Is your child’s body producing enough growth hormone?

Growth hormone deficiency is one of the endocrine (hormonal) disorders that can cause poor growth. In order for a child to grow properly, an important gland called the pituitary must release enough growth hormone called somatropin. Somatropin stimulates growth and cell reproduction. When the pituitary does not release enough somatropin, growth hormone deficiency (GHD) occurs and a child’s growth may slow down.1
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Many factors influence the release of growth hormone from the pituitary gland in a child. These may include:

  • Nutrition
  • Sleep
  • Exercise
  • High levels of physical and mental stress
  • Types of prescription medications taken
  • Amounts of other hormones produced in the body
  • Amount of blood sugar released after eating
  • Elevated levels of insulin-like growth factor-1 (IGF-1)

What causes growth hormone deficiency?

A Congenital Disorder

Sometimes, a child is born with growth hormone deficiency, possibly because of a problem with the pituitary gland. A congenital disorder may be the result of a genetic or chromosomal abnormality, or a problem during pregnancy.

An Acquired Disorder

In some cases, a disorder develops later in life. An acquired disorder refers to a condition that is not present at birth, and may result from illness or accident. Possible reasons why a child may develop an acquired disorder include illness—such as a tumor affecting the pituitary gland or a part of the brain called the hypothalamus—or trauma to the head that caused brain damage.

Idiopathic Growth Hormone Deficiency

Occasionally, doctors cannot find any reason for a child’s growth hormone deficiency. This is known as idiopathic growth hormone deficiency. Idiopathic growth hormone deficiency seems to occur in one of every 3,800 live births; exact rates of older children affected by this condition are harder to obtain.2

What are the signs of growth hormone deficiency?

From around the age of two and through puberty, children should grow, on average, two inches per year and gain roughly six pounds per year. Some children may not meet these average milestones, and that does not mean there is a growth hormone deficiency. However, in some cases it does.

Signs and symptoms of a possible growth hormone deficiency can include:

  • Slow growth; less than two inches of growth per year3
  • An immature appearance—making the child look younger than his or her peers
  • A history of low blood sugar as an infant

How is growth hormone deficiency diagnosed?

If your child appears to have a growth problem, your pediatrician may refer you to a pediatric endocrinologist—a doctor who specializes in diagnosing, treating and managing disorders involving hormones and the glands that make them.

At your first visit, your pediatric endocrinologist will be interested in your child’s birth and medical history. The doctor may also ask you about family history and the adult height of both parents.

In addition to taking a patient history, the doctor will conduct a physical evaluation that may include the following:

  • Laboratory evaluation: This may include blood tests to help rule out other illnesses.
  • A stimulation test, also known as a STIM test: This test helps the doctor find out if your child’s body is producing enough growth hormone over time. During the test, your child receives a drug agent that can stimulate the pituitary gland to release GH. This is done in an effort to simulate the natural GH release from the pituitary gland. An IV is inserted into a vein, and a small amount of blood is taken, usually five times, 30 minutes apart. If the blood samples don’t show an increase in growth hormone, your healthcare team is one step closer to the diagnosis of growth hormone deficiency.
  • Bone age X-rays: An X-ray of the left hand and wrist may be taken. The bone images will help determine the maturity of the bone and growth potential.

How is growth hormone deficiency treated?

Growth hormone deficiency is often treated with growth hormone replacement therapy. Growth hormone therapy helps bones grow, which causes an increase in height, but the process takes patience. It may take time before you begin to see a distinct change.

The structure of the growth hormone used in treatment is identical to the growth hormone produced by the pituitary gland. One brand of growth hormone, approved to treat appropriate growth hormone deficient children and adults, is called Saizen® (somatropin) for injection.

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.

1. Atil Y. Kargi, George R. Merriam. “Diagnosis and Treatment of Growth Hormone Deficiency in Adults.” Nature Reviews: Endocrinology, Vol. 9; pg. 335-345. June 2013.
2. “Growth Hormone Deficiency.” UK Child Growth Foundation. 2012–2014.
3. “How Kids Grow.” EMD Serono, Inc. 2013