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OMNITROPE is a brand name for Somatropin (also known as Somatotropin), supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Omnitrope (somatropin for injection) is indicated for: Children The long-term treatment of children, who have growth failure due to an inadequate secretion of endogenous growth hormone (growth hormone deficiency [GHD]). Other causes of short stature should be excluded. SGA Indication Omnitrope is indicated for the…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations Therapy with Omnitrope (somatropin for injection) should be supervised by a physician who is experienced in the diagnosis and management of pediatric patients with growth failure associated with growth hormone deficiency (GHD), Turner syndrome (TS), those who were born small for gestational age (SGA) or Idiopathic Short Stature (ISS), and adult patients with either childhood onset or adult onset GHD.
The Omnitrope dosage and administration schedule should be individualized based on the growth response of each patient. Response to somatropin therapy in pediatric patients tends to decrease with time. However, in pediatric patients, the failure to increase growth rate, particularly during the first year of therapy, indicates the need for close assessment of compliance and evaluation for other causes of growth failure, such as hypothyroidism, undernutrition, advanced bone age and antibodies to recombinant human GH (rhGH).
Treatment with Omnitrope for short stature should be discontinued when the epiphyses are fused. 24 mg/kg body weight/week SC Divided into 6-7 doses diagnosis of GHD should be confirmed before Omnitrope is administered. 48 mg/kg body weight per week SC Divided into 6-7 doses 1 Omnitrope dosage must be adjusted for the individual patient.
33 mg. Women may require higher doses than men. This means that there is a risk that women, especially those on oral estrogen replacement may be under-treated. As normal physiological growth hormone production decreases with age, dose requirements may be reduced.
3 Treatment should stop when near adult height is achieved (height velocity < 2 cm/ yr and/or bone age >16 yr in boys and >14 yr in girls) or when height is in the normal adult range (above -2 SDS). 4 Omnitrope may be administered in the thigh, buttocks or abdomen; the site of SC injections (administered preferably in the evenings) should be rotated daily to help prevent lipoatrophy.
OMNITROPE (somatropin for injection) Page 7 of 69 Adults Growth Hormone Deficiency Clinical response, side effects and determination of IGF-1 in serum may be used as guidance for dose titration. The level of IGF-1 should not exceed the upper limit of normal IGF-1 levels matched to age and sex.
It is recommended that IGF-1 concentrations be monitored regularly and GH dose be reduced in children with a plasma IGF-1 above + 2SD. 24 mg/kg/week) should be considered if substantial catch-up growth is observed during the first few years of therapy.
). g. hypertension, stroke, and aortic dilatation, aneurysm and dissection) and these patients should be monitored closely for development or worsening of these conditions before and during treatment with somatropin. Patients with Turner syndrome have an inherently increased risk of developing autoimmune thyroid disease.
Therefore, these patients should have periodic thyroid function tests performed and be OMNITROPE (somatropin for injection) Page 12 of 69 treated appropriately (see 7 WARNINGS AND PRECAUTIONS, Endocrine and Metabolism).
Note:
Skeletal abnormalities including scoliosis are commonly seen in untreated patients with Turner syndrome. Dependence/ Liability Somatropin is not considered to be a drug that has potential to produce drug dependency. Somatropin does not have stimulant, depressant or hallucinogenic effects on the central nervous system that could be expected to lead to psychological or physical dependency.
Potential for Misuse:
Inappropriate use of somatropin by individuals who do not have indications for which growth hormone is approved, may result in clinically significant negative health consequences Endocrine and Metabolism Patients with diabetes mellitus or glucose intolerance should be monitored closely during therapy with somatropin as an adjustment of their antidiabetic therapy may be required.
Treatment with somatropin may decrease insulin sensitivity, particularly at higher doses in patients with risk factors for diabetes mellitus, such as obesity, Turner syndrome, or a family history of diabetes mellitus, those receiving high dose corticosteroid therapy, and patients with impaired glucose tolerance or pre-existing diabetes mellitus.
As a result, previously undiagnosed impaired glucose tolerance and overt diabetes mellitus may be unmasked during somatropin treatment. Therefore, patients who receive somatropin should be monitored for evidence of abnormal glucose metabolism and/or diabetes mellitus.
4 Geriatrics). 2 CONTRAINDICATIONS Omnitrope (somatropin for injection) should not be used when there is any evidence of neoplastic activity. Intracranial lesions must be inactive and antitumour therapy complete prior to the institution of therapy.
Treatment with Omnitrope should be discontinued if there is evidence of tumour growth. Growth hormone should not be used for growth promotion in children with fused epiphyses. Somatropin is contraindicated in patients with active proliferative or severe non-proliferative diabetic retinopathy.
