Roarlix 120mg Tablet

Relugolix is indicated for the treatment of adult patients with advanced prostate cancer. Relugolix is a gonadotropin-releasing hormone (GnRH) receptor antagonist indicated for the treatment of adult patients with advanced prostate cancer.

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Source: US FDA prescribing information, via openFDA. Provided for general information only — it is not a substitute for your doctor's or pharmacist's advice. Always follow your prescriber's instructions.

QT/QTc Interval Prolongation: Androgen deprivation therapy may prolong the QT interval. Hypersensitivity: Relugolix can cause hypersensitivity reactions, including angioedema. Withhold Relugolix in patients who experience symptoms of hypersensitivity. Discontinue Relugolix for severe hypersensitivity reactions and manage as clinically indicated. Embryo-Fetal Toxicity: Relugolix can cause fetal harm. Advise males with female partners of reproductive potential to use effective contraception. QT/QTc Interval Prolongation Androgen deprivation therapy, such as Relugolix, may prolong the QT/QTc interval. Providers should consider whether the benefits of androgen deprivation therapy outweigh the potential risks in patients with congenital long QT syndrome, congestive heart failure, or frequent electrolyte abnormalities and in patients taking drugs known to prolong the QT interval. Electrolyte abnormalities should be corrected. Consider periodic monitoring of electrocardiograms and electrolytes. Hypersensitivity Reactions Relugolix is contraindicated in patients with severe hypersensitivity to relugolix or any of the product components. Hypersensitivity reactions, including pharyngeal edema and other serious cases of angioedema, have been reported postmarketing in patients treated with Relugolix. In HERO, patients treated with relugolix reported angioedema (0.2%). Advise patients who experience any symptoms of hypersensitivity to temporarily discontinue Relugolix and promptly seek medical care. Embryo-Fetal Toxicity The safety and efficacy of Relugolix have not been established in females. Based on findings in animals and mechanism of action, Relugolix can cause fetal harm and loss of pregnancy when administered to a pregnant female. In an animal reproduction study, oral administration of relugolix to pregnant rabbits during the period of organogenesis caused embryo-fetal lethality at maternal exposures that were 0.3 times the human exposure at the recommended dose of 120 mg daily based on area under the curve (AUC). Advise males with female partners of reproductive potential to use effective contraception during treatment and for 2 weeks after the last dose of Relugolix. Laboratory Testing Therapy with Relugolix results in suppression of the pituitary gonadal system. Results of diagnostic tests of the pituitary gonadotropic and gonadal functions conducted during and after Relugolix may be affected. The therapeutic effect of Relugolix should be monitored by measuring serum concentrations of prostate specific antigen (PSA) periodically. If PSA increases, serum concentrations of testosterone should be measured.

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Source: US FDA prescribing information, via openFDA. Provided for general information only — it is not a substitute for your doctor's or pharmacist's advice. Always follow your prescriber's instructions.

The following clinically significant adverse reactions are described elsewhere in the labeling: QT/QTc Interval Prolongation. The most common adverse reactions (≥ 10%) and laboratory abnormalities (≥ 15%) were hot flush, glucose increased, triglycerides increased, musculoskeletal pain, hemoglobin decreased, alanine aminotransferase (ALT) increased, fatigue, aspartate aminotransferase (AST) increased, constipation, and diarrhea.. 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 Relugolix was evaluated in HERO, a randomized (2:1), open-label, clinical study in patients with advanced prostate cancer. Patients received orally administered Relugolix 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 dosing regimen that is not recommended for this indication in the US. Among patients who received Relugolix, 91% were exposed for at least 48 weeks. Ninety-nine (16%) patients received concomitant radiotherapy and 17 (3%) patients received concomitant enzalutamide with Relugolix. Serious adverse reactions occurred in 12% of patients receiving Relugolix. 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 Relugolix 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 Relugolix. Permanent discontinuation of Relugolix due to an adverse reaction occurred in 3.5% of patients. Adverse reactions which resulted in permanent discontinuation of Relugolix 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 Relugolix 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%). Abridged from the full prescribing information.

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Source: US FDA prescribing information, via openFDA. Provided for general information only — it is not a substitute for your doctor's or pharmacist's advice. Always follow your prescriber's instructions.