Injection Training With Omnitrope

Patients and caregivers who will administer Omnitrope should receive training and instruction on the proper use of Omnitrope. Patients should review the full Prescribing Information and Instructions for Use, and ask their healthcare professional about anything they do not understand.

Highlights of Omnitrope Pen

Available in 5 mg and 10 mg
Flexible dosing provides a broad injection range for patients
Ready-to-use liquid cartridge eliminates the need to reconstitute
Liquid cartridge remains stable for 28 days after first injection*

Preservatives: phenol (10 mg) and benzyl alcohol (5 mg)

One-time priming upon insertion of new cartridge

The Omnitrope Pen is covered by a 2-year guarantee for defective materials or workmanship. If the pen breaks or is not working properly, patients can call their Omnitrope Case Manager for a new one at 877.456.6794 (Monday – Friday, 8 AM – 8 PM ET).

*Cartridge must be stored or refrigerated from 36°F to 46°F.

Highlights of Omnitrope Vial and Syringe

Each 5.8 mg vial of Omnitrope is matched with a 1.14 mL vial of bacteriostatic water (preserved with benzyl alcohol) for reconstitution
Three-week stability once reconstituted^†

After reconstitution, the vial should be stored in a carton in the refrigerator from 36°F to 46°F.

You may also download the Omnitrope Administration Guide for your reference:

Omnitrope Administration Guide

REFERENCES

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

^‡Omnitrope Co-Pay Savings Program Eligibility:

The Omnitrope Co-Pay Savings Program provides up to $5000 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 $5000 annually, and patients who are uninsured may receive Co-Pay support in the amount of up to $417 monthly, with an annual cap of $5000. 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.

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

Intracranial Hypertension: Intracranial hypertension with papilledema, visual changes, headache, nausea, and/or vomiting have been reported in a small number of patients treated with somatropin. Funduscopic examination is recommended at the initiation of and periodically during therapy. If papilledema is observed by funduscopy during treatment with somatropin, treatment should be stopped and the patient’s condition should be reassessed before treatment is resumed. Patients with Turner syndrome and Prader-Willi Syndrome may be at increased risk for the development of intracranial hypertension
Hypersensitivity: Serious systemic hypersensitivity reactions including anaphylactic reactions and angioedema have been reported with postmarketing use of somatropin products. Patients and caregivers should be informed that such reactions are possible and that prompt medical attention should be sought if an allergic reaction occurs
Fluid Retention: Transient and dose-dependent fluid retention during somatropin replacement in adults may frequently occur
Hypoadrenalism: Monitor patients for reduced serum cortisol levels and/or need for glucocorticoid dose increases in those with known hypoadrenalism
Hypothyroidism: Patients treated with somatropin should have periodic thyroid function tests, and thyroid hormone replacement therapy should be initiated or appropriately adjusted in cases of unmasked or worsening hypothyroidism
Slipped Capital Femoral Epiphysis in Pediatric Patients: Slipped capital femoral epiphysis may occur more frequently in patients with endocrine disorders and in patients undergoing rapid growth. Any pediatric patient with the onset of a limp or complaints of hip or knee pain during somatropin therapy should be carefully evaluated
Progression of Scoliosis in Pediatric Patients: Progression of scoliosis can occur in patients who experience rapid growth. Because somatropin increases growth rate, patients with a history of scoliosis who are treated with somatropin should be monitored for progression of scoliosis. However, somatropin has not been shown to increase the occurrence of scoliosis
Confirmation of Childhood Onset Adult GHD: Patients with epiphyseal closure who were treated with somatropin replacement therapy in childhood should be reevaluated before continuation of somatropin therapy at the reduced dose level recommended for GH deficient adults
Otitis Media and Cardiovascular Disorders in Patients with Turner Syndrome: Patients with Turner Syndrome should be evaluated carefully for otitis media and other ear disorders as somatropin treatment may increase the occurrence of otitis media in these susceptible patients. In addition, patients with Turner Syndrome should be monitored closely for cardiovascular disorders (e.g., stroke, aortic aneurysm or dissection, hypertension) as they are at increased risk for these conditions
Lipoatrophy: Injection site should be rotated to avoid tissue atrophy
Laboratory Tests: Serum levels of inorganic phosphorus, alkaline phosphatase, parathyroid hormone and IGF-I may increase after somatropin therapy
Pancreatitis: Cases of pancreatitis have been reported rarely in children and adults receiving somatropin. Pancreatitis should be considered in any somatropin-treated patient, especially a child, who develops persistent severe abdominal pain. Girls who have Turner Syndrome may be at greater risk than other somatropin-treated children
Benzyl Alcohol: Benzyl alcohol, an ingredient in Omnitrope Cartridge 5 mg/1.5 mL and the diluent for Omnitrope for injection 5.8 mg/vial, has been associated with serious adverse events and death, particularly in pediatric patients and should not be used in premature babies or neonates. Consider the combined daily metabolic load of benzyl alcohol from all sources
Pregnancy/Nursing Mothers: Somatropin should be used during pregnancy only if clearly needed and with caution in nursing mothers because it is not known whether somatropin is excreted in human milk
Special Populations: The safety and effectiveness of somatropin in patients aged 65 years and over have not been evaluated in clinical studies. Elderly patients may be more sensitive to the action of somatropin and may be more prone to adverse reactions
Potential Drug Interactions:
- Somatropin inhibits 11β-hydroxysteroid dehydrogenase type 1 (11βHSD-1) in adipose/hepatic tissue and may significantly impact the conversion of cortisone to its active metabolite cortisol. As a consequence, in patients treated with somatropin, previously undiagnosed central (secondary) hypoadrenalism may be unmasked, requiring glucocorticoid replacement therapy
- Careful monitoring is advisable when growth hormone is administered in combination with insulin and/or other hypoglycemic agents, other drugs metabolized by CYP450 liver enzymes (e.g., hydrocortisone or other corticosteroids, sex steroids, anticonvulsants, cyclosporine), or other hormone replacement therapy

ADVERSE REACTIONS

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 hypothyroidism

Please see full Prescribing Information for Omnitrope.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

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