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HomeAbout NGENLAEfficacySafetyEfficacy & SafetyEfficacy & SafetyPhase III Pivotal Trial & Open Label ExtensionPhase II Dose Finding StudyDosingDosingDosing & AdministrationMyNgenla PlanSupport and ServicesSupport and ServicesMaterialsVideosPatient Support
Prescribing InformationIndication Patient Site
NGENLA offers once-weekly subcutaneous administration
NGENLA offers once-weekly subcutaneous administrationA multidose, disposable pen that is prefilled and ready to use, shipped directly through specialty pharmacies1A multidose, disposable pen that is prefilled and ready to use, shipped directly through specialty pharmacies1

See below for an overview of NGENLA dosing and administration steps.

 Dosing overview1Dosing overview1• NGENLA is available in 2 different dosing strengths:

     ‣ 24 mg/1.2 mL (dose can be adjusted in 0.2-mg intervals)
     ‣ 60 mg/1.2 mL (dose can be adjusted in 0.5-mg intervals) 

• Dosing is based on weight: 0.66 mg/kg of body weight administered once weekly by subcutaneous injection

• NGENLA is available in 2 different dosing strengths:
     ‣ 24 mg/1.2 mL (dose can be adjusted in 0.2-mg intervals)
     ‣ 60 mg/1.2 mL (dose can be adjusted in 0.5-mg intervals) 

• Dosing is based on weight: 0.66 mg/kg of body weight administered once weekly by subcutaneous injection

If a dose is missed, NGENLA should be administered as soon as possible within 3 days after the missed dose, then the usual once-weekly dosing schedule should be resumed. If more than 3 days have passed, the missed dose should be skipped and the next dose should be administered on the regularly scheduled day.

MyNgenla Plan Tool

Use MyNgenla Plan to see how many pens are needed to meet your patients’ dosing needs.

 Learn more LoadingAdministration1Administration1

Refer to the How to Use NGENLA Video for detailed steps.

  • Patients should administer NGENLA once weekly, on the same day each week, at any time of the day
  • The day of weekly administration can be changed if necessary as long as the time between 2 doses is at least 3 days (>72 hours)
  • NGENLA can be given in the abdomen, thighs, buttocks, or upper arms. The site of injection should be rotated weekly
  • If more than one injection is required to deliver a complete dose, each injection should be administered at a different injection site

Prepare the injection

  • Choose the injection site. Injection can be given in the abdomen, thighs, buttocks, or upper arms
  • Clean the injection site with an alcohol swab and let the area dry
  • 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 uses

IMPORTANT: Priming a new pen
The purpose of priming is to remove air bubbles and make sure you get the correct dose. You may skip these steps if you have already set up your pen.
To prime a 24-mg pen, first turn the dose knob to 0.4.
To prime a 60-mg pen, turn the dose knob to 1.0.
If you turn the dose knob too far, you can turn it back.

  • Point the pen needle up and tap the holder to get rid of any air bubbles. Follow this step even if bubbles are not visible
  • Holding the needle upward, press the injection button completely until you see “0” in the dose window. Once you see liquid at the needle tip, your pen is set up
  • If liquid does not appear after repeating these steps 5 times, attach a new needle and try 1 more time. Do not use the pen if liquid still does not appear
  • Discard pen if empty or it has been more than 28 days after first use
 INSTRUCTIONAL 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 video Loading Efficacy

See height outcomes compared to a daily GH with fewer injections.1

 View the Phase III Trial Loading Safety

Demonstrated an adverse event profile similar to daily GENOTROPIN®.1

 View the Phase III Trial Loading Support and Services

Support for your patients throughout their treatment journey.

 Explore more LoadingReference:NGENLA. Prescribing information. Pfizer Inc.; 2023.

To report an adverse event, please call 1-800-438-1985

Pfizer for Professionals 1-800-505-4426

This site is intended only for U.S. healthcare professionals. The products discussed in this site may have different product labeling in different countries. The information provided is for educational purposes only.

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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.
Important Safety Information CONTRAINDICATIONS
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.

Please see full Prescribing Information.