somatropin (Rx)

Brand and Other Names:Genotropin, Genotropin Miniquick, more...Genotropin Pen 12, Humatrope, Norditropin FlexPro, Nutropin, Nutropin AQ NuSpin 20, Nutropin AQ NuSpin 10, Nutropin AQ NuSpin 5, Omnitrope, Saizen, Serostim, Zorbtive, Nutropin AQ Pen 20, Nutropin AQ Pen 10, Zomacton
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Dosing & Uses

AdultPediatricGeriatric

Dosage Forms & Strengths

injection, powder for reconstitution

Genotropin Miniquick

  • 0.2mg, 0.4mg, 0.6mg, 0.8mg, 1mg, 1.2mg, 1.4mg, 1.6mg, 1.8mg, 2mg

Genotropin

  • 5mg, 12mg

Humatrope

  • 5mg, 6mg, 12mg, 24mg

Nutropin

  • 10mg

Omnitrope

  • 5.8mg

Saizen

  • 5mg, 8.8mg

Serostim

  • 4mg, 5mg, 6mg

Zomacton

  • 5mg, 10mg

Zorbtive

  • 8.8mg

injection, solution

Norditropin FlexPro

  • 5mg/1.5mL, 10mg/1.5mL, 15mg/1.5mL, 30mg/3mL

Nutropin AQ NuSpin 20

  • 20mg/2mL

Nutropin AQ NuSpin 10

  • 10mg/2mL

Nutropin AQ NuSpin 5

  • 5mg/2mL

Omnitrope

  • 5mg/1.5mL, 10mg/1.5mL

Growth Hormone Deficiency

Weight-based dosing

  • Norditropin: Initiate at 0.004 mg/kg daily and may increase the dose according to individual patient requirements to up to 0.016 mg/kg daily  
  • Nutropin or Nutropin AQ: Not to exceed 0.006 mg/kg/day SC initially for 6 weeks; may increase up to 0.025 mg/kg/day if patient ≤35 years and up to 0.0125 mg/kg/day if patient >35 years
  • Humatrope: Not to exceed 0.006 mg/kg/day SC initially; may increase dose up to 0.0125 mg/kg/day maximum depending on response
  • Genotropin or Omnitrope: Not to exceed 0.04 mg/kg/week SC initially divided in equal doses over 7 days; may increase dose at 4-8 week intervals up to 0.08 mg/kg/week
  • Saizen: Not to exceed 0.005 mg/kg/day SC initially for 4 weeks; may increase dose up to 0.01 mg/kg/day
  • Zomacton: Initiate at 0.006 mg/kg/day SC; may increase dose, not to exceed 0.0125 mg/kg/day; not recommended for obese patients due to increased likelihood of adverse reactions

Nonweight-based dosing

  • 0.2 mg/day (0.15-0.3 mg/day range) SC initially; may increase dose every 1-2 months by 0.1-0.2 mg/day based on clinical response and/or serum IGF-I levels

Short-bowel Syndrome

Zorbtive

  • 0.1 mg/kg/day SC (rotating injection sites to avoid lipodystrophy) for 4 weeks; may increase up to 8 mg/day maximum; treatment exceeding 4 weeks not studied

HIV-associated Wasting or Cachexia

Serostim

  • Serostim: 0.1 mg/kg/day SC at bedtime (rotating injection sites to avoid lipodystrophy) up to 6 mg/day; if at risk for side effects may administer 0.1 mg/kg every other day; if loss of body weight continues after 12 weeks re-evaluate for opportunistic infections or other clinical events; to avoid lipodystrophy rotate injection site; adjust dose to manage side effects
  • Alternatively:
  • >55 kg: 6 mg/day SC
  • 45-55 kg: 5 mg/day SC
  • 35-45 kg: 4 mg/day SC
  • <35 kg: 0.1 mg/kg/day SC

HIV Adipose Tissue Redistribution Syndrome (Off-label)

Serostim

  • 4 mg/day SC at bedtime for 12 weeks; follow by 2-4 mg every other day at bedtime for 12-24 weeks for maintenance

Dosage Modifications

Renal impairment

  • Renal clearance may decrease; dosing reommendations have not been reported
  • Nutropin AQ
    • Renal transplantation: May continue with treatment
    • Hemodialysis patients: Administer at night just prior to going to sleep or at least 3-4 hr after their hemodialysis to prevent hematoma formation due to the heparin
    • Chronic cycling peritoneal dialysis (CCPD): Administer in the morning after they have completed dialysis
    • Chronic ambulatory peritoneal dialysis (CAPD): Administer in the evening at the time of the overnight exchange

Hepatic impairment

  • Safety and efficacy not established

Dosing Considerations

Growth Hormone Deficiency

  • Reevaluate patients treated with somatropin for GH deficiency in childhood and whose epiphyses before continuation of somatropin for GH deficient adults
  • Estrogen-replete women and patients receiving oral estrogen may require higher doses

