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Medical Information | Non-US Health Care Professionals
Important Safety Information | Patient Site
Prescribing Information
Norditropin® (somatropin) injection 5 mg, 10 mg, 15 mg, 30 mg logo

For pediatric patients with growth failure due to inadequate secretion of endogenous growth hormone (GH) and Prader-Willi Syndrome; short stature associated with Noonan Syndrome, Turner Syndrome, and children born small for gestational age; idiopathic short stature; and for the replacement of endogenous GH in adults with growth hormone deficiency (GHD). Please see full indications.

Prescribing Information
Important Safety Information | Patient Site

Supporting growth-related disorders for 25 years and counting1

Norditropin® was first approved by the FDA in 1995.1

Supporting growth for 25 years and counting1

Norditropin® was first approved by the FDA in 1995.1

Actor portrayal

Father and daughter

How Norditropin® indications compare to other therapies1-8,a

More indications to help more of your patients.

 


aThis chart is not intended to be a comparison of efficacy or safety.

bThese products are recommended for once-weekly treatment.

How Norditropin® (somatropin) injection works to improve height

Somatropin binds to dimeric growth-hormone receptors located within the cell membranes of target tissue cells. This interaction results in intracellular signal transduction and subsequent induction of transcription and translation of GH-dependent proteins including IGF-1. Somatropin has direct tissue and metabolic effects or mediated indirectly by IGF-1, including stimulation of chondrocyte differentiation and proliferation, and protein synthesis.1


Somatropin stimulates skeletal growth in pediatric patients with GHD as a result of effects on the growth plates (epiphyses) of long bones, leading to increased linear growth rate (height velocity) in most cases. Linear growth is facilitated in part by increased cellular protein synthesis.1

Molecule icon

See Prescribing Information for complete description.

 

Norditropin pens

What’s the right dose for your patients?

The daily dose for pediatric patients is based on the patient’s indication and weight. Individualize dosage for each patient based on the growth response.1

 

Easy to use and preferred by a majority of patients over their current device9,c,d

See study design (Fuchs, et al.)

96% icon

of patients were comfortable with the idea of future self-injection with Norditropin® FlexPro®9,d

Zero icon

missed injections in a typical month

Report from 76% of patients/caregivers using a storage-flexible GH10,e

 

See study design (Kappelgaard, et al.)

cPlease see Instructions for Use for complete instructions.

dBased on an open-label, uncontrolled study assessing the usability and acceptability of Norditropin® FlexPro® 10 mg in 70 children and adolescents between 10 and <18 years of age on daily treatment of human growth hormone injections. Usability responses were gathered in a face-to-face interview after being given written/verbal instructions for use of the pen; acceptability of the device was also assessed through a 21-item questionnaire for device preparation, ease of use, and learning, as well as patient preference.9

eThis study surveyed 146 respondents (48 patients, 98 caregivers) with experience using one type of GH product (storage-flexible or refrigeration-only). Respondents provided feedback on their GH product with respect to the basic GH therapy overview, typical injection process, how they manage their injection when special occasions or other activities arise, and wastage and storage. The functional and emotional impact of storage-flexible GH products vs that of refrigeration-only GH products on patients’ and caregivers’ daily lives was assessed using a web-based survey.10

of patients were comfortable with the idea of future self-injection with Norditropin® FlexPro®9,d

missed injections in a typical month

Report from 76% of patients/caregivers using a storage-flexible GH10,e

See study design (Kappelgaard, et al.)

cPlease see Instructions for Use for complete instructions.

dBased on an open-label, uncontrolled study assessing the usability andacceptability of Norditropin® FlexPro® 10 mg in 70 children and adolescents between 10 and <18 years of age on daily treatment of human growth hormone injections. Usability responses were gathered in a face-to-face interview after being given written/verbal instructions for use of the pen; acceptability of the device was also assessed through a 21-item questionnaire for device preparation, ease of use, and learning, as well as patient preference.9

eThis study surveyed 146 respondents (48 patients, 98 caregivers) with experience using one type of GH product (storage-flexible or refrigeration-only). Respondents provided feedback on their GH product with respect to the basic GH therapy overview, typical injection process, how they manage their injection when special occasions or other activities arise, and wastage and storage. The functional and emotional impact of storage-flexible GH products vs that of refrigeration-only GH products on patients’ and caregivers’ daily lives was assessed using a web-based survey.10

