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Prescribing Information

Web-based version

This version provides the growth plotting and dosage calculating features you've come to expect from Nutropin GenenCalc, now in a streamlined and easy-to-use interface.

Launch GenenCalc Now

If GenenCalc does not launch, upgrade to the latest version of the Flash Player.

Desktop version

This version provides growth plotting and dosage calculating features, while allowing you to save your patient's data, so you can plot and track their progress over the course of their treatment.

First download and install Adobe AIR.

Then, download and install GenenCalc for PC/MAC.

Download For PC/MAC [1.5 MB]

Frequently Asked Questions

Click questions to see answers.

What is GenenCalc?

A: GenenCalc is an application comprised of a Growth Rate Calculator and Dose Calculator for pediatric patients.

The Growth Rate Calculator calculates growth information for a patient over time and plots the information in a graph. It is used to determine whether a patient needs growth hormone treatment.

The Dose Calculator calculates dosages for Genentech growth hormone products based on the patient's weight and dose schedule.

What is the difference between the Online and Desktop versions?

A: The Online version opens in a new browser window directly from the Nutropin.com website. It consists of the Growth Rate and Dose Calculators.

The Desktop version is downloaded from the Nutropin.com website to a PC or Mac computer. It is compatible with Windows Vista, Windows XP, and Mac OS X v10.5 Leopard operating systems.

This version allows the user to save patient calculations from the Growth Rate and Dose Calculators. Search for patients in the Patient List.

How do I run the Online version?

A: Click the link from the Nutropin.com website. If GenenCalc does not launch, upgrade to the latest version of the Flash Player.

How do I install the Desktop version?

A: First, you must install Adobe AIR on your computer. Adobe AIR allows you to run AIR applications like GenenCalc.

Once Adobe AIR is installed, download the GenenCalc.AIR file and double-click to install.

How do I use the Growth Calculator?

A: First, select the patient’s sex, type in the patient's date of birth, and enter the father's and mother's heights in the Patient Information Bar.

Select either Metric (cm + kg) or English (in + lbs) units for the calculation.

Then, for each visit, enter the date and the patient’s height and weight at that visit:

  • Height and weight are required for each visit
  • The Bone Age is used to calculate the Bayley-Pinneau predicted height. This may or may not be performed at a given visit. The patient’s bone age must be between 6 years and 18 years, 6 months.
  • The Serum Creatinine is used to calculate the Creatinine Clearance. You must enter a creatinine level to calculate. This may or may not be performed at a given visit

GenenCalc will calculate body surface area, body mass index, ideal body weight, height standard deviations and percentiles, weight standard deviations and percentiles, growth rate standard deviations and percentiles, growth rate, and creatinine clearance for that visit. It also calculates Bayley-Pinneau predicted height, and parental target heights.

The Graph will plot the growth curve for the patient over time. It will also show the parental target heights, the Bayley-Pinneau predicted height, and the date when growth hormone treatment began.

How do I indicate that growth hormone treatment has started for a patient?

A: Each visit has an arrow icon indicating that treatment occurred on that visit.

  • Click the arrow on each visit for which treatment occurred
  • The Treatment Began box in the Patient Information Bar will show the earliest date for which treatment occurred
  • A "treatment began" indicator will appear as a line in the Graph, representing the earliest date for which treatment occurred
What is the Bayley-Pinneau Height Prediction?

A: The Latest Bayley-Pinneau Height Prediction is the patient’s predicted adult height based on the bone age for that visit.

What information is saved for each patient in the Desktop version?

A: The patient’s name, date of birth, and parent’s heights are saved for each patient. Visit information and calculations are saved for each visit.

How do I use the Dose Calculator?

A: First select the product with which the patient will be treated. Then, select the dose schedule and enter the patient’s weight. Select the treatment dose from the dropdown list and GenenCalc will calculate the other values.

If the product is Nutropin, you must also specify volumes and vial size.

How do I print my calculations?

A: To print the growth calculations and the graph, click on the Visits Tab, and click the print button.

What does the Help button do?

A: The Help button opens a PDF of a Help file that explains how to use GenenCalc.

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INDICATIONS

Pediatric Patients

Nutropin AQ® [somatropin (rDNA origin) injection] and Nutropin [somatropin (rDNA origin) for injection] are indicated for the long-term treatment of growth failure due to a lack of adequate endogenous GH secretion.

Nutropin AQ and Nutropin are also indicated for the treatment of growth failure associated with chronic renal insufficiency up to the time of renal transplantation. Nutropin AQ and Nutropin therapy should be used in conjunction with optimal management of chronic renal insufficiency.

Nutropin AQ and Nutropin are also indicated for the long-term treatment of short stature associated with Turner syndrome.