Dosage Forms & Strengths

injection powder for reconstitution

Genotropin Miniquick

  • 0.2mg, 0.4mg, 0.6mg, 0.8mg, 1mg, 1.2mg, 1.4mg, 1.6mg, 1.8mg, 2mg

Genotropin

  • 5mg, 12mg

Humatrope

  • 5mg, 6mg, 12mg, 24mg

Nutropin

  • 10mg

Omnitrope

  • 5.8mg

Saizen

  • 5mg, 8.8mg

Serostim

  • 4mg, 5mg, 6mg

Zomacton

  • 5mg
  • 10mg

Zorbtive

  • 8.8mg

injection solution

Norditropin FlexPro

  • 5mg/1.5mL, 10mg/1.5mL, 15mg/1.5mL

Nutropin AQ NuSpin 20

  • 20mg/2mL

Nutropin AQ NuSpin 10

  • 10mg/2mL

Nutropin AQ NuSpin 5

  • 5mg/2mL

Omnitrope

  • 5mg/1.5mL, 10mg/1.5mL

Growth Hormone Deficiency

Genotropin

  • 0.16 mg/kg to 0.24 mg/kg per week; divided into equal 6-7 SC doses/week  

Humatrope

  • 0.18-0.3 mg/kg/week (0.026-0.043 mg/kg/day) SC; divided into equal 6-7 SC doses/week

Norditropin

  • 0.17-0.24 mg/kg/week (0.024-0.034 mg/kg/day) SC; divided into equal 6-7 SC doses/week

Nutropin and Nutropin AQ

  • 0.3 mg/kg/week SC weekly divided into equal daily doses
  • Prepuberty: Not to exceed 0.7 mg/kg/week divided into equal daily doses

Omnitrope

  • 0.16-0.24 mg/kg/week SC divided into 6-7 doses/week
  • Alternatively, 0.06 mg/kg/dose administered 3 days/week or 0.03 mg/kg/dose administered 6 days/week

Saizen

  • 0.18 mg/kg/week SC/IM divided into equal doses
  • Alternatively, 0.06 mg/kg/dose administered 3 days/week or 0.03 mg/kg/dose administered 6 days/week

Zomacton

  • Up to 0.1 mg/kg SC 3x/week

Small for Gestational Age

Humatrope

  • 0.47 mg/kg/week SC divided into equal doses 6-7 days/week  

Genotropin, Omnitrope

  • 0.48 mg/kg/week SC divided into equal doses 6-7 days/week
  • Initial treatment with larger doses of somatropin (eg, 0.48 mg/kg/week), especially in very short children (ie, height SDS <–3), and/or older/ pubertal children; consider a reduction in dosage (eg, gradually towards 0.24 mg/kg/week) if substantial catch-up growth is observed during the first few years of therapy
  • Consider in younger SGA children (eg, ~<4 years) (who respond the best in general) with less severe short stature (ie, baseline height SDS values between -2 and -3) to initiating treatment at a lower dose (eg, 0.24 mg/kg/week), and titrating the dose as needed over time; carefully monitor the growth response, and adjust the somatropin dose as necessary

Norditropin

  • 0.47 mg/kg/week SC divided into equal doses 6-7 days/week (up to 0.067 mg/kg/day SC)
  • In very short pediatric patients, HSDS less than -3, and older pubertal pediatric patients consider initiating treatment with a larger dose of Norditropin (up to 0.067 mg/kg/day); consider gradual dosage reduction if substantial catch-up growth is observed during the first few years of therapy
  • <4 years of age with less severe short stature, baseline HSDS values between -2 and -3: Consider initiating at 0.033 mg/kg/day and titrate dose as needed

Chronic Renal Insufficiency

Nutropin, Nutropin AQ

  • Not to exceed 0.35 mg/kg/week divided into equal doses for 6-7 days; continue until time of renal transplantation

Short stature associated with Noonan syndrome

Norditropin

  • Up to 0.46 mg/kg/week (not to exceed 0.066 mg/kg/day) SC divided into equal doses 6-7 days/week  

Growth failure with Prader-Willi syndrome

Genotropin

  • 0.24 mg/kg/week SC divided into equal doses for 6-7 daily injection  

Omnitrope

  • 0.24 mg/kg/week SC divided into 6-7 daily injections

Norditropin

  • Up to 0.24 mg/kg/week SC divided into equal doses 6-7 days/week (not to exceed 0.034 mg/kg/day)

Short stature associated with Turner syndrome

Genotropin

  • 0.33 mg/kg/week SC divided into 6-7 days/week  

Humatrope

  • 0.375 mg/kg/week divided into 6-7 days/week (Not to exceed 0.054 mg/kg/day SC)

Norditropin

  • Up to 0.47 mg/kg/week SC divided into equal doses 6-7 days/week (up to 0.067 mg/kg/day)

Nutropin and Nutropin AQ

  • Not to exceed 0.375 mg/kg/week SC divided into 3-7 days/week

Omnitrope

  • 0.33 mg/kg/week SC divided into 6-7 daily injections/week

Idiopathic Short Stature

Genotropin

  • Not to exceed 0.35 mg/kg/week SC divided into 6-7 days/week  

Humatrope

  • Not to exceed 0.053 mg/kg/day SC (0.37 mg/kg/week divided into 6-7 days/week)

Norditropin

  • Up to 0.47 mg/kg/week SC divided into equal doses 6-7 days/week (not to exceed 0.067 mg/kg/day)

Nutropin and Nutropin AQ

  • Not to exceed 0.3 mg/kg/week SC divided into 6-7 days/week

Omnitrope

  • Not to exceed 0.47 mg/kg/week SC divided into 6-7 daily injections/week

Short Stature Homeobox-Containing Gene

Humatrope

  • 0.05 mg/kg/day SC (0.35 mg/kg/week divided into 6-7 days)  