Omnitrope is contraindicated in patients with acute critical illness due to complications following open heart or abdominal surgery, multiple accidental trauma, or acute respiratory failure. 5 mL solution which also contains the preservative benzyl alcohol, should not be administered in newborns or in patients with a known sensitivity to benzyl alcohol (see 7 WARNINGS AND PRECAUTIONS).
Omnitrope is contraindicated in patients with a history of hypersensitivity to any of its components. 3 SERIOUS WARNINGS AND PRECAUTIONS BOX Serious Warnings and Precautions • Therapy with somatropin should be supervised by a physician who is experienced in the diagnosis and management of patients with growth hormone deficiency and that any change in brand of somatropin products should be made cautiously and only under medical supervision.
5 mL solution has been associated with toxicity in newborns. It must not be used in newborns (see 7 WARNINGS AND PRECAUTIONS, Sensitivity/Resistance). 1 Dosing Considerations Therapy with Omnitrope (somatropin for injection) should be supervised by a physician who is experienced in the diagnosis and management of pediatric patients with growth failure associated with growth hormone deficiency (GHD), Turner syndrome (TS), those who were born small for gestational age (SGA) or Idiopathic Short Stature (ISS), and adult patients with either childhood onset or adult onset GHD.
Omnitrope (somatropin for injection) should not be used when there is any evidence of neoplastic activity. Intracranial lesions must be inactive and antitumour therapy complete prior to the institution of therapy. Treatment with Omnitrope should be discontinued if there is evidence of tumour growth.
Growth hormone should not be used for growth promotion in children with fused epiphyses. Somatropin is contraindicated in patients with active proliferative or severe non-proliferative diabetic retinopathy. Omnitrope is contraindicated in patients with acute critical illness due to complications following open heart or abdominal surgery, multiple accidental trauma, or acute respiratory failure.
5 mL solution which also contains the preservative benzyl alcohol, should not be administered in newborns or in patients with a known sensitivity to benzyl alcohol (see 7 WARNINGS AND PRECAUTIONS). Omnitrope is contraindicated in patients with a history of hypersensitivity to any of its components.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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24 mg/kg/week), and titrating the dose as needed over time. In all children, clinicians should carefully monitor the growth response, and adjust the somatropin dose as necessary. Dosing should continue until final height is reached. Treatment should be discontinued after the first year of treatment if the height velocity SDS is below + 1.
Treatment should be discontinued if height velocity is < 2 cm/year and, if confirmation is required, bone age is > 14 years (girls) or > 16 years (boys) corresponding to closure of the epiphyseal growth plates. In short children born SGA, it is recommended that IGF I concentration be measured before initiation of treatment and monitored every 6 months thereafter.
If on repeated measurements IGF-1 concentrations exceed +2 SD compared to references for age and pubertal status, the IGF-1/IGFBP-3 ratio could be taken into account to consider dose adjustment. No studies with somatropin have been carried out in geriatric patients or in patients with hepatic or renal impairment.
5 mL solutions for injection, are sterile, ready-to-use solutions filled in pen cartridges. The presentations are indicated for multiple use. 5 mL respectively. The solutions must be administered using sterile, disposable pen needles.
The solution must be clear prior to insertion of the cartridge into the Pen. Do not inject if the solution is cloudy. Patients and caregivers have to receive appropriate training and instruction on the proper use of the Omnitrope cartridges and pens from the physician or other suitable qualified healthcare professionals.
After the first injection, the content of the cartridge must be used within 28 days. The cartridge should remain in the pen and be refrigerated between 2 and 8°C. Do not freeze. Protect from light (see 11 OMNITROPE (somatropin for injection) Page 8 of 69 STORAGE, STABILITY AND DISPOSAL).
The following is a general description of […]
New-onset type 2 diabetes mellitus has been reported in children and adults receiving somatropin. In patients with hypopituitarism standard hormonal replacement therapy should be monitored closely when Omnitrope therapy is administered.
Somatropin can increase the extrathyroidal conversion of thyroxine (T4) to triiodothyronine (T3) and may unmask incipient hypothyroidism. Because inadequate treatment of hypothyroidism may prevent optimal response to somatropin, thyroid function should be evaluated before starting somatropin therapy and should be monitored regularly during treatment, not less frequently than annually.
Notes Regarding Potential Effects of Somatropin on Glucocorticoid Metabolism:
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. Endogenous growth hormone and exogenous somatropin inhibit the activity of 11βHSD-1.
Therefore growth hormone deficiency is associated with a relative increase in 11βHSD-1 activity, which in turn results in a relative increase in serum cortisol. Somatropin treatment may inhibit 11βHSD-1, resulting in relative reduction of serum cortisol concentrations.
