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growth hormone therapy patient glossary

A glossary of terms for use in discussing growth hormone therapy with patients, parents, and caregivers.

Adipose

The word ‘adipose’ refers to fat or tissue made up mainly of fat cells.

Adult Growth Hormone Deficiency

Adult Growth Hormone Deficiency (AGHD) is classified as either Adult Onset (AO) or Chidhood Onset (CO).

AO: Patients who have GHD, either alone or associated with multiple hormone deficiencies (hypopituitarism), as a result of pituitary disease, hypothalamic disease, surgery, radiation therapy, or trauma
CO: Patients who were GH deficient during childhood as a result of congenital, genetic, acquired, or idiopathic causes

Bone mineral density (BMD)

BMD is a measure of the strength of your bones based on the concentration of calcium and other minerals present in them.

Catch-up growth

GHD results in growth that is slower than normal. When GHD is treated with human growth hormone (hGH) therapy, the body starts to grow faster and there is "catch-up" growth. In other words, the body tries to catch up to reach the limit of what is considered normal for that age. The age at which a person starts growth hormone therapy is very important, since the potential for catch-up growth may decrease as the child becomes older. The goal of treatment is to promote catch-up growth, enabling the child or teenager to reach his or her full potential adult height – the height the child would have reached if he or she did not have GHD.

Closed epiphyses

The epiphyses (i-PIF-uh-sees) are centers of growth, extending from the ends of our long bones. The epiphyses remain open while a person still has potential for growth; when the epiphyses are closed, there is no potential for growth.

Full growth potential

Everyone has a different full growth potential, the maximum (most) height a person can grow. A person's full growth potential depends on many things, including the height of the person’s mother, father, and other family members.

Glands

Glands are specialized parts of the body that make hormones which act as chemical messengers relaying messages from one part of the body to another. The pituitary gland sends out growth hormone, which leads to growth. There are numerous glands and hormones in the body that perform a variety of important functions.

Growth hormone deficiency (GHD)

GHD is a condition in which a person's body does not make enough growth hormone. GHD may be present at birth or at any time during infancy or childhood. It is usually the result of the pituitary gland failing to produce enough growth hormone. Fortunately, growth hormone treatment does exist in the form of a commercially produced, biosynthetic GH hormone replacement therapy.

Human growth hormone (hGH)

A hormone is a special chemical made by our glands that can carry messages from one part of the body to another. Our bodies make many different types of hormones. hGH is the growth hormone made by the pituitary gland in humans.

Hypopituitarism

Hypopituitarism (high-po-PIT-oo-i-tar-ism) is a condition in which the pituitary gland does not make enough of several different types of hormones, not just growth hormone. Some of these other hormones include thyroid-stimulating hormone (TSH), adrenocorticotropic hormone (ACTH), luteinizing hormone (LH), and follicle-stimulating hormone (FSH). Children who have hypopituitarism are usually normal in size at birth and have relatively normal growth when they are infants. But during childhood, growth slows down considerably.

Intracranial hypertension (IH)

This is a condition in which the pressure of the cerebrospinal fluid (CSF) inside the skull is too high. Intracranial hypertension, along with papilledema, vision change, headache, nausea, and vomiting, has been reported in a small number of patients on growth hormone therapy.

Lean body mass (LBM)

Lean body mass is an estimate of the mass of your body minus the fat.

Papilledema

Papilledema is a swelling of the optic nerve where it enters the back of the eye. It is caused by increased pressure from the cerebrospinal fluid that can cause headache, nausea, vomiting, and visual changes.

Pituitary

The pituitary (PI-too-i-ter-ee) is a very small yet important gland in our bodies. About the size of a pea, it is located just below the brain and just behind the top of the nose. When triggered by signals from the brain, the pituitary gland sends growth hormone to our bones, which causes us to grow.

Stimulation Test (Stim Test)

A Stim Test is a procedure used to determine if the pituitary gland, the gland that produces growth hormone, is doing its job. The test will “stimulate” the pituitary gland, helping the doctor understand if hormones are being secreted in normal amounts. During the test, one or more medicines will be administered – some in pill form (which can usually be dissolved, if necessary), some by injection, or by intravenous (IV) needle. At various time intervals, samples of blood will be taken so the doctor can measure how the pituitary gland is responding. Often, a small needle is inserted into a vein (also called a ‘port’) for the duration of the test so that several blood samples can be taken with only one needle insertion. Throughout the test, the patient will be kept comfortable in a recliner, on a hospital bed, or on an exam table. Total testing time may take several hours.

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Indications and Usage:

Norditropin^® (somatropin [rDNA origin] injection) is indicated for the treatment of children with growth failure due to inadequate secretion of endogenous growth hormone, the treatment of children with short stature associated with Noonan syndrome or Turner syndrome, the treatment of children with short stature born small for gestational age (SGA) with no catch-up growth by age 2-4 years, and for the replacement of endogenous growth hormone in adults with growth hormone deficiency (GHD) who meet either of the following two criteria: 1. Adult Onset: Patients who have GHD, either alone or associated with multiple hormone deficiencies (hypopituitarism), as a result of pituitary disease, hypothalamic disease, surgery, radiation therapy, or trauma; or 2. Childhood Onset: Patients who were growth hormone deficient during childhood as a result of congenital, genetic, acquired, or idiopathic causes.

