Frequently Asked Questions

Omnitrope (somatropin) is a prescription medicine that contains human growth hormone and is used to treat:

• Children with growth failure due to growth hormone deficiency (GHD), Prader-Willi syndrome, small for gestational age, Turner syndrome, and idiopathic short stature
• Adults with either adult-onset or childhood-onset GHD

Omnitrope (somatropin) is made by recombinant technology. The amino acid sequence of the product is identical to that of human growth hormone of pituitary origin (somatropin), but it is not taken from the human body. Instead, Omnitrope is made in a laboratory.

Omnitrope is taken via injection and travels through the bloodstream, the same way growth hormone naturally produced in our body would. With the help of another protein called IGF, it helps support the growth and development of our bones and muscles.¹

• Patients and caregivers who will administer Omnitrope should receive appropriate training and instruction on the proper use of Omnitrope. For further information on OmniSource and training, visit the Omnitrope Injection Instructions page
• Use Omnitrope exactly as your healthcare provider prescribes
• Properly dispose of used syringes and needles in a puncture-resistant container
• Never share an Omnitrope Pen with another person, even if the needle is changed
• Sharing the pen may lead to infection

See the Instructions for Use section of the Prescribing Information for detailed information.

Omnitrope is supplied in prefilled liquid cartridges for use with the Omnitrope Pen or a vial
for reconstitution.

Read more about the Omnitrope Pen and Vial and Syringe.

Omnitrope is given as a subcutaneous (under-the-skin) injection each day or several times a week, as directed by a healthcare provider.

Injecting Omnitrope is convenient with the Omnitrope Pen 5 or Omnitrope Pen 10. Each pen uses liquid cartridges.

Omnitrope is also available as a vial for injection with a syringe. Find out more about growth hormone treatment options.

Patients and caregivers who will administer Omnitrope should receive appropriate training and instruction on the proper use of Omnitrope. For further information on OmniSource and training, visit the Omnitrope Injection Instructions page.

Before use, keep Omnitrope cartridges and loaded pens in the refrigerator between 36°F and 46°F (2°C and 8°C).

Once a cartridge has been loaded into the pen, it should not be removed until it is empty, or 28 days have passed since its first use.

The pen with the loaded cartridge should be stored in the refrigerator for a maximum of 28 days. Do not freeze Omnitrope.

To protect medicine from light, keep the Omnitrope cartridges in their original packaging until a cartridge is loaded into the pen.

Remember to always keep Omnitrope and injection needles away from children.

After reconstitution of Omnitrope vials, the contents of the vial must be used within 3 weeks.

Before use and after the first injection, the vial should be stored in the carton in a refrigerator between 36°F and 46°F.

You will receive a pen based on the dose of Omnitrope your healthcare provider prescribes.

Omnitrope is injected just below the skin. A healthcare provider will suggest the best areas of the body to inject Omnitrope.

Recommended areas include the thigh, stomach, or buttocks. Your healthcare provider will also advise on how to rotate injection sites to avoid tissue atrophy (damage to local tissue).

Through the OmniSource Patient Support service, your Nurse Trainer is available to teach you how to inject safely at home.

Click here to find out more about our OmniSource Patient Support Program.

Omnitrope should not be used in children and adults with any of the following medical conditions because serious side effects, including death, can occur:

• A critical illness caused by certain types of heart or stomach surgery, accidental trauma, or a sudden and severe breathing problem (respiratory failure)
• Patients with Prader-Willi syndrome who are severely overweight or have a history of breathing problems, including sleep apnea
• Cancer or other tumors
• Allergies to growth hormone or any of the ingredients in the medicine
• Certain types of eye problems caused by diabetes
• Closed bone growth plates

Omnitrope should also not be used in children who have completed growth.

Patients should tell their healthcare provider about all of their medical conditions, including:

• Have had heart or stomach surgery, trauma, or serious breathing problems
• Have or have had cancer or any tumor
• Have diabetes
• Take any prescription and non-prescription medicines, steroids, vitamins, or herbal supplements
• Are pregnant or breastfeeding, or plan to become pregnant or breastfeed

For further information, review the Important Safety Information below, as well as the full Prescribing Information for Omnitrope.

Be sure to talk to your healthcare provider if you have questions about the uses or safety considerations of Omnitrope.

The most common side effects of Omnitrope are:

• Local reactions at the injection site (such as pain, numbness, redness, and swelling)
• Headaches
• Swelling associated with fluid retention
• Pain in the joints and muscle pain
• Carpal tunnel syndrome
• Tingling and numbness
• High blood sugar (hyperglycemia/diabetes) and sugar in your urine (glucosuria)
• Unusual skin sensations
• Low levels of thyroid hormone (hypothyroidism)

For further information, review the Important Safety Information below, as well as the full Prescribing Information for Omnitrope.

