Medical Information
|
Non-US Health Care Professionals
Account Settings
Sign Out
Sign In | Create Account
  • Growth-Related Disorders Home
  •  Icon
    Products
    Treatments
     Icon
    Professional Resources
    Product Resources Library
    Contact Your Representative
    Growth Calculators
    Medical Information
    |
    Non-US Health Care Professionals
  •  Icon
    Disease Education
    Pediatric Growth-Related Disorders (Basics)
    Adult Growth Hormone Deficiency
     Icon
    Treatment Guidelines
    PES & AACE Guidelines
     Icon
    Additional Resources
    Organizations & Conferences
    Medical Information
    |
    Non-US Health Care Professionals
  •  Icon
    Product Education
    Product Education Materials
     Icon
    Disease Education
    Advocacy & Support Groups
    Disease Education Resources
     Icon
    Access & Affordability
    Insurance Support & Prescription Savings
    ICD-10 Codes for Growth-Related Disorders
    Medical Information
    |
    Non-US Health Care Professionals
Growth-Related Disorders
Norditropin® (somatropin) injection 5 mg, 10 mg, 15 mg, 30 mg logo
  • About Norditropin®
  • Overview Growth Hormone Deficiency Other Growth-Related Disorders ANSWER Program
  • Dosing FlexPro® Pen Selector FlexPro® Pen Instructions Device Attribute Chart
  • Insurance Coverage Patient Savings Programs
  • Patient Materials Provider Materials FAQ
Prescribing Information | Important Safety Information | Patient Site

Explore Therapeutic Areas

Diabetes Icon
Diabetes
Our broad treatment portfolio supports individualized patient care.
Obesity Icon
Obesity
Our treatments are part of a comprehensive approach to weight-loss management.
MASH Icon
MASH
Our commitment is to treat and help people living with MASH.
Growth-Related Disorders Icon
Growth-Related Disorders
Our products help children with a range of growth-related disorders and adults with growth hormone deficiency.
Rare Bleeding Disorders Icon
Rare Bleeding Disorders
Our commitment to patients with hemophilia and rare bleeding disorders is reflected in our broad therapy portfolio.
Rare Renal Disorders Icon
Rare Renal Disorders
Our treatment helps patients with the rare genetic disorder primary hyperoxaluria type 1 (PH1).
Multiple Indications Icon
Multiple Indications
Medical Information
|
Non-US Health Care Professionals
  • Growth-Related Disorders Home
Account Settings
Sign Out
Sign In | Create Account
Update your account
Medical Information
|
Non-US Health Care Professionals

Explore the Hub

Products
Samples
Patient Savings
Contact

Explore Therapeutic Areas

Diabetes
Diabetes
Obesity
Obesity
MASH
MASH
Growth-Related Disorders
Growth-Related Disorders
Rare Bleeding Disorders
Rare Bleeding Disorders
Rare Renal Disorders
Rare Renal Disorders
Multiple Indications
Multiple Indications
Claim your personalized professional hub
What can novoMEDLINK™ do for you? With your account you can discover professional news, order samples, get supply updates, browse patient support materials, and much more.
Personalize your novoMEDLINK™ experience
Ready to further optimize your content recommendations and resource suggestions? Head to your account page to edit your settings.
Account Settings
Sign Out
Sign In | Create Account
Update your account
  • Products
    Samples
    Patient Savings
    Contact
    Diabetes
    Diabetes
    Obesity
    Obesity
    MASH
    MASH
    Growth-Related Disorders
    Growth-Related Disorders
    Rare Bleeding Disorders
    Rare Bleeding Disorders
    Rare Renal Disorders
    Rare Renal Disorders
    Multiple Indications
    Multiple Indications
Claim your personalized
professional hub
Personalize your novoMEDLINK™ experience
Account Settings
Sign Out
Sign In | Create Account
Update your account
Medical Information
|
Non-US Health Care Professionals
  • Growth-Related Disorders Home
  •  Icon
    Products
    Treatments
     Icon
    Professional Resources
    Product Resources Library
    Contact Your Representative
    Growth Calculators
  •  Icon
    Disease Education
    Pediatric Growth-Related Disorders (Basics)
    Adult Growth Hormone Deficiency
     Icon
    Treatment Guidelines
    PES & AACE Guidelines
     Icon
    Additional Resources
    Organizations & Conferences
  •  Icon
    Product Education
    Product Education Materials
     Icon
    Disease Education
    Advocacy & Support Groups
    Disease Education Resources
     Icon
    Access & Affordability
    Insurance Support & Prescription Savings
    ICD-10 Codes for Growth-Related Disorders
Medical Information
|
Non-US Health Care Professionals