Nutropin AQ and Nutropin are also indicated for the long-term treatment of idiopathic short stature, also called non-growth hormone deficient short stature, defined by height 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.

Adult Patients

Nutropin AQ and Nutropin are indicated for replacement of endogenous GH in adults with GH deficiency who meet either of the following two criteria:

  • Adult-Onset: Patients who have GH deficiency, either alone or associated with multiple hormone deficiencies (hypopituitarism), as a result of pituitary disease, hypothalamic disease, surgery, radiation therapy, or trauma; or
  • Childhood-Onset: Patients who were GH deficient during childhood as a result of congenital, genetic, acquired, or idiopathic causes.

In general, confirmation of the diagnosis of adult GH deficiency in both groups usually requires an appropriate GH stimulation test. However, confirmatory GH stimulation testing may not be required in patients with congenital/genetic GH deficiency or multiple pituitary hormone deficiencies due to organic disease.

IMPORTANT SAFETY INFORMATION

Contraindications

GROWTH HORMONE (GH) SHOULD NOT BE USED IN PATIENTS WITH:

  • Closed epiphyses for pediatric growth promotion
  • Active proliferative or severe non-proliferative diabetic retinopathy
  • Active malignancy
  • Acute critical illness due to complications following open heart surgery, abdominal surgery, or multiple accidental trauma, or those with acute respiratory failure
  • Prader-Willi syndrome who are severely obese or have severe respiratory impairment. Nutropin AQ and Nutropin are not indicated in patients with Prader-Willi syndrome who do not also have a diagnosis of GH deficiency
  • Known sensitivity to benzyl alcohol when using Nutropin reconstituted with Bacteriostatic Water for Injection, USP (benzyl alcohol preserved). For use in newborns, see WARNINGS in full Prescribing Information

Additional Safety Information

  • Nutropin AQ and Nutropin should be prescribed by physicians experienced in the diagnosis and management of patients with pediatric or adult GH deficiency, Turner syndrome (TS), or chronic renal insufficiency (CRI).
  • Patients should be monitored for signs of glucose intolerance. Patients taking antihyperglycemic agents may require dose adjustment when GH therapy is instituted.
  • Patients with preexisting tumors or growth hormone deficiency secondary to an intracranial lesion should be examined routinely for progression or recurrence of the underlying disease process.
  • Intracranial hypertension (IH) with papilledema, visual changes, headache, nausea, and/or vomiting has been reported in a small number of patients treated with GH products.
  • In patients with hypopituitarism (multiple hormone deficiencies), standard hormonal replacement therapy should be monitored closely when GH therapy is administered.
  • Periodic thyroid function tests and thyroid replacement therapy should be initiated or appropriately adjusted when indicated.
  • Injection site discomfort has been reported.
  • Rotate injection site to avoid tissue atrophy that may result from subcutaneous administration of GH at the same site over a long period of time.
  • As with any protein, local or systemic allergic reactions may occur.

Pediatric Patients

  • Slipped capital femoral epiphysis may occur more frequently in patients with endocrine disorders or in patients undergoing rapid growth.
  • Children with growth failure secondary to CRI should be examined periodically for evidence of progression of renal osteodystrophy.
  • Progression of scoliosis can occur in patients who experience rapid growth. Patients with a history of scoliosis who are treated with GH should be monitored for progression of scoliosis.

Adult Patients

  • GH therapy may cause fluid retention.
  • Carpal tunnel syndrome, arthralgia, and other joint disorders have been reported in GH-treated patients.

Drug Interactions

  • Patients on GH therapy, with previously undiagnosed central (secondary) hypoadrenalism, may require glucocorticoid replacement therapy. Patients already on glucocorticoid replacement therapy for previously diagnosed hypoadrenalism may require an increase in their maintenance or stress doses.
  • Glucocorticoid replacement therapy should be carefully adjusted in children with concomitant GH and glucocorticoid deficiency to avoid both hypoadrenalism and an inhibitory effect on growth.
  • Careful monitoring is advisable when GH is given in any combination with agents metabolized by CP450 liver enzymes.
  • In women on oral estrogen replacement, a larger dose of somatropin may be required to achieve the defined treatment goal.

Please see full Prescribing Information for additional Important Safety Information.

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 and Nutropin AQ are registered trademarks; and NuSpin, growingopportunity, and Nutropin GPS are trademarks of Genentech Inc.

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Important Safety Information

INDICATIONS

Pediatric Patients

Nutropin AQ® [somatropin (rDNA origin) injection] and Nutropin [somatropin (rDNA origin) for injection] are indicated for the long-term treatment of growth failure due to a lack of adequate endogenous GH secretion.

