GROWTH HORMONE THERAPY
Hormones are chemical messengers produced in one part of the body that travel to another part of the body to create some sort of change. Growth hormone is made in the pituitary gland, at the base of the brain, and is very important in helping children grow.
When growth hormone is released from the pituitary gland, it makes the liver release a second hormone called insulin-like growth factor-1 (IGF-1). Together, growth hormone and IGF-1 tell the bones, muscle, and many other organs and tissue to grow by adding more cells. The growth of the bones also requires bone cells to add minerals such as calcium and phosphate, which results in bones that are strong and long.
Norditropin® is a man-made form of growth hormone called "recombinant human growth hormone." Although it’s made in a lab, it is identical to the growth hormone your body makes.
Norditropin® is indicated for the treatment of children who are not growing because of low or no growth hormone. It is also indicated to help children who are short in stature due to Noonan syndrome or Turner syndrome. And it is approved to help children who were born small (small for gestational age-SGA) and have not caught-up in growth by age 2 to 4 years. Norditropin® is also used to treat children who are short (in stature) with no underlying disorder, hormonal issue, or nutritional problem (Idiopathic Short Stature), children who are not growing who have Prader-Willi syndrome (PWS), and adults who do not make enough growth hormone.
GROWTH HORMONE DEFICIENCY
A deficiency means there is not enough of something. Growth hormone deficiency means just that: your body is not making enough growth hormone.
Lack of treatment for growth hormone deficiency could result in a child being significantly shorter than they otherwise would be when they reach adulthood. Adults who are not treated for GHD may have changes in the body such as weakening of bones, decrease in amount of muscle, and increase in fat and cholesterol.
Usually an endocrinologist (a doctor who specializes in the study of the hormone system in your body) will be able to tell if you have growth hormone deficiency. The doctor will ask many questions about your health and growth history and about the health and growth history of your family. You will have a physical exam. The doctor may also order a growth hormone stimulation test, or "stim" test.
There are different types of growth hormone stimulation tests. Some are able to measure the level of growth hormone when it is at its highest, for example, after sleep or exercise, because both of these activities increase the level of growth hormone. Another type of test uses a medicine to make the pituitary gland release growth hormone. If the pituitary does not produce growth hormone in response to this "stimulation," it is a sign that the person has a deficiency.
There are several organizations dedicated to education, awareness, and advocacy for people with growth-related disorders. Take a look at the Patient Advocacy Groups.
No; the only delivery device for Norditropin® is our FlexPro® pen. With Norditropin®, you never have to deal with a typical syringe.
Growth hormone is produced by the body every single day, with most being produced at night. Taking injections every day keeps the level of growth hormone steady, so it is closest to how the body normally works. Your doctor will prescribe the right amount you will need to keep a steady level in your body. Remember, it’s important to take your medication just the way you were told by your doctor in order for it to work the best.
If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose. Just take the next dose at your regular time. Remember that it is important to follow the dosing schedule you were given by your doctor, so do not take 2 doses at the same time unless your health care provider tells you to.
It is important to take Norditropin® exactly as the doctor has directed. If you take too much, tell your doctor right away.
The most important thing to remember is to take your injection exactly the way your doctor or nurse tells you to.
How long a patient is treated with Norditropin® depends upon their individual circumstances. Talk with your health care professional about how long therapy will last in your specific situation.
Norditropin® is a specialized medicine; it’s not something you’ll go down to the corner drugstore to pick up. Instead, your prescription will be filled through a Specialty Pharmacy and shipped to you.
A Specialty Pharmacy is a pharmacy with expertise in specific medical conditions, such as growth hormone deficiency, and focuses specifically on medications related to those conditions.
DEVICE & STORAGE
Norditropin® pens are designed to be easy to learn to use. FlexPro® is designed to be easy to hold, and requires little thumb reach, making it easy to give yourself an injection.
Norditropin® pens come refrigerated and each one must be kept that way until it is used the first time. After that, they can be stored outside of the refrigerator for up to 21 daysa (or in the refrigerator for up to 4 weeks), so you can take them almost anywhere you're going.
aAll unused Norditropin® products must be refrigerated (36°F to 46°F) prior to first use. Do not freeze and avoid direct light. After first injection, Norditropin® pens can either be stored outside of the refrigerator (up to 77°F) for use within 3 weeks, or in the refrigerator (between 36°F and 46°F) for use within 4 weeks.
FlexPro® pens come premixed and preloaded, so you have 2 less things to worry about.
Growth hormone breaks down immediately when it spoils. Look at the medicine through the window on the pen. If it appears cloudy or discolored, call your Specialty Pharmacy or NordiCare® to inquire further. If it appears clear, and you’ve followed all storage requirements and precautions regarding handling of the pen, the medication has not spoiled and is safe to use.
Norditropin® pens use NovoFine® needles, which are the thinnest needles on the market. They’re not like some of the needles you may be used to seeing at the doctor’s office. Our thinnest NovoFine® needle in the United States is 32 gauge at the tip.a,b
aNeedles are sold separately and may require a prescription in some states.
bDo not share your Norditropin® pens and needles with another person even if the needle has been changed. You may give another person an infection or get an infection from them.
We have 2 options for patients who prefer not to see the needle.
