Norditropin Mexico - How it works
What growth hormone does
Growth hormone plays an important part in the complex system of the body.
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.
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.
What Norditropin® does
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.
Norditropin® is one of these therapies, and it’s often prescribed for several growth-related conditions. It’s 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 or Turner Syndrome.
- Children who are short (in stature) because they were born small (small for gestational age-SGA) and have not caught-up in growth by age 2 to 4 years.
- 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).
- Adults who do not make enough growth hormone.
Safety and side effects of Norditropin®
Safety is always a top priority. Here are some key facts about the safety and side effects of Norditropin® to help you and your doctor make the right decision about growth hormone therapy.
About clinical studies
The safety of growth hormone treatment, and the safety profile of Norditropin®, have been established in many clinical studies. In fact, there have been studies that followed pediatric patients for up to 13 years. But it doesn’t stop there; following US Food and Drug Administration (FDA) approval, Novo Nordisk continues to review new data as it arises, including analyzing studies done in other countries.
Not for everyone
It’s important to realize that Norditropin® is not for everyone. You should not use Norditropin® 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 Norditropin® (see the Prescribing Information for a complete list of ingredients in Norditropin®).
- Your health care 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).
Common side effects
Knowing what to look for will help you identify growth hormone side effects if they should arise. The most common side effects of Norditropin® include:
- Injection site reactions and rashes.
- Headaches
Serious side effects
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. Your or your child’s health care provider will need to monitor you or your child for a return of cancer or a tumor. Contact the health care provider if you or your child starts 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. Your or your child’s blood sugar may need to be monitored during treatment with Norditropin®.
- Increase in pressure in the skull (intracranial hypertension). If you or your child has headaches, eye problems, nausea or vomiting, contact the health care 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.
- 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. Fluid retention can happen in adults during treatment with Norditropin®. Tell your health care provider if you have any of these signs or symptoms of fluid retention.
- Decrease in a hormone called cortisol. The health care provider will do blood tests to check your or your child’s cortisol levels. Tell your or your child’s health care provider if you or your child has darkening of the skin, severe fatigue, dizziness, weakness, or weight loss.
- Decrease in thyroid hormone levels. Decreased thyroid hormone levels may affect how well Norditropin® works. The health care provider will do blood tests to check your or your child’s thyroid hormone levels.
- Hip and knee pain or a limp in children (slipped capital femoral epiphysis).
- Worsening of curvature of the spine (scoliosis).
- severe and constant abdominal pain. This could be a sign of pancreatitis. Tell your or your child’s health care provider if you or your child has any new abdominal pain.
- Loss of fat and tissue weakness in the area of skin you inject. Talk to your health care provider about rotating the areas where you inject Norditropin®.
- Increase in phosphorus, alkaline phosphatase and parathyroid hormone levels in your blood. Your or your child’s health care provider will do blood tests to check this.
There are other possible side effects, too. See the complete list in the Prescribing Information. For more information, talk to your health care provider or pharmacist.
What to tell your doctor
Before taking Norditropin®, 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 a history of problems breathing while you sleep (sleep apnea).
- Have or have had cancer or any tumor.
- Have diabetes.
- Are pregnant or plan to become pregnant. It is not known if Norditropin® will harm your unborn baby. Talk to your healthcare provider if you are pregnant or plan to become pregnant.
- Are breastfeeding or plan to breastfeed. It is not known if Norditropin® passes into your breast milk. You and your healthcare provider should decide if you will take Norditropin® while you breastfeed.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Norditropin® may affect how other medicines work, and other medicines may affect how Norditropin® works.
Read about all of the risk factors in the Prescribing Information, and talk with your health care provider about these or any other concerns you may have. Be sure to tell your doctor if your child has any serious medical conditions or is taking any other medications.
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 Norditropin®.
When to look for growth
You should understand that Norditropin® 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.
Talk to Your Child
Make sure your child knows what to expect. This could help avoid disappointment about the time it takes to see the benefits of growth hormone, and might smooth the path for future injections.
You may want to set up a special day, perhaps once a quarter (depending on your doctor’s advice), to measure your child. Growth will be easier to identify this way than by measuring more frequently.
How much growth to expect
How much your child will grow while taking Norditropin® 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.
Target Height
Talk to your child about the target height. Realistic expectations might increase a child’s confidence in the way the treatment is working. It can also be valuable to discuss the target height and what to expect with other family members, especially relatives who may see the child less frequently and may be likely to comment on growth.
How long treatment will last
As with how much growth can be expected, how long a person should take Norditropin® 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.
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NORDITROPIN.MX Is an informational page maintained and operated by Grupo IC Pharma an FDA registered establishment providing information about Norditropin® from Mexico.
FDA Establishment Number: 3012586435
Norditropin® is a registered trademark of Novo Nordisk®.
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