Frequently Asked Questions
Frequently Asked Questions about Omnitrope®
How does Omnitrope work?
Omnitrope is identical in structure to naturally occurring growth hormone, but it is produced in a laboratory and meets strict standards of product quality. Omnitrope works in much the same way as growth-hormone produced in the body does: it stimulates the body’s bones and cartilage to grow.
Does Omnitrope have any unwanted side effects?
Omnitrope® Important Safety Information
What is the most important information I should know about Omnitrope?
- Omnitrope is a man-made human growth hormone.
- Omnitrope is used in children to manage growth failure and in adults to manage growth hormone deficiency.
Who should not take Omnitrope?
Do not take Omnitrope:
- If you have an illness from recent surgery, trauma, or your lungs do not work properly
- For growth failure due to Prader-Willi Syndrome if you are severely over weight or have severe
- breathing problems
- For growth failure if you have cancer
- For growth failure if you have a diabetic eye disease
- For growth failure if your bones have stopped growing
- If you are allergic to somatropin, the active ingredient in Omnitrope®, or excipients
What is Omnitrope?
- Omnitrope is a man-made human growth hormone
- Omnitrope is used in children to manage growth failure caused by: growth hormone deficiency, Prader-Willi Syndrome, Small for Gestational Age, Turner Syndrome, and Idiopathic Short Stature.
- Omnitrope is used in adults to manage growth hormone deficiency.
What should I tell my healthcare provider before taking Omnitrope?
Before taking Omnitrope, tell your healthcare provider if you:
- Have had surgery
- Have or had trouble breathing
- Have or had cancer
- Have or had diabetes
- Have or had increased pressure inside the skull
- Have or had a build-up of fluid or water in your body
- Have or had pituitary deficiency
- Have or had thyroid problems
- Have a limp, hip or knee pain
- Have or had spine problems
- Have or had ear infections
- Have or had heart problems
- Are pregnant or planning to become pregnant
- Are breastfeeding or plan to breastfeed
- Are 65 years old or older
- Have any other medical conditions
Tell your healthcare provider about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Sometimes, the doses of certain medicines and Omnitrope need to be changed if used together. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.
How should I use Omnitrope?
- Use Omnitrope exactly as your healthcare provider tells you to.
- Patients and caregivers who will administer Omnitrope should receive appropriate training and instruction on the proper use of Omnitrope.
- See the “Instructions for Use” section of the prescribing information for detailed information.
- Properly dispose of used syringes and needles.
- Never share an Omnitrope Pen with another person, even if the needle is changed.
- Sharing the pen may lead to infection.
What are the possible side effects of Omnitrope?
The most common side effects of Omnitrope are:
- Injection site reactions or rashes
- Lipoatrophy, a loss of fat right under the skin that can be caused by not rotating injection sites Headaches
Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of Omnitrope. For more information, ask your healthcare provider or pharmacist for a complete list of side effects.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1- 800-FDA-1088.
What other safety information should I know?
Omnitrope should not be started if your child is ill due to surgery, trauma or respiratory failure. Also do not start Omnitrope if your child has cancer, active proliferative or nonproliferative diabetic retinopathy, or known hypersensitivity to somatropin.1
Omnitrope should not be used to increase height in children after their bones’ growth plates have closed.1
Children with Prader-Willi Syndrome who are severely obese or have severe respiratory impairment should not be given Omnitrope.1
Formulations containing benzyl alcohol (5 mg/1.5 mL Omnitrope Cartridges and the Bacteriostatic Water for Injection diluent for the Omnitrope 5.8 mg vial) should not be used in premature babies or neonates.1
Be sure to talk to your child’s doctor if you have questions about these safety considerations.
What is OmniSource?
REFERENCE: 1. Omnitrope (package insert). Princeton, NJ; Sandoz, Inc; 2011.
Frequently Asked Questions about Dosing and Delivery
How is Omnitrope administered?
Like other forms of growth hormone therapy, Omnitrope is given as an injection each day or several times a week. Injecting Omnitrope is easy with the Omnitrope Pen 5 or Omnitrope Pen 10. These convenient pens hold the medication and allow for simple dosing and injection.
Each pen uses liquid cartridges. This eliminates the need to mix or reconstitute the medication, enables an easy way to “dial in” the correct dose and helps avoid wasting or spilling medication.
Which Omnitrope Pen will my child receive?
Your child will receive a pen based on the dose of Omnitrope your doctor prescribes. Omnitrope Pen 5 delivers a maximum single dose of 2.7 mg in increments of 0.05 mg. Omnitrope Pen 10 delivers a maximum single dose of 5.4 mg in increments of 0.1 mg. This flexibility makes dosing much easier for you and your child.
Where on the body is Omnitrope injected?
Omnitrope is injected just below the skin. Your child’s doctor or nurse will tell you the best areas of your child’s body to inject Omnitrope. Recommended areas include the thigh, stomach or buttocks. The doctor or nurse will also tell you how to rotate injection spots to prevent soreness.
Can Omnitrope be injected with a syringe?
Yes. Omnitrope is also available in a vial, and your child’s doctor may prescribe this option instead of a pen. With either pen or vial, your child’s doctor or other healthcare professional will instruct you on the proper use of Omnitrope. When your child is old enough and comfortable with the process, he or she can be trained to inject Omnitrope if desired.
Frequently Asked Questions about OmniSource
What is an OmniSource Fulfillment Specialist?
This behind-the-scenes person works with you, the caregiver, to help you obtain the answers you need, ranging from insurance questions, to questions about Omnitrope (somatropin [rDNA origin] for injection) and injection training. Thanks to a special phone number (877.456.6794), your Fulfillment Specialist will be there to answer your questions directly, or will put you in contact with the appropriate person who can help. Your Fulfillment Specialist will be familiar with your child’s story and insurance background, saving you from constantly repeating your information to a new person.
What is a Nurse Trainer and what does he or she do?
A Nurse Trainer will come to your home and give you an expert lesson on how to properly use the Omnitrope Pen or vial and syringe. It’s free and open to any family member or authorized caregiver. Should you need a refresher or additional training, a dedicated Nurse Trainer is always there for you and is always just a phone call away. Please note that in order to receive assistance from a Nurse Trainer, your Healthcare Provider needs to request it for you on the Statement of Medical Necessity.
Frequently Asked Questions about Insurance
How do I know if my insurance covers Omnitrope?
Omnitrope is covered by most insurance carriers. Please contact your Omnitrope Fulfillment Specialist with any questions you may have about insurance — he or she will be glad to help you. Have your insurance card handy when you call: 877.456.6794.
How does the Save As You Grow Program work?
If you have a co-pay, co-insurance, or pay cash, the Sandoz Save As You Grow program can help. It provides qualified patients with up to $250 a month to help them pay for their prescription. That’s up to $3,000 a year to help you pay for your prescriptions. For more information, call us at 877.456.6794.
What if I don’t have insurance or am underinsured?
For qualified uninsured and underinsured patients, we offer the Patient Assistance Program. When it is time for you or your child to start their Omnitrope treatment, this program provides Omnitrope and supplies at no cost to qualified uninsured and underinsured patients. Contact your OmniSource Fulfillment Specialist for eligibility requirements and application assistance.