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HomeAbout NGENLAEfficacy & SafetyEfficacy &
SafetyPhase 3 Main Study + SafetyPhase 3 OLE Study + SafetyPhase 2 Study + SafetyDosingDosingDosingAdministrationMyNgenla PlanIGF-1 MonitoringAccess & SupportAccess &
SupportUS Formulary CoverageAccessPatient SupportDevice Training EducationRequest a Pfizer RepDownloadable MaterialsVideos
Prescribing InformationIndication Patient Site
Once-weekly NGENLAUp to 8 years of clinical data1‑3Phase 3 Main Study + SafetyPhase 3 OLE Study + SafetyPhase 2 Study + SafetyPhase 3 open-label extension (OLE) study design2,4,5Evaluated vs daily GENOTROPIN® (somatropin) for injection in a phase 3 study of 224 patients with pGHD2,4
Study design4
  • Open-label, single-arm extension, phase 3 study continuation of the randomized 12-month study 
Dosing2
  • Patients who received NGENLA during the phase 3 study continued with the same dose during the OLE 
  • Patients who received GENOTROPIN during the phase 3 study were switched to NGENLA and began treatment with a dose of 0.66 mg/kg/week 
  • The dose of NGENLA can be adjusted every 3 months based on the patient's body weight and may be decreased for safety reasons based on predefined dose-adjustment criteria
End points4†
  • AHV, change in height SDS 
  • Insulin-like growth factor 1 (IGF-1) levels and IGF-1 SDS assessed on day 4 after NGENLA dosing across study visits 
Study participants2
  • 212 patients completed the phase 3 study and enrolled in the OLE 
  • Patients who received NGENLA in the phase 3 study continued to receive NGENLA 0.66 mg/kg/week (n=104) 
  • Patients who received GENOTROPIN in the phase 3 study were switched to NGENLA 0.66 mg/kg/week (n=108)
Key inclusion criteria4
  • Patients who completed the phase 3 study and provided their consent were eligible to be enrolled
0.034 mg/kg/day is the equivalent of 0.24 mg/kg/week.Efficacy and safety were assessed every 3 months for the first year of OLE.Mean AHV for the phase 3 OLE5

Study limitations
The primary objective of the phase 3 OLE was to evaluate the efficacy and safety of NGENLA. Any inference of clinical significance should be interpreted with caution as the study was open label and lacked a comparator arm.5

These efficacy data represent the pivotal study year (year 1), as well as the first 4 years of the phase 3 OLE (year 2, year 3, year 4, and year 5). Statistical analyses of these data are descriptive, and no formal hypothesis testing was performed.5

Patients with HV data as of May 2024. Error bars represent SD.5Mean height standard deviation score (SDS) at month 12 of each study year5

Study limitations
The primary objective of the phase 3 OLE was to evaluate the efficacy and safety of NGENLA. Any inference of clinical significance should be interpreted with caution as the study was open label and lacked a comparator arm.5

These efficacy data represent the pivotal study year (year 1), as well as the first 4 years of the phase 3 OLE (year 2, year 3, year 4, and year 5). Statistical analyses of these data are descriptive, and no formal hypothesis testing was performed.5

Patients with HV data as of May 2024. Error bars represent SD.5Change in mean height SDS (from baseline) at month 12 of each study year5

Study limitations
The primary objective of the phase 3 OLE was to evaluate the efficacy and safety of NGENLA. Any inference of clinical significance should be interpreted with caution as the study was open label and lacked a comparator arm.5

These efficacy data represent the pivotal study year (year 1), as well as the first 4 years of the phase 3 OLE (year 2, year 3, year 4, and year 5). Statistical analyses of these data are descriptive, and no formal hypothesis testing was performed.5

Patients with HV data as of May 2024. Error bars represent SD.5Phase 3 OLE safety results5

A phase 3 open-label extension continues to monitor patients’ AEs

SUMMARY OF ALL-CAUSALITY TEAEs (MAIN STUDY AND OLE)5

Study limitations
The primary objective of the phase 3 OLE was to evaluate the efficacy and safety of NGENLA. Any inference of clinical significance should be interpreted with caution as the study was open label and lacked a comparator arm. Statistical analyses of these data are descriptive, and no formal hypothesis testing was performed.5

AE, adverse event; TEAE, treatment-emergent adverse event.References:NGENLA. Prescribing information. Pfizer Inc.; 2025.Data on file. Pfizer Inc., New York, NY.Zadik Z, Zelinska N, Iotova V, et al. Long-term efficacy and safety of once-weekly somatrogon in pediatric subjects with growth hormone deficiency: results from up to 8 years of somatrogon treatment. Poster presented at: Annual Meeting of the Endocrine Society 2023; June 15-18, 2023.Wajnrajch M, Miller BS, Steelman J, et al. Switch data from the open-label extension of the pivotal phase 3 study of once weekly somatrogon compared with daily somatropin in pediatric patients with growth hormone deficiency (GHD). Poster presented at: Annual Meeting of the Endocrine Society 2021; March 20-23, 2021. Poster 7129.Silverman L, et al. Up to 5 Years of Once-Weekly Somatrogon Treatment in Paediatric Patients With Growth Hormone Deficiency: Results From an Open-label Extension of a Global Phase 3 Study. Poster presented at: 62nd Annual European Society for Paediatric Endocrinology (ESPE) Meeting, November 16–18, 2024, Liverpool, UK.Access & Support