Designed with patients in mind

Norditropin FlexPro pen
  • Prefilled, premixed, and preloaded1
  • Easy-to-push dose button9,d,f
  • Multidose1
  • 19mm diameter11
  • 32-gauge needleg
  • Optional PenMate® accessory keeps needle out of sight1,h
  • Prefilled, premixed, and preloaded1
  • Easy-to-push dose button9,d,f
  • Multidose1
  • 19mm diameter11
  • 32-gauge needleg
  • Optional PenMate® accessory keeps needle out of sight1,h

fSee study design (Fuchs, et al.).9
gNeedles are sold separately, will need a prescription, and need to be processed by a pharmacist.
hPenMate® is available for Norditropin® FlexPro® 5, 10, and 15 mg pens only. It is reusable.2

Room temperature stable for up to 21 days after first use1

After first injection, Norditropin® pens can either be stored outside of the refrigerator (up to 77°F) for use within 3 weeks, or in the refrigerator (between 36°F and 46°F) for use within 4 weeks. All unused Norditropin® FlexPro® prefilled pens must be refrigerated (36°F to 46°F) prior to first use. Do not freeze, and avoid direct light.1

Storage information icon
Coverage icon

Broad coverage for commercial and Medicaid patients11

Norditropin® has the broadest coverage in its class.1,f See coverage in your area with one quick search.

fPreferred status BioPharm Insights as of January 2022. Nationally, Norditropin® is preferred for 89% of Commercial and 89% of Medicaid patients.1

 

Intended for use by healthcare professionals only

Questions about Norditropin®?

Study designs

(Fuchs, et al.) Ease of Use and Acceptability of a New Pen Device for the Administration of GH Therapy in Pediatric Patients: An Open-Label, Uncontrolled Usability Test

Participants:

Seventy patients (children and adolescents) aged between 10 to <18 years who were diagnosed with GHD and receiving daily treatment with self-injectable GH were eligible for the study. At screening, agreement from the patients and informed consent from a parent/guardian was obtained.9

Methods:

The open-label, uncontrolled study was conducted at the Murray Hill Center, New York, New York, and in the patients’ homes. The usability and acceptability of the Norditropin® FlexPro® pen were the primary endpoints. Norditropin® FlexPro® pens, prefilled with test medium, and NovoFine® G32 (Novo Nordisk A/S) needles were used to inject test medium into an injection pad. In a face-to-face interview, the moderator presented the device to the patient, demonstrated how to use it, and observed any technical issues (i.e., device not functioning properly) (secondary endpoint) to assess reliability. After receiving instructions, patients received 2 pens and were instructed to attach the needle, prime the pens, and inject the equivalent volume of their daily GH dose and a 4-mg dose into an injection pad several times until the pens were empty (equating to ≈7 injections, on average, between the 2 pens). To gauge acceptance of the device, patients were asked to complete a 21-item questionnaire which covered: ease of preparing the pen for injection, the ease, comfort, and confidence experienced by patients while performing the injection, ease of learning to operate the pen, comfort with the idea of future self-injection without guidance, perceptions of the pen vs their current pen in terms of stability when injecting, confidence that the right dose was being delivered, and preference. Patients were addressed directly by the moderator and answered all of the questions without assistance from parents/guardians present during the interview.9

(Kappelgaard, et al.) Web-based Survey Assessing the Impact of Storage Flexibility on the Daily Life of Patients and Caregivers Administering GH

Participants:

Survey respondents (N=146; 48 patients, 98 caregivers) who had experience using only one type of GH product (storage-flexible or refrigeration-only) were included. In order to qualify for the study, patients (≥5 to ≤25 years) or their caregivers were required to use a pen device to administer GH for a growth-related disorder (more than once per week but no more than once daily) and be involved in either the injection itself or in managing the materials required for injection. Caregivers completed the survey for patients <14 years. In the United States, patients 14 to 17 years of age were required to have their caregiver present during the survey. In Europe, caregivers were required to be present during the interview or give consent.10 The classification of GH product type for each patient was determined based on screening question responses. Storage-flexible products included Norditropin® FlexPro®, Norditropin® NordiPen®, and Genotropin® MiniQuick® while refrigeration-only products included Omnitrope® Pen, Humatrope®, Genotropin®, Saizen®, Nutropin AQ®, Nutropin AQ® NuSpin™, easypod®, Tev-Tropin®/Tjet®, Genotropin GoQuick®, one.click®, and other pens (from Pfizer or Lilly).10

