Some side effects you may experience.

Here are some suggestions that may help manage them. 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. These tips should not replace your doctor’s advice and have not been studied in men taking ORGOVYX. Make sure to check with your doctor before starting a new physical activity.

Keep cool. Keeping your home cool can help with hot flashes. When experiencing a hot flash, try lowering the room temperature, opening a window, or turning on a fan.

Focus on relaxing. Deep breathing and other relaxation techniques can also help with hot flashes. A good technique to start with is to close your eyes and breathe in slowly and deeply through your nose. Pause a few seconds, then slowly breathe out through your mouth. Repeat 5 to 10 times.

Use hot or cold compresses. When experiencing muscle or joint pain, use a heating pad or an ice pack to help ease discomfort.

Get moving. Sitting or standing for long periods of time can be difficult on muscles and joints. When possible, switch between the two to help ease stiffness or strains. If you mostly sit during the day, try taking a break every 30 minutes to walk and stretch.

Take a break. If you’re feeling tired, it can help to take short naps and breaks throughout the day. When napping, remember to keep it short. Napping for 20-30 minutes can help, but any longer may make you feel more tired or groggy.

Talk with your doctor about your diet. The food you eat can make you feel sluggish or more energized. Take note of how you feel after eating certain foods. You might find some foods make you feel more tired while others may give you more energy.

Drink plenty of fluids. Constipation can sometimes be caused by not drinking enough fluids. So try to make sure you’re drinking enough water. It may help to start your day with a cup of water or to carry a water bottle when leaving home.

Eat more food with fiber. Constipation can also be caused by a lack of fiber in the diet. You can add more fiber to your diet by eating more vegetables, fruits, and whole grain cereals.

Try the BRAT diet. BRAT stands for Bananas, Rice, Applesauce, and Toast. Bland and starchy foods like these are easier on the stomach because they’re low in fiber. They can also help you have firmer bowel movements.

Stay hydrated. Diarrhea can dehydrate you. So it’s important to drink plenty of fluids. Try staying hydrated by drinking clear liquids like water, broth, or ginger ale.

Try exercising your pelvic floor. To find the muscles in the pelvic floor (lower pelvis), try stopping your stream in the middle of peeing. The muscles you clench are the ones you need to exercise. Squeeze those muscles, hold for 3 seconds, then relax and repeat a few times in a row.

Ask about other options. Your doctor may have information on prescriptions or procedures that may help. Ask your doctor at your next appointment so you can better understand your options.

See Important Safety Information below for a complete list of side effects.

IMPORTANT SAFETY INFORMATION & USE
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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.

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