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HomeAbout NGENLAEfficacy & SafetyPhase 3 Main Study + SafetyPhase 3 OLE Study + SafetyPhase 2 Study + SafetyDosingDosingDosingAdministrationMyNgenla PlanIGF-1 MonitoringAccess & SupportAccess &
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Dosing

Administration

MyNgenla Plan

Tab Number 4

Tab Number 5

Once-weekly NGENLA2 pens with dial-your-dose
precisionOnce-weekly NGENLA2 pens with dial-your-dose precision

Straightforward, subcutaneous administration through a multidose, disposable pen that is ready to use, with no reconstitution required1

Keep in mind: The 0.66-mg/kg/week dose of NGENLA is biologically similar to a 0.24-mg/kg/week dose of GENOTROPIN® (somatropin). This is largely because NGENLA has a higher molecular weight than GENOTROPIN, as it contains additional, naturally occurring peptides to enable its extended half-life and once-weekly dosing. Dosing less than the recommended 0.66 mg/kg/week could potentially result in diminished efficacy of NGENLA.1

Sample dosing guide: 24-mg pen
Weight (lb/kg) Prescribed dosage 
(mg/week)		 Full doses in 1 pen* Number of pens needed for 5 doses over 28 days (ie, day 0, 7, 14, 21, 28)
17 lb / 7.7 kg 5.0 4 2
18 lb / 8.2 kg 5.4 4 2
19 lb / 8.6 kg 5.6 4 2
20 lb / 9.1 kg 6.0 4 2
21 lb / 9.5 kg 6.2 3 2
22 lb / 10.0 kg 6.6 3 2
23 lb / 10.4 kg 6.8 3 2
24 lb / 10.9 kg 7.2 3 2
25 lb / 11.3 kg 7.4 3 2
26 lb / 11.8 kg 7.8 3 2
27 lb / 12.2 kg 8.0 3 2
28 lb / 12.7 kg 8.4 2 2
29 lb / 13.2 kg 8.6 2 2
30 lb / 13.6 kg 9.0 2 2
31 lb / 14.1 kg 9.2 2 2
32 lb / 14.5 kg 9.6 2 2
33 lb / 15.0 kg 9.8 2 2
34 lb / 15.4 kg 10.2 2 3
35 lb / 15.9 kg 10.4 2 3
36 lb / 16.3 kg 10.8 2 3
37 lb / 16.8 kg 11.0 2 3
38 lb / 17.2 kg 11.4 2 3
39 lb / 17.7 kg 11.6 2 3
40 lb / 18.1 kg 12.0 2 3
Sample dosing guide: 60-mg pen
Weight (lb/kg) Prescribed dosage 
(mg/week)		 Full doses in 1 pen* Number of pens needed for 5 doses over 28 days (ie, day 0, 7, 14, 21, 28)
40 lb / 18.1 kg 12.0 5 1
41 lb / 18.6 kg 12.5 4 2
42 lb / 19.1 kg 12.5 4 2
43 lb / 19.5 kg 13.0 4 2
44 lb / 20.0 kg 13.0 4 2
45 lb / 20.4 kg 13.5 4 2
46 lb / 20.9 kg 14.0 4 2
47 lb / 21.3 kg 14.0 4 2
48 lb / 21.8 kg 14.5 4 2
49 lb / 22.2 kg 14.5 4 2
50 lb / 22.7 kg 15.0 4 2
51 lb / 23.1 kg 15.5 3 2
52 lb / 23.6 kg 15.5 3 2
53 lb / 24.0 kg 16.0 3 2
54 lb / 24.5 kg 16.0 3 2
55 lb / 24.9 kg 16.5 3 2
56 lb / 25.4 kg 17.0 3 2
57 lb / 25.9 kg 17.0 3 2
58 lb / 26.3 kg 17.5 3 2
59 lb / 26.8 kg 17.5 3 2
60 lb / 27.2 kg 18.0 3 2
61 lb / 27.7 kg 18.5 3 2
62 lb / 28.1 kg 18.5 3 2
63 lb / 28.6 kg 19.0 3 2
64 lb / 29.0 kg 19.0 3 2
65 lb / 29.5 kg 19.5 3 2
66 lb / 29.9 kg 20.0 3 2
67 lb / 30.4 kg 20.0 3 2
68 lb / 30.8 kg 20.5 2 2
69 lb / 31.3 kg 20.5 2 2
70 lb / 31.8 kg 21.0 2 2
71 lb / 32.2 kg 21.5 2 2
72 lb / 32.7 kg 21.5 2 2
73 lb / 33.1 kg 22.0 2 2
74 lb / 33.6 kg 22.0 2 2
75 lb / 34.0 kg 22.5 2 2
76 lb / 34.5 kg 23.0 2 2
77 lb / 34.9 kg 23.0 2 2
78 lb / 35.4 kg 23.5 2 2
79 lb / 35.8 kg 23.5 2 2
80 lb / 36.3 kg 24.0 2 2
81 lb / 36.7 kg 24.0 2 2
82 lb / 37.2 kg 24.5 2 3
83 lb / 37.6 kg 25.0 2 3
84 lb / 38.1 kg 25.0 2 3
85 lb / 38.6 kg 25.5 2 3
86 lb / 39.0 kg 25.5 2 3
87 lb / 39.5 kg 26.0 2 3
88 lb / 39.9 kg 26.5 2 3
89 lb / 40.4 kg 26.5 2 3
90 lb / 40.8 kg 27.0 2 3
91 lb / 41.3 kg 27.0 2 3
92 lb / 41.7 kg 27.5 2 3
93 lb / 42.2 kg 28.0 2 3
94 lb / 42.6 kg 28.0 2 3
95 lb / 43.1 kg 28.5 2 3
96 lb / 43.5 kg 28.5 2 3
97 lb / 44.0 kg 29.0 2 3
98 lb / 44.5 kg 29.5 2 3
99 lb / 44.9 kg 29.5 2 3
100 lb / 45.4 kg 30.0 2 3
Patients weighing >100 lb are still eligible for NGENLA. Calculate the dose for these patients by multiplying 0.66 by their weight in kg.

Patients weighing >100 lb are still eligible for NGENLA. Calculate the dose for these patients by multiplying 0.66 by their weight in kg.

References:NGENLA. Prescribing information. Pfizer Inc.; 2023.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.
Administration Overview1

The recommended dose is 0.66 mg/kg of body weight administered once weekly by subcutaneous injection, on the same day each week, at any time of the day

The day of the weekly administration can be changed if necessary as long as the time between the 2 doses is at least 3 days. If more than 3 days (>72 hours) have passed, skip the missed dose and take your next dose on the regularly scheduled day

NGENLA should be given subcutaneously in the abdomen, thighs, buttocks, or rear upper arms. The site of injection should be rotated weekly

If more than 1 injection is required to deliver a complete dose, each injection should be administered at a different injection site

Visually inspect 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

Abbreviated instructions for use1

Please see full Instructions for Use for detailed steps

  • Instruct patients to read the NGENLA Instructions for Use in full before using their pen
  • A How to Use NGENLA Placemat is also included in the Patient Starter Kit to guide patients through the administration process
Prepare the pen for injection

If setting up the first use of a new pen:

  • Turn the dose knob to 1.0 for the 60-mg pen; for the 24-mg pen, set the dose knob to 0.4. If the knob goes too far, it can be turned back

  • Hold the pen with the needle pointing up. Tap the cartridge holder gently to float any air bubbles to the top

  • Press the injection button until it cannot go any further and you see “0” in the dose window. If liquid appears at the needle tip, prepare the injection

Getting ready

  • Instruct patients/caregivers to always wash hands with soap and dry well before handling a pen

  • Use the pen straight from the refrigerator or leave it at room temperature for up to 30 minutes for a more comfortable injection

  • Check the expiration date on the pen label. Do not use if the expiration date has passed
Choose and clean the injection site
  • Injection should be given in the abdomen, front of the upper thighs, buttocks, or back of the upper arms

  • Select a different site for each injection

  • Do not inject into bony areas; areas that are bruised, red, sore, or hard; and areas that have scars or skin conditions

  • Clean the injection site with an alcohol swab and let dry
Letting the injection site dry completely before dosing may help provide a more comfortable injection
Ready the injection and dose

Prepare the injection

Pull off the pen cap and check that the medicine is colorless to slightly light yellow and is free of flakes or particles

  • Do not inject the medicine if it is cloudy or dark yellow

Attach the needle by gently pushing and then screwing it onto the pen

Pull off the outer needle cover

Pull off the inner needle cap and dispose of it in a sharps container

Set the prescribed dose
  • Turn the knob to set the dose
    • For the 24-mg/1.2-mL pen, the dose knob turns 0.2 mg at a time
    • For the 60-mg/1.2-mL pen, the dose knob turns 0.5 mg at a time
  • Check the dose window to make sure the correct dose has been set
 Inject the dose
  • Hold the pen so the numbers in the dose window can be seen
  • Insert the needle straight into the skin
  • Press the injection button until it cannot go down any further and hold for 10 seconds
    • Counting to 10 will allow the full dose of medicine to be given
  • After counting to 10, let go of the injection button and slowly remove the pen from the injection site by pulling the needle straight out
 Finish up Carefully replace the outer needle cover