Methods:

The survey was conducted from April 2014 to June 2014 in France, Germany, Italy, and the United States. Respondents completed a 20-minute, computer-assisted, web-based interview at home. Interviewers were aware of the sponsor, but patients and caregivers were blinded to reduce potential bias. They were allowed to discuss the questions with the interviewer by telephone as they proceeded through the survey or could complete the survey by web only without assistance. The questionnaire comprised 4 sections, with a maximum of 66 total questions: basic GH therapy overview, typical injection process, special occasions (weddings, vacations) or activities (overnight stays, social occasions, school/work trips), and wastage and storage.10

Selected Important Safety Information for Norditropin®

Contraindications

Norditropin® is contraindicated in patients with:

  • 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
  • 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
  • Active Malignancy
  • Hypersensitivity to Norditropin® or any of its excipients. Systemic hypersensitivity reactions have been reported with postmarketing use of somatropin products
  • Active proliferative or severe non-proliferative diabetic retinopathy
  • Pediatric patients with closed epiphyses

Indications and Usage

Norditropin® (somatropin) injection is indicated for the treatment of pediatric patients with:

  • growth failure due to inadequate secretion of endogenous growth hormone (GH)
  • short stature associated with Noonan syndrome,
  • short stature associated with Turner syndrome,
  • short stature born small for gestational age (SGA) with no catch-up growth by age 2 to 4 years of age
  • Idiopathic Short Stature (ISS), height standard deviation score (SDS) <-2.25, and associated with growth rates unlikely to permit attainment of adult height in the normal range
  • growth failure due to Prader-Willi syndrome (PWS) 

Norditropin® is also indicated for the replacement of endogenous GH in adults with growth hormone deficiency (GHD)

Important Safety Information

Contraindications

Norditropin® is contraindicated in patients with:

  • 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
  • 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
  • Active Malignancy
  • Hypersensitivity to Norditropin® or any of its excipients. Systemic hypersensitivity reactions have been reported with postmarketing use of somatropin products
  • Active proliferative or severe non-proliferative diabetic retinopathy
  • Pediatric patients with closed epiphyses

Warnings and Precautions

  • Increased mortality in patients with acute critical illness due to complications following open heart or abdominal surgery or multiple accidental trauma, or those with respiratory failure has been reported.
  • Sudden death in pediatric patients with Prader-Willi Syndrome has been reported after initiating treatment with somatropin with one or more of the following risk factors: severe obesity, history of upper airway obstruction or sleep apnea, or unidentified respiratory infection. Evaluate patients for signs of upper airway obstruction and sleep apnea before initiation of treatment.
  • Increased risk of neoplasms: Monitor patients with preexisting tumors for progression or recurrence. 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, in particular meningiomas, has been reported. Pediatric patients with certain rare genetic causes of short stature have an increased risk of developing malignancies and should be carefully monitored for development of neoplasms. Monitor patients carefully for increased growth, or potential malignant changes, of preexisting nevi.
  • Glucose intolerance and diabetes mellitus: Treatment with somatropin may decrease insulin sensitivity, particularly at higher doses. New-onset type 2 diabetes mellitus has been reported. Monitor glucose levels in all patients. Doses of concurrent antidiabetic drugs may require adjustment.
  • Intracranial hypertension has been reported in a small number of patients, usually within the first 8 weeks of somatropin treatment. Funduscopic examination should be performed before initiating treatment and periodically thereafter.
  • Severe hypersensitivity: Serious systemic hypersensitivity reactions including anaphylactic reactions and angioedema have been reported with postmarketing use of somatropin products.
  • Fluid retention in adults (clinically manifesting as edema, arthralgia, myalgia, nerve compression syndromes including carpal tunnel syndrome/paraesthesias) may frequently occur and is usually transient and dose-dependent.
  • Hypoadrenalism: 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. In addition, patients treated with glucocorticoid replacement for previously diagnosed hypoadrenalism may require an increase in their maintenance or stress doses following initiation of Norditropin® treatment.
  • Hypothyroidism if undiagnosed/untreated, may prevent an optimal response to Norditropin®, in particular, the growth response in pediatric patients. In patients with GHD, central (secondary) hypothyroidism may first become evident or worsen during somatropin treatment. Periodic thyroid function tests and thyroid hormone replacement therapy should be initiated or adjusted when indicated.
  • Slipped capital femoral epiphysis in pediatric patients may occur more frequently in patients with endocrine disorders or in patients undergoing rapid growth. Pediatric patients with the onset of a limp or complaints of hip or knee pain should be evaluated.
  • Progression of preexisting scoliosis in pediatric patients can occur in patients who experience rapid growth. Patients with a history of scoliosis should be monitored for progression.
  • Pancreatitis: Cases of pancreatitis have been reported. Pancreatitis should be considered in any patient who develops persistent severe abdominal pain.
  • Lipoatrophy: Tissue atrophy may result when somatropin is administrated subcutaneously at the same site over a long period of time. Rotate injection sites when administering Norditropin® to reduce this risk.

