Guide for patients

A description of growth hormone

Growth hormone is a necessary protein produced by the pituitary gland in the hypothalamus of the brain. Growth hormone is the primary hormone responsible for the growth that occurs as a child matures into a full sized adult. Growth hormone plays an integral role in the metabolism of proteins, fats and carbohydrates, in people of all ages. Fully grown adults still require an adequate level of growth hormone for good health and correct body composition. Growth hormone will influence factors such as the ratio of good to bad cholesterol in the body, the ratio of lean muscle mass to fat and bone metabolism and promotion of healthy bone density throughout the full course of life. With insufficient levels of growth hormone, adults will experience poor metabolism, and an unhealthy body composition.

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What is AGHD (adult growth hormone deficiency)?

Adults can experience a deficiency in growth hormone, and the health effects of this deficiency can be profound. Adults will experience a GH deficiency if their pituitary gland is not secreting an appropriate quantity of GH into the blood stream, or if through surgery or medical treatment, the pituitary is absent or underperforming. The pituitary is a vital gland, and is often named "the master gland" as the hormone secretions from the pituitary are responsible for the regulation and control of a number of different glands in the body. If an adult presents with an underperforming pituitary gland, it will be necessary to supplement the levels of the endogenous hormones with medical hormone supplements. One of the most important supplements in the treatment of a pituitary condition is supplementary growth hormone GH.

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What are the causes of a growth hormone deficiency?

The primary causes of adult onset GH deficiency are surgery, accident trauma, disease of the hypothalamus or intra cranial radiation therapy.

GH deficient patients are usually segregated into two distinct groups. The first group comprises patients who were GH deficient as children, and continue to experience a GH deficiency, and the second group is adult onset GH deficiency.

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Symptoms of growth hormone deficiency

People are not always aware of their GH deficiency, and the condition is under diagnosed. Some of the symptoms that may indicate a GH deficiency are:

 An unusual proportion of fat to lean muscle mass; GH deficient sufferers will have unusually high fat to muscle ratios, and will present especially with excess fat around the abdomen.

Heightened bad cholesterol levels can also be an indicator of a GH deficiency, as can changes in bone density. If you are very prone to breaking or fracturing bones, this could be a sign of a GH deficiency.

GH deficient patients show a reduced ability for exercise, and present with diminished stamina, diminished general energy levels, and reduced muscle strength. GH deficient patients may also suffer from a diminished psychological well being, and or feelings of social isolation.

These symptoms can present as symptoms for a number of disorders, but a GH deficiency should possibly be evaluated if you experience one or more of these symptoms.

Children who were GH deficient, but have since stopped growing, may or may not continue to be GH deficient, and should be tested for GH levels.

The test for GH deficiency is a standard growth hormone stimulation test. This test is used to diagnose both pediatric onset and adult onset GH deficiency. There are risks and side effects with GH treatment, and patients should be made aware of these risks and side effects, as to be able to make an informed decision as to whether GH treatment is right for them.

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Why will I need to supplement my levels of GH

Even if you have finished growing, GH continues to play an important function in your body; and is essential for good health. If your doctor has determined that you are GH deficient, then your doctor will likely recommend supplementing your endogenous GH with a lab made GH supplement. GH is essential for correct metabolism, muscle to fat ratio promotion, and other important health factors. If you are GH deficient, GH treatment should greatly improve your affective health.

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What is the replacement therapy for GH deficiency?

Replacement therapy for GH is no different from other hormone therapies. The primary goal of GH therapy is to restore the correct level of GH to the body for healthy and efficient metabolism and other processes.

Norvotrop is used for the replacement of endogenous growth hormone in patients with biochemically confirmed AGHD (peak GH <5 ?g/L).

Patients must present with two criteria to be eligible for GH replacement treatment.

Firstly, the patient must show evidence of a GH deficiency on a GH stimulation test. Without a subnormal response to this test, GH therapy can not be initiated.

Additionally, if the condition is adult onset, the patient must also show evidence of a pituitary influencing condition such as, hypothalamus disease, intra cranial radiation, pituitary disease or trauma. If the GH deficiency began as child onset GH deficiency, the patient must confirm through a GH stimulation test administered as an adult, that there remains a need for GH treatment.

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How is Norvotrop administered?

NorvotropNorvotrop is an inject able hormone that should be injected into the fatty subcutaneous layer, directly below the skin. You should receive training from your health care team on the correct procedures for self injection, and on how best to inject Norvotrop effectively, and safely.

Norvotrop is a lyophilized powder formulation that is available in 4 mg vials. It is reconstituted, or mixed, with plain sterile water prior to an injection.

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What are the storage requirements for Norvotrop?