NGENLA has broad formulary coverage. Pfizer offers the NGENLA Copay Program and additional resources to help eligible patients starting on NGENLA

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PP-SMT-USA-0722
You are now leaving PfizerPro You are now leaving a Pfizer-operated website. Links to all outside sites are provided as a resource to our visitors. Pfizer accepts no responsibility for the content of sites that are not owned and operated by Pfizer.PP-SMT-USA-0592
INDICATIONNgenla 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.
IMPORTANT SAFETY INFORMATIONCONTRAINDICATIONS
Ngenla is contraindicated in patients with:
  • Acute critical illness after open heart surgery, abdominal surgery or multiple accidental trauma, or acute respiratory failure due to the risk of increased mortality with somatropin
  • Hypersensitivity to somatrogon-ghla or any of the excipients in Ngenla
  • Closed epiphyses
  • Active malignancy due to the risk of malignancy progression
  • Active proliferative or severe non-proliferative diabetic retinopathy
  • 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 sudden risk of death
WARNINGS AND PRECAUTIONS
Increased Mortality in Patients with Acute Critical Illness: Increased 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.Severe Hypersensitivity: Severe systemic hypersensitivity reactions including anaphylactic reactions and angioedema have been reported with somatropin. Inform patients and/or caregivers that such reactions are possible, and to seek prompt medical attention if allergic reaction occurs.Increased Risk of Neoplasms: There is an increased risk of malignancy progression with somatropin treatment in patients with active malignancy. Any preexisting malignancy should be inactive, and its treatment should be completed, prior to instituting therapy. In childhood cancer survivors treated with radiation to the brain/head for their first neoplasm and developed subsequent GHD and were treated with somatropin, an increased risk of a second neoplasm has been reported. Monitor patients with a history of GHD secondary to an intracranial neoplasm for progression or recurrence of the tumor. Children with certain rare genetic causes of short stature have an increased risk of developing malignancies. Monitor for development of neoplasms. Monitor patients 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. Glucose Intolerance and Diabetes Mellitus: Treatment with growth hormone may decrease insulin sensitivity, particularly at higher doses. New-onset type 2 diabetes mellitus has been reported. 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. The doses of antidiabetic agents may require adjustment when Ngenla is initiated. Intracranial Hypertension (IH): Has been reported in patients treated with somatropin, usually within 8 weeks of treatment initiation. Perform fundoscopic examination prior to initiation of treatment and periodically thereafter. If papilledema is identified, evaluate the etiology, and treat the underlying cause before initiating Ngenla. Temporarily discontinue Ngenla in patients with evidence of IH. If IH is confirmed, restart Ngenla at a lower dose after IH signs and symptoms have resolved. Fluid Retention: May occur during Ngenla therapy. Clinical manifestations of fluid retention are usually transient and dose dependent. Hypoadrenalism: Patients receiving growth hormone therapy who have or are at risk for pituitary hormone deficiencies may be at risk for reduced serum cortisol levels and/or unmasking of central (secondary) hypoadrenalism. Patients treated with glucocorticoid replacement for previously diagnosed hypoadrenalism may require an increase in their maintenance or stress doses following initiation of Ngenla. Monitor patients with known hypoadrenalism for reduced serum cortisol levels and/or need for glucocorticoid dose increases. Hypothyroidism: Undiagnosed/untreated hypothyroidism may prevent an optimal response to Ngenla. Central (secondary) hypothyroidism may first become evident or worsen during treatment with growth hormone therapy. Monitor thyroid function periodically and appropriately initiate or adjust thyroid hormone replacement therapy. 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 with the onset of a limp or complaints of persistent hip or knee pain for slipped capital femoral epiphysis and osteonecrosis and manage accordingly. Progression of Preexisting Scoliosis: Monitor patients with a history of scoliosis for disease progression. Pancreatitis: Cases of pancreatitis have been reported in patients receiving somatropin. The risk may be greater in pediatric patients compared with adults. Consider pancreatitis in patients who develop persistent severe abdominal pain. Lipoatrophy: May occur if Ngenla is administered at the same site over a long period of time. Rotate injection sites to reduce this risk. Sudden Death in Pediatric Patients with Prader-Willi Syndrome: There 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. Ngenla is not indicated for the treatment of pediatric patients who have growth failure due to genetically confirmed Prader‑Willi syndrome. Laboratory Tests: Serum levels of phosphorus, alkaline phosphatase, and parathyroid hormone may increase with NGENLA therapy. Monitor as appropriate. ADVERSE REACTIONS
Adverse reactions reported in ≥5% of patients treated with Ngenla are injection site reactions, nasopharyngitis, headache, pyrexia, anemia, cough, vomiting, hypothyroidism, abdominal pain, rash, and oropharyngeal pain. Health care providers should supervise the first injection and provide appropriate training and instruction for the proper use of all NGENLA devices.DRUG INTERACTIONS
Glucocorticoids: Patients treated with glucocorticoid for hypoadrenalism may require an increase in their maintenance or stress doses.Cytochrome P450-Metabolized Drugs: Ngenla may alter the clearance. Monitor carefully.Oral Estrogen: Patients receiving oral estrogen replacement may require higher Ngenla dosages.Insulin and/or Other Antihyperglycemic Agents: Dose adjustment of insulin and/or antihyperglycemic agent may be required.
INDICATION
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.