Orgovyx is a brand-name medication that’s FDA-approved to treat advanced prostate cancer in adults. “Advanced” means the cancer has spread from the prostate to other parts of the body.*

The active drug in Orgovyx is relugolix. This drug belongs to a class of medications known as gonadotropin-releasing hormone antagonists. (A medication class is a group of medications that work in a similar way.) Orgovyx works to decrease levels of hormones that can make prostate cancer worse.

Orgovyx comes as tablets that you take by mouth, once per day. It’s available in one strength: 120 milligrams.

* To learn more about this condition and how Orgovyx is used, see the “Orgovyx uses” section below.

FDA approval

The Food and Drug Administration (FDA) approved Orgovyx to treat advanced prostate cancer in 2020. It’s the only medication used to provide androgen deprivation therapy (ADT) that isn’t given by injection. For more information about ADT, see the “How Orgovyx works” section below.

Effectiveness

For information about the effectiveness of Orgovyx, see the “Orgovyx uses” section below.

Orgovyx is available only as a brand-name medication. It’s not currently available in generic form.

A generic drug is an exact copy of the active drug in a brand-name medication. Generics usually cost less than brand-name drugs.

The Orgovyx dosage your doctor prescribes will depend on several factors. These include:

  • other medications you take
  • other medical conditions you may have
  • any side effects you experience while taking Orgovyx

The following information describes dosages that are commonly used or recommended. However, be sure to take the dosage your doctor prescribes for you. Your doctor will determine the best dosage to fit your needs.

Drug forms and strengths

Orgovyx comes as tablets that you swallow. It’s available in one strength: 120 milligrams (mg).

Dosage for prostate cancer

Orgovyx is approved to treat advanced* prostate cancer. On the first day of treatment, you’ll take a 360-mg dose, which is 3 tablets. This is known as a loading dose. A loading dose is used to provide more of the drug when you begin treatment, so that the drug starts to work quickly.

After the loading dose, you’ll typically take 120 mg (1 tablet) of Orgovyx, once per day. The drug should be taken at about the same time each day.

* “Advanced” means the cancer has spread from the prostate to other parts of the body.

What if I miss a dose?

If you miss a dose of Orgovyx, you can take it when you remember only if there are at least 12 hours before your next dose. If there are less than 12 hours before your next dose is due, skip your missed dose and take your next dose as usual. Call your doctor or pharmacist if you aren’t sure whether to take or skip a missed dose.

It’s important to remember that if you go more than 7 days without taking Orgovyx, you’ll need to take another loading dose. And, missing doses may cause the medication to be less effective for treating the cancer.

To help make sure that you don’t miss a dose, try using a medication reminder. This can include setting an alarm or timer on your phone or downloading a reminder app. A kitchen timer can work, too.

Will I need to use this drug long term?

Orgovyx is meant to be used as a long-term treatment. If you and your doctor decide that the drug is safe and effective for you, you’ll likely take it long term.

Orgovyx can cause mild or serious side effects. The following lists contain some of the key side effects that may occur while taking Orgovyx. These lists do not include all possible side effects.

For more information about the possible side effects of Orgovyx, talk with your doctor or pharmacist. They can give you tips on how to deal with any side effects that may be concerning or bothersome.

Note: The Food and Drug Administration (FDA) tracks side effects of drugs it has approved. If you would like to notify the FDA about a side effect you’ve had with Orgovyx, you can do so through MedWatch.

Mild side effects

Mild side effects* of Orgovyx can include:

Most of these side effects may go away within a few days or a couple of weeks. But if they become more severe or don’t go away, talk with your doctor or pharmacist.

* This is a partial list of mild side effects from Orgovyx. To learn about other mild side effects, talk with your doctor or pharmacist, or view Orgovyx’s patient information.
† For more information about this side effect, see “Side effect details” below.

Serious side effects

Serious side effects from Orgovyx aren’t common, but they can occur. Call your doctor right away if you have serious side effects. Call 911 or your local emergency number if your symptoms feel life threatening or if you think you’re having a medical emergency.

Serious side effects and their symptoms can include:

* For more information about this side effect, see “Side effect details” below.

Side effect details

Here’s some detail on certain side effects this drug may cause.

Abnormal heart rhythm

Orgovyx can cause an abnormal heart rhythm, including a specific type called long QT syndrome. Long QT syndrome may also be called QT prolongation.

Abnormal heart rhythm was rare in Orgovyx’s clinical studies. Symptoms may include:

Your risk for an abnormal heart rhythm may be higher if you’ve had long QT syndrome since birth. It may also be higher if you have heart failure or problems with blood electrolyte levels. Taking certain drugs with Orgovyx may also increase your risk for this side effect. Examples of these drugs include the antibiotic clarithromycin and the heart medication amiodarone (Pacerone).

