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Selected Important Safety Information

Contraindications

• 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

• 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)

Important Safety Information

Contraindications

• 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.

Do not use Norditropin^® if:

• you have a critical illness caused by certain types of heart or stomach surgery, trauma or breathing (respiratory) problems
• you are a child with Prader-Willi syndrome who is severely obese or has breathing problems including sleep apnea
• you have cancer or other tumors
• you are allergic to somatropin or any of the ingredients in Norditropin®
• your healthcare provider tells you that you have certain types of eye problems caused by diabetes (diabetic retinopathy)
• you are a child with closed bone growth plates (epiphyses)

Indications and Usage

What is Norditropin^® (somatropin) injection?

Norditropin^® is a prescription medicine that contains human growth hormone and is used to treat:

• children who are not growing because of low or no growth hormone
• children who are short (in stature) and who have Noonan syndrome, Turner syndrome, or were born small (small for gestational age-SGA) and have not caught-up in growth by age 2 to 4 years
• children who have Idiopathic Short Stature (ISS)
• children who are not growing who have Prader-Willi syndrome (PWS)
• adults who do not make enough growth hormone

Important Safety Information

Do not use Norditropin® if:

• you have a critical illness caused by certain types of heart or stomach surgery, trauma or breathing (respiratory) problems
• you are a child with Prader-Willi syndrome who is severely obese or has breathing problems including sleep apnea
• you have cancer or other tumors
• you are allergic to somatropin or any of the ingredients in Norditropin®
• your healthcare provider tells you that you have certain types of eye problems caused by diabetes (diabetic retinopathy)
• you are a child with closed bone growth plates (epiphyses)

Before taking Norditropin®, tell your healthcare provider about all of your medical conditions, including if you:

• have had heart or stomach surgery, trauma or serious breathing (respiratory problems)
• have had a history of problems breathing while you sleep (sleep apnea)
• have or have had cancer or any tumor
• have diabetes
• are pregnant or breastfeeding, or plan to become pregnant or breastfeed

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Norditropin® may affect how other medicines work, and other medicines may affect how Norditropin® works.

How should I use Norditropin®?

• Use Norditropin® exactly as your health care provider tells you to
• Do not share your Norditropin® pens and needles with another person even if the needle has been changed. You may give another person an infection or get an infection from them.

What are the possible side effects of Norditropin®?

Norditropin® may cause serious side effects, including:

• high risk of death in people who have critical illnesses because of heart or stomach surgery, trauma or serious breathing (respiratory) problems
• high risk of sudden death in children with Prader-Willi syndrome who are severely obese or have breathing problems including sleep apnea
• increased risk of growth of cancer or a tumor that is already present and increased risk of the return of cancer or a tumor in people who were treated with radiation to the brain or head as children and who developed low growth hormone problems. Contact the healthcare provider if you or your child start to have headaches, or have changes in behavior, changes in vision, or changes in moles, birthmarks, or the color of your skin
• new or worsening high blood sugar (hyperglycemia) or diabetes
• increase in pressure in the skull (intracranial hypertension). If you or your child has headaches, eye problems, nausea or vomiting, contact the healthcare provider
• serious allergic reactions. Get medical help right away if you or your child has the following symptoms: swelling of your face, lips, mouth or tongue, trouble breathing, wheezing, severe itching, skin rashes, redness or swelling, dizziness or fainting, fast heartbeat or pounding in your chest, or sweating
• your body holding too much fluid (fluid retention) such as swelling in the hands and feet, pain in your joints or muscles or nerve problems that cause pain, burning, or tingling in the hands, arms, legs and feet. Tell your healthcare provider if you have any of these signs or symptoms of fluid retention.
• decrease in a hormone called cortisol. Tell your or your child’s healthcare provide if you or your child has darkening of the skin, severe fatigue, dizziness, weakness or weight loss
• decrease in thyroid hormone levels
• hip and knee pain or a limp in children (slipped capital femoral epiphysis)
• worsening of pre-existing curvature of the spine (scoliosis)
• severe and constant abdominal pain can be a sign of pancreatitis. Tell your or your child’s healthcare provider if you or your child has any new abdominal pain.
• loss of fat and tissue weakness in the area of skin you inject
• increase in phosphorus, alkaline phosphatase, and parathyroid hormone levels in your blood

The most common side effects of Norditropin® include:

• injection site reactions and rashes, and headaches

Please click here for Norditropin^® Prescribing Information.

Norditropin^® is a prescription medication.

Novo Nordisk provides patient assistance for those who qualify. Please call 1-866-310-7549 to learn more about Novo Nordisk assistance programs.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Talk to your healthcare provider and find out if Norditropin^® is right for you or your child.