Setting Individualized
Treatment Goals

Each patient’s growth hormone replacement therapy should be individualized. The outcome of treatment is influenced by many factors, including but not limited to the age at which the patient starts treatment, the condition of the patient prior to and during treatment, and the dose prescribed by the patient’s physician.

Saizen® (somatropin) for injection works to stimulate skeletal growth, increase the number and size of skeletal muscle cells, influence the size and function of internal organs, and has important effects on metabolism. But the process takes patience.

What to Expect when Children are on Treatment

In children, growth hormone therapy helps bones grow, which causes an increase in height. However, it may take time before you begin to see a distinct change. During the first two years of therapy, your child may grow several inches. After that, growth continues until the growth plates close and treatment with Saizen for growth failure should be discontinued.

Just as it takes a child a number of years to naturally grow to his or her adult height, treatment may be recommended for several years. Growth hormone treatment can continue until your child has achieved his or her final goal height as determined by their physician. It is more than likely your child will take growth hormone until bone growth is complete.

Helping Your Child Stay Committed to Therapy

Long-term commitment to growth hormone therapy can be especially difficult for a child. It’s important to remember that people who take growth hormone as prescribed have better outcomes than those who miss doses or take breaks from treatment. Remind your child that stopping therapy may limit the growth benefit he or she gets.

Here are a few ideas to encourage your child to stay committed to therapy:

  • Set realistic expectations; your child should know that even with therapy, growth and an increase in height takes time
  • Plan a small reward after every week or month your child takes growth hormone as prescribed
  • Everyone likes praise; let your child know you appreciate the commitment he or she is making

What Adults Might Expect with Treatment

In adults, growth hormone therapy will likely not affect height; however, a clinical trial showed beneficial effects on several bone turnover markers, lean body mass and total fat mass in adults treated with Saizen® (somatropin) for injection compared to the placebo group.

Indication

What is SAIZEN® (somatropin) for injection?

Saizen is a prescription medicine that is used to treat growth hormone deficiency (GHD) in:

1- Children with growth failure who produce low amounts of growth hormone.
2- Adults with GHD that started as a child or as an adult.

Saizen is an injectable form of a protein called growth hormone that is produced by your body.

Important Risk Information

Who should not take SAIZEN?

Saizen should not be used in children after the growth plates have closed.

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 from surgery, serious injuries, or a severe breathing problem
  • Prader-Willi syndrome who are severely overweight or have a history of breathing
    problems including sleep apnea
  • Cancer or other tumors
  • Allergies to growth hormone
  • Eye problems caused by diabetes

What should patients tell their doctor before taking SAIZEN?

  • If you have or had cancer as a child. There is an increased risk of getting another tumor if you are a childhood cancer survivor
  • If you have diabetes, are at risk for getting diabetes, or have blood sugar levels that are higher than normal. New cases of type 2 diabetes have been reported in patients taking Saizen
  • If you are allergic to growth hormone, or other ingredients such as benzyl alcohol, sucrose, phosphoric acid, sodium hydroxide, or metacresol
  • If you are taking any other medicines (both prescription or over the counter), vitamins, or supplements because these medicines may affect each other. Your doctor may need to adjust the dose of Saizen or other medicines you are taking
  • If you are nursing, pregnant, or plan to become pregnant. It is not known if Saizen passes into your breast milk or could harm your unborn baby

Your doctor will perform certain tests before prescribing SAIZEN and will monitor progress during the course of treatment.

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

The most common side effects reported are:

  • An injection site reaction such as pain, numbness, redness, and swelling
  • Muscle and joint pain
  • Tingling and numbness
  • Unusual skin sensations
  • Headache
  • Adults also commonly report swelling associated with fluid retention especially in the legs, arms, and face

Other less common but serious side effects of SAIZEN are:

  • Tumors or cancerous growths
  • High blood sugar (hyperglycemia/diabetes) which can include symptoms of increased thirst and urination, tiredness, trouble concentrating and weight loss
  • Headaches, changes in vision, nausea or vomiting which requires immediate medical attention
  • Serious allergic reactions that require immediate medical attention.
  • Hip and knee pain or a limp in children, which can be a sign that the thigh bone and hip joint may have slipped out of place
  • Curvature of the spine or backbone in children (scoliosis)
  • Pain and tenderness in the abdomen, which could be a sign of a problem with the pancreas

These are not all of the possible side effects. Let your doctor know about any side effects you may experience.

How should you administer SAIZEN?

Patients and caregivers should be trained by a healthcare professional on how to mix and inject Saizen prior to use. Children should always be supervised.

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.

Please see the Prescribing Information for a complete list of SAIZEN Risk Information.