Relugolix Instructions

1. Indications and usage

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

2. Dosage and usage

Recommended dosage: A loading dose of 360mg on the first day of treatment, followed by 120mg orally at approximately the same time each day.

Regaglic can be taken with or without food, Instruct patients to swallow the tablets whole and not to crush or chew the tablets.

Three. Dosage form and strength

Tablet: 120mg

Four. Contraindications

Known severe allergy to Regolic or any product ingredient.

Five. Warnings and Precautions

1.Prolongation of the QT/QTc interval may occur. Androgen deprivation therapy (such as ORGOVYX) can prolong the QT/QTc interval. Providers should consider whether the benefits of androgen deprivation therapy outweigh the potential risks in patients with congenital longQT 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 regular EKG and electrolyte monitoring.

2.Allergic reaction. Repagliflozin is contraindicated in patients with severe allergy to Repagliflozin or any product ingredient. Post-marketing, anaphylactic reactions, including pharyngeal edema and other severe cases of angioedema, have occurred in patients receiving regaglic. In the HERO study, angioedema (0.2%). Patients who experience any allergic symptoms are advised to temporarily discontinue use of Regolic and seek immediate medical attention. Discontinue Repagliflox due to severe allergic reactions and manage as clinically indicated.

3.Embryo-Fetal toxicity. The safety and effectiveness of regagrex in women have not been established. Based on animal studies and its mechanism of action, repagliflozin may cause fetal harm and miscarriage when taken by pregnant women. In an animal reproduction study, oral administration of repagliflozin during organogenesis in pregnant rabbits resulted in maternally exposed fetal lethality, calculated as the area under the curve (AUC), of 120 per day mg0.3 times human exposure at the recommended dose. Advise men with female partners of childbearing potential to use effective contraception during treatment and for 2 weeks after the last dose of ORGOVYX.

4.Laboratory testing

Treatment with repagliflozin may result in suppression of the pituitary gonadal system. The results of diagnostic tests for pituitary gonadotropins and gonadal function performed during and after gonadal periods may be affected. The therapeutic effect of repagliflozin should be monitored by periodic measurement of serum concentrations of prostate-specific antigen (PSA). If PSA is elevated, serum testosterone concentration should be measured.

6. adverse reactions

RepagolicThe most common adverse reactions (≥ 10%) and laboratory abnormalities (≥ 15%) were hot flashes, elevated blood sugar, elevated triglycerides, musculoskeletal pain, reduced hemoglobin, elevated alanine aminotransferase (ALT), fatigue, elevated aspartate aminotransferase (AST), constipation and diarrhea.

7. Drug interactions

P-gpInhibitors:Avoid concomitant use. If unavoidable, administer repagliflozin first, at least 6 hours apart, and monitor patients more frequently for adverse reactions.

CombinedP-gpand strongCYP3A inducers:Avoid coadministration. If unavoidable, increase repagliflozin dose to 240 mg once daily.

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