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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

Safety and efficacy demonstrated in a real-world setting1

Norditropin® was assessed in an observational study (ANSWER—originally a post-marketing registry) that allowed evaluation of its safety and effectiveness in pediatric patients in a real-world setting.1,a

aThe ANSWER Program was originally a post-marketing registry of adults and pediatric patients treated with Norditropin® as prescribed by their physician and according to routine clinical practice. Since it did not investigate treatment specifics, it was developed as a non-interventional, observational study that allowed evaluation of the safety and effectiveness of Norditropin® in a real-world setting in the United States.1 ANSWER had 19,847 pediatric patients in the full analysis set (FAS), used to evaluate safety outcomes, and 12,660 in the effectiveness analysis set (EAS), used to analyze effectiveness outcomes.1 Pediatric patients in the FAS included GH-naïve and non-naïve patients.1 In the FAS, mean duration of GH treatment with known dose within the study was 2.305 (SD: 12.79) years for GHD, 2.432 (SD: 2.120) years for SGA, 3.090 (SD: 2.580) years for Turner syndrome, 2.147 (SD: 5.188) years for ISS, 2.686 (SD: 2.111) years for Noonan syndrome, and 3.522 (SD: 3.110) years for PWS.1 Pediatric patients in the EAS were included in the FAS, GH-naïve at baseline, had valid baseline height, age, and dosing information, and diagnosed with one of the following: GHD, SGA, Turner syndrome, ISS, Noonan syndrome, or PWS.1 In the EAS, mean duration of GH treatment with known dose within the study was 2.195 (SD: 15.46) years for GHD, 2.240 (SD: 2.014) years for SGA, 3.047 (SD: 2.361) years for TS, 2.055 (SD: 6.015) years for ISS, 2.589 (SD: 2.02) years for NS, and 3.331 (SD: 3.118) years for PWS.1

Pediatric patients on Norditropin® achieved improved height outcomes1

No additional safety concerns were observed.1

Height outcomes chart
Pediatric patients indications chart

GHD=growth hormone deficiency; HSDS=height standard deviation score; HSVDS = height velocity standard deviation score; ISS=idiopathic short stature; PWS=Prader-Willi syndrome; SGA=small gestational age.
bAt Year 1 of follow-up, n=1569 for ISS, n=47 for PWS, n=6123 for GHD, n=591 for SGA, and n=417 for Turner syndrome.1
cAt Year 1 of follow-up, n=3083 for GHD, n=250 for SGA, n=142 for Turner syndrome.1
dFor Noonan syndrome (mean HSDS), n=107 and 73 at Year 1 and Year 2 of follow-up, respectively.1
eFor Noonan syndrome (peak HVSDS), n=43 and n=63 at Year 1 and Year 2 of follow-up, respectively.1

Treating patients with GHD?

Safety and efficacy studies for Norditropin® have included pediatric and adult patients with growth hormone deficiency (GHD).2

Looking for data about other growth-related disorders?

Explore clinical studies which included pediatric patients diagnosed with idiopathic short stature, Noonan syndrome, Turner syndrome, born small for gestational age, and Prader-Willi syndrome.

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Individualized treatment

Norditropin® FlexPro® pens allow you to personalize your patients’ dosing regimens from childhood through adolescence.1

Study design

The ANSWER Program: An Observational Study (Registry) Assessing Treatment Outcomes and Safety for Children and Adults Who Are Prescribed Norditropin® (Human Growth Hormone):

Participants:
The study population consisted of children and adults treated with commercially available Norditropin® for an appropriate diagnostic indication as prescribed by their physician in the course of routine clinical practice.

Pediatric:
ANSWER had 19,847 pediatric patients in the FAS, used to evaluate safety outcomes, and 12,660 in the EAS, used to analyze effectiveness outcomes.1
Pediatric patients in the FAS included GH-naïve and non-naïve individuals.1 Patients were included in the FAS if Norditropin® was initiated before the age of 18 years. Pediatric patients could be treated to final height after the age of 18 years. Patients with GH treatment initiation before 18 years of age and Norditropin® treatment initiation after the age of 18 years and no Norditropin® treatment after the age of 20 years were also included in the pediatric FAS.1
In the FAS, mean duration of GH treatment with a known dose within the study was 2.305 years for GHD (SD: 12.79), 2.432 years for SGA (SD: 2.120), 3.090 years for Turner syndrome (SD: 2.580), 2.147 years for ISS (SD: 5.188), 2.686 years for Noonan syndrome (SD: 2.111), and 3.522 years for PWS (SD: 3.110).1
Pediatric patients in the EAS were included in the FAS, GH-naïve at baseline, had valid baseline height, age, and dosing information, and were diagnosed with one of the following: GHD, SGA, Turner syndrome, ISS, Noonan syndrome, or PWS.1 In the EAS, mean duration of GH treatment with a known dose within the study was 2.195 years for GHD (SD: 15.46), 2.240 years for SGA (SD: 2.014), 3.05 years for Turner syndrome (SD: 2.36), 2.055 years for ISS (SD: 6.015), 2.59 years for Noonan syndrome (SD: 2.02), and 3.331 years for PWS (SD: 3.118).1

Adult:
ANSWER included 966 adults in the FAS and 304 in the EAS.2 Adults in the FAS included GH-naïve and non-naïve patients. Patients initiating Norditropin® treatment after the age of 18 years and treated with Norditropin® after the age of 20 years were included in the adult FAS.1 Adults in the EAS were included in the FAS, GH-naïve at baseline, diagnosed with adult GHD, had valid baseline BMI, age, and dosing information, and their first dose was administered at or after the age of 20 years.1

Methods:
The ANSWER Program was originally a post-marketing registry of adults and pediatric patients treated with Norditropin® as prescribed by their physician and according to routine clinical practice. Since it did not investigate treatment specifics, it was developed as a non-interventional, observational study that allowed evaluation of the safety and effectiveness of Norditropin® in a real-world setting. The study included patient data from June 24, 2002 to September 30, 2016 from 207 planned sites located within the US, of which 144 participating sites were active at Last Patient Last Visit.1 Participating physicians made all diagnostic and therapeutic decisions according to their routine clinical practice, including frequency of visits, and recorded patient data in electronic case report forms using the NovoNet® web application.1 The sponsor did not provide Norditropin® to the patients in this observational study. Norditropin® was available as cartridges for use with NordiPen® (5 mg/1.5 mL and 15 mg/1.5 mL), or pre-filled NordiFlex® (5 mg/1.5 mL, 10 mg/1.5 mL, 15 mg/1.5 mL, and 30 mg/3.0 mL), and FlexPro® (5 mg/1.5 mL, 10 mg/1.5 mL, and 15 mg/1.5 mL) for subcutaneous injection.1 There were 4 analysis sets including a FAS and an EAS for each of the adult and pediatric patient populations. The FAS was used to evaluate the safety information and all effectiveness endpoints were evaluated using the EAS.1 The primary endpoint for short-term outcomes (within 1 year) was change in HSDS for pediatric patients, and waist-to-hip circumference ratio for adult and transition GHD patients. Descriptive statistics were applied for these endpoints.1

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. Data on file. Novo Nordisk Inc; Plainsboro, NJ.
  2. Norditropin [prescribing information]. Plainsboro, NJ: Novo Nordisk Inc.