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Prescribing Information

Reimbursement & Support

Dedicated to Reimbursement Services and Patient Support

Nutropin GPS™ (Growing Patient Support) offers you and your patients assistance throughout treatment from a dedicated case manager. Following the decision to prescribe growth hormone therapy, GPS services include device and injection training, insurance process management, a nurse hotline, and ongoing patient access and support programs. Call 1‐866‐NUTROPIN (1‐866‐688‐7674) to get started.

Priority Review
Check if Nutropin AQ® is available on a patient’s formulary within one working day.

 

NuAccessSM
A program providing medicine for a limited time for eligible pediatric patients while their insurance coverage is being evaluated.

Nutropin GPS Patient Support

Nutropin® Co-pay Card Program
Help with out‐of‐pocket costs for qualified Nutropin AQ patients.

 

Electronic Patient Consent Form
Ask your patients to fill the Patient Consent Form online.

Priority Review
Check if Nutropin AQ® is available on a patient’s formulary within one working day.

Nutropin® Co-pay Card Program
Help with out‐of‐pocket costs for qualified Nutropin AQ patients.

NuAccessSM
A program providing medicine for a limited time for eligible pediatric patients while their insurance coverage is being evaluated.

Electronic Patient Consent Form
Ask your patients to fill the Patient Consent Form online.

Patient: My insurance covers Nutropin, but can I receive help with my co-pay?

Nutropin® Co-pay Card Program

Your patients may be eligible for help with treatment costs

Key Features of the Nutropin Co-pay Card Program

  • The Nutropin AQ® NuSpin® Co-pay Card Program provides support to eligible patients of up to $5,000 per 12-month enrollment cycle*
  • Patients are not required to meet any income criteria to qualify for this benefit
  • Eligible patients may pay as little as $5 monthly co-pay per prescription/refill
  • The maximum co-pay assistance allowable to any patient under the program is $5,000 annually
  • Patients are responsible for all out-of-pocket costs after $5,000
  • Co-pay assistance is capped at $500 per month, however, patients may submit any unreimbursed out-of-pocket co-pay expenses, up to the $5,000 maximum, directly to Nutropin GPS at the end of the 12-month enrollment period
Co-pay card example

*Co-pay assistance is capped at $500 per month, however, outstanding co-pay expenses above the $500 monthly cap may be submitted (up to the $5,000 cap) directly to Nutropin GPS at the end of the 12-month enrollment period. Co-pay assistance may be renewable for eligible patients after 12 months.

If you have questions, talk to your healthcare providers’ office or call us at: 1-866-688-7674.

Patients can enroll in the Co-pay Card Program online.

e-Submit

For more information, review the co-pay brochure.

Nutropin GPS Co-Pay Brochure - Download PDF (4.3 MB)

This Nutropin GPS™ Co-pay Program is valid ONLY for patients with commercial (private or non-governmental) insurance who have a valid prescription for a Food and Drug Administration (FDA)-approved indication of a Genentech medication. Patients using Medicare, Medicaid, Medigap, Veteran’s Affairs (VA), Department of Defense (DoD), TRICARE or any other federal or state government program (collectively, “Government Programs”) to pay for their medications are not eligible. The program is not valid for medications that are eligible to be reimbursed in their entirety by private insurance plans or other programs.

Under the program, the patient will pay a co-pay. After reaching the maximum program benefit, the patient will be responsible for all remaining out-of-pocket expenses. This program is not health insurance or a benefit plan. The program does not obligate the use of any specific product or provider. Patients receiving assistance from charitable assistance programs (such as Genentech Patient Foundation) are not eligible. The co-pay benefit cannot be combined with any other rebate, free trial or similar offer for the medication. No party may seek reimbursement for all or any part of the benefit received through this program.

The program may be accepted by participating pharmacies, physician offices or hospitals. Once a patient is enrolled, this program will not honor claims with date of service or medication dispensing that precede program enrollment by more than 180 days. Use of this program must be consistent with all relevant health insurance requirements. Participating patients, pharmacies, physician offices and hospitals are responsible for reporting the receipt of all program benefits as required by any insurer or by law. Program benefits may not be sold, purchased, traded or offered for sale.

The patient or their guardian must be 18 years or older to receive program assistance. This program is only valid in the United States and U.S. Territories. This program is void where prohibited by law and shall follow state restrictions in relation to AB-rated generic equivalents (e.g., MA, CA) where applicable. Program eligibility is contingent upon the patient’s ability to meet and maintain all requirements set forth by the program. Genentech reserves the right to rescind, revoke or amend the program without notice at any time.

Patient: Can I receive assistance while I wait for insurance approval?

