Nutropin Aq
(Somatropin)Dosage & Administration
For subcutaneous injection
Therapy with Nutropin AQ should be supervised by a physician who is experienced in the diagnosis and management of pediatric patients with short stature associated with growth hormone deficiency (GHD), chronic kidney disease, Turner syndrome, idiopathic short stature, or adult patients with either childhood-onset or adult-onset GHD.
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Nutropin AQ Prescribing Information
Warnings and Precautions, Slipped Capital Femoral Epiphysis in Pediatric Patients (SCFE may occur more frequently in patients with endocrine disorders (including GHD and TS) or in patients undergoing rapid growth. SCFE may lead to osteonecrosis. Cases of SCFE with or without osteonecrosis have been reported in pediatric patients with short stature receiving somatropin, including NUTROPIN AQ. Any pediatric patient with the onset of a limp or complaints of hip or knee pain during NUTROPIN AQ therapy should be evaluated for SCFE and osteonecrosis and managed accordingly. | 07/2025 |
Nutropin AQ is a recombinant human growth hormone indicated for:
- Pediatric Patients: Treatment of children with growth failure due to growth hormone deficiency (GHD), idiopathic short stature (ISS), Turner syndrome (TS), and chronic kidney disease (CKD) up to the time of renal transplantation ().
1.1 Pediatric PatientsGrowth Hormone Deficiency (GHD)- Nutropin AQ®is indicated for the treatment of pediatric patients who have growth failure due to inadequate secretion of endogenous growth hormone (GH).Growth Failure Secondary to Chronic Kidney Disease (CKD)- Nutropin AQ is indicated for the treatment of growth failure associated with CKD up to the time of renal transplantation. Nutropin AQ therapy should be used in conjunction with optimal management of CKD.Idiopathic Short Stature (ISS)- Nutropin AQ is indicated for the treatment of ISS, also called non-GHD 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.Short Stature Associated with Turner Syndrome (TS)- Nutropin AQ is indicated for the treatment of short stature associated with TS. - Adult Patients:Treatment of adults with either childhood-onset or adult-onset GHD ().
1.2 Adult PatientsNutropin AQ is indicated for the replacement of endogenous GH in adults with GHD who meet either of the following two criteria:
Adult Onset: Patients who have GHD, either alone or associated with multiple hormone deficiencies (hypopituitarism), as a result of pituitary disease, hypothalamic disease, surgery, radiation therapy, or trauma; orChildhood Onset: Patients who were GH deficient during childhood as a result of congenital, genetic, acquired, or idiopathic causes.Patients who were treated with somatropin for GHD in childhood and whose epiphyses are closed should be reevaluated before continuation of somatropin therapy at the reduced dose level recommended for GH deficient adults. According to current standards, confirmation of the diagnosis of adult GHD in both groups involves an appropriate GH provocative test with two exceptions: (1) patients with multiple pituitary hormone deficiencies due to organic disease; and (2) patients with congenital/genetic GHD.
For subcutaneous injection
Therapy with Nutropin AQ should be supervised by a physician who is experienced in the diagnosis and management of pediatric patients with short stature associated with growth hormone deficiency (GHD), chronic kidney disease, Turner syndrome, idiopathic short stature, or adult patients with either childhood-onset or adult-onset GHD.
Nutropin AQ is available in the following pen cartridge and NuSpin forms:
- Pen Cartridge: 10 mg/2 mL (yellow color band), and 20 mg/2 mL (purple color band)
- NuSpin: 5 mg/2 mL (clear device), 10 mg/2 mL (green device), and 20 mg/2 mL (blue device)
Pregnancy Category C. Animal reproduction studies have not been conducted with Nutropin AQ. It is also not known whether Nutropin AQ can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Nutropin AQ should be given to a pregnant woman only if clearly needed.
- Acute critical illness ().
4 CONTRAINDICATIONS- Acute critical illness .
- Children with Prader-Willi syndrome (PWS) who are severely obese or have severe respiratory impairment – reports of sudden death .
- Active malignancy .
- Hypersensitivity to somatropin or excipients .
- Active proliferative or severe non-proliferative diabetic retinopathy .
- Children with closed epiphysis .
- Acute Critical Illness
Treatment with pharmacologic amounts of somatropin is contraindicated in patients with acute critical illness due to complications following open heart surgery, abdominal surgery or multiple accidental trauma, or those with acute respiratory failure
[see Warnings and Precautions (5.1)].- Prader-Willi Syndrome (PWS) in Children
Somatropin is contraindicated in 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 when somatropin was used in such patients. Nutropin AQ is not indicated for the treatment of pediatric patients who have growth failure due to genetically confirmed PWS
[see Warnings and Precautions (5.2)].- Active Malignancy
In general, somatropin is contraindicated in the presence of active malignancy. Any pre-existing malignancy should be inactive and its treatment complete prior to instituting therapy with somatropin. Somatropin should be discontinued if there is evidence of recurrent activity. Since growth hormone deficiency (GHD) may be an early sign of the presence of a pituitary tumor (or, rarely, other brain tumors), the presence of such tumors should be ruled out prior to initiation of treatment. Somatropin should not be used in patients with any evidence of progression or recurrence of an underlying intracranial tumor
[see Warnings and Precautions (5.3)].- Hypersensitivity
Nutropin AQ is contraindicated in patients with a known hypersensitivity to somatropin or any of its excipients. Systemic hypersensitivity reactions have been reported with postmarketing use of somatropin products
[see Warnings and Precautions (5.6)].- Diabetic Retinopathy
Somatropin is contraindicated in patients with active proliferative or severe non-proliferative diabetic retinopathy.
- Closed Epiphysis
Somatropin should not be used for growth promotion in pediatric patients with closed epiphysis.
- Children with Prader-Willi syndrome (PWS) who are severely obese or have severe respiratory impairment – reports of sudden death ().
4 CONTRAINDICATIONS- Acute critical illness .
- Children with Prader-Willi syndrome (PWS) who are severely obese or have severe respiratory impairment – reports of sudden death .
- Active malignancy .
- Hypersensitivity to somatropin or excipients .
- Active proliferative or severe non-proliferative diabetic retinopathy .
- Children with closed epiphysis .
- Acute Critical Illness
Treatment with pharmacologic amounts of somatropin is contraindicated in patients with acute critical illness due to complications following open heart surgery, abdominal surgery or multiple accidental trauma, or those with acute respiratory failure
[see Warnings and Precautions (5.1)].- Prader-Willi Syndrome (PWS) in Children
Somatropin is contraindicated in 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 when somatropin was used in such patients. Nutropin AQ is not indicated for the treatment of pediatric patients who have growth failure due to genetically confirmed PWS
[see Warnings and Precautions (5.2)].- Active Malignancy
In general, somatropin is contraindicated in the presence of active malignancy. Any pre-existing malignancy should be inactive and its treatment complete prior to instituting therapy with somatropin. Somatropin should be discontinued if there is evidence of recurrent activity. Since growth hormone deficiency (GHD) may be an early sign of the presence of a pituitary tumor (or, rarely, other brain tumors), the presence of such tumors should be ruled out prior to initiation of treatment. Somatropin should not be used in patients with any evidence of progression or recurrence of an underlying intracranial tumor
[see Warnings and Precautions (5.3)].- Hypersensitivity
Nutropin AQ is contraindicated in patients with a known hypersensitivity to somatropin or any of its excipients. Systemic hypersensitivity reactions have been reported with postmarketing use of somatropin products
[see Warnings and Precautions (5.6)].- Diabetic Retinopathy
Somatropin is contraindicated in patients with active proliferative or severe non-proliferative diabetic retinopathy.
- Closed Epiphysis
Somatropin should not be used for growth promotion in pediatric patients with closed epiphysis.
- Active malignancy ().
4 CONTRAINDICATIONS- Acute critical illness .
- Children with Prader-Willi syndrome (PWS) who are severely obese or have severe respiratory impairment – reports of sudden death .
- Active malignancy .
- Hypersensitivity to somatropin or excipients .
- Active proliferative or severe non-proliferative diabetic retinopathy .
- Children with closed epiphysis .
- Acute Critical Illness
Treatment with pharmacologic amounts of somatropin is contraindicated in patients with acute critical illness due to complications following open heart surgery, abdominal surgery or multiple accidental trauma, or those with acute respiratory failure
[see Warnings and Precautions (5.1)].- Prader-Willi Syndrome (PWS) in Children
Somatropin is contraindicated in 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 when somatropin was used in such patients. Nutropin AQ is not indicated for the treatment of pediatric patients who have growth failure due to genetically confirmed PWS
[see Warnings and Precautions (5.2)].- Active Malignancy
In general, somatropin is contraindicated in the presence of active malignancy. Any pre-existing malignancy should be inactive and its treatment complete prior to instituting therapy with somatropin. Somatropin should be discontinued if there is evidence of recurrent activity. Since growth hormone deficiency (GHD) may be an early sign of the presence of a pituitary tumor (or, rarely, other brain tumors), the presence of such tumors should be ruled out prior to initiation of treatment. Somatropin should not be used in patients with any evidence of progression or recurrence of an underlying intracranial tumor
[see Warnings and Precautions (5.3)].- Hypersensitivity
Nutropin AQ is contraindicated in patients with a known hypersensitivity to somatropin or any of its excipients. Systemic hypersensitivity reactions have been reported with postmarketing use of somatropin products
[see Warnings and Precautions (5.6)].- Diabetic Retinopathy
Somatropin is contraindicated in patients with active proliferative or severe non-proliferative diabetic retinopathy.
- Closed Epiphysis
Somatropin should not be used for growth promotion in pediatric patients with closed epiphysis.
- Hypersensitivity to somatropin or excipients ().
4 CONTRAINDICATIONS- Acute critical illness .
- Children with Prader-Willi syndrome (PWS) who are severely obese or have severe respiratory impairment – reports of sudden death .
- Active malignancy .
- Hypersensitivity to somatropin or excipients .
- Active proliferative or severe non-proliferative diabetic retinopathy .
- Children with closed epiphysis .
- Acute Critical Illness
Treatment with pharmacologic amounts of somatropin is contraindicated in patients with acute critical illness due to complications following open heart surgery, abdominal surgery or multiple accidental trauma, or those with acute respiratory failure
[see Warnings and Precautions (5.1)].- Prader-Willi Syndrome (PWS) in Children
Somatropin is contraindicated in 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 when somatropin was used in such patients. Nutropin AQ is not indicated for the treatment of pediatric patients who have growth failure due to genetically confirmed PWS
[see Warnings and Precautions (5.2)].- Active Malignancy
In general, somatropin is contraindicated in the presence of active malignancy. Any pre-existing malignancy should be inactive and its treatment complete prior to instituting therapy with somatropin. Somatropin should be discontinued if there is evidence of recurrent activity. Since growth hormone deficiency (GHD) may be an early sign of the presence of a pituitary tumor (or, rarely, other brain tumors), the presence of such tumors should be ruled out prior to initiation of treatment. Somatropin should not be used in patients with any evidence of progression or recurrence of an underlying intracranial tumor
[see Warnings and Precautions (5.3)].- Hypersensitivity
Nutropin AQ is contraindicated in patients with a known hypersensitivity to somatropin or any of its excipients. Systemic hypersensitivity reactions have been reported with postmarketing use of somatropin products
[see Warnings and Precautions (5.6)].- Diabetic Retinopathy
Somatropin is contraindicated in patients with active proliferative or severe non-proliferative diabetic retinopathy.
- Closed Epiphysis
Somatropin should not be used for growth promotion in pediatric patients with closed epiphysis.
- Active proliferative or severe non-proliferative diabetic retinopathy ().
4 CONTRAINDICATIONS- Acute critical illness .
- Children with Prader-Willi syndrome (PWS) who are severely obese or have severe respiratory impairment – reports of sudden death .
- Active malignancy .
- Hypersensitivity to somatropin or excipients .
- Active proliferative or severe non-proliferative diabetic retinopathy .
- Children with closed epiphysis .
- Acute Critical Illness
Treatment with pharmacologic amounts of somatropin is contraindicated in patients with acute critical illness due to complications following open heart surgery, abdominal surgery or multiple accidental trauma, or those with acute respiratory failure
[see Warnings and Precautions (5.1)].- Prader-Willi Syndrome (PWS) in Children
Somatropin is contraindicated in 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 when somatropin was used in such patients. Nutropin AQ is not indicated for the treatment of pediatric patients who have growth failure due to genetically confirmed PWS
[see Warnings and Precautions (5.2)].- Active Malignancy
In general, somatropin is contraindicated in the presence of active malignancy. Any pre-existing malignancy should be inactive and its treatment complete prior to instituting therapy with somatropin. Somatropin should be discontinued if there is evidence of recurrent activity. Since growth hormone deficiency (GHD) may be an early sign of the presence of a pituitary tumor (or, rarely, other brain tumors), the presence of such tumors should be ruled out prior to initiation of treatment. Somatropin should not be used in patients with any evidence of progression or recurrence of an underlying intracranial tumor
[see Warnings and Precautions (5.3)].- Hypersensitivity
Nutropin AQ is contraindicated in patients with a known hypersensitivity to somatropin or any of its excipients. Systemic hypersensitivity reactions have been reported with postmarketing use of somatropin products
[see Warnings and Precautions (5.6)].- Diabetic Retinopathy
Somatropin is contraindicated in patients with active proliferative or severe non-proliferative diabetic retinopathy.
- Closed Epiphysis
Somatropin should not be used for growth promotion in pediatric patients with closed epiphysis.
- Children with closed epiphysis ().
4 CONTRAINDICATIONS- Acute critical illness .
- Children with Prader-Willi syndrome (PWS) who are severely obese or have severe respiratory impairment – reports of sudden death .
- Active malignancy .
- Hypersensitivity to somatropin or excipients .
- Active proliferative or severe non-proliferative diabetic retinopathy .
- Children with closed epiphysis .
- Acute Critical Illness
Treatment with pharmacologic amounts of somatropin is contraindicated in patients with acute critical illness due to complications following open heart surgery, abdominal surgery or multiple accidental trauma, or those with acute respiratory failure
[see Warnings and Precautions (5.1)].- Prader-Willi Syndrome (PWS) in Children
Somatropin is contraindicated in 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 when somatropin was used in such patients. Nutropin AQ is not indicated for the treatment of pediatric patients who have growth failure due to genetically confirmed PWS
[see Warnings and Precautions (5.2)].- Active Malignancy
In general, somatropin is contraindicated in the presence of active malignancy. Any pre-existing malignancy should be inactive and its treatment complete prior to instituting therapy with somatropin. Somatropin should be discontinued if there is evidence of recurrent activity. Since growth hormone deficiency (GHD) may be an early sign of the presence of a pituitary tumor (or, rarely, other brain tumors), the presence of such tumors should be ruled out prior to initiation of treatment. Somatropin should not be used in patients with any evidence of progression or recurrence of an underlying intracranial tumor
[see Warnings and Precautions (5.3)].- Hypersensitivity
Nutropin AQ is contraindicated in patients with a known hypersensitivity to somatropin or any of its excipients. Systemic hypersensitivity reactions have been reported with postmarketing use of somatropin products
[see Warnings and Precautions (5.6)].- Diabetic Retinopathy
Somatropin is contraindicated in patients with active proliferative or severe non-proliferative diabetic retinopathy.
- Closed Epiphysis
Somatropin should not be used for growth promotion in pediatric patients with closed epiphysis.