While you’re taking Orgovyx, your doctor may monitor your heart rhythm and your blood electrolyte levels. Talk with your doctor right away if you notice any symptoms of an abnormal heart rhythm. If you experience this side effect, your doctor may have you stop taking Orgovyx.

Hot flushes

Mild hot flushes were the most common side effect reported by people taking Orgovyx in clinical studies. Hot flushes refer to a sudden, short-lived feeling of intense warmth. This often affects the chest and face. These may also be referred to as hot flashes.

If you experience hot flushes while taking Orgovyx, talk with your doctor. They may recommend ways to manage this side effect. Or, they may decide to have you switch to a different cancer treatment. For more information or if you have other questions, talk with your doctor or pharmacist.

Abnormal lab test results

It’s possible for treatment with Orgovyx to cause abnormal lab test results as a side effect. Abnormal lab results were one of the most common side effects reported by people taking Orgovyx in clinical studies. Rarely, these lab abnormalities can be serious.

Lab results that may be abnormal due to treatment with Orgovyx include:

While you’re taking Orgovyx, you’ll have blood tests to check if the drug is causing any abnormal results. If any of your test results are abnormal, your doctor may have you stop taking Orgovyx until your results return to normal. Or, they may have you switch to a different cancer treatment.

To find out how often abnormal lab test results occurred in clinical studies, see Orgovyx’s prescribing information. Talk with your doctor or pharmacist if you have additional questions about this side effect.

Allergic reaction

As with most drugs, some people can have an allergic reaction after taking Orgovyx, although this wasn’t reported in clinical studies. Symptoms of a mild allergic reaction can include:

  • skin rash
  • itchiness
  • flushing (temporary warmth, redness, or deepening of skin color)

A more severe allergic reaction is rare but possible. Symptoms of a severe allergic reaction can include:

  • swelling under your skin, typically in your eyelids, lips, hands, or feet
  • swelling of your tongue, mouth, or throat
  • trouble breathing

Call your doctor right away if you have an allergic reaction to Orgovyx, as the reaction could become severe. Call 911 or your local emergency number if your symptoms feel life threatening or if you think you’re having a medical emergency.

The Food and Drug Administration (FDA) approves prescription drugs such as Orgovyx to treat certain conditions. Orgovyx may also be used off-label for other conditions. Off-label drug use means using a drug for a purpose other than what it’s been approved for by the FDA.

Orgovyx for prostate cancer

Orgovyx is approved to treat advanced prostate cancer in adults. The prostate gland is part of the male* reproductive system. “Advanced” means the cancer has spread from the prostate to other parts of the body. This may also be called “metastatic” cancer.

Cancer cells are abnormal cells in the body that grow too quickly. A hormone called testosterone signals prostate gland cells (normal or cancerous) to grow. Orgovyx works to decrease the amount of testosterone in the body to very low levels. These prevent testosterone from signaling the prostate cancer cells to grow.

Note: The safety and effectiveness of Orgovyx in females* has not been studied.

* Sex and gender exist on spectrums. Use of the terms “male” and “female” in this article refers to sex assigned at birth.

Effectiveness for prostate cancer

In clinical studies, Orgovyx was effective at decreasing testosterone levels to treat prostate cancer. And, the American Cancer Society recommends Orgovyx as a hormone therapy treatment option to treat advanced prostate cancer.

For more information on how the drug performed in clinical studies, see Orgovyx’s prescribing information.

Orgovyx and children

The safety and effectiveness of Orgovyx in children ages 18 years and younger has not been studied.

Prostate cancer rarely forms in people ages 40 years and younger. If you have additional questions about prostate cancer and children, talk with your doctor.

There aren’t any known interactions between alcohol and Orgovyx.

However, drinking alcohol could increase your risk for certain side effects of Orgovyx, or make these side effects worse. These side effects can include:

If you drink alcohol, talk with your doctor about how much is safe for you to have while you’re taking Orgovyx.

* For more information about this side effect, see the “Orgovyx side effects” section above.

Orgovyx can interact with several other medications. It can also interact with certain supplements.

Different interactions can cause different effects. For instance, some interactions can interfere with how well a drug works. Other interactions can increase side effects or make them more severe.

Orgovyx and other medications

Below is a list of medications that can interact with Orgovyx. This list does not contain all drugs that may interact with Orgovyx.

