WHAT IS ORGOVYX?

ORGOVYX is the only oral androgen deprivation therapy (ADT) and was shown to lower testosterone and PSA levels* in adults with advanced prostate cancer.

*Even though it wasn’t the main focus of the clinical trial, PSA (prostate-specific antigen) levels were monitored. Because the clinical trial included many different types of patients, the results of PSA monitoring should be interpreted with caution. How quickly PSA is lowered should not be used to determine the clinical effectiveness of ORGOVYX.

Pill not shownin actual size.

HOW ORGOVYX WORKS

Lowering testosterone is one of the main ways to treat prostate cancer. That’s why ORGOVYX works to lower the amount of testosterone your body makes. As a result, this helps lower the amount of testosterone in your body.

Imagine the body makes testosterone the way that water comes out of a faucet

Testosterone as water from a faucet without treatment and with ORGOVYX, Graphic

Without treatment, the faucet is turned on

and testosterone flows freely.
Testosterone as water from a faucet without treatment and with ORGOVYX, Graphic

With ORGOVYX, the faucet is almost turned off

and the flow of testosterone is slowed. This means there is less testosterone in the body.
It’s important to remember that lowering testosterone is one of the main ways to help manage advanced prostate cancer.

How ORGOVYX May Help

Clinical Trial Population, Graphic Clinical Trial Population, Graphic

ORGOVYX was studied in a clinical trial in more than 900 men with advanced prostate cancer.

Men in the trial were treated for 48 weeks and received either ORGOVYX or leuprolide acetate injections.

The purpose of the trial was to measure how well ORGOVYX lowered testosterone to the treatment goal of below 50 ng/dL from day 29 through week 48.

While it wasn’t the main focus of the trial, the trial also monitored how much ORGOVYX was able to lower prostate-specific antigen (PSA) levels.

Because the clinical trial included many different types of patients, the results of PSA monitoring should be interpreted with caution. How quickly PSA is lowered should not be used to determine the clinical effectiveness of ORGOVYX.

ORGOVYX was proven to lower testosterone and keep it low

ORGOVYX major outcome measure result, Graphic

taking ORGOVYX lowered their testosterone (below 50 ng/dL) by day 29 and kept it low through week 48. For men receiving leuprolide injections, 89% lowered their testosterone by day 29 and kept it low through week 48.

It’s important to know that everyone is unique and may see different results. Talk to your doctor about what these clinical trial results may mean for you.

SELECT IMPORTANT SAFETY INFORMATION

Most common side effects of ORGOVYX include:

  • hot flushes
  • increased blood sugar levels
  • increased blood fat (triglyceride) levels
  • muscle and joint pain
  • decreased blood hemoglobin levels
  • increased liver enzymes
  • tiredness
  • constipation
  • diarrhea

ORGOVYX may cause other side effects including weight gain, decreased sex drive, and erectile function problems.

ORGOVYX may cause fertility problems in males, which may affect your ability to father children. Talk to your healthcare provider if this is a concern for you.

These are not all the possible side effects of ORGOVYX. Call your doctor for medical advice about side effects or if you have a side effect that bothers you or does not go away.

You may report side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please see below for additional safety information.

ORGOVYX was proven to lower testosterone levels fast

After 15 days of treatment, 99% of men taking ORGOVYX lowered their testosterone levels to below 50 ng/dL in the clinical trial and 12% of men receiving leuprolide injections lowered their testosterone levels to below 50 ng/dL.

ORGOVYX clinical trial results after 15 days, Graphic

ORGOVYX lowered PSA levels, on average, by 92% after 3 months

In the clinical trial, PSA levels were also monitored. The longer men were on treatment, the more their PSA levels were lowered and remained low throughout the 48 weeks of treatment.

In the clinical trial, PSA levels were also monitored. The longer men were on treatment, the more their PSA levels were lowered and remained low throughout the 48 weeks of treatment.

It’s important to know that everyone is unique and may see different results. Talk to your doctor about what these clinical trial results may mean for you.

Even though it wasn’t the main focus of the clinical trial, PSA (prostate-specific antigen) levels were monitored. Because the clinical trial included many different types of patients, the results of PSA monitoring should be interpreted with caution. How quickly PSA is lowered should not be used to determine the clinical effectiveness of ORGOVYX.

PSA levels after 2 weeks, 4 weeks, and 3 months, Graphic PSA levels after 2 weeks, 4 weeks, and 3 months, Graphic

It’s important to know that everyone is unique and may see different results. Talk to your doctor about what these clinical trial results may mean for you.

Even though it wasn’t the main focus of the clinical trial, PSA (prostate-specific antigen) levels were monitored. Because the clinical trial included many different types of patients, the results of PSA monitoring should be interpreted with caution. How quickly PSA is lowered should not be used to determine the clinical effectiveness of ORGOVYX.

PSA, Callout PSA, Callout
After 3 months, ORGOVYX continued to keep PSA levels low throughout the rest of the 48 weeks of treatment.

