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Prescribing Information

Indications

Nutropin therapy is indicated for the treatment of pediatric patients who have short stature or growth failure as a result of:

Nutropin therapy is indicated for the replacement of endogenous GH in adults with GH deficiency, either:

Dosing Information

The dosage and administration schedule for Nutropin AQ should be individualized for each patient. However, in pediatric patients whose failure to increase growth rate, particularly during the first year of therapy, suggests the need for close assessment of compliance and evaluation of other causes of growth failure, such as hypothyroidism, under-nutrition, and advanced bone age.

Dosing for Pediatric Patients

Pediatric Growth Hormone Deficiency (GHD): A weekly dosage of up to 0.3 mg/kg of body weight divided into daily subcutaneous injection is recommended. In pubertal patients, a weekly dosage of up to 0.7 mg/kg divided daily may be used.

Turner Syndrome: A weekly dosage of up to 0.375 mg/kg of body weight divided into equal doses 3 to 7 times per week by subcutaneous injection is recommended.

Chronic Kidney Disease (CKD): A weekly dosage of up to 0.35 mg/kg of body weight divided into daily subcutaneous injection is recommended.

Nutropin therapy may be continued up to the time of renal transplantation. In order to optimize therapy for patients who require dialysis, the following guidelines for injection schedule are recommended:

  1. Hemodialysis patients should receive their injection at night just prior to going to sleep or at least 3-4 hours after their hemodialysis to prevent hematoma formation due to the heparin.
  2. Chronic Cycling Peritoneal Dialysis (CCPD) patients should receive their injection in the morning after they have completed dialysis.
  3. Chronic Ambulatory Peritoneal Dialysis (CAPD) patients should receive their injection in the evening at the time of the overnight exchange.

Idiopathic Short Stature (ISS): A weekly dosage of up to 0.3 mg/kg of body weight divided into daily subcutaneous injection has been shown to be safe and efficacious, and is recommended.

Please see Nutropin AQ full Prescribing Information

Dosing for Adult Patients

Adult Growth Hormone Deficiency (GHD)

Based on the weight-based dosing utilized in the original pivotal studies described herein, the recommended dosage at the start of therapy is not more than 0.006 mg/kg given as a daily subcutaneous injection. The dose may be increased according to individual patient requirements to a maximum of 0.025 mg/kg daily in patients under 35 years old and to a maximum of 0.0125 mg/kg daily in patients over 35 years old. Clinical response, side effects, and determination of age- and gender-adjusted serum IGF-1 levels may be used as guidance in dose titration.

Alternatively, taking into account more recent literature, a starting dose of approximately 0.2 mg/day (range, 0.15-0.30 mg/day) may be used without consideration of body weight. This dose can be increased gradually every 1-2 months by increments of approximately 0.1-0.2 mg/day, according to individual patient requirements based on the clinical response and serum IGF-1 concentrations. During therapy, the dose should be decreased if required by the occurrence of adverse events and/or serum IGF-1 levels above the age- and gender-specific normal range. Maintenance dosages vary considerably from person to person.

A lower starting dose and smaller dose increments should be considered for older patients, who are more prone to the adverse effects of somatropin than younger individuals. In addition, obese individuals are more likely to manifest adverse effects when treated with a weight-based regimen. In order to reach the defined treatment goal, estrogen-replete women may need higher doses than men. Oral estrogen administration may increase the dose requirements in women.

The following Nutropin products are available to assist with dosing considerations:

Please see Nutropin AQ full Prescribing Information

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INDICATIONS

Nutropin therapy is indicated for the treatment of pediatric patients who have short stature or growth failure as a result of:

  • Growth hormone deficiency (GHD)
  • Idiopathic short stature (ISS), defined by height standard deviation score ≤-2.25, associated with growth rates unlikely to result in normal adult height, in whom other causes of short stature have been excluded
  • Turner syndrome (TS)
  • Chronic kidney disease (CKD) up to the time of renal transplantation

Nutropin therapy is indicated for the replacement of endogenous GH in adults with GH deficiency, either:

  • Adult onset, as a result of pituitary disease, hypothalamic disease, surgery, radiation therapy, or trauma; or
  • Childhood onset. Patients treated for GH deficiency in childhood who have closed epiphyses should be reevaluated

