Dosing & Uses
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
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
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
Growth failure with Prader-Willi syndrome
Genotropin
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
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
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
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
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (0)
Serious - Use Alternative (2)
- 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.
- pacritinib
somatropin will decrease the level or effect of pacritinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
Monitor Closely (20)
- 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.
- atogepant
somatropin will decrease the level or effect of atogepant by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- bexagliflozin
somatropin decreases effects of bexagliflozin by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Growth hormone products may decrease insulin sensitivity, particularly at higher doses. Antidiabetic agents may require dose adjustment after initiating growth hormone.
- 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.
- isavuconazonium sulfate
somatropin will decrease the level or effect of isavuconazonium sulfate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. 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.
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
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
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.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)
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
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| Genotropin Miniquick subcutaneous - | 2 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 - | 1.6 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 |  | |
| Genotropin subcutaneous - | 5 mg/mL (15 unit/mL) solution |  | |
| Genotropin subcutaneous - | 12 mg/mL (36 unit/mL) solution |  | |
| Norditropin FlexPro subcutaneous - | 15 mg/1.5 mL (10 mg/mL) injection |  | |
| Norditropin FlexPro subcutaneous - | 5 mg/1.5 mL (3.3 mg/mL) injection |  | |
| Norditropin FlexPro subcutaneous - | 30 mg/3 mL (10 mg/mL) injection |  | |
| Norditropin FlexPro subcutaneous - | 10 mg/1.5 mL (6.7 mg/mL) injection |  | |
| Zomacton subcutaneous - | 10 mg vial |  | |
| Zomacton subcutaneous - | 10 mg vial |  | |
| Zomacton subcutaneous - | 5 mg vial |  | |
| Humatrope injection - | 6 mg (18 unit) solution |  | |
| Humatrope injection - | 5 (15 unit) mg vial |  | |
| Humatrope injection - | 24 mg (72 unit) solution |  | |
| Humatrope injection - | 12 mg (36 unit) solution |  | |
| Nutropin AQ Nuspin subcutaneous - | 10 mg/2 mL (5 mg/mL) injection |  | |
| Nutropin AQ Nuspin subcutaneous - | 5 mg/2 mL (2.5 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 |  |
Copyright © 2010 First DataBank, Inc.
Patient Handout
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, tiredness, 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: nausea/vomiting that doesn't stop, development of a limp, unusual tiredness, unusual/unexplained weight gain, cold intolerance, fast/slow 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, 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 ( such as 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, 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 to lonapegsomatropin; 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 (such as diabetic retinopathy), recent major surgery/injury, breathing problems, diabetes or family history of diabetes, obesity, kidney disease, cancer/tumor (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.During pregnancy, this medication should be used only when clearly needed. 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.Somatropin is very similar to lonapegsomatropin. Do not use medications containing lonapegsomatropin while using somatropin.
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, severe nausea/vomiting, signs of low blood sugar (such as sudden sweating, shaking, confusion), ongoing swelling of the hands and feet.
NOTES: Do not share this medication with others.Lab and/or medical tests (such as eye exams, thyroid function, glucose levels, growth hormone antibody levels) will be done while you are using this medication. Keep all medical and lab appointments. 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 December 2022. Copyright(c) 2023 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.
Formulary
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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.
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