Generic drug: relugolix
Brand name: Orgovyx
What is Orgovyx (relugolix), and how does it work?
Orgovyx (relugolix) 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.
It is not known if Orgovyx is safe or effective in children.
What are the side effects of Orgovyx?
Orgovyx may cause serious side effects, including:
- 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:
The most common side effects of Orgovyx include:
- hot flashes
- increased blood sugar levels
- increased blood fat (triglyceride) levels
- muscle and joint pain
- decreased blood hemoglobin levels
- increased liver enzymes
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. You may report side effects to FDA at 1-800-FDA-1088.
What is the dosage for Orgovyx?
- Initiate treatment of Orgovyx with a loading dose of 360 mg on the first day and continue treatment with a 120 mg dose taken orally once daily at approximately the same time each day.
- Orgovyx can be taken with or without food. Instruct patients to swallow tablets whole and not to crush or chew tablets.
- Advise patients to take a missed dose of Orgovyx as soon as they remember. If the dose was missed by more than 12 hours, patients should not take the missed dose and resume with the next scheduled dose.
- If treatment with Orgovyx is interrupted for greater than 7 days, restart Orgovyx with a loading dose of 360 mg on the first day, and continue with a dose of 120 mg once daily.
- In patients treated with GnRH receptor agonists and antagonists for prostate cancer, treatment is usually continued upon development of nonmetastatic or metastatic castration-resistant prostate cancer.
Dose Modification For Use With P-gp Inhibitors
- Avoid co-administration of Orgovyx with oral P-gp inhibitors.
- If co-administration is unavoidable, take Orgovyx first and separate dosing by at least 6 hours.
- Treatment with Orgovyx may be interrupted for up to two weeks if a short course of treatment with a P-gp inhibitor is required.
Dose Modification For Use With Combined P-gp And Strong CYP3A Inducers
- Avoid co-administration of Orgovyx with combined P-gp and strong CYP3A inducers.
- If co-administration is unavoidable, increase the Orgovyx dose to 240 mg once daily. After discontinuation of the combined P-gp and strong CYP3A inducer, resume the recommended Orgovyx dose of 120 mg once daily.
What drugs interact with Orgovyx?
Effect Of Other Drugs On Orgovyx
- Co-administration of Orgovyx with a P-gp inhibitor increases the AUC and the maximum concentration (Cmax) of relugolix, which may increase the risk of adverse reactions associated with Orgovyx. Avoid co-administration of Orgovyx with oral P-gp inhibitors.
- If co-administration is unavoidable, take Orgovyx first, separate dosing by at least 6 hours, and monitor patients more frequently for adverse reactions.
- Treatment with Orgovyx may be interrupted for up to 2 weeks for a short course of treatment with certain P-gp inhibitors.
- If treatment with Orgovyx is interrupted for more than 7 days, resume administration of Orgovyx with a 360 mg loading dose on the first day, followed by 120 mg once daily.
Combined P-gp And Strong CYP3A Inducers
- Co-administration of Orgovyx with a combined P-gp and a strong CYP3A inducer decreases the AUC and Cmax of relugolix, which may reduce the effects of Orgovyx. Avoid co-administration of Orgovyx with combined P-gp and strong CYP3A inducers.
- If co-administration is unavoidable, increase the Orgovyx dose. After discontinuation of the combined P-gp and strong CYP3A inducer, resume the recommended dose of Orgovyx once daily.
Is Orgovyx safe to use while pregnant or breastfeeding?
- The safety and efficacy of Orgovyx have not been established in females.
- Based on findings in animals and mechanism of action, Orgovyx can cause fetal harm and loss of pregnancy when administered to a pregnant female.
- There are no human data on the use of Orgovyx in pregnant females to inform the drug-associated risk.
- The safety and efficacy of Orgovyx at the recommended dose of 120 mg daily have not been established in females.
- There are no data on the presence of relugolix in human milk, the effects on the breastfed child, or the effects on milk production.
