What Is Skytrofa?
Skytrofa is a long-acting form of somatropin. Somatropin is also called human growth hormone. Skytrofa is also considered a pegylated somatropin product. Pegylated means the medication is attached to a compound called polyethylene glycol, or PEG. This helps the medicine stay in the body longer by slowing down how quickly it is broken down. For Skytrofa, being pegylated allows the growth hormone to work with just one injection per week. Some other somatropin products require daily injections.
How Does Skytrofa Treat GHD?
People with growth hormone deficiency, or GHD, have low levels of human growth hormone, also called somatropin. People with GHD are often treated with synthetic somatropin medicines. Synthetic somatropin works like the body’s natural human growth hormone. Children with GHD may have reduced height or delayed puberty, and this medicine can help children's bodies grow and mature. In adults with GHD, somatropin helps improve body composition.
How Do I Store Skytrofa?
Skytrofa cartridges should be stored inside their outer carton in a refrigerator between 36 F to 46 F (2 C to 8 C). Do not freeze. You can also store the cartridges inside their outer carton at room temperature (up to 86 F or 30 C) for up to six months. If you do this, write the date that you first take them out of the refrigerator on the carton. You can return them to the refrigerator during the six months, but do not use Skytrofa more than six months after taking it out of the refrigerator.
If you store Skytrofa cartridges in the refrigerator, remove only the cartridge you plan to use and let it sit at room temperature for 15 minutes before use.
How Is Skytrofa Used?
Refer to the Instructions for Use for complete administration instructions with illustrations. The instructions can also be found on www.Skytrofa.com/IFU.
The autoinjector should only be used with Skytrofa cartridges and needles that are prescribed by your health care provider.
Skytrofa should be injected under the skin into the abdomen, buttock, or thigh. You should rotate between these sites each time you inject Skytrofa. Avoid injecting into the same spot repeatedly because it can cause fat loss under your skin in that area.
Skytrofa comes in a cartridge that contains both the medicine (a powder) and water. The cartridge is designed to work with the Skytrofa autoinjector. The Skytrofa autoinjector is an electronic and reusable device that is used to automate parts of the process for injecting Skytrofa. The autoinjector features built-in electronics and software to guide you through the preparation and injection process. You must charge the autoinjector before using it.
Use the Skytrofa cartridge within four hours after the autoinjector mixes the medicine (a powder) and water for injection.
How Do I Use the Skytrofa Autoinjector Device?
After a cartridge is inserted into the autoinjector, the device mixes the medicine (a powder) and water, making it ready for injection. The mixing process usually takes four to eight minutes. The autoinjector will beep when the mixing process is complete. When the injection needle on the autoinjector is placed into the skin, the autoinjector injects the medicine under your skin. The injection process usually takes 10 to 15 seconds. The autoinjector will beep when the injection process is done.
After the autoinjector mixes the medicine (a powder) and water that is in the cartridge, the Skytrofa solution should look clear and colorless or slightly opalescent. It may occasionally contain air bubbles, which is normal. Do not use the solution if it looks cloudy or contains particles in it.
How Was Skytrofa Studied for the Treatment of GHD?
It is already well understood that growth hormone (somatropin) is beneficial for children and adults with GHD.
To determine whether Skytrofa once weekly is as helpful as daily somatropin injections, a clinical study compared once-weekly Skytrofa with somatropin daily injection in 161 children who had never been treated for GHD. The average age of enrolled patients was eight years. Most of the patients in the study were male (82%). Children were included in the study if they were aged 3 to 12 years for boys and aged 3 to 11 years for girls. Both groups received the same total weekly dose of somatropin (0.24 mg/kg/week) for one year. The primary study measure was the change in growth after one year of treatment.
For adults, a study compared once-weekly Skytrofa with a placebo (no medicine) in 259 adults with GHD. Adults in this study were 23 to 81 years of age and had a mean body mass index of 28. Most (218) were Caucasian, 28 were Asian, and 1 was American Indian or Alaska Native, and 1 was or Black or African American. The primary study measure was the change in trunk percent fat after 38 weeks of treatment.
