ORGOVYX Results

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Testosterone
LevelsPSA
MonitoringSide
Effects

ORGOVYX can help lower testosterone and keep it low

The main goal of the study was to measure thenumber of men who lowered their testosterone to goal.*

Study Design

ORGOVYX was studied in a clinical trial of 930 men with advanced prostate cancer for 48 weeks. Of these men:

  • 622 were selected randomly to receive ORGOVYX (360 mg on the first day followed by a once-a-day dose of 120 mg orally)
  • 308 were selected randomly to receive a treatment† of leuprolide acetate‡ injections (22.5 mg injection [or 11.25 mg§ in Japan and Taiwan per local guidelines])

†Active control.
‡Given as an injection under the skin every 3 months.
§The dosage of leuprolide was 11.25 mg in Japan and Taiwan per local guidelines and is not recommended for advanced prostate cancer in the US.

Image showing the results with ORGOVYX in a clinical study

For men receiving leuprolide acetate injections, approximately 89% lowered their testosterone by Day 29 and kept it low through Week 48.*

*Below 50 ng/dL from Day 29 through Week 48.

It’s important to know that everyone is unique and may see different results.

ORGOVYX lowered testosterone fast

An additional goal of the trial was to measure testosterone suppression rates on Day 4 and Day 15.

DAY 4

By Day 4, 56% of those taking ORGOVYX reached the goal level set by the clinical trial.||

Image showing the results with ORGOVYX at day 4Image showing the results of leuprolide acetate injections at day 4
||The treatment goal set by the trial was a castrate level of <50 ng/dL.
DAY 15

By Day 15, 99% of those taking ORGOVYX reached the goal level set by the clinical trial.||

Image showing the results with ORGOVYX at day 15Image showing the results of leuprolide acetate injections at day 15
||The treatment goal set by the trial was a castrate level of <50 ng/dL.

ORGOVYX lowered PSA levels by 92% within 3 months on average

Your healthcare provider may check your PSA levels over time.

There is a blood test that measures prostate-specific antigen (PSA), a protein made by the prostate. PSA levels can change in men with prostate cancer. Your doctor will decide how often your PSA should be checked to help monitor your prostate cancer over time.

ORGOVYX lowered PSA levels on average

(average starting baseline PSA in 622 patients was 104.2 ng/mL)

Image showing results with ORGOVYX after 2 weeks, after 4 weeks, and after 3 months

Even though it wasn’t the main focus of the clinical trial, PSA levels were monitored. Because the clinical trial included many different types of patients, the results of PSA monitoring should be interpreted with caution. No evidence has shown that the speed of PSA decline is related to a clinical benefit.

#Percentages are based on patients who had PSA results available at each timepoint.

after 3 months

ORGOVYX continued to keep PSA levels reduced throughout the 48-week trial.

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What happens to my testosterone if my doctor needs to change my treatment?

Sometimes, your doctor may want to change your treatment plan. If and when your doctor decides to stop treatment with ORGOVYX, you may experience changes in your hormone levels.

There was a substudy that measured the speed at which men who were taking ORGOVYX returned to their baseline testosterone levels after stopping treatment. Do not change your treatment without instruction from your doctor. In the substudy, 184 patients who had completed 48 weeks of treatment had their testosterone recovery evaluated. 90 days after stopping treatment:

  • 55% of the 137 men who took ORGOVYX had testosterone levels return to above the lower limit of the normal range**

This endpoint was analyzed for exploratory purposes without formal testing. The data from the leuprolide arm were not included in the US Prescribing Information for ORGOVYX. Always take ORGOVYX exactly as prescribed by your doctor.

**The lower limit of the normal range was ≥280 ng/dL.

Ready to talk about treatment options with your doctor?

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ADT=androgen deprivation therapy; PSA=prostate-specific antigen.

ORGOVYX may cause serious 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:

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

ORGOVYX may also cause allergic reactions. Stop taking ORGOVYX and tell your doctor or get emergency medical help right away if you get any signs or symptoms of an allergic reaction, including:

  • ·Swelling of your face, lips, tongue, throat, or trouble swallowing
  • ·Trouble breathing
  • ·Hives (raised bumps), rash, or redness all over your body

Common side effects

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

Hot flashes/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 men, which may affect your ability to father children. Talk to your doctor if this is a concern for you.

  • ·In the clinical trial, 3.5% of men taking ORGOVYX permanently stopped taking it due to side effects
  • ·Dosage interruptions of ORGOVYX due to an adverse reaction occurred in 2.7% of patients

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.

Understanding side effects

Every medication has risks and benefits. Talking to your doctor about the possible side effects of ORGOVYX can help you feel more prepared.

Before taking ORGOVYX, tell your doctor about all 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)
  • ·Are breastfeeding or plan to breastfeed. It is not known if ORGOVYX passes into your breast milk
  • ·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

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

See our guide for information and tips to help manage side effects

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Frequently Asked Questions

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How to get ORGOVYX

IMPORTANT SAFETY INFORMATION & USE

Do not take ORGOVYX if you have had a severe allergic reaction to relugolix or any of the ingredients in ORGOVYX.

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
  • Allergic reactions. Stop taking ORGOVYX and tell your healthcare provider or get emergency medical help right away if you get any signs or symptoms of an allergic reaction, including:
    • swelling of your face, lips, tongue, throat, or trouble swallowing
    • trouble breathing
    • hives (raised bumps), rash, or redness all over your body

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 full Prescribing Information and Patient Product Information for ORGOVYX.

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.