Consumer Information

Omnitrope

Generic Name: somatropin (soe ma TROE pin)
Brand Names: Genotropin, Genotropin Miniquick, Humatrope, Norditropin, Norditropin Cartridge, Norditropin Nordiflex Pen, Nutropin, Nutropin AQ, Omnitrope, Saizen, Serostim, Tev-tropin, Zorbtive

What is Omnitrope?

Omnitrope is a form of human growth hormone. Human growth hormone is important in the body for the growth of bones and muscles.

Omnitrope is used to treat children with growth failure due to growth hormone deficiency. It is also used to treat adults with either adult onset or childhood onset growth hormone deficiency.

Omnitrope may also be used for other purposes not listed in this medication guide.

Important information about Omnitrope

Before you receive Omnitrope, 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 Omnitrope. Do not stop using a steroid suddenly or change any of your medication doses without your doctor's advice.

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 discuss with my healthcare provider before using Omnitrope?

Before you receive Omnitrope, 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 Omnitrope if you are allergic to somatropin, or if you have:

diabetic retinopathy (a serious eye condition caused by diabetes);
cancer; or
Prader-Willi syndrome and are also overweight or have sleep apnea or severe respiratory (lung) problems.

You should also not use Omnitrope if you have a serious medical condition after having:

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 Omnitrope, tell your doctor if you have:

liver disease;
kidney disease (or if you are on dialysis);
diabetes;
scoliosis;
high blood pressure (hypertension);
a pancreas disorder;
a history of cancer;
carpal tunnel syndrome;
underactive thyroid; or
a brain tumor or lesion.

FDA pregnancy category C. It is not known whether Omnitrope 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 Omnitrope without telling your doctor if you are breast-feeding a baby.

How should I use Omnitrope?

Use Omnitrope 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 of this medicine and how often you give it will depend on what you are being treated for. Follow the directions on your prescription label.

Omnitrope 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 Omnitrope. 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 Omnitrope 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.

How you store this medicine will depend on if you are using a cartridge or vial and the strength of the cartridge or vial. After mixing Omnitrope, 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 Omnitrope before and after it has been mixed. Ask your pharmacist if you have any questions about proper storage of your medication.

Throw away any Omnitrope left over after the expiration date on the label has passed.

What happens if I miss a dose?

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.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Overdose can cause tremors or shaking, cold sweats, increased hunger, headache, drowsiness, weakness, dizziness, fast heartbeat, and nausea. Long-term overdose may cause excessive growth.

What should I avoid while using Omnitrope?

Avoid drinking alcohol if you have short bowel syndrome. Alcohol can irritate your stomach and could make your condition worse.

Omnitrope side effects

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;
nausea, vomiting, sweating, fever, fast heartbeat, yellowing of the skin or eyes;
increased thirst and urination;
sudden and severe pain behind your eyes, vision changes;
swelling in your head, face, hands, or feet; or
numbness or tingling in your wrist, hand, or fingers.

Less serious Omnitrope side effects may include:

headache;
redness, soreness, swelling, skin rash, itching, pain, or bruising where the medicine was injected;
breast swelling;
joint pain, swelling, or stiffness; or
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 other drugs will affect Omnitrope?

Before using Omnitrope, tell your doctor if you use insulin or take oral (by mouth) medicine to treat diabetes. Omnitrope 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 Omnitrope 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 Omnitrope. 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.

Where can I get more information?

Your pharmacist can provide more information about Omnitrope.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
Every effort has been made to ensure that the information provided is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects.