undrestanding the therapy
take deep breath…. many of the question you need are right here
Sometimes people’s bodies don’t produce enough growth hormone on their own. This is called growth hormone deficiency. When this happens, both children and adults may be treated with man-made growth hormone called recombinant human growth hormone. This hormone is identical to the growth hormone that human bodies make.
Growth hormone has an important job.
What is growth hormone? A role of growth hormone is to tell organs, tissues, and other parts of the body to grow. Knowing exactly how it functions in the body will help you understand the mechanics of treatment with Plextropin.
What growth hormone does.
Growth hormone plays an important part in the complex system of the body.
Hormones are messengers.
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.
Special cells in glands and other organs produce hormones and release them into the body at specific times for specific reasons, depending upon the type of hormone. The hormones’ job is to tell parts of the body to do certain things. They travel through the bloodstream to their “target organ” or tissue, where they exert their effect by giving their instructions.
Growth hormone tells the body to grow.
What is growth hormone? Growth hormone is made in the pituitary gland, which is located at the base of the brain. It does a lot more than just make a child grow taller; it’s responsible for the growth of the body, including organs and bones, and it helps the body’s metabolic processes.
When growth hormone is released from the pituitary gland, it “tells” the liver to release a second hormone, called insulin-like growth factor-1 (IGF-1).
Together, growth hormone and IGF-1 tell the bones, muscles, and other organs and tissues to grow by adding more cells.
Straight talk about safety.
For parents, and for Novo Nordisk, safety is always a top priority. We’ve spelled out some key facts about the safety and side effects of Plextropin to help you and your doctor make the right decision about growth hormone therapy.
We’ve studied it extensively.
The safety of growth hormone treatment, and the safety profile of Plextropin, have been established in many clinical studies. In fact, one of our studies followed pediatric patients for up to 13 years. We don’t stop there; following US Food and Drug Administration (FDA) approval, we continue to review new data as it arises, including analyzing studies done in other countries.
Some people should not use Plextropin.
It’s important to realize that Plextropin is not for everyone. You should not use Plextropin if:
Setting expectations about growing.
We can’t see into the future or provide answers that are specific to your child—this is advice your doctor should provide. But, we can give you a general idea of what others have experienced, which can help you set reasonable expectations for therapy with Plextropin.
When to look for growth.
You should understand that Plextropin takes time to work—the regimen of daily injections usually lasts several years—so it’s not realistic to expect that your child will begin to grow immediately. The greatest results usually do appear within the first year of therapy, though, so don’t get discouraged.
Age plays an important part. In studies, people who begin therapy at a younger age tend to see more catch-up growth, so early diagnosis is important, and treatment should be started when appropriate and determined by your health care provider.
How much growth to expect.
How much your child will grow while taking Plextropin depends on many factors, including his or her “target height,” which is based on the parents’ height. Your health care practitioner has a formula to determine your child’s target height. Some studies have shown that the earlier a person starts, the better the response to treatment.
How long treatment will last.
As with how much growth can be expected, how long a person should take Plextropin depends on factors specific to each person. Not everyone stays on growth hormone therapy for the same length of time. Your doctor can best answer this question for you. It is important that people don’t stop taking growth hormone until the doctor says it is time to stop.
Do not use PLEXTROPIN if:
you have a critical illness caused by certain types of heart or stomach surgery, trauma or breathing (respiratory) problems; you are a child with Prader-Willi syndrome who is severely obese or has breathing problems including sleep apnea; you have cancer or other tumors; you are allergic to somatropin or any of the ingredients in Plextropin; your healthcare provider tells you that you have certain types of eye problems caused by diabetes (diabetic retinopathy); you are a child with closed bone growth plates (epiphyses).
Indications and Usage
What is Plextropin (somatropin) injection?
Plextropin is a prescription medicine that contains human growth hormone and is used to treat:
- children who are not growing because of low or no growth hormone
- children who are short (in stature) and who have Noonan syndrome, Turner syndrome, or were born small (small for gestational age-SGA) and have not caught-up in growth by age 2 to 4 years
- children who have Idiopathic Short Stature (ISS)
- children who are not growing who have Prader-Willi syndrome (PWS)
- adults who do not make enough growth hormone
ImportantSafety Information (cont’d)
Before taking Plextropin, tell your healthcare provider about all of your medical conditions, including if you:
- have had heart or stomach surgery, trauma or serious breathing (respiratory problems)
- have had heart or stomach surgery, trauma or serious breathing (respiratory problems)
- have or have had cancer or any tumor
- have diabetes
- are pregnant or breastfeeding, or plan to become pregnant or breastfeed
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Plextropin may affect how other medicines work, and other medicines may affect how Plextropin works.
How should I use Plextropin?
- Use Plextropin exactly as your health care provider tells you to
- Do not share your Plextropin 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.
What are the possible side effects of Plextropin?
Plextropin 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
The most common side effects of Plextropin include:
- injection site reactions and rashes, and headaches