somatropin (Genotropin, HumatroPen, 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)
Classes: Growth Hormone Analogs
Dosing and uses of Genotropin, Humatrope (somatropin)
Adult dosage forms and 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
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: Not to exceed 0.004 mg/kg/day SC initially for 6 weeks; may increase up to 0.016 mg/kg/day maximum
- 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 of age and up to 0.0125 mg/kg/day if patient >35 years
- Homatrope: 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 maximum
- Saizen: Not to exceed 0.005 mg/kg/day SC initially for 4 weeks; may increase dose up to 0.01 mg/kg/day
Nonweight-based dosing
- 0.2 mg/day (0.15-0.3 mg/day range) SC initially; may increase 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 lipodistrophy 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
Geriatric
>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
Pediatric dosage forms and 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
- 0.026-0.043 mg/kg/day (0.18 mg/kg/week - 0.3 mg/kg/week) SC divided into 6-7 equal doses/week SC doses)
Norditropin
- 0.024-0.034 mg/kg/day SC 6-7 days/week
Nutropin and Nutropin AQ
- Prepuberty: 0.3 mg/kg/week SC weekly divided into equal daily doses
- Postpuberty: 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/wek 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
Norditropin
- Not to exceed 0.067 mg/kg/day SC
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
Nooman Syndrome With Growth Hormone Deficiency
Norditropin
- Not to exceed 0.066 mg/kg/week SC
Prader-Willi Syndrome With Growth Hormone Deficiency
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
Turner Syndrome With Growth Hormone Deficiency
Genotropin
- 0.33 mg/kg/week SC divided into 6-7 days/week
Humatrope
- Not to exceed 0.054 mg/kg/day SC (0.375 mg/kg/week divided into 6-7 days/week)
Norditropin
- Not to exceed 0.067 mg/kg/day SC
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 0.47 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)
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)
Renal Impairment
Renal clearance may decrease; dosing reommendations have not been reported
Hepatic Impairment
Hepatic clearance may decrease; dosing recommendations have not been reported
Genotropin, Humatrope (somatropin) adverse (side) effects
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)
- 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
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
Warnings
Contraindications
Hypersensitivity to metacresol or glycerin (diluent)
Hypersensitivity to benzyl alcohoL
Acute critical illness
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
Use in patients with Prader-Willi syndrome without growth hormone deficiency or with growth hormone deficiency but severely obese
History of upper airway obstruction or sleep apnea or severe respiratory impairment
Cautions
Increased risk of glucose intolerance; monitor
Monitor patients for increased growth, or potential malignant changes of preexisting nevi
Evaluate for signs of upper airway obstruction and sleep apnea in children with Prader-Willi syndrome before initiation of treatment; discontinue treatment if these signs occur
Rule out pituitary or brain tumors as cause of hGH deficiency before initiating treatment
Discontinue if evidence of tumorigenesis
Fluid Retention (i.e., edema, arthralgia, carpal tunnel syndrome – especially in adults) may occur frequently; reduce dose as necessary
If patient is hypersensitive to diluent, reconstitute with SWI (vials only)
Cartridges must be reconstituted with supplied diluent
Glucocorticoid therapy may attenuate growth promoting effects of somatropin in children; carefully adjust glucocorticoid therapy to avoid both hypoadrenalism and an inhibitory effect on growth
Closely monitor other hormonal replacement treatments in patients with hypopituitarism during somatropin treatment
Pancreatitis reported rarely in children and adults, with some evidence supporting a greater risk in children compared with adults; published literature indicates that girls who have Turner syndrome may be at greater risk than other somatropin-treated children
Consider pancreatitis in patients with persistent severe abdominal pain
New onset type 2 diabetes mellitus reported, monitor glucose levels periodically; doses of concurrent antihyperglycemic drugs in diabetics may require adjustment
Exclude preexisting papilledema; intracranial hypertension with headache, visual changes, papilledema, nausea may occur and is usually reversible after discontinuation or dose reduction
Contains benzyl alcohol; gasping syndrome (characterized by CNS depression, metabolic acidosis, gasping respirations, and high levels of benzyl alcohol and its metabolites found in the blood and urine) has been associated with benzyl alcohol dosages >99 mg/kg/day in neonates and low-birth weight neonates
Progression of scoliosis can occur in patients who experience rapid growth; monitor patients with history of scoliosis during somatropin therapy; not shown to increase occurrence of scoliosis
As with all therapeutic proteins, there is potential for immunogenicity
Consider risks and benefits of starting somatropin in patients with short stature as they have increased risk of developing malignancies
Patients with Turner syndrome should be evaluated carefully for otitis media and other ear disorders
When somatropin is administered SC at same site over long period of time, tissue atrophy may result; may avoid by rotating injection site
Hypothyroidism may first become evident or worsen; undiagnosed/untreated hypothyroidism may prevent an optimal response to somatropin, in particular, growth response in children; monitor thyroid function periodically
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
Secondary carcinoma: In childhood cancer survivors who were treated with radiation to the brain/head for their first neoplasm and who developed subsequent GHD and were treated with somatropin, an increased risk of a second neoplasm has been reported; intracranial tumors, in particular meningiomas, were the most common of these second neoplasms; monitor all patients with history of GHD secondary to an intracranial neoplasm routinely while on somatropin therapy for progression or recurrence of the tumor
Patients with endocrine disorders, including growth hormone deficiency, may have an increased incidence of slipped capital femoral epiphysis; evaluate any child who develops a limp or complains of hip or knee pain during somatropin therapy
Monitor bone age periodically during somatropin administration, especially in patients who are pubertal and/or receiving concomitant thyroid hormone replacement therapy; epiphyseal maturation may progress rapidly
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
Pregnancy and lactation
Pregnancy category: B/C depending on manufacturer
Lactation: Use caution
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 of Genotropin, Humatrope (somatropin)
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.
Duration
Supraphysiologic levels maintained for 18-20 hours
Metabolism
Liver, kidneys
Elimination
Half-life
- 2-4 hours depending on formulation and route of administration
Absorption
IM/SC: Approximately 63% to 90% depending on formulation and route of administration
Distribution
Genotropin: 1.3 L/kg
Humatrope: 0.07 L/kg
Nutropin and Nutropin AQ: 50 mL/kg
Omniprobe: 1.4 L/kg
Saizen, Serostim, and Zorbtive: 12 L
