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Omnitrope® Has a Well-Established and Proven Safety Profile

Omnitrope has been approved since 20061

Omnitrope has been
approved since 20061

 

More than 808,000 prescriptions have been filled since 20072

More than 808,000
prescriptions have been
filled since 20072

 

12 clinical trials and 5 post-approval studies

12 clinical trials and
5 post-approval studies1,4

 


Overview of Omnitrope®
Clinical Studies

Pediatric Growth Hormone Deficiency (GHD)

In two Phase III sequential clinical trials, the efficacy and safety of Omnitrope® (somatropin) were compared with another somatropin product approved for GHD in 89 pediatric patients with GHD:

  • In study 1, 44 patients received Omnitrope for Injection (lyophilized powder) 5.8 mg/vial and 45 patients received the comparator somatropin product for 9 months
  • In study 2, patients who had received the comparator somatropin product for 9 months were switched to Omnitrope Cartridge (liquid) 5 mg/1.5 mL. After 15 months of treatment, all patients were switched to Omnitrope Cartridge to collect long-term efficacy and safety data
  • In both groups, somatropin was administered as a daily subcutaneous injection at a dose of 0.03 mg/kg
  • The primary endpoints were the mean change in height from pre-treatment to Month 9 and Month 15

Key Efficacy Results

Baseline Growth Characteristics and Effect of Omnitrope® After 9 and 15 Months of Treatment

HCP-Study Table

IGF-1=insulin-like growth factor 1; IGFBP-3=insulin-like growth factor binding protein 3; SDS=Standard Deviation Score.
*Calculated only for patients with measurements above the level of detection.

Key Safety Results

Adverse Reactions Reported in ≥ 5% of Pediatric GHD Patients Treated with Omnitrope® Cartridge (N=86)†

HCP Study Table

Adverse Reactions Reported in ≥ 5% of Pediatric GHD Patients Treated with Omnitrope® for Injection (N=44)†

HCP Study Table

HbA1c=hemoglobin A1C.

†Because clinical trials are conducted under varying conditions, adverse reaction rates observed during the clinical trials performed with one somatropin formulation cannot always be directly compared to the rates observed during the clinical trials performed with a second somatropin formulation and may not reflect the adverse reaction rates observed in practice.
Because clinical trials are conducted under varying conditions, adverse reaction rates observed during the clinical trials performed with one somatropin formulation cannot always be directly compared to the rates observed during the clinical trials performed with a second somatropin formulation and may not reflect the adverse reaction rates observed in practice.

Adult Growth Hormone Deficiency (GHD)

In six randomized Phase III clinical trials, another somatropin product was compared with placebo in 172 adult patients with GHD:

  • The trials included a 6-month, double-blind treatment period, where 85 patients received this other somatropin product and 87 patients received placebo
  • This was followed by an open-label treatment period where participating patients received this other somatropin product for up to a total of 24 months
  • This other somatropin product was administered as a daily SC injection at a dose of 0.04 mg/kg/week for the first month of treatment and 0.08 mg/kg/week for subsequent months
  • The primary endpoint measured the beneficial changes in body composition at the end of the 6-month treatment period

Key Efficacy Results

Beneficial changes in body composition were observed after 6 months of treatment for patients receiving this other somatropin product when compared to patients on placebo.

  • Lean body mass, total body water, and lean/fat ratio increased while total body fat mass and waist circumference decreased. These effects on body composition were maintained when treatment was continued beyond 6 months. Bone mineral density declined after 6 months of treatment but returned to baseline values after 12 months of treatment

Key Safety Considerations

In clinical trials with another somatropin product among adult GHD patients, the majority of adverse events consisted of mild to moderate symptoms of fluid retention, including peripheral swelling, arthralgia, pain and stiffness of the extremities, peripheral edema, myalgia, paresthesia, and hypoesthesia. These events were reported early during therapy and tended to be transient and/or responsive to dosage reduction.*


Adverse Events Reported by ≥ 5% of Adult GHD Patients During Clinical Trials of Another Somatropin Product and Placebo, Grouped by Duration of Treatment (N=1,145)*

HCP Study Table

*Because clinical trials are conducted under varying conditions, adverse reaction rates observed during the clinical trials performed with one somatropin formulation cannot always be directly compared to the rates observed during the clinical trials performed with a second somatropin formulation and may not reflect the adverse reaction rates observed in practice.