Discuss ORGOVYX with your doctor

Managing advanced prostate cancer is a partnership between you and your doctor. It’s important to have an active role and to communicate openly with your doctor.

Side Effects

Before taking ORGOVYX, tell your doctor about all of your medical conditions, including:

  • If you have any heart problems, including a condition called long QT syndrome
  • If you are pregnant or plan to become pregnant. ORGOVYX can harm your unborn baby and cause loss of pregnancy (miscarriage)
  • If you have a partner who is pregnant or may become pregnant. Men who have female partners who are able to become pregnant should use effective birth control (contraception) during treatment with ORGOVYX and for 2 weeks after the last dose of ORGOVYX
  • If you are breastfeeding or plan to breastfeed. It is not known if ORGOVYX passes into your breast milk

What are the possible side effects?

ORGOVYX may cause serious side effects, such as changes in the electrical activity of your heart. This is called QT prolongation. Your doctor may check your salt levels, also known as electrolytes, and the electrical activity of your heart while you are taking ORGOVYX.

Tell your doctor right away if you have any of these signs or symptoms of QT prolongation:

  • Dizziness
  • Fainting
  • Feeling that your heart is pounding or racing (palpitations)
  • Chest pain

Common side effects

The most common side effects men experienced while taking ORGOVYX were:

  • Flame representing hot flashes, Icon

    Hot flushes, also known as hot flashes

  • Droplets representing Increased blood sugar and/or blood fat levels, Icon

    Increased blood sugar and/or increased blood fat (triglyceride) levels

  • Joint representing muscle or joint pain, Icon

    Muscle and joint pain

  • Blood cell representing decreased blood hemoglobin levels, Icon

    Decreased blood hemoglobin levels

  • Arrow pointing upward representing increased liver enzymes, Icon

    Increased liver enzymes

  • Low battery representing tiredness, Icon

    Tiredness

  • Toilet with clock representing constipation, Icon

    Constipation

  • Toilet paper representing diarrhea, Icon

    Diarrhea

ORGOVYX may cause other side effects such as weight gain, decreased sex drive, and erectile function problems.

ORGOVYX may cause fertility problems, which may affect your ability to have children. Talk to your doctor if this is a concern for you.

These are not all the possible side effects of ORGOVYX. Call your doctor for medical advice about side effects or if you have a side effect that bothers you or does not go away.

You may report side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Tell your doctor about any side effects that bother you or don’t go away. Your doctor may be able to help you find ways to manage them.
ORGOVYX fact light bulb, Icon ORGOVYX fact light bulb, Icon
In the clinical trial, 3.5% of men taking ORGOVYX stopped taking it due to side effects.
IMPORTANT SAFETY INFORMATION & INDICATION

What should I tell my healthcare provider before taking ORGOVYX?

Tell your healthcare provider about all of your medical conditions, including if you:

  • Have any heart problems, including a condition called long QT syndrome.
  • Are pregnant or plan to become pregnant. ORGOVYX can harm your unborn baby and cause loss of pregnancy (miscarriage).
  • Have a partner who is pregnant or may become pregnant.
    • Males who have female partners who are able to become pregnant should use effective birth control (contraception) during treatment with ORGOVYX and for 2 weeks after the last dose of ORGOVYX.
  • Are breastfeeding or plan to breastfeed. It is not known if ORGOVYX passes into your breast milk.

Tell your healthcare provider about all the medicines or treatments you receive, including: prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking ORGOVYX with certain other medicines can affect how ORGOVYX works or may cause side effects.

You should not start or stop any medicine before you talk with your healthcare provider who prescribed ORGOVYX.

What are the possible side effects of ORGOVYX?

Serious side effects of ORGOVYX include:

  • Changes in the electrical activity of your heart (QT prolongation). Your healthcare provider may check your body salts (electrolytes) and the electrical activity of your heart during treatment with ORGOVYX. Tell your healthcare provider right away if you get any signs or symptoms of QT prolongation, including:
    • dizziness
    • fainting
    • feeling that your heart is pounding or racing (palpitations)
    • chest pain

Most common side effects of ORGOVYX include:

  • hot flushes
  • increased blood sugar levels
  • increased blood fat (triglyceride) levels
  • muscle and joint pain
  • decreased blood hemoglobin levels
  • increased liver enzymes
  • tiredness
  • constipation
  • diarrhea

ORGOVYX may cause other side effects including weight gain, decreased sex drive, and erectile function problems.

ORGOVYX may cause fertility problems in males, which may affect your ability to father children. Talk to your healthcare provider if this is a concern for you.

These are not all the possible side effects of ORGOVYX. Call your doctor for medical advice about side effects or if you have a side effect that bothers you or does not go away.

You may report side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

What is ORGOVYX?

ORGOVYX is a prescription medicine used in adults for the treatment of advanced prostate cancer.

It is not known if ORGOVYX is safe or effective in females or children.

Please see full Prescribing Information and Patient Product Information for ORGOVYX.