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Adult Growth Hormone Deficiency

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Adult Growth Hormone Deficiency A Guide for Patients • Patients should be sure to inject Nutropin at a different recommended place on their body each time to avoid tissue breakdown. A doctor or nurse should provide injection training and supervise the fi rst injection • The use of Nutropin therapy has not been studied in patients over 65 years of age. Elderly patients may be more sensitive to Nutropin therapy and may experience more side effects with Adult • Patients with Turner syndrome should be monitored closely by a doctor for ear infections and cardiovascular problems during Nutropin therapy Growth Hormone Defi ciency What are common possible side effects of Nutropin therapy? Common side effects reported in adults and children taking Nutropin therapy include injection site reactions. Additional common side effects in adults include swelling, For easily accessible answers, education, joint pain, and carpal tunnel syndrome. and support, visit Nutropin.com You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech or call 1-866-NUTROPIN (1-866-688-7674). at (888) 835-2555. How should you store Nutropin? 14 Nutropin must be kept refrigerated (36° to 46°F [2° to 8°C]). Do not freeze. NuSpin 15 pens must be used within 28 days of initial use. Throw away any unused Nutropin after 28 days of initial use. Before giving an injection, check the manufacturer’s expiration date on the pen. Do not use if it has expired. Do not inject medication if the solution is cloudy. Your healthcare team is your primary source of information about your treatment. Please see the accompanying full Prescribing Information, including Instructions for Use, and additional Important Safety Information throughout and on pages 14-15. Models used for illustrative purposes only. Your healthcare team is your primary source of information about your treatment. Nutropin, Nutropin AQ, and NuSpin are registered trademarks, Nutropin GPS is a trademark, and NuAccess is a service mark of Genentech, Inc. Please see the accompanying full Prescribing Information, including Instructions © 2020 Genentech USA, Inc., 1 DNA Way, So. San Francisco, CA 94080 M-US-00005838(v1.0) 06/20 for Use, and additional Important Safety Information throughout and on pages 14-15. Questions? Call the Nurse Hotline at 1-866-NUTROPIN (1-866-688-7674). FPO Table of Contents Indications: Understanding Adult Growth Hormone Defi ciency (AGHD) . 4 Who is Nutropin Therapy for? How AGHD Is Diagnosed . 5 Nutropin AQ® (somatropin) injection for subcutaneous use is a human growth hormone that is available by prescription only. What to Expect From Stimulation (Stim) Testing . 6 Doctors prescribe Nutropin therapy for children and teenagers who are short or growing slowly because they: How to Prepare for Stim Testing . 6 • Do not make enough growth hormone on their own • Have idiopathic short stature, which means they are shorter than 98.8% of other How Growth Hormone (GH) Therapy May Help . 8 children of the same age and sex; are growing at a rate not likely to allow them to reach normal adult height; and no other cause of short stature can be found Nutropin AQ®: A Treatment Option for AGHD . 8 • Have Turner syndrome NuSpin®: Designed to Be Simple . 10 • Have chronic kidney disease (CKD) up to the time of kidney transplant Doctors prescribe Nutropin therapy for adults who have growth hormone Turn to Nutropin GPS™ . 12 defi ciency that began either in: • Adulthood as a result of pituitary disease, diseases of the hypothalamus, Important Safety Information . 14 surgery, radiation therapy, or trauma; or • Childhood. Patients treated for growth hormone defi ciency in childhood, whose bones have stopped growing, should be reevaluated to see if they 02 need to continue with growth hormone therapy 03 Your doctor will test to see if growth hormone is right for you. Select Important Safety Information: Nutropin therapy and your safety: Please read this Important Safety Information carefully. Then, if you have any questions, talk with your doctor. Nutropin Therapy is NOT for: • Patients having serious complications after undergoing open heart surgery, abdominal surgery, serious injuries involving many body systems, or life- threatening breathing problems. Deaths have been reported in such cases • Children who have Prader-Willi syndrome (PWS) and are very overweight or have a history of severe breathing problems. Deaths have been reported in children with PWS who are very overweight, have a history of blocked upper airways, sleep For easily accessible answers, education, and support, visit Nutropin.com. Your apnea (pauses in breathing during sleeping), or other severe breathing problems healthcare team is your primary source of information about your treatment. • Patients who have active cancer. Because growth hormone defi ciency can be an early sign of some tumors in the brain or pituitary