Description and Brand Names

Drug information provided by: IBM Micromedex

US Brand Name

  1. Orgovyx

Descriptions


Relugolix is used in men to treat advanced prostate cancer. Relugolix is a type of medicine called a gonadotropin-releasing hormone (GnRH) antagonist. It helps treat prostate cancer by lowering the amount of testosterone hormone in the blood. In some patients, testosterone will cause prostate cancer to grow larger.

This medicine is available only with your doctor's prescription.

This product is available in the following dosage forms:

  • Tablet

Before Using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of relugolix in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of relugolix in the elderly.

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Amiodarone
  • Apalutamide
  • Carbamazepine
  • Carvedilol
  • Clarithromycin
  • Cobicistat
  • Conivaptan
  • Cyclosporine
  • Dronedarone
  • Erythromycin
  • Flibanserin
  • Fosphenytoin
  • Itraconazole
  • Ketoconazole
  • Lapatinib
  • Phenytoin
  • Quinidine
  • Ranolazine
  • Rifampin
  • Ritonavir
  • St John's Wort
  • Telaprevir
  • Vemurafenib
  • Verapamil

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Congestive heart failure or
  • Electrolyte imbalance or
  • Heart rhythm problems (eg, long QT syndrome)—May increase risk for more serious side effects.

Proper Use

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

This medicine comes with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

This medicine may be taken with or without food.

Swallow the tablet whole. Do not crush, break, or chew the tablet.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage form (tablets):
    • For treatment of advanced prostate cancer:
      • Adults—At first, 360 milligrams (mg) once on the first day, then 120 mg once a day at the same time each day. If the treatment is stopped for more than 7 days, take 360 mg once on the first day, then 120 mg once a day.
      • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If you miss a dose, take it as soon as possible, and then go back to your regular schedule. If you miss a dose and it is more than 12 hours, skip the missed dose and take your next dose at the regular time.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Women should not use this medicine, especially women who are pregnant or able to become pregnant. This medicine can harm an unborn baby. It can also cause birth defects if the father is using it when his sexual partner becomes pregnant. Males with female partners who can become pregnant must use an effective birth control during treatment and for at least 2 weeks after the last dose. If a pregnancy occurs while you are using this medicine, tell your doctor right away.

Some men who use this medicine have become infertile (unable to have children). Talk with your doctor before using this medicine if you plan to have children.

This medicine can cause a change in heart rhythm called prolongation of the QT interval. This condition may change the way your heart beats (faster or slower) and can cause chest pain, dizziness, fainting, or trouble breathing. Contact your doctor right away if you have any of these symptoms or any questions.

Make sure any doctor or dentist who treats you knows that you are using this medicine. This medicine may affect the results of certain tests.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common

  1. Chest pain or discomfort
  2. confusion
  3. difficulty in speaking
  4. double vision
  5. headache
  6. inability to move the arms, legs, or facial muscles
  7. inability to speak
  8. nausea
  9. pain or discomfort in the arms, jaw, back, or neck
  10. slow speech
  11. sweating
  12. vomiting

Rare

  1. Bleeding gums
  2. cloudy urine
  3. coughing up blood
  4. decreased frequency or amount of urine
  5. difficult, burning, or painful urination
  6. difficulty in swallowing
  7. dizziness
  8. fainting
  9. frequent urge to urinate
  10. increased menstrual flow or vaginal bleeding
  11. increased thirst
  12. loss of appetite
  13. lower back or side pain
  14. nosebleeds
  15. paralysis
  16. prolonged bleeding from cuts
  17. red or black, tarry stools
  18. red or dark brown urine
  19. slow, fast, pounding, or irregular heartbeat
  20. swelling of the face, fingers, or lower legs
  21. trouble breathing
  22. unusual tiredness or weakness
  23. weight gain

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

  1. Bone pain
  2. constipation
  3. diarrhea
  4. difficulty in moving
  5. feeling of warmth
  6. fever
  7. lack or loss of strength
  8. muscle aches, cramps, pain, or stiffness
  9. neck pain
  10. pain in the joints
  11. redness of the face, neck, arms and occasionally, upper chest
  12. stomach cramps or tenderness
  13. swollen joints
  14. watery or bloody diarrhea

Less common

  1. Decreased interest in sexual intercourse
  2. discouragement
  3. feeling sad or empty
  4. inability to have or keep an erection
  5. irritability
  6. loss in sexual ability, desire, drive, or performance
  7. loss of interest or pleasure
  8. swelling of the breasts or breast soreness
  9. trouble concentrating
  10. trouble sleeping

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.