Ngenla
Ngenla (somatrogon or somatrogon-ghla) is a growth hormone medication used in children ages 3 years and older who have problems growing due to low growth hormone. It's given as an injection under the skin once per week. The medication is available as a prefilled pen that can conveniently be given at home. Common side effects include injection-site reactions (e.g., pain, redness, itching), headache, and fever.
What is Ngenla (somatrogon)?
What is Ngenla (somatrogon) used for?
- Low growth hormone levels in children 3 years and older
How Ngenla (somatrogon) works
Ngenla (somatrogon) is a growth hormone analog. It works just like the growth hormone (GH) the body naturally makes. By acting like growth hormone, Ngenla (somatrogon) starts a series of steps in the body that help your child grow.
Drug facts
Side effects of Ngenla (somatrogon)
The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.
Common Side Effects
- Injection-site reactions (42%)
- Common cold symptoms (33%)
- Headache (17%)
- Fever (17%)
- Low red blood cells (9%)
- Cough (8%)
- Vomiting (7%)
- Low thyroid hormone (6%)
- Stomach pain (6%)
- Rash (6%)
- Mouth and throat pain (6%)
Less Common Side Effects
- Joint pain
- Ear infection
- Swollen tonsils
- Bronchitis
Ngenla (somatrogon) serious side effects
Contact your healthcare provider immediately if you experience any of the following.
- Serious allergic reactions: hives, dizziness, fever, rash, shaking, itching, nausea, flushing, dizziness, trouble breathing, chest pain
- High blood pressure in the brain: changes in vision, headache, nausea, vomiting
- Swelling of the pancreas (pancreatitis): nausea, vomiting, severe abdominal pain that spreads to your back
- Cancer
The following Ngenla (somatrogon) side effects have also been reported
Side effects that you should report to your care team as soon as possible:
- Allergic reactions or angioedema—skin rash, itching or hives, swelling of the face, eyes, lips, tongue, arms, or legs, trouble swallowing or breathing
- High blood sugar (hyperglycemia)—increased thirst or amount of urine, unusual weakness or fatigue, blurry vision
- Increased pressure around the brain—severe headache, blurry vision, change in vision, nausea, vomiting
- Low adrenal gland function—nausea, vomiting, loss of appetite, unusual weakness or fatigue, dizziness
- Low thyroid levels (hypothyroidism)—unusual weakness or fatigue, increased sensitivity to cold, constipation, hair loss, dry skin, weight gain, feelings of depression
- Pancreatitis—severe stomach pain that spreads to your back or gets worse after eating or when touched, fever, nausea, vomiting
Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):
- Bone, joint, or muscle pain
- Burning or tingling sensation in hands or feet
- Lipodystrophy—hardening or scarring of tissue at injection site
- Pain, redness, or irritation at injection site
- Swelling of the ankles, hands, or feet
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Pros and cons of Ngenla (somatrogon)
Pros
- Only injected once per week
- Available as a multiple dose, prefilled pen
- Pens aren't made with natural rubber latex
Cons
- Commonly causes injection-site reactions
- Has a potential risk for cancer
- Only available as a brand-name medication
Pharmacist tips for Ngenla (somatrogon)
- Mark your child's appointments on your calendar to see their endocrinologist and get any blood tests (e.g., phosphorus level, hormone levels) done while taking Ngenla (somatrogon). It's important your child sees them on time so their treatment is checked properly.
- Make sure to tell your child's endocrinologist or pharmacist about all the medications your child is taking, especially diabetes medications or corticosteroids. Because they might interact with Ngenla (somatrogon), your child's prescriber might need to adjust the doses of these medications.
Tips on how to use Ngenla (somatrogon)
- There are two strengths of Ngenla (somatrogon): 24 mg/1.2 mL and 60 mg/1.2 mL. Know which strength you have and what the dose is.
- Make sure your child's endocrinologist or pharmacist teaches you how to inject Ngenla (somatrogon) to avoid injury or wasting the medication. Carefully read the directions, or watch this video on how to mix and inject the medication.
