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Indications
Pediatric patients
Nutropin AQ and Nutropin are indicated for the long-term treatment of growth failure due to a lack of adequate endogenous GH secretion.
Nutropin AQ and Nutropin are 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 indicated for the long-term treatment of short stature associated with Turner syndrome.
Nutropin AQ and Nutropin are 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 the 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.
Dosing Information
The dosage and administration schedule for Nutropin products should be individualized for each patient. However, in pediatric patients whose failure to increase growth rate, particularly during the first year of therapy, suggests the need for close assessment of compliance and evaluation of other causes of growth failure, such as hypothyroidism, under-nutrition, and advanced bone age.
Dosing for Pediatric Patients
Pediatric Growth Hormone Deficiency (GHD)
A weekly dosage of up to 0.3 mg/kg of body weight divided into daily subcutaneous injection is recommended. In pubertal patients, a weekly dosage of up to 0.7 mg/kg divided daily may be used.
Turner Syndrome
A weekly dosage of up to 0.375 mg/kg of body weight divided into equal doses 3 to 7 times per week by subcutaneous injection is recommended.
Chronic Renal Insufficiency (CRI)
A weekly dosage of up to 0.35 mg/kg of body weight divided into daily subcutaneous injection is recommended.
Nutropin AQ and Nutropin therapy may be continued up to the time of renal transplantation. In order to optimize therapy for patients who require dialysis, the following guidelines for injection schedule are recommended:
- Hemodialysis patients should receive their injection at night just prior to going to sleep or at least 3-4 hours after their hemodialysis to prevent hematoma formation due to the heparin.
- Chronic Cycling Peritoneal Dialysis (CCPD) patients should receive their injection in the morning after they have completed dialysis.
- Chronic Ambulatory Peritoneal Dialysis (CAPD) patients should receive their injection in the evening at the time of the overnight exchange.
Idiopathic Short Stature (ISS)
A weekly dosage of up to 0.3 mg/kg of body weight divided into daily subcutaneous injection has been shown to be safe and efficacious, and is recommended.
Please see Nutropin AQ full Prescribing Information
Dosing for Adult Patients
Adult Growth Hormone Deficiency (GHD)
Based on the weight-based dosing utilized in the original pivotal studies described herein, the recommended dosage at the start of therapy is not more than 0.006 mg/kg given as a daily subcutaneous injection. The dose may be increased according to individual patient requirements to a maximum of 0.025 mg/kg daily in patients under 35 years old and to a maximum of 0.0125 mg/kg daily in patients over 35 years old. Clinical response, side effects, and determination of age- and gender-adjusted serum IGF-1 levels may be used as guidance in dose titration.
Alternatively, taking into account more recent literature, a starting dose of approximately 0.2 mg/day (range, 0.15-0.30 mg/day) may be used without consideration of body weight. This dose can be increased gradually every 1-2 months by increments of approximately 0.1-0.2 mg/day, according to individual patient requirements based on the clinical response and serum IGF-1 concentrations. During therapy, the dose should be decreased if required by the occurrence of adverse events and/or serum IGF-1 levels above the age- and gender-specific normal range. Maintenance dosages vary considerably from person to person.
A lower starting dose and smaller dose increments should be considered for older patients, who are more prone to the adverse effects of somatropin than younger individuals. In addition, obese individuals are more likely to manifest adverse effects when treated with a weight-based regimen. In order to reach the defined treatment goal, estrogen-replete women may need higher doses than men. Oral estrogen administration may increase the dose requirements in women.
The following Nutropin products are available to assist with dosing considerations:
- Dosing information for Nutropin AQ, Nutropin AQ Pen 10, Nutropin AQ Pen 20, Nutropin AQ NuSpin 20, Nutropin AQ NuSpin 10, and Nutropin AQ NuSpin 5
- Dosing information for Nutropin
Please see Nutropin AQ full Prescribing 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.
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.
