Important Safety Information Prescribing Information
Norditropin® (somatropin) injection 5 mg, 10 mg, 15 mg, 30 mg pens Sogroya® (somapacitan-beco) injection 5 mg, 10 mg, 15 mg pens
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Important Safety Information Prescribing Information Support for patients
Growth-related disorders Select condition

Resources for you, support for your patients

To support patients through their treatment, NovoCare® offers a range of services through the Patient Enrollment Form (PEF). You can enroll patients in the below access assistance and affordability programs once you have decided to prescribe them a Novo Nordisk growth hormone medication. A NovoCare® Case Manager will contact you within 48 business hours (8:00 am-8:00 pm ET, Monday-Friday) after receiving a completed form.
 

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Benefits investigation

NovoCare® can determine if your patient's treatment is covered by their insurance and often provide an estimated cost, so they know what to expect. We also partner with you on a more detailed benefits review.

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Prior authorization and appeals support

NovoCare® keeps a patient's path to treatment moving forward each time a prior authorization is required. We'll work with you to determine the correct form and support the submission process.

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A patient starter kit

NovoCare® is here to help with a free Patient Starter Kit, with information to assist patients. During the welcome call with NovoCare®, they can ask for a kit to be shipped to them.

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Pen device training

Your patients may be new to taking a medication that requires self-injection with a pen device. NovoCare® is here to help. When it’s time, we’ll schedule an in-person or virtual training session with them. Throughout their treatment, they can always reach us with any questions about their device.

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JumpStart™ and Interim programs

If your patient is experiencing a delay or gap with insurance coverage, they may be eligible for a limited free supply of their medication that helps them start treatment right away or stay on treatment. Please note: JumpStartTM is available for patients who are prescribed Sogroya® (somapacitan-beco) injection 5 mg, 10 mg, 15 mg pens but is not available for patients who are prescribed Norditropin® (somatropin) injection 5 mg, 10 mg, 15 mg, 30 mg pens.

Eligibility and other restrictions apply.

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Patient Assistance Program (PAP)

NovoCare® can help patients with financial barriers to treatment. Eligible patients can begin therapy at no cost until insurance or financial circumstances change. Eligibility is reviewed quarterly, and patients must be requalified annually.

Eligibility and other restrictions apply.

See savings offers below.

To enroll your patient in additional NovoCare® support programs, please complete the required information

Request support through the Patient Enrollment Form (PEF)

*Indicates required field.
 

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Unfortunately, the diagnosis code selected is not an FDA-approved indication. We are unable to provide support for this use.

Unfortunately, the diagnosis code selected is not an FDA-approved indication. We are unable to provide support for this use.

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Full enrollment includes a benefit investigation, Patient Starter Kit, device training, support for prior authorization and appeals, prescription triage to a specialty pharmacy, and information about savings offer enrollment (if patient is eligible).

Full enrollment includes a benefit investigation, Patient Starter Kit, JumpStart™ request, device training, support for prior authorization and appeals, prescription triage to a specialty pharmacy, and information about savings offer enrollment (if patient is eligible).

Next

Note: If you’re interested only in a savings offer for your patient, you don’t need to fill out the Patient Enrollment Form. You can view our savings offers below and share the information directly with your patient.

Note: Prescribers can complete the PEF, sign, and electronically submit to NovoCare®.

Authorized staff members can complete the PEF, then select "Email form to prescriber." Please have the prescriber's email address ready to enter so that the PEF can be emailed to them to review, sign, and submit.

Next

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Prefer to submit offline?
You can download the offline form and fax the completed form to 1‑888‑508‑8200.

Download PEF

For assistance with your request, call 1-888-668-6444.

*Indicates required field.

Please enter your patient's details below.

Note: Novo Nordisk and its partners recognize that patients may not identify as male or female. However, many insurance companies still require that 1 of these 2 fields be used for each of their members. Please indicate the gender on file with the patient's insurance company.

Alternate contact
Primary guardian/caregiver contact

Address and contact

Shipping address

Next

Primary pharmacy insurance

Primary medical insurance

Secondary medical insurance

Next

Prescription information

Directions:*

Directions:*

Medical assessment

Initial GH Stimulation Testing for CO-GHD: Please include copies of test results if available.

GH stim test 1

GH stim test 2

Files

Do you have file(s) to upload?

Note: You are limited to a PNG, JPG, or PDF file format, no larger than 5MB across all files. Examples may include a growth hormone stimulation test, X-ray, MRI, or other relevant tests.

Add more files

Next

Please enter the prescriber's information below.

Note: You can look up your NPI using the public database and copy your NPI number onto this form.

If you would like to have the completed form sent to a member of your office staff, please enter their email.

By clicking "E-sign," you will be taken to a digital PDF where you can confirm all information collected and you'll be required to sign and submit the form to NovoCare®. Please note: The information you have provided will not be submitted until you sign and submit that digital PDF.