FlexPro® PenMate® is for people who prefer not to see the needle on their pens at all.a PenMate®, which comes separately, is designed exclusively for use with FlexPro® 5 mg, 10 mg, and 15 mg pens. PenMate® helps people who don’t like needles and prefer them to be hidden during injection. PenMate® completely covers the needle—you won’t see the needle during injection. Pressing the insertion button inserts the needle into the skin for you. With its large gripping surface, you can hold it firmly in your hands. PenMate® is reusable, too: just remove it from a used FlexPro® pen and reuse it with the next one.
NovoFine® Autocover® needles have a shield that hides the needle before, during, and after the injection. The shield covers the needle, retracts during growth hormone injection, and then covers the needle again. Because it "locks" after use, it may also reduce the risk of accidentally sticking yourself with the needle after you’ve used it. Autocover® can be used with all Norditropin® FlexPro® pens.
aPenMate® can't be used with the Norditropin® FlexPro® 30 mg pen or NovoFine® Autocover®.
GROWTH & TREATMENT EXPECTATIONS
Usually you see the greatest results within the first year, but it might also take at least 6 months before you see an increase in growth rate. Also, there tends to be greater catch-up growth with patients who start at a younger age. However, individual results may vary, so you should check with your doctor.
That depends on many factors, including the patient’s target height, which is based on the height of his or her parents. Some studies have shown that the earlier a patient starts, the better they respond to treatment. However, individual results may vary, so you should check with your doctor.
Not everyone stays on growth therapy for the same length of time. It depends on what your doctor thinks is best for you. Your doctor or nurse can best answer this question for you. It is important that you don’t stop taking your growth hormone until your doctor says it is time.
HISTORY OF NORDITROPIN®
Norditropin® was approved for use in the United States in 1995. Novo Nordisk, the company that makes Norditropin®, is a trusted leader in endocrinology. Novo Nordisk has done drug research and development for 90 years, with 40 of those years focused on growth hormone around the world.
The safety profile of Norditropin® has been established in many clinical studies conducted around the world. In fact, one of our studies followed pediatric patients for up to 13 years. The most common side effects of Norditropin® include injection site reactions and rashes, and headaches.
These are not all the possible side effects of Norditropin®.
Norditropin® may cause serious side effects, including:
- high risk of death in people who have critical illnesses because of heart or stomach surgery, trauma or serious breathing (respiratory) problems
- high risk of sudden death in children with Prader-Willi syndrome who are severely obese or have breathing problems including sleep apnea
- increased risk of growth of cancer or a tumor that is already present and increased risk of the return of cancer or a tumor in people who were treated with radiation to the brain or head as children and who developed low growth hormone problems. Contact the healthcare provider if you or your child start to have headaches, or have changes in behavior, changes in vision, or changes in moles, birthmarks, or the color of your skin
- new or worsening high blood sugar (hyperglycemia) or diabetes
- increase in pressure in the skull (intracranial hypertension). If you or your child has headaches, eye problems, nausea or vomiting, contact the healthcare provider
- serious allergic reactions. Get medical help right away if you or your child has the following symptoms: swelling of your face, lips, mouth or tongue, trouble breathing, wheezing, severe itching, skin rashes, redness or swelling, dizziness or fainting, fast heartbeat or pounding in your chest, or sweating
- your body holding too much fluid (fluid retention) such as swelling in the hands and feet, pain in your joints or muscles or nerve problems that cause pain, burning, or tingling in the hands, arms, legs and feet. Tell your healthcare provider if you have any of these signs or symptoms of fluid retention.
- decrease in a hormone called cortisol. Tell your or your child’s healthcare provider if you or your child has darkening of the skin, severe fatigue, dizziness, weakness or weight loss
- decrease in thyroid hormone levels
- hip and knee pain or a limp in children (slipped capital femoral epiphysis)
- worsening of pre-existing curvature of the spine (scoliosis)
- severe and constant abdominal pain can be a sign of pancreatitis. Tell your or your child’s healthcare provider if you or your child has any new abdominal pain.
- loss of fat and tissue weakness in the area of skin you inject
- increase in phosphorus, alkaline phosphatase, and parathyroid hormone levels in your blood
Call your health care provider for medical advice about side effects. You may report side effects to the FDA at 1-800-332-1088. You may also report side effects to Novo Nordisk at 1-888-NOVO-444 (1-888-668-6444).
Novo Nordisk, the maker of Norditropin®, offers several different ways to help patients get, and stay on, therapy. These include the NordiSure™ Co-pay Assistance Program, which reduces your co-payments as much as $250 a month, up to $3,000 a year; the NordiSure™ Coinsurance Program, which helps with high out-of-pocket prescription costs; the Patient Access Program (PAP), which provides free product to eligible patients who show financial need; and JumpStart™, which provides free Norditropin® at the beginning of therapy, or in special circumstances later in therapy, to make sure patients receive treatment. These programs have strict eligibility requirements. Call your NordiCare® Case Manager (1-888-NOVO-444, or 1-888-668-6444) to find out whether you qualify.
No, NordiCare® is a free program, and our Case Managers are dedicated to helping you deal with insurance and financial matters and stay on therapy. You do not have to pay for the service.
Individual insurance plans vary. If your pen should become lost or damaged and you need a replacement, the JumpStart™ program might be able to help you if it’s not covered by your insurance. Call your Case Manager to see whether you’re eligible for assistance in situations like this.