Before taking Orgovyx, talk with your doctor and pharmacist. Tell them about all prescription, over-the-counter, and other drugs you take. Also tell them about any vitamins, herbs, and supplements you use. Sharing this information can help you avoid potential interactions.

Types of medications that can interact with Orgovyx include the following.

P-gp inhibitors. P-gp is a protein that helps your body break down medications such as Orgovyx. P-gp inhibitors are drugs that stop P-gp from working, which may increase the amount of Orgovyx in your body. Taking these drugs together can increase your risk for side effects.

Examples of P-gp inhibitors include:

You shouldn’t take P-gp inhibitors with Orgovyx unless your doctor determines that this is the best treatment for you. In this case, you’ll need to take Orgovyx first, at least 6 hours apart from the P-gp inhibitor. And you’ll be closely monitored for side effects from Orgovyx.

Drugs that are both P-gp inducers and strong CYP3A inducers. Some drugs induce (increase amounts of) both P-gp and CYP3A proteins. Similar to P-gp, CYP3A is a group of proteins that help your body get rid of medications such as Orgovyx. Drugs that induce P-gp and CYP3A may decrease Orgovyx levels in your body. This could make Orgovyx less effective.

Examples of drugs that are both P-gp inducers and strong CYP3A inducers include:

You shouldn’t take these types of drugs with Orgovyx, unless your doctor thinks this is the best treatment for you. In this case, they’ll likely increase your Orgovyx dose to 240 milligrams (two tablets) every day.

If you have questions about drug interactions that may affect you, talk with your doctor or pharmacist.

Orgovyx and herbs and supplements

You shouldn’t take the herb St. John’s wort while using Orgovyx, unless your doctor approves. St. John’s wort could cause Orgovyx to be less effective or not work for treating the cancer. (This is because St. John’s wort is a P-gp inducer and a strong CYP3A inducer, like some of the drugs described above.)

If your doctor determines that using St. John’s wort with Orgovyx is the best treatment for you, they’ll likely increase your Orgovyx dose to 240 milligrams (two tablets) every day.

Check with your doctor or pharmacist before using any herbs or supplements while taking Orgovyx. They can tell you whether they’ll interact with Orgovyx.

Orgovyx and foods

There aren’t any foods that have been specifically reported to interact with Orgovyx. If you have any questions about eating certain foods with Orgovyx, talk with your doctor.

As with all medications, the cost of Orgovyx can vary. The actual price you’ll pay depends on your insurance plan, your location, and the pharmacy you use.

Keep in mind that you may be able to get a 90-day supply of Orgovyx. If approved by your insurance company, getting a 90-day supply of the drug could reduce your number of trips to the pharmacy and help lower the cost. If you’re interested in this option, check with your doctor or your insurance company.

It’s important to note that you may have to get Orgovyx at a specialty pharmacy. This type of pharmacy is authorized to carry specialty medications. These are drugs that may be expensive or may require help from healthcare professionals to be used safely and effectively.

Before approving coverage for Orgovyx, your insurance company may require you to get prior authorization. This means that your doctor and insurance company will need to communicate about your prescription before the insurance company will cover the drug. The insurance company will review the prior authorization request and decide if the drug will be covered.

If you’re not sure if you’ll need to get prior authorization for Orgovyx, contact your insurance company.

Financial and insurance assistance

If you need financial support to pay for Orgovyx, or if you need help understanding your insurance coverage, help is available.

Myovant Sciences, the manufacturer of Orgovyx, offers a program that may help lower the cost of their drug. For more information and to find out if you’re eligible for support, call 833-ORGOVYX (833-674-6899) or visit the drug’s website.

Mail-order pharmacies

Orgovyx may be available through a mail-order pharmacy. Using this service may help lower the drug’s cost and allow you to get your medication without leaving home.

If recommended by your doctor, you may be able to receive a 90-day supply of Orgovyx, so there’s less concern about running out of the medication. If you’re interested in this option, check with your doctor and your insurance company. Some Medicare plans may help cover the cost of mail-order medications.

If you don’t have insurance, you can ask your doctor or pharmacist about online pharmacy options.

Generic version

Orgovyx is not available in a generic form. A generic drug is an exact copy of the active drug in a brand-name medication. Generics tend to cost less than brand-name drugs.

You should take Orgovyx according to your doctor’s or healthcare professional’s instructions.

When to take

Orgovyx comes as tablets that you swallow. It’s taken once per day. You should try and take your Orgovyx dose at about the same time every day.

To help make sure that you don’t miss a dose, try using a medication reminder. This can include setting an alarm or timer on your phone or downloading a reminder app. A kitchen timer can work, too.

Taking Orgovyx with food

You can take Orgovyx with or without food.

