Like other human growth hormone brands, Omnitrope is a synthetic form of the growth hormone that occurs naturally in the human body. Human growth hormone is a protein that stimulates bones and cartilage to grow. Omnitrope is highly similar in structure to naturally occurring human growth hormone, but it is produced in a laboratory and meets strict standards of product quality. Omnitrope is an FDA-approved product that is proven to help children grow. Omnitrope is also easy to use and can cost less than other treatments.

Omnitrope is indicated for the treatment of children with growth failure due to inadequate secretion of growth hormone produced in the body.

Omnitrope is also indicated for the treatment of children who have growth failure due to Prader-Willi syndrome (PWS). The diagnosis of PWS should be confirmed by appropriate genetic testing.

In addition, Omnitrope is indicated for the treatment of growth failure in children born small for gestational age (SGA) who fail to manifest catch-up growth by age 2 years.

Omnitrope is also indicated for treatment of children with growth failure due to idiopathic short stature (short with no known cause).

In adults, Omnitrope is indicated for the treatment of adult onset or childhood onset growth hormone deficiency.

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.

Omnitrope should not be used to increase height in children after their bone growth plates have closed. Children with Prader-Willi syndrome who are severely obese or have severe respiratory impairment should not be given Omnitrope. In addition, 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.

After Omnitrope treatment has been started, speak with your child's doctor about the possible risks of continuing Omnitrope treatment if your child has any of the following: surgery, trauma, difficulty breathing, cancer, diabetes, other hormone deficiencies, limping or complains about hip or knee pain, or scoliosis (curvature of the spine). The doctor should test your child's blood sugar level for diabetes and perform an eye test called a funduscopic examination for intracranial hypertension before starting Omnitrope and periodically afterwards. You should speak with the doctor if your child is being treated for Prader-Willi syndrome and starts having difficulty breathing, starts snoring or snoring increases. Fluid retention may occur in adults treated with Omnitrope. Tell the doctor about any other medications your child is taking.

Along with its benefits, any medication may cause unwanted effects. These effects with Omnitrope may include headaches, lipoatrophy (a loss of fatty tissue under the skin), and a rash at the injection site. Your child’s doctor will explain the potential for unwanted effects.

Be sure to talk to your child’s doctor if you have questions about the uses or safety considerations of Omnitrope.

To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Download the full Prescribing Information for Omnitrope.

Like other forms of growth hormone therapy, Omnitrope is given as an injection each day or several times a week. But don’t worry—giving Omnitrope is easy with the Omnitrope Pen 5 and Omnitrope Pen 10. These convenient pens hold the medication and allow for simple dosing and injection.

Your child will receive a pen based on the dose of Omnitrope the 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.

Each pen uses prefilled liquid cartridges. This eliminates the need to mix or reconstitute the medication, enables you to give the correct dose, and helps you avoid wasting or spilling medication.

The pens don’t need batteries and don’t require rewinding. So Omnitrope Pen 5 and Omnitrope Pen 10 eliminate steps, which saves you time.

Omnitrope is also available in a vial, and your child’s doctor may prescribe this option instead of a pen.

For more information, see pages 8 and 9 of the Omnitrope Patient Brochure. Also see the video.

Your child’s doctor or other healthcare professional will instruct you on the proper use of Omnitrope. In addition, OmniSource, the comprehensive insurance services and product support center for Omnitrope, offers free in-home injection training with a fully qualified registered nurse. Your child’s doctor may choose this option or provide in-office training with the doctor's staff.

Speak to your child’s doctor about injection training and the proper use of Omnitrope. You can also call OmniSource toll-free at 877-456-6794. OmniSource Specialists are available Monday through Friday from 9 AM to 8 PM ET and will be happy to help you.

Omnitrope is a proven and cost-effective human growth hormone for those requiring treatment. After a review of the human growth hormone products available, your managed care company has selected Omnitrope as a preferred agent because it offers you and your child an effective, convenient, and easy-to-use therapy that can help your child grow while ensuring you pay the lowest available out-of-pocket amount through your insurance company.

Contact your child’s doctor immediately to begin the transition process. The doctor will work with you and OmniSource to ensure that you receive Omnitrope in a timely manner.

You likely received a letter or other notification from your insurance plan about the date when Omnitrope becomes the preferred human growth hormone. You can verify the effective date with your insurance plan. Contact your insurance plan or your child’s doctor for more information.

You can access numerous services and personalized support with OmniSource, the comprehensive support center dedicated to helping children and their families. The people at OmniSource are skilled at answering your questions, supporting you through the insurance approval process, and providing helpful Omnitrope materials.

Your healthcare team will select the OmniSource services that will benefit you and your child the most. For example, OmniSource:

• Helps with insurance approvals and keeps you informed throughout the process
• Arranges for an OmniSource nurse to provide training for your first Omnitrope injection, if your child’s doctor requests
• Sends a starter kit when your insurance coverage is approved, which includes a backpack containing either an Omnitrope Pen 5 or Omnitrope Pen 10 as prescribed, an insulated bag for travel, an instructional DVD, a guide on how to use the Omnitrope pen, and more
• Answers your questions about insurance and OmniSource services

Once you’re registered with OmniSource, you won’t have to manage your child’s treatment alone. You can contact a friendly, caring OmniSource Specialist who is informed about insurance and OmniSource services and is familiar with your needs and circumstances.

You can call OmniSource toll-free at 877-456-6794. OmniSource Specialists are available Monday through Friday from 9 AM to 8 PM ET and will be happy to help you.

For more information, see pages 10 and 11 of the Omnitrope Patient Brochure, or the OmniSource section of this Web site.

The US Food and Drug Administration (FDA) has approved Omnitrope as safe and effective when used as indicated. (For more information, see What is Omnitrope used for? above.) In addition, a clinical study evaluating Omnitrope and another brand of human growth hormone found that safety and effectiveness were maintained following a switch from the other brand to Omnitrope. Ask your child’s doctor whether Omnitrope is safe and appropriate for your child.