Rezvilutamide(瑞维鲁胺片)

Introduction of Rezvilutamide

As a second-generation androgen receptor inhibitor, Rezvilutamide Tablets competitively block the binding of androgens to receptors with high affinity, inhibit receptor nuclear translocation and DNA binding, thereby blocking the androgen-induced proliferation-stimulating signals in prostate cancer cells, and then effectively inhibit the proliferation and metastasis of prostate cancer cells.

Indications

Rezvilutamide Tablets are mainly indicated for patients with hormone-sensitive prostate cancer who have developed metastases and have large tumor burden (i.e., patients with high-volume metastatic hormone-sensitive prostate cancer, mHSPC). Such patients usually present with symptoms such as bone pain and dysuria, and the efficacy of conventional hormone therapy may gradually diminish.

It should be specially noted that no definite overall survival benefit has been observed with this drug so far, and its long-term efficacy requires continuous follow-up observation.

Overview

Dosage and Administration

Administration Method

The tablets should be swallowed whole; do not break, crush or chew them. They can be taken either with or without food.

Dosage

Recommended Dose: The standard dosage is 240 mg (3 tablets of 80 mg each) once daily.

Concurrent Therapy: During treatment, patients should receive concomitant androgen deprivation therapy (ADT). This can be achieved either by administration of a gonadotropin-releasing hormone agonist (GnRHa), or directly in patients who have undergone bilateral orchiectomy.

Management of Special Circumstances

Missed Dose

If a dose is missed on a given day, take the missed dose as soon as it is remembered. If the dose is forgotten for an entire day, resume the regular daily dosage on the next day. Do not take a double dose to make up for the missed one.

Dosage Adjustment Principