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 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.

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.

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.

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.

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.

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.

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.