Can Orgovyx be crushed, split, or chewed?

No, you shouldn’t crush, split, or chew Orgovyx tablets. The tablets should be swallowed whole.

If you have problems swallowing tablets, talk with your doctor. They may recommend other treatment options for your condition.

Orgovyx is approved to treat advanced prostate cancer in adults. “Advanced” means the cancer has spread from the prostate to other parts of the body.

Cancer cells are abnormal cells in your body that grow too quickly. A hormone called testosterone signals prostate gland cells (normal or cancerous) to grow.

What Orgovyx does

Orgovyx is used as hormone therapy for prostate cancer. This may also be called androgen suppression therapy, or androgen deprivation therapy. Orgovyx works to decrease levels of hormones that can make prostate cancer worse.

Relugolix, the active drug in Orgovyx, belongs to a class* of medications known as gonadotropin-releasing hormone (GnRH) antagonists. GnRH is a hormone that’s made in your brain. It causes your body to release hormones such as follicle-stimulating hormone (FSH) and luteinizing hormone (LH). LH and FSH are hormones that cause your body to make more sex hormones, including testosterone.

Orgovyx works to ultimately decrease levels of testosterone in your body. It does this by increasing your blood levels of GnRH. If your GnRH levels become high enough, your body will stop making hormones such as FSH and LH. This will lower the amount of testosterone in your blood, which prevents testosterone from signaling prostate cancer cells to grow.

* A medication class is a group of medications that work in a similar way.

How long does it take to work?

Orgovyx begins working as soon as you take your first dose. Because the drug works by affecting your hormone levels, it may take a few weeks for your testosterone levels to reach what are called “castration levels”. Castration levels refers to testosterone levels that are so low they’re barely detectable on certain lab tests, due to medication.

In clinical studies, some people taking Orgovyx reached castration levels of testosterone by day 4 of Orgovyx treatment. But it may take up to a month before your testosterone levels reach castration levels.

If you have additional questions about whether Orgovyx is working for you, talk with your doctor.

Orgovyx hasn’t been studied in females.* Based on how the drug works, it’s thought that it could cause harm to a fetus or pregnancy loss if taken during pregnancy.

If you’re able to become pregnant, talk with your doctor about treatment options for your condition that are safe for use during pregnancy.

* Sex and gender exist on spectrums. Use of the terms “male” and “female” in this article refers to sex assigned at birth.

Orgovyx and fertility

It’s possible for Orgovyx to affect fertility (the ability to conceive a child) in males.* This is based on results seen in animal studies. And, the way Orgovyx works to treat advanced prostate cancer could also cause fertility problems. (Orgovyx works to lower the levels of testosterone, which is a male* reproductive hormone.)

If you’re worried about the potential effects of Orgovyx on fertility, be sure to talk with your doctor before you start treatment. They may recommend other cancer treatments.

* Sex and gender exist on spectrums. Use of the terms “male” and “female” in this article refers to sex assigned at birth.

It’s thought that Orgovyx is not safe to take during pregnancy. If you’re sexually active and your partner or you can become pregnant, talk with your doctor about birth control needs while you’re using Orgovyx.

For more information about taking Orgovyx during pregnancy, see the “Orgovyx and pregnancy” section above.

For males using Orgovyx

If you’re a male* and your sexual partner is able to become pregnant, you’ll need to use an effective form of birth control while you’re taking Orgovyx. And you’ll need to continue to use birth control for 2 weeks after your last dose of the drug.

If you have additional questions, talk with your doctor.

* Sex and gender exist on spectrums. Use of the terms “male” and “female” in this article refers to sex assigned at birth.

It is not known if Orgovyx is safe to take while breastfeeding.

Orgovyx hasn’t been studied in females.* And it isn’t known whether relugolix, the active drug in Orgovyx, passes into breast milk or whether it could harm a breastfed child.

Make sure to talk with your doctor about which cancer treatment is safest for you.

* Sex and gender exist on spectrums. Use of the terms “male” and “female” in this article refers to sex assigned at birth.

Here are answers to some frequently asked questions about Orgovyx.

Is Orgovyx chemotherapy?

No, Orgovyx isn’t a chemotherapy drug.

Chemotherapy treatments work by attacking all cells in the body that are multiplying rapidly. This includes cancer cells, but can also affect healthy cells. This is why chemotherapy can cause many side effects.

Examples of chemotherapy drugs include:

  • cabazitaxel (Jevtana)
  • docetaxel (Taxotere)
  • estramustine (Emcyt)

Instead, Orgovyx is what’s known as hormone therapy for treating advanced* prostate cancer. This may also be called androgen suppression therapy, or androgen deprivation therapy. For more information on how Orgovyx works to treat prostate cancer, see the “How Orgovyx works” section above.