Dosage Modifications

Renal impairment

  • Renal clearance may decrease; dosing reommendations have not been reported
  • Nutropin AQ
    • Renal transplantation: May continue with treatment
    • Hemodialysis patients: Administer at night just prior to going to sleep or at least 3-4 hr after their hemodialysis to prevent hematoma formation due to the heparin
    • Chronic cycling peritoneal dialysis (CCPD): Administer in the morning after they have completed dialysis
    • Chronic ambulatory peritoneal dialysis (CAPD): Administer in the evening at the time of the overnight exchange

Hepatic impairment

  • Safety and efficacy not established

Dosing Considerations

Growth Hormone Deficiency

  • Reevaluate patients treated with somatropin for GH deficiency in childhood and whose epiphyses before continuation of somatropin for GH deficient adults
  • Estrogen-replete women and patients receiving oral estrogen may require higher doses

>65 years: Administer at low end of dosing range described in adults

May be more sensitive to somatropin action and more prone to adverse reactions

Consider a lower starting dose and smaller dose increment increases for geriatric patients as they may be at increased risk for adverse reactions

Norditropin

≥65 years: Safety and efficacy not established

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Interactions

Interaction Checker

and somatropin

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    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

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            Contraindicated (0)

              Serious - Use Alternative (1)

              • macimorelin

                somatropin, macimorelin. unspecified interaction mechanism. Avoid or Use Alternate Drug. Drugs that may blunt the growth hormone (GH) response to macrimorelin may impact the accuracy of the diagnostic test. Discontinue GH products at least 1 week before administering macimorelin.

              Monitor Closely (17)

              • albiglutide

                somatropin decreases effects of albiglutide by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Somatropin may potentially diminish hypoglycemic effects of antidiabetic agent. May consider modifying therapy.

              • insulin aspart

                somatropin decreases effects of insulin aspart by pharmacodynamic antagonism. Use Caution/Monitor.

              • insulin degludec

                somatropin decreases effects of insulin degludec by pharmacodynamic antagonism. Use Caution/Monitor. Growth hormone decreases insulin sensitivity by opposing the effects of insulin on carbohydrate metabolism.

              • insulin degludec/insulin aspart

                somatropin decreases effects of insulin degludec/insulin aspart by pharmacodynamic antagonism. Use Caution/Monitor. Growth hormone decreases insulin sensitivity by opposing the effects of insulin on carbohydrate metabolism.

              • insulin detemir

                somatropin decreases effects of insulin detemir by pharmacodynamic antagonism. Use Caution/Monitor.

              • insulin glargine

                somatropin decreases effects of insulin glargine by pharmacodynamic antagonism. Use Caution/Monitor.

              • insulin glulisine

                somatropin decreases effects of insulin glulisine by pharmacodynamic antagonism. Use Caution/Monitor.

              • insulin inhaled

                somatropin decreases effects of insulin inhaled by pharmacodynamic antagonism. Use Caution/Monitor. Growth hormone decreases insulin sensitivity by opposing the effects of insulin on carbohydrate metabolism.

              • insulin lispro

                somatropin decreases effects of insulin lispro by pharmacodynamic antagonism. Use Caution/Monitor.

              • insulin NPH

                somatropin decreases effects of insulin NPH by pharmacodynamic antagonism. Use Caution/Monitor.

              • insulin regular human

                somatropin decreases effects of insulin regular human by pharmacodynamic antagonism. Use Caution/Monitor.

              • liraglutide

                somatropin decreases effects of liraglutide by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Somatropin may potentially diminish hypoglycemic effects of antidiabetic agent. May consider modifying therapy.

              • maraviroc

                somatropin will decrease the level or effect of maraviroc by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • metformin

                somatropin decreases levels of metformin by pharmacodynamic antagonism. Use Caution/Monitor.

              • nateglinide

                somatropin decreases effects of nateglinide by pharmacodynamic antagonism. Use Caution/Monitor. Coadministration may reduce nateglinide's hypoglycemic action.

              • tazemetostat

                somatropin will decrease the level or effect of tazemetostat by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • ubrogepant

                somatropin will decrease the level or effect of ubrogepant by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Dose adjustment is recommended with concomitant use of ubrogepant and moderate and weak CYP3A4 inducers. (see Dosage Modifications)

              Minor (10)

              • budesonide

                budesonide decreases effects of somatropin by pharmacodynamic antagonism. Minor/Significance Unknown.

              • cortisone

                cortisone decreases effects of somatropin by pharmacodynamic antagonism. Minor/Significance Unknown.

              • deflazacort

                deflazacort decreases effects of somatropin by pharmacodynamic antagonism. Minor/Significance Unknown.

              • dexamethasone

                dexamethasone decreases effects of somatropin by pharmacodynamic antagonism. Minor/Significance Unknown.

              • fludrocortisone

                fludrocortisone decreases effects of somatropin by pharmacodynamic antagonism. Minor/Significance Unknown.

              • hydrocortisone

                hydrocortisone decreases effects of somatropin by pharmacodynamic antagonism. Minor/Significance Unknown.

              • methylprednisolone

                methylprednisolone decreases effects of somatropin by pharmacodynamic antagonism. Minor/Significance Unknown.

              • prednisolone

                prednisolone decreases effects of somatropin by pharmacodynamic antagonism. Minor/Significance Unknown.

              • prednisone

                prednisone decreases effects of somatropin by pharmacodynamic antagonism. Minor/Significance Unknown.

              • triamcinolone acetonide injectable suspension

                triamcinolone acetonide injectable suspension decreases effects of somatropin by pharmacodynamic antagonism. Minor/Significance Unknown.

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              Adverse Effects

              <10%

              Norditropin

              • Peripheral edema (42%)
              • Edema (25%)
              • Arthralgia (19%)
              • Leg Edema (15%)
              • Myalgia (15%)
              • Infection (non-viral) (13%)
              • Paraesthesia (11%)
              • Skeletal Pain (11%)

              Humatrope

              • Edema (21.2%)
              • Arthralgia (17.3%)
              • Paresthesia (17.3%)
              • Rhinitis (13.5%)
              • Pain (13.5%)
              • Myalgia (13.5%)
              • Peripheral edema (11.5%)

              1-10%

              Norditropin

              • Headache (9%)
              • Bronchitis (9%)
              • Flu-like symptoms (8%)
              • Hypertension (8%)
              • Gastroenteritis (8%)
              • Other non-classifiable disorders (excludes accidental injury) (8%)
              • Increased sweating (8%)
              • Glucose tolerance abnormal (6%)
              • Laryngitis (6%)
              • Type 2 diabetes mellitus (5%)

              Humatrope

              • Back pain (9.6%)
              • Headache (7.7%)
              • Hypertension (7.7%)
              • Acne (5.8%)
              • Joint disorder (5.8%)
              • Surgical procedure (5.8%)
              • Flu syndrome (3.9%)

              Postmarketing Reports

              Immune system disorders: Serious systemic hypersensitivity reactions including anaphylactic reactions and angioedema

              Skin: Increase in size or number of cutaneous nevi

              Endocrine disorders: Hypothyroidism

              Metabolism and nutrition disorders: Hyperglycemia

              Musculoskeletal and connective tissue disorders: Slipped capital femoral epiphysis, Legg-Calvé-Perthes disease

              Investigations: Increase in blood alkaline phosphatase level, decrease in serum thyroxin (T4) levels

              Gastrointestinal: Pancreatitis

              Neoplasm: Leukemia reported in a small number of GH deficient children treated with somatropin, somatrem (methionylated rhGH) and GH of pituitary origin

              Frequency Not Defined

              New onset type 2 diabetes mellitus reported in children and adults

              Pediatric

              • Slipped capital femoral epiphysis and Legg-Calve-Perthes disease (osteonecrosis/avascular necrosis; occasionally associated with slipped capital femoral epiphysis)
              • Progression of preexisting scoliosis
              • Hypothyroidism
              • Hypoglycemia
              • Seizures
              • Pancreatitis
              • Exacerbation of psoriasis
              • Benign intracranial hypertension (uncommon)
              • Hematuria
              • Hematoma
              • Leukemia
              • Papilledema

              Patients with Idiopathic Short Stature

              • Otitis media
              • Myalgia
              • Scoliosis
              • Arthralgia
              • Hyperlipidemia
              • Arthrosis
              • Benign intracranial hypertension
              • Type 2 diabetes mellitus
              • Gyencomastia
              • Arthralgia

              Adults

              • Headache
              • Weakness
              • Muscle pain
              • Hyperglycemia
              • Pancreatitis
              • Glucosuria
              • Edema
              • Gastritis
              • Diaphoresis
              • Dizziness
              • Joint disorder

              Patients with Prader-Willi Syndrome

              • Aggressiveness
              • Arthralgia
              • Edema
              • Hair loss
              • Headache
              • Hypertension
              • Benign intracranial hypertension
              • Myalgia
              • Increased mortality

              Turner Syndrome

              • Otitis media
              • Ear disorders
              • Joint pain
              • Respiratory Illness
              • Urinary tract infection
              • Surgical procedures

              HIV Patients with Wasting or Cachexia

              • Arthralgia
              • Arthrosis
              • Myalgia
              • Peripheral edema
              • Headache
              • Nausea
              • Paresthesia
              • Gynecomastia
              • Edema

              Short-bowel Syndrome

              • Peripheral edeam
              • Facial edema
              • Arthralgia
              • Nausea
              • Flatulence
              • Abdominal pain
              • Vomiting

              SHOX Deficiency

              • Arthralgia
              • Gynecomastia
              • Excessive cutaneous nevi
              • Scoliosis

              Small for Gestational Age

              • Mild, transient hyperglycemia
              • Benign intracranial hypertension
              • Precocious puberty
              • Aggravation of pre-existing scoliosis
              • Carpal tunnel syndrome
              • Type 2 diabetes mellitus
              • Otitis Media
              • Headache

              Postmarketing Reports

              Acute critical illness

              Sudden death

              Intracranial tumors

              Central hypothyroidism

              Cardiovascular disorders

              Serious systemic hypersensitivity reactions including anaphylactic reactions and angioedema

              Fluid retention

              Hypoadrenalism

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              Warnings

              Contraindications

              Hypersensitivity to metacresol or glycerin (diluent)

              Hypersensitivity to benzyl alcohol

              Acute critical illness after open heart surgery, abdominal surgery or multiple accidental trauma, or those with acute respiratory failure due to the risk of increased mortality with use of pharmacologic doses of somatropin

              Active malignancy

              Pediatric patients with closed epiphyses

              Active proliferative or severe non-proliferative diabetic retinopathy

              Active malignancy, acute complications of open heart or abdominal surgery, multiple trauma, acute respiratory failure

