Genotropin
(Somatropin)Dosage & Administration
The weekly dose should be divided into 6 or 7
Therapy with GENOTROPIN should be supervised by a physician who is experienced in the diagnosis and management of pediatric patients with growth failure associated with growth hormone deficiency (GHD), Prader-Willi syndrome (PWS), Turner syndrome (TS), those who were born small for gestational age (SGA) or Idiopathic Short Stature (ISS), and adult patients with either childhood onset or adult onset GHD.
Genotropin Prescribing Information
Warnings and Precautions, Slipped Capital Femoral Epiphysis in Pediatric Patients ( Slipped capital femoral epiphyses may occur more frequently in patients with endocrine disorders (including GHD and Turner syndrome) or in patients undergoing rapid growth. Slipped capital femoral epiphysis may lead to osteonecrosis. Cases of slipped capital femoral epiphysis with or without osteonecrosis have been reported in pediatric patients with short stature receiving somatropin, including GENOTROPIN. Any pediatric patient with the onset of a limp or complaints of hip or knee pain duringGENOTROPIN therapy should beevaluated for slipped capital femoral epiphysis and osteonecrosis and managed accordingly. | 07/2025 |
GENOTROPIN is a recombinant human growth hormone indicated for:
• Treatment of children with growth failure due to growth hormone deficiency (GHD), Prader-Willi syndrome, Small for Gestational Age, Turner syndrome, and Idiopathic Short Stature (Pediatric:)1.1 Pediatric PatientsGENOTROPIN is indicated for the treatment of pediatric patients who have growth failure due to an inadequate secretion of endogenous growth hormone.
GENOTROPIN is indicated for the treatment of pediatric patients who have growth failure due to Prader-Willi syndrome (PWS). The diagnosis of PWS should be confirmed by appropriate genetic testing
[seeContraindications (4)].GENOTROPIN is indicated for the treatment of growth failure in pediatric patients born small for gestational age (SGA) who fail to manifest catch-up growth by age 2 years.
GENOTROPIN is indicated for the treatment of growth failure associated with Turner syndrome.
GENOTROPIN is indicated for the treatment of idiopathic short stature (ISS), also called non-growth hormone-deficient short stature, defined by height standard deviation score (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.
• Treatment of adults with either adult onset or childhood onset GHD (Adult:)1.2 Adult PatientsGENOTROPIN is indicated for replacement of endogenous growth hormone in adults with growth hormone deficiency who meet either of the following two criteria:
Adult Onset (AO):Patients who have growth hormone deficiency, either alone or associated with multiple hormone deficiencies (hypopituitarism), as a result of pituitary disease, hypothalamic disease, surgery, radiation therapy, or trauma; orChildhood Onset (CO): Patients who were growth hormone deficient during childhood as a result of congenital, genetic, acquired, or idiopathic causes.Patients who were treated with somatropin for growth hormone deficiency in childhood and whose epiphyses are closed should be reevaluated before continuation of somatropin therapy at the reduced dose level recommended for growth hormone deficient adults. According to current standards, confirmation of the diagnosis of adult growth hormone deficiency in
bothgroups involves an appropriate growth hormone provocative test with two exceptions: (1) patients with multiple other pituitary hormone deficiencies due to organic disease; and (2) patients with congenital/genetic growth hormone deficiency.
The weekly dose should be divided into 6 or 7
Therapy with GENOTROPIN should be supervised by a physician who is experienced in the diagnosis and management of pediatric patients with growth failure associated with growth hormone deficiency (GHD), Prader-Willi syndrome (PWS), Turner syndrome (TS), those who were born small for gestational age (SGA) or Idiopathic Short Stature (ISS), and adult patients with either childhood onset or adult onset GHD.
