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Prescribing Information

About Genentech Access to Care Foundation (GATCF)

GATCF was established to help patients with unmet medical needs who are uninsured or rendered uninsured by payer denial and who meet specific financial and medical criteria to receive Nutropin free of charge.

Eligibility criteria

GATCF has defined specific insurance, financial, and medical criteria that must be met for individual patients to be eligible for assistance:

Key points to remember about GATCF:

If Nutropin is administered and the patient's insurance denies the treatment, practices or patients must supply the denied insurance claim to Nutropin GPS for evaluation of appeal. If the practice and patient choose to pursue appeal and treatment is still denied, the patient must provide full financial documentation (IRS 1040 tax form is preferred) within 45 days to transition to full GATCF approval.

Once financial documentation is verified, full GATCF approval will allow for shipment of Nutropin, as needed, for up to 1 year. Patients may reapply yearly to continue receiving assistance through GATCF.

Contact Information

Please direct requests for application forms, and more specific information about eligibility to:

Genentech Access to Care Foundation
PO Box 220039
Charlotte, NC 28222-0039
Phone: 1-866-NUTROPIN (1-866-688-7674)
Fax: 1-800-545-0612

Please note: This description is provided for informational purposes only. The submission and completion of reimbursement- or coverage-related documentation are the responsibility of the patient and healthcare provider. Genentech, Inc. makes no representation or guarantees concerning reimbursement or coverage for any service or item.

The Genentech Access to Care Foundation, at its sole and absolute discretion, reserves the right to modify or discontinue the program at any time and to verify the accuracy of the information submitted.

*Special consideration will be given to patients with unique circumstances.

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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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You can also speak to your dedicated case manager by calling:

1-866-NUTROPIN
(1-866-688-7674)

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.

Scroll down to view complete indication and safety information

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