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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.