Prescribing Information

Indications and Usage

Norditropin^® (somatropin [rDNA origin] injection) is used to treat: children who have growth failure because of low or no growth hormone; children who are short (in stature) and who have Noonan syndrome or Turner syndrome; children who are short (in stature) because they were born small (small for gestational age-SGA) and have not caught-up in growth by age 2 to 4 years; and 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; your healthcare provider tells you that you have certain types of eye problems caused by diabetes; you are a child with closed bone growth plates (epiphyses) or you are allergic to any of the ingredients in the medicine.

Before you take Norditropin^®, tell your healthcare provider if you: have diabetes; had cancer or any tumor; have any other medical condition; are pregnant or plan to become pregnant; are breast-feeding or plan to breast-feed.

Norditropin^® can 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 death in children with Prader-Willi syndrome who are severely obese or have breathing problems including sleep apnea; return of tumor or cancerous growths; high blood sugar (hyperglycemia); increase in pressure in the skull (intracranial hypertension); swollen hands and feet due to fluid retention; 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); middle ear infection, hearing problems or ear problems in patients with Turner syndrome.

Patients with Noonan syndrome and Turner syndrome should be closely monitored by their doctors as they are more likely to have congenital heart disease.

The most common side effects of Norditropin^® include: headaches, muscle pain, joint stiffness, 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 headaches, eye problems, nausea or vomiting, contact your healthcare provider right away.

Norditropin^® may affect how other medicines work, and other medicines may affect how Norditropin^® works so be sure to tell your healthcare provider about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Especially tell your healthcare provider if you take: glucocorticoid medication, thyroid hormone, insulin or other medicine for diabetes, medicines that are metabolized by the liver (e.g., corticosteroids, sex steroids, anticonvulsants, cyclosporine), or oral estrogen replacement medicine.