†Increased significantly when compared to placebo, P ≤ .025: Fisher’s Exact Test (one-sided).

Pradar-Willi Syndrome (PWS)

In two randomized, open-label, controlled Phase III clinical trials, the safety and efficacy of another somatropin product were evaluated in the treatment of 43 pediatric patients with PWS:

  • Patients received either this other somatropin product or no treatment for the first year of the studies, followed by all patients receiving this other somatropin product during the second year
  • This other somatropin product was administered as a daily SC injection, and the dose was calculated for each patient every 3 months
  • In Study 1, the treatment group (n=15) received this other somatropin product at a dose of 0.24 mg/kg/week throughout the entire study. During the second year, the control group (n=12) received this other somatropin product at a dose of 0.48 mg/kg/week
  • In Study 2, the treatment group (n=7) received this other somatropin product at a dose of 0.36 mg/kg/week throughout the entire study. During the second year, the control group (n=9) received this other somatropin product at a dose of 0.36 mg/kg/week
  • The primary endpoint measured the increases in linear growth of patients who received this other somatropin product compared with patients who received no treatment

Key Efficacy Results

Significant increases in linear growth were experienced by patients who received the other somatropin during the first year of the study when compared to patients who received no treatment.

  • Linear growth continued to increase in the second year after both groups received treatment with this other somatropin product

Key Safety Considerations

In two clinical studies in pediatric patients with Prader-Willi Syndrome carried out with another somatropin product, the following drug-related events were reported:*

  • Edema
  • Aggressiveness
  • Arthralgia
  • Benign intracranial hypertension
  • Hair loss
  • Headache
  • Myalgia

*Because clinical trials are conducted under varying conditions, adverse reaction rates observed during the clinical trials performed with one somatropin formulation cannot always be directly compared to the rates observed during the clinical trials performed with a second somatropin formulation and may not reflect the adverse reaction rates observed in practice.

Pediatric Patients Born Small for Gestational Age (SGA)

Pediatric Patients Born Small for Gestational Age (SGA) Who Fail to Manifest Catch-up Growth by Age 2

In four randomized, open-label, controlled Phase III clinical trials, the safety and efficacy of another somatropin product were evaluated in the treatment of 209 children born small for gestational age (SGA) who ranged in age from 2 to 8 years:

  • These pediatric patients were observed for 12 months before being randomized to receive either this other somatropin product (n=169) as a daily SC injection or no treatment (n=40) for the first 24 months of the studies
  • After 24 months in the studies, all patients received this other somatropin product
  • The patients treated with this other somatropin product received two doses per study, most often 0.24 and 0.48 mg/kg/week
  • The primary endpoint measured growth of patients who received any dose of this other somatropin compared with patients who received no treatment

Key Efficacy Results

Significant increases in growth were experienced by patients who received any dose of this other somatropin product during the first 24 months of the study compared with patients who received no treatment.

  • Children receiving 0.48 mg/kg/week demonstrated a significant improvement in height standard deviation score (SDS) compared with children treated with 0.24 mg/kg/week. Both of these doses resulted in a slower but constant increase in growth between months 24 to 72

Key Safety Considerations

In clinical studies of 273 pediatric patients born small for gestational age treated with another somatropin product, the following clinically significant events were reported: mild transient hyperglycemia, 1 patient had benign intracranial hypertension, 2 patients had central precocious puberty, 2 patients had jaw prominence, and several patients had aggravation of preexisting scoliosis, injection site reactions, and self-limited progression of pigmented nevi.*

*Because clinical trials are conducted under varying conditions, adverse reaction rates observed during the clinical trials performed with one somatropin formulation cannot always be directly compared to the rates observed during the clinical trials performed with a second somatropin formulation and may not reflect the adverse reaction rates observed in practice.

