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Indication

NGENLA is a prescription medicine that contains a form of human growth hormone, like the growth hormone made by the human body, for children 3 years of age and older who are not growing because of low or no growth hormone levels.

Switching to once-weekly NGENLA could mean 6 fewer injection days each week vs daily dosing!

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Switching to once-weekly NGENLA could mean 6 fewer injection days each week vs daily dosing!

NGENLA was studied in an FDA-approved primary clinical trial for 12 months in 224 pediatric patients with GHD. Patients were given either:

  • A weekly dose of NGENLA at 0.66 mg/kg or
  • A daily dose of somatropin at 0.034 mg/kg

Children taking once-weekly NGENLA for 1 year had a similar growth rate to children taking daily somatropin

In a follow-up to this study, children who switched from daily somatropin to once-weekly NGENLA grew an average of 8.2 cm in the next year.

In another study focusing on safety and growth, 35 children who have taken NGENLA for up to 5 years on average have continued to see growth in the normal range.

The most common side effects with NGENLA (>20%) were injection site reactions, the common cold, fever, and headache.

Check out answers to commonly asked questions about NGENLA. Additional answers to questions about NGENLA can be found in our FAQs Flash Card located under Patient Resources.

  • Does my child have to take NGENLA at a certain time of day?

    What side effects      should I look out for?

  • How can I ensure that I remember to take my next dose?

  • Who should not take NGENLA?

    Q. Who should not take  NGENLA?

  • What if I miss a dose?

Does my child have to take NGENLA at a certain time of day?

Once-weekly NGENLA can be taken any time, day or night. You decide which time is best for you and your child.   

How can I ensure that I remember to take my next dose?

Pfizer, the makers of NGENLA, offers a patient support program that will send you dosing reminders via text. To sign up for these reminders, text MYNGENLA to 46286.

By entering your mobile phone number above you consent to receive marketing and/or non-marketing texts from Pfizer and/or EngagedMedia with information regarding the NGENLA Text Reminder Program at the phone number you provided. You understand that providing this consent is not required or a condition of purchasing any products or services. Message frequency varies. Message and data rates may apply. Complete terms can be found at https://engagedrx.com/pghd/. Text HELP to 46286 for info, Text STOP to 46286 to opt out.

Who should not take NGENLA?

Children should not take NGENLA if any of the following applies to them:

  • Their growth plates have closed

  • They have active cancer

  • They have known allergic or autoimmune reactions to NGENLA

  • They have acute critical illness due to complications from open heart or abdominal surgery, multiple accidental trauma, or acute respiratory failure
  • They have diabetes with certain types of diabetic retinopathy (eye problems) 
  • They have Prader-Willi syndrome, are severely obese, or have breathing problems including sleep apnea (briefly stop breathing during sleep)
What if I miss a dose?

With NGENLA, you have a flexible, 3-day window to catch up on your missed dose. It's important that the time between 2 doses is 3 days. If more than 3 days have passed, skip the missed dose and administer the next dose to your child on the regularly scheduled day. You can then resume your child’s regular once-weekly dosing schedule.

See what a patient and caregiver have to say
about their treatment journey with NGENLA.

Important Safety Information & Use

Important Safety
Information & Use

INDICATION
NGENLA is a prescription medicine that contains a form of human growth hormone, like the growth hormone made by the human body, for children 3 years of age and older who are not growing because of low or no growth hormone levels.
IMPORTANT SAFETY INFORMATION
Do not use NGENLA if:
  • your child has a critical illness caused by certain types of heart or stomach surgery, trauma or breathing problems.
  • your child is allergic to somatrogon-ghla or any of the ingredients in NGENLA.
  • your child has closed bone growth plates.
  • 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.
  • your child has Prader-Willi syndrome, is severely obese, or has breathing problems including sleep apnea (briefly stopping 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.
  • 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.

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: swelling of the face, lips, mouth, or tongue, trouble breathing, wheezing, severe itching, skin rashes, redness, or swelling, dizziness or fainting, fast heartbeat or pounding in the chest, 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 or diabetes. Your child’s blood sugar may need to be monitored during treatment with NGENLA.
  • increase in pressure inside the skull. 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 (≥5%) of NGENLA include: injection site reactions (such as pain, swelling, rash, itching, bleeding), common cold, headache, fever, low red blood cells (anemia), cough, vomiting, decrease in thyroid hormone levels, stomach (abdominal) pain, rash, throat pain.

This site is intended only for U.S. residents. The products discussed in this site may have different product labeling in different countries. The information provided is for educational purposes only and is not intended to replace discussions with a healthcare provider.

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