site reactions; progression of pigmented nevi; carpal tunnel syndrome (rare) diabetes mellitus (rare); otitis media; headache; slipped capital femoral epiphysis

Warnings/Precautions

Concerns related to adverse effects:

• Fluid retention: May occur frequently in adults during use; manifestations of fluid retention (eg, edema, arthralgia, myalgia, nerve compression syndromes/paresthesias) are generally transient and dose dependent.

• Hypersensitivity: Reactions are possible; monitor closely.

• Intracranial hypertension (IH): IH with headache, nausea, papilledema, visual changes, and/or vomiting has been reported with somatropin; 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 failure and Prader-Willi syndrome may be at increased risk for IH.

• Neoplasm: Use in contraindicated with active malignancy. Monitor patients with pre-existing tumors or growth failure secondary to an intracranial lesion for recurrence or progression of underlying disease; discontinue therapy with evidence of recurrence. 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.

• Pancreatitis: Has been rarely reported; incidence in children (especially girls) with Turner syndrome may be greater than adults.

• Slipped capital epiphyses: Patients with growth hormone deficiency may develop slipped capital 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 (GHD): Children with epiphyseal closure who are treated with somatropin replacement therapy should be reassessed before continuation of therapy at reduced dose recommended for GH deficient adults.

• Diabetes mellitus (DM): Use with caution in patients with diabetes or with risk factors for impaired glucose tolerance; may decrease insulin sensitivity. Risk factors for diabetes in this population include obesity, Turner syndrome, or a family history of DM. Adjustment of antidiabetic medications may be necessary.

• Hypoadrenalism: Patients with hypoadrenalism may require increased dosages of glucocorticoids (especially cortisone acetate and prednisone) due to somatropin-mediated inhibition of 11 beta-hydroxysteroid dehydrogenase type 1; undiagnosed central hypoadrenalism may be unmasked. Excessive glucocorticoid therapy may inhibit the growth promoting effects of somatropin in children; monitor and adjust glucocorticoids carefully.

• Hypopituitarism: Closely monitor other hormonal replacement treatments in patients with hypopituitarism.

• Hypothyroidism: Untreated/undiagnosed hypothyroidism may decrease response to therapy; monitor thyroid function test periodically and initiate/adjust thyroid replacement therapy as needed.

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

• Obesity: Increased incidence of adverse events may occur when using a weight-based dosing regimen.

• 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, sleep apnea, respiratory impairment, or unidentified respiratory infection; male patients with one or more of these factors 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. In addition, evaluation of and/or monitoring for sleep apnea and respiratory infections are recommended.

• 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, cardiovascular disorders (including stroke, aortic aneurysm, hypertension), and thyroid disease, monitor carefully

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.

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

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).

Other warnings/precautions:

• Administration: Not for IV injection. Subcutaneous administration sites must be rotated to prevent tissue atrophy.

Monitoring Parameters

Growth curve, Tanner staging (children), periodic thyroid function tests, bone age (annually), periodical urine testing for glucose, somatomedin C (IGF-I) levels; funduscopic examinations at initiation of therapy and periodically during treatment; serum phosphorus, alkaline phosphatase and parathyroid hormone. If growth deceleration is observed in children treated for growth hormone deficiency, and not due to other causes, evaluate for presence of antibody formation. Periodic blood glucose monitoring; strict blood glucose monitoring in patients with diabetes. Progression or recurrence of pre-existing tumors or malignant transformation of skin lesions. Note: Practice guidelines recommend monitoring for efficacy and adverse effects every 1-2 months during dose titration and semiannually, thereafter (TES, 2006).

CRI: Progression of renal osteodystrophy

Prader-Willi syndrome: Monitor for sleep apnea, respiratory infections, snoring (onset of or increased)

Turner syndrome: Ear disorders including otitis media; cardiovascular disorders

Noonan syndrome: Prior to use, verify short stature syndrome.

Pregnancy Risk Factor

B/C (depending upon manufacturer)

Pregnancy Considerations

Teratogenic effects were not observed in animal studies. 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, feeling sleepy, more thirst, hunger, passing urine more often, flushing, fast breathing, or breath that smells like fruit), signs of pancreatitis (severe abdominal pain, severe back pain, severe nausea, or vomiting), signs of severe cerebrovascular disease (change in strength on one side is greater than the other, trouble speaking or thinking, change in balance, or change in eyesight), shortness of breath, mood changes, depression, vision changes, angina, numbness or tingling of hands or feet, severe swelling of hands or feet, bone pain, severe muscle pain, severe joint pain, mole changes, hematuria, injection site irritation, hip pain, limp, knee pain, 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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