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Class: Hormonal therapy

Generic Name: relugolix

Trade Name: Orgovyx®

How is Orgovyx used? Orgovyx is used for the treatment of advanced prostate cancer.

What is the mechanism of action? Orgovyx is classified as a gonadotropoin-releasing hormone (GnRH) agonist. GnRH is a naturally occurring hormone in the body that is involved in stimulating the production of female and male hormones such as estrogen and testosterone. Orgovyx inhibits the signaling of GnRH so that the production of estrogen or testosterone is reduced. Certain cancers, such as prostate cancer, are stimulated to grow from hormones. The reduction in the production of growth-stimulatory hormones inhibits the growth of cancer cells.

How is Orgovyx given (administered)? Orgovyx is taken orally (by mouth) once daily with or without food at the same time each day. Follow your physician’s instructions on how many tablets to take on the first day for the loading dose. Orgovyx is the first oral anti-androgen therapy and its availability reduces the need for in person clinic visits.

How are patients monitored? Patients will usually have scheduled meetings with their healthcare provider while they are being treated with Orgovyx. Blood may be drawn to check for side effects and to monitor functions of some organ systems. Patients may also undergo physical examinations or other measures to assess side effects and response to therapy.

What are the most common side effects of treatment with Orgovyx?

  • Hot flush
  • Increased blood sugar levels
  • Increased blood fat levels
  • Muscle and joint pain
  • Decreased blood hemoglobin levels
  • Increased liver enzymes
  • Fatigue
  • Constipation
  • Diarrhea

This is not a complete list of side effects. Some patients may experience other side effects that are not listed here such as weight gain, decreased sex drive and erectile function problems. Patients may wish to discuss with their physician the other less common side effects of this drug, some of which may be serious.

Some side effects may require medical attention. Other side effects do not require medical attention and may go away during treatment. Patients should check with their physician about any side effects that continue or are bothersome.

What can patients do to help alleviate or prevent discomfort and side effects?

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  • Pay careful attention to the physician’s instructions and discuss side effects with your physician.
  • Swallow Orgovyx capsules whole.

Are there any special precautions patients should be aware of before starting treatment?

  • Patients should inform their physician about all medical conditions, including heart problems and long QT syndrome.
  • Patients should inform their physician of any other medication or supplement they are taking (whether prescription or over-the-counter).
  • Talk to your doctor if your partner is pregnant or planning to become pregnant. If a man’s sexual partner is not pregnant but could become pregnant, effective birth control should be used during treatment and for two weeks after treatment ends.
  • Orgovyx may cause fertility problems, talk to your physician if you have concerns about fertility.
  • Orgovyx may cause harm to an unborn baby if taken by a pregnant woman. It is not known if Orgovyx passes into breast milk.

When should patients notify their physician?

Tell your doctor if you experience any side effects that bother you or don’t go away. Tell your doctor right away if you have any signs or symptoms of QT prolongation which include dizziness, fainting, heart palpitations or chest pain.

What is a package insert?
A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers. A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug. By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.

Important Limitations of Use

The information provided above on the drug you have selected is provided for your information only and is not a substitute for consultation with an appropriate medical doctor. We are providing this information solely as a courtesy and, as such, it is in no way a recommendation as to the safety, efficacy or appropriateness of any particular drug, regimen, dosing schedule for any particular cancer, condition or patient nor is it in any way to be considered medical advice. Patients should discuss the appropriateness of a particular drug or chemotherapy regimen with their physician.

As with any printed reference, the use of particular drugs, regimens and drug dosages may become out-of-date over time, since new information may have been published and become generally accepted after the latest update to this printed information. Please keep in mind that health care professionals are fully responsible for practicing within current standards, avoiding use of outdated regimens, employing good clinical judgment in selecting drugs and/or regimens, in calculating doses for individual patients, and verifying all dosage calculations.

DISCLAIMER OF WARRANTIES

CANCERCONNECT SPECIFICALLY DISCLAIMS AND EXCLUDES ALL EXPRESSED OR IMPLIED WARRANTIES, INCLUDING ANY IMPLIED WARRANTIES AS TO QUALITY, ACCURACY (INCLUDING TYPOGRAPHICAL ERRORS), MERCHANTABILITY, OR FITNESS FOR ANY PARTICULAR PURPOSE OF THE INFORMATION CONTAINED HEREIN. CANCERCONNECT DISCLAIMS ALL LIABILITY OR DAMAGES ARISING FROM ANY USE OF THE INFORMATION.

The prescribing physician is solely responsible for making all decisions relating to appropriate patient care including, but not limited to, drugs, regimens, dose, schedule, and any supportive care.