Norvotrop can be stored at room temperature for at least 30 days. Extreme tests have been done in which Norvotrop remained potent at 37 degrees Celsius (98 degrees Fahrenheit) for 30 days and 45 degrees Celsius (113 degrees Fahrenheit) for 7 days. You should however always store Norvotrop in refrigerator between 2 - 8 degrees Celsius (35 - 46 Fahrenheit). Do not freeze it! Norvotrop is light-sensitive and should be protected from light. Store the vials refrigerated in a dark place when they are not in use.

When mixed with water Norvotrop is good for 20 days if properly refrigerated between 2 - 8 degrees Celsius (35 - 46 Fahrenheit).

You should never freeze human growth hormone. It is light-sensitive, so protect vials from light by storing them (refrigerated) in a dark place when you are not using them.

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What benefits will you experience as a result of GH therapy?

Your body requires the correct levels of growth hormone for efficient and effective metabolism of food, and for correct body composition. The goal of GH therapy is to restore the correct level of GH in patients who present with a GH deficiency.

GH is also necessary for achieving optimum bone density and strength, for regulating the proper ratio between good cholesterol and bad cholesterol, and promoting a correct bodily proportion of muscle to fat. If you are suffering from a GH deficiency, GH supplementary treatment will offer you many benefits.

GH treatment will help you maintain a better body shape. You will achieve a leaner physique, and shed unwanted excess fat through the natural regulatory processes offered by a correct level of GH in the body. Clinical studies have shown a dramatic transformation of fat to lean mass in patients treated for twelve months with GH.

GH therapy will reduce your body fat percentage. If you are deficient in endogenous GH, you are very likely carrying more body fat than would be ideal. Supplementing your GH levels will help you to naturally lose that extra fat. Maintaining extra fat is not healthy and corresponds with increased cardiovascular health risks, as well as increased risks for certain cancers. Clinical studies on GH therapy show that people undergoing GH therapy will lose a significant proportion of their total body fat, particularly body fat around the abdomen. Patients show this dramatic fat loss after 12 months of GH treatment.  This fat loss occurs equally for people with adult onset or pediatric onset AGHD, who are treated with supplementary GH.

GH treatment will alter your cholesterol ratio for the better. It is important to keep the correct ratio of good (HDL), to bad (LDL) cholesterol, and GH deficient patients often present with abnormally high bad cholesterol. GH therapy will lower bad cholesterol levels and restore the correct balance between good and bad cholesterol. GH therapy will not impact total cholesterol levels, or triglyceride levels. This improved cholesterol ratio will occur for adult onset patients, as well as for pediatric onset patients who were treated with a higher dosage of Norvotrop. Adult onset patients will not well tolerate the higher dosages that are given to child onset patients.

GH treatment will improve the bone and mineral density in the spine. Pediatric onset patients who are treated with higher doses of Norvotrop will show improved mineral density in the spine bone. These child onset patients do not show increased mineral densities in other bones. Adult onset patients given a normal adult onset dosage do not show bone density improvements.

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What is some important health and safety information for GH treatment?

GH treatment can alter your body's reaction to insulin. This can occur particularly in obese people.

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Important information about GH treatment

You need to educate yourself about the potential risks and side effects associated with GH treatment. There is a risk of increased insulin sensitivity, especially for obese patients presenting a GH deficiency. GH treatment will affect insulin dosage if you are diabetic and taking GH supplementary treatment.

GH treatment can sometimes cause an intracranial hyper tension. If you experience visual changes, nausea and vomiting, get medical attention immediately, as these can be signs of intracranial hypertension.

You should ensure that your doctor is made aware of any other medicat6ions that you are taking. If you are taking steroids, anticonvulsants or cyclosporine, the dosages of these medications will likely need to be monitored and adjusted with the beginning of GH treatment.

You should seek emergency medical attention if you observe rash itchiness or hives. These can indicate an allergic reaction to the medication.

If you are pregnant, or a nursing mother, you should speak with your doctor about the possibility of continuing treatment. It is not yet known if Norvotrop is passed through breast milk.

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Possible side effects

By far the most common side effect to GH therapy is joint pain or joint swelling. Joint pain presents 27% of the time, and joint swelling will present 41% of the time. These joint issues are related to incorrect dosages, and your doctor will adjust the dose should these side effects occur. Correct dosage alteration will cause these side effects to disappear.

A very small percentage of people may develop antibodies to the protein. This will occur with any protein therapy treatment.

GH treatment can cause high levels of the protein IGF-I. 35% of child onset patients treated for two years with GH, developed an elevated IGF-I protein count at some time in the course of treatment. The long term effects of this elevated IGF-I count are not yet known. Should a patient present higher than normal levels of IGF-I, the dosage will be altered in an effort to normalize IGF-I levels.

