Relugolix

Generic name: Relugolix
Brand names: Orgovyx
Dosage form: oral tablet (120 mg)
Drug class: Gonadotropin-releasing hormone antagonists

Usage of Relugolix

Relugolix is a prescription medicine used to treat advanced prostate cancer (cancer that begins in the prostate [a male reproductive gland]) in adult men. Relugolix belongs to a class of medications called gonadotropin-releasing hormone (GnRH) receptor antagonists.

Relugolix tablets work by decreasing the amount of testosterone (a male hormone) produced by the body. This may slow or stop the spread of prostate cancer cells that need testosterone to grow.

Relugolix side effects

Get emergency medical help if you have signs of an allergic reaction to relugolix: hives, difficult breathing, swelling of your face, lips, tongue, or throat, trouble swallowing.

Relugolix may cause serious side effects. Call your doctor at once if you have:

  • fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness (like you might pass out);
  • chest pain or pressure;
  • sudden numbness or weakness on one side of the body;
  • little or no urination, pain or burning when you urinate; or
  • unusual bleeding.
  • Common relugolix side effects may include:

  • flushing (sudden warmth, redness, or tingly feeling);
  • feeling tired;
  • high blood sugar;
  • high cholesterol or triglycerides;
  • (anemia) low red blood cells;
  • depressed mood;
  • weight gain;
  • impotence, sexual problems;
  • abnormal growth of breast tissue;
  • diarrhea, constipation;
  • muscle or joint pain; or
  • abnormal lab tests (liver, blood).
  • This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

    Before taking Relugolix

    You should not use relugolix if you are allergic to it, or if you have:

  • heart problems; or
  • long QT syndrome (in you or a family member).
  • Relugolix can harm an unborn baby and cause loss of pregnancy (miscarriage).

  • If you are a man, use birth control if your sex partner is able to get pregnant. Keep using birth control for at least 2 weeks after your last dose.
  • Tell your doctor if your partner is pregnant or plans to get pregnant.
  • It may be harder for you to get a woman pregnant while you are using this medicine. You should still use birth control to prevent pregnancy because the medicine can harm an unborn baby.

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    How to use Relugolix

    Usual Adult Dose for Prostate Cancer:

    Loading Dose: 300 mg orally once on the first day Maintenance Dose: 120 mg orally once a day Comment: -Treatment is usually continued upon development of nonmetastatic or metastatic castration-resistant prostate cancer in patients treated with GnRH receptor agonists and antagonists. Use: For the treatment of adult patients with advanced prostate cancer

    Warnings

    Relugolix may decrease fertility in men. Talk to your doctor about the risks.

    Relugolix is intended only for use in men. This medicine is not intended for use alone in women, but can be used in combination with other medications for other uses. If you are a male and your female partner can become pregnant, you should use effective contraception during treatment and for 2 weeks after the last dose. Relugolix may harm the fetus.

    Tell your doctor if you or anyone in your family has or has ever had long QT syndrome (a rare heart problem that may cause irregular heartbeat, fainting, or sudden death). Also, tell your doctor if you have or have ever had an electrolyte imbalance in your blood, heart failure, diabetes, high triglycerides (fatty substances in the blood), anemia, or liver problems.

    Tell your doctor and pharmacist if you are allergic to relugolix, any other medications, or any of the ingredients in the tablets. Ask your pharmacist for a list of the ingredients.

    What other drugs will affect Relugolix

    Sometimes it is not safe to use certain medicines at the same time. Some drugs can affect your blood levels of other drugs you use, which may increase side effects or make the medicines less effective.

    Relugolix can cause a serious heart problem. Your risk may be higher if you also use certain other medicines for infections, asthma, heart problems, high blood pressure, depression, mental illness, cancer, malaria, or HIV.

    Certain other drugs should not be used within 6 hours after you take relugolix. Your dose should be taken first, before other medicines. Carefully follow your doctor's instructions about how to schedule the doses of all your medicines.

    Many drugs can interact with relugolix. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all other medicines you use.

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