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Administering Nutropin AQ with the Nutropin AQ Pen 10
Components of the Nutropin AQ Pen 10
The Nutropin AQ Pen 10 comes with the following:
- Instructions for use
- Pen needles
- Active shield
- Passive shield
Nutropin AQ Pen 10 mg Cartridges are supplied separately.
Follow the instructions in the steps below if the pen is being used for the first time or if an empty cartridge is being replaced.
- Step 1. Inserting or changing a cartridge
- Step 2. Priming the pen
- Step 3. Dialing in the dose and giving the injection
Step 1. Inserting or changing a cartridge
1. Wash hands thoroughly, then remove the green pen cap and unscrew the cartridge holder from the pen. If necessary, remove the empty cartridge and discard it properly. Inspect the cartridge prior to use. The medication should be clear and colorless with no floating particles. If not, the patient should call the specialty pharmacy (SP) for a replacement.
2. Press the white reset button.
3. Turn the black dose knob counterclockwise back to its starting position until it no longer turns (see illustration). When the dose knob is dialed back, dashes ("--") will appear on the screen. Now turn the dose knob clockwise until the first click position is reached (approximately 1/8 turn). This ensures that the plunger push rod is reset to the starting position. If this is not done when the dosage knob is first depressed, Nutropin AQ will be wasted or the cartridge may crack.
4. Make sure that the cartridge and the Nutropin AQ Pen are the same strength (10 mg cartridge with 10 mg pen). Insert the cartridge into the cartridge holder, then screw the cartridge holder back onto the pen (be careful not to touch the rubber seal). Align the small end of the cartridge with the small end of the cartridge holder. If the rubber stopper becomes contaminated when transferring to the cartridge holder or between doses, it should be cleaned with an alcohol prep prior to attaching the needle assembly.
5. Remove the paper seal from a new needle assembly and screw it onto the cartridge holder. Be sure the threads of the needle assembly match up with the cartridge holder tip. If the needle is not screwed on the tip properly, the needle will not align with the hole in the shield. This may cause the needle to bend.
6. Carefully remove both protective caps from the needle by pulling gently. Do not throw the larger cap away as it will be used later for proper needle removal and disposal.
Step 2. Priming the pen
1. 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. You should see a drop of medicine appear. Since the cartridges are slightly overfilled, a drop of medication will normally appear the first time the black dose knob is depressed. The only time the pen is primed is when a new cartridge is inserted.
If the medicine doesn't appear within a few seconds it needs to be primed again. Push the white reset button again. Turn the black dose knob clockwise (see illustration) by 1 click, which equals 0.1 mg.
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. Repeat these steps as needed until medicine appears.
Using the needle shields
Patients have 3 shield options:
- No shield
- Passive shield—this is the plain shield, which will hide the needle
- Active shield—this is the shield with the 2 small black buttons at the tip. This shield will hide the needle and provides a safety mechanism to prevent an accidental needle stick.
If using the passive shield, carefully slide the needle shield over the needle end of the pen. Secure the shield by aligning the curved grooves until it clicks into place. If you are using the active shield, push the 2 black lock knobs on the needle shield toward the tip. If a needle shield is not used, please proceed to step 3.
Step 3. Dialing in the dose and giving the injection
1. Press the white reset button.
2. Set the required dose by turning the black dose knob. If you accidentally turn it too far, go back 1 click. The digital dose display will show the dose in milligrams (mg). It is not necessary to convert to volume (mL or units).
3. Prepare the injection site by wiping with an alcohol wipe and letting it dry. Injection sites include the upper arms, abdomen, upper thighs, and buttocks. Injection sites should be rotated.
4. Set the tip of the pen on the prepared injection site at the angle recommended by the healthcare professional (HCP). If a needle shield is used, the angle needs to be 90 degrees. Press the needle into the skin by pushing the pen downward until the shield (if you are using one) is totally depressed. Then, press down on the black dose knob until it locks in place. Wait 5 seconds then withdraw the needle from the skin.
5. Pull the needle shield off the pen (if applicable) and place the larger needle cap on a flat surface. Slide the needle in to pick it up and push the cap completely down over the needle. Twist off the needle and discard properly.
6. Attach the pen cap and return it to its case with the black dose knob pressed in. The pen should always be stored in a refrigerator. Do not remove the cartridge between injections. DO NOT FREEZE. KEEP DRY.
For subsequent injections with the Nutropin AQ Pen 10, follow steps in step 2—attach a new needle, push the white reset button, and dial in the dose.
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.
