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The Nutropin AQ NuSpin is available in three formulations:
- The Nutropin AQ NuSpin 5 (Clear color, 5 mg/2 mL) delivers doses from 0.05 to 1.75 mg in increments of 0.05 mg
- The Nutropin AQ NuSpin 10 (Teal color, 10 mg/2 mL) delivers doses from 0.1 to 3.5 mg in increments of 0.1 mg
- The Nutropin AQ NuSpin 20 (Blue color, 20 mg/2 mL) delivers doses from 0.2 to 7.0 mg in increments of 0.2 mg
The Nutropin AQ NuSpin is intended for use by a healthcare professional for training purposes, or for a trained patient to deliver a Nutropin AQ injection.
Click through the four steps below for step-by-step instructions on the first use of each new Nutropin AQ NuSpin.
Attaching the needle
Wash hands thoroughly. Gently twist and pull to remove the NuSpin device cap. Inspect the cartridge before use to ensure that the medicine in it is clear. If it is cloudy or hazy, it should not be injected.
Open a new needle by peeling off the paper tab from the needle package.
Attach the needle by carefully screwing it onto the needle holder—do not overtighten. Carefully remove both protective covers from the needle and save the outer cover.
Priming the Nutropin AQ NuSpin
The Nutropin AQ NuSpin is filled to accommodate priming, and only needs to be primed for the first injection with each NuSpin device.
Turn the dose knob to the "P" position in the dose window. It may take multiple clicks to get to "P."
- The "P" position on the Nutropin AQ NuSpin 5 represents a 0.35 mg dose
- The "P" position on the Nutropin AQ NuSpin 10 represents a 0.7 mg dose
- The "P" position on the Nutropin AQ NuSpin 20 represents a 1.4 mg dose
Hold the NuSpin device with the needle pointing upward. Gently tap the cartridge holder to move any air bubbles to the tip of the device.
Slide the Activator toward the needle. If you do not see fluid at the needle tip, redial to "P" and slide the Activator forward again. Repeat until you see fluid.
Setting the dose
Make sure the dose window reads "0.0." Then, turn the dose knob until the prescribed dose appears in the dose window. If you turn the dose knob too far, simply turn it back to the correct dose. Do not press or hold the Activator while turning the dose knob.
This example shows a dose of 0.9 mg represented by "-".
If your dose is "between" two numbers in the dose window, the "-" marking between those two numbers indicates your dose.
For example:
- In the Nutropin AQ NuSpin 5, a dose of 0.45 mg would lie between the 0.4 mg and 0.5 mg mark
- In the Nutropin AQ NuSpin 10, a dose of 0.9 mg would lie between the 0.8 mg and 1.0 mg mark
- In the Nutropin AQ NuSpin 20, a dose of 1.8 mg would lie between the 1.6 mg and 2.0 mg mark
Giving the injection
Once the injection site has been selected and prepared, position a hand so that one may easily slide the Activator. While holding the NuSpin device, insert the needle into the skin by pushing downward until the appropriate depth is reached.
Slide the Activator toward the needle. Continue to hold the Activator down until the dose knob returns to "0.0." Then hold the NuSpin device in place for 5 seconds before withdrawing from the skin. If the dose knob returns to "0.0," the full dose has been delivered.
If the dose knob stops before it returns to "0.0", the Nutropin AQ NuSpin is empty and the full dose has not been delivered. The number shown in the dose window is the amount needed to obtain a full dose. The Prescriber should advise the patient/caregiver on the procedure for using the last dose in the NuSpin device.
Removal and disposal of the needle
To remove the needle, carefully place the needle outer cover over the needle (via scoop method), unscrew, and dispose of in a needle disposal box.
Storage and next use
Replace the cap and store the NuSpin inside the refrigerator at 2° to 8°C (36° to 46°F). Protect from light.
For the next use, attach a new needle, dial in the dose, and give the injection. THE NUSPIN DEVICE ONLY NEEDS TO BE PRIMED PRIOR TO THE FIRST INJECTION.
Rotating the injection site
Injection site discomfort has been reported. 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. Even if the patient develops a preference for one site, he or she should still rotate the injection site. The drawings below show suggested injection sites on the body.
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.
