Nutropin AQ® NuSpin™ — Designed to be simple

Nutropin AQ® NuSpin™ is a disposable, multi-dose, dial-a-dose injection device prefilled with Nutropin AQ® [somatropin (rDNA origin) injection] for subcutaneous use. NuSpin™ devices are designed to be simple to use.


Device Overview Chart

 

Instructions for Use

NuSpin 20 Instructions for Use - PDF (4.3 MB) NuSpin 10 Instructions for Use - PDF (4.3 MB) NuSpin 5 Instructions for Use - PDF (4.3 MB)

Watch the NuSpin
Demonstration Video

Read Important Safety Information

Storage and Maintenance

When not in use, the Nutropin AQ® NuSpin™ should be refrigerated at 2°-8°C (36°-46°F) to maintain the potency of the medication. The NuSpin device should never be frozen.
During use, it is recommended that patients have their device outside of the refrigerator for no longer than one hour per day. 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.
Patients should keep their medication out of direct sunlight.

When traveling, instruct patients to keep their device dry and stored within the appropriate temperature range noted above.

If the Nutropin AQ NuSpin requires cleaning, a damp cloth should be used.

Patients should never place their injection device under water. If their device is accidentally immersed, they should remove it from the water and dry it immediately. Also, remind patients to never use alcohol when cleaning their device.

Patients are instructed to call 1-866-NUTROPIN, their specialty pharmacy, or their healthcare team if the Nutropin AQ NuSpin malfunctions.

Read Important Safety Information

Needles

Patients must use a new needle for every injection. The needle is sterile only for a single injection. The following needles fit and work on the NuSpin:

BD Ultra-Fine is a trademark of Becton, Dickinson and Company. NovoFine is a registered trademark of Novo Nordisk A/S.

Needle Disposal

To prevent injury, patients should safely dispose of the needles after each use, and always store disposal containers and needles out of the reach of small children. There may be special regulations in each state regarding what kind of containers can be used for needle disposal.

Please see additional information about proper needle disposal: Genentech Information on Sharps Disposal

The Coalition for Safe Community Needle Disposal- A searchable database of locations accepting used sharps

Select Important Safety Information

Patients should be sure to inject Nutropin at a different recommended place on their body each time to avoid tissue breakdown. A doctor or nurse should provide injection training and supervise the first injection.

Patients should not inject Nutropin AQ until they have been properly trained. If patients have not been trained yet, they may call 1-866-NUTROPIN (1-866-688-7674) to set up an appointment.

Nutropin AQ Pen® 10 and 20

Device Overview Chart

Nutropin AQ Pen® is a device that is used to administer Nutropin AQ [somatropin (rDNA origin) injection].

Read Important Safety Information

Instructions for Use

AQ Pen 10 and 20 Instructions for Use - PDF (4.3 MB)

The Nutropin AQ Pen should be primed each time a new cartridge is inserted. Once a cartridge is loaded (refer to instructions for use), the pen can be primed. First, holding the pen with the needle pointing upward, gently tap the cartridge holder to move any air bubbles to the top. While still holding the pen in the upright position, push in the black dose knob until it locks into position. One should see a drop of medicine appear. If no drop of medicine appears, push the white reset button again. Then turn the black dose knob clockwise by one click, which equals:

  • 0.1 mg for the Nutropin AQ Pen 10
  • 0.2 mg for the Nutropin AQ Pen 20

While still holding the pen in the upright position, push in the black dose knob again and watch the needle tip for a drop of medicine to appear.

Once primed, the pen is ready to be used for injection. Please refer to the instructions for use for detailed instructions.

Read Important Safety Information

Storage and Maintenance

  • Nutropin AQ® [somatropin (rDNA origin) injection] must be refrigerated at 36° to 46°F (2°-8°C), and cannot continue to be used beyond 28 days after initial use and should be discarded. Nutropin AQ should not be frozen.
  • The Nutropin AQ cartridges are light-sensitive and should be protected from light when not in use.

Please see full Prescribing Information for additional Important Safety Information.

Nutropin AQ is available in the United States by prescription only.

For questions, patients may call 1-866-NUTROPIN (1-866-688-7674) or visit Nutropin.com.

Needles

BD Ultra-Fine™ 29 gauge / 12.7 mm needles are provided by Genentech USA, Inc. in the patient's Nutropin AQ Pen kit. The following needles fit and work on the Nutropin AQ Pen:

BD Ultra-Fine is a trademark of Becton, Dickinson and Company. NovoFine is a registered trademark of Novo Nordisk A/S.

Needles from other countries may not fit the Nutropin AQ Pen. When patients travel outside the United States, make sure that they take enough needles for the duration of their stay.

Needle Disposal

To prevent injury, patients should safely dispose of needles after each use, and always store disposal containers and needles out of the reach of small children. There may be special regulations in each state regarding what kind of containers can be used for needle disposal.

Please see additional information about proper needle disposal: Genentech Information on Sharps Disposal

The Coalation for Safe Community Needle Disposal- A searchable database of locations accepting used sharps

BD Ultra-Fine is a trademark of Becton, Dickinson and Company. NovoFine is a registered trademark of Novo Nordisk A/S.

Read 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.

You may report side effects to the FDA by calling 1-800-FDA-1088 or visiting www.fda.gov/medwatch.
You may also report side effects to Genentech by calling 1-888-835-2555.

Please see accompanying full Prescribing Information and full Important Safety Information.

Back to Top