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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

Learn about the features of Norditropin® FlexPro® and other devices

Use our device tool to learn about differences across a range of daily growth hormone therapy devices.

Dosing pens

Learn about the features of Norditropin® FlexPro® and other devices

Use our pen device tool to learn about differences across a range of daily and long-acting growth hormone therapy devices.

This chart is not intended to be a comparison of safety and efficacy.

Dosing pens

Learn about the features of Norditropin® FlexPro® and other devices

Use our device tool to learn about differences across a range of daily growth hormone therapy devices.

This chart is not intended to be a comparison of efficacy or safety of any of these products.

This is neither a comprehensive description of each product nor a complete list of available therapies. Only select attributes of select devices are shown. 

Please refer to each product’s full prescribing information including instructions for use.

Please refer to the complete Prescribing Information for Norditropin® before use.

Choose a device that fits your patients’ needs

The word "Zero"

Zero missed injections in a typical month

In one study, 76% of patients and caregivers using a storage-flexible device reported zero missed injections in a typical month.8,d

View full study design (Kappelgaard, et al.).

dThis 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.

 

Choose a device that fits your patients’ needs

The word "Zero"

Zero missed injections in a typical month

Some device features may be a better fit for different lifestyles and routines.

In one study, 76% of patients and caregivers using a storage-flexible device reported zero missed injections in a typical month.1,b

In one study, 76% of patients and caregivers using a storage-flexible device reported zero missed injections in a typical month.8,d

View full study design (Kappelgaard, et al.).

dThis 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.

 

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Study designs

(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.8 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).8

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.8

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]. Novo Nordisk, Inc.; 2020. 
  2. NutropinAQ [prescribing information]. Genentech, Inc; 2016.
  3. Omnitrope [prescribing information]. Sandoz, Inc; 2019.
  4. Genotropin [prescribing information]. Pharmacia & Upjohn Co; 2019.
  5. Humatrope [prescribing information]. Eli Lilly & Co; 2019.
  6. SKYTROFA [prescribing information]. Ascendis Pharma, Inc.; 2022.
  7. SKYTROFA [instructions for use]. Ascendis Pharma, Inc.; 2021
  8. 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.