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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

 
 
 

Dosing & Uses

AdultPediatric

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

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
more...

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

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
more...

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

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Interactions

Interaction Checker

somatropin and

No Results

     
     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            Frequency Not Defined

            Pediatric

            • Slipped capital epiphyses
            • 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

            Renal Impairment

            New onset type 2 diabetes mellitus reported in children and adults

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            Warnings

            Contraindications

            Hypersensitivity to metacresol or glycerin (diluent)

            Hypersensitivity to benzyl alcohol

            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

            Rule out pituitary or brain tumors as cause of hGH deficiency before initiating treatment

            Discontinue if evidence of tumorigenesis

            Fluid retention may occur

            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

            Intracranial hypertension with headache, visual changes, papilledema, nausea may occur

            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

            Undiagnosed/untreated hypothyroidism may prevent an optimal response to somatropin, in particular, growth response in children

            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
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            Pregnancy & 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.

            more...
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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.

            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

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            Images

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            Formulary

            FormularyPatient Discounts

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            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.
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            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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