              Pediatric patients with Prader-Willi syndrome who are severely obese, have a history of upper airway obstruction or sleep apnea, or have severe respiratory impairment due to the risk of sudden death

              Cautions

              Increased mortality reported among patients with acute critical illness due to complications following open heart surgery, abdominal surgery or multiple accidental trauma, or those with acute respiratory failure; benefit of treatment continuation should be weighed against potential risk (see Contraindications)

              Reports of sudden death after initiating therapy with somatropin documented in pediatric patients with Prader-Willi syndrome who had ≥1 of the following risk factors: severe obesity, history of upper airway obstruction or sleep apnea, or unidentified respiratory infection; male patients with ≥1 factors may be at greater risk than females

              Monitor blood glucose in patients with other risk factors (eg, obesity, Turner syndrome, family history of diabetes mellitus [DM]) for glucose intolerance during therapy and adjust antidiabetic treatment, as needed; new onset type 2 DM reported, monitor glucose levels periodically; doses of concurrent antihyperglycemic drugs in diabetics may require adjustment

              Intracranial hypertension (IH) with papilledema, visual changes, headache, nausea, and/or vomiting reported; symptoms usually occurred within the first 8 weeks after initiation of therapy; all reported cases, IH-associated signs and symptoms rapidly resolved after cessation of therapy or a reduction of the somatropin dose; perform funduscopic examination should be performed routinely before initiating treatment to exclude preexisting papilledema, and periodically thereafter

              Serious systemic hypersensitivity reactions (eg, anaphylactic reactions, angioedema) reported with postmarketing use of somatropin products; inform patients and caregivers that such reactions are possible and prompt medical attention should be sought if allergic reaction occurs

              Cases of pancreatitis reported; pediatric patients possibly at a greater risk compared to adults; published literature indicates that females who have Turner syndrome may be at greater risk than other pediatric patients receiving somatropin products; consider pancreatitis in patients who develop persistent severe abdominal pain

              When somatropin is administered SC at same site over long period of time, tissue atrophy may result; may avoid by rotating injection site (see Administration)

              Somatropin increases growth rate, and progression of existing scoliosis can occur in patients who experience rapid growth; monitor patients with a history of scoliosis for progression of scoliosis

              Slipped capital femoral epiphysis may occur more frequently in patients with endocrine disorders (including GH deficiency and Turner syndrome) or in patients undergoing rapid growth; evaluate pediatric patients with the onset of a limp or complaints of hip or knee pain

              Not indicated for the treatment of non-GH deficient adults

              Serious and fatal adverse reactions including “gasping syndrome” can occur in neonates and infants treated with benzyl alcohol; “gasping syndrome” is characterized by central nervous system depression, metabolic acidosis, and gasping respirations

              When administering therapy to infants, reconstitute with normal saline, not the diluent provided; only one dose should be used per vial and the reconstituted product should be discarded after use

              Serum levels of inorganic phosphorus, alkaline phosphatase, parathyroid hormone and IGF-1 may increase after therapy

              Somatropin-treated 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; patients treated with glucocorticoid replacement for previously diagnosed hypoadrenalism may require an increase in their maintenance or stress doses following initiation of treatment; monitor for reduced serum cortisol levels and/or need for glucocorticoid dose increases in those with known hypoadrenalism

              Hypothyroidism

              • Undiagnosed/untreated hypothyroidism may prevent an optimal response to therapy, in particular, the growth response in pediatric patients
              • Patients with Turner syndrome have an inherently increased risk of developing autoimmune thyroid disease and primary hypothyroidism
              • In patients with GH deficiency, central (secondary) hypothyroidism may first become evident or worsen during somatropin treatment; consider periodic thyroid function tests and initiate or appropriately adjust thyroid hormone replacement therapy when indicated

              Increased risk of neoplasms

              • There is an increased risk of malignancy progression with somatropin treatment in patients with active malignancy; any preexisting malignancy should be inactive and its treatment complete prior to instituting somatotropin; discontinue somatotropin if there is evidence of recurrent activity (See Contraindications)
              • An increased risk of a second neoplasm reported in patients treated with somatotropins after first neoplasm; intracranial tumors, in particular meningiomas, in patients treated with radiation to head for first neoplasm, were the most common of these second neoplasms; in adult cancer survivors, risk of occurrence unknown; given the limited data available, carefully monitor patients under growth hormone therapy for progression or recurrence of the tumor
              • Owing to pediatric patients with certain rare genetic causes of short stature have an increased risk of developing malignancies, thoroughly consider the risks and benefits of starting treatment in these patients; monitor patients for increased growth, or potential malignant changes of preexisting nevi; any preexisting malignancy should be inactive and its treatment complete prior to instituting therapy with somatropin; discontinue somatotropin if there is evidence of recurrent activity

              Zorbtive

              • If moderate fluid retention, arthralgia, treat symptomatically or reduce dose by 50%
              • Discontinue up to 5 days if severe toxicity, then restart at 50% dose; permanently discontinue if severe toxicity recurs or does not disappear within 5 days