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. A significant increase in mortality has been reported in such cases
  • Prader-Willi syndrome (PWS) in children: Somatropin should not be used in pediatric patients with PWS 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 after initiation of somatropin treatment in such patients. Nutropin AQ is not indicated for the treatment of pediatric patients who have growth failure due to genetically confirmed PWS.
  • 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: Nutropin therapy is contraindicated in patients with a known sensitivity to somatropin or excipients. Localized reactions are the most common hypersensitivity reactions

WARNINGS AND PRECAUTIONS

  • Glucose intolerance and diabetes mellitus
  • Intracranial hypertension
  • Fluid retention
  • Patients with hypopituitarism should have their other hormonal replacement treatments closely monitored during somatropin treatment
  • Hypothyroidism
  • Slipped capital femoral epiphysis in pediatric patients
  • Progression of pre-existing scoliosis in pediatric patients
  • Otitis media and cardiovascular disorders in patients with Turner syndrome
  • Pancreatitis
  • Children with growth failure secondary to CKD should be examined periodically for evidence of progression of renal osteodystrophy
  • Injection site should be rotated to avoid tissue atrophy. Patients should be informed that local or systemic allergic reactions may occur and that prompt medical attention should be sought in such cases
  • Serum levels of inorganic phosphorus, alkaline phosphatase, parathyroid hormone, and IGF-I may increase after somatropin therapy
  • 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
  • Clinical studies of somatropin did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger patients
  • Somatropin inhibits 11ß-hydroxysteroid dehydrogenase type 1 (11ßHSD-1) in adipose/hepatic tissue and may significantly impact the metabolism of cortisol and cortisone. 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 somatropin is administered in combination with insulin and/or other hypoglycemic agents, other drugs metabolized by CYP450 liver enzymes (eg, hydrocortisone or other corticosteroids, sex steroids, anticonvulsants, cyclosporine), or other hormone replacement therapy

MOST COMMON ADVERSE REACTIONS

  • Common adverse reactions reported in adult and pediatric patients taking somatropin include injection site reactions. Additional common adverse reactions in adults include edema, arthralgia, and carpal tunnel syndrome

Please see accompanying full Prescribing Information for additional Important Safety Information.

Please see additional Important Safety Information below.

The content available from this website is for informational purposes only. Individual results may vary. You may report side effects to the FDA at 1-800-FDA-1088 or to Genentech Drug Safety/Adverse Events at 1-888-835-2555.

Nutropin AQ is a registered trademark and NuSpin, growingopportunity, and Nutropin GPS are trademarks of Genentech, Inc.

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Important Safety Information

INDICATIONS

Nutropin therapy is indicated for the treatment of pediatric patients who have short stature or growth failure as a result of:

  • Growth hormone deficiency (GHD)
  • Idiopathic short stature (ISS), defined by height standard deviation score ≤-2.25, associated with growth rates unlikely to result in normal adult height, in whom other causes of short stature have been excluded
  • Turner syndrome (TS)
  • Chronic kidney disease (CKD) up to the time of renal transplantation

Nutropin therapy is indicated for the replacement of endogenous GH in adults with GH deficiency, either:

  • Adult onset, as a result of pituitary disease, hypothalamic disease, surgery, radiation therapy, or trauma; or
  • Childhood onset. Patients treated for GH deficiency in childhood who have closed epiphyses should be reevaluated

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. A significant increase in mortality has been reported in such cases
  • Prader-Willi syndrome (PWS) in children: Somatropin should not be used in pediatric patients with PWS 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 after initiation of somatropin treatment in such patients. Nutropin AQ is not indicated for the treatment of pediatric patients who have growth failure due to genetically confirmed PWS.
  • 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: Nutropin therapy is contraindicated in patients with a known sensitivity to somatropin or excipients. Localized reactions are the most common hypersensitivity reactions

