![Nutropin [somatropin (rDNA origin) for injection]: Growing Opportunity](/images/logo-nutropin-growing.png){kind=logo}
Before teaching the actual administration of the Nutropin product, it is important to make sure you have discussed all of the training steps to ensure patients understand all aspects of Nutropin therapy. It is suggested that the training should begin with introductions and the expectations for the training session. It is important to compare the prescription to the medication and supplies delivered to the patient. Review the supplies, storage, and needle disposal. Then discuss the Nutropin product, expiration dates, indications, and safety information. Assess if the learner(s) understands the purpose of therapy and the importance of compliance, expectations, and follow-up. The learner should understand aseptic technique and good hand-washing prior to preparation of the medication and giving the injection.
Preparation
It is important that the patient/caregiver learns to review the Nutropin product and/or device as follows:
- Check the Nutropin product and the device to make sure it matches the prescription
- Inspect the cartridge or vial to ensure that the medicine is not expired and is clear. If it is cloudy or hazy, it should not be injected, and the patient or caregiver should contact the specialty pharmacy (SP) or Nutropin Hotline
- Hands should be properly washed before preparing and injecting Nutropin products
Rotating the injection site—It is important that the patient is taught how to properly give the injection. Teach your patients how to locate appropriate injection sites—such as the back of the upper arms, the upper thighs, the upper buttocks, and abdomen. 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.
Patients may use the Injection Rotation Calendar included in their patient educational kit to keep track of their daily injections, where they've injected medication, and their dose.
Injecting the medication—Nutropin is administered as an injection in the subcutaneous fat tissue. It is important to select a needle specific to each patient to enable delivery of GH to the subcutaneuous layer of the skin. To avoid the risk of injecting into muscle, injection technique is important, and a grasp of the skin may be required when inserting the needle.
When using the Nutropin AQ Pen® or Nutropin AQ® NuSpin™ the healthcare professional (HCP) should choose the pen needle that is appropriate for each individual patient. Using a pen needle that is ≥6 mm in length would provide appropriate penetration into the subcutaneous tissue. Some needles may not work with the Nutropin AQ Pen or Nutropin AQ NuSpin.
The following needles will fit and work on the Nutropin AQ Pen and Nutropin AQ NuSpin:
- BD Ultra-Fine™ 29 g x 1/2 inch (12.7 mm)
- BD Ultra-Fine™ III short pen needle 31 g x 5/16 inch (8 mm)
- NovoFine® pen needle 30 g x 1/3 inch (8 mm)
Medication that has been allowed to come to room temperature may result in a more comfortable injection. Remind patients that this can be done by either leaving the medication out of the refrigerator up to 45 minutes or warming Nutropin AQ in their hand for about 5 minutes prior to injection.
Injection Routine—Getting into a routine may help patients stay on top of their GH therapy and prevent them from missing doses. The patient should try to take this medication at the same time each day, preferably in the evening. Patients who are on chronic cyclic peritoneal dialysis should take this medication in the morning after dialysis is completed. As you know, it's important not to miss any doses. Discuss how to handle possible missed doses with your patients at each visit.
BD Ultra-Fine is a trademark of Becton, Dickinson and Company. NovoFine is a registered trademark of Novo Nordisk A/S.
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.
