What is somatropin?
Somatropin is a form of human growth hormone. Human growth hormone is important in the
body for the growth of bones and muscles.
Somatropin is used to treat growth failure in children and adults who lack natural growth
hormone, and in those with chronic kidney failure, Noonan syndrome, Turner syndrome, short stature
at birth with no catch-up growth, and other causes. Somatropin is also used to prevent severe weight
loss in people with AIDS, or to treat short bowel syndrome.
Somatropin may also be used for other purposes not listed in this medication guide.
What should I discuss with my healthcare provider before taking somatropin?
Before you receive somatropin, tell your doctor if you have ever had an allergic reaction to a
growth hormone medicine, or to drug preservatives such as benzyl alcohol, metacresol or glycerin.
You should not use this medication if you are allergic to somatropin, or if you have:
You should also not use somatropin if you have a serious medical condition
after having:
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open heart surgery or stomach surgery;
-
trauma or other medical emergency; or
-
breathing problems (such as lung failure).
If you have certain conditions, you may need a dose adjustment or special
tests to safely use this medication. Before using somatropin, tell your doctor if you have:
FDA pregnancy category C. It is not known whether somatropin is
harmful to an unborn baby. Before using this medication, tell your doctor if you are pregnant or plan to
become pregnant during treatment.
It is not known whether somatropin passes into breast milk or if it could harm a nursing
baby. Do not use somatropin without telling your doctor if you are breast-feeding a baby.
How should I take somatropin?
Use this medication exactly as it was prescribed for you. Do not use the medication in larger
amounts, or use it for longer than recommended by your doctor.
Your dose and brand of somatropin, and how often you give it will depend on what you are
being treated for. Follow the directions on your prescription label.
Somatropin is given as an injection under the skin or into a muscle. Your doctor, nurse, or other
healthcare provider will give you this injection. You may be given instructions on how to inject your
medicine at home. Do not use this medicine at home if you do not fully understand how to give the
injection and properly dispose of needles and syringes used in giving the medicine.
Your doctor or nurse will show you several areas on your body where you can inject
somatropin. Use a different injection place each time you give yourself the shot. Do not inject this
medicine into skin or muscle that is red, sore, infected, or injured.
Do not shake the medication vial (bottle). Vigorous shaking can ruin the medicine. When
mixing somatropin with a diluent (liquid), use a gentle swirling motion. Do not use the medication if it has
changed colors or is cloudy. Call your doctor for a new prescription.
Use each disposable needle only one time. Throw away used needles in a puncture-proof
container (ask your pharmacist where you can get one and how to dispose of it). Keep this container
out of the reach of children and pets.
To be sure this medication is helping your condition and not causing harm, your blood and
growth progress will need to be tested on a regular basis. Your eyes may also need to be checked.
Do not miss any scheduled visits to your doctor.
If you are being treated for short bowel syndrome, follow the diet plan created for you by your
doctor or nutrition counselor to help control your condition. Somatropin is not a cure for short bowel
syndrome.
If you use a form of somatropin that comes in a cartridge for use with an injection pen, use only
the pen injection system provided with the somatropin brand you use.
How you store this medicine will depend on what brand you are using and what diluent you are
mixing somatropin with. After mixing somatropin, you may need to use it right away or you may be
able to store it for later use. Read and carefully follow the instructions provided with your medicine
about proper storage of somatropin before and after it has been mixed. Ask your pharmacist if you
have any questions about proper storage of your medication.
Throw away any somatropin left over after the expiration date on the label has passed.
What happens if I miss a dose of somatropin?
Use the medication as soon as you remember. If it is almost time for the next dose, skip the
missed dose and use the medicine at the next regularly scheduled time.
Do not
use
extra medicine to make up the missed dose.
Call your doctor if you miss more than 3 doses in a row.
Where can I get more information about somatropin?
Your pharmacist has information about somatropin written for health professionals that you may read.
What are the possible side effects of somatropin?
If you have Prader-Willi syndrome, call your doctor promptly if you develop signs of lung or
breathing problems such as shortness of breath, coughing, or new or increased snoring. Rare cases of
serious breathing problems have occurred in patients with Prader-Willi syndrome who use somatropin.
Get emergency medical help if you have any of these
signs of an allergic
reaction:
hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have any of these serious side effects:
-
sudden and severe pain or tenderness in your upper stomach;
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nausea, vomiting, sweating, fever, fast heartbeat, yellowing
of the skin or eyes;
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increased thirst and urination;
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sudden and severe pain behind your eyes, vision changes;
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swelling in your head, face, hands, or feet; or
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numbness or tingling in your wrist, hand, or fingers.
Less serious side effects may include:
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headache;
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redness, soreness, swelling, skin rash, itching, pain, or
bruising where the medicine was injected;
-
breast swelling;
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joint pain, swelling, or stiffness; or
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mild nausea, stomach pain, gas.
This is not a complete list of side effects and others may occur. Tell your
doctor about any unusual or bothersome side effect. You may report side effects to FDA at
1-800-FDA-1088.
What is the most important information I should know about somatropin?
Before you receive somatropin, tell your doctor about all your past and present medical
conditions, especially allergies, trauma, surgery, diabetes, cancer, breathing problems, liver or kidney
disease, scoliosis, high blood pressure, pancreas disorder, underactive thyroid, or a brain tumor.
Also tell your doctor about all other medications you use, especially steroids or diabetes
medications. Your dosages of these medicines may need to be changed when you start using
somatropin.
Do not stop using a steroid suddenly or change any of your medication
doses without your doctor's advice.
If you have Prader-Willi syndrome and are using somatropin, call your doctor promptly if you
develop signs of lung or breathing problems such as shortness of breath, coughing, or new or increased
snoring.
Call your doctor at once if you have sudden and severe pain or tenderness in your upper
stomach, with nausea, vomiting, sweating, fever, fast heartbeat, and yellowing of the skin or eyes. You
should also call your doctor promptly if you have vision changes and sudden, severe pain behind your
eyes.
What should I avoid while taking somatropin?
If you use Zorbtive to treat short bowel syndrome, avoid drinking fruit juices or soda
beverages. Follow the instructions of your doctor or nutrition counselor about what types of liquids you
should drink while using Zorbtive.
Avoid drinking alcohol if you have short bowel syndrome. Alcohol can irritate your
stomach and could make your condition worse.
What other drugs will affect somatropin?
Before using somatropin, tell your doctor if you use insulin or take oral (by mouth) medicine to
treat diabetes. Somatropin may affect blood sugar levels and you may need to adjust your dose of the
diabetes medication.
Do not change the dose of your diabetes medication without your
doctor's advice.
Tell your doctor if you use any type of steroid medicine such as cortisone, dexamethasone,
methylprednisolone, prednisone, and others. Steroids can make somatropin less effective and your
doses may need to be adjusted.
Do not stop using a steroid suddenly. Follow your
doctor's instructions.
Tell your doctor about all other medications you use, especially cyclosporine (Gengraf, Neoral,
Sandimmune), seizure medication, birth control pills, anabolic steroids, or hormone replacement
medications for men or women.
This list is not complete and there may be other drugs that can interact with somatropin. Tell
your doctor about all the prescription and over-the-counter medications you use. This includes
vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new
medication without telling your doctor.
What happens if I have an overdose of somatropin?