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The prostate is a gland that is part of the male reproductive system and is located between the bladder and penis. Signs and symptoms of prostate problems include painful ejaculation, burning or pain while urinating, blood in the urine or semen, dribbling urine, frequent urination, urinary incontinence, and pain in the lower back, hips, upper thighs, or the pelvic or rectal area. Common causes of prostate problems in men are prostatitis, enlargement of the prostate gland (benign prostatic hyperplasia (BPH), and prostate cancer. Causes of prostate problems can assist in diagnosing prostate cancer. Treatments for prostate problems include medications, surgery, and hormone or radiation therapy.
Prostatitis (Inflammation of the Prostate Gland)
Prostatitis is an inflammation of the prostate gland. Signs and symptoms of prostatitis include painful or difficulty urinating; fever; chills; body aches; blood in the urine; pain in the rectum, groin, abdomen, or low back; and painful ejaculation or sexual dysfunction. Causes of prostatitis include STDs, bacteria from urinary tract infections, or E. coli. Treatment for prostatitis depends on if it is a bacterial infection or chronic inflammation of the prostate gland.
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An enlarged prostate can cause sexual problems in men. Sexual problems, such as erectile dysfunction or ejaculation problems, may occur in men with noncancerous enlargement of the prostate (benign prostatic hyperplasia or BPH).
Prostatitis vs. BPH (Enlarged Prostate): What Is the Difference?
Prostatitis and BPH (benign prostatic hyperplasia, enlarged prostate gland) are both conditions of the prostate gland. There are four types of prostatitis that can be caused by infections (usually bacterial) or other health conditions or problems, acute bacterial prostatitis (type I), chronic bacterial prostatitis (type II), chronic prostatitis and chronic pelvic pain syndrome (type III), and asymptomatic inflammatory prostatitis (type IV). BPH is inflammation of the prostate gland, and most men have the condition by age 50. Doctor's don't know what causes this inflammation, but they theorize that it may be related to hormones. Both of these conditions can cause similar symptoms like low back pain, pain during urination, or difficulty or the inability to urinate. However, prostatitis has many more symptoms and signs than BPH, and they based on the type of prostatitis. Examples include low back pain and/or abdominal pain, painful urination, fever, chills, feeling tired, recurrent urinary tract infections (UTIs), painful urination intermittently, intermittent obstruction urinary tract symptoms (frequent, painful, or incomplete urination), pelvic pain and/or discomfort, pain with ejaculation, and erectile dysfunction (ED). If you think you have either of these conditions contact your doctor or other health care professional. Bacterial prostatitis can be cured with antibiotics; however, there is no cure for BPH.
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Prostate Cancer Staging and Survival Rates
The prognosis for prostate cancer, as with any cancer, depends on how advanced the cancer has become, according to established stage designations. The patient's PSA score at diagnosis, as well as their Gleason score (the grading system used to determine the aggressiveness of prostate cancer) determines the prognosis and final stage designation. Prostate cancer has a high survival rate in general, but your chances depend on the stage of the cancer.
Enlarged Prostate (BPH, Benign Prostatic Hyperplasia)
Benign prostatic hyperplasia (BPH or enlarged prostate) is very common in men over 50 years of age. Half of all men over the age of 50 develop symptoms of BPH, but few need medical treatment. This noncancerous enlargement of the prostate can impede urine flow, slow the flow of urine, create the urge to urinate frequently and cause other symptoms like complete blockage of urine and urinary tract infections. More serious symptoms are urinary tract infections (UTIs) and complete blockage of the urethra, which may be a medical emergency. BPH is not cancer. Not all men with the condition need treatment, and usually is closely monitored if no symptoms are present. Treatment measures usually are reserved for men with significant symptoms, and can include medications, surgery, microwave therapy, and laser procedures. Men can prevent prostate problems by having regular medical checkups that include a prostate exam.
Prostate Cancer Early Signs and Symptoms
Difficulty with urination – frequency, weak stream, trouble getting started, etc. – is usually the first sign of prostate cancer. But these and other early symptoms of prostatic cancer can also come from benign prostate conditions, so diagnostic testing is important, including PSA tests and digital rectal exam.