Continue to E-sign

Next steps: Select the button “Email form to prescriber,” and we’ll send an email to the prescriber you specified with a PDF link to the form. After the PDF opens, the prescriber should enter their signature and select the "sign and submit" button. Please notify them that they must complete both steps in order to submit this form successfully to NovoCare®.

Email form to prescriber

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*Indicates required field.

Please enter your patient's details below.

Note: Novo Nordisk and its partners recognize that patients may not identify as male or female. However, many insurance companies still require that 1 of these 2 fields be used for each of their members. Please indicate the gender on file with the patient's insurance company.

Alternate contact
Primary guardian/caregiver contact

Address and contact

Shipping address

Next

Prescription Information

Directions:*

Directions:*

Medical assessment

Next

Please enter the prescriber's information below.

Note: You can look up your NPI using the public database and copy your NPI number onto this form.

If you would like to have the completed form sent to a member of your office staff, please enter their email.

By clicking "E-sign," you will be taken to a digital PDF where you can confirm all information collected and you'll be required to sign and submit the form to NovoCare®. Please note: The information you have provided will not be submitted until you sign and submit that digital PDF.

Continue to E-sign

Next steps: Select the button “Email form to prescriber,” and we’ll send an email to the prescriber you specified with a PDF link to the form. After the PDF opens, the prescriber should enter their signature and select the "sign and submit" button. Please notify them that they must complete both steps in order to submit this form successfully to NovoCare®.

Email form to prescriber

Patient information banner with person and magnifying glass icon
Insurance information banner with card icon
Clinical information banner with injection icon
Prescriber information banner with stethoscope icon

*Indicates required field.

Please enter your patient's details below.

Note: Novo Nordisk and its partners recognize that patients may not identify as male or female. However, many insurance companies still require that 1 of these 2 fields be used for each of their members. Please indicate the gender on file with the patient's insurance company.

Alternate contact
Primary guardian/caregiver contact

Address and contact

Shipping address

Next

Please enter the prescriber's information below.

Note: You can look up your NPI using the public database and copy your NPI number onto this form.

If you would like to have the completed form sent to a member of your office staff, please enter their email.

By clicking "E-sign," you will be taken to a digital PDF where you can confirm all information collected and you'll be required to sign and submit the form to NovoCare®. Please note: The information you have provided will not be submitted until you sign and submit that digital PDF.

Continue to E-sign

Next steps: Select the button “Email form to prescriber,” and we’ll send an email to the prescriber you specified with a PDF link to the form. After the PDF opens, the prescriber should enter their signature and select the "sign and submit" button. Please notify them that they must complete both steps in order to submit this form successfully to NovoCare®.

Email form to prescriber

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Insurance information banner with card icon
Clinical information banner with injection icon
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Help your patient save with savings offers from Novo Nordisk

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

Patients who have private or commercial insurance with coverage may be eligible to pay as little as $0 per year for their supply of Sogroya® (with an annual maximum cap of $5,000).a

Direct patients to visit SogroyaSavings.com to get this savings offer.

aEligibility and other restrictions apply.

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

Patients who have private or commercial insurance with coverage may be eligible to pay as little as $0 per year for their supply of Norditropin® (with an annual maximum cap of $1,500).b

Direct patients to visit NorditropinSavings.com to get this savings offer.

bEligibility and other restrictions apply.

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Please select one of the following forms to download
Sogroya® forms
Pediatric PEF
Adult PEF
Norditropin® forms
Pediatric PEF
Adult PEF
NovoCare_HCP_Norditropin_v01 Skip to main content

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.

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

Warnings and Precautions (cont'd)

  • 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 see Norditropin® Prescribing Information.

 

NovoCare_HCP_Sogroya_v01 Skip to main content

Important Safety Information for Sogroya®

Contraindications

Sogroya® is contraindicated in patients with:

  • acute critical illness after open-heart surgery, abdominal surgery, multiple accidental trauma, or acute respiratory failure because of the risk of increased mortality with use of Sogroya®
  • hypersensitivity to Sogroya® or any of its excipients. Systemic hypersensitivity reactions have been reported postmarketing with somatropin
  • pediatric patients with closed epiphyses
  • active malignancy
  • active proliferative or severe non-proliferative diabetic retinopathy
  • 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 risk of sudden death

Warnings and Precautions

  • Increased Mortality in Patients with Acute Critical Illness: Increased mortality has been reported after treatment with somatropin in patients with acute critical illness due to complications following open-heart surgery, abdominal surgery, multiple accidental trauma, and in patients with acute respiratory failure

Indications and Usage

Sogroya® (somapacitan-beco) injection 5 mg, 10 mg, or 15 mg is indicated for the:

  • treatment of pediatric patients aged 2.5 years and older who have growth failure due to inadequate secretion of endogenous growth hormone (GH)
  • replacement of endogenous GH in adults with growth hormone deficiency (GHD)

Important Safety Information

Warnings and Precautions (cont'd)

