Orgovyx (relugolix) is a medicine used to treat advanced prostate cancer in adults. Advanced prostate cancer means that the cancer has spread outside of the prostate. Advanced cancers have often come back after having a previous treatment.
How Does Orgovyx Work for Prostate Cancer?
Orgovyx causes your body to decrease the release of certain hormones that prostate cancer cells need to grow and spread. It works in the pituitary gland of your brain by targeting and attaching itself to certain receptors. Specifically, Orgovyx causes the pituitary gland to release less luteinizing hormone (LH) and follicle-stimulating hormone (FSH), which causes your body to make less testosterone. Prostate cancer cells need testosterone to grow, so when Orgovyx limits the amount of testosterone, it can help stop prostate cells from growing and multiplying.
How Do I Use Orgovyx for Prostate Cancer?
Orgovyx is a tablet that you swallow. You take Orgovyx once a day with or without food. You should try to take it around the same time every day. Orgovyx tablets should be taken whole, and you should not crush or chew them. You start with a loading dose of Orgovyx, which means your first dose of medicine will be higher than your ongoing (maintenance) dose. The loading dose allows the medicine to quickly reach a certain level in your body so it can be effective in treating your cancer. Your maintenance dose will keep this level consistent in your body so it can treat your cancer. You continue taking Orgovyx for as long as possible. This means you take it until your cancer progresses or you have side effects that make it not safe for you to take. In some cases, you may even continue taking the medicine if your cancer progresses. Your health care provider will talk with you about which dose of Orgovyx to take and how long you can expect to take Orgovyx.
If you are taking certain medications, you may need to take Orgovyx a certain time before or after the other medicines. Depending on the medicines you are taking, your dose of Orgovyx may also be changed. Tell your health care provider about all medications and supplements you are taking or plan to take while taking Orgovyx. They will help to tell you how to take Orgovyx so it can be safe and effective for treating your cancer.
How Well Does Orgovyx Work for Prostate Cancer?
Orgovyx was approved by the FDA based on clinical trials that compared Orgovyx against a medicine called leuprolide that is given as an injection. This clinical trial was called HERO. A total of 934 people were included in the clinical trial, and 622 of those people took Orgovyx. Many people who took Orgovyx also had another treatment or medicine along with Orgovyx. They had their testosterone concentrations measured while taking the medicine. The goal was to lower their testosterone since testosterone is needed for their prostate cancer cells to grow and multiply. When their testosterone was under a certain level (50 nanograms per deciliter (ng/dL), this is known as medical castration and this measurement in the clinical trial is called the castration rate. The people who took Orgovyx had a castration rate of 96.7% compared to a castration rate of 88.8% in people who used leuprolide. This means that Orgovyx worked better to lower testosterone levels to treat prostate cancer than leuprolide.
How Will I Know If It Is Working?
Orgovyx will start working as soon as you take your first dose. Your health care provider will do regular blood tests to see how your body is responding to the treatment. They may also decide to do scans of your body to monitor your tumor.
The blood tests will monitor your prostate-specific antigen (PSA) and testosterone levels. The PSA test allows your health care provider to monitor your prostate cancer and how active it is in your body. Your testosterone level will show how well Orgovyx is working and if you are at a castration testosterone level of less than 50 ng/dL. If Orgovyx is working for you, both your PSA and your testosterone level should go down.
Your health care provider may also decide to do additional blood count tests such as white blood cells, neutrophils, and platelets so that your health care provider knows that you can continue to take Orgovyx safely. If you have certain side effects such as a change in your urine output, your health care provider may do additional tests to make sure it is safe for you to continue to use Orgovyx.
How Can I Prevent and Manage Side Effects?
Side effects are common with medicines that treat cancer, including Orgovyx. It is important to tell your health care provider about any side effects you have during or after taking Orgovyx. They can help to determine if your side effects are serious or provide more information to help you manage the side effect.
Your health care provider may instruct you to take certain medicines while you are taking Orgovyx to help prevent and treat some of the most common side effects such as constipation and diarrhea. It is important to follow their instructions. You can also ask your health care provider what else you can do to prevent or treat common side effects. For example, drinking plenty of fluids and eating a balanced diet can help with constipation.
What Are Other Unique Considerations to Be Aware Of?
Orgovyx can harm an unborn baby. It’s important to tell your healthcare provider if you or your partner are planning to become pregnant. It’s also possible for Orgovyx to cause infertility in men or people assigned male at birth. Talk with your health care provider about the risks to your fertility and any family planning you should do before taking Orgovyx.
You should talk with your health care provider about any medical conditions you’ve had in the past, particularly if you have had any heart problems. Orgovyx can cause a dangerous heart condition called long QT syndrome. If you have had certain heart problems in the past such as long QT syndrome, heart failure, or issues with your electrolyte balance, Orgovyx may not be safe to take. Your health care provider will review your health history with you to make sure Orgovyx is safe for you to take.
Tell your health care provider about all medications you are taking. This includes prescription and over-the-counter medications as well as vitamins, supplements, and herbal medicines. Certain medications may interact with Orgovyx or increase the risk of long QT syndrome. Your health care provider will review all of the medications you are taking or plan to take and determine if they are safe to take with Orgovyx.
Is There Any Cost Assistance Available?
The manufacturer of Orgovyx has a program called Orgovyx Support Program and may be able to offer assistance for paying for Orgovyx.