GENOTROPIN is a white, lyophilized powder available as:
• For injection: 5 mg or 12 mg in a single-patient-use two-chamber cartridge• For injection: 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg, 1 mg, 1.2 mg, 1.4 mg, 1.6 mg, 1.8 mg, or 2 mg in a single‑dose Growth Hormone Delivery Device containing a two-chamber cartridge (GENOTROPIN MINIQUICK)
Limited available data with somatropin use in pregnant women are insufficient to determine a drug-associated risk of adverse developmental outcomes. In animal studies (rats and rabbits), there was no evidence of embryo‑fetal or neonatal harm following somatropin administration during organogenesis at doses approximately 24 times and 19 times the recommended human therapeutic levels, respectively, based on body surface area
The estimated background risk of birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.
Animal reproduction studies with somatropin during the period of organogenesis at doses of 0.3, 1, and 3.3 mg/kg/day administered subcutaneously (SC) in pregnant rats and 0.08, 0.3, and 1.3 mg/kg/day administered intramuscularly in pregnant rabbits were not teratogenic (highest doses approximately 24 times and 19 times the recommended human therapeutic levels, respectively, based on body surface area).
In perinatal and postnatal studies in rats, somatropin doses of 0.3, 1, and 3.3 mg/kg/day produced growth‑promoting effects in the dams but not in the fetuses. Young rats at the highest dose showed increased weight gain during suckling but the effect was not apparent by 10 weeks of age. No adverse effects were observed on gestation, morphogenesis, parturition, lactation, postnatal development, or reproductive capacity of the offspring due to somatropin.
• Acute Critical Illness ()4 CONTRAINDICATIONS• Acute Critical Illness• Children with Prader-Willi syndrome 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 epiphyses
GENOTROPIN is contraindicated in patients with:
•
Acute Critical IllnessTreatment 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 in ChildrenSomatropin is contraindicated in patients with Prader-Willi syndrome 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
[see Warnings and Precautions (5.2)].•
Active MalignancyIn general, somatropin is contraindicated in the presence of active malignancy. Any preexisting 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 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.
•
HypersensitivityGENOTROPIN is contraindicated in patients with a known hypersensitivity to somatropin or any of its excipients. The 5 mg and 12 mg presentations of GENOTROPIN lyophilized powder contain m-cresol as a preservative. Systemic hypersensitivity reactions have been reported with postmarketing use of somatropins
[see Warnings and Precautions (5.6)].•
Diabetic RetinopathySomatropin is contraindicated in patients with active proliferative or severe non-proliferative diabetic retinopathy.
•
Closed EpiphysesSomatropin should not be used for growth promotion in pediatric patients with closed epiphyses.
• Children with Prader-Willi syndrome who are severely obese or have severe respiratory impairment – reports of sudden death ()4 CONTRAINDICATIONS• Acute Critical Illness• Children with Prader-Willi syndrome 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 epiphyses
GENOTROPIN is contraindicated in patients with:
•
Acute Critical IllnessTreatment 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 in ChildrenSomatropin is contraindicated in patients with Prader-Willi syndrome 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
[see Warnings and Precautions (5.2)].•
Active MalignancyIn general, somatropin is contraindicated in the presence of active malignancy. Any preexisting 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 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.
•
HypersensitivityGENOTROPIN is contraindicated in patients with a known hypersensitivity to somatropin or any of its excipients. The 5 mg and 12 mg presentations of GENOTROPIN lyophilized powder contain m-cresol as a preservative. Systemic hypersensitivity reactions have been reported with postmarketing use of somatropins
[see Warnings and Precautions (5.6)].•
Diabetic RetinopathySomatropin is contraindicated in patients with active proliferative or severe non-proliferative diabetic retinopathy.
•
Closed EpiphysesSomatropin should not be used for growth promotion in pediatric patients with closed epiphyses.
• Active Malignancy ()4 CONTRAINDICATIONS• Acute Critical Illness• Children with Prader-Willi syndrome 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 epiphyses
GENOTROPIN is contraindicated in patients with:
•
Acute Critical IllnessTreatment 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 in ChildrenSomatropin is contraindicated in patients with Prader-Willi syndrome 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
[see Warnings and Precautions (5.2)].•
Active MalignancyIn general, somatropin is contraindicated in the presence of active malignancy. Any preexisting 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 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.
