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.