Frequently Asked Questions

About Omnitrope

Omnitrope is a recombinant human growth hormone indicated for:

  • Pediatric: Treatment of children with growth failure due to growth hormone deficiency (GHD), Prader-Willi Syndrome, Small for Gestational Age, Turner Syndrome, and Idiopathic Short Stature
  • Adult: Treatment of adults with either adult onset or childhood onset GHD

The primary action of somatropin is growth, including tissue, skeletal, cell, and organ growth. Growth hormone also influences protein, carbohydrate, lipid, mineral, and connective tissue metabolism.

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

Call a healthcare professional if you or your child takes more medicine than prescribed.

Take the missed dose as soon as possible. If it is almost time for the next scheduled dose, do not use extra medicine to make up for the missed dose.

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 up to 28 days. Do not freeze Omnitrope. To protect medicine from light, keep 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.

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 complications from heart or stomach surgery, serious injury, or a sudden and severe breathing problem (respiratory failure)
  • Prader-Willi Syndrome patients, 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

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

Patients should tell their doctor about their medical and family history, treatment use, and past and existing medical conditions such as, but not limited to, the following:

  • cancer or any tumor
  • diabetes
  • use of prescription and nonprescription medicines, steroids, vitamins, and herbal supplements
  • pregnancy
  • nursing

The most common side effects of Omnitrope include:

  • local reactions at the injection site (such as pain, numbness, redness, and swelling)
  • headaches
  • swelling associated with fluid retention
  • pain in 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 (hypothryroidism)

Review Important Safety Information below, as well as the full Prescribing Information.

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

Other possible side effects of Omnitrope are:

  • return of tumor 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, that 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

 

Review Important Safety Information below, as well as the full Prescribing Information.

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

  • Patients and caregivers who will administer Omnitrope should receive appropriate training and instruction on the proper use of Omnitrope
  • Use Omnitrope exactly as your healthcare professional 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 Infomation for detailed information

About Dosing and Delivery

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

You or your child will receive a pen based on the dose of Omnitrope the healthcare professional prescribes.

Omnitrope is injected just below the skin. A healthcare professional will suggest the best areas of the body to inject Omnitrope. Recommended areas include the thigh, stomach, or buttocks. The healthcare professional will also advise on how to rotate injection sites to avoid tissue atrophy (damage to local tissue).

About OmniSource®

OmniSource is a support program for Omnitrope patients and caregivers. The professionals at OmniSource are skilled at answering questions about patient services, guiding patients through the insurance process, and providing helpful Omnitrope materials. They also can arrange for a Nurse Trainer to provide injection training.

An OmniSource Patient Support Specialist is skilled at getting the answers needed, guiding through the onboarding process, and providing personalized service for the growth hormone journey.

During the Omnitrope onboarding process, the OmniSource Patient Support Specialist will call to make an introduction and welcome you to the OmniSource Program. He or she will also confirm contact information and address and help identify the resources OmniSource offers to answer nonmedical questions and needs.

Expect a call from an OmniSource Patient Support Specialist with important information about beginning treatment. The OmniSource Patient Support Specialist 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 (Mon – Fri, 8AM – 8PM ET).

A 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 a Nurse Trainer, a 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 a Patient Support Specialist for more information.

About Insurance

Please contact an Omnitrope Patient Support Specialist with questions about insurance—he or she will be glad to help. Have an insurance card handy when you call 877.456.6794 (Mon – Fri, 8AM – 8PM ET).

Eligible* patients may receive a $5,000 upfront annual benefit and pay no more than $0 for their monthly co-pay for up to 12 months.

*Omnitrope Co-Pay Savings Program Eligibility

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, or TriCare, or 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. 

Contact an OmniSource Patient Support Specialist at 877.456.6794 (Mon – Fri, 8AM – 8PM ET).

INDICATIONS

Omnitrope is a recombinant human growth hormone indicated for :

  • Pediatric: Treatment of children with growth failure due to growth hormone deficiency (GHD), Prader-Willi Syndrome, Small for Gestational Age, Turner Syndrome, and Idiopathic Short Stature
  • Adult: Treatment of adults with either adult onset or childhood onset GHD

IMPORTANT SAFETY INFORMATION

Who should not take Omnitrope®?

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, serious injury or a sudden and severe breathing problem (respiratory failure)
  • 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

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

What should patients tell their doctor before taking Omnitrope?

Patients should tell their doctor about their medical and family history, treatment use and past and existing medical conditions, such as but not limited to the following:

  • cancer or any tumor
  • diabetes
  • use of prescription and non-prescription medicines, steroids, vitamins, and herbal supplements
  • pregnancy
  • nursing

What are the most common side effects of Omnitrope?

  • local reactions at the injection site (such as pain, numbness, redness and swelling)
  • headaches
  • swelling associated with fluid retention
  • pain in 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)

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