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Prescribing Information

Answers to frequently asked questions about the Nutropin AQ NuSpin

Questions regarding NuSpin device needles

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Should patients change the needle every time they use the Nutropin AQ NuSpin?

A: Yes. A new needle must be used for every injection. The needle is sterile only for one single injection.

What should be done with the needles after an injection is given?

A: The patient/caregiver should dispose of needles in a proper sharps disposal container. Improper disposal of needles and other medical sharps can cause needle-stick injuries, especially for garbage collectors. Advise patients to throw used needles away safely. Needles, sharps, or sharps containers should not be included in household trash. Collection programs for these items are available in many locations throughout the country. The specialty pharmacy (SP) or local health department may also be able to advise patients on disposal of containers.

The Coalition for Safe Community Needle Disposal is a coalition of businesses, community groups, nonprofit organizations, and the government that promotes public awareness and solutions for safe disposal of needles, syringes, and other sharps in the community. The Coalition website provides a searchable database of locations that accept used sharps. Patients can search for locations by visiting www.safeneedledisposal.org/.

Please see additional information about proper needle disposal and how to travel with GH medication.

What if medication is leaking from the needle?

A: A very small amount of drug may be expelled when the dose knob is dialed up. This is expected and does not indicate a malfunction. After the injection is completed it is important to promptly remove the needle and replace with the NuSpin device cap.

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Questions regarding proper use of the NuSpin device

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Does the Nutropin AQ NuSpin have to be primed for each use?

A: No. The NuSpin only needs to be primed once, at first use.

When and how should patients dispose of the Nutropin AQ NuSpin?

A: The NuSpin device is prefilled and the cartridge cannot be replaced. When the NuSpin device is empty, instruct patients to dispose of the entire NuSpin device. If the empty NuSpin device is disposed of with the needle attached, discard the entire device using the same procedure as for needle disposal.

Please see additional information about proper needle disposal and how to travel with GH medication.

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Questions regarding proper storage and maintenance of the NuSpin device

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Where should the Nutropin AQ NuSpin be stored?

A: When not in use, the NuSpin device should be stored, without the needle, inside a refrigerator at 2° to 8°C (36° to 46°F) to maintain the potency of Nutropin AQ. During use, it is recommended to keep the NuSpin device outside of the refrigerator for no longer than one hour per day. When traveling, the NuSpin device should be kept dry and stored within the appropriate temperature range. DO NOT FREEZE. KEEP DRY.

Nutropin AQ NuSpin should be protected from light. Store the Nutropin AQ NuSpin refrigerated in a dark place when it is not in use.

What if the device has been left out?

A: If the Nutropin AQ NuSpin is kept outside of the refrigerator for longer than one hour, the medication should not be used. Direct patients to call 1-866-NUTROPIN for additional assistance.

What if the Nutropin AQ NuSpin is dropped or damaged?

A: If patients drop their NuSpin device, they should check to see if it is damaged. They should also check to see that the black dose knob and the Activator are moving properly. If the NuSpin device is damaged, advise patients to call their specialty pharmacy (SP) for a replacement, or have them contact 1-866-NUTROPIN.

How should patients clean the Nutropin AQ NuSpin?

A: Patients may use a damp cloth to clean the NuSpin device. Do not place under water. Do not use alcohol.

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Questions regarding Nutropin AQ NuSpin injection safety

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What sites should the patient use for injection?

A: The medication should be given subcutaneously as ordered by the Prescriber. Suggested injection sites include the back of the upper arms, upper thighs, upper buttocks, and abdomen. It’s important that patients alternate injection sites to minimize tissue atrophy (or wasting).

Why is it important to rotate injection sites?

A: Injection site discomfort has been reported. It's important that patients rotate the injection site to avoid tissue atrophy that may result from subcutaneous administration of GH at the same site over a long period of time

What are the most common adverse events?

A: The most common adverse event is an injection site reaction. Other adverse events may include mild, transient peripheral edema, arthralgias, scoliosis, changes in vision, headache, nausea, carpal tunnel syndrome, and allergic reactions.

Who should the patient contact if he or she experiences a side effect or adverse event?

A: If a patient experiences side effects or an adverse event, instruct them to call the HCP. They are also encouraged to report this information to the FDA at 1-800-FDA-1088.

If the HCP receives information from a patient that indicates he or she is experiencing an adverse event, what should be done?

A: If the HCP becomes aware of a patient having an adverse event, he or she should call the FDA at 1-800-FDA-1088 or contact Genentech Drug Safety/Adverse Events at 1-888-835-2555.

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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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