Norditropin® (somatropin [rDNA origin] injection)
Norditropin® is a growth hormone, sometimes referred to as somatropin, that is produced by a company called Novo Nordisk. It is made in a laboratory and is made to be as close as possible to the growth hormone made naturally in the human body. Norditropin® is indicated for the long-term treatment of children with growth failure due to inadequate secretion of endogenous growth hormone and for replacement of endogenous growth hormone in adults with growth hormone deficiency (GHD) who meet either of the following two criteria: |
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Adult Onset (AO): Patients who have GHD, either alone or associated with multiple hormone deficiencies (hypopituitarism), as a result of pituitary disease, hypothalamic disease, surgery, radiation therapy, or trauma; or |
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Childhood Onset (CO): Patients who were growth hormone deficient during childhood should have GHD confirmed as an adult before replacement therapy with Norditropin® is started. GHD should be confirmed by an appropriate GH Stimulation Test.
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What about precautions and side effects?
General
Remember, your doctor is the main source of information about you and your health. Please consult your doctor if you have any questions about your health or your medication.
Do not use Norditropin® if you have any of the following conditions: an allergy to phenol or any other ingredients in the medicine; active cancer or other forms of tumor; acute critical illness due to certain types of heart or abdomen surgery, trauma, or acute respiratory failure.
Children should not use Norditropin® if they have any of the following conditions:
closed epiphyses (closed bone growth plates), Prader-Willi syndrome with severe obesity, or Prader-Willi syndrome with significant respiratory impairment.
Be sure to tell your doctor if you have diabetes mellitus; have had cancer or other forms of tumor; are pregnant, planning to be pregnant or are breastfeeding; or if you have had a kidney transplant.
Be sure to tell your doctor about all medications you are taking especially if they are: a glucocorticoid medication such as hydrocortisone or cortisone acetate, thyroid hormone, insulin and/or oral diabetes medicines, drugs metabolized by the liver (for example, corticosteroids, sex steroids, anticonvulsants, cyclosporine), or oral estrogen replacement.
Adult height can be influenced if you are on Norditropin® for growth failure and at the same time using glucocorticoids or thyroid hormone.
If you are treated with insulin and/or oral diabetes medicines, the dose of your insulin/oral diabetes medicines may need to be adjusted.
Side effects are usually mild and temporary. Side effects may include headaches, muscle pain, joint stiffness, weakness, high blood sugar (hyperglycemia), sugar in your urine (glucosuria), swollen hands and feet due to fluid retention, and redness and itching in the area you inject.
If you have any of these symptoms, discuss them with your doctor.
If you have headaches, eyesight problems, nausea and/or vomiting, these may be symptoms of raised pressure in the brain. Contact your doctor right away.
In very rare cases children treated with somatropin have experienced pain in the hip or knee or a limp. These symptoms may be caused by a slippage of the growth plate in the hip (slipped capital femoral epiphysis).
Scoliosis (curvature of the spine) can occur in children who experience rapid growth. Because growth hormone increases growth rate, children should be monitored for progression of scoliosis.
Thyroid function tests should be performed periodically.
Skin lesions should be checked carefully for any unusual changes.
Talk to your doctor if you think you have any of these conditions.
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Does growth hormone have to be taken by injection?
Any growth hormone—including Norditropin®—has to be injected so that it can work properly. Here's why: growth hormone is a "peptide." This means it is similar to a protein, like the protein we eat in certain foods. When protein is eaten, the acids in the stomach break it down so it can be digested. If you took growth hormone by mouth—say as a pill or a liquid—the same thing would happen. The stomach would break it down and digest it. In a "broken down" state, growth hormone would not be effective. And because the growth hormone molecule is so big, the stomach couldn't absorb it.
Will the injection hurt?
NovoFine® disposable needles have an ultra-sharp, low-angle point designed to help increase injection comfort. They're electropolished for smoothness and coated with silicone to reduce friction. Less friction may also mean less pain. Needles may require a prescription in some states.
I don't like needles. What can I do?
If you do not like needles, there is a solution that hides the needle during injections. NovoFine® Autocover® needle is available for use with Norditropin NordiFlex®, the injection pen that is used to inject Norditropin®. NovoFine® Autocover® needle keeps the needle hidden so you do not have to worry about seeing the needle during the injection.
Please make sure your prescription reads "NovoFine® Autocover®."
Is the dose the same for everyone?
Your doctor will tell you how much Norditropin® you or your child should take and how and when it should be taken. The dose is usually based on body size (body surface area) or body weight. Be sure to follow the schedule given by the doctor—do not change the dose on your own. If you or your child forget an injection, the next injection should be taken as usual. Do not double the dose to "catch up."
Learn more about Norditropin®: |
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Considering Norditropin® |
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Norditropin NordiFlex® |
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NordiPen® delivery system |
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Norditropin® cartridges |
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Norditropin® Starter Kit |
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Norditropin® Indications and Usage
Norditropin® (somatropin [rDNA origin] injection) is used to treat children with growth failure caused by very low or no production of growth hormone. It is also used to treat children who have short stature associated with Noonan syndrome and Turner syndrome, for treatment of children with short stature born small for gestational age with no catch-up growth by age 2-4 years, and to treat adults who do not make enough growth hormone.
Important Safety Information
Remember, your doctor is the main source of information about you and your health. Please consult your doctor if you have any questions about your health or your medication.
Do not use Norditropin® if you have any of the following conditions: an allergy to phenol or any other ingredients in the medicine; active cancer or other forms of tumor; severe diabetic eye disease; acute critical illness due to certain types of heart or abdomen surgery, trauma, or acute respiratory failure.
Children should not use somatropin if they have any of the following conditions: closed epiphyses (closed bone growth plates), Prader-Willi syndrome with severe obesity, upper airway obstruction or sleep apnea, or Prader-Willi syndrome with significant respiratory impairment.
Be sure to tell your doctor if you have diabetes mellitus; have had cancer or other forms of tumor; are pregnant, planning to be pregnant or are breastfeeding.
Be sure to tell your doctor about all medications you are taking especially if they are: a glucocorticoid medication such as hydrocortisone or cortisone acetate, thyroid hormone, insulin and/or oral diabetes medicines, drugs metabolized by the liver (for example, corticosteroids, sex steroids, anticonvulsants, cyclosporine), or oral estrogen replacement.
Adult height can be influenced if you are on Norditropin® for growth failure and at the same time using glucocorticoids or thyroid hormone.
If you are treated with insulin and/or oral diabetes medicines, the dose of your insulin/oral diabetes medicines may need to be adjusted.
Side effects are usually mild and temporary. Side effects may include headaches, muscle pain, joint stiffness, weakness, high blood sugar (hyperglycemia), sugar in your urine (glucosuria), swollen hands and feet due to fluid retention, and redness and itching in the area you inject.
If you have any of these symptoms, discuss them with your doctor.
If you have headaches, eyesight problems, nausea and/or vomiting, these may be symptoms of raised pressure in the brain. Contact your doctor right away.
In very rare cases children treated with somatropin have experienced pain in the hip or knee or a limp. These symptoms may be caused by a slippage of the growth plate in the hip (slipped capital femoral epiphysis).
Scoliosis (curvature of the spine) can occur in children who experience rapid growth. Because growth hormone increases growth rate, children should be monitored for progression of scoliosis.
Thyroid function tests should be performed periodically.
Skin lesions should be checked carefully for any unusual changes.
Somatropin treatment can increase the chances of developing middle ear infections in patients with Turner syndrome.
Congenital heart disease is a common finding in Noonan syndrome and patients should be closely monitored.
Talk to your doctor if you think you have any of these conditions.