Idiopathic Short Stature (ISS)

In one randomized, open-label, Phase III clinical trial, the long-term efficacy and safety of another somatropin product were evaluated in 177 pediatric patients with ISS:

  • Main inclusion criteria were on the basis of short stature, stimulated GH secretion >10 ng/mL, and prepubertal status (criteria for ISS were retrospectively applied and included 126 patients)
  • Baseline patient characteristics for the ISS patients who remained prepubertal at randomization (n=105) were: mean (+/- SD): chronical age 11.4 (1.3) years, height SDS -2.4 (0.4), height velocity SDS -1.1 (0.8), and height velocity 4.4 (0.9) cm/yr, IGF-1 SDS -0.8 (1.4)
  • Two somatropin doses were evaluated in this trial: 0.23 mg/kg/week (0.033 mg/kg/day) (n=30) and 0.47 mg/kg/week (0.067 mg/kg/day)(n=42) and patients were treated for a median duration of 5.7 years. Untreated patient population (n=30)
  • All patients were observed for height progression for 12 months and were subsequently randomized to this other somatropin product or observation only and followed to final height

Key Efficacy Results

The observed mean gain in final height was 9.8 cm for females and 5.0 cm for males for both doses combined compared to untreated control subjects.

  • A height gain of 1 SDS was observed in 10% of untreated subjects, 50% of subjects receiving 0.23 mg/kg/week, and 69% of subjects receiving 0.47 mg/kg/week

Key Safety Considerations

In 2 open-label clinical studies conducted with another somatropin product in pediatric patients with ISS, the most commonly encountered adverse events were:*

  • Upper respiratory tract infections
  • Influenza
  • Tonsillitis
  • Nasopharyngitis
  • Gastroenteritis
  • Headaches
  • Increased appetite
  • Pyrexia
  • Fracture
  • Altered mood
  • Arthralgia

In one of the two studies, during treatment with this other somatropin product, the mean IGF-1 standard deviation (SD) scores were maintained in the normal range. IGF-1 SD scores above +2 SD were observed as follows: 1 subject (3%), 10 subjects (30%) and 16 subjects (38%) in the untreated control, 0.23 and the 0.47 mg/kg/week groups respectively, had at least one measurement; while 0 subjects (0%), 2 subjects (7%) and 6 subjects (14%) had two or more consecutive IGF-1 measurements above +2 SD.*

IGF-1=insulin-like growth factor 1.
*Because clinical trials are conducted under varying conditions, adverse reaction rates observed during the clinical trials performed with one somatropin formulation cannot always be directly compared to the rates observed during the clinical trials performed with a second somatropin formulation and may not reflect the adverse reaction rates observed in practice.

Turner Syndrome

In two randomized, open-label, Phase III clinical trials, the efficacy and safety of another somatropin product were evaluated in 38 Turner syndrome patients with short stature:

  • Turner syndrome patients were treated with this other somatropin product alone or this other somatropin product plus adjunctive hormonal therapy (ethinylestradiol or oxandrolone)
  • A total of 38 patients were treated with this other somatropin product alone in the two studies
  • In Study 1, 22 patients were treated for 12 months, and in Study 2, 16 patients were treated for 12 months
  • Patients received this other somatropin product at a dose between 0.13 to 0.33 mg/kg/week
  • Primary endpoint measured the increase from baseline in all of the linear growth variables, such as mean height velocity, height velocity SDS and height SDS, after treatment with the other somatropin product

Key Efficacy Results

Both studies demonstrated statistically significant increases from baseline in all of the linear growth variables, such as mean height velocity, height velocity SDS, and height SDS after treatment with this other somatropin product.