- Store unopened pens in the refrigerator and keep them in the original container to protect from light. These can be stored until the expiration date printed on the carton. After opening a pen, it's good for 28 days, so mark that date on the pen.
- When it's time for your child's dose, take the pen out of the refrigerator and lay it on a flat surface for about 30 minutes to warm up to room temperature. Don't try to warm it up any other way, such as with a microwave, because doing so can damage your medication.
- Inject the medication under the skin in your child's stomach, upper rear arm, front upper thigh, or buttocks (if administered by a caregiver). Choose a different injection site every time, even if the dose requires more than 1 injection. Using the same site over and over again can lead to lipoatrophy, or loss and damage to the fat tissue at that site.
- If you're injecting into your child's stomach, keep it at least 2 inches away from the belly button. Don't inject into bony areas, areas that are bruised, red, sore or hard, and areas that have scars or skin conditions.
- After an injection, throw away the needle in a sharps container. This helps prevent needle-stick injuries. Don't throw them away in your trash can.
Common questions about Ngenla (somatrogon)
In studies, children taking Ngenla (somatrogon) at the typical dose for 1 year grew about 10 cm, about the same as they would grow with daily growth hormone injections. Keep in mind that everyone responds differently to medications. Your child's endocrinologist will regularly check your child's progress while they're taking this medication. Talk to your child's endocrinologist if you're concerned about how well Ngenla (somatrogon) is working for your child.
If your child misses a dose, you can give Ngenla (somatrogon) up to 3 days after the missed dose. If it's been more than 3 days since the missed dose, skip it and give the next dose on the regularly scheduled day. If needed, you can change the day of the week your child takes their dose, as long as there are at least 3 days between the two doses. After you pick a new dosing day, continue once-weekly dosing.
Yes, Ngenla (somatrogon) is a type of biologic medication. Biologics are medications that are made from living sources, like cells, in the lab. Ngenla (somatrogon) is a lab-made protein that's made from cells.
It takes about 6 to 8 days for most of Ngenla (somatrogon) to leave your body after a single dose. This time-frame is estimated based on the half-life of Ngenla (somatrogon).
No, Ngenla (somatrogon) isn't considered a controlled substance by the Drug Enforcement Administration (DEA). But, medications like Ngenla (somatrogon) that promote growth can be used illegally for the purpose of improving athletic or bodybuilding performance and lowering body fat. Use Ngenla (somatrogon) exactly as prescribed for your child. Make sure to keep it in a secure place away from others who don't need access to the medication.
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Risks and warnings for Ngenla (somatrogon)
Ngenla (somatrogon) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Higher risk of death in people with a short-term critical illness
- Risk factor: Open heart or stomach surgery | Serious injuries | Severe breathing problems
There have been reports of growth hormone medications similar to Ngenla (somatrogon) raising the risk of death when used in people with a critical illness from open heart or stomach surgery, serious injuries, or a severe breathing problem. Speak to your child's endocrinologist if you have questions or concerns.
Severe allergic reactions
Severe allergic reactions to growth hormone medications similar to Ngenla (somatrogon) have been reported, including life-threatening reactions like anaphylaxis (closing of the throat). If you notice your child experiencing dizziness, a choking sensation, nausea, swelling around the eyes, swelling of the lips or tongue, or difficulty breathing after using Ngenla (somatrogon), get medical attention right away.
New or worsening cancer
- Risk factors: History of cancer | Genetic causes of short stature
Ngenla (somatrogon) shouldn't be used in people with an active tumor or cancer. Let your child's endocrinologist know if your child has a history of any type of cancer. Growth hormone replacement medications like Ngenla (somatrogon) can raise the risk of cancer. Your child's endocrinologist will monitor your child during and after treatment with the medication and will stop treatment at the first sign of potential cancer development.
High blood sugar
- Risk factors: People who are considered obese | Turner syndrome | Family history of diabetes
Ngenla (somatrogon) can lower your body's sensitivity to insulin, the hormone that lowers your blood sugar. This can lead to high blood sugar and raise your risk of diabetes. Your child's endocrinologist will likely have you check your child's blood sugar level while taking Ngenla (somatrogon). Make sure you're familiar with symptoms of high blood sugar, such as feeling very thirsty, needing to urinate often, and feeling very tired. Contact your child's provider if you notice any of these.
High blood pressure in the brain (intracranial hypertension)
Rarely, a medication similar to Ngenla (somatrogon) has caused high blood pressure in the blood vessels in the brain, or intracranial hypertension. This can lead to changes in your child's vision and cause symptoms like headache, nausea, and vomiting. Symptoms usually occur within 2 months after starting treatment. Your child's endocrinologist will likely perform routine examinations before your child starts and throughout treatment with Ngenla (somatrogon).
Swelling in the body
It's possible for Ngenla (somatrogon) to cause a buildup of fluid in the body. This can cause swelling in the body, joint pain, muscle pain, and nerve compression problems like carpal tunnel syndrome. Contact your child's endocrinologist if you notice any swelling in the arms and legs, shortness of breath, or weight gain in a short amount of time.
Low hormone levels
Ngenla (somatrogon) can lower levels of cortisol, a hormone made by your body that's involved in many processes, such as controlling your blood sugar and blood pressure, and lowering inflammation. Let your child's endocrinologist know if you notice them having symptoms of low cortisol, such as weakness, fatigue, loss of appetite, feeling faint or dizzy, or mood changes.
Ngenla (somatrogon) can also lower thyroid hormone levels. This can prevent the medication from working well. Your child's endocrinologist will likely perform routine tests to make sure hormone levels are healthy and adjust the dose if needed.
Bone problems
Since Ngenla (somatrogon) stimulates growth in children, it can cause a hip problem known as slipped capital femoral epiphysis, where the thigh bone slips out of the socket. This problem is seen in children who start to grow quickly. Contact your child's endocrinologist if they have a limp or complain of hip or knee pain while they're being treated with Ngenla (somatrogon).
If your child has scoliosis, taking Ngenla (somatrogon) can cause their condition to get worse because they're growing much more quickly. It's important to note that the medication itself doesn't cause this condition. Your child's endocrinologist will check them regularly for worsening symptoms of scoliosis (e.g., uneven waist or shoulders, or entire body leans to one side).
Inflammation of the pancreas (pancreatitis)
- Risk factors: Children
Rarely, another medication like Ngenla (somatrogon) has caused pancreatitis, or inflammation of the pancreas. The risk might be higher for children who're using Ngenla (somatrogon) compared to adults. Contact your child's endocrinologist if they complain of sudden, severe stomach pain.
Sudden death in children with Prader-Willi syndrome
- Risk factors: Boys | Children with Prader-Willi syndrome that also are considered obese, have blocked airways, sleep apnea, or an unknown respiratory infection
Ngenla (somatrogon) shouldn't be used in children who have growth problems due to a genetic condition called Prader-Willi syndrome. This is because death has occurred when a similar medication was used in these children who also had certain risk factors like obesity or sleep apnea.
Ngenla (somatrogon) dosage
Carton| Dosage | Quantity | Price as low as | Price per unit |
|---|---|---|---|
| 1.2ml prefilled pen of 24mg/1.2ml | 2 cartons | $4,263.08 | $2,131.54 |
| 1.2ml prefilled pen of 60mg/1.2ml | 1 carton | $5,327.28 | $5,327.28 |
Typical dosage for Ngenla (somatrogon)
The dose of Ngenla (somatrogon) is based on your child's weight.
The typical dose is 0.66 mg/kg of body weight injected under the skin once per week.
How much does Ngenla (somatrogon) cost?
$4,263.08
Ngenla (somatrogon) contraindications
Contraindications are specific health conditions or situations in which a person should not take a medication due to safety concerns. If you have any of the following conditions or if any of the following apply to you, let your healthcare provider know because Ngenla (somatrogon) will not be safe for you to take.
- A short-term, critical illness from surgery, serious injuries, or a severe breathing problems
- Children who have stopped growing (or have a closed growth plates)
- Currently have cancer
- Active or severe eye damage caused by diabetes (diabetic retinopathy)
- Prader-Willi syndrome and have been identified as obese or have severe breathing problems or sleep apnea
