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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

Personalized dosing for growing patients

Norditropin® FlexPro® pens are available in 4 strengths with fine dosing increments to help you give patients precisely the dose they need.

Already know your patient’s daily dose? Find out which FlexPro® pens they can use with our pen selector.

Personalize your patients' dosing regimen

Norditropin® FlexPro® pens are available in 4 strengths with fine dosing increments to help you give patients the dose they need.

Already know your patient’s daily dose? Find out which FlexPro® pens they can use with our pen selector.

Vertical Norditropin® pens

Norditropin® (somatropin) injection dosage varies by indication

Select a classification to view dosage summary. For detailed dosing information, please see the Prescribing Information.

Dosing for pediatric patients is based on weight1

Per week

Per day

Pediatric GH Deficiency

Pediatric GH Deficiency

0.17 to 0.24 mg/kg

Per week

0.024 to 0.034 mg/kg

Per day

Prader-Willi Syndrome

Prader-Willi Syndrome

0.24 mg/kg

Per week

0.034 mg/kg

Per day

Noonan Syndrome

Noonan Syndrome

up to 0.46 mg/kg

Per week

up to 0.066 mg/kg

Per day

Turner Syndrome
Idiopathic Short Stature

Turner Syndrome
Idiopathic Short Stature

up to 0.47 mg/kg

Per week

up to 0.067 mg/kg

Per day

Small for Gestational Age (SGA)a

Small for Gestational Age (SGA)

up to 0.47 mg/kg

Per week

up to 0.067 mg/kg

Per day

In very short pediatric patients, HSDS less than -3, and older pubertal pediatric patients consider initiating treatment with a larger dose of Norditropin® (up to 0.067 mg/kg/day). Consider a gradual reduction in dosage if substantial catch-up growth is observed during the first few years of therapy. In pediatric patients less than 4 years of age with less severe short stature, baseline HSDS values between -2 and -3, consider initiating treatment at 0.033 mg/kg/day and titrate the dose as needed.

Please see Prescribing Information for full dosing instructions.

Dosing for adults with GH deficiency can be weight-based or non-weight based1

Weight-based
(not recommended for obese patients)

  • Initiate at 0.004 mg/kg/day
  • Increase the dose according to individual patient requirements to a maximum of 0.016 mg/kg daily
  • Use the patient's clinical response, adverse reactions, and determination of age- and gender-adjusted serum IGF-1 concentrations as guidance in dose titration

Non-weight based

  • Initiate with a dose of ~0.2 mg/day (range, 0.15 to 0.3 mg/day)
  • Increase by ~0.1 to 0.2 mg/day every 1 to 2 months based on clinical response and serum insulin-like growth factor 1 (IGF-1) concentrations
  • Decrease the dose as necessary on the basis of adverse reactions and/or serum IGF-1 concentrations above the age- and gender-specific normal range

Please see Prescribing Information for full dosing instructions.

Individualized treatment with FlexPro®

Pens are available in 4 strengths and 160 total dosing options.1,2

Strength

Max dose1

Dose increments1

Norditropin® 5mg/1.5 mL pen

Strength

5 mg/1.5 mL

Max dose1

2 mg

Dose increments1

0.025 mg

Norditropin® 10mg/1.5 mL pen

Strength

10 mg/1.5 mL

Max dose1

4 mg

Dose increments1

0.05 mg

Norditropin® 15mg/1.5 mL pen

Strength

15 mg/1.5 mL

Max dose1

8 mg

Dose increments1

0.1 mg

Norditropin® 30mg/3 mL pen

Strength

30 mg/3 mL

Max dose1

8 mg

Dose increments1

0.1 mg

Which pens do they need?

See the strength and number of pens your patients need for a 30-day supply of Norditropin®.b,c

bNorditropin® should be administered subcutaneously to the back of the upper arm, abdomen, buttocks, or thigh with regular rotation of injection sites to avoid lipoatrophy.1

cAll unused Norditropin® products must be refrigerated (36°F to 46°F) prior to first use. Do not freeze, and avoid direct light. 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.1

Looking for a weekly GH option for your patients on daily GH treatments?

Sogroya® pen

Meet Sogroya® (somapacitan-beco) injection, the first and only once-weekly growth hormone (GH) treatment approved for both pediatric patients aged 2.5 years and older with growth failure due to inadequate secretion of endogenous GH, and for replacement of endogenous GH in adults with growth hormone deficiency (GHD).

Please see Sogroya® Prescribing Information.

Assessing your patients’ growth?

Calculator icon

Our calculators can help you estimate height velocity and other metrics used in clinical practice.
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Intended for use by healthcare professionals only

Product samples and support

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 somatropins
  • Active proliferative or severe non-proliferative diabetic retinopathy
  • Pediatric patients with closed epiphyses

Indications and Usage

Norditropin® (somatropin) injection 5 mg, 10 mg, 15 mg, or 30 mg 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 somatropins
  • 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 somatropins.
  • 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

  • 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. Data on file. Novo Nordisk Inc; Plainsboro, NJ.