NuAccessSM Program

A program providing medicine for a limited time for eligible pediatric patients while their insurance coverage is being evaluated.

  • Patients must meet medical criteria for initial and subsequent requests
  • Product will be delivered to the patient’s home by a Genentech-designated pharmacy
Prescriber Service Form

Patient Access and Assistance Programs

Genentech is committed to helping your patients receive the treatment and medications they need. To this end, we provide a broad range of patient access and assistance programs, including:

Priority Review

Use Priority Review to check if Nutropin AQ is available on formulary. Check off "Priority Review" and complete the fields on the Prescriber Service Form to request this service.

Prescriber Service Form

Patient: What other co-pay support options are available to me?

Referral to Co-pay Assistance Foundations

If privately or publicly insured patients have difficulty paying for their Nutropin AQ co-pay, co-insurance, or other expenses, Nutropin GPS can refer them to a co-pay assistance foundation* that supports their disease state. For more information, contact Genentech at 1-866-688-7674.

*Genentech and Nutropin GPS™ do not influence or control the operations or eligibility criteria of any independent co-pay assistance foundation and cannot guarantee co-pay assistance after a referral from Nutropin GPS™. The foundations to which we refer patients are not exhaustive or indicative of Genentech’s or Nutropin GPS™ endorsement or financial support. There may be other foundations to support the patient's disease state.

Patient: I have no insurance or Nutropin is not covered by my plan. Can you help?

Genentech Patient Foundation

The Genentech Patient Foundation gives free Genentech medicine to patients who don’t have insurance coverage or who have financial concerns.

Patients will get free Genentech medicine if they:

  • Do not have insurance or coverage for their Genentech medicine and their household makes less than $150,000 per year 
  • Have insurance, can’t afford their out-of-pocket costs, have pursued all available financial assistance, and meet certain income requirements

Download the Genentech Patient Foundation Enrollment Form to get started with your application. Once completed follow the instructions on where to send the enrollment form.

Download the Enrollment Form

Once we receive your information, Genentech Patient Foundation will contact you with further instructions. This may include verifying financial eligibility.

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.
  • Prader-Willi Syndrome (PWS) in Children: Somatropin is contraindicated in 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. Somatropin should not be used in patients with any evidence of progression or recurrence of an underlying intracranial tumor.
  • Hypersensitivity: Nutropin AQ is contraindicated in patients with a known hypersensitivity to somatropin or any of its excipients. Systemic hypersensitivity reactions have been reported with postmarketing use of somatropin products.
  • Diabetic Retinopathy: Somatropin is contraindicated in patients with active proliferative or severe non-proliferative diabetic retinopathy.
  • Closed Epiphysis: Somatropin should not be used for growth promotion in pediatric patients with closed epiphysis.

WARNINGS AND PRECAUTIONS

  • 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 doses of somatropin. The safety of continuing somatropin treatment in patients receiving replacement doses for approved indications who concurrently develop these illnesses has not been established.
  • Prader-Willi Syndrome (PWS) in Children: There have been reports of fatalities after initiating therapy with somatropin in pediatric patients with PWS 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 PWS should be evaluated for signs of upper airway obstruction 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 PWS 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.
  • 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. 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. Monitor patients on somatropin therapy carefully for increased growth, or potential malignant changes, of preexisting nevi. Because children with certain rare genetic causes of short stature have an increased risk of developing malignancies, these patients should be carefully monitored for development of neoplasms, if treatment with somatropin is initiated.
  • Glucose Intolerance and Diabetes Mellitus: Previously undiagnosed impaired glucose tolerance and overt diabetes mellitus may be unmasked during somatropin treatment. New-onset type 2 diabetes mellitus has been reported. As a result, blood glucose concentrations should be monitored periodically in all patients taking somatropin, especially in those with risk factors for diabetes mellitus. Patients with pre-existing type 1 or type 2 diabetes mellitus or impaired glucose tolerance should be monitored closely during somatropin treatment. The doses of antihyperglycemic drugs (i.e. insulin or oral/injectable agents) may require adjustment when somatropin therapy is instituted in these patients.
  • Intracranial Hypertension (IH): Funduscopic examination is recommended at the initiation of and periodically during therapy as intracranial hypertension with papilledema, visual changes, headache, nausea, and/or vomiting have been reported in a small number of patients treated with somatropin. If papilledema is observed by funduscopy during treatment with somatropin, 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 TS, CKD, and PWS may be at increased risk for the development of IH.
  • Severe Hypersensitivity: Serious systemic hypersensitivity reactions including anaphylactic reaction and angioedema have been reported with postmarketing use of somatropin products. Patients and caregivers should be informed that such reactions are possible and that prompt medical attention should be sought if an allergic reaction occurs.
  • Fluid Retention: Transient and dose-dependent fluid retention during somatropin replacement in adults may occur.
  • 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. Patients treated with glucocorticoid replacement for previously diagnosed hypoadrenalism may require an increase in their maintenance or stress doses following initiation of somatropin treatment.
  • Hypothyroidism: Patients treated with somatropin should have periodic thyroid function tests, and thyroid hormone replacement therapy should be initiated or appropriately adjusted in cases of unmasked or worsening hypothyroidism.
  • Slipped Capital Femoral Epiphysis in Pediatric Patients (SCFE): SCFE may occur more frequently in patients with endocrine disorders and 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.
  • Progression of Preexisting Scoliosis in Pediatric Patients:Progression of scoliosis can occur in patients who experience rapid growth. Somatropin has not been shown to increase the occurrence of scoliosis. Physicians should be alert to these abnormalities, which may manifest during somatropin therapy.
  • Otitis Media and Cardiovascular Disorders in Patients with Turner Syndrome: Patients with TS should be evaluated carefully for otitis media and other ear disorders as somatropin treatment may increase the occurrence of otitis media in these susceptible patients. In addition, patients with Turner syndrome should be monitored closely for cardiovascular disorders (eg, hypertension, aortic aneurysm or dissection, stroke) as they are at increased risk for these conditions.
  • Osteodystrophy in Pediatric Patients with Chronic Kidney Disease: Children with growth failure secondary to CKD should be examined periodically for evidence of progression of renal osteodystrophy. SCFE or avascular necrosis of the femoral head may be seen in children with advanced renal osteodystrophy. X-rays of the hip should be obtained prior to initiating somatropin therapy in CKD patients and physicians and parents should be alert to the development of a limp or complaints of hip or knee pain in these patients.
  • 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.
  • Laboratory Tests: Serum levels of inorganic phosphorus, alkaline phosphatase, parathyroid hormone and IGF-I may increase during somatropin therapy.
  • Pancreatitis: Cases of pancreatitis have been reported rarely in children and adults receiving somatropin. Pancreatitis should be considered in any somatropin-treated patient, especially a child, who develops persistent, severe abdominal pain. Girls who have TS may be at greater risk than other somatropin-treated children.

DRUG INTERACTIONS

  • 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. Patients treated with glucocorticoid replacement for previously diagnosed hypoadrenalism may require an increase in their maintenance or stress doses following initiation of somatropin treatment.
  • 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. Concomitant glucocorticoid therapy may inhibit the growth promoting effect of Nutropin AQ.
  • Careful monitoring is advisable when somatropin is administered in combination with other drugs metabolized by CYP450 liver enzymes (e.g., corticosteroids, sex steroids, anticonvulsants, cyclosporine), hormone replacement therapy, insulin and/or other hypoglycemic agents.

USE IN SPECIFIC POPULATIONS

  • Pregnancy/Nursing Mothers: 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.
  • Geriatric Use: 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. Elderly patients may be more sensitive to the action of somatropin and may be more prone to adverse reactions.

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

You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at (888) 835-2555.

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

    • CliniicalTrials.gov. A service of the U.S. National Institutes of Health. A Postmarketing Surveillance Program for Nutropin, Nutropin AQ®, and Protropin. Genentech. October 1985-July 2010.

      CliniicalTrials.gov. A service of the U.S. National Institutes of Health. A Postmarketing Surveillance Program for Nutropin, Nutropin AQ®, and Protropin. Genentech. October 1985-July 2010.

    • Nutropin AQ® (somatropin) injection, for subcutaneous use. So. San Francisco, CA: Genentech, Inc; 2016.

      Nutropin AQ® (somatropin) injection, for subcutaneous use. So. San Francisco, CA: Genentech, Inc; 2016.

    • Data on file. Genentech, Inc.

      Data on file. Genentech, Inc.

    • Dook DM, Yuen KCJ, Biller BMK, et al. AACE Guidelines for use of growth hormone in clinical practice. Endocr Pract. 2009;15(Suppl 2), 1-29.

      Dook DM, Yuen KCJ, Biller BMK, et al. AACE Guidelines for use of growth hormone in clinical practice. Endocr Pract. 2009;15(Suppl 2), 1-29.

    • Hokken-Koelega ACS, Saenger P, Cappa M, et al. Unresolved problems concerning optimal therapy of puberty in children with chronic renal diseases. J Pediatric Endocrinol Metab. 2001, Jul;14 Suppl2:945-952.

      Hokken-Koelega ACS, Saenger P, Cappa M, et al. Unresolved problems concerning optimal therapy of puberty in children with chronic renal diseases. J Pediatric Endocrinol Metab. 2001, Jul;14 Suppl2:945-952.