Ngenla

Pronunciation: en-JEN-lah
Generic name: somatrogon-ghla
Dosage form: subcutaneous injection
Drug class: Growth hormones

Medically reviewed by Carmen Pope, BPharm. Last updated on Oct 26, 2023.

What is 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.

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.

Before taking this medicine

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.

How is Ngenla administered?

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.

Directions

Each turn (click) of the dose knob dials 0.2mg or 0.5 mg of medicine, depending on the pen’s strength.

You can give from 0.2 mg to 12 mg in a single injection with the 24mg/1.2mL pen. If your dose is more than 12 mg, you will need to give more than 1 injection or ask for the higher strength pen.
You can give from 0.5 mg to 30 mg in a single injection with the 60mg/1.2mL pen. If your dose is more than 30 mg, you will need to give more than 1 injection. A new pen may contain slightly more than 60 mg of medicine, this is normal.

Always use a new sterile needle for each injection. This will decrease the risk of contamination, infection, leakage of medicine, and blocked needles leading to the wrong dose.

Do not shake your pen. Shaking can damage the medicine.

What happens if I miss a dose?

Inject the missed dose as soon as possible within 3 days after the missed dose.

If more than 3 days have passed, skip the missed dose and administer the next dose on the regularly

scheduled day.

What happens if I overdose?

An acute overdosage may lead initially to low blood glucose levels and subsequently to high blood glucose levels. Overdose with growth hormone may cause fluid retention. Long-term overdosage could result in signs and symptoms of gigantism consistent with the effects of excess growth hormone.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while using Ngenla?

Do not share your pen with other people, even if the needle has been changed. You may give other people a serious infection or get a serious infection from them.

The pen is not recommended for use by the blind or visually impaired without the assistance of a person trained in the proper use of the product.

What are the side effects of Ngenla?

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.

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.

Storage

Before use: Store refrigerated at 36°F to 46°F (2°C to 8°C) in the original carton to protect from light.

Once a pen is in use: Store the pen in a refrigerator at 36°F to 46°F (2°C to 8°C) between each use, for up to 28 days. Do not freeze or shake. Do not expose to heat. Do not use it if it has been frozen. Store away from direct sunlight.

Always change the needle with each use. Remove and safely discard the needle after each injection and store the prefilled pen without an injection needle attached. Always use a new needle for each injection. Replace the cap on your prefilled pen when it is not in use. Write the date of first use in the space provided on the pen label. The prefilled pen should not be used more than 28 days after first use.

Ingredients

Active ingredient: somatrogon-ghla

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

Available in two different strengths:

24 mg/1.2 mL (20 mg/mL) single-patient-use prefilled pen that delivers a dose in 0.2 mg increments
60 mg/1.2 mL (50 mg/mL) single-patient-use prefilled pen that delivers a dose in 0.5 mg increments.

The pens are disposable and should be thrown away in a sharps bin once empty. You can give more than 1 dose from the pen.