Ngenla
(Somatrogon-Ghla)Dosage & Administration
Ngenla Prescribing Information
Warnings and Precautions, Slipped Capital Femoral Epiphysis ( Slipped capital femoral epiphysis may occur more frequently 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. Evaluate pediatric patients receiving NGENLA with the onset of a limp or complaints of persistent hip or knee painfor slipped capital femoral epiphysis and osteonecrosis and manage accordingly. | 07/2025 |
NGENLA is indicated for the treatment of pediatric patients aged 3 years and older who have growth failure due to an inadequate secretion of endogenous growth hormone.
• NGENLA treatment should be supervised by a healthcare provider who is experienced in the diagnosis and management of pediatric patients with growth hormone deficiency ().2.1 Important Dosing and Administration Information• NGENLA treatment should be supervised by a healthcare provider who is experienced in the diagnosis and management of pediatric patients aged 3 years and older with growth failure due to growth hormone deficiency (GHD)[see Indications and Usage (1)].• Refer patient to the Instructions for Use for complete administration instructions.• Administer NGENLA by subcutaneous injection, once weekly, on the same day each week, at any time of the day in the abdomen, thighs, buttocks, or upper arms. Rotate the injection site weekly.• Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. If flakes, particles or discoloration are observed, do not use the pen. Do not shake; shaking can damage the product.• Prefilled pens deliver somatrogon-ghla in 0.2 mg or 0.5 mg increments.
• Administer NGENLA by subcutaneous injection once weekly, on the same day each week, at any time of the day in the abdomen, thighs, buttocks, or upper arms with weekly rotation of injection site ().2.1 Important Dosing and Administration Information• NGENLA treatment should be supervised by a healthcare provider who is experienced in the diagnosis and management of pediatric patients aged 3 years and older with growth failure due to growth hormone deficiency (GHD)[see Indications and Usage (1)].• Refer patient to the Instructions for Use for complete administration instructions.• Administer NGENLA by subcutaneous injection, once weekly, on the same day each week, at any time of the day in the abdomen, thighs, buttocks, or upper arms. Rotate the injection site weekly.• Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. If flakes, particles or discoloration are observed, do not use the pen. Do not shake; shaking can damage the product.• Prefilled pens deliver somatrogon-ghla in 0.2 mg or 0.5 mg increments.
• The recommended dosage is 0.66 mg/kg based on actual body weight administered once weekly ().2.3 Recommended Dosage and Monitoring for Pediatric Patients with GHD• Recommended dosage of NGENLA is 0.66 mg/kg based on actual body weight administered once weekly by subcutaneous (SC) injection.• Individualize dosage for each patient based on the growth response.• The day of weekly administration can be changed if necessary as long as the time between 2 doses is at least 3 days. After selecting a new dosing day, the once weekly dosing should be continued.• When switching from daily growth hormone, the once-weekly NGENLA may be initiated on the day following their last daily injection.• If more than one injection is required to deliver a complete dose, each injection should be administered at a different injection site.
• Individualize dosage for each patient based on the growth response ().2.3 Recommended Dosage and Monitoring for Pediatric Patients with GHD• Recommended dosage of NGENLA is 0.66 mg/kg based on actual body weight administered once weekly by subcutaneous (SC) injection.• Individualize dosage for each patient based on the growth response.• The day of weekly administration can be changed if necessary as long as the time between 2 doses is at least 3 days. After selecting a new dosing day, the once weekly dosing should be continued.• When switching from daily growth hormone, the once-weekly NGENLA may be initiated on the day following their last daily injection.• If more than one injection is required to deliver a complete dose, each injection should be administered at a different injection site.
• Patients switching from daily growth hormone may initiate treatment with once-weekly NGENLA on the day following their last daily injection ().2.3 Recommended Dosage and Monitoring for Pediatric Patients with GHD• Recommended dosage of NGENLA is 0.66 mg/kg based on actual body weight administered once weekly by subcutaneous (SC) injection.• Individualize dosage for each patient based on the growth response.• The day of weekly administration can be changed if necessary as long as the time between 2 doses is at least 3 days. After selecting a new dosing day, the once weekly dosing should be continued.• When switching from daily growth hormone, the once-weekly NGENLA may be initiated on the day following their last daily injection.• If more than one injection is required to deliver a complete dose, each injection should be administered at a different injection site.
• If more than one injection is required to deliver a complete dose, each injection should be administered at a different injection site ().2.3 Recommended Dosage and Monitoring for Pediatric Patients with GHD• Recommended dosage of NGENLA is 0.66 mg/kg based on actual body weight administered once weekly by subcutaneous (SC) injection.• Individualize dosage for each patient based on the growth response.• The day of weekly administration can be changed if necessary as long as the time between 2 doses is at least 3 days. After selecting a new dosing day, the once weekly dosing should be continued.• When switching from daily growth hormone, the once-weekly NGENLA may be initiated on the day following their last daily injection.• If more than one injection is required to deliver a complete dose, each injection should be administered at a different injection site.
