Ngenla

Generic name: Somatrogon-ghla
Dosage form: subcutaneous injection
Drug class: Growth hormones

Usage of Ngenla

Ngenla (somatrogon-ghla) is a once-weekly human growth hormone analog that is given suBCutaneously (under the skin) to treat children aged three years and older who are not growing because their bodies produce little or no growth hormone. It is available as a pre-filled injectable pen in 2 strengths: 24mg/1.2ml and 60mg/1.2ml.

Growth hormone deficiency (GHD) is a rare disease affecting approximately one in every 4000 to 10 000 children. It is characterized by inadequate secretion of somatropin (the growth hormone) from the pituitary gland. Without treatment, a child will not grow properly, puberty may be delayed, and as an adult, they will not be tall. This can have an impact on a child’s physical health and mental well-being.

Ngenla was FDA approved on June 28, 2023.

Ngenla side effects

Ngenla may cause fluid retention. This is more likely with higher dosages. The dosage may need to be reduced by your doctor.

Ngenla may increase the risk of serious side effects such as:

Slipped Capital Femoral Epiphysis: Investigate children who develop a limp or persistent hip or knee pain

Pancreatitis: Consider with persistent severe abdominal pain

Lipoatrophy (localized loss of fat tissue): The risk is higher if Ngenla is administered in the same location over a long period. Rotate injection sites.

Ngenla may decrease insulin sensitivity and cause high blood sugar levels. Glucose levels should be monitored periodically in all patients, especially those with existing diabetes mellitus or at risk for its development.

Other serious side effects associated with Ngenla include:

Fluid retention

Glucose intolerance and diabetes mellitus

Hypoadrenalism

Hypothyroidism

Increased mortality in patients with acute critical illness

Increased risk of neoplasm

Intracranial hypertension

Progression of preexisting scoliosis

Severe hypersensitivity

Sudden death in pediatric patients with Prader-Willi syndrome.

The most common side effects reported with Ngenla are:

Injection site reactions

Nasopharyngitis,

Headache,

Pyrexia

Anemia

Cough

Vomiting

Hypothyroidism

Abdominal pain

Rash

and oropharyngeal pain.

Before taking Ngenla

You should not use Ngenla if you are allergic to somatrogon-ghla or any of the inactive ingredients in the injection. Discontinue if a clinically significant hypersensitivity reaction occurs.

Tell your doctor if your child has had:

Heart or stomach surgery, trauma, or serious breathing (respiratory) problems

A history of problems breathing while they slept (sleep apnea)

Cancer or a tumor

Diabetes.

Tell your doctor if your child is pregnant or plans to become pregnant. It is not known if Ngenla will harm an unborn baby. It is not known if Ngenla passes into breast milk.

Relate drugs

How to use Ngenla

Ngenla can be self-administered or administered by a caregiver once a healthcare provider has demonstrated the correct administration technique. A healthcare provider can also administer a dose.

Ngenla is administered once weekly, on the same day each week, subcutaneously into the abdomen, thighs, buttocks, or upper arms with a weekly rotation of injection sites.

The recommended dosage is 0.66 mg/kg once weekly (based on actual body weight)

Dosages should be individualized based on the growth response.

When switching from a daily growth hormone product, start once-weekly Ngenla on the day following the last daily injection.

If more than one injection is required to deliver a complete dose, each injection should be administered at a different injection site.

Mark your calendar ahead of time to help you remember the correct day. You can change the day of weekly administration as long as the time between 2 doses is at least 3 days. After selecting a new dosing day, the once-weekly dosing should be continued.

Call your healthcare provider if you or your caregiver have any questions about the right way to inject Ngenla or call the helpline at 1-800-645-1280.

Warnings

Ngenla should not be given to children with:

A critical illness caused by certain types of heart or stomach surgery, trauma, or breathing (respiratory) problems

An allergy to somatrogon-ghla or any of the ingredients in Ngenla

Closed bone growth plates (epiphyses)

Cancer or other tumors

Diabetic eye problems (such as diabetic retinopathy)

Prader-Willi syndrome, severe obesity, or breathing problems including sleep apnea.

Severe hypersensitivity reactions may occur with Ngenla, including anaphylaxis. Seek prompt medical attention with any signs of an allergic reaction including difficulty breathing, swelling, or a rash.

There is an increased risk of a second cancer in children with preexisting tumors or in those who have survived childhood cancer, particularly meningiomas in patients treated with radiation to the head for their first neoplasm.

There is a higher risk of death with somatropin reported in children with acute critical illness due to complications following open heart surgery, abdominal surgery, multiple accidental trauma, or those with acute respiratory failure. The safety of continuing Ngenla treatment in these children has not been established.

Your doctor may perform other examinations to check for any underlying conditions or to monitor preexisting ones such as intracranial high blood pressure, hypoadrenalism, hypothyroidism, or preexisting scoliosis.

What other drugs will affect Ngenla

Tell your child’s healthcare provider about all the medicines your child takes, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Medications that may interact with Ngenla include:

Glucocorticoid treatment

Cytochrome P450-metabolized drugs (Ngenla may alter their clearance)

Oral estrogen (larger doses of Ngenla may be required)

Insulin and/or other antihyperglycemics (a dosage adjustment of these may be required).

This list is not complete. Other drugs may affect Ngenla, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Disclaimer

Every effort has been made to ensure that the information provided by Drugslib.com is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Drugslib.com information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Drugslib.com does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Drugslib.com's drug information does not endorse drugs, diagnose patients or recommend therapy. Drugslib.com's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Drugslib.com does not assume any responsibility for any aspect of healthcare administered with the aid of information Drugslib.com provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.