gland, the presence of Please see the accompanying full Prescribing Information, including Instructions for these types of tumors should be ruled out by your doctor before you start Use, and additional Important Safety Information throughout and on pages 14-15. Nutropin therapy • Patients who are allergic to somatropin, the active ingredient in Nutropin therapy, or the inactive ingredients in Nutropin therapy • Adults or children with certain types of eye disease caused by diabetes • Children and teenagers whose bones have fi nished growing Understanding adult growth How AGHD is diagnosed hormone defi ciency (AGHD) What is adult growth hormone defi ciency? In the United States, approximately 6,000 new cases of AGHD It is commonly believed that only children can have growth hormone defi ciency (GHD). are diagnosed each year.* But people can have GHD after they’ve stopped growing. Adult growth hormone AGHD is diagnosed by an endocrinologist or other qualifi ed healthcare defi ciency (AGHD) occurs when the pituitary gland does not produce enough growth professional (HCP). hormone (GH). In adults, GH is needed by the body to maintain lean muscle mass, healthy A person with AGHD can have a range of symptoms including: cholesterol levels, strong bones, and decreased body fat (especially around the waist). • Increased body fat, especially in the abdomen What causes AGHD? • Reduced muscle mass AGHD can be caused by damage to the pituitary gland or hypothalamus, • Fatigue which can result from: • Decreased strength and exercise tolerance • Pituitary tumors • Weight gain • Pituitary surgery • Decreased spine bone mineral density • Radiation treatment You may be referred to an endocrinologist for an evaluation based • Head injury on a physical exam, lab work, and your medical history. • Congenital defects The tests may include: 04 • Infection • A DEXA scan, which uses x-rays to scan your body and measure 05 Damage to the pituitary gland or hypothalamus may impact the pituitary bone mineral density as well as lean tissue gland’s ability to produce enough GH. • A physical exam What are the types of AGHD? • Body mass index, a measure of body fat based on height and weight • Insulin-like growth factor (IGF) levels and GH stimulation testing (stim testing) There are two types of AGHD: Childhood-onset AGHD—patients who were growth hormone defi cient Your healthcare professional (HCP) will review the test results and discuss as children and continue to be so as adults treatment options with you. Adult-onset AGHD—patients with pituitary or hypothalamus disease, or who have had surgery, radiation treatment, or trauma and became growth hormone–defi cient as adults * American Association of Clinical Endocrinologists Medical Guidelines for Clinical Practice for Growth Your healthcare team is your primary source of information about your treatment. Hormone Use in Growth-Hormone-Defi cient Adults and Transition Patients—2009 Update. What to expect from stimulation (stim) testing Stimulation testing or stim testing measures the body’s ability to produce GH over time. What to expect Testing can be done in your HCP’s offi ce or during a brief hospital stay. • Your HCP will tell you how long not to eat before your test HCPs use stim testing because it’s diffi cult to measure the presence of GH in the body; • You will be given medicine(s) that challenge your body to produce GH is secreted in bursts throughout the day and peaks during sleep, and a single blood GH for a short period of time during testing test may not indicate how much GH your body produces. • Usually, an intravenous (IV) line is used. It may be placed into a vein Stim testing uses testing agents such as insulin, arginine, or glucagon to stimulate in your hand or arm so you won’t have to be pricked each time a blood the body to make GH. The amount of GH in the bloodstream is then measured by sample is taken. The IV may sting a bit when it fi rst goes in taking small blood samples over a period of time. If GH levels fail to rise as they should, AGHD is confi rmed. • You will have multiple blood samples taken over the test period Stim testing will clarify whether you have AGHD and help your HCP determine • The lab will measure the amount of GH in each blood sample to fi nd appropriate next steps. out whether your body is making enough GH • Be sure to check with your HCP for more on what to expect How to prepare for stim testing What to do afterward Stim testing requires some time and preparation. Here are a few tips to help you prepare. • Have someone drive you home, as you may be drowsy after testing and need to rest 06 Check with your HCP about what to bring to testing • Contact your HCP to discuss the results and next steps 07 • A short-sleeve shirt—something you are comfortable in and can easily pull up the sleeves • Any medications that your HCP prescribes in preparation for the stim testing • A quick-energy, high-protein snack and drink for after testing.
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