Important Safety Information:

Somatropin should not be used to treat patients with acute critical illness due to complications following open heart or abdominal surgery, multiple accidental trauma or acute respiratory failure as increased mortality may occur.

Somatropin is contraindicated in patients with Prader-Willi syndrome who are severely obese, have a history of upper airway obstruction or sleep apnea, or have severe respiratory impairment. There have been reports of sudden death when somatropin was used in such patients. Norditropin^® is not indicated for the treatment of patients who have growth failure due to genetically confirmed Prader-Willi syndrome.

Somatropin should not be used or should be discontinued with any evidence of active malignancy. Any preexisting malignancy should be inactive and its treatment complete prior to instituting therapy with somatropin. Somatropin should be discontinued if there is evidence of recurrent activity. Patients with preexisting tumors or GHD secondary to an intracranial lesion should be monitored routinely for progression or recurrence. In childhood cancer survivors, an increased risk of a second neoplasm, particularly meningiomas in patients treated with radiation to the head for their first neoplasm, has been reported in patients treated with somatropin.

Somatropin should not be used in patients with active proliferative or severe non-proliferative diabetic retinopathy, for growth promotion in pediatric patients with closed epiphyses, or in patients with known hypersensitivity to somatropin or any of its excipients.

Somatropin may decrease insulin sensitivity particularly at higher doses in susceptible patients. Glucose levels should be monitored periodically, including close monitoring of patients with preexisting diabetes or glucose intolerance. Doses of anti-hyperglycemic drugs (insulin or oral agents) may require adjustment for patients with diabetes on somatropin therapy.

Intracranial hypertension (IH) with papilledema, visual changes, headache, nausea and/or vomiting, usually occurring within the first eight (8) weeks after initiation of somatropin therapy, has been reported in a small number of patients. In all reported cases, rapid resolution has occurred after therapy cessation or a reduction of dose.

Funduscopic examination should be performed routinely before and during somatropin therapy. If papilledema is observed, somatropin treatment should be discontinued.

Fluid retention during somatropin replacement therapy in adults may frequently occur. Clinical manifestations of fluid retention are usually transient and dose dependent.

In patients with GHD, central (secondary) hypothyroidism may first become evident or worsen during somatropin treatment. Periodic thyroid function tests are recommended and thyroid hormone replacement therapy should be initiated or adjusted as needed.

Slipped capital femoral epiphysis may occur more frequently in patients with endocrine disorders (including GHD and Turner syndrome) or with rapid growth. Onset of a limp or complaints of hip or knee pain in somatropin patients should be carefully evaluated. Rapid growth may also result in progression of preexisting scoliosis. Patients with a history of scoliosis or skeletal abnormalities, which may be present in untreated Noonan, Turner or Prader-Willi syndrome, should be monitored.

Patients with Turner Syndrome should be evaluated carefully for otitis media and other ear disorders since these patients have an increased risk of ear and hearing disorders. Somatropin treatment may increase the occurrence of otitis media in patients with Turner syndrome. Somatropin may also increase the risk of IH in Turner patients. In addition, patients with Turner syndrome should be monitored closely for cardiovascular disorders (e.g., stroke, aortic aneurysm/dissection, hypertension) as these patients are also at risk for these conditions.

Congenital heart disease is an inherent component of Noonan syndrome. Though a clinical study in Noonan syndrome reported no evidence of somatropin-induced ventricular hypertrophy or exacerbation of preexisting ventricular hypertrophy (as judged by echocardiography), the safety of Norditropin^® in children with Noonan syndrome and significant cardiac disease is not known.

Other somatropin-related adverse reactions include injection site reactions/rashes, lipoatrophy and headaches. Subcutaneous injection of somatropin at the same site repeatedly may result in tissue atrophy and can be avoided by rotating the injection site.

Somatropin inhibits 11ß-hydroxysteroid dehydrogenase type 1 (11ßHSD-1) in adipose/hepatic tissue, and may significantly impact the metabolism of cortisol and cortisone. In patients treated with somatropin, previously undiagnosed central (secondary) hypoadrenalism may be unmasked requiring glucocorticoid replacement therapy. In addition, patients treated with glucocorticoid replacement therapy, especially with cortisone acetate and prednisone, for previously diagnosed hypoadrenalism may require an increase in their maintenance or stress doses.

Careful monitoring is advisable when somatropin is administered in combination with other drugs known to be metabolized by CP450 liver enzymes (e.g., corticosteroids, sex steroids, anticonvulsants, cyclosporine) as limited published data suggest somatropin may alter clearance of these compounds.

In adult women on oral estrogen replacement, a larger dose of somatropin may be required to achieve the defined treatment goal.

The safety and effectiveness of Norditropin^® in patients age 65 years and older has not been evaluated in clinical studies. Elderly patients may be more sensitive to the actions of somatropin and may be more prone to develop adverse reactions.