Ngenla®(somatrogon)

NGENLA is a prescription medicine that contains a form of human growth hormone, like the growth hormone made by the human body.

NGENLA is used in children who are not growing because of low or no growth hormone. It is administered by injection under the skin (subcutaneous injection).

• has a critical illness caused by certain types of heart or stomach surgery, trauma (accidental or surgical), or acute respiratory (breathing) problems
• is allergic to somatrogon-ghla or any of the ingredients in NGENLA
• has closed bone growth plates (epiphyses)
• has active cancer or other tumors
• has certain types of diabetic eye problems (diabetic retinopathy)
• has Prader-Willi syndrome and is severely obese or has severe breathing problems including sleep apnea

• has had surgery, trauma, or a serious medical condition
• has breathing problems or sleep apnea
• has a history of cancer or any tumor
• has diabetes
• is pregnant or plans to become pregnant
• is breastfeeding or plans to breastfeed

Tell your healthcare provider about all the medicines the 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. Especially tell your healthcare provider if the child takes:

• insulin or other diabetes medicines
• corticosteroids (steroids)
• seizure medicines
• sex hormones (estrogen, androgen)
• cyclosporine

• Inject NGENLA 1 time each week, on the same day each week, at any time of the day.
• NGENLA is given as an injection under the skin (subcutaneously).
• Injection sites include the abdomen (stomach area), thighs, buttocks, or upper arms.
• Rotate the injection site with each weekly injection.
• You may change the day of the week as long as at least 3 days have passed since the last injection.
• Do not share pens or needles with others.
• Your healthcare provider will show you how to inject NGENLA properly.

If you miss a dose:

• If 3 days or less have passed since the missed dose, give the dose as soon as possible.
• If more than 3 days have passed, skip the missed dose and give the next dose on the regularly scheduled day.

NGENLA can cause serious side effects, including:

• Increased risk of death in patients with critical illness. NGENLA should not be used in patients with critical illness caused by certain types of heart or stomach surgery, trauma, or acute respiratory problems.

• Severe allergic reactions. Get medical help right away if the child has swelling of the face, lips, or throat, trouble breathing, or skin rash.

• Increased risk of cancer in childhood cancer survivors. Children who received radiation treatment to the brain or head and developed growth hormone deficiency may have an increased risk of a new tumor.

• High blood sugar or diabetes. Blood sugar levels should be monitored, especially in patients at risk for diabetes.

• Increased pressure in the brain (intracranial hypertension). Tell your healthcare provider if the child has severe or recurrent headaches, vision problems, nausea, or vomiting.

• Fluid retention. This may cause swelling, joint pain, or nerve problems such as carpal tunnel syndrome.

• Low cortisol levels (hypoadrenalism). Symptoms may include fatigue, weakness, nausea, vomiting, or low blood pressure.

• Low thyroid hormone levels (hypothyroidism). Thyroid function should be monitored during treatment.

• Hip and knee pain or limp (slipped capital femoral epiphysis). Children may develop a limp or have hip or knee pain.

• Worsening of spine curvature (scoliosis). Children with scoliosis should be monitored.

• Pancreatitis (inflammation of the pancreas). Call your healthcare provider if the child has severe stomach pain that does not go away.

• Fat loss at injection sites (lipohypertrophy). Rotate injection sites to reduce this risk.

• Sudden death risk in patients with Prader-Willi syndrome. Patients with severe obesity or breathing problems, including sleep apnea, have an increased risk of sudden death.

• Elevated blood phosphorus, alkaline phosphatase, or parathyroid hormone. These levels may increase during treatment.

The most common side effects of NGENLA include:

• injection site reactions (pain, swelling, rash, itching, bleeding)
• common cold
• headache
• fever
• low red blood cells (anemia)
• cough
• vomiting
• low thyroid hormone levels (hypothyroidism)
• abdominal pain
• rash
• throat pain

These are not all the possible side effects of NGENLA. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

• Store NGENLA in the refrigerator at 36°F to 46°F (2°C to 8°C) before first use. Keep in the original carton to protect from light.
• After first use, NGENLA may be stored in the refrigerator and must be used within 28 days.
• Do not freeze NGENLA. Do not use NGENLA if it has been frozen.
• Do not expose NGENLA to heat.
• Do not use NGENLA after the expiration date.
• Keep NGENLA and all medicines out of the reach of children.

Active ingredient: somatrogon-ghla

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