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Who should avoid GH therapy?

If you are a cancer patient you may not take Norvotrop. If you develop cancer or tumors while undergoing GH therapy, you must immediate desist from GH treatment.

If you present with unusual lumps or masses that do not dissipate in time, submit for a full examination to your doctor.

If you have any history of intracranial lesions, you will need to be monitored closely by your health care team, to ensure that there are no re emergences of lesions.

GH treatment is not appropriate for acute and critical illness in the period following open heart surgery, respiratory distress or failure, or severe multiple traumas.

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How will the correct dosage be determined?

The dosage will vary greatly depending on the age of the GH deficient patient. Children will take considerably higher levels of the hormone than will adults who present with a GH deficiency.

Norvotrop offers flexible dosing to make this simple. AGHD patients who are beginning replacement therapy receive a dosage of not more than 0.006 mg/kg/d. For adult patients under 35 years of age, the recommended dose is up to 0.025 mg/kg/d, and for patients over 35 years of age, the recommended dose is up to 0.0125 mg/kg/d.

GH therapy will take some time to really start to show benefits. You should make sure that you get regular monitoring examinations from your health care providers, to ensure that the GH therapy is working as well as it should. There may be some dosage adjustments required, depending on the incidence of side effects and the efficacy shown by the treatment.

How soon will I start to see positive results from GH therapy?

GH therapy can require several months of continuous treatment before you will see any concrete results. The changes that occur will not occur immediately, or drastically, and may be so gradual and slow, that you at first may not recognize the improvements for what they are. With time you will start to see a significant and steady improvement. It is very important that you follow the dosage routine exactly as directed by your doctor. You will need to take this supplement every day, and should you miss or forget a dose, you will not experience the results that you otherwise would. You will with time see great results, and beginning GH therapy is an important step towards improved health and happiness.

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Considerations on GH therapy

If you are GH deficient, beginning GH therapy will have a great impact on the restoration of your health to a more optimal level. GH therapy alone will never be the only consideration for best results. You will need to follow a healthy dietary plan, and consume a large amount of fresh fruits and vegetables, dairy products, healthy whole grains and lean meats, if you are to see maximal improvements. This correct dietary intake is vital for energy promotional and health maintenance, and should be incorporated as a part of GH therapy.

GH deficient patients often suffer from greatly reduced energy levels. GH treatment will improve your energy levels, and you should strive to further increase your energy naturally, through healthy and regular physical activities. This will both increase your energy level, and have a positive effect on your psychological well being.

A healthy and optimistic outlook on life has been clinically proven to result in increased well being and health. You should try to maintain a positive outlook as you incorporate GH treatment into your life.

You will need to make a serious and concerted effort to modify your lifestyle in the interest of getting healthier. Work hard at eating right and getting regular exercise. Your doctor or health care team can advise you on appropriate dietary plans and exercise routines for your level of fitness. You should strive to maintain healthy eating and regular exercise over the duration of your GH treatment for best effects.

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Support organizations

The following are some of the support and resource based organizations for information on GH therapy. They may offer supportive services and information to you as you consider and then undergo GH treatment.

MAGIC Foundation

The MAGIC foundation is a support organization that provides information and supportive services to patients undergoing hormone replacement therapy. 1327 N. Harlem Avenue
Oak Park, IL 60302

Human Growth Foundation

This foundation is an advocacy group for people with GH disorders and their families. They offer educational resources and fund research in addition to serving as an advocacy group.
997 Glen Cove Avenue
Glen Head, NY 11545

The Endocrine Society

This society is primary mandated to support leading research initiatives in the area of endocrinology. They support research, education and clinical trials and practices. They have operated since 1916, and are globally recognized as one of the world's leading endocrinology based research and support organizations.
4350 East West Highway, Suite 500
Bethesda, MD 20814

American Association of Clinical Endocrinologists (AACE)

this is a referral organization, with a database of more than 3000 doctors throughout the world.
1000 Riverside Avenue, Suite 205
Jacksonville, FL 32204

Pediatric Endocrine Nursing Society (PENS)

This organization is a voluntary nursing based organization that is dedicated to improving the care of pediatric endocrinology. They offer various professional development services to nursing health care workers who specialize in this field.
PO Box 2933
Gaithersburg, MD 20886-2933

Norvotrop is a prescription medication, and you will need to secure a valid doctor's prescription prior to taking the medication.

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1. AACE Clinical Practice Guidelines for Growth Hormone Use in Adults and Children. Endocr Pract. 1998;4:165-173.
2. Isotropin full prescribing information, Knightsbridge Pharmaceutical. 2005.
3. Isotropin full prescribing information, Knightsbridge Pharmaceutical. 200

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