NGENLA (somatrogon-ghla) is a clear and colorless to slightly light yellow solution available as:
• Injection: 24 mg/1.2 mL (20 mg/mL) in a single-patient-use, disposable prefilled pen that delivers a dose in 0.2 mg increments.• Injection: 60 mg/1.2 mL (50 mg/mL) in a single-patient-use, disposable prefilled pen that delivers a dose in 0.5 mg increments.
There are no available data on NGENLA use in pregnant women to evaluate for a drug associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. In reproduction studies with pregnant rats, there was no evidence of embryo-fetal toxicity following administration of somatrogon-ghla subcutaneously during organogenesis at doses up to 45 times the maximum recommended human dose based on exposure
In an embryo-fetal development toxicity study in rats, no adverse maternal or embryo-fetal effects were observed when somatrogon-ghla was administered via subcutaneous injection every 2 days from gestation day (GD) 6 to 18 at doses up to 30 mg/kg (45 times the maximum recommended human dose based on Cavexposure).
In a pre- and postnatal development study in rats, somatrogon-ghla was administered via subcutaneous injection to pregnant rats every 2 days from GD 6 to lactation day 20 at doses up to 30 mg/kg. There was no evidence of maternal toxicity and no adverse effects on the first generation (F1) offspring. Somatrogon-ghla elicited an increase in F1 mean body weights in both sexes and increased the mean copulatory interval in F1 females at the highest dose (30 mg/kg), consistent with a longer estrous cycle length. However, there were no effects on mating indices in F1 females.
The background risk of major birth defects and miscarriage in 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% to 4% and 15% to 20%, respectively.
• Acute critical illness after open heart surgery, abdominal surgery or multiple accidental trauma, or those with acute respiratory failure due to the risk of increased mortality with somatropin[see.]5.1 Increased Mortality in Patients with Acute Critical IllnessIncreased mortality 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 has been reported with somatropin
[see Contraindications (4)]. The safety of continuing NGENLA treatment for the approved indication in patients who concurrently develop these illnesses has not been established.• Hypersensitivity to somatrogon-ghla or any of the excipients in NGENLA[see.]5.2 Severe HypersensitivitySevere systemic hypersensitivity reactions including anaphylaxis and angioedema have been reported with somatropin. Inform patients and/or caregivers that such reactions are possible and that prompt medical attention should be sought if an allergic reaction occurs. NGENLA is contraindicated in patients with known hypersensitivity to somatrogon-ghla or any excipients in NGENLA
[see Contraindications (4)].• Closed epiphyses.• Active malignancy due to the risk of malignancy progression[see.]5.3 Increased Risk of NeoplasmsActive MalignancyThere is an increased risk of malignancy progression with somatropin treatment in patients with active malignancy
[see Contraindications (4)]. Any preexisting malignancy should be inactive, and its treatment should be completed prior to instituting therapy with NGENLA. Discontinue NGENLA if there is evidence of recurrent malignancy.Risk of Second Neoplasm in Pediatric PatientsIn childhood cancer survivors, who were treated with radiation to the brain/head for their first neoplasm and who developed subsequent GHD and were treated with somatropin, an increased risk of a second neoplasm has been reported. Intracranial tumors, in particular meningiomas, were the most common of these second neoplasms. Monitor all patients with a history of GHD secondary to an intracranial neoplasm while on NGENLA therapy for progression or recurrence of the tumor.
New Malignancy During TreatmentBecause children with certain rare genetic causes of short stature have an increased risk of developing malignancies, thoroughly consider the risks and benefits of starting NGENLA in these patients. If treatment with NGENLA is initiated, carefully monitor these patients for development of neoplasms.
Monitor patients on NGENLA therapy carefully for increased growth or potential malignant changes of preexisting nevi. Advise patients and/or caregivers to report marked changes in behavior, onset of headaches, vision disturbances and/or changes in skin pigmentation or changes in the appearance of preexisting nevi.
• Active proliferative or severe non-proliferative diabetic retinopathy[see.]5.4 Glucose Intolerance and Diabetes MellitusTreatment with growth hormone may decrease insulin sensitivity, particularly at higher doses. New onset type 2 diabetes mellitus has been reported in patients receiving growth hormone. Patients with undiagnosed pre-diabetes and diabetes mellitus may experience worsened glycemic control and become symptomatic. Monitor glucose levels periodically in all patients receiving NGENLA, especially in those with risk factors for diabetes mellitus, such as obesity, Turner syndrome, or a family history of diabetes mellitus. Patients with preexisting type 1 or type 2 diabetes mellitus or pre-diabetes should be monitored closely. The doses of antidiabetic agents may require adjustment when NGENLA is initiated.
• Prader-Willi syndrome who are severely obese, have a history of upper airway obstruction or sleep apnea or have severe respiratory impairment due to the risk of sudden death[see.]5.13 Sudden Death in Pediatric Patients with Prader-Willi SyndromeThere have been reports of sudden death after initiating therapy with somatropin in pediatric patients with Prader-Willi syndrome who had one or more of the following risk factors: severe obesity, history of upper airway obstruction or sleep apnea, or unidentified respiratory infection. Male patients with one or more of these factors may be at greater risk than females. NGENLA is not indicated for the treatment of pediatric patients who have growth failure due to genetically confirmed Prader-Willi syndrome.