              Drug interactions overview

              • Microsomal enzyme 11β-hydroxysteroid dehydrogenase type 1 (11βHSD-1) is required for conversion of cortisone to its active metabolite, cortisol, in hepatic and adipose tissue; somatotropin inhibits 11βHSD-1; individuals with untreated GH deficiency have relative increases in 11βHSD-1 and serum cortisol; initiation of somatotropin may result in inhibition of 11βHSD-1 and reduced serum cortisol concentrations
              • Pharmacologic glucocorticoid therapy and supraphysiologic glucocorticoid treatment may attenuate the growth promoting effects of somatotropin in pediatric patients
              • Limited published data indicate that somatropin treatment increases CYP450 mediated antipyrine clearance; somatotropin may alter the clearance of compounds known to be metabolized by CYP450 liver enzymes
              • Oral estrogens may reduce the serum IGF-1 response to somatotropin
              • Treatment with somatotropin may decrease insulin sensitivity, particularly at higher doses
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              Pregnancy & Lactation

              Pregnancy

              Limited available data with somatropin use in pregnant women are insufficient to determine a drug-associated risk of adverse developmental outcomes

              In animal reproduction studies, there was no evidence of fetal or neonatal harm when pregnant rats were administered SC somatotropin during organogenesis or during lactation at doses ~10-times higher than the maximal clinical dose of 0.016 mg/kg, based on body surface area

              Diluent contains benzyl alcohol, which has been associated with gasping syndrome in neonates; the preservative benzyl alcohol can cause serious adverse events and death when administered intravenously to neonates and infants; if therapy needed during pregnancy, reconstitute with normal saline, use only one dose per vial, and discard reconstituted product after use, or use a benzyl alcohol-free formulation

              Lactation

              There are no data on presence of somatropin in human milk; limited published literature reports no adverse effects on breastfed infants with maternal administration of somatropin; no decrease in milk production or change in milk content during treatment with somatropin reported; developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for somatotropin and any potential adverse effects on breastfed infant from therapy or from underlying maternal condition

              Diluent contains benzyl alcohol; if therapy needed during lactation, reconstitute with normal saline, use only one dose per vial, and discard after use or use a benzyl alcohol-free formulation

              Pregnancy Categories

              A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

              B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

              C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

              D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

              X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

              NA: Information not available.

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              Pharmacology

              Mechanism of Action

              Purified polypeptide of recombinant human growth hormone

              Human growth hormone plays a role in the growth of linear bone, skeletal muscle, and organs by stimulating chondrocyte proliferation and differentiation. It also stimulates erythropoietin.

              Absorption

              Humatrope

              • Peak plasma concentration: 415 ng/mL (0.02 mg/kg-dose); 53.2 ng/mL (0.1 mg/kg SC-dose); 63.3 ng/mL (0.1 mg/kg IM-dose)
              • AUC: 156 ng•hr/mL (0.02 mg/kg-dose); 495 ng•hr/mL (0.1 mg/kg SC-dose); 585 ng•hr/mL (0.1 mg/kg IM-dose)

              Norditropin

              • IM/SC: Approximately 63% to 90% depending on formulation and route of administration
              • Peak plasma concentration: 34.9 ng/mL (single 4 mg-dose); 13.8 ng/mL (0.024 mg/kg SC-dose)
              • Peak plasma time: 3 hr (single 4 mg-dose)

              Genotropin

              • Bioavailability: ~80.5%
              • Peak plasma time: 5.9 hr
              • Peak plasma concentration, adults: 23 ng/mL (0.03 mg/kg SC-dose); 17.4 ng/mL (5.3 mg/mL)
              • Peak plasma concentration, pediatric: 12.4 ng/mL (first injection) and 12.2 ng/mL (second injection), achieved at approximately 6 hr after dosing

              Distribution

              Vd (Genotropin): 1.3 L/kg

              Vd (Humatrope): 0.0703 L/kg (0.02 mg/kg-dose); 1.55 L/kg (0.1 mg/kg SC-dose); 0.957 L/kg (0.1 mg/kg IM-dose)

              Vd (Nutropin and Nutropin AQ): 50 mL/kg

              Vd (Omniprobe): 1.4 L/kg

              Vd (Saizen, Serostim, and Zorbtive): 12 L

              Metabolism

              Liver, kidneys

              Elimination

              Norditropin

              • Half-life: 2hr; 7-10 hr (0.024 mg/kg SC-dose)
              • Clearance: 2.3 mL/min/kg (infusion)
              • Longer half-life observed after SC administration is due to slow absorption from the injection site
              • Urinary excretion of intact somatropin has not been measured

              Genotropin

              • Half-life: 0.4 hr (IV); 3 hr (SC)
              • Clearance: 0.3 L/hr/kg

              Humatrope

              • Half-life: 0.363 hr (0.02 mg/kg-dose); 4.hr (0.1 mg/kg SC-dose); 3.81 hr (0.1 mg/kg IM-dose)
              • Clearance: 0.135 L/kg•hr (0.02 mg/kg-dose); 4.93 L/kg•hr (0.1 mg/kg SC-dose); 3.81 L/kg•hr (0.1 mg/kg IM-dose)
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              Administration

              SC Administration

              Do not administer IV

              Administer by SC injection into back of upper arm, abdomen, buttock, or thigh with regular rotation of injection sites to avoid lipoatrophy

              Visually inspect for particulate matter and discoloration; solution appear clear and colorless; do not use if solution is cloudy or contains particulate matter

