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The #1 prescribed growth hormone therapy in the U.S.1
Norditropin® (somatropin) is preloaded in FlexPro® pens and is the only growth hormone therapy approved for 7 indications.2-8
The #1 prescribed growth hormone therapy in the U.S.1
Norditropin® (somatropin) injection is available as FlexPro® prefilled pens and is the only daily growth hormone therapy approved for 7 indications.2-8
William, age 4,
born with GHD
The #1 prescribed growth hormone therapy in the U.S.1
Norditropin® (somatropin) injection is available as FlexPro® prefilled pens and is the only daily growth hormone therapy approved for 7 indications.2-8
Achieve treatment goals2
Proven safety and efficacy1,2
The safety and efficacy of Norditropin® has been evaluated in clinical studies, as well as an observational study in a real-world setting (originally a post-marketing registry).1,2,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 into 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
≈80% preferred coverage1,b
Norditropin® has the broadest preferred coverage in its class, including 89% of Commercial and 89% of Medicaid patients.1,a Our online tool can quickly show you formulary information for your local area.
bPreferred status BioPharm Insights as of January 2022.
Our calculators can help estimate height velocity and other metrics routinely used in clinical practice. For US health care professionals only.
Our calculators can help estimate height velocity and other metrics routinely used in clinical practice.
For US health care professionals only.
Patient use and access
Easy to use9,c,d
Patients reported FlexPro® pens as easy to use and a majority of patients preferred it to their current devices.9,c,d
See study design (Fuchs, et al.)
Expanded co-pay assistance
Eligible patients may pay as little as $0 per calendar year for their supply of Norditropin® (with an annual maximum cap of $1,500 per calendar year).e
cPlease see Instructions for Use for complete instructions.
dBased on an open-label, uncontrolled study assessing the usability and acceptability of Norditropin® FlexPro® 10 mg in 70 children and adolescents between 10 and <18 years of age on daily treatment of human growth hormone injections. Usability responses were gathered in a face-to-face interview after being given written/verbal instructions for use of the pen; acceptability of the device was also assessed through a 21-item questionnaire for device preparation, ease of use, and learning, as well as patient preference.9
eEligibility 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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Study design
(Fuchs, et al.) Ease of Use and Acceptability of a New Pen Device for the Administration of GH Therapy in Pediatric Patients: An Open-Label, Uncontrolled Usability Test
Participants:
Seventy patients (children and adolescents) aged between 10 to <18 years who were diagnosed with GHD and receiving daily treatment with self-injectable GH were eligible for the study. At screening, agreement from the patients and informed consent from a parent/guardian was obtained.9
Methods:
The open-label, uncontrolled study was conducted at the Murray Hill Center, New York, New York, and in the patients’ homes. The usability and acceptability of the Norditropin® FlexPro® pen were the primary endpoints. Norditropin® FlexPro® pens, prefilled with test medium, and NovoFine® G32 (Novo Nordisk A/S) needles were used to inject test medium into an injection pad. In a face-to-face interview, the moderator presented the device to the patient, demonstrated how to use it, and observed any technical issues (i.e., device not functioning properly) (secondary endpoint) to assess reliability. After receiving instructions, patients received 2 pens and were instructed to attach the needle, prime the pens, and inject the equivalent volume of their daily GH dose and a 4-mg dose into an injection pad several times until the pens were empty (equating to ≈7 injections, on average, between the 2 pens). To gauge acceptance of the device, patients were asked to complete a 21-item questionnaire which covered: ease of preparing the pen for injection, the ease, comfort, and confidence experienced by patients while performing the injection, ease of learning to operate the pen, comfort with the idea of future self-injection without guidance, perceptions of the pen vs their current pen in terms of stability when injecting, confidence that the right dose was being delivered, and preference. Patients were addressed directly by the moderator and answered all of the questions without assistance from parents/guardians present during the interview.9
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 $1,500 per calendar year. Annual maximum cap of $1,500 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.
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:
- Data on file. Novo Nordisk Inc; Plainsboro, NJ.
- Norditropin [prescribing information]. Plainsboro, NJ: Novo Nordisk Inc; 2020.
- Nutropin AQ [prescribing information]. San Francisco, CA: Genentech, Inc; 2016.
- Genotropin [prescribing information]. New York, NY: Pharmacia & Upjohn Co; 2019.
- Humatrope [prescribing information]. Indianapolis, IN: Eli Lilly & Co; 2019.
- Saizen [prescribing information]. Rockland, MA: EMD Serono, Inc; 2020.
- Omnitrope [prescribing information]. Princeton, NJ: Sandoz, Inc; 2019.
- Zomacton [prescribing information]. Parsippany, NJ: Ferring Pharmaceuticals, Inc; 2018.
- Fuchs GS, Mikkelsen S, Knudsen TK, Kappelgaard AM. Ease of use and acceptability of a new pen device for the administration of growth hormone therapy in pediatric patients: an open-label, uncontrolled usability test. Clin Ther. 2009; 31(12):2906-2914.