(somatrogon-ghla)

Prescribing Information
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6 ADVERSE REACTIONS

6 ADVERSE REACTIONS

The following clinically significant adverse reactions are described elsewhere in the labeling:

•
Increased mortality in patients with acute critical illness [see Warnings and Precautions (5.1)]
•
Severe hypersensitivity [see Warnings and Precautions (5.2)]
•
Increased risk of neoplasm [see Warnings and Precautions (5.3)]
•
Glucose intolerance and diabetes mellitus [see Warnings and Precautions (5.4)]
•
Intracranial hypertension [see Warnings and Precautions (5.5)]
•
Fluid retention [see Warnings and Precautions (5.6)]
•
Hypoadrenalism [see Warnings and Precautions (5.7)]
•
Hypothyroidism [see Warnings and Precautions (5.8)]
•
Slipped capital femoral epiphysis [see Warnings and Precautions (5.9)]
•
Progression of preexisting scoliosis [see Warnings and Precautions (5.10)]
•
Pancreatitis [see Warnings and Precautions (5.11)]
•
Lipoatrophy [see Warnings and Precautions (5.12)]
•
Sudden death in pediatric patients with Prader-Willi syndrome [see Warnings and Precautions (5.13)]

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Safety data are derived from a safety and efficacy study in pediatric patients with GHD [see Clinical Studies (14.1)]. The data from the 12-month main study period reflect exposure of 109 patients to NGENLA administered once weekly (0.66 mg/kg/wk) and 115 patients to somatropin administered once daily (0.034 mg/kg/day).

The mean age across the treatment groups, was 7.7 years (min 3.01, max 11.96); 40.2% of patients were >3 years to ≤7 years, 59.8% were >7 years, 71.9% of patients were male, and 28.1% were female. In this study, 74.6% of patients were White, 20.1% were Asian, 0.9% were Black or African American, 0.5% were American Indian or Alaska Native, 0.5% were Native Hawaiian or Other Pacific Islander, and for 3.6% race information was missing; 10.7% of patients identified as Hispanic or Latino. Baseline disease characteristics were balanced across treatment groups.

Table 1 shows the adverse reactions that occurred in ≥5% of patients treated with NGENLA or daily somatropin during the 12-month main study period. Reporting of injection site reactions was solicited through the use of a patient diary after each weekly injection for patients administered NGENLA and once weekly for patients administered daily injections of somatropin.

Table 1  Adverse Reactions Occurring in ≥5% of NGENLA- or Somatropin-Treated Pediatric Patients (52 Weeks of Treatment)
Adverse reactions that are medically related were grouped to a single preferred term.
*
Injection site reactions included: injection site pain (39% somatrogon-ghla vs 25% daily somatropin), injection site swelling/induration/hypertrophy/inflammation (10% somatrogon-ghla vs 1% daily somatropin), injection site erythema (8% somatrogon-ghla vs none daily somatropin), injection site pruritus (5% somatrogon-ghla vs none daily somatropin), injection site hemorrhage (5% somatrogon-ghla vs none daily somatropin).
†
Nasopharyngitis included: rhinitis, pharyngitis, rhinitis allergic, pharyngitis streptococcal, viral pharyngitis, nasopharyngitis.

Adverse Drug Reactions

Daily Somatropin

(N=115)

n (%)

NGENLA

(N=109)

n (%)

Injection site reactions*

29 (25.2)

46 (42.2)

Nasopharyngitis†

33 (28.7)

36 (33)

Headache

25 (21.7)

18 (16.5)

Pyrexia

17 (14.8)

18 (16.5)

Anemia

10 (8.7)

10 (9.2)

Cough

9 (7.8)

9 (8.3)

Vomiting

9 (7.8)

8 (7.3)

Hypothyroidism

3 (2.6)

7 (6.4)

Abdominal pain

8 (7.0)

7 (6.4)

Rash

7 (6.1)

6 (5.5)

Oropharyngeal pain

4 (3.5)

6 (5.5)

Arthralgia

8 (7.0)

5 (4.6)

Otitis media

10 (8.7)

5 (4.6)

Tonsillitis

6 (5.2)

5 (4.6)

Bronchitis

9 (7.8)

3 (2.8)

Laboratory Tests

More NGENLA-treated patients shifted from normal eosinophil levels at baseline to elevated eosinophil levels at the end of the 12-month study compared to the daily somatropin group (29% vs 12%).

6.2 Postmarketing Experience

The following adverse reactions have been identified during post-approval use of somatropin products or NGENLA. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Skin and subcutaneous tissue disorders – lipoatrophy

Musculoskeletal and connective tissue disorders – osteonecrosis in pediatric patients, slipped capital femoral epiphysis

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.
•
has diabetes.
•
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.
•
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.
•
Inject NGENLA exactly as your child’s healthcare provider tells you to.
•
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.
•
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.
•
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.
•
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?

•
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):

•
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).
•
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):

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