Indication

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 a deficiency that started as a child or started as an adult due to pituitary disease, hypothalamic disease, surgery, radiation therapy, or trauma

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

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:

  • diabetes
  • cancer or any tumor
  • use of prescription and non prescription medicines, steroids, vitamins, and herbal supplements
  • allergies
  • pregnancy
  • nursing

What are the most common side effects of Saizen® reported in clinical trials in patients treated for GHD?

CHILDREN ADULTS
  • local reactions at the injection site (such as pain, numbness, redness and swelling)
  • low levels of thyroid hormone (hypothyroidism)
  • low blood sugar (hypoglycemia)
  • seizures or convulsions
  • worsening of skin psoriasis
  • swelling associated with fluid retention

 

  • local reactions at the injection site (such as pain, numbness, redness and swelling)
  • low levels of thyroid hormone (hypothyroidism)
  • pain in joints and muscle pain
  • swelling associated with fluid retention
  • tingling and numbness
  • unusual skin sensations
  • carpal tunnel syndrome
  • increased blood sugar (hyperglycemia)

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 in children, that can be a sign of slipped capital femoral epiphysis
  • worsening of pre-existing curvature of the spine in children (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 needles between patients may pose a risk of transmission of infection. EMD Serono medical devices 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 EMD Serono medical devices.

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.

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