Explore Current Therapy Area

Growth-Related Disorders Home
Products
Treatments
Professional Resources
Product Resources Library
Contact Your Representative
Growth Calculators
Disease Education
Pediatric Growth-Related Disorders (Basics)
Adult Growth Hormone Deficiency
Treatment Guidelines
PES & AACE Guidelines
Additional Resources
Organizations & Conferences
Product Education
Product Education Materials
Disease Education
Advocacy & Support Groups
Disease Education Resources
Access & Affordability
Insurance Support & Prescription Savings
ICD-10 Codes for Growth-Related Disorders
Diabetes
Diabetes
Obesity
Obesity
MASH
MASH
Growth-Related Disorders
Growth-Related Disorders
Rare Bleeding Disorders
Rare Bleeding Disorders
Rare Renal Disorders
Rare Renal Disorders
Multiple Indications
Multiple Indications
Medical Information
|
Non-US Health Care Professionals
Claim your personalized professional hub
What can novoMEDLINK™ do for you? With your account you can discover professional news, order samples, get supply updates, browse patient support materials, and much more.
Personalize your novoMEDLINK™ experience
Ready to further optimize your content recommendations and resource suggestions? Head to your account page to edit your settings.
Account Settings
Sign Out
Sign In | Create Account
Update your account

Explore Current Therapy Area

  • Growth-Related Disorders Home
  •  Icon
    Products
    Treatments
     Icon
    Professional Resources
    Product Resources Library
    Contact Your Representative
    Growth Calculators
  •  Icon
    Disease Education
    Pediatric Growth-Related Disorders (Basics)
    Adult Growth Hormone Deficiency
     Icon
    Treatment Guidelines
    PES & AACE Guidelines
     Icon
    Additional Resources
    Organizations & Conferences
  •  Icon
    Product Education
    Product Education Materials
     Icon
    Disease Education
    Advocacy & Support Groups
    Disease Education Resources
     Icon
    Access & Affordability
    Insurance Support & Prescription Savings
    ICD-10 Codes for Growth-Related Disorders
  • Diabetes
    Diabetes
    Obesity
    Obesity
    MASH
    MASH
    Growth-Related Disorders
    Growth-Related Disorders
    Rare Bleeding Disorders
    Rare Bleeding Disorders
    Rare Renal Disorders
    Rare Renal Disorders
    Multiple Indications
    Multiple Indications

Claim your personalized
professional hub

Personalize your novoMEDLINK™ experience

Account Settings
Sign Out
Sign In | Create Account
Update your account
Medical Information
|
Non-US Health Care Professionals
  • About Norditropin®
  • Overview
    Growth Hormone Deficiency
    Other Growth-Related Disorders
    ANSWER Program
  • Dosing
    FlexPro® Pen Selector
    FlexPro® Pen Instructions
    Device Attribute Chart
  • Insurance Coverage
    Patient Savings Programs
  • Patient Materials
    Provider Materials
    FAQ
Prescribing Information | Important Safety Information | Patient Site
Medical Information
|
Non-US Health Care Professionals
 |  Important Safety Information

Norditropin® (somatropin) injection 5 mg, 10 mg, 15 mg, 30 mg

Sogroya® (somapacitan-beco) injection 5 mg, 10 mg, 15 mg

  • About Norditropin®
    • Overview
    • Growth Hormone Deficiency
    • Other Growth-Related Disorders
    • ANSWER Program
    • Dosing
    • FlexPro® Pen Selector
    • FlexPro® Pen Instructions
    • Device Attribute Chart
    • Insurance Coverage
    • Patient Savings Programs
    • Patient Materials
    • Provider Materials
    • FAQ

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.