              Do not shake the drug

              Storage

              Humatrope

              • Vials
                • Unused vials: Refrigerate at 2-8°C (36-46°F); do not freeze
                • Reconstituted vials: Refrigerate at 2-8°C (36-46°F) for up to 14 days
              • Cartridges
                • Unused cartridges: Refrigerate at 2-8ºC (36-46ºF);do not freeze
                • Reconstituted cartridges: Refrigerate at 2-8ºC (36-46ºF) for up to 28 days after reconstitution; do not freeze; protect from heat

              Genotropin

              • Lyophilized powder
                • Unused drug: Refrigerate at 2-8ºC (36-46ºF); do not freeze; protect from light
              • Cartridges
                • Unused cartridges: Refrigerate at 2-8ºC (36-46ºF) for up to 4 weeks; store in room temperature at <25ºC (77ºF) up to 3 months; do not freeze
                • Reconstituted cartridges: Refrigerate at 2-8ºC (36-46ºF) for up to 28 days after reconstitution; do not freeze; protect from heat
              • Miniquick
                • After dispensing: Refrigerate at ≤25ºC (77ºF) for up to 3 months after dispensing
                • Reconstituted drug: Refrigerate at 2-8ºC (36-46ºF) for up to 24 hours after mixing it; do not freeze

              Norditropin

              • Unused vial: Refrigerate at 2-8ºC (36-46ºF) until expiration date; do not freeze; avoid direct light
              • After first injection: Refrigerate at 2-8ºC (36-46ºF) for up to 4 weeks; store in room temperature at <25ºC (77ºF) up to 3 weeks

              Nutropin AQ cartridge and NuSpin injection device content

              • After initial use: Refrigerate at 2-8ºC (36-46ºF) for up to 28 days; do not freeze; protect from light
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              Images

              BRAND FORM. UNIT PRICE PILL IMAGE
              Norditropin FlexPro subcutaneous
              -
              15 mg/1.5 mL (10 mg/mL) injection
              Norditropin FlexPro subcutaneous
              -
              10 mg/1.5 mL (6.7 mg/mL) injection
              Norditropin FlexPro subcutaneous
              -
              30 mg/3 mL (10 mg/mL) injection
              Norditropin FlexPro subcutaneous
              -
              5 mg/1.5 mL (3.3 mg/mL) injection
              Humatrope injection
              -
              12 mg (36 unit) solution
              Humatrope injection
              -
              5 (15 unit) mg vial
              Humatrope injection
              -
              24 mg (72 unit) solution
              Humatrope injection
              -
              6 mg (18 unit) solution
              Genotropin subcutaneous
              -
              5 mg/mL (15 unit/mL) solution
              Genotropin subcutaneous
              -
              12 mg/mL (36 unit/mL) solution
              Genotropin Miniquick subcutaneous
              -
              2 mg/0.25 mL suspension
              Genotropin Miniquick subcutaneous
              -
              1.6 mg/0.25 mL suspension
              Genotropin Miniquick subcutaneous
              -
              1.4 mg/0.25 mL suspension
              Genotropin Miniquick subcutaneous
              -
              1 mg/0.25 mL suspension
              Genotropin Miniquick subcutaneous
              -
              0.6 mg/0.25 mL suspension
              Genotropin Miniquick subcutaneous
              -
              0.4 mg/0.25 mL suspension
              Genotropin Miniquick subcutaneous
              -
              0.2 mg/0.25 mL suspension
              Genotropin Miniquick subcutaneous
              -
              1.8 mg/0.25 mL suspension
              Genotropin Miniquick subcutaneous
              -
              1.2 mg/0.25 mL suspension
              Genotropin Miniquick subcutaneous
              -
              0.8 mg/0.25 mL suspension
              Nutropin AQ Nuspin subcutaneous
              -
              5 mg/2 mL (2.5 mg/mL) injection
              Nutropin AQ Nuspin subcutaneous
              -
              10 mg/2 mL (5 mg/mL) injection
              Nutropin AQ Nuspin subcutaneous
              -
              20 mg/2 mL (10 mg/mL) injection
              Omnitrope subcutaneous
              -
              5.8 mg vial
              Omnitrope subcutaneous
              -
              10 mg/1.5 mL (6.7 mg/mL) solution
              Omnitrope subcutaneous
              -
              5 mg/1.5 mL (3.3 mg/mL) solution
              Saizen subcutaneous
              -
              8.8 mg vial
              Saizen subcutaneous
              -
              5 mg vial
              Zomacton subcutaneous
              -
              5 mg vial
              Zomacton subcutaneous
              -
              10 mg vial
              Zomacton subcutaneous
              -
              10 mg vial

              Copyright © 2010 First DataBank, Inc.

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              Patient Handout

              Select a drug:
              Patient Education
              somatropin subcutaneous

              SOMATROPIN - INJECTION

              (so-mah-TROW-pin)

              COMMON BRAND NAME(S): Genotropin, Humatrope, Norditropin, Nutropin, Saizen, Serostim, Zorbtive

              USES: Various brands of this medication are used for the treatment of one of the following medical conditions: growth failure, growth hormone deficiency, intestinal disorder (short bowel syndrome) or HIV-related weight loss or wasting.Somatropin is also used to increase height in children with certain disorders (such as Noonan syndrome, Turner syndrome, idiopathic short stature).