In addition, somatropin may enhance the activity of CYP3A4, a cytochrome P450 enzyme involved in glucocorticoid catabolism. Therefore, by increasing the activity of CYP3A4, somatropin could potentially decrease serum cortisol concentration.
Because somatropin may both inhibit 11βHSD-1 (an enzyme required for production of cortisol) and induce activity of CYP3A4 (an enzyme involved in cortisol breakdown), careful monitoring of serum cortisol concentrations is required for all patients receiving concomitant glucocorticoid and somatropin therapy.
OMNITROPE (somatropin for injection) Page 13 of 69 As a consequence of its actions on enzymes involved in cortisol metabolism, somatropin treatment may unmask previously undiagnosed central (secondary) hypoadrenalism, and glucocorticoid replacement may be required.
In addition, patients treated with glucocorticoids for previously diagnosed hypoadrenalism (primary or secondary) may require adjustments of their maintenance or stress doses following initiation of somatropin treatment; this may be especially true for patients treated with cortisone acetate and prednisone, because conversion of these drugs to their biologically active metabolites is dependent on the activity of 11βHSD-1 (see 7 WARNINGS AND PRECAUTIONS, Monitoring and Laboratory Tests).
Fluid Retention Fluid retention during somatropin replacement therapy in adults may occur. Clinical manifestations of fluid retention are usually transient and dose dependent.
Immune Local allergic reactions:
Patients receiving somatropin treatment may experience redness, swelling, pain, inflammation, or itching at the site of injection (see 8 ADVERSE REACTIONS). Most of these minor reactions usually resolve in a few days to a few weeks.
Such reactions may occur if the injection is given incorrectly (irritants in the skin cleansing agent or poor injection technique), or if the patient is allergic to somatropin or any non-medicinal ingredient (see 2 CONTRAINDICATIONS).
Rarely, subcutaneous administration of somatropin can result in lipoatrophy or lipohypertrophy. Regular rotation of the injection site may help reduce or prevent these reactions. Patients should be advised to consult their doctor if they notice any of the conditions described above.
On rare occasion, injection site reactions may require discontinuation of somatropin therapy.
Systemic allergic reactions:
As with any protein, local or systemic allergic reactions may occur. Parents/patients should be informed that such reactions are possible and that prompt medical attention should be sought if allergic reactions occur. These reactions may be characterized by a generalized rash (with pruritus), shortness of breath, wheezing, […]
The Omnitrope dosage and administration schedule should be individualized based on the growth response of each patient. Response to somatropin therapy in pediatric patients tends to decrease with time. However, in pediatric patients, the failure to increase growth rate, particularly during the first year of therapy, indicates the need for close assessment of compliance and evaluation for other causes of growth failure, such as hypothyroidism, undernutrition, advanced bone age and antibodies to recombinant human GH (rhGH).
Treatment with Omnitrope for short stature should be discontinued when the epiphyses are fused. 24 mg/kg body weight/week SC Divided into 6-7 doses diagnosis of GHD should be confirmed before Omnitrope is administered. 48 mg/kg body weight per week SC Divided into 6-7 doses 1 Omnitrope dosage must be adjusted for the individual patient.
33 mg. Women may require higher doses than men. This means that there is a risk that women, especially those on oral estrogen replacement may be under-treated. As normal physiological growth hormone production decreases with age, dose requirements may be reduced.
3 Treatment should stop when near adult height is achieved (height velocity < 2 cm/ yr and/or bone age >16 yr in boys and >14 yr in girls) or when height is in the normal adult range (above -2 SDS). 4 Omnitrope may be administered in the thigh, buttocks or abdomen; the site of SC injections (administered preferably in the evenings) should be rotated daily to help prevent lipoatrophy.
OMNITROPE (somatropin for injection) Page 7 of 69 Adults Growth Hormone Deficiency Clinical response, side effects and determination of IGF-1 in serum may be used as guidance for dose titration. The level of IGF-1 should not exceed the upper limit of normal IGF-1 levels matched to age and sex.
It is recommended that IGF-1 concentrations be monitored regularly and GH dose be reduced in children with a plasma IGF-1 above + 2SD. 24 mg/kg/week) should be considered if substantial catch-up growth is observed during the first few years of therapy.
24 mg/kg/week), and titrating the dose as needed over time. In all children, clinicians should carefully monitor the growth response, and adjust the somatropin dose as necessary. Dosing should continue until final height is reached. Treatment should be discontinued after the first year of treatment if the height velocity SDS is below + 1.
Treatment should be discontinued if height velocity is < 2 cm/year and, if confirmation is required, bone age is > 14 years (girls) or > 16 years (boys) corresponding to closure of the epiphyseal growth plates. In short […]