Orgovyx Side Effects Center

Last updated on RxList: 11/21/2022
Orgovyx Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Orgovyx?

Orgovyx (relugolix) is a gonadotropin-releasing hormone (GnRH) receptor antagonist used to treat adult patients with advanced prostate cancer.

What Are 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:
    • dizziness
    • fainting
    • feeling that your heart is pounding or racing (palpitations)
    • chest pain

Side effects of Orgovyx include:

  • hot flushes,
  • increased glucose,
  • increased triglycerides,
  • musculoskeletal pain,
  • decreased hemoglobin,
  • increased alanine aminotransferase (ALT),
  • fatigue,
  • increased aspartate aminotransferase (AST),
  • constipation, and
  • diarrhea

Seek medical care or call 911 at once if you have the following serious side effects:

  • Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
  • Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in your chest; shortness of breath; and sudden dizziness, lightheadedness, or passing out;
  • Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors.

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

Dosage for Orgovyx

The recommended dosage of Orgovyx is a loading dose of 360 mg on the first day of treatment followed by 120 mg taken orally once daily, at approximately the same time each day.

Orgovyx In Children

The safety and efficacy of Orgovyx in pediatric patients have not been established.

What Drugs, Substances, or Supplements Interact with Orgovyx?

Orgovyx may interact with other medicines such as:

  • P- gp inhibitors and
  • combined P- gp and strong CYP3A inducers

Tell your doctor all medications and supplements you use.

Orgovyx During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using Orgovyx; it may harm a fetus. Based on findings in animals and mechanism of action, male patients with female partners of reproductive potential are advised to use effective contraception during treatment and for 2 weeks after the last dose of Orgovyx. Consult your doctor before breastfeeding. The safety and efficacy of Orgovyx have not been established in females.

Additional Information

Our Orgovyx (relugolix) Tablets, for Oral Use Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

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.

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.

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Orgovyx Consumer Information

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

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;
  • breast pain or swelling;
  • depressed mood; or
  • unusual bleeding.

Common side effects may include:

  • flushing (sudden warmth, redness, or tingly feeling);
  • feeling tired;
  • weight gain;
  • impotence, sexual problems;
  • diarrhea, constipation;
  • muscle or joint pain; or
  • abnormal lab tests.

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.

SLIDESHOW

Screening Tests Every Man Should Have See Slideshow
Orgovyx Professional Information

SIDE EFFECTS

The following clinically significant adverse reactions are described elsewhere in the labeling:

  • QT/QTc Interval Prolongation [see WARNINGS AND PRECAUTIONS].

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The safety of ORGOVYX was evaluated in HERO, a randomized (2:1), open-label, clinical study in patients with advanced prostate cancer [see Clinical Studies]. Patients received orally administered ORGOVYX as a loading dose of 360 mg on the first day followed by 120 mg taken orally once daily (n = 622) or received leuprolide acetate administered by depot injection at doses of 22.5 mg (n = 264) or 11.25 mg (n = 44) per local guidelines every 12 weeks (n = 308). Leuprolide acetate 11.25 mg is a dosage regimen that is not recommended for this indication in the US. Among patients who received ORGOVYX, 91% were exposed for at least 48 weeks. Ninety-nine (16%) patients received concomitant radiotherapy and 17 (3%) patients received concomitant enzalutamide with ORGOVYX.

Serious adverse reactions occurred in 12% of patients receiving ORGOVYX. Serious adverse reactions in = 0.5% of patients included myocardial infarction (0.8%), acute kidney injury (0.6%), arrhythmia (0.6%), hemorrhage (0.6%), and urinary tract infection (0.5%). Fatal adverse reactions occurred in 0.8% of patients receiving ORGOVYX including metastatic lung cancer (0.3%), myocardial infarction (0.3%), and acute kidney injury (0.2%). Fatal and non-fatal myocardial infarction and stroke were reported in 2.7% of patients receiving ORGOVYX.

Permanent discontinuation of ORGOVYX due to an adverse reaction occurred in 3.5% of patients. Adverse reactions which resulted in permanent discontinuation of ORGOVYX in = 0.3 % of patients included atrioventricular block (0.3%), cardiac failure (0.3%), hemorrhage (0.3%), increased transaminases (0.3%), abdominal pain (0.3%), and pneumonia (0.3%).

Dosage interruptions of ORGOVYX due to an adverse reaction occurred in 2.7% of patients. Adverse reactions which required dosage interruption in = 0.3% of patients included fracture (0.3%).

The most common adverse reactions ( = 10%) and laboratory abnormalities (= 15%), were hot flush (54%), glucose increased (44%), triglycerides increased (35%), musculoskeletal pain (30%), hemoglobin decreased (28%), alanine aminotransferase increased (ALT) (27%), fatigue (26%), aspartate aminotransferase increased (AST) (18%), constipation (12%), and diarrhea (12%).

Table 1 summarizes the adverse reactions in HERO.

Table 1: Adverse Reactions ( = 10%) of Patients with Advanced Prostate Cancer WhoReceived ORGOVYX in HERO

Adverse ReactionORGOVYX
N = 622
Leuprolide Acetate
N = 308
All Grades
(%)
Grade 3-4
(%)
All Grades
(%)
Grade 3-4
(%)
Vascular disorders
  Hot flush540.6520
Musculoskeletal and connective tissue disorders
  Musculoskeletal paina301.1291.6
General
  Fatigueb260.3240
Gastrointestinal disorders
  Diarrheac120.270
  Constipation120100
a Includes arthralgia, back pain, pain in extremity, musculoskeletal pain, myalgia, bone pain, neck pain, arthritis, muculoskeletal stiffness, non-cardiac chest pain, musculoskeletal chest pain, spinal pain, and musculoskeletal discomfort.
b Includes fatigue and asthenia.
c Includes diarrhea and colitis.

Clinically relevant adverse reactions in < 10% of patients who received ORGOVYX included increased weight, insomnia, gynecomastia, hyperhidrosis, depression, and decreased libido.

Table 2 summarizes the laboratory abnormalities in HERO.

Table 2: Select Laboratory Abnormalities ( = 15%) That Worsened from Baseline inPatients with Advanced Prostate Cancer Who Received ORGOVYX in HERO

Laboratory TestORGOVYXaLeuprolide Acetatea
All Grades
(%)
Grade 3-4
(%)
All Grades
(%)
Grade 3-4
(%)
Chemistry
  Glucose increased442.9546
  Triglycerides increased352360.7
  ALT increased270.3280
  AST increased180190.3
Hematology
  Hemoglobin decreased280.5290.7
a The denominator used to calculate the rate varied from 611 to 619 in the ORGOVYX arm and from 301 to 306 in the leuprolide arm based on the number of patients with a baseline value and at least one post-treatment value.

Read the entire FDA prescribing information for Orgovyx (Relugolix Tablets)

© Orgovyx Patient Information is supplied by Cerner Multum, Inc. and Orgovyx Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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