Prostate cancer is the most common cancer in men after skin cancer. Risk factors include age, family history, ethnicity, and diet. Prostate cancer is diagnosed by a digital rectal exam, prostate-specific antigen (PSA) test, and prostate biopsy. Symptoms may include frequent need to urinate, incontinence, pain, blood in the urine, fatigue, and more. Prognosis and treatment depend on cancer staging. Watchful waiting, surgery, radiation, cryotherapy, and other management strategies are available. Research and clinical trials strive to find new and better treatments for prostate cancer.
Prostate Cancer Facts
Prostate cancer is a leading cause of cancer and cancer death in males; in some men, identifying it early may prevent or delay metastasis and death from prostate cancer. The prostate is a walnut-shaped gland that is a part of the male reproductive system that wraps around the male urethra at it exits the bladder. Prostate cancer is common in men over 50 years of age, with the risk of developing prostate cancer increases with aging.
Can Prostate Cancer Be Completely Cured?
Prostate cancer is the second most common cancer in men. Due to routine screening of prostate-specific antigen (PSA) levels in the United States, nearly 90% of prostate cancers get detected in early stages. When found early, there are several treatment options available and prostate cancer has a high chance of getting cured.
Early-Stage Prostate Cancer Treatment
If prostate cancer is detected early and appears to be slow-growing, invasive procedures, chemotherapy, radiation and other approaches can sometimes do more harm than good. Many prostate cancer treatments come with side effects, like incontinence or impotence, so it’s in the patient’s interest to put off invasive treatments as long as is medically safe. Active surveillance is where doctors "watch and wait" for changes that could prompt medical intervention.
What Are the First Signs of Prostate Problems?
The first signs and symptoms of prostate disorder usually include problems with urination. Please consult your doctor if you experience any of the signs and symptoms to avoid the worsening of the prostate problems.
How Is Prostate Cancer Diagnosed?
Prostate cancer is largely a disease of men over 40, so it’s around this age doctors recommend the first prostate screening. The first exam is a blood test to determine if there are abnormal prostate specific antigen (PSA) levels in your blood – PSA is produced by the prostate. If the PSA is high, your doctor will perform a digital rectal exam, during which the doctor feels your prostate from inside your rectum with a gloved finger. Other diagnostic tests include an endoscopic biopsy of tumor tissue for analysis in a lab.
Prostate Cancer: Radical Prostatectomy Surgery
Radical prostatectomy, or surgical removal of the entire prostate gland, isn’t typically the first choice in prostate cancer treatment. Sometimes a radical approach is necessary to keep the cancer from metastasizing, however. Some cases are too severe or diagnosed too late for drugs or radiation to have much effect. In these cases, treatment teams may opt for a radical prostatectomy, despite potential side effects like impotence and incontinence.
Prostate Cancer: Radiation, Brachytherapy and Radiopharmaceuticals
Radiation treatment for prostate cancer is a powerful tool at doctors’ disposal. Using radiation vs. surgery or other invasive treatments to kill cancer cells may still cause side effects, but ideally they are less severe. Radiation therapy can be performed via external beam therapy (EBRT) or the placement of radioactive seeds into the prostate (prostate brachytherapy) or using radioactive drugs (radiopharmaceuticals).
Prostate Cancer Treatment: Hormonal Therapy
Prostate cancer is highly sensitive to, and dependent on, the level of the male hormone testosterone, which drives the growth of prostate cancer cells. Testosterone belongs to a family of hormones called androgens, and today front-line hormonal therapy for advanced and metastatic prostate cancer is called androgen deprivation therapy (ADT).
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Where Is the Prostate?
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Prostate Cancer Treatment: Focal Therapy and Other Experimental Treatments
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How Is Prostate Cancer Screening Done?
There are no standard or routine screening tests for prostate cancer. Studies are being done to find ways to make prostate-specific antigen (PSA) testing more accurate for early cancer detection.
When Should You Screen for Prostate Cancer?
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