What is Saizen® [somatropin (rDNA origin) for injection]?
Saizen® [somatropin (rDNA origin) for injection] is a prescription medicine indicated for the treatment of growth hormone deficiency (GHD) in children and adults:
|1-||to increase growth rate in children with growth failure and who produce low amounts of growth hormone.|
|2-||to replace growth hormone in adults because of either of a deficiency that started as a child or started as an adult due to of pituitary disease, hypothalamic disease, surgery, radiation therapy, or trauma; and has been confirmed using medical tests|
As with any prescription medicine, your doctor will do a complete health evaluation prior to prescribing Saizen® and will monitor your progress and possible side effects during the course of treatment.
Important Risk Information including side effects
Who should not take Saizen®?
Saizen® should not be used in children and adults with any of the following medical conditions because serious side effects can occur:
- a critical illness caused by certain types of heart or stomach surgery, serious injury or a sudden and severe breathing problem (respiratory failure)
- cancer or other tumors
- certain types of eye problems caused by diabetes
- allergies to any of the ingredients in the medicine including benzyl alcohol
- Prader-Willi syndrome who are severely overweight or have a history of breathing problems including sleep apnea
Saizen® should also not be used in children who have completed growth.
What should patients tell their doctor before taking Saizen®?
Patients should tell their doctor about their medical and family history, treatment use and past and existing medical conditions, such as but not limited to the following:
- cancer or any tumor
- use of prescription and non prescription medicines, steroids, vitamins, and herbal supplements
What are the most common side effects of Saizen® reported in clinical trials in patients treated for GHD?
Other possible side effects of Saizen® are:
- return of tumor or cancerous growths
- headaches, changes in vision, nausea or vomiting (these may be symptoms of raised pressure in the brain which requires immediate medical attention)
- hip and knee pain or a limp that can be a sign of slipped capital femoral epiphysis
- worsening of pre-existing curvature of the spine (scoliosis)
- intense pain and tenderness in the abdomen as consequence of an inflammation of the pancreas (pancreatitis)
- high blood sugar (hyperglycemia/diabetes)
Never share a Saizen® needle with another person, even if the needle is changed. Sharing of the pen between patients may pose a risk of transmission of infection. easypod® should only be used according to the instruction manual and only after proper training from a healthcare provider. For children, an adult should supervise the use of easypod®.
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.