Not actual patients.
NGENLA was studied in a primary clinical trial for 12 months in 224 pediatric patients with GHD. Patients were given either:
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 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 should I do if I inject too much NGENLA?
What if I miss a dose?
Once-weekly NGENLA can be taken any time, day or night. You decide which time is best for you and your child.
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.
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
If you accidently inject more NGENLA than was prescribed, contact your child's doctor. Short-term overdosage might temporarily cause your child's sugar levels to go up or down.
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.
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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This confirms that you will soon be receiving weekly dosing reminders for NGENLA.
Growth hormone should not be used in children after the growth plates have closed.
Growth hormone should not be used in children with some types of eye problems caused by diabetes (diabetic retinopathy).
Growth hormone should not be used in children who have cancer or other tumors.
Growth hormone should not be used in children who are critically ill because of some types of heart or stomach surgery, trauma, or breathing (respiratory) problems.
Growth hormone should not be used in children with Prader-Willi syndrome who are very overweight or have breathing problems including sleep apnea.
NGENLA should not be used by children who have had an allergic reaction to somatrogon-ghla or any of the ingredients in NGENLA. Look for prompt medical attention in case of an allergic reaction.
Some children have developed diabetes mellitus while taking growth hormone. Dosages of diabetes medicines may need to be adjusted during treatment with NGENLA. Children should be watched carefully if NGENLA is given along with glucocorticoid therapy and/or other drugs that are processed by the body in the same way.
In childhood cancer survivors, treatment with growth hormone may raise the likelihood of a new tumor, particularly some benign (non-cancerous) brain tumors. This likelihood may be higher in children who were treated with radiation to the brain or head. Your child’s health care provider will need to check your child for a return of cancer or a tumor.
Children treated with growth hormone have had increased pressure in the brain. If your child has headaches, eye problems, nausea (feeling like you are going to be sick), or vomiting, contact your child’s health care provider.
NGENLA may decrease thyroid hormone levels. Decreased thyroid hormone levels may change how well NGENLA works. Your child’s health care provider will do blood tests to check your child’s hormone levels.
Children treated with growth hormone should be checked regularly for low serum cortisol levels and/or the need to increase the dose of the glucocorticoids they are taking.
In children experiencing fast growth, curvature of the spine may develop or worsen. This is also called scoliosis. Children with scoliosis should be checked regularly to make sure their scoliosis does not get worse during their growth hormone therapy.
Use a different area on the body for each injection. This can help to avoid skin problems such as lumpiness or soreness.
Growth hormone treatment may cause serious and constant stomach (abdominal) pain. This could be a sign of pancreatitis. Tell your child’s health care provider if your child has any new stomach (abdominal) pain.
In studies of NGENLA in children with GHD, side effects included injection site reactions such as pain, swelling, rash, itching, or bleeding. Other side effects were the common cold, headache, fever (high temperature), low red blood cells (anemia), cough, vomiting, decreased thyroid hormone levels, stomach pain, rash, or throat pain.
A health care provider will help you with the first injection. He or she will also train you on how to inject NGENLA.
NGENLA is a prescription product for the treatment of growth failure in children 3 years of age and older who do not make enough growth hormone on their own. This condition is called growth hormone deficiency (GHD).