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Glossary

Catch-up Growth: Accelerated growth of small infants during the first 2 years of life, which enables them to attain a normal size. Most children born SGA will have their catch-up growth by ages 2 to 3 years, but some do not.

Chromosomes: The entire body is made of tiny units called cells. Inside each cell are 23 pairs of chromosomes. Chromosomes are linear strands made of DNA that contain a person’s genes.

Genes: Genes are the basic units of hereditary. They are located in specific places on chromosomes. Genes are made of DNA, which is a code to tell the body how to build a specific protein. All the hereditary information contained in a person is called a genotype.

Geneticist: A scientist who specializes in genetics, the study of heredity and its variants.

Genetic Mutation: A permanent change in a gene’s structure that is potentially capable of being transmitted to children.

Gestational Age: The age of a fetus in weeks, measured from the first day of a woman’s last menstrual cycle to the current date. A normal pregnancy can range from 37 to 41 weeks.

Growth Hormone: A hormone produced by the pituitary gland that is necessary for normal growth.

Growth Hormone Deficiency: A disorder in which the body does not make enough growth hormone.

Infantometer: A device used to measure length in infants and children up to 2 years of age. It consists of a firm, flat surface with an immovable headpiece and a movable footpiece, which are perpendicular to the measuring tape.

Karyotype: A representation of the chromosomes in a single cell, which are arranged in numerical order from largest to smallest.

Pediatric endocrinologist: A specialist who diagnoses and treats hormonal diseases in children.

Percentile: 1 of 100 equal divisions that indicates how much of a group is equal to or below it. For example, a percentile score of 92 is equal to or higher than 92% of other scores.

Pituitary Gland: A small, round gland located at the base of the brain. The pituitary gland produces a number of hormones, including growth hormone, which it sends via the bloodstream throughout the body to regulate growth.

Pubertal growth: The growth period related to or occurring in puberty (the period of sexual maturity).

Stadiometer: A device used to measure the height of children older than 2 years. It consists of a vertical board with an attached metric ruler and a movable horizontal headpiece.

Stature: The standing height of a person.

Stimulate: To increase activity.

Selected 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; you are allergic to somatropin or any of the ingredients in Norditropin®; your healthcare 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).

Indications and Usage

What is Norditropin® (somatropin) injection?
 
Norditropin® is a prescription medicine that contains human growth hormone and is used to treat:
  • children who are not growing because of low or no growth hormone 
  • children who are short (in stature) and who have Noonan syndrome, Turner syndrome, or were born small (small for gestational age-SGA) and have not caught-up in growth by age 2 to 4 years 
  • children who have Idiopathic Short Stature (ISS) 
  • children who are not growing who have Prader-Willi syndrome (PWS) 
  • adults who do not make enough growth hormone

Important Safety Information (cont’d)

Before taking Norditropin®, tell your healthcare provider about all of your medical conditions, including 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 
  • have diabetes 
  • are pregnant or breastfeeding, or plan to become pregnant or breastfeed

Tell your healthcare provider about all the medicines you take, 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.

How should I use Norditropin®?

  • Use Norditropin® exactly as your health care provider tells you to 
  • Do not share your Norditropin® pens and needles with another person even if the needle has been changed. You may give another person an infection or get an infection from them.

What are the possible side effects of Norditropin®?
Norditropin® may 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 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. Contact the healthcare provider if you or your child start to have headaches, or have changes in behavior, changes in vision, or changes in moles, birthmarks, or the color of your skin 
  • new or worsening high blood sugar (hyperglycemia) or diabetes 
  • increase in pressure in the skull (intracranial hypertension). If you or your child has headaches, eye problems, nausea or vomiting, contact the healthcare provider 
  • 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, wheezing, severe itching, skin rashes, redness or swelling, dizziness or fainting, fast heartbeat or pounding in your chest, or sweating 
  • 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. Tell your healthcare provider if you have any of these signs or symptoms of fluid retention. 
  • decrease in a hormone called cortisol. Tell your or your child’s healthcare provider if you or your child has darkening of the skin, severe fatigue, dizziness, weakness or weight loss 
  • 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) 
  • severe and constant abdominal pain can be a sign of pancreatitis. Tell your or your child’s healthcare provider if you or your child has any new abdominal pain. 
  • loss of fat and tissue weakness in the area of skin you inject 
  • increase in phosphorus, alkaline phosphatase, and parathyroid hormone levels in your blood

The most common side effects of Norditropin® include:

  • injection site reactions and rashes, and headaches

Please click here for Norditropin® Prescribing Information.

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 health care provider and find out if Norditropin® is right for you or your child.