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 (these may be symptoms of
raised pressure in the brain), 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.
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.