Norditropin® FlexPro® injection instructions

In a usability study, participants reported the FlexPro® pen to be easy to learn to use.1,a,b

Norditropin 5mg/1.5mL pen with open cap

Norditropin® FlexPro® injection instructions

In a usability study, participants reported the FlexPro® pen to be easy to learn to use.1,a,b

Norditropin 5mg/1.5mL pen with open cap

aNeedles are sold separately and may require a prescription in some states.

bBased on a human factors study of the safety and usability of the Norditropin® FlexPro® 30 mg pen in 94 participants (children ages 10-17 with growth-related disorders; adults with GHD; HCPs; and caregivers). Participants, excluding inpatient nurses, received training and performed injections using a foam cushion and then completed a device-specific questionnaire. Participants rated the device a 6.7 out of 7 (range 5 to 7 on a scale of 1 to 7, where 1 means “strongly disagree” and 7 means “strongly agree”) for the statement, "FlexPro® was easy to learn to use.”1 


How to inject Norditropin®—at a glance

Norditropin® is available as prefilled FlexPro® pens. The injection process includes 5 steps, from preparing the pen to storing or disposing of it afterward.2,a

See Instructions for Use for complete instructions.

aDo not share your Norditropin® Pen and needles with another person. You may give another person an infection or get an infection from them. Do not use your Pen without proper training from your healthcare provider. Make sure that you are confident in giving an injection with the Pen before you start your treatment. If you are blind or have poor eyesight and cannot read the dose counter on the Pen, do not use this Pen without help. Get help from a person with good eyesight who is trained to use the Pen.2

Step 1:

Step 2:

Step 3:

Step 4:

Step 5:

  • Patients should wash hands with soap and water. They should check the name, strength, and colored label on their pen to make sure that it contains Norditropin® in the right strength.2
  • Pull off the pen cap. Turn the pen 1 or 2 times to check that the Norditropin® in the pen is clear and colorless. If the Norditropin® looks unclear or cloudy, do not use the pen
  • Tear the paper tab off of a new disposable needle. Screw the needle straight onto the pen tightly. Always use a new needle for each injection. This reduces the risk of contamination, infection, leakage of Norditropin®, and blocked needles leading to incorrect dosing.
  • Pull off the outer needle cap and the inner needle cap, and throw them both away.2
Hand preparing the Norditropin® FlexPro® pen
  • Before patients inject their first dose using a new FlexPro® pen, patients must check the medication flow by priming the pen2
  • Turn the dose selector clockwise to 1 tick mark to select the smallest amount of medicine for the pen
  • Hold the Pen with the needle pointing up. Press and hold in the dose button until the dose counter returns to “0” and lines up with the dose pointer. A drop of Norditropin® then appears at the needle tip
  • If no drop appears, repeat the priming process up to 6 times. If no drop appears, change the needle and prime one more time. If a drop of liquid still does not appear, call 1-888-NOVO-444 (1-888-668-6444) for help.2
Hand holding the dose button
  • Select the prescribed dose by turning the dose selector clockwise or counterclockwise until the correct dose in the dose counter lines up with the dose pointer. Do not rely on pen clicks to select a dose
  • If there is not enough Norditropin® (somatropin) injection left in the pen to deliver the full prescribed dose, patients may deliver the amount left in the pen. Then, inject the remainder of the dose using a new Norditropin® FlexPro® pen, prepared as described in steps 1 and 2. Patients should only split their dose if they have been trained or advised by their healthcare provider on how to do this2
Hands selecting the dose on the Norditropin® FlexPro® pen
  • Norditropin can be injected under the skin to the back of the upper arm, abdomen, buttocks, or thigh, as instructed by the healthcare provider. It is important to change the injection site every day
  • Injection site should be wiped with an alcohol swab and the area should be dry before injecting
  • Insert the needle under the skin
  • Press and hold the dose button to inject until the “0” appears in the dose counter and lines up with the dose pointer. A firm click may be heard or felt
  • Needle should be kept in the skin after the dose counter has returned to "0." To ensure that the full dose is administered, count slowly to 6
  • Carefully remove the needle from the skin. A drop of Norditropin® may appear at the needle tip. This is normal and does not affect the injected amount2
Person injecting the Norditropin® FlexPro® pen and counting to 6
  • Patients should carefully remove the needle from the pen by turning the needle counterclockwise and placing it in an appropriate sharps disposal container immediately 
  • Pen cap should be placed on the pen after each use to protect Norditropin® from light
  • When there is not enough Norditropin® in the FlexPro® pen, it may be thrown away in household trash after removal of the needle2
Needle being placed in a sharps disposal container
Prescribing Information | Important Safety Information
Norditropin® FlexPro® Instruction Video
(13:04)
Share
A link has been copied to your clipboard.