  • The linear growth response was greater in Study 1 wherein patients were treated with a larger dose of this other somatropin product

Key Safety Considerations

In two clinical studies with another somatropin product in pediatric patients with Turner syndrome, the most frequently reported adverse events were:*

  • Respiratory illnesses (influenza, tonsillitis, otitis, sinusitis)
  • Joint pain
  • Urinary tract infection

The only treatment-related adverse event that occurred in more than 1 patient was joint pain.*

*Because clinical trials are conducted under varying conditions, adverse reaction rates observed during the clinical trials performed with one somatropin formulation cannot always be directly compared to the rates observed during the clinical trials performed with a second somatropin formulation and may not reflect the adverse reaction rates observed in practice.

Post-approval Study

PATRO Children®: Long-Term Efficacy & Safety

Study Design

PATRO Children* is a multicenter, open, longitudinal, non-interventional study. Children study is conducted in hospitals and specialized endocrinology clinics across 14 countries (Austria, Canada, Czech Republic, France, Germany, Italy, Poland, Romania, Slovenia, Spain, Sweden, Taiwan, the UK, and the USA).3

The PATRO Children study was not designed to provide comparative efficacy data and should not be interpreted as providing evidence of either superiority or noninferiority of Omnitrope. The study was not prespecified and not powered to detect a statistically significant difference. Results should be considered for descriptive purposes only.

Primary Objective

Collect and analyze data on the long-term safety of somatropin in infants, children, and adolescents treated in routine clinical practice, with particular emphasis on the following4:

  • Diabetogenic potential (both type 1 and type 2 diabetes) of rhGH therapy in children born SGA and treated for growth disturbance
  • Occurrence of malignancies in rhGH-treated patients across all indications
  • Respiratory and diabetogenic side effects of rhGH treatment in PWS patients
  • Occurrence and clinical implications of anti-hGH antibodies

Secondary Objective

Collect and analyze data on the long-term efficacy of somatropin treatment4:

  • Height velocity (HV, cm/year); height velocity standard deviation score (HVSDS); height standard deviation score (HSDS)

Methodology

The study population includes infants, children, and adolescents receiving Omnitrope®. Patients who have been treated with another hGH product before starting somatropin therapy are also eligible for inclusion. All visits and assessments are carried out as per routine clinical practice, and doses of Omnitrope® are given according to country-specific prescribing information.5

Material limitations related to study design, methodology, and results

The PATRO Children study has some limitations, which are found in all observational studies. First, as data are collected according to routine clinical practice (as opposed to standardized protocols in controlled clinical trials), there is a risk of bias due to missing or erroneous data collection. The interpretation of some data may be limited as the mean duration of Omnitrope® treatment in the study is approximately 3 years. For instance, rare events such as malignancies may take several years to develop. Due to the observational nature of the study, a few discrepancies were reported in the data. Treatment duration during the study was not assessable or recorded as lower than 0 for some patients, resulting in a reported duration of 0 months. The maximum Omnitrope® dose recorded was very high (0.145 mg/kg), which may be a data entry error.5

rhGH=recombinant human growth hormone; PWS=Prader–Willi syndrome; SGA=small for gestational age.
*PATRO Children was part of a risk management plan commitment to the European Medicines Agency prior to the launch of Omnitrope.

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PATRO Children®: Interim results after 5 years of treatment5
 

Primary Endpoint

Safety†

Diabetogenic
Potential

  • Type 1 diabetes mellitus (treatment-related, clinically significant) in n=1 SGA patient; FG-475.6 mg/dL
  • Impaired glucose tolerance in n=7 patients (suspected to be treatment-related)

Malignancies
 

  • Neoplasms reported in 94 patients (1.6%) (n=48 patients with GHD). There were 4 patients (0.1%) with neoplasms that developed de novo during treatment and were considered possibly related to treatment

Respiratory and Diabetogenic Side Effects (PWS patients)