Adverse Reactions

  • Other common adverse reactions in adults and pediatric patients include: upper respiratory infection, fever, pharyngitis, headache, otitis media, edema, arthralgia, paresthesia, myalgia, peripheral edema, flu syndrome, and impaired glucose tolerance

Drug Interactions

  • Glucocorticoids: Patients treated with glucocorticoid for hypoadrenalism may require an increase in their maintenance or stress doses following initiation of Norditropin®
  • Pharmacologic Glucocorticoid Therapy and Supraphysiologic Glucocorticoid Treatment: Adjust glucocorticoid replacement dosing in pediatric patients receiving glucocorticoid treatment to avoid both hypoadrenalism and an inhibitory effect on growth
  • Cytochrome P450-Metabolized Drugs: Norditropin® may alter the clearance. Monitor carefully if used with Norditropin®
  • Oral Estrogen: Larger doses of Norditropin® may be required
  • Insulin and/or Other Hypoglycemic Agents: Dose adjustment of insulin or hypoglycemic agent may be required

Use in Specific Populations

  • Pregnancy and Nursing Mothers: There are limited data with somatropin use in pregnant women and nursing mothers to inform a drug-associated risk for adverse developmental outcomes.
  • Geriatric Use: The safety and effectiveness in patients aged 65 and over has not been evaluated in clinical studies.

Please click here for Norditropin® Prescribing Information.

References:
  1. Norditropin [prescribing information]. Plainsboro, NJ: Novo Nordisk Inc; 2020.
  2. Nutropin AQ [prescribing information]. San Francisco, CA: Genentech, Inc; 2016.
  3. Genotropin [prescribing information]. New York, NY: Pharmacia & Upjohn Co; 2019.
  4. Humatrope [prescribing information]. Indianapolis, IN: Eli Lilly & Co; 2019.
  5. Saizen [prescribing information]. Rockland, MA: EMD Serono, Inc; 2020.
  6. Omnitrope [prescribing information]. Princeton, NJ: Sandoz, Inc; 2019.
  7. Zomacton [prescribing information]. Parsippany, NJ: Ferring Pharmaceuticals, Inc; 2018.
  8. Skytrofa [prescribing information]. Palo Alto, CA: Ascendis Pharma, Inc; 2021.
  9. Fuchs GS, Mikkelsen S, Knudsen TK, Kappelgaard AM. Ease of use and acceptability of a new pen device for the administration of growth hormone therapy in pediatric patients: an open-label, uncontrolled usability test. Clin Ther. 2009;31(12):2906-2914.
  10. Kappelgaard AM, Metzinger CP, Schnabel D. A web-based survey assessing the impact of storage flexibility on the daily life of patients and caregivers administering growth hormone. Expert Rev Med Devices. 2015;12(5):517-527.
  11. Data on file. Novo Nordisk Inc; Plainsboro, NJ.