Nutropin AQ and Nutropin are also indicated for the treatment of growth failure associated with chronic renal insufficiency up to the time of renal transplantation. Nutropin AQ and Nutropin therapy should be used in conjunction with optimal management of chronic renal insufficiency.

Nutropin AQ and Nutropin are also indicated for the long-term treatment of short stature associated with Turner syndrome.

Nutropin AQ and Nutropin are also indicated for the long-term treatment of idiopathic short stature, also called non-growth hormone deficient short stature, defined by height 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.

Adult Patients

Nutropin AQ and Nutropin are indicated for replacement of endogenous GH in adults with GH deficiency who meet either of the following two criteria:

  • Adult-Onset: Patients who have GH deficiency, either alone or associated with multiple hormone deficiencies (hypopituitarism), as a result of pituitary disease, hypothalamic disease, surgery, radiation therapy, or trauma; or
  • Childhood-Onset: Patients who were GH deficient during childhood as a result of congenital, genetic, acquired, or idiopathic causes.

In general, confirmation of the diagnosis of adult GH deficiency in both groups usually requires an appropriate GH stimulation test. However, confirmatory GH stimulation testing may not be required in patients with congenital/genetic GH deficiency or multiple pituitary hormone deficiencies due to organic disease.

IMPORTANT SAFETY INFORMATION

Contraindications

GROWTH HORMONE (GH) SHOULD NOT BE USED IN PATIENTS WITH:

  • Closed epiphyses for pediatric growth promotion
  • Active proliferative or severe non-proliferative diabetic retinopathy
  • Active malignancy
  • Acute critical illness due to complications following open heart surgery, abdominal surgery, or multiple accidental trauma, or those with acute respiratory failure
  • Prader-Willi syndrome who are severely obese or have severe respiratory impairment. Nutropin AQ and Nutropin are not indicated in patients with Prader-Willi syndrome who do not also have a diagnosis of GH deficiency
  • Known sensitivity to benzyl alcohol when using Nutropin reconstituted with Bacteriostatic Water for Injection, USP (benzyl alcohol preserved). For use in newborns, see WARNINGS in full Prescribing Information

Additional Safety Information

  • Nutropin AQ and Nutropin should be prescribed by physicians experienced in the diagnosis and management of patients with pediatric or adult GH deficiency, Turner syndrome (TS), or chronic renal insufficiency (CRI).
  • Patients should be monitored for signs of glucose intolerance. Patients taking antihyperglycemic agents may require dose adjustment when GH therapy is instituted.
  • Patients with preexisting tumors or growth hormone deficiency secondary to an intracranial lesion should be examined routinely for progression or recurrence of the underlying disease process.
  • Intracranial hypertension (IH) with papilledema, visual changes, headache, nausea, and/or vomiting has been reported in a small number of patients treated with GH products.
  • In patients with hypopituitarism (multiple hormone deficiencies), standard hormonal replacement therapy should be monitored closely when GH therapy is administered.
  • Periodic thyroid function tests and thyroid replacement therapy should be initiated or appropriately adjusted when indicated.
  • Injection site discomfort has been reported.
  • Rotate injection site to avoid tissue atrophy that may result from subcutaneous administration of GH at the same site over a long period of time.
  • As with any protein, local or systemic allergic reactions may occur.

Pediatric Patients

  • Slipped capital femoral epiphysis may occur more frequently in patients with endocrine disorders or in patients undergoing rapid growth.
  • Children with growth failure secondary to CRI should be examined periodically for evidence of progression of renal osteodystrophy.
  • Progression of scoliosis can occur in patients who experience rapid growth. Patients with a history of scoliosis who are treated with GH should be monitored for progression of scoliosis.

Adult Patients

  • GH therapy may cause fluid retention.
  • Carpal tunnel syndrome, arthralgia, and other joint disorders have been reported in GH-treated patients.

Drug Interactions

  • Patients on GH therapy, with previously undiagnosed central (secondary) hypoadrenalism, may require glucocorticoid replacement therapy. Patients already on glucocorticoid replacement therapy for previously diagnosed hypoadrenalism may require an increase in their maintenance or stress doses.
  • Glucocorticoid replacement therapy should be carefully adjusted in children with concomitant GH and glucocorticoid deficiency to avoid both hypoadrenalism and an inhibitory effect on growth.
  • Careful monitoring is advisable when GH is given in any combination with agents metabolized by CP450 liver enzymes.
  • In women on oral estrogen replacement, a larger dose of somatropin may be required to achieve the defined treatment goal.

Please see full Prescribing Information for additional Important Safety Information.

View indication and safety information

INDICATIONS

Pediatric Patients

Nutropin AQ® [somatropin (rDNA origin) injection] and Nutropin [somatropin (rDNA origin) for injection] are indicated for the long-term treatment of growth failure due to a lack of adequate endogenous GH secretion.

