From the FDA Drug Label
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 2 summarizes the laboratory abnormalities in HERO Laboratory TestORGOVYXaLeuprolide Acetatea All Grades (%)Grade 3-4 (%)All Grades (%)Grade 3-4 (%) Chemistry Glucose increased 44 2.9 54 6
Hypoglycemia is not mentioned in the drug label as an adverse reaction. However, glucose increased is reported in 44% of patients, with 2.9% of patients experiencing grade 3-4 increased glucose levels 1.
Changes in stool are reported as diarrhea (12%) and constipation (12%) in the drug label 1.
From the Research
Orgovyx can potentially cause changes in stool, including constipation, but hypoglycemia is not a commonly reported side effect. Orgovyx is a GnRH receptor antagonist used primarily to treat advanced prostate cancer by reducing testosterone levels. Regarding stool changes, some patients taking Orgovyx may experience constipation, as reported in the study published in PloS one 2. This study analyzed adverse events associated with Relugolix (Orgovyx) using data from the FDA Adverse Event Reporting System (FAERS) and found that constipation was one of the common adverse events.
Some key points to consider when taking Orgovyx include:
- Monitoring for gastrointestinal effects, such as constipation, which can occur in some patients
- Being aware of the potential for other adverse events, such as hot flush, fatigue, asthenia, and myalgia, as reported in the study 2
- Understanding that hypoglycemia is not a commonly reported side effect of Orgovyx, but hormonal therapies can sometimes affect metabolic processes indirectly
- If symptoms of hypoglycemia occur while taking Orgovyx, it is essential to consult a healthcare provider to determine the cause and appropriate management.
The study published in PloS one 2 provides the most recent and highest quality evidence on the adverse events associated with Orgovyx, and it is essential to consider this information when making treatment decisions. Other studies, such as those published in The American journal of nursing 3 and European urology 4, provide additional context and concerns regarding the approval and use of Orgovyx, but the PloS one study 2 is the most relevant to the question of adverse events. Therefore, it is crucial to prioritize the findings from the PloS one study 2 when assessing the potential risks and side effects of Orgovyx.