What Is Sogroya?
Sogroya is a long-acting form of somatropin. Somatropin is also called human growth hormone. Sogroya is made by attaching human growth hormone to a small protein that helps it stay in the body longer by slowing down how quickly it is broken down. This design allows the growth hormone in Sogroya to keep working throughout the week, so it only needs to be injected once each week. Some other somatropin medicines need to be injected every day.
How Does Sogroya Treat Growth Hormone Deficiency?
People with growth hormone deficiency (GHD) have low levels of human growth hormone, also called somatropin. People with GHD are often treated with somatropin medicines that are made in a lab (synthetic). Synthetic somatropin works like the body’s natural human growth hormone. Children with GHD may have shorter height or delayed puberty, and this medicine can help their bodies grow and mature. In adults with GHD, somatropin helps improve body composition.
How Was Sogroya Studied for the Treatment of GHD?
It is well understood that growth hormone (somatropin) is beneficial for children and adults with GHD. To study once-weekly Sogroya, two clinical trials were done. The REAL1 study in adults compared weekly Sogroya with placebo (containing no medicine). The REAL4 study in children compared weekly Sogroya with daily somatropin injections. These studies helped look at how well Sogroya works in both adults and children with GHD.
REAL1 study
The REAL1 study enrolled 301 adults (aged 23-79) with GHD who had never been treated for the condition. People were enrolled in the U.S. and 16 other countries. People in the study were randomly assigned to receive Sogroya once weekly, somatropin once daily, or a placebo (containing no medicine) for 34 weeks. The people who were randomly assigned to daily somatropin knew which treatment they were being given, but those who were randomly assigned to once-weekly Sogroya or placebo did not know which treatment they were receiving. The doses of growth hormone were adjusted for each person to keep growth hormone levels within a safe and effective range.
After the main treatment period, people continued into a 52-week extension phase of the study, for a total study duration of 86 weeks. During the extension phase, people received either once-weekly Sogroya or daily growth hormone injections. The main goal of the study was to look at the effects of once-weekly Sogroya on body composition compared with placebo, focusing on changes in truncal (abdominal) fat percentage. Body composition was measured using a scan called dual-energy X-ray absorptiometry (DXA).
In the REAL1 study, just over half of the enrolled people were women (about 52%). The average age was 45 years, and most people (nearly 70%) had GHD that began in adulthood. On average, people weighed about 75 kg (165 pounds). Overall, about two-thirds of people were White (67%), 29% were Asian, and 2.3% were Black or African American or of another race.
REAL4 study
The REAL4 study enrolled 200 children (aged 2.5-11) with GHD who had not yet gone through puberty and who had never been treated for GHD. Children were enrolled in the U.S. and 19 other countries. Children in the study were randomly assigned to receive Sogroya once weekly or somatropin daily for 52 weeks. The doses of growth hormone were adjusted for each child to keep growth hormone levels within a safe and effective range.
After the main treatment period, children continued into a three-year extension phase of the study. During the extension phase, all children received once-weekly Sogroya. The main goal of the study was to measure the change in growth after one year of treatment with once-weekly Sogroya or daily somatropin.
In the REAL4 study, the average age of enrolled children was 6.4 years, with 48.5% of children being under 6 years of age. On average, children weighed 16.5 kg (36 pounds) and were 101.6 cm (40 inches) tall. Overall, 57% of children were White, 37% were Asian, 0.5% were Black or African American, and about 5% were of another race or did not have a race reported.
What Did the Studies Show?
In the REAL1 study, adults receiving once-weekly Sogroya for 34 weeks showed a significant reduction in truncal (abdominal) fat compared with placebo (a decrease of 1.16%, while placebo increased truncal fat by 0.63%). The group that received daily somatropin had a 2.47% decrease in truncal fat. After 86 weeks of treatment, the improvements in body composition seen with Sogroya and daily somatropin were maintained.
In the REAL4 study, children who used Sogroya for one year grew an average of 11.2 cm, while those who used daily somatropin grew an average of 11.7 cm. This shows that both treatments helped children grow taller and that Sogroya was not worse than daily somatropin. Improvements in growth were maintained after three years of continuous Sogroya treatment and after two years in a group that switched from daily somatropin to Sogroya.
Your results may differ from what was seen in clinical studies.
How Strong Is the Evidence for Sogroya?
Based on current clinical studies, Sogroya is safe and effective for adults and children with GHD. Clinical guidelines recommend human growth hormone products for people with GHD.
How Is Sogroya Used?
Sogroya is injected under the skin (subcutaneous). It can be injected into the stomach, thigh, upper arm, or buttock, depending on what your health care provider recommends. Be sure to use a different spot each week. Injecting into the same spot repeatedly can cause fat to build up under your skin in that area.
Before using your Sogroya pen for the first time, your health care provider will show you how to give an injection safely. Read and follow the “Instructions for Use” for complete administration instructions with pictures. The instructions can also be found on the drugmaker’s website at www.sogroya.com.
Sogroya comes in a ready-to-use injection pen. It is available in three different strengths:
- 5 mg pen: Gives doses between 0.025 mg and 2 mg
- 10 mg pen: Gives doses between 0.05 mg and 4 mg
- 15 mg pen: Gives doses between 0.1 mg and 8 mg
Your health care provider will tell you which pen to use and how much medicine to use for each injection. Each pen works with needles that are very thin and designed to minimize pain. Do not reuse or share the needle or pen with anyone else, even if you have changed the needle. This can increase the risk of infection.