Nutropin AQ and Nutropin are also indicated for the treatment of growth failure associated with chronic renal insufficiency up to the time of renal transplantation. Nutropin AQ and Nutropin therapy should be used in conjunction with optimal management of chronic renal insufficiency.

Nutropin AQ and Nutropin are also indicated for the long-term treatment of short stature associated with Turner syndrome.

Nutropin AQ and Nutropin are also indicated for the long-term treatment of idiopathic short stature, also called non-growth hormone deficient short stature, defined by height 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.

Adult Patients

Nutropin AQ and Nutropin are indicated for replacement of endogenous GH in adults with GH deficiency who meet either of the following two criteria:

  • Adult-Onset: Patients who have GH deficiency, either alone or associated with multiple hormone deficiencies (hypopituitarism), as a result of pituitary disease, hypothalamic disease, surgery, radiation therapy, or trauma; or
  • Childhood-Onset: Patients who were GH deficient during childhood as a result of congenital, genetic, acquired, or idiopathic causes.

In general, confirmation of the diagnosis of adult GH deficiency in both groups usually requires an appropriate GH stimulation test. However, confirmatory GH stimulation testing may not be required in patients with congenital/genetic GH deficiency or multiple pituitary hormone deficiencies due to organic disease.

IMPORTANT SAFETY INFORMATION

Contraindications

GROWTH HORMONE (GH) SHOULD NOT BE USED IN PATIENTS WITH:

  • Closed epiphyses for pediatric growth promotion
  • Active proliferative or severe non-proliferative diabetic retinopathy
  • Active malignancy
  • Acute critical illness due to complications following open heart surgery, abdominal surgery, or multiple accidental trauma, or those with acute respiratory failure
  • Prader-Willi syndrome who are severely obese or have severe respiratory impairment. Nutropin AQ and Nutropin are not indicated in patients with Prader-Willi syndrome who do not also have a diagnosis of GH deficiency
  • Known sensitivity to benzyl alcohol when using Nutropin reconstituted with Bacteriostatic Water for Injection, USP (benzyl alcohol preserved). For use in newborns, see WARNINGS in full Prescribing Information

Additional Safety Information

  • Nutropin AQ and Nutropin should be prescribed by physicians experienced in the diagnosis and management of patients with pediatric or adult GH deficiency, Turner syndrome (TS), or chronic renal insufficiency (CRI).
  • Patients should be monitored for signs of glucose intolerance. Patients taking antihyperglycemic agents may require dose adjustment when GH therapy is instituted.
  • Patients with preexisting tumors or growth hormone deficiency secondary to an intracranial lesion should be examined routinely for progression or recurrence of the underlying disease process.
  • Intracranial hypertension (IH) with papilledema, visual changes, headache, nausea, and/or vomiting has been reported in a small number of patients treated with GH products.
  • In patients with hypopituitarism (multiple hormone deficiencies), standard hormonal replacement therapy should be monitored closely when GH therapy is administered.
  • Periodic thyroid function tests and thyroid replacement therapy should be initiated or appropriately adjusted when indicated.
  • Injection site discomfort has been reported.
  • Rotate injection site to avoid tissue atrophy that may result from subcutaneous administration of GH at the same site over a long period of time.
  • As with any protein, local or systemic allergic reactions may occur.

Pediatric Patients

  • Slipped capital femoral epiphysis may occur more frequently in patients with endocrine disorders or in patients undergoing rapid growth.
  • Children with growth failure secondary to CRI should be examined periodically for evidence of progression of renal osteodystrophy.
  • Progression of scoliosis can occur in patients who experience rapid growth. Patients with a history of scoliosis who are treated with GH should be monitored for progression of scoliosis.

Adult Patients

  • GH therapy may cause fluid retention.
  • Carpal tunnel syndrome, arthralgia, and other joint disorders have been reported in GH-treated patients.

Drug Interactions

  • Patients on GH therapy, with previously undiagnosed central (secondary) hypoadrenalism, may require glucocorticoid replacement therapy. Patients already on glucocorticoid replacement therapy for previously diagnosed hypoadrenalism may require an increase in their maintenance or stress doses.
  • Glucocorticoid replacement therapy should be carefully adjusted in children with concomitant GH and glucocorticoid deficiency to avoid both hypoadrenalism and an inhibitory effect on growth.
  • Careful monitoring is advisable when GH is given in any combination with agents metabolized by CP450 liver enzymes.
  • In women on oral estrogen replacement, a larger dose of somatropin may be required to achieve the defined treatment goal.

Please see full Prescribing Information for additional Important Safety Information.

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