Unscrew the needle and dispose of it in a sharps container. Never reuse needles

 Replace the pen cap. If there is any medicine left, store it in the
refrigerator between usesINSTRUCTIONAL VIDEO

Step-by-step video tutorial on how to prepare and give an injection with the NGENLA prefilled pen. You can also download the complete Instructions for Use here.

Go to VideoLoadingReferences:NGENLA. Prescribing information. Pfizer Inc.; 2023.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.
MyNgenla Plan ToolUse the MyNgenla Plan to see how many pens are needed to meet your patients’ dosing needs

This tool helps you see how many pens are needed to meet your patient’s dosing needs, including when to use 2 pens. 

It is not to determine treatment or calculate their NGENLA dose.

This tool also generates a printable PDF patients can use to help stay on track with their NGENLA dosing.

Reference: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.
Efficacy & Safety

NGENLA has 8 years of clinical data2

Discover the Data Loading

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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
Somatrogon is contraindicated in patients with 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 growth hormones.NGENLA is contraindicated in patients with hypersensitivity to somatrogon or any of its excipients. Somatrogon is contraindicated in patients with closed epiphyses. Somatrogon is contraindicated in patients with active malignancy due to the risk of malignancy progression. Somatrogon is contraindicated in patients with active proliferative or severe non-proliferative diabetic retinopathy. Somatrogon 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 due to the risk of sudden death. WARNINGS AND PRECAUTIONS
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. The safety of continuing NGENLA treatment for the approved indication who concurrently develop these illnesses has not been established.Severe systemic hypersensitivity reactions including anaphylactic reactions and angioedema have been reported with somatropin. Inform patients and caregivers that such reactions are possible and that prompt medical attention should be sought if allergic reaction occurs.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 with NGENLA. Discontinue NGENLA if there is evidence of recurrent malignancy. In 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. Because 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. Treatment 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. Intracranial hypertension (IH) with papilledema, visual changes, headache, nausea, and/or vomiting has been reported in patients treated with somatropin. Symptoms usually occurred within the first 8 weeks after the initiation of somatropin therapy. In all reported cases, IH-associated signs and symptoms rapidly resolved after cessation of therapy or a reduction of somatropin dose. NGENLA should be temporarily discontinued in patients with clinical or fundoscopic evidence of IH. If IH is confirmed, restart treatment with NGENLA at a lower dose after IH-associated signs and symptoms have resolved. Fluid retention during NGENLA therapy may occur. Clinical manifestations of fluid retention (eg, edema and nerve compression syndromes including carpal tunnel syndrome/paresthesia) are usually transient and dose dependent. 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. In addition, patients treated with glucocorticoid replacement for previously diagnosed hypoadrenalism may require an increase in their maintenance or stress doses following initiation of NGENLA treatment. Monitor patients for reduced serum cortisol levels and/or need for glucocorticoid dose increases in those with known hypoadrenalism. Undiagnosed/untreated hypothyroidism may prevent an optimal response to NGENLA therapy. In patients with GH deficiency, central (secondary) hypothyroidism may first become evident or worsen during treatment with growth hormone therapy. Therefore, patients should have periodic thyroid function tests and thyroid hormone replacement therapy should be initiated or appropriately adjusted when indicated. Slipped capital femoral epiphysis may occur more frequently in patients undergoing rapid growth. Evaluate pediatric patients with the onset of a limp or complaints of persistent hip or knee pain. NGENLA increases growth rate, and progression of preexisting scoliosis can occur in patients who experience rapid growth. Growth hormone treatment has not been shown to increase the occurrence of scoliosis. Monitor patients with a history of scoliosis for disease progression. 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. When growth hormone is administered subcutaneously at the same site over a long period of time, lipoatrophy may result. Rotate injection sites when administering NGENLA to reduce this risk. 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 than females. NGENLA is not indicated for the treatment of pediatric patients who have growth failure due to genetically confirmed Prader-Willi syndrome. Serum levels of phosphorus, alkaline phosphatase, and parathyroid hormone may increase with NGENLA therapy. If a patient is found to have abnormal laboratory tests, monitor as appropriate. ADVERSE EFFECTS
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.
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.