* “Advanced” means the cancer has spread from the prostate to other parts of the body.

Does Orgovyx cure prostate cancer?

No, Orgovyx isn’t a cure for prostate cancer. Currently, there isn’t a cure for prostate cancer.

However, in a clinical study, Orgovyx lowered testosterone levels in adults with advanced* prostate cancer as well as, if not better than, another medication used to treat advanced prostate cancer.† Lowering testosterone levels helps stop prostate cancer cells from growing.

If you have additional questions about treatment options for your prostate cancer, talk with your doctor.

* “Advanced” means the cancer has spread from the prostate to other parts of the body.
† This medication was called leuprolide acetate, which is available as the brand-name drug Lupron.

Will I need to have lab tests done while I’m taking Orgovyx?

Yes, you’ll need to have some lab tests done while you’re taking Orgovyx.

While you’re taking Orgovyx, your doctor will monitor your prostate specific antigen (PSA) levels. PSA is a protein made by your prostate. Regularly testing your PSA levels helps your doctor see how well Orgovyx is working to treat your prostate cancer.

If your PSA levels increase, your doctor may also order a test to check your blood testosterone levels. This is because prostate cancer cells need hormones such as testosterone in order to grow. Higher PSA levels may be a sign that your testosterone levels are also increasing, which could lead to the cancer growing.

If you have other questions about lab tests during Orgovyx treatment, talk with your doctor.

Before taking Orgovyx, talk with your doctor about your health history. Orgovyx may not be right for you if you have certain medical conditions or other factors affecting your health. These include:

  • Heart problems, including long QT syndrome. If you have long QT syndrome or other heart problems, your doctor may monitor you more closely than usual during Orgovyx treatment. This may include ordering additional lab tests. Or, they may have you take a cancer treatment other than Orgovyx. This is because Orgovyx can cause long QT syndrome (also called QT prolongation) as a side effect. Be sure to tell your doctor about any heart problems you have, especially long QT syndrome, before you begin taking Orgovyx.
  • Having a partner who may become pregnant. If you’re a male* with a partner who can become pregnant, you’ll need to use an effective form of birth control while you’re taking Orgovyx. And you’ll need to continue to use birth control for 2 weeks after your last dose of the drug. Talk with your doctor if you have further questions about your birth control needs while taking Orgovyx.
  • Allergic reaction. If you’ve had an allergic reaction to Orgovyx or any of its ingredients, you shouldn’t take this drug. Ask your doctor about other medications that might be better options for you.
  • Pregnancy. Orgovyx use hasn’t been studied during pregnancy. For more information, see the “Orgovyx and pregnancy” section above.
  • Breastfeeding. It isn’t known whether Orgovyx may be safe to take while breastfeeding. For more information, see the “Orgovyx and breastfeeding” section above.

Note: For more information about the potential negative effects of Orgovyx, see the “Orgovyx side effects” section above.

* Sex and gender exist on spectrums. Use of the terms “male” and “female” in this article refers to sex assigned at birth.

Do not use more Orgovyx than your doctor recommends. For some drugs, doing so may lead to unwanted side effects or overdose.

What to do in case you take too much Orgovyx

If you think you’ve taken too much of this drug, call your doctor. You can also call the American Association of Poison Control Centers at 800-222-1222 or use their online tool. But if your symptoms are severe, call 911 or your local emergency number, or go to the nearest emergency room right away.

When you get Orgovyx from the pharmacy, the pharmacist will add an expiration date to the label on the bottle. This date is typically 1 year from the date they dispensed the medication.

The expiration date helps guarantee that the medication is effective during this time. The current stance of the Food and Drug Administration (FDA) is to avoid using expired medications. If you have unused medication that has gone past the expiration date, talk to your pharmacist about whether you might still be able to use it.

Storage

How long a medication remains good can depend on many factors, including how and where you store the medication.

Orgovyx tablets should be stored at room temperature that’s no higher than 86°F (30°C). The tablets should be kept in their original container, away from light. Avoid storing this medication in areas where it could get damp or wet, such as bathrooms.

Disposal

If you no longer need to take Orgovyx and have leftover medication, it’s important to dispose of it safely. This helps prevent others, including children and pets, from taking the drug by accident. It also helps keep the drug from harming the environment.

This article provides several useful tips on medication disposal. You can also ask your pharmacist for information about how to dispose of your medication.

Disclaimer: Medical News Today has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or other healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.

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