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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

Helping your patients—every step of the way

NovoCare® offers a variety of programs to help patients access treatment.

Helping your patients—every step of the way

NovoCare® offers a variety of programs to help patients access treatment.

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Novo Nordisk savings card

Co-pays as low as $0
per yeara

Eligible patients can lower or even eliminate annual co-pay costs for their supply of Norditropin® with the Norditropin® Savings Card.a Maximum savings are $3,000 per calendar year.

To request and print a card, direct your patients to
NorditropinSavings.com 

aEligibility and restrictions apply. Patient is not eligible if he/she participates in or seeks reimbursement or submits a claim for reimbursement to any Government Program. Patient must be enrolled in a commercial insurance plan.

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Assistance for patients with limited or no insurance

Patients experiencing a gap or delay in insurance coverage or who do not have adequate coverage for their Norditropin® prescription may be eligible to receive some medication for free.b

Call 1-888-668-6444 to learn more. Specialists are available from 8:00 am to 8:00 pm ET.

Questions about patient savings programs?

Education for your patients

Our injection instruction video and other helpful materials are available to share with patients and caregivers.

Education for your patients

Our injection instruction video and other helpful materials are available to share with patients and caregivers.

Co-Pay Assistance Program eligibility

In order to redeem this offer, patient must have a valid prescription for the brand being filled. A valid Prescriber ID# is required on the prescription. Patient is not eligible if he/she participates in or seeks reimbursement or submits a claim for reimbursement to any federal or state health care program with prescription drug coverage, such as Medicaid, Medicare, Medigap, VA, DOD, TRICARE, or any similar federal or state health care program (each a Government Program), or where prohibited by law. Patient must be enrolled in, and must seek reimbursement from or submit a claim for reimbursement to, a commercial insurance plan. The brand and the prescription being filled must be covered by the patient's commercial insurance plan. Offer excludes full cash-paying patients. This offer may not be redeemed for cash. By using this offer, you are certifying that you meet the eligibility criteria and will comply with the terms and conditions described herein and will not seek reimbursement for any benefit received through this card. Novo Nordisk's Eligibility and Restrictions, and Offer Details may change from time to time, and for the most recent version, please visit this webpage. Re-confirmation of information may be requested periodically to ensure accuracy of data and compliance with terms. Patients with questions about the Savings Card offer may call 1-877-304-6855.

This offer is valid in the United States and may be redeemed at participating retail pharmacies. Availability of the Savings Offer in Massachusetts will be dependent upon state law in effect at the time patient presents the Savings Offer when paying for the covered medications.

This offer is not transferable and is limited to one offer per person. Not valid if reproduced. Cash Discount Cards and other non-insurance plans are not valid as primary insurance under this offer. If the patient is eligible for drug benefits under any such program, the patient cannot use this offer. This Savings Card cannot be combined with any coupon, certificate, voucher, or similar offer.

Patient is responsible for complying with any insurance carrier co-payment disclosure requirements, including disclosing any savings received from this program. It is illegal to (or offer to) sell, purchase, or trade this offer.

This program is managed by ConnectiveRx on behalf of Novo Nordisk. The parties reserve the right to rescind, revoke or amend this offer without notice at any time.

Offer Details: Pay as little as (“PALA”) $0 with an annual maximum cap of $3,000 per calendar year. Annual maximum cap of $3,000 will reset every January 1st until program expiration.

Pharmacist: When you apply this offer, you are certifying that you have not submitted a claim for reimbursement under any Government Program for this prescription, or where prohibited by law. Participation in this program must comply with all applicable laws and regulations as a pharmacy provider. By participating in this program, you are certifying that you will comply with the eligibility criteria, and terms and conditions described herein. You also certify that you will not seek reimbursement for any benefit received through this card.

Pharmacist instructions for a patient with an Eligible Third Party: Submit the claim to the primary Third Party Payer first, then submit the balance due to CHANGE HEALTHCARE as a Secondary Payer COB [coordination of benefits] with patient responsibility amount and a valid Other Coverage Code, (eg, 8). The patient is responsible initially for the PALA amount and the card pays up to the Savings Benefit. Offer excludes full cash-paying patients. Reimbursement will be received from CHANGE HEALTHCARE. For any questions regarding CHANGE HEALTHCARE online processing, please call the Help Desk at 1–800–433–4893.

 

 

Patient Access Program (PAP) eligibility

Patients who meet program eligibility criteria and financial need requirements are eligible to receive a free supply of Norditropin® for up to one (1) year with requalification process to occur thirty (30) days prior to PAP expiration.

Eligibility requirements:

  • Patient must be a US citizen or legal resident
  • Patient total household income must be at or below 350% of the federal poverty level (FPL) after inclusion of Norditropin® estimated cost deduction. Visit the NeedyMeds website, which lists the current FPL guidelines
  • Patient must have been prescribed therapy for a diagnosis that is an FDA approved indication for Norditropin®
  • Patient cannot have or qualify for government benefit coverage, including any federal state, or local program such as Medicare or Medicaid:
    • Exceptions include:
      • Government beneficiary with diagnosis or therapy exclusion
        Patients who are eligible for Department of Veterans Affairs (VA) prescription benefits or Medicaid must have applied for and been denied enrollment, including exhaustion of all appeals
      • Patients who are Medicare eligible and do not have Medicare Part D coverage who have applied for and been denied Extra Help/Low Income Subsidy (LIS). To apply for LIS, please contact the Social Security Administration at 1-800-722-1213 (TTY 1-800-325-0778) or go to ssa.gov/benefits /medicare/prescriptionhelp/      

Patients who meet program eligibility criteria and financial need requirements are eligible to receive a free supply of Norditropin® for up to one (1) year with requalification process to occur thirty (30) days prior to PAP expiration.

Eligibility requirements:

  • Patient must be a US citizen or legal resident
  • Patient total household income must be at or below 350% of the federal poverty level (FPL) after inclusion of Norditropin® estimated cost deduction. Visit the NeedyMeds website, which lists the current FPL guidelines
  • Patient must have been prescribed therapy for a diagnosis that is an FDA approved indication for Norditropin®
  • Patient cannot have or qualify for government benefit coverage, including any federal state, or local program such as Medicare or Medicaid:
    • Exceptions include:
      • Government beneficiary with diagnosis or therapy exclusion
      • Patients who are eligible for Department of Veterans Affairs (VA) prescription benefits or Medicaid must have applied for and been denied enrollment, including exhaustion of all appeals
      • Patients who are Medicare eligible and do not have Medicare Part D coverage who have applied for and been denied Extra Help/Low Income Subsidy (LIS). To apply for LIS, please contact the Social Security Administration at 1-800-722-1213 (TTY 1-800-325-0778) or go to ssa.gov/benefits/medicare/prescriptionhelp/    

 

JumpStart™ eligibility

Patients who have been prescribed Norditropin® for an FDA-approved indication and who have commercial insurance may be eligible to receive a limited supply of free product from JumpStart™. Patients who participate in any government, state, or federally funded medical or prescription benefit programs, including Medicare, Medicaid, Medigap, VA, DOD, and TRICARE, including patients who participate in a managed Medicaid program or have Medicaid as secondary insurance, are not eligible to participate in JumpStart™.

JumpStart™ product is provided at no cost to the patient or the HCP, is not contingent on any product purchase, and the patient and HCP must not: (1) bill any third party for the free product, or (2) resell the free product.

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.