somatropin (Rx)

Brand and Other Names:Genotropin, HumatroPen, more...Genotropin Miniquick, Genotropin Pen 12, Humatrope, Norditropin FlexPro, Norditropin NordiFlex, Nutropin, Nutropin AQ, 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

  • 10mg/2mL

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

Nutropin AQ Pen

  • 20mg/2mL
  • 10mg/2mL

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

  • 10mg/2mL

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

Nutropin AQ Pen

  • 20mg/2mL
  • 10mg/2mL

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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            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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            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.
            Additional Offers
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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.