Paste it into your email or chat app to share

Close
Norditropin® FlexPro® Instruction Video
Patient-friendly instructions on giving an injection of Norditropin® Flexpro® 30 mg. Also see Instructions for Use provided with the Prescribing Information.
Watch video
Prescribing Information | Important Safety Information

How to store Norditropin®

All 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.2

Storage temperature on a sticky note
Calculator icon

Growth calculators

Our online calculators can help you estimate your patients’ height velocity and other metrics used in clinical practice. For US health care professionals only.

Growth calculators

Our online calculators can help you estimate your patients’ height velocity and other metrics used in clinical practice. For US health care professionals only.

Get estimates
Show More Show Less

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

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. Slipped capital femoral epiphysis may lead to osteonecrosis. Cases of slipped capital femoral epiphysis with or without osteonecrosis have been reported in pediatric patients with short stature receiving somatropin, including Norditropin®. Evaluate pediatric patients receiving Norditropin® with the onset of a limp or complaints of hip or knee pain for slipped capital femoral epiphysis and osteonecrosis and manage accordingly.
  • 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.

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)

 

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 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

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. Slipped capital femoral epiphysis may lead to osteonecrosis. Cases of slipped capital femoral epiphysis with or without osteonecrosis have been reported in pediatric patients with short stature receiving somatropin, including Norditropin®. Evaluate pediatric patients receiving Norditropin® with the onset of a limp or complaints of hip or knee pain for slipped capital femoral epiphysis and osteonecrosis and manage accordingly.
  • 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.

Show More Show Less
Show More Show Less

Indications and Usage

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 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

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

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. Slipped capital femoral epiphysis may lead to osteonecrosis. Cases of slipped capital femoral epiphysis with or without osteonecrosis have been reported in pediatric patients with short stature receiving somatropin, including Norditropin®. Evaluate pediatric patients receiving Norditropin® with the onset of a limp or complaints of hip or knee pain for slipped capital femoral epiphysis and osteonecrosis and manage accordingly.
  • 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.

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

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. Slipped capital femoral epiphysis may lead to osteonecrosis. Cases of slipped capital femoral epiphysis with or without osteonecrosis have been reported in pediatric patients with short stature receiving somatropin, including Norditropin®. Evaluate pediatric patients receiving Norditropin® with the onset of a limp or complaints of hip or knee pain for slipped capital femoral epiphysis and osteonecrosis and manage accordingly.
  • 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.

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)

 

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 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

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. Slipped capital femoral epiphysis may lead to osteonecrosis. Cases of slipped capital femoral epiphysis with or without osteonecrosis have been reported in pediatric patients with short stature receiving somatropin, including Norditropin®. Evaluate pediatric patients receiving Norditropin® with the onset of a limp or complaints of hip or knee pain for slipped capital femoral epiphysis and osteonecrosis and manage accordingly.
  • 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. Data on File. Novo Nordisk, Inc.; Plainsboro, NJ.
  2. Norditropin [prescribing information]. Plainsboro, NJ: Novo Nordisk Inc.
For Health Care Professionals
  • Growth-Related Disorders Home
  • Product Information
    Products
    • Treatments
    Professional Resources
    • Product Resources Library
      Contact Your Representative
      Growth Calculators
  • Professional Education
    Disease Education
    • Pediatric Growth-Related Disorders (Basics)
      Adult Growth Hormone Deficiency
    Treatment Guidelines
    • PES & AACE Guidelines
    Additional Resources
    • Organizations & Conferences
  • Patient Support
    Product Education
    • Product Education Materials
    Disease Education
    • Advocacy & Support Groups
      Disease Education Resources
    Access & Affordability
    • Insurance Support & Prescription Savings
      ICD-10 Codes for Growth-Related Disorders

FlexPro® and Norditropin® are registered trademarks of Novo Nordisk Health Care AG. 
novoMEDLINK™ is a trademark of Novo Nordisk A/S.
Novo Nordisk is a registered trademark of Novo Nordisk A/S. 
All other trademarks, registered or unregistered, are the property of their respective owners.

Terms of Use | Privacy Notice | Consumer Health Privacy Notice | Cookie Notice | Cookie Settings | California Consumer Privacy Act (CCPA) Opt-Out Icon Your Privacy Choices | Contact Us |
novonordisk-us.com    
© 2024 Novo Nordisk All rights reserved. US23NORD00064 April 2024

What can we help you do today?

Quick links

Treatments

Insurance support & patient savings

Pediatric disorders overview

Clinical education for your patients

Medical Information     |     Non-US Health Care Professionals