What Did the Studies Show?
After one year, children who used Skytrofa grew an average of 11.2 cm (range, 5.9 to 18 cm), while those who used somatropin grew an average of 10.3 cm (range, 4.7 to 16.3). This shows that both treatments helped children grow taller, but children who used Skytrofa grew about 1 cm more on average than those who used somatropin.
There were no serious side effects caused by either medicine used in the study, and no one had to stop taking either medicine because of side effects. The most common side effects in people who took Skytrofa were upper respiratory infection (37.1%), fever (15.2%), and headache (12.4% ). The most common side effects in people who took somatropin daily injections were also upper respiratory infection ( 41.4%), fever (8.9%), and headache (12.5%).
After 38 weeks, adults who used Skytrofa had a 1.7% reduction in trunk percent fat, while those who used a once-weekly placebo had a 0.4% increase in trunk percent fat. Both peripheral swelling (arms, legs, feet) and low thyroid levels were side effects that were more common with Skytrofa (8% and 7%, respectively) than with placebo (1% each).
Your results may differ from what was seen in clinical studies.
How Strong Is the Evidence for Skytrofa?
Based on current clinical studies, Skytrofa is safe and effective for children and adults with GHD. Clinical guidelines recommend human growth hormone products for both age groups.
How Long Until I See the Effects of Skytrofa?
It can take several months to see the effects of Skytrofa. 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 continue to use Skytrofa every week as prescribed by your health care provider. Make sure that you get any blood work done that your health care provider orders. These lab results may be needed to determine the desired dose of this medicine. Talk to your health care provider if you have questions or concerns about whether Skytrofa is working. Your health care provider may increase your dose if you are not already at the highest dose.
Do not stop taking Skytrofa without talking to your health care provider first.
How Do I Know If Skytrofa Is Working?
In children, you can tell if Skytrofa is working by keeping track of your growth. Your health care provider will measure your height during regular checkups to see if you are growing faster than before starting Skytrofa. It may take a few months to notice a change in your 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 Skytrofa use.
What Types of Drug Interactions Can Happen?
Skytrofa can interact with many different 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.
Skytrofa may alter the blood levels of many other medicines. In some cases, your health care provider may need to adjust the doses of these medicines.
If you are taking a medicine called a corticosteroid, your dose may need to be adjusted when you start using Skytrofa. Your health care provider may also have you start taking a corticosteroid while you are using Skytrofa. Talk to your health care provider if you have any questions about the benefits or risks of corticosteroids while using Skytrofa.
Oral estrogen, which is a type of hormone therapy, can reduce how well Skytrofa works. Your health care provider may increase your dose of Skytroa if you also take oral estrogen.
Skytrofa can make the body less sensitive to insulin, raising blood sugar levels. If you take medicines for diabetes, your health care provider may adjust the dose of these medicines.
Is Anyone at Higher Risk When Using this Medicine?
Certain people are at higher risk when taking any form of growth hormone, not just Skytrofa. Tell your health care provider about all of your health conditions. This will help them determine if Skytrofa is right for you.
You may be at higher risk when using this medicine if you have or have had cancer. If you currently have cancer, you should not take Skytrofa because it could make the cancer grow. If you had cancer in the past, you should only take 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 developing another tumor, especially in the brain. Your health care provider will need to monitor you closely while you are taking Skytrofa.
If you have a rare genetic condition that causes short height, you may also have a higher risk of developing cancer. If you take Skytrofa, your health care provider will need to watch for any signs of tumors.
While taking 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 scoliosis (a curved spine) and are a child, using Skytrofa might make the curve worse. Talk to your health care provider if you have scoliosis.
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 $5 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 Ascendis Signature Access program at skytrofa.com/support-for-caregivers/patient-resources or by calling 844-442-7236.