              HOW TO USE: Read the Patient Information Leaflet that may come with your brand of this medication provided by your pharmacist before you start using somatropin and each time you get a refill. If you have any questions, consult your doctor or pharmacist.Some brands of this medication are given by injection into a muscle or under the skin. Some brands may only be injected under the skin. The way you inject this medicine will depend on the brand that you are using. Check with your pharmacist to ensure that the way you are injecting your medicine is correct. It is important to change the location of the injection site to avoid problem areas under the skin. For best results, this medication must be used exactly as prescribed by your doctor. It is important to understand your therapy and to follow your doctor's instructions closely.The dosage is based on your age, weight, medical condition and response to treatment.If you are giving this medication to yourself at home, learn all preparation and usage instructions from your health care professional. Do not shake while mixing the solution. Shaking makes the medication not work properly. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. Learn how to store and discard medical supplies safely.If you are using a pen device, do not share your pen device with another person, even if the needle is changed. You may give other people a serious infection, or get a serious infection from them. Learn how to store and discard medical supplies safely.If this medicine is used for short bowel syndrome, consult your doctor if a special diet (high carbohydrate/low-fat) or the use of nutritional supplements may be helpful.If this medicine is used for weight loss/muscle wasting, it may take up to 2 weeks to notice the effects of the drug. Do not use more of this medication than prescribed or use it more often since the risk of side effects will be increased.

              SIDE EFFECTS: Headache, nausea, vomiting, fatigue, muscle pain, or weakness may occur. If these symptoms continue or become bothersome, inform your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if you have any serious side effects, including: development of a limp, persistent fatigue, unusual/unexplained weight gain, persistent cold intolerance, persistent slow heartbeat, fast heartbeat, ear pain/itching, hearing problems, joint/hip/knee pain, numbness/tingling, unusual increase in thirst or urination, swelling hands/ankles/feet, change in the appearance or size of any mole, persistent nausea/vomiting, severe stomach/abdominal pain.Get medical help right away if you have any very serious side effects, including: vision problems/changes, seizure, severe headache.Rare (possibly fatal) lung/breathing problems may be caused by this medication in children with Prader-Willi syndrome. Those at higher risk include males, severely overweight children, or those with serious lung/breathing problems ( e.g., sleep apnea, lung infections, lung disease). Children should be checked for certain breathing problems (upper airway obstruction) before and during treatment. Heavy snoring or irregular breathing during sleep (sleep apnea) are signs of airway obstruction. Tell the doctor right away if these signs occur. Also report any signs of lung infection, such as fever, persistent cough, or trouble breathing.Somatropin may increase your risk of getting a tumor or cancer. Discuss the details and the risks and benefits of this medication with your doctor.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any of the following symptoms of a serious allergic reaction: rash, itching/severe swelling (especially of the face/tongue/throat), dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

              PRECAUTIONS: See also Side Effects section.Before using somatropin, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as benzyl alcohol or metacresol found in some brands), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: adrenal gland problems, eye problems (e.g., diabetic retinopathy), recent major surgery/injury, severe breathing problems (acute respiratory failure), diabetes or family history of diabetes, obesity, kidney disease, tumors (cancer, especially of the head/neck), thyroid problems, back problems (scoliosis).If you have diabetes, this drug may increase your blood sugar. Check your blood sugar regularly as directed and share the results with your doctor. Tell your doctor right away if you have symptoms of high blood sugar such as increased thirst/urination. Your doctor may need to adjust your diabetes medication, exercise program, or diet.When this medication is given to newborns, mix with sterile water for injection that does not contain a preservative. A preservative (benzyl alcohol) which may be found in the liquid used to mix this product can rarely cause serious problems (sometimes death), if given by injection to an infant during the first months of life. The risk is greater with lower birth weight infants and is greater with increased amounts of benzyl alcohol. Symptoms include sudden gasping, low blood pressure, or a very slow heartbeat. Report these symptoms to the doctor right away should they occur.Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).Older adults may be more sensitive to the side effects of this drug, especially effects on blood sugar, or swelling ankles/feet.This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.It is not known if this drug passes into breast milk. Consult your doctor before breast-feeding.

              DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with this drug include: estrogen hormone replacement.

              OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include severe headache, nausea, or vomiting; sudden onset of sweating, fatigue, shakiness, confusion (hypoglycemia); or persistent swelling of hands and feet.

              NOTES: Do not share this medication with others.Laboratory and/or medical tests (e.g., eye exams, thyroid function tests, glucose levels, growth hormone antibody levels) will be done routinely to monitor your response to the medication or check for side effects. Keep all medical appointments and laboratory visits so your therapy can be monitored closely. Consult your doctor for more details.

              MISSED DOSE: It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule. Do not double the dose to catch up.

              STORAGE: Consult the product instructions and your pharmacist for storage details. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

              Information last revised August 2021. Copyright(c) 2021 First Databank, Inc.

              IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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              Formulary

              FormularyPatient Discounts

              Adding plans allows you to compare formulary status to other drugs in the same class.

              To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

              Adding plans allows you to:

              • View the formulary and any restrictions for each plan.
              • Manage and view all your plans together – even plans in different states.
              • Compare formulary status to other drugs in the same class.
              • Access your plan list on any device – mobile or desktop.

              The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

              Tier Description
              1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
              2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
              3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
              4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
              5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
              6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
              NC NOT COVERED – Drugs that are not covered by the plan.
              Code Definition
              PA Prior Authorization
              Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
              QL Quantity Limits
              Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
              ST Step Therapy
              Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
              OR Other Restrictions
              Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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              Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.