Before each injection, always check the liquid in the pen. The liquid should look clear and colorless. Do not use the medicine if it looks cloudy or contains particles in it.
How Do I Know if Sogroya Is Working?
In children, you can tell if Sogroya is working by keeping track of their growth. Your health care provider will measure your child’s height during regular checkups to see if they are growing faster than before starting Sogroya. It may take a few months to notice a change in your child’s height.
In adults, you may notice less fat around your stomach area after many months of use. Your health care provider may also share improvements in certain blood tests as a result of Sogroya use.
It can take several months to see the full effects of Sogroya. You may notice faster growth in children during the first few months of treatment, but the full effects can take longer. It is important to keep using Sogroya every week as prescribed by your health care provider.
Make sure to get all the blood tests done as your health care provider orders. These lab results may be needed to find the desired dose of this medicine. Talk to your health care provider if you have questions or concerns about whether Sogroya is working. Your health care provider may adjust your dose based on your lab results.
Do not stop using Sogroya without talking to your health care provider first.
What Types of Drug Interactions Can Happen?
Sogroya may affect the CYP3A enzymes in your body, which can affect the blood levels of medicines that are metabolized (broken down) by these enzymes. If you take medicines that are metabolized by CYP3A4 enzymes, your health care provider may adjust the dose of these medicines.
Sogroya may lower your cortisol levels by affecting how some corticosteroids (such as cortisone and prednisone) are converted into their active forms. You may need higher corticosteroid doses when starting Sogroya. However, large doses of corticosteroids can make Sogroya not work as well. If you take corticosteroids, your health care provider may adjust your dose of the corticosteroids so they do not interfere with your growth.
Oral estrogen, which is a type of hormone therapy, can lower how well Sogroya works. Some birth control pills contain oral estrogen. Your health care provider may increase your dose of Sogroya if you also take medicines that contain oral estrogen.
Sogroya can make the body less sensitive to insulin, raising your blood sugar levels. If you take medicines for diabetes, your health care provider may adjust the dose of these medicines.
Always tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using or have recently taken. This will help make sure your medicines work well together.
Who Is at Higher Risk for Problems When Using This Medicine?
Certain people are at higher risk when taking any form of growth hormone, including Sogroya. Tell your health care provider about all of your health conditions. This will help them know if Sogroya is right for you.
If you have or have had cancer, you may be at higher risk of cancer returning or new tumors forming when using this medicine. If you currently have cancer, you should not use Sogroya because it could make the cancer grow. If you had cancer in the past, you should only use this medicine if your cancer is in remission.
If you had radiation treatment to your brain or head as a child and later developed growth hormone problems, you may have a higher risk of having another tumor, especially in the brain. Your health care provider will need to monitor you closely while you are using Sogroya.
If you have a rare genetic condition that causes short height, you may also have a higher risk of cancer. If you use Sogroya, your health care provider will need to watch for any signs of tumors.
While using this medicine, pay close attention to any unusual changes in your body, such as new growths, changes in your skin, headaches, vision problems, or changes in behavior. Tell your health care provider right away about any new symptoms.
If you have diabetes, you may need to test your blood sugar more often while using Sogroya.
If you have scoliosis (a curved spine) and are a child, using Sogroya might make the curve in your spine worse. Talk to your health care provider if you have scoliosis.
What Are the Possible Side Effects, and How Can I Manage or Prevent Them?
The most common side effects in children using Sogroya are the common cold, headache, and pain in the arms and legs. The most common side effects in adults using Sogroya are back pain, joint pain, and upset stomach.
If the spot where you injected yourself hurts a bit, you can put a warm or cold compress on it to get some relief. Ask your pharmacist or other health care provider whether you can take over-the-counter pain medicines to get relief.
While not common, a severe allergic reaction may happen with Sogroya. Stop using Sogroya and get medical help right away if you have symptoms of an allergic reaction, such as trouble breathing or a severe rash.
These are not all of the possible side effects. Talk with your health care provider if you are having symptoms that bother you. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088 (800-332-1088). In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.
How Do I Store Sogroya?
Sogroya should be stored in a refrigerator, between 36 F and 46 F (2 C and 8 C). Make sure it is stored with the cap on, inside its outer carton. Do not store Sogroya next to the refrigerator’s cooling element. You should write the date of first use in the space provided on the carton. Once Sogroya has been used and if there is still medicine left, you should store the remaining Sogroya in the refrigerator for up to six weeks. Do not store Sogroya with the needle attached.
If needed, unused or in-use Sogroya may also be stored for up to three days at room temperature no warmer than 77 F (25 C). It can then be returned to the refrigerator.
Do not use Sogroya if it has been frozen or stored in temperatures warmer than 86 F (30 C).
Is There Any Cost Assistance Available?
Yes. There is a cost savings and support program offered by the drugmaker that may allow you to pay as little as $0 for your prescription. Whether you are eligible depends on whether you have prescription insurance and what type of insurance you have. You can find out more about the Sogroya Savings Offer at www.novocare.com/growth-related-disorders/products/sogroya/savings-offer.html or by calling 866-316-2404.