•
HypersensitivityGENOTROPIN is contraindicated in patients with a known hypersensitivity to somatropin or any of its excipients. The 5 mg and 12 mg presentations of GENOTROPIN lyophilized powder contain m-cresol as a preservative. Systemic hypersensitivity reactions have been reported with postmarketing use of somatropins
[see Warnings and Precautions (5.6)].•
Diabetic RetinopathySomatropin is contraindicated in patients with active proliferative or severe non-proliferative diabetic retinopathy.
•
Closed EpiphysesSomatropin should not be used for growth promotion in pediatric patients with closed epiphyses.
• Hypersensitivity to somatropin or excipients ()4 CONTRAINDICATIONS• Acute Critical Illness• Children with Prader-Willi syndrome 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 epiphyses
GENOTROPIN is contraindicated in patients with:
•
Acute Critical IllnessTreatment 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 in ChildrenSomatropin is contraindicated in patients with Prader-Willi syndrome 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
[see Warnings and Precautions (5.2)].•
Active MalignancyIn general, somatropin is contraindicated in the presence of active malignancy. Any preexisting 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 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.
•
HypersensitivityGENOTROPIN is contraindicated in patients with a known hypersensitivity to somatropin or any of its excipients. The 5 mg and 12 mg presentations of GENOTROPIN lyophilized powder contain m-cresol as a preservative. Systemic hypersensitivity reactions have been reported with postmarketing use of somatropins
[see Warnings and Precautions (5.6)].•
Diabetic RetinopathySomatropin is contraindicated in patients with active proliferative or severe non-proliferative diabetic retinopathy.
•
Closed EpiphysesSomatropin should not be used for growth promotion in pediatric patients with closed epiphyses.
• Active Proliferative or Severe Non-Proliferative Diabetic Retinopathy ()4 CONTRAINDICATIONS• Acute Critical Illness• Children with Prader-Willi syndrome 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 epiphyses
GENOTROPIN is contraindicated in patients with:
•
Acute Critical IllnessTreatment 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 in ChildrenSomatropin is contraindicated in patients with Prader-Willi syndrome 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
[see Warnings and Precautions (5.2)].•
Active MalignancyIn general, somatropin is contraindicated in the presence of active malignancy. Any preexisting 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 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.
•
HypersensitivityGENOTROPIN is contraindicated in patients with a known hypersensitivity to somatropin or any of its excipients. The 5 mg and 12 mg presentations of GENOTROPIN lyophilized powder contain m-cresol as a preservative. Systemic hypersensitivity reactions have been reported with postmarketing use of somatropins
[see Warnings and Precautions (5.6)].•
Diabetic RetinopathySomatropin is contraindicated in patients with active proliferative or severe non-proliferative diabetic retinopathy.
•
Closed EpiphysesSomatropin should not be used for growth promotion in pediatric patients with closed epiphyses.
• Children with closed epiphyses ()4 CONTRAINDICATIONS• Acute Critical Illness• Children with Prader-Willi syndrome 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 epiphyses
GENOTROPIN is contraindicated in patients with:
•
Acute Critical IllnessTreatment 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 in ChildrenSomatropin is contraindicated in patients with Prader-Willi syndrome 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
[see Warnings and Precautions (5.2)].•
Active MalignancyIn general, somatropin is contraindicated in the presence of active malignancy. Any preexisting 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 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.
•
HypersensitivityGENOTROPIN is contraindicated in patients with a known hypersensitivity to somatropin or any of its excipients. The 5 mg and 12 mg presentations of GENOTROPIN lyophilized powder contain m-cresol as a preservative. Systemic hypersensitivity reactions have been reported with postmarketing use of somatropins
[see Warnings and Precautions (5.6)].•
Diabetic RetinopathySomatropin is contraindicated in patients with active proliferative or severe non-proliferative diabetic retinopathy.
•
Closed EpiphysesSomatropin should not be used for growth promotion in pediatric patients with closed epiphyses.