  • 3 patients with PWS required treatment interruption due to a treatment-related SAE, which included:
    • Upper airway resistance syndrome (n=1)
    • Sleep apnea syndrome (n=1)
    • Increased insulin-like growth factor (n=1)

Anti-rhGH Antibodies
(as of Nov. 2017)
 

  • No positive anti-hGH antibody titres detected in N=22 anti-rhGH assessments (n=19 patients) (Assessed at >2 years of Omnitrope treatment)

 

 

Safety (Safety population): At the time of the current analysis, 2,286 patients (38.0%) had discontinued Omnitrope® treatment. The most commonly reported reason for discontinuation was the patient reaching AH/bone age maturation (n = 581; 25.4%). In total, 124 patients (5.4%) discontinued because they were satisfied with their current height and 225 (9.8%) discontinued due to reaching near AH. Overall, 90 patients (3.9%) discontinued treatment due to an AE, which was treatment-related in 44 patients (1.9%). In total, 10,360 AEs were reported in 2,750 patients (45.8%; incidence of 152.3 per 1,000 patient-years). The majority of AEs were mild to moderate in intensity and did not result in any change to Omnitrope® treatment. Treatment-related AEs were reported in 396 patients (6.6%; incidence of 21.9 per 1,000 patient-years). Headache was the most commonly reported treatment-related AE (n = 95 patients; 1.6%), followed by injection-site pain (n = 42 patients; 0.7%), and injection-site hematoma (n = 35; 0.6%). Overall, 1,191 serious AEs (SAEs) were reported in 636 patients (10.6%; incidence of 35.2 per 1,000 patient-years). Of the reported SAEs, 50 events in 37 patients (0.6%) were considered treatment-related (incidence of 2.1 per 1,000 patient-years). In 19 patients, treatment-related SAEs led to the interruption or discontinuation of Omnitrope® treatment.5

Secondary Endpoint:

Efficacy

Omnitrope resulted in improvements in growth parameters across rhGH treatment-naïve patients with growth hormone deficiency (GHD), small for gestational age (SGA), and Turner syndrome (TS) (5-year efficacy population)

Height standard deviation score (HSDS)

 

Height standard deviation score (HSDS)
Height standard deviation score (HSDS) 2

Peak-centered height velocity standard deviation score (PC HVSDS)

Peak-centered height velocity standard deviation score (PC HVSDS)
Peak-centered height velocity standard deviation score (PC HVSDS) 2

FG=fasting glucose; hGH=human growth hormone.

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Getting Patients Started With Omnitrope

Learn more about the process and support resources available to help you initiate therapy with Omnitrope

Learn More


Interested in learning more about Omnitrope?

Browse our Frequently Asked Questions (FAQs) for answers to common questions about treatment with Omnitrope.

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References: 1. Omnitrope [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corp; 2019. 2. Data on File. Based on Symphony Data through January 2023; sum of projected Retail, Mail and LTC data. 3. Kanumakala S, Pfaffle R, Hoybye C, et al. Poster RFC 15.6. Presented at ESPE 2018. Latest Results From PATRO Children, a Multi-Centre, Non-Interventional Study of the Long-Term Safety and Efficacy of Omnitrope® in Children Requiring Growth Hormone Treatment. Abstract accepted for poster presentation at the 57th Annual ESPE Meeting, Athens, Greece. September 27-29, 2028. 4. Pfaffle R, Schwab KO, Marginean O, et al. Design of, and first data from, PATRO Children, a multicentre, noninterventional study of the long-term efficacy and safety of Omnitrope® in children requiring growth hormone treatment. Ther Adv Endocrinol Metab. 2013:4(1);3-11. 5. Pfaffle R, Bidlingmaier M, Kreitschmann-Andermahr I, et al. Safety and effectiveness of Omnitrope®, a biosimilar recombinant human growth hormone: more than 10 years' experience from the PATRO Children study. Horm Res Paediatr. 2020:93(3);154-163.

Indications and Important Safety Information

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.
  • 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.
  • Hypersensitivity: Omnitropeis 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.

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.