Be sure to talk to your healthcare provider if you have questions about the uses or safety considerations of Omnitrope.

Other possible side effects of Omnitrope are:

• Return of tumors or cancerous growths
• Headaches, changes in vision, nausea, or vomiting (these may be symptoms of raised pressure in the brain, which requires immediate medical attention)
• Hip and knee pain or a limp in children, which can be a sign of slipped capital femoral epiphysis
• Worsening of pre-existing curvature of the spine in children (scoliosis)
• Increased ear infections and ear disorders in children with Turner syndrome; check for cardiovascular disorders (hypertension, stroke)
• Intense pain and tenderness in the abdomen as a consequence of an inflammation of the
  pancreas (pancreatitis)
• Gasping syndrome (decreased rate of breathing) in children from high levels of benzyl alcohol (an inactive ingredient)
• Increased mortality in patients with Prader-Willi syndrome and acute illness

For further information, review the Important Safety Information below, as well as the full Prescribing Information for Omnitrope.

Be sure to talk to your or your child's healthcare provider if you have questions about the use or safety of Omnitrope.

OmniSource is a support program for Omnitrope patients and caregivers.

The professionals at OmniSource are skilled at answering your questions about patient services, guiding you through the insurance process, and providing helpful Omnitrope materials.

They also can arrange for a Nurse Trainer to provide injection training.

An OmniSource Case Manager is skilled at getting the answers needed, guiding you through the onboarding process, and providing personalized service for the growth hormone journey.

Once you have enrolled, your OmniSource Case Manager will call you to introduce themselves and welcome you to the OmniSource Program. They will also confirm your contact information and address and help identify the resources OmniSource offers to answer any nonmedical questions and needs that you may have.

Expect a call from an OmniSource Case Manager with important information about beginning treatment. The OmniSource Case Manager will help to provide growth hormone product and supplies, including shipment of the Starter Kit and pen device, if applicable.

OmniSource is here for support. Call 877-456-6794 (Monday–Friday, 8 AM – 8 PM ET).

An OmniSource Nurse Trainer is a professional who can provide in-home training on how to properly use the Omnitrope Pen or vial and syringe.

It’s a free service, and open to any family member or authorized caregiver. Please note that in order to receive injection training from an OmniSource Nurse Trainer, your doctor must order it on the Statement of Medical Necessity at the patient’s request.

If a refresher or additional training is needed, a Nurse Trainer is available. Please call your OmniSource Case Manager for more information.

Please contact OmniSource with questions about insurance—they will be glad to help. Have an insurance card handy when you call 877-456-6794 (Monday–Friday, 8 AM – 8 PM ET).

Please contact OmniSource with questions about insurance—they will be glad to help. Call 877-456-6794 (Monday–Friday, 8 AM – 8 PM ET).

If you don’t have insurance, or you wish to pay in cash or skip the reimbursement process and begin growth hormone treatment as soon as possible, visit the Omnitrope Self Pay page to find more information.

The Omnitrope Co-Pay Savings Program provides up to $5,000 in annual co-pay support for Omnitrope prescriptions.

With the Omnitrope Co-Pay Savings Program, eligible patients may pay $0 for their co-pay. Eligible patients who are commercially insured may receive co-pay support in the amount of up to $5,000 annually, and patients who are uninsured may receive co-pay support in the amount of up to $417 monthly, with an annual cap of $5,000.

Prescription must be for an approved indication. This program is not health insurance.
Patients are not eligible if prescriptions are paid, in whole or in part, by any state-or federally funded programs, including but not limited to:

• Medicare (including Part D, even in the coverage gap) or Medicaid
• Medigap
• VA
• DoD
• TRICARE
• Private indemnity, or HMO insurance plans that reimburse you for the entire cost of your prescription drugs, or where prohibited by law

Patients can participate for a maximum of 12 months.

Eligible patients must have a first use of the program by December 31 of the current year.

Omnitrope Co-Pay Savings Program may not be combined with any other rebate, coupon, or offer.

Omnitrope Co-Pay Savings Program has no cash value.

Sandoz reserves the right to rescind, revoke, or amend this offer without further notice.

Click here to apply for Co-Pay savings.

If you don’t have insurance, wish to pay for your growth hormone treatment in cash, or want to skip the reimbursement process and begin growth hormone treatment as soon as possible, the Omnitrope Self Pay Program may be the right option for you.

Visit the Omnitrope Self Pay Program page for more information on cost-saving options available for eligible† patients.

If your insurance process takes longer than 10 days, you may be eligible for the Sandoz OmniStart (SOS) Interim Drug Program, which can help you get started on Omnitrope free of charge.^‡