  • Severe Hypersensitivity: Serious systemic hypersensitivity reactions including anaphylactic reactions and angioedema have been reported postmarketing with use of somatropin. Inform patients and/or caregivers that such reactions are possible, and that prompt medical attention should be sought if an allergic reaction occurs
  • Increased Risk of Neoplasms: There is an increased risk of malignancy progression with somatropin in patients with active malignancy. Any preexisting malignancy should be inactive, and its treatment complete prior to instituting Sogroya®. In childhood cancer survivors treated with radiation to the brain/head for their first neoplasm who developed subsequent GHD and were treated with somatropin, an increased risk of a second neoplasm has been reported. Monitor patients with a history of GHD secondary to an intracranial neoplasm for progression or recurrence of the tumor. Children 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 for increased growth or potential malignant changes of preexisting nevi. Advise patients/caregivers to report changes in the appearance of preexisting nevi
  • Glucose Intolerance and Diabetes Mellitus: Treatment with somatropin may decrease insulin sensitivity, particularly at higher doses. New onset type 2 diabetes has been reported. Monitor glucose levels in all patients, especially in those with existing diabetes mellitus or with risk factors for diabetes mellitus, such as obesity, Turner syndrome or a family history of diabetes mellitus. The doses of antidiabetic agents may require adjustment when Sogroya® is initiated
  • Intracranial Hypertension: Has been reported usually within 8 weeks of treatment initiation. Perform fundoscopic examination prior to initiation of treatment and periodically thereafter. If papilledema is identified, evaluate the etiology, and treat the underlying cause before initiating Sogroya®. If papilledema is observed, stop treatment. If intracranial hypertension is confirmed, Sogroya® can be restarted at a lower dose after intracranial hypertension signs and symptoms have resolved
  • Fluid retention: May occur during Sogroya® therapy. Clinical manifestations of fluid retention (e.g. edema and nerve compression syndromes including carpal tunnel syndrome/paresthesia) are usually transient and dose dependent
  • Hypoadrenalism: Patients receiving somatropin therapy who have or are at risk for corticotropin deficiency may be at risk for reduced serum cortisol levels and/or unmasking of central (secondary) hypoadrenalism. Patients treated with glucocorticoid replacement for previously diagnosed hypoadrenalism may require an increase in their maintenance or stress doses following initiation of Sogroya®. Monitor patients with known hypoadrenalism for reduced serum cortisol levels and/or need for glucocorticoid dose increases
  • Hypothyroidism: Undiagnosed/untreated hypothyroidism may prevent an optimal response to Sogroya®. Monitor thyroid function periodically as hypothyroidism may occur or worsen after initiation of Sogroya®
  • Slipped Capital Femoral Epiphysis in Pediatric Patients: Slipped capital femoral epiphysis may occur more frequently in patients undergoing rapid growth. Evaluate pediatric patients with the onset of a limp or complaints of persistent hip or knee pain
  • Progression of Preexisting Scoliosis in Pediatric Patients: Monitor patients with a history of scoliosis for disease progression
  • Pancreatitis: Cases of pancreatitis have been reported in patients receiving somatropin. The risk may be greater in pediatric patients compared to adults. Consider pancreatitis in patients with persistent severe abdominal pain
  • Lipohypertrophy/Lipoatrophy: May occur if Sogroya® is administered at the same site over a long period of time. Rotate injection sites to reduce this risk
  • Sudden death in Pediatric Patients with Prader-Willi Syndrome: There have been reports of fatalities after initiating therapy with somatropin in pediatric patients with Prader-Willi syndrome who had one or more of the following risk factors: severe obesity, history of upper airway obstruction or sleep apnea, or unidentified respiratory infection. Male patients with one or more of these factors may be at greater risk than females. Sogroya® is not indicated for the treatment of pediatric patients who have growth failure due to genetically confirmed Prader-Willi syndrome
  • Laboratory Tests: Serum levels of inorganic phosphorus and alkaline phosphatase may increase after Sogroya® therapy. Serum levels of parathyroid hormone may increase with somatropin treatment

Adverse Reactions

  • Pediatric patients with GHD: Adverse reactions reported in ≥5% of patients are nasopharyngitis, headache, pyrexia, pain in extremity, and injection site reaction
  • Adult patients with GHD: Adverse reactions reported in >2% of patients are back pain, arthralgia, dyspepsia, sleep disorder, dizziness, tonsillitis, peripheral edema, vomiting, adrenal insufficiency, hypertension, blood creatine phosphokinase increase, weight increase, and anemia

Drug Interactions

  • Glucocorticoids: Patients treated with glucocorticoid for hypoadrenalism may require an increase in their maintenance or stress doses following initiation of Sogroya®
  • Cytochrome P450-Metabolized Drugs: Sogroya® may alter the clearance. Monitor carefully if used with Sogroya®
  • Oral Estrogen: Patients receiving oral estrogen replacement may require higher Sogroya® dosages
  • Insulin and/or Other Antihyperglycemic Agents: Dose adjustment of insulin and/or antihyperglycemic agent may be required for patients with diabetes mellitus

Please see Sogroya® Prescribing Information.

 

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