WARNINGS AND PRECAUTIONS

  • Glucose intolerance and diabetes mellitus
  • Intracranial hypertension
  • Fluid retention
  • Patients with hypopituitarism should have their other hormonal replacement treatments closely monitored during somatropin treatment
  • Hypothyroidism
  • Slipped capital femoral epiphysis in pediatric patients
  • Progression of pre-existing scoliosis in pediatric patients
  • Otitis media and cardiovascular disorders in patients with Turner syndrome
  • Pancreatitis
  • Children with growth failure secondary to CKD should be examined periodically for evidence of progression of renal osteodystrophy
  • Injection site should be rotated to avoid tissue atrophy. Patients should be informed that local or systemic allergic reactions may occur and that prompt medical attention should be sought in such cases
  • Serum levels of inorganic phosphorus, alkaline phosphatase, parathyroid hormone, and IGF-I may increase after somatropin therapy
  • 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
  • Clinical studies of somatropin did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger patients
  • Somatropin inhibits 11ß-hydroxysteroid dehydrogenase type 1 (11ßHSD-1) in adipose/hepatic tissue and may significantly impact the metabolism of cortisol and cortisone. 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 somatropin is administered in combination with insulin and/or other hypoglycemic agents, other drugs metabolized by CYP450 liver enzymes (eg, hydrocortisone or other corticosteroids, sex steroids, anticonvulsants, cyclosporine), or other hormone replacement therapy

MOST COMMON ADVERSE REACTIONS

  • Common adverse reactions reported in adult and pediatric patients taking somatropin include injection site reactions. Additional common adverse reactions in adults include edema, arthralgia, and carpal tunnel syndrome

Please see accompanying full Prescribing Information for additional Important Safety Information.

Please see additional Important Safety Information below.

View Indications and Safety Information

INDICATIONS

Nutropin therapy is indicated for the treatment of pediatric patients who have short stature or growth failure as a result of:

  • Growth hormone deficiency (GHD)
  • Idiopathic short stature (ISS), defined by height standard deviation score ≤-2.25, associated with growth rates unlikely to result in normal adult height, in whom other causes of short stature have been excluded
  • Turner syndrome (TS)
  • Chronic kidney disease (CKD) up to the time of renal transplantation

Nutropin therapy is indicated for the replacement of endogenous GH in adults with GH deficiency, either:

  • Adult onset, as a result of pituitary disease, hypothalamic disease, surgery, radiation therapy, or trauma; or
  • Childhood onset. Patients treated for GH deficiency in childhood who have closed epiphyses should be reevaluated

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. A significant increase in mortality has been reported in such cases
  • Prader-Willi syndrome (PWS) in children: Somatropin should not be used in pediatric patients with PWS 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 after initiation of somatropin treatment in such patients. Nutropin AQ is not indicated for the treatment of pediatric patients who have growth failure due to genetically confirmed PWS.
  • 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: Nutropin therapy is contraindicated in patients with a known sensitivity to somatropin or excipients. Localized reactions are the most common hypersensitivity reactions

WARNINGS AND PRECAUTIONS

  • Glucose intolerance and diabetes mellitus
  • Intracranial hypertension
  • Fluid retention
  • Patients with hypopituitarism should have their other hormonal replacement treatments closely monitored during somatropin treatment
  • Hypothyroidism
  • Slipped capital femoral epiphysis in pediatric patients
  • Progression of pre-existing scoliosis in pediatric patients
  • Otitis media and cardiovascular disorders in patients with Turner syndrome
  • Pancreatitis
  • Children with growth failure secondary to CKD should be examined periodically for evidence of progression of renal osteodystrophy
  • Injection site should be rotated to avoid tissue atrophy. Patients should be informed that local or systemic allergic reactions may occur and that prompt medical attention should be sought in such cases
  • Serum levels of inorganic phosphorus, alkaline phosphatase, parathyroid hormone, and IGF-I may increase after somatropin therapy
  • 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
  • Clinical studies of somatropin did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger patients
  • Somatropin inhibits 11ß-hydroxysteroid dehydrogenase type 1 (11ßHSD-1) in adipose/hepatic tissue and may significantly impact the metabolism of cortisol and cortisone. 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 somatropin is administered in combination with insulin and/or other hypoglycemic agents, other drugs metabolized by CYP450 liver enzymes (eg, hydrocortisone or other corticosteroids, sex steroids, anticonvulsants, cyclosporine), or other hormone replacement therapy

MOST COMMON ADVERSE REACTIONS

  • Common adverse reactions reported in adult and pediatric patients taking somatropin include injection site reactions. Additional common adverse reactions in adults include edema, arthralgia, and carpal tunnel syndrome

Please see accompanying full Prescribing Information for additional Important Safety Information.

Please see additional Important Safety Information below.

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