Norditropin® is the prescription human growth hormone made by Novo Nordisk. It is indicated for the treatment of: growth failure, growth hormone deficiency, or HIV-related weight loss or wasting. Norditropin® may also be prescribed to increase height in children with certain disorders such as Noonan syndrome, Turner syndrome, idiopathic short stature, or Prader-Willi syndrome.
Dosage Forms and Strengths Available
Norditropin® is available as a sterile solution for subcutaneous use in ready-to-administer prefilled pens with a volume of 1.5 mL or 3 mL as follows:
5 mg/1.5 mL (orange): FlexPro® pen
10 mg/1.5 mL (blue): FlexPro® pen
15 mg/1.5 mL (green): FlexPro® pen
30 mg/3 mL (purple): FlexPro® pen
In people with growth hormone deficiency, Norditropin® replenishes the growth hormone that the body isn’t making. The primary and most intensively studied benefit of Norditropin® in adults and children with GHD is the stimulation of linear growth. This effect is most clearly demonstrated in children with GHD. In addition to tissue growth, other documented benefits of Norditropin® include:
Increased protein metabolism
Improved carbohydrate metabolism
Improved Lipid Metabolism
Improved Mineral Metabolism – particularly resulting in an increase in bodily potassium and phosphorus levels
Improved tissue metabolism – particularly an increase in collagen production
More common – According to the manufacturer, the most common side effects of Norditropin® are:
Injection site reactions and rashes
Less common – some of the potentially severe, though less common side effects of Norditropin® include:
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
New or worsening high blood sugar (hyperglycemia) or diabetes
Increase in pressure in the skull (intracranial hypertension)
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
– severe itching
– skin rashes, redness, or swelling
– dizziness or fainting
– fast heartbeat or pounding in your chest
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
Hip and knee pain or a limp in children (slipped capital femoral epiphysis)
Worsening of curvature of the spine (scoliosis)
See your medication’s insert for a complete list of potential side-effects.
Your prescription for Norditropin® will be tailored to best meet your particular goals and lifestyle. You will be carefully monitored over the course of your treatment with Norditropin®, so any chance of side effects should be kept to a minimum. Tell your doctor if you are experiencing any of these or other side effects while taking Norditropin®.
Overdose of Norditropin® could lead to hypoglycemia and subsequently to hyperglycemia. Overdose can also result in fluid retention. Long-term over-dosage could result in signs and symptoms of gigantism and/or acromegaly consistent with the known effects of excess growth hormone.
As with any medication, in case of accidental overdose, seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Keep Norditropin® and all prescription medications out of the reach of children.
According to its manufacturer, Norditropin® should not be used 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® (see the Prescribing Information for a complete list of ingredients in Norditropin®)
Your health care 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 accepting a prescription for Norditropin®, tell your doctor 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
Are pregnant or plan to become pregnant. It is not known if Norditropin® will harm your unborn baby. Talk to your healthcare provider if you are pregnant or plan to become pregnant
Are breastfeeding or plan to breastfeed. It is not known if Norditropin® passes into your breast milk. You and your healthcare provider should decide if you will take Norditropin® while you breastfeed.
In addition, tell your healthcare provider about any medicines you are taking, 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.
See your medication’s insert for a complete list of potential drug interactions.
How to Use
Only use Norditropin® exactly as you are instructed to by your doctor or pharmacist. Never share your Norditropin® pens and needles with another person. Norditropin® is injected into a muscle or under the skin. You will be shown exactly how to administer your Norditropin® injections. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used pens, needles and syringes.
Use exactly as prescribed by your doctor
Do not use in larger or smaller amounts or for longer than recommended
Follow the directions on your prescription label
Use a different place on your body each time you give the injection
Do not inject this medicine into skin or muscle that is red, sore, infected, or injured
To further assist with the Norditropin® injection process, the manufacturer has provided a complete step-by-step guide to injection.
The daily dosage of Norditropin® varies by your age, weight and the condition it is being prescribed for. According to the Prescribing Information provided by the National Institutes for Health, Norditropin® should be administered subcutaneously as follows:
Pediatric Dosage – divide the calculated weekly dosage into equal doses given either 6, or 7 days per week.
For GHD: 0.17 mg/kg/week to 0.24 mg/kg/week
For Noonan Syndrome: Up to 0.46 mg/kg/week
For Turner Syndrome: Up to 0.47 mg/kg/week
For SGA: Up to 0.47 mg/kg/week
For ISS: Up to 0.47 mg/kg/week
For Prader-Willi Syndrome: 0.24 mg/kg/week
Adult Dosage: Either of the following two dosing regimens may be used:
Non-weight based dosing: Initiate with a dose of approximately 0.2 mg/day (range, 0.15 mg/day-0.3 mg/day) and increase the dose every 1-2 months by increments of approximately 0.1 mg/day-0.2 mg/day, according to individual patient requirements
Weight-based dosing (Not recommended for obese patients): Initiate at 0.004 mg/kg daily and increase the dose according to individual patient requirements to a maximum of 0.016 mg/kg daily
*Dosing information is provided for informational purposes only, and should not be construed as any kind of instructions for use. Consult your physician or pharmacist for guidance regarding your particular dose of Norditropin®