Frequently Asked Questions

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 linear growth (eg, increase in height), including skeletal and cell growth. Growth hormone also influences protein, carbohydrate, lipid, mineral, and connective tissue metabolism.1

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

Instruct your patient or his or her caregiver to take the missed dose as soon as possible. If the patient realizes a dose was missed and it is almost time for the next scheduled dose, tell your patient or his or her caregiver to not use extra medicine to make up for the missed dose.

Store Omnitrope refrigerated at 2°C to 8°C (36°F to 46°F). Do not freeze. Omnitrope is light sensitive and should be stored in the carton. After first use of a cartridge, the cartridge should remain in the pen and kept in a refrigerator at 2°C to 8°C (36°F to 46°F) for a maximum of 28 days. After reconstitution of a vial, the contents of the vial must be used within 3 weeks. After the first injection, the vial should be stored in the carton in a refrigerator at 2°C to 8°C (36°F to 46°F).1

Omnitrope is contraindicated in the following1:

  • Acute Critical Illness: Treatment with pharmacologic amounts of somatropin is contraindicated in patients with acute critical illness due to complications following open heart surgery, abdominal surgery or multiple accidental trauma, or those with acute respiratory failure
  • Prader-Willi Syndrome in Children: Somatropin is contraindicated in patients with Prader-Willi Syndrome who are severely obese, have a history of upper airway obstruction or sleep apnea, or have severe respiratory impairment. There have been reports of sudden death when somatropin was used in such patients
  • Active Malignancy: In general, somatropin is contraindicated in the presence of active malignancy. Any preexisting malignancy should be inactive and its treatment complete prior to instituting therapy with somatropin. Somatropin should be discontinued if there is evidence of recurrent activity. Since GHD may be an early sign of the presence of a pituitary tumor (or, rarely, other brain tumors), the presence of such tumors should be ruled out prior to initiation of treatment. Somatropin should not be used in patients with any evidence of progression or recurrence of an underlying intracranial tumor
  • Hypersensitivity: Omnitrope is contraindicated in patients with a known hypersensitivity to somatropin or any of its excipients. Systemic hypersensitivity reactions have been reported with postmarketing use of somatropin products
  • Diabetic Retinopathy: Somatropin is contraindicated in patients with active proliferative or severe non-proliferative diabetic retinopathy
  • Closed Epiphyses: Somatropin should not be used for growth promotion in pediatric patients with closed epiphyses

Common adverse reactions reported in adult and pediatric patients taking somatropin include injection site reactions/rashes and lipoatrophy and headaches. Additional common adverse reactions include edema, arthralgia, myalgia, carpal tunnel syndrome, paresthesias, and hypothyroidisms.

Reference: 1. Omnitrope [package insert]. Princeton, NJ: Sandoz Inc; 2016.

Frequently Asked Questions About Dosing and Delivery

Omnitrope is given as a weekly dose that should be divided over 6 or 7 days of subcutaneous injections. Omnitrope offers a liquid-formulation pen and a lyophilized powder: Omnitrope® Pen 5, Omnitrope® Pen 10, and Omnitrope® 5.8 mg Vial. Multiple options for administration allow for a more personalized and broader injection range for you and your patients.1

Omnitrope is injected just below the skin. Recommended areas include the thigh, stomach, or buttocks. Advise on how to rotate injection spots to avoid tissue atrophy (damage to local tissue).

Frequently Asked Questions 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 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 the patient to the OmniSource Program. He or she will also confirm contact information and help identify the resources OmniSource offers to answer nonmedical questions and needs.

Your patient should 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.

Frequently Asked Questions About Insurance

Your patient can contact an Omnitrope Patient Support Specialist with questions about insurance—he or she will be glad to help. Your patient should have an insurance card handy when he or she calls 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. Sandoz reserves the right to rescind, revoke, or amend this offer without further notice. Omnitrope Co-Pay Savings Program has no cash value.

Instruct your patient to 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

CONTRAINDICATIONS

  • Acute Critical Illness: Somatropin should not be used to treat patients with acute critical illness due to complications following open heart surgery, abdominal surgery or multiple accidental trauma, or those with acute respiratory failure
  • Prader-Willi Syndrome in Children: Somatropin should not be used in patients with Prader-Willi syndrome who are severely obese, have a history of upper airway obstruction or sleep apnea, or have severe respiratory impairment. There have been reports of sudden death when somatropin was used in such patients
  • Active Malignancy: Somatropin is contraindicated in patients with any evidence of active malignancy. Growth hormone deficiency may be an early sign of a pituitary tumor or other intracranial tumor; the presence of such a tumor should be excluded before initiation of somatropin treatment
  • Hypersensitivity: Omnitrope® is contraindicated in patients with a known hypersensitivity to somatropin or any of its excipients. Systemic hypersensitivity reactions have been reported with postmarketing use of somatropin products
  • Diabetic Retinopathy: Somatropin is contraindicated in patients with active proliferative or severe non-proliferative diabetic retinopathy
  • Closed Epiphyses: Somatropin should not be used for growth promotion in pediatric patients with closed epiphyses

WARNINGS AND PRECAUTIONS

  • Acute Critical Illness: Increased mortality in patients with acute critical illness due to complications following open heart surgery, abdominal surgery or multiple accidental trauma, or those with acute respiratory failure has been reported after treatment with pharmacologic doses of somatropin
  • Prader-Willi Syndrome in Children: There have been reports of fatalities after initiating therapy with somatropin in pediatric patients with Prader-Willi syndrome who had one or more of the following risk factors: severe obesity, history of upper airway obstruction or sleep apnea, or unidentified respiratory infection. Male patients with one or more of these factors may be at greater risk than females. Patients with Prader-Willi syndrome should be evaluated for signs of upper airway obstruction and sleep apnea before initiation of treatment with somatropin. If, during treatment with somatropin, patients show signs of upper airway obstruction (including onset of or increased snoring) and/or new onset sleep apnea, treatment should be interrupted
  • Neoplasms: An increased risk of a second neoplasm has been reported for childhood cancer survivors treated with somatropin for GH deficiency that developed following radiation to the brain/head. Intracranial tumors, in particular meningiomas, were the most common of these. The relationship between somatropin therapy and CNS tumor recurrence in adults is unknown. Monitor for progression or recurrence in patients receiving somatropin therapy who have a history of GH deficiency secondary to an intracranial neoplasm. Thoroughly consider the risks and benefits of starting somatropin in children at increased risk for developing malignancies due to certain rare genetic causes of short stature. These patients should be carefully monitored for development of neoplasms. Any pre-existing nevi should be monitored carefully for increased growth or potential malignant changes
  • Impaired Glucose Intolerance and Diabetes Mellitus: Previously undiagnosed impaired glucose tolerance and overt diabetes mellitus may be unmasked during somatropin treatment. New-onset type 2 diabetes mellitus has been reported. As a result, blood glucose concentrations should be monitored periodically in all patients taking somatropin, especially in those with risk factors for diabetes mellitus. Patients with pre-existing type 1 or type 2 diabetes mellitus or impaired glucose tolerance should be monitored closely during somatropin treatment

Show more....