(somatrogon-ghla)

Prescribing Information
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5 WARNINGS AND PRECAUTIONS

5 WARNINGS AND PRECAUTIONS

5.1 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 [see Contraindications (4)]. The safety of continuing NGENLA treatment for the approved indication in patients who concurrently develop these illnesses has not been established.

5.2 Severe Hypersensitivity

Severe 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)].

5.3 Increased Risk of Neoplasms

Active Malignancy

There 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 Patients

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.

New Malignancy During Treatment

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.

5.4 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 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.

5.5 Intracranial Hypertension

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 eight (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.

Perform fundoscopic examination before initiating treatment with NGENLA to exclude preexisting papilledema and periodically thereafter. If papilledema is identified prior to initiation, evaluate the etiology and treat the underlying cause before initiating NGENLA. 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.

5.6 Fluid Retention

Fluid retention during NGENLA therapy may occur. Clinical manifestations of fluid retention (e.g. edema and nerve compression syndromes including carpal tunnel syndrome/paresthesia) are usually transient and dose dependent.

5.7 Hypoadrenalism

Patients receiving growth hormone therapy who have or are at risk for pituitary hormone deficiency(s) 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 [see Drug Interactions (7)].

5.8 Hypothyroidism

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.

5.9 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 products or NGENLA. Evaluate pediatric patients receiving NGENLA with the onset of a limp or complaints of persistent hip or knee pain for slipped capital femoral epiphysis and osteonecrosis and manage accordingly.

5.10 Progression of Preexisting Scoliosis

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.

5.11 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.

5.12 Lipoatrophy

When NGENLA 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 [see Dosage and Administration (2.1)].

5.13 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 than females. NGENLA is not indicated for the treatment of pediatric patients who have growth failure due to genetically confirmed Prader-Willi syndrome.

5.14 Laboratory Tests

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.

Medication Guide

MEDICATION GUIDE

This Patient Information has been approved by the U.S. Food and Drug Administration.     Revised: 04/2026

PATIENT INFORMATION
NGENLA® (en’ JEN-lah)

(somatrogon-ghla)

injection, for subcutaneous use

What is NGENLA?
NGENLA is a prescription medicine that contains a form of human growth hormone, like the growth hormone made by the human body. NGENLA is given by injection under the skin (subcutaneous) in children who are not growing because of low or no growth hormone levels.

Do not use NGENLA if:

•
your child has a critical illness caused by certain types of heart or stomach surgery, trauma or breathing (respiratory) problems.
•
your child is allergic to somatrogon-ghla or any of the ingredients in NGENLA. See the end of this leaflet for a complete list of ingredients in NGENLA.
•
your child has closed bone growth plates (epiphyses).
•
your child has cancer or other tumors.
•
your child’s healthcare provider tells you that your child has certain types of eye problems caused by diabetes (diabetic retinopathy).
•
your child has Prader-Willi syndrome, is severely obese, or has breathing problems including sleep apnea (briefly stop breathing during sleep).

Before using NGENLA, tell your child’s healthcare provider about all of your child’s medical conditions, including if your child:

•
has had heart or stomach surgery, trauma or serious breathing (respiratory) problems.
•
has had a history of problems breathing while they slept (sleep apnea).
•
has or has had cancer or any tumor.
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has diabetes.
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is pregnant or plans to become pregnant. It is not known if NGENLA will harm your child’s unborn baby. Talk to your child’s healthcare provider if your child is pregnant or plans to become pregnant.
•
is breastfeeding or plans to breastfeed. It is not known if NGENLA passes into breast milk. You and your child’s healthcare provider should decide if they will take NGENLA while breastfeeding.

Tell your child’s healthcare provider about all the medicines your child takes, including prescription and over-the-counter medicines, vitamins, and herbal supplements. NGENLA may affect how other medicines work, and other medicines may affect how NGENLA works.

How should I use NGENLA?

•
Read the detailed Instructions for Use that come with NGENLA.
•
NGENLA comes in 2 different dosage strengths. Your child’s healthcare provider will prescribe the dose of medicine and the dosage strength that is right for your child.
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Your child’s healthcare provider will show you how to inject NGENLA before it is used for the first time. Do not try to inject NGENLA until you have been shown the right way by your child’s healthcare provider.
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Inject NGENLA exactly as your child’s healthcare provider tells you to.
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NGENLA is injected under the skin (subcutaneously) and can be given in the stomach (abdomen), thighs, buttocks, or upper arms. Rotate the site of injection weekly.
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Inject NGENLA 1 time each week, on the same day each week, at any time of the day.
•
You may change the day of the week NGENLA is used as long as the last dose was injected 3 or more days before. After the new day of the week has been chosen, continue with the 1 time a week schedule.
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If your child misses a dose of NGENLA the missed dose should be injected as soon as possible within 3 days after the missed dose. If more than 3 days have passed, skip your child’s missed dose. Inject the next dose on the regularly scheduled day.
•
NGENLA prefilled pens are for use by 1 person only.
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Do not share your child’s NGENLA prefilled pens and needles with another person, even if the needle has been changed. Your child may give another person an infection or get an infection from them.

What are the possible side effects of NGENLA?

NGENLA may cause serious side effects, including:

•
high risk of death in people who have critical illnesses because of heart or stomach surgery, trauma or serious breathing (respiratory) problems.
•
serious allergic reactions. Get medical help right away if your child has the following symptoms:
o
swelling of the face, lips, mouth, or tongue
o
trouble breathing
o
wheezing
o
severe itching
o
skin rashes, redness, or swelling
o
dizziness or fainting
o
fast heartbeat or pounding in the chest
o
sweating
•
increased risk of growth of cancer or a tumor that is already present and increased risk of the return of cancer or a tumor in people who were treated with radiation to the brain or head as children and who developed low growth hormone problems. Your child’s healthcare provider will need to monitor your child for a return of cancer or a tumor. Contact your child’s healthcare provider if your child starts to have headaches, or has changes in behavior, changes in vision, or changes in moles, birthmarks, or the color of the skin.
•
new or worsening high blood sugar (hyperglycemia) or diabetes. Your child’s blood sugar may need to be monitored during treatment with NGENLA.
•
increase in pressure inside the skull (intracranial hypertension). If your child has headaches, eye problems, nausea or vomiting, contact your child’s healthcare provider.
•
your child’s body holding too much fluid (fluid retention) such as swelling in the hands and feet, pain in the joints or muscles or nerve problems that cause pain, burning or tingling in the hands, arms, legs and feet. Fluid retention can happen in children during treatment with NGENLA. Tell your child’s healthcare provider if your child has any of these signs or symptoms of fluid retention.
•
decrease in a hormone called cortisol. Your child’s healthcare provider will do blood tests to check your child’s cortisol levels. Tell your child’s healthcare provider if your child has severe fatigue, dizziness, weakness, vomiting, dehydration, or weight loss.
•
decrease in thyroid hormone levels. Decreased thyroid hormone levels may affect how well NGENLA works. Your child’s healthcare provider will do blood tests to check your child’s hormone levels.
•
hip and knee pain or limp (slipped capital femoral epiphysis). This may lead to a serious condition where bone tissue dies due to a lack of blood supply (osteonecrosis). Get medical help for your child right away if your child develops a limp or has hip or knee pain.
•
worsening of curvature of the spine (scoliosis). If your child has scoliosis, your child will need to be checked often for an increase in the curve of the spine.
•
severe and constant stomach (abdominal) pain. This could be a sign of pancreatitis. Tell your child’s healthcare provider if your child has any new abdominal pain.
•
loss of fat and tissue weakness in the area of skin you inject. Talk to your child’s healthcare provider about rotating the areas where you inject NGENLA.
•
high risk of sudden death in children with Prader-Willi syndrome who are severely obese or have breathing problems, including sleep apnea.
•
increase in phosphorus, alkaline phosphatase and parathyroid hormone levels in the blood. Your child’s healthcare provider will do blood tests to check this.

The most common side effects of NGENLA include:

 
o
injection site reactions (such as pain, swelling, rash, itching, bleeding)
o
common cold
o
headache
o
fever
o
low red blood cells (anemia)
o
cough
o
vomiting
o
decrease in thyroid hormone levels
o
stomach (abdominal) pain
o
rash
o
throat pain

These are not all the possible side effects of NGENLA. You should tell your child’s healthcare provider if your child has any side effect that bothers them or that does not go away.

Call your child’s doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store NGENLA?

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Do not freeze your pen or expose it to heat.
•
Do not use your pen if it has been frozen or stored in direct sunlight.
•
Do not use after the expiration date printed on the label has passed or if it has been more than 28 days after first use.

Before you use NGENLA pens for the first time (unused pens):

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Store in the original carton.
•
Store the new, unused NGENLA pen in the refrigerator between 36°F to 46°F (2°C to 8°C).
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Unused prefilled pens may be used until the expiration date printed on the pen label, if kept in the refrigerator.

After you use NGENLA pens and there is still medicine left (up to 28 days of use):

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To help you remember when to dispose of (throw away) the pen, write the date of first use on the pen label.
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Store remaining NGENLA in the refrigerator between 36°F to 46°F (2°C to 8°C) and use within 28 days.
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Keep the pen cap on the NGENLA pen when it is not in use.
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Do not store the remaining NGENLA pen with a needle attached.
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Do not use the NGENLA pen if it has been more than 28 days after first use, even if it contains unused medicine.

Keep NGENLA and all medicines out of the reach of children.

General information about the safe and effective use of NGENLA.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use NGENLA for a condition for which it was not prescribed. Do not give NGENLA to other people, even if they have the same symptoms because it may harm them. You can ask your pharmacist or healthcare provider for information about NGENLA that is written for health professionals.

What are the ingredients in NGENLA?

Active ingredient: somatrogon-ghla


Inactive ingredients: citric acid monohydrate, histidine, metacresol (as a preservative), poloxamer 188, sodium chloride, sodium citrate, water for injection.

This product's labeling may have been updated. For the most recent prescribing information, please visit www.pfizer.com.


Manufactured by:
Pfizer Ireland Pharmaceuticals Unlimited Company
Ringaskiddy,
Co. Cork,
Ireland

US License No: 2060

Logo


LAB-1449-4.0

For more information, go to website www.NGENLA.com or call 1-800-438-1985.

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