INDICATIONS

Genotropin (somatropin) is a prescription medicine that contains a form of human growth hormone and is used to treat:

• children who are not growing because of low or no growth hormone
• children who are not growing who have Prader-Willi syndrome (PWS)
• children who were born small for gestational age (SGA) and have not caught-up in growth by age 2
• idiopathic short stature (ISS)
• adults who do not make enough growth hormone and have either adult onset or childhood onset growth hormone deficiency

Important Safety Information

• 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 Genotropin
• you have certain types of eye problems caused by diabetes (diabetic retinopathy)
• you are a child with closed bone growth plates (epiphyses)

Before using Genotropin, 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
• have ear problems
• 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. Genotropin may affect how other medicines work, and other medicines may affect how Genotropin works.

Genotropin may cause serious side effects, including:

• higher risk of death in people who have critical illnesses because of heart or stomach surgery, trauma or serious breathing (respiratory) problems
• risk of sudden death in children with Prader-Willi syndrome who are severely obese or have breathing problems including sleep apnea
• 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. Your healthcare provider will need to monitor you for a return of cancer or a tumor
• new or worsening high blood sugar (hyperglycemia) or diabetes. Your blood sugar may need to be monitored during treatment
• increase in pressure in the skull. If you have headaches, eye problems, nausea or vomiting, contact your healthcare provider
• serious allergic reactions. Get medical help right away if you have 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 healthcare provider if you have darkening of the skin, severe fatigue, dizziness, weakness or weight loss
• decrease in thyroid hormone levels. Decreased thyroid hormone levels may affect how well Genotropin works. Your healthcare provider will do blood tests to check your hormone levels
• hip and knee pain or a limp in children (slipped capital femoral epiphysis). This may lead to a serious condition where bone tissue dies due to a lack of blood supply (osteonecrosis). Get medical help right away if you develop a limp or has hip or knee pain
• worsening of pre-existing curvature of the spine (scoliosis). If you have scoliosis, you will need to be checked often for an increase in the curve of the spine
• increased risk of ear and hearing problems and heart problems if you have Turner syndrome
• 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
• severe and constant abdominal pain. This could be a sign of pancreatitis. Tell your healthcare provider if you have any new abdominal pain

Other common side effects of Genotropin include:

• injection site reactions and rashes, loss of fat and tissue weakness, and headaches