1.1 Pediatric Patients

OMNITROPE is indicated for the treatment of children with growth failure due to inadequate secretion of endogenous growth hormone (GH).

OMNITROPE is indicated for the treatment of pediatric patients who have growth failure due to Prader-Willi Syndrome (PWS). The diagnosis of PWS should be confirmed by appropriate genetic testing [see Contraindications (4) and Warnings and Precautions (5.2)].

OMNITROPE is indicated for the treatment of growth failure in children born small for gestational age (SGA) who fail to manifest catch-up growth by age 2 years.

OMNITROPE is indicated for the treatment of growth failure associated with Turner Syndrome.

OMNITROPE is indicated for the treatment of idiopathic short stature (ISS), also called non-growth hormone-deficient short stature, defined by height standard deviation score (SDS) ≤ -2.25, and associated with growth rates unlikely to permit attainment of adult height in the normal range, in pediatric patients whose epiphyses are not closed and for whom diagnostic evaluation excludes other causes associated with short stature that should be observed or treated by other means.

1.2 Adult Patients

OMNITROPE is indicated for the replacement of endogenous GH in adults with growth hormone deficiency (GHD) who meet either of the following two criteria:

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Adult Onset (AO): Patients who have GHD, either alone or associated with multiple hormone deficiencies (hypopituitarism), as a result of pituitary disease, hypothalamic disease, surgery, radiation therapy, or trauma; or

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Childhood Onset (CO): Patients who were GH deficient during childhood as a result of congenital, genetic, acquired, or idiopathic causes.

Patients who were treated with somatropin for growth hormone deficiency in childhood and whose epiphyses are closed should be reevaluated before continuation of somatropin therapy at the reduced dose level recommended for growth hormone deficient adults. Confirmation of the diagnosis of adult growth hormone deficiency in both groups involves an appropriate growth hormone provocative test with two exceptions: (1) patients with multiple other pituitary hormone deficiencies due to organic disease; and (2) patients with congenital/genetic growth hormone deficiency.

2.1 Dosing of Pediatric Patients

2.2 Dosing of Adult Patients

2.3 Preparation and Administration

5.1 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 amounts of somatropin [see Contraindications (4)]. Two placebo-controlled clinical trials in non-growth hormone deficient adult patients (n=522) with these conditions in intensive care units revealed a significant increase in mortality (42% vs. 19%) among somatropin-treated patients (doses 5.3-8 mg/day) compared to those receiving placebo. The safety of continuing somatropin treatment in patients receiving replacement doses for approved indications who concurrently develop these illnesses has not been established. Therefore, the potential benefit of treatment continuation with somatropin in patients experiencing acute critical illnesses should be weighed against the potential risk.

5.2 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 (including onset of or increased snoring) 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. All patients with Prader-Willi Syndrome treated with somatropin should also have effective weight control and be monitored for signs of respiratory infection, which should be diagnosed as early as possible and treated aggressively [see Contraindications (4)].

5.3 Neoplasms

In childhood cancer survivors who were treated with radiation to the brain/head for their first neoplasm and who developed subsequent GHD and were treated with somatropin, an increased risk of a second neoplasm has been reported. Intracranial tumors, in particular meningiomas, were the most common of these second neoplasms. In adults, it is unknown whether there is any relationship between somatropin replacement therapy and CNS tumor recurrence [see Contraindications (4)]. Monitor all patients with a history of GHD secondary to an intracranial neoplasm routinely while on somatropin therapy for progression or recurrence of the tumor [see Contraindications (4)].

Because children with certain rare genetic causes of short stature have an increased risk of developing malignancies, practitioners should thoroughly consider the risks and benefits of starting somatropin in these patients. If treatment with somatropin is initiated, these patients should be carefully monitored for development of neoplasms.

Monitor patients on somatropin therapy carefully for increased growth, or potential malignant changes, of preexisting nevi.

5.4 Impaired Glucose Tolerance and Diabetes Mellitus

Treatment with somatropin may decrease insulin sensitivity, particularly at higher doses in susceptible patients. As a result, previously undiagnosed impaired glucose tolerance and overt diabetes mellitus may be unmasked, and new onset type 2 diabetes mellitus has been reported in patients taking somatropin. Therefore, glucose levels should be monitored periodically in all patients treated with somatropin, especially in those with risk factors for diabetes mellitus, such as obesity, Turner Syndrome, or a family history of diabetes mellitus. Patients with preexisting type 1 or type 2 diabetes mellitus or impaired glucose tolerance should be monitored closely during somatropin therapy. The doses of antihyperglycemic drugs (i.e., insulin or oral agents) may require adjustment when somatropin therapy is instituted in these patients [see Drug Interactions (7.5)].

5.5 Intracranial Hypertension (IH)

Intracranial hypertension (IH) with papilledema, visual changes, headache, nausea, and/or vomiting has been reported in a small number of patients treated with somatropins. Symptoms usually occurred within the first eight (8) weeks after the initiation of somatropin therapy. In all reported cases, IH-associated signs and symptoms rapidly resolved after cessation of therapy or a reduction of the somatropin dose.

Funduscopic examination should be performed routinely before initiating treatment with somatropin to exclude preexisting papilledema, and periodically during the course of somatropin therapy. If papilledema is observed by fundoscopy during somatropin treatment, treatment should be stopped. If somatropin-induced IH is diagnosed, treatment with somatropin can be restarted at a lower dose after IH-associated signs and symptoms have resolved. Patients with Turner Syndrome and Prader-Willi Syndrome may be at increased risk for the development of IH.

5.6 Hypersensitivity

Serious systemic hypersensitivity reactions including anaphylactic reactions and angioedema have been reported with postmarketing use of somatropins. Patients and caregivers should be informed that such reactions are possible and that prompt medical attention should be sought if an allergic reaction occurs [see Contraindications (4)].

5.7 Fluid Retention

Fluid retention during somatropin replacement therapy in adults may frequently occur. Clinical manifestations of fluid retention (e.g. edema, arthralgia, myalgia, nerve compression syndromes including carpal tunnel syndrome/paresthesias) are usually transient and dose dependent.

5.8 Hypoadrenalism

Patients receiving somatropin therapy who have or are at risk for pituitary hormone deficiency(s) may be at risk for reduced serum cortisol levels and/or unmasking of central (secondary) hypoadrenalism. In addition, patients treated with glucocorticoid replacement for previously diagnosed hypoadrenalism may require an increase in their maintenance or stress doses following initiation of somatropin treatment [see Drug Interactions (7.1)].

5.9 Hypothyroidism

Undiagnosed/untreated hypothyroidism may prevent an optimal response to somatropin, in particular, the growth response in children. Patients with Turner Syndrome have an inherently increased risk of developing autoimmune thyroid disease and primary hypothyroidism and should have their thyroid function checked prior to initiation of somatropin therapy. In patients with GHD, central (secondary) hypothyroidism may first become evident or worsen during somatropin treatment. Therefore, patients treated with somatropin should have periodic thyroid function tests and thyroid hormone replacement therapy should be initiated or appropriately adjusted when indicated.

5.10 Slipped Capital Femoral Epiphysis in Pediatric Patients

Slipped capital femoral epiphysis may occur more frequently in patients with endocrine disorders (including GHD and Turner Syndrome) or 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.

5.11 Progression of Preexisting 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. Skeletal abnormalities including scoliosis are commonly seen in untreated Turner Syndrome patients. Scoliosis is also commonly seen in untreated patients with Prader-Willi Syndrome. Physicians should be alert to these abnormalities, which may manifest during somatropin therapy.

5.12 Otitis Media and Cardiovascular Disorders in Turner Syndrome

Patients with Turner Syndrome should be evaluated carefully for otitis media and other ear disorders since these patients have an increased risk of ear and hearing disorders. Somatropin treatment may increase the occurrence of otitis media in patients with Turner Syndrome. In addition, patients with Turner Syndrome should be monitored closely for cardiovascular disorders (e.g., stroke, aortic aneurysm/dissection, hypertension) as these patients are also at risk for these conditions.

5.13 Lipoatrophy

When somatropin is administered subcutaneously at the same site over a long period of time, tissue atrophy may result. This can be avoided by rotating the injection site [see Dosage and Administration (2.3)].

5.14 Laboratory Tests

Serum levels of inorganic phosphorus, alkaline phosphatase, parathyroid hormone (PTH) and IGF-1 may increase after somatropin therapy.

5.15 Pancreatitis

Cases of pancreatitis have been reported rarely in children and adults receiving somatropin treatment, with some evidence supporting a greater risk in children compared with adults. Published literature indicates that girls who have Turner Syndrome may be at greater risk than other somatropin-treated children. Pancreatitis should be considered in any somatropin treated patient, especially a child, who develops persistent severe abdominal pain.

5.16 Benzyl Alcohol

Benzyl alcohol, a component of 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. The “gasping syndrome,” (characterized by central nervous system depression, metabolic acidosis, gasping respirations, and high levels of benzyl alcohol and its metabolites found in the blood and urine) has been associated with benzyl alcohol dosages >99 mg/kg/day in neonates and low-birth weight neonates. Additional symptoms may include gradual neurological deterioration, seizures, intracranial hemorrhage, hematologic abnormalities, skin breakdown, hepatic and renal failure, hypotension, bradycardia, and cardiovascular collapse. Practitioners administering this and other medications containing benzyl alcohol should consider the combined daily metabolic load of benzyl alcohol from all sources.

The following important adverse reactions are also described elsewhere in labeling:

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Increased mortality in patients with acute critical illness [see Warnings and Precautions (5.1)]

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Fatalities in children with Prader-Willi Syndrome [see Warnings and Precautions (5.2)]

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Neoplasms [see Warnings and Precautions (5.3)]

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Glucose intolerance and diabetes mellitus [see Warnings and Precautions (5.4)]

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Intracranial hypertension [see Warnings and Precautions (5.5)]

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Severe hypersensitivity [see Warnings and Precautions (5.6)]

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Fluid retention [see Warnings and Precautions (5.7)]

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Hypoadrenalism [see Warnings and Precautions (5.8)]

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Hypothyroidism [see Warnings and Precautions (5.9)]

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Slipped capital femoral epiphysis in pediatric patients [see Warnings and Precautions (5.10)]

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Progression of preexisting scoliosis in pediatric patients [see Warnings and Precautions (5.11)]

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Otitis media and cardiovascular disorders in patients with Turner Syndrome [see Warnings and Precautions (5.12)]

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Lipoatrophy [see Warnings and Precautions (5.13)]

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Pancreatitis [see Warnings and Precautions (5.15)]

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Benzyl Alcohol [see Warnings and Precautions (5.16)]

6.1 Clinical Trials Experience

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.

6.2 Postmarketing Experience

Because these adverse events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The adverse events reported during postmarketing surveillance do not differ from those listed/discussed above in Sections 6.1 and 6.2 in children and adults.

Serious systemic hypersensitivity reactions including anaphylactic reactions and angioedema have been reported with postmarketing use of somatropins [see Warnings and Precautions (5.6)].

Leukemia has been reported in a small number of GH deficient children treated with somatropin, somatrem (methionylated rhGH) and GH of pituitary origin. It is uncertain whether these cases of leukemia are related to GH therapy, the pathology of GHD itself, or other associated treatments such as radiation therapy. On the basis of current evidence, experts have not been able to conclude that GH therapy per se was responsible for these cases of leukemia. The risk for children with GHD, if any, remains to be established [see Contraindications (4) and Warnings and Precautions (5.3)].

The following additional adverse reactions have been observed during the use of somatropin: headaches (children and adults), gynecomastia (children), and pancreatitis (children and adults) [see Warnings and Precautions (5.16)].

New-onset type 2 diabetes mellitus has been reported.

7.1 11β-Hydroxysteroid Dehydrogenase Type 1 (11βHSD-1)

The microsomal enzyme 11β-hydroxysteroid dehydrogenase type 1 (11βHSD-1) is required for conversion of cortisone to its active metabolite, cortisol, in hepatic and adipose tissue. GH and somatropin inhibit 11βHSD-1. Consequently, individuals with untreated GH deficiency have relative increases in 11βHSD-1 and serum cortisol. Introduction of somatropin treatment may result in inhibition of 11βHSD-1 and reduced serum cortisol concentrations. As a consequence, previously undiagnosed central (secondary) hypoadrenalism may be unmasked and glucocorticoid replacement may be required in patients treated with somatropin. In addition, patients treated with glucocorticoid replacement for previously diagnosed hypoadrenalism may require an increase in their maintenance or stress doses following initiation of somatropin treatment; this may be especially true for patients treated with cortisone acetate and prednisone since conversion of these drugs to their biologically active metabolites is dependent on the activity of 11βHSD-1 [see Warnings and Precautions(5.8)].

7.2 Pharmacologic Glucocorticoid Therapy and Supraphysiologic Glucocorticoid Treatment

Pharmacologic glucocorticoid therapy and supraphysiologic glucocorticoid treatment may attenuate the growth promoting effects of somatropin in children. Therefore, glucocorticoid replacement dosing should be carefully adjusted in children receiving concomitant somatropin and glucocorticoid treatments to avoid both hypoadrenalism and an inhibitory effect on growth.

7.3 Cytochrome P450-Metabolized Drugs

Limited published data indicate that somatropin treatment increases cytochrome P450 (CYP450)-mediated antipyrine clearance in man. These data suggest that somatropin administration may alter the clearance of compounds known to be metabolized by CYP450 liver enzymes (e.g., corticosteroids, sex steroids, anticonvulsants, cyclosporine). Careful monitoring is advisable when somatropin is administered in combination with other drugs known to be metabolized by CYP450 liver enzymes. However, formal drug interaction studies have not been conducted.

7.4 Oral Estrogen

In adult women on oral estrogen replacement, a larger dose of somatropin may be required to achieve the defined treatment goal [see Dosage and Administration (2.2)].

7.5 Insulin and/or Oral Hypoglycemic Agents

In patients with diabetes mellitus requiring drug therapy, the dose of insulin and/or oral agent may require adjustment when somatropin therapy is initiated [see Warnings and Precautions (5.4)].

8.1 Pregnancy

Risk Summary

OMNITROPE contains the preservative benzyl alcohol. Because benzyl alcohol is rapidly metabolized by a pregnant woman, benzyl alcohol exposure in the fetus is unlikely. However, adverse reactions have occurred in premature neonates and low birth weight infants who received intravenously administered benzyl alcohol-containing drugs [see Warnings and Precautions (5.16)].

Limited available data with somatropin use in pregnant women are insufficient to determine a drug-associated risk of adverse developmental outcomes. In animal studies (rats and rabbits), there was no evidence of embryo‑fetal or neonatal harm following somatropin administration during organogenesis at doses approximately 24 times and 19 times the recommended human therapeutic levels, respectively, based on body surface area (see Data).

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Data

Animal Data

Animal reproduction studies with somatropin during the period of organogenesis at doses of 0.3, 1, and 3.3 mg/kg/day administered subcutaneously in pregnant rats and 0.08, 0.3, and 1.3 mg/kg/day administered intramuscularly in pregnant rabbits were not teratogenic (highest doses approximately 24 times and 19 times the recommended human therapeutic levels, respectively, based on body surface area).

In perinatal and postnatal studies in rats, doses of 0.3, 1, and 3.3 mg/kg/day somatropin produced growth-promoting effects in the dams but not in the fetuses. Young rats at the highest dose showed increased weight gain during suckling but the effect was not apparent by 10 weeks of age. No adverse effects were observed on gestation, morphogenesis, parturition, lactation, postnatal development, or reproductive capacity of the offspring due to somatropin.

8.2 Lactation

Risk Summary

There is no information regarding the presence of somatropin in human milk. Limited published data indicate that exogenous somatropin does not increase normal breastmilk concentrations of growth hormone. No adverse effects related to somatropin in the breastfed infant have been reported. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for OMNITROPE and any potential adverse effects on the breastfed infant from OMNITROPE or from the underlying maternal condition.

8.5 Geriatric Use

The safety and effectiveness of OMNITROPE in patients aged 65 and over have not been evaluated in clinical studies. Elderly patients may be more sensitive to the action of somatropin, and therefore may be more prone to develop adverse reactions. A lower starting dose and smaller dose increments should be considered for older patients [see Dosage and Administration (2.2)].

12.1 Mechanism of Action

Somatropin (as well as endogenous GH) binds to a dimeric GH receptor in the cell membrane of target cells resulting in intracellular signal transduction and a host of pharmacodynamic effects. Some of these pharmacodynamic effects are primarily mediated by IGF-1 produced in the liver and also locally (e.g., skeletal growth, protein synthesis), while others are primarily a consequence of the direct effects of somatropin (e.g., lipolysis) [see Pharmacodynamics (12.2)].

12.2 Pharmacodynamics

12.3 Pharmacokinetics

There are no pharmacokinetic studies using OMNITROPE Cartridges in patients with growth hormone deficiency.

12.6 Immunogenicity

The observed incidence of anti-drug antibodies is highly dependent on the sensitivity and specificity of the assay. Differences in assay methods preclude meaningful comparisons of the incidence of anti-drug antibodies in the studies described below with the incidence of anti-drug antibodies in other studies, including those of OMNITROPE or other somatropins.

In the case of growth hormone, antibodies with binding capacities lower than 2 mg/mL have not been associated with growth attenuation. In a very small number of patients treated with somatropin, when binding capacity was greater than 2 mg/mL, interference with the growth response was observed.

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenicity, mutagenicity, and fertility studies have not been conducted with OMNITROPE.

In rats receiving subcutaneous somatropin doses during gametogenesis and up to 7 days of pregnancy, 3.3 mg/kg/day (approximately 24 times human dose) produced anestrus or extended estrus cycles in females and fewer and less motile sperm in males. When given to pregnant female rats (days 1 to 7 of gestation) at 3.3 mg/kg/day a very slight increase in fetal deaths was observed. At 1 mg/kg/day (approximately seven times human dose) rats showed slightly extended estrus cycles, whereas at 0.3 mg/kg/day no effects were noted.

14.1 Pediatric Growth Hormone Deficiency (GHD)

The efficacy and safety of OMNITROPE were compared with another somatropin product approved for growth hormone deficiency (GHD) in pediatric patients. In sequential clinical trials involving a total of 89 GHD children, 44 patients received OMNITROPE for Injection (lyophilized powder) 5.8 mg/vial and 45 patients received the comparator somatropin product for 9 months. After 9 months of treatment patients who had received the comparator somatropin product 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. Similar effects on growth were observed between OMNITROPE for Injection and the comparator somatropin product during the initial 9 months of treatment.

The efficacy results after 9 months of treatment (OMNITROPE for Injection vs. the comparator somatropin product) and after 15 months (OMNITROPE Cartridge) are summarized in Table 5.

14.2 Adult Growth Hormone Deficiency (GHD)

Another somatropin lyophilized powder was compared with placebo in six randomized clinical trials involving a total of 172 adult GHD patients. These trials included a 6-month double-blind treatment period, during which 85 patients received this other somatropin and 87 patients received placebo, followed by an open-label treatment period in which participating patients received this other somatropin 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.

Beneficial changes in body composition were observed at the end of the 6-month treatment period for the patients receiving this other somatropin product as compared with the placebo patients. 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.

14.3 Prader-Willi Syndrome (PWS)

The safety and efficacy of another somatropin product in the treatment of pediatric patients with Prader-Willi Syndrome (PWS) were evaluated in two randomized, open-label, controlled clinical trials. Patients received either this other somatropin product or no treatment for the first year of the studies, while all patients received 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 received this other somatropin product at a dose of 0.24 mg/kg/week during the entire study. During the second year, the control group received this other somatropin product at a dose of 0.48 mg/kg/week. In Study 2, the treatment group received this other somatropin product at a dose of 0.36 mg/kg/week during the entire study. During the second year, the control group received this other somatropin product at a dose of 0.36 mg/kg/week.

Patients who received this other somatropin product showed significant increases in linear growth during the first year of study, compared with patients who received no treatment (see Table 6). Linear growth continued to increase in the second year, when both groups received treatment with this other somatropin product.

Changes in body composition were also observed in the patients receiving this other somatropin product (see Table 7). These changes included a decrease in the amount of fat mass, and increases in the amount of lean body mass and the ratio of lean-to-fat tissue, while changes in body weight were similar to those seen in patients who received no treatment. Treatment with this other somatropin product did not accelerate bone age, compared with patients who received no treatment.

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

The safety and efficacy of another somatropin product in the treatment of children born small for gestational age (SGA) were evaluated in 4 randomized, open-label, controlled clinical trials. Patients (age range of 2 to 8 years) were observed for 12 months before being randomized to receive either this other somatropin product (two doses per study, most often 0.24 and 0.48 mg/kg/week) as a daily SC injection or no treatment for the first 24 months of the studies. After 24 months in the studies, all patients received this other somatropin product.

Patients who received any dose of this other somatropin product showed significant increases in growth during the first 24 months of study, compared with patients who received no treatment (see Table 8). 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 (data not shown).

14.5 Idiopathic Short Stature (ISS)

The long-term efficacy and safety of another somatropin product in patients with idiopathic short stature (ISS) were evaluated in one randomized, open-label, clinical trial that enrolled 177 children. Patients were enrolled on the basis of short stature, stimulated GH secretion > 10 ng/mL, and prepubertal status (criteria for idiopathic short stature were retrospectively applied and included 126 patients). 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. Two somatropin doses were evaluated in this trial: 0.23 mg/kg/week (0.033 mg/kg/day) and 0.47mg/kg/week (0.067 mg/kg/day). Baseline patient characteristics for the ISS patients who remained prepubertal at randomization (n= 105) were: mean (± SD): chronological 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). Patients were treated for a median duration of 5.7 years. Results for final height SDS are displayed by treatment arm in Table 9. Therapy with this other somatropin product improved final height in ISS children relative to untreated controls. 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.

14.6 Turner Syndrome

Two randomized, open-label, clinical trials were conducted that evaluated the efficacy and safety of another somatropin product in 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.

SDS for height velocity and height are expressed using either the Tanner (Study 1) or Sempé (Study 2) standards for age-matched normal children as well as the Ranke standard (both studies) for age-matched, untreated Turner Syndrome patients. As seen in Table 10, height velocity SDS and height SDS values were smaller at baseline and after treatment with this other somatropin product when the normative standards were utilized as opposed to the Turner Syndrome standard.

Both studies demonstrated statistically significant increases from baseline in all of the linear growth variables (i.e., mean height velocity, height velocity SDS, and height SDS) after treatment with this other somatropin product (see Table 10). The linear growth response was greater in Study 1 wherein patients were treated with a larger dose of this other somatropin product.

16.1 How Supplied

OMNITROPE (somatropin) injection is a clear, colorless, sterile solution for subcutaneous injection supplied in a cartridge for use with OMNITROPE Pen delivery system.

OMNITROPE (somatropin) for injection is a white to off-white lyophilized powder supplied in a vial for subcutaneous injection after reconstitution with co-packaged diluent.

a For use only with the OMNITROPE Pen 5 delivery system, which is sold separately.

b For use only with the OMNITROPE Pen 10 delivery system, which is sold separately.

16.2 Storage and Handling

Before use, store OMNITROPE vials and cartridges refrigerated at 2° to 8°C (36° to 46°F) in the original carton to protect from light. Do not freeze.

After first use, the OMNITROPE cartridge should remain in the pen and kept the original carton in a refrigerator at 2° to 8°C (36° to 46°F) for a maximum of 28 days (see Table 11). Discard unused portions in the cartridge after 28 days.

After reconstitution of the lyophilized powder, the contents of the OMNITROPE vial must be used within 21 days. After the first injection, store the vial in the original carton in a refrigerator at 2° to 8°C (36° to 46°F) (see Table 11). Discard unused portions after 21 days.

INSTRUCTIONS FOR USE

OMNITROPE® PEN 5

OMNITROPE (om-KNEE-trope)

(somatropin) injection, for subcutaneous use

5 mg/1.5 mL Single-Patient-Use cartridges for use with

Omnitrope Pen 5

Read this Instructions for Use before you start using Omnitrope Pen 5 and each time you get a refill. There may be new information. This information does not take the place of talking to the healthcare provider about the medical condition or the treatment.

Note:

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Omnitrope is for use under the skin only (subcutaneous).

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Do not share your Omnitrope Pen or needles with anyone else. You may give an infection to them or get an infection from them.

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The “Start use by no later than” date, printed in year, month, and day on the outer carton, shows the date after which treatment should not be started with this pen.

Omnitrope Pen 5, Single-Patient-Use cartridge containing Omnitrope, needle, alcohol swab and storage case:

Figure A

Supplies you will need to give an Omnitrope Injection. See Figure A.

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Omnitrope Pen 5

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5 mg/1.5 mL cartridge containing Omnitrope

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1 new BD™ Pen needle (29G x 12.7 mm or 31G x 8 mm or 31G x 5 mm). Needles are not included with the Pen.

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1 alcohol swab

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flat surface like a table

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a sharps disposal container. See Step 6 for information on how to throw away (dispose of) used needles and cartridges.

Steps you should follow to give an Omnitrope injection:

Step 1. Placing the cartridge in the Omnitrope Pen 5

Step 2. Attaching the needle to the Omnitrope Pen 5

Step 3. Priming a new cartridge

Step 4. Selecting the correct dose of Omnitrope

Step 5. Selecting the injection site and injecting the dose of Omnitrope

Step 6. Removing and throwing away the needle and empty cartridge

Step 1. Placing the cartridge in the Omnitrope Pen 5

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Take an Omnitrope cartridge out of the refrigerator and leave at room temperature for about 30 minutes. Wash and dry your hands while you wait.

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Assemble all of the supplies needed on a flat surface. Remove the Pen and cartridge from their cartons if you are preparing the injection for the first time.

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Hold the body of the Pen with 1 hand and pull off the Pen cap with the other hand. See Figure B.

Figure B

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Hold the body of the Pen with 1 hand and unscrew the cartridge holder in a clockwise direction until the Pen and cartridge holder are completely separated. See Figure C.

Figure C

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Hold the cartridge in 1 hand with the metal cap end pointing down. Insert the cartridge into the cartridge holder. See Figure D.

Figure D

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Lower the Pen body onto the cartridge holder so that the black rod presses against the cartridge plunger. Screw the cartridge holder onto the Pen body in a counterclockwise direction until the cartridge holder will not turn anymore. One of the blue arrows on the cartridge holder must line up with the yellow line mark on the Pen body. Do not over tighten the cartridge holder. See Figure E.

Figure E

Step 2. Attaching the needle to the Omnitrope Pen 5

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Take a new disposable needle and tear off the paper tab. Do not touch the needle or lay it on a surface. See Figure F.

Figure F

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Holding the cartridge holder with 1 hand, firmly press the needle onto the cartridge holder end of the Pen. See Figure G. Screw the threaded part of the needle onto the cartridge holder in a counterclockwise direction until the needle will not turn anymore. See Figure H.

Figure G

Figure H

•

Gently pull off the outer needle shield and put it on a flat surface. You will use the outer needle shield later to remove the needle from the Pen after the injection is finished. See Figure I.

Figure I

Note: Check that the cartridge holder is attached to the Pen body before each injection. One of the blue arrows on the cartridge should be lined up with the yellow mark on the Pen body. After you attach the needle, you may see a few drops of medicine at the tip of the needle.

Step 3. Priming a new cartridge

•

Priming is not needed for a cartridge you have used before. If the cartridge has already been primed, go to Step 4.

•

Before you use a new cartridge you must first prepare it for use. Hold the Pen with the needle pointing upwards. Gently tap the cartridge holder with your finger to help air bubbles rise to the top of the cartridge. See Figure J.

Figure J

•

Hold the pen with the needle pointing up and the dose window facing you and you will see the numbers in the dose window at the bottom of the Pen body. Using the dose knob on the bottom of the Pen, slowly turn the dose knob in a clockwise direction as shown in Figure K until you hear 1 “click”. The arrow on the Pen body will then be lined up with the small line between “0” and “0.1” (0.05 mg). See Figure K.

Figure K

•

Remove the inner needle shield. See Figure L.

•

With the needle pointing up, firmly turn the dose knob in a counterclockwise direction and back to the “0” position.

Figure L

At least 2 drops of medicine must flow out of the needle for the Pen to be properly primed. See Figure M.

Figure M

•

If at least 2 drops of medicine do not flow out, set the dose to 0.05 mg and repeat this step until at least 2 drops of medicine appear at the tip of the needle.

•

When you see 2 drops of medicine flow out of the needle, the Pen is correctly primed and ready to use.

Step 4. Selecting the correct dose of Omnitrope

•

Hold the pen with the needle pointing up and the dose window facing you and turn (dial) the dose knob in a clockwise direction until you see the number of mg for the prescribed dose in the middle of the dose window. The dose should be lined up with the arrow on the Pen body. You will hear 1 click for every single unit you dial. See Figure N.

Do not count the clicks to measure the correct dose of medicine.

Figure N

•

If you turn the dose knob past the correct dose, do not dial counterclockwise.

Instead, hold the Pen body with the needle pointing up and turn the dose knob in a clockwise direction until you see a bent arrow () in the dose dialing window. See Figure O. Now continue to turn the dose knob in a clockwise direction until you hear a click and the entire Pen body is fully extended.

The injection button can now be fully pressed, resetting the dial to “0” without giving medicine. The correct dose can now be redialed.

Figure O

•

Check that the cartridge holder is still attached to the Pen body, with the blue arrow lined up with the yellow mark on the Pen body.

Step 5. Selecting the injection site and injecting the dose of Omnitrope

The best sites for injection are tissues with a layer of fat between skin and muscle such as the upper leg (thigh), buttocks, or stomach area (abdomen) as in the picture shown below. Do not inject near your belly button (navel) or waistline.

Change the injection site every day. See Figure P.

Figure P

•

Select the injection site and wipe the skin with an alcohol swab as your healthcare provider showed you.

•

With 1 hand, pinch a fold of loose skin at the injection site.

•

With your other hand, insert the needle under the skin (at an angle of 45° to 90°) as your healthcare provider showed you. See Figure Q.

Figure Q

•

After inserting the needle into the skin, push the injection button as far in as it will go and press the button firmly. A clicking sound will be heard while the dose is being injected. Continue to press firmly on the injection button for 5 seconds before you remove the needle from the skin. See Figure R.

Figure R

•

Stop pressing the injection button before you carefully remove the needle from the skin.

•

If the injection button cannot be pushed in completely or stops during the injection, and the cartridge is empty, then the full dose has not been given. The dose indicator window will show the amount of medicine still needed. Reset the dose knob to “0” as described in Step 4. Remove the needle as described in Step 6. Replace the empty cartridge with a new cartridge as described in Step 1. Prime the new cartridge as described in Step 3. Set the dose, which you noted, and inject. This completes your dose.

Step 6. Removing and throwing away the needle and empty cartridge

•

Carefully replace the outer needle shield. See Figure S.

Figure S

•

Hold the Pen by the cartridge holder and carefully remove the needle from the Pen by turning the needle in a clockwise direction. See Figure T. Recap the pen.

Figure T

•

Put your used needles and cartridges in a FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) loose needles and cartridges in your household trash.

•

If you do not have a FDA-cleared sharps disposal container, you may use a household container that is:

o

made of a heavy-duty plastic,

o

can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,

o

upright and stable during use,

o

leak-resistant, and

o

properly labeled to warn of hazardous waste inside the container.

•

When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and cartridges. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA’s website at: http://www.fda.gov/safesharpsdisposal.

•

Do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. Do not recycle your used sharps disposal container.

How should I store Omnitrope Pen 5?

•

Store Omnitrope cartridges in the refrigerator between 36°F and 46°F (2°C and 8°C).

•

When the Omnitrope Pen 5 contains a cartridge, do not remove the cartridge from the Pen in between injections. Store the Pen containing the cartridge in the storage case provided and place in the refrigerator.

•

When the Pen does not contain a cartridge, you may store the Pen at room temperature.

•

Do not freeze Omnitrope cartridges.

•

Protect the Omnitrope Pen 5 and cartridge from light by storing in their cartons or the storage case.

•

The Omnitrope cartridge must be thrown away 28 days after the first injection. The Omnitrope Pen 5 can be reloaded with a new cartridge and can be used multiple times.

Important information about possible problems you may have with the Omnitrope Pen 5

If the Omnitrope Pen 5 is damaged or does not work, call the pharmacy where you got the Omnitrope Pen 5. If you got your Omnitrope Pen 5 from OmniSource, call 1-877-456-6794.

For other questions or additional information, call OmniSource at 1-877-456-6794. Do not try to repair the Pen yourself.

Your Omnitrope Pen 5 is covered by a 2 year guarantee. Contact your Omnitrope Pen 5 provider after you have used the pen for 2 years to have it replaced by a new one.

This guarantee is invalid if your Omnitrope Pen 5 has not been used in accordance with the manufacturer’s instruction leaflet or if the defect has been caused by neglect, misuse or accident.

BD and BD Logo are trademarks of Becton, Dickinson and Company © 2019 BD. All rights reserved.

Manufactured by:

Sandoz Inc.

Princeton, NJ 08540

US License No. 2003

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

November 2024

INSTRUCTIONS FOR USE

OMNITROPE® PEN 10

OMNITROPE (om-KNEE-trope)

(somatropin) injection, for subcutaneous use

10 mg/1.5 mL Single-Patient-Use cartridges for use with

Omnitrope Pen 10

Read this Instructions for Use before you start using Omnitrope Pen 10 and each time you get a refill. There may be new information. This information does not take the place of talking to the healthcare provider about the medical condition or the treatment.

Note:

•

Omnitrope is for use under the skin only (subcutaneous).

•

Do not share your Omnitrope Pen or needles with anyone else. You may give an infection to them or get an infection from them.

•

The “Start use by no later than” date, printed in year, month, and day on the outer carton, shows the date after which treatment should not be started with this pen.

Omnitrope Pen 10, Single-Patient-Use cartridge containing Omnitrope, needle, alcohol swab and storage case:

Figure A

Supplies you will need to give an Omnitrope Injection. See Figure A.

•

Omnitrope Pen 10

•

10 mg/1.5 mL cartridge containing Omnitrope

•

1 new BD™ Pen needle (29G x 12.7 mm or 31G x 8 mm or 31G x 5 mm). Needles are not included with the Pen.

•

1 alcohol swab

•

flat surface like a table

•

a sharps disposal container. See Step 6 for information on how to throw away (dispose of) used needles and cartridges.

Steps you should follow to give an Omnitrope injection:

Step 1. Placing the cartridge in the Omnitrope Pen 10

Step 2. Attaching the needle to the Omnitrope Pen 10

Step 3. Priming a new cartridge

Step 4. Selecting the correct dose of Omnitrope

Step 5. Selecting the injection site and injecting the dose of Omnitrope

Step 6. Removing and throwing away the needle and empty cartridge

Step 1. Placing the cartridge in the Omnitrope Pen 10

•

Take an Omnitrope cartridge out of the refrigerator and leave at room temperature for about 30 minutes. Wash and dry your hands while you wait.

•

Assemble all of the supplies needed on a flat surface. Remove the Pen and cartridge from their cartons if you are preparing the injection for the first time.

•

Hold the body of the Pen with 1 hand and pull off the Pen cap with the other hand. See Figure B.

Figure B

•

Hold the body of the Pen with 1 hand and unscrew the cartridge holder in a clockwise direction until the Pen and cartridge holder are completely separated. See Figure C.

Figure C

•

Hold the cartridge in 1 hand with the metal cap end pointing down. Insert the cartridge into the cartridge holder. See Figure D.

Figure D

•

Lower the Pen body onto the cartridge holder so that the black rod presses against the cartridge plunger. Screw the cartridge holder onto the Pen body in a counterclockwise direction until the cartridge holder will not turn anymore. One of the blue arrows on the cartridge holder must line up with the white line mark on the Pen body. Do not over tighten the cartridge holder. See Figure E.

Figure E

Step 2. Attaching the needle to the Omnitrope Pen 10

•

Take a new disposable needle and tear off the paper tab. Do not touch the needle or lay it on a surface. See Figure F.

Figure F

•

Holding the cartridge holder with 1 hand, firmly press the needle onto the cartridge holder end of the Pen. See Figure G. Screw the threaded part of the needle onto the cartridge holder in a counterclockwise direction until the needle will not turn anymore. See Figure H.

Figure G

Figure H

•

Gently pull off the outer needle shield and put it on a flat surface. You will use the outer needle shield later to remove the needle from the Pen after the injection is finished. See Figure I.

Figure I

Note: Check that the cartridge holder is attached to the Pen body before each injection. One of the blue arrows on the cartridge should be lined up with the white mark on the Pen body. After you attach the needle, you may see a few drops of medicine at the tip of the needle.

Step 3. Priming a new cartridge

•

Priming is not needed for a cartridge you have used before. If the cartridge has already been primed, go to Step 4.

•

Before you use a new cartridge you must first prepare it for use. Hold the Pen with the needle pointing upwards. Gently tap the cartridge holder with your finger to help air bubbles rise to the top of the cartridge. See Figure J.

Figure J

•

Hold the pen with the needle pointing up and the dose window facing you and you will see the numbers in the dose window at the bottom of the Pen body. Using the dose knob on the bottom of the Pen, slowly turn the dose knob in a clockwise direction as shown in Figure K until you hear 1 “click”. The arrow on the Pen body will then be lined up with the small line between “0” and “0.2” (0.1 mg). See Figure K.

Figure K

•

Remove the inner needle shield. See Figure L.

•

With the needle pointing up, firmly turn the dose knob in a counterclockwise direction and back to the “0” position.

Figure L

At least 2 drops of medicine must flow out of the needle for the Pen to be properly primed. See Figure M.

Figure M

•

If at least 2 drops of medicine do not flow out, set the dose to 0.1 mg and repeat this step until at least 2 drops of medicine appear at the tip of the needle.

•

When you see 2 drops of medicine flow out of the needle, the Pen is correctly primed and ready to use.

Step 4. Selecting the correct dose of Omnitrope

•

Hold the pen with the needle pointing up and the dose window facing you and turn (dial) the dose knob in a clockwise direction until you see the number of mg for the prescribed dose in the middle of the dose window. The dose should be lined up with the arrow on the Pen body. You will hear 1 click for every single unit you dial. See Figure N.

Do not count the clicks to measure the correct dose of medicine.

Figure N

•

If you turn the dose knob past the correct dose, do not dial counterclockwise.

Instead, hold the Pen body with the needle pointing up and turn the dose knob in a clockwise direction until you see a bent arrow () in the dose dialing window. See Figure O. Now continue to turn the dose knob in a clockwise direction until you hear a click and the entire Pen body is fully extended.

The injection button can now be fully pressed, resetting the dial to “0” without giving medicine. The correct dose can now be redialed.

Figure O

•

Check that the cartridge holder is still attached to the Pen body, with the blue arrow lined up with the white mark on the Pen body.

Step 5. Selecting the injection site and injecting the dose of Omnitrope

The best sites for injection are tissues with a layer of fat between skin and muscle such as the upper leg (thigh), buttocks, or stomach area (abdomen) as in the picture shown below. Do not inject near your belly button (navel) or waistline.

Change the injection site every day. See Figure P.

Figure P

•

Select the injection site and wipe the skin with an alcohol swab as your healthcare provider showed you.

•

With 1 hand, pinch a fold of loose skin at the injection site.

•

With your other hand, insert the needle under the skin (at an angle of 45° to 90°) as your healthcare provider showed you. See Figure Q.

Figure Q

•

After inserting the needle into the skin, push the injection button as far in as it will go and press the button firmly. A clicking sound will be heard while the dose is being injected. Continue to press firmly on the injection button for 5 seconds before you remove the needle from the skin. See Figure R.

Figure R

•

Stop pressing the injection button before you carefully remove the needle from the skin.

•

If the injection button cannot be pushed in completely or stops during the injection, and the cartridge is empty, then the full dose has not been given. The dose indicator window will show the amount of medicine still needed. Reset the dose knob to “0” as described in Step 4. Remove the needle as described in Step 6. Replace the empty cartridge with a new cartridge as described in Step 1. Prime the new cartridge as described in Step 3. Set the dose, which you noted, and inject. This completes your dose.

Step 6. Removing and throwing away the needle and empty cartridge

•

Carefully replace the outer needle shield. See Figure S.

Figure S

•

Hold the Pen by the cartridge holder and carefully remove the needle from the Pen by turning the needle in a clockwise direction. See Figure T. Recap the pen.

Figure T

•

Put your used needles and cartridges in a FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) loose needles and cartridges in your household trash.

•

If you do not have a FDA-cleared sharps disposal container, you may use a household container that is:

o

made of a heavy-duty plastic,

o

can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,

o

upright and stable during use,

o

leak-resistant, and

o

properly labeled to warn of hazardous waste inside the container.

•

When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and cartridges. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA’s website at: http://www.fda.gov/safesharpsdisposal.

•

Do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. Do not recycle your used sharps disposal container.

How should I store Omnitrope Pen 10?

•

Store Omnitrope cartridges in the refrigerator between 36°F and 46°F (2°C and 8°C).

•

When the Omnitrope Pen 10 contains a cartridge, do not remove the cartridge from the Pen in between injections. Store the Pen containing the cartridge in the storage case provided and place in the refrigerator.

•

When the Pen does not contain a cartridge, you may store the Pen at room temperature.

•

Do not freeze Omnitrope cartridges.

•

Protect the Omnitrope Pen 10 and cartridge from light by storing in their cartons or the storage case.

•

The Omnitrope cartridge must be thrown away 28 days after the first injection. The Omnitrope Pen 10 can be reloaded with a new cartridge and can be used multiple times.

Important information about possible problems you may have with the Omnitrope Pen 10

If the Omnitrope Pen 10 is damaged or does not work, call the pharmacy where you got the Omnitrope Pen 10. If you got your Omnitrope Pen 10 from OmniSource, call 1-877-456-6794.

For other questions or additional information, call OmniSource at 1-877-456-6794. Do not try to repair the Pen yourself.

Your Omnitrope Pen 10 is covered by a 2 year guarantee. Contact your Omnitrope Pen 10 provider after you have used the pen for 2 years to have it replaced by a new one.

This guarantee is invalid if your Omnitrope Pen 10 has not been used in accordance with the manufacturer’s instruction leaflet or if the defect has been caused by neglect, misuse or accident.

BD and BD Logo are trademarks of Becton, Dickinson and Company © 2019 BD. All rights reserved.

Manufactured by:

Sandoz Inc.

Princeton, NJ 08540

US License No. 2003

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

November 2024

INSTRUCTIONS FOR USE

OMNITROPE (om-KNEE-trope)

(somatropin) for injection, for subcutaneous use

OMNITROPE® 5.8 mg/vial

The following instructions explain how to inject OMNITROPE 5.8 mg. Do not inject OMNITROPE yourself until your healthcare provider has taught you and you understand the instructions. Ask your healthcare provider or pharmacist if you have any questions about injecting OMNITROPE.

•

OMNITROPE 5.8 mg is for Single-Patient-Use.

•

The concentration of OMNITROPE after mixing is 5 mg/mL.

•

After mixing, OMNITROPE 5.8 mg contains a preservative and should not be used in newborns.

Preparation

Collect the needed items before you begin:

•

a vial with OMNITROPE 5.8 mg

•

a vial with diluent (mixing liquid - Bacteriostatic Water for Injection containing benzyl alcohol as preservative) for OMNITROPE 5.8 mg

•

a sterile, disposable 3 mL syringe and needle for withdrawing the diluent from the vial (not supplied in the pack)

•

sterile disposable 1 mL syringes and needles for under the skin (subcutaneous) injection (not supplied in the pack)

•

2 alcohol swabs (not supplied in the pack)

Wash your hands before you start with the next steps.

Mixing OMNITROPE 5.8 mg

•

Remove the protective caps from the two vials. With one alcohol swab, clean both the rubber top of the vial that contains the powder and the rubber top of the vial that contains diluent.

•

Next use the sterile diluent vial, the disposal 3 mL syringe and a needle.

•

Attach the needle to the syringe (if not attached already). Pull back the syringe plunger and fill the syringe with air. Push the needle fitted to the syringe through the rubber top of the diluent vial, push all the air from the syringe into the vial, turn the vial upside down, and withdraw all the diluent from the vial into the syringe. Remove the syringe and needle.

•

Next take the syringe with the diluent in it and push the needle through the rubber stopper of the vial that contains the white powder. Inject the diluent slowly. Aim the stream of liquid against the glass wall in order to avoid foam. Remove the syringe and needle and throw them away.

•

Gently swirl the vial until the content is completely dissolved. Do not shake.

•

If the medicine is cloudy or contains particles, it should not be used. The medicine must be clear and colorless after mixing.

•

After mixing the medicine, the medicine in the vial must be used within 3 weeks. Store the vial in a refrigerator between 36°F to 46°F (2°C to 8°C) after mixing and using it each time.

Measuring the Dose of OMNITROPE 5.8 mg to Be Injected

•

Next use the sterile, disposable 1 mL (or similar) syringe and needle for subcutaneous injection. Push the needle through the rubber top of the vial that contains the medicine that you have just mixed.

•

Turn the vial and the syringe upside down.

•

Be sure the tip of the syringe is in the OMNITROPE mixed medicine.

•

Pull back on the plunger slowly and withdraw the dose prescribed by your healthcare provider into the syringe.

•

Hold the syringe with the needle in the vial pointing up and remove the syringe from the vial.

•

Check for air bubbles in the syringe. If you see any bubbles, pull the plunger slightly back; tap the syringe gently, with the needle pointing upwards, until the bubble disappears. Push the plunger slowly back up to the correct dose. If there is not enough medicine in the syringe after removing the air bubbles, draw more medicine into the syringe from the mixed medicine vial and repeat checking for bubbles.

•

Look at the mixed medicine in the syringe before using. Do not use if discolored or particles are present. You are now ready to inject the dose.

Injecting OMNITROPE 5.8 mg

•

Choose the site of injection on your body. The best sites for injection are tissues with a layer of fat between skin and muscle such as the upper leg (thigh), buttocks, or stomach area (abdomen) as in the picture shown below. Do not inject near your belly button (navel) or waistline.

•

Make sure you rotate the injection sites on your body. Inject at least 1/2 inch from the last injection. Change the places on your body where you inject, as instructed by your healthcare provider.

•

Before you make an injection, clean your skin well with an alcohol swab. Wait for the area to air dry.

•

With one hand, pinch a fold of loose skin at the injection site. With your other hand, hold the syringe as you would hold a pencil. Insert the needle into the pinched skin straight in or at a slight angle (an angle of 45° to 90°). After the needle is in, remove the hand used to pinch the skin and use it to hold the syringe barrel. Pull back the plunger very slightly with one hand. If blood comes into the syringe, the needle has entered a blood vessel. Do not inject into this site; withdraw the needle and repeat the procedure at a different site. If no blood comes into the syringe, inject the solution by pushing the plunger all the way down gently.

•

Pull the needle straight out of the skin. After injection, press the injection site with a small bandage or sterile gauze if needed for bleeding, for several seconds. Do not massage or rub the injection site.

After Injecting OMNITROPE 5.8 mg

•

Put your used needles and syringes in a FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) loose needles and syringes in your household trash.

•

If you do not have a FDA-cleared sharps disposal container, you may use a household container that is:

o

made of a heavy-duty plastic,

o

can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,

o

upright and stable during use,

o

leak-resistant, and

o

properly labeled to warn of hazardous waste inside the container.

•

When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and cartridges. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA’s website at: http://www.fda.gov/safesharpsdisposal.

•

Do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. Do not recycle your used sharps disposal container.

How should I store OMNITROPE 5.8 mg?

•

Before Use: store the vials in the refrigerator between 36°F to 46°F (2°C to 8°C) until the expiration date. Do not use if the expiration date has passed.

•

After Mixing: store the vial of mixed medicine in the refrigerator between 36°F to 46°F (2°C to 8°C) and use within 3 weeks. Throw away any unused medicine after 3 weeks.

•

Protect the vials from light by storing in their cartons.

•

Do not freeze.

•

The liquid should be clear after removal from the refrigerator. If the liquid is cloudy or contains particles, throw away the vial. Do not inject the medicine from this vial. Start over with a new vial of OMNITROPE 5.8 mg. Call your pharmacist if you need a replacement.

•

Before each use clean the rubber top of the mixed medicine vial with an alcohol swab. You must use a new disposable 1 mL syringe and needle for each injection.

Manufactured by:

Sandoz Inc.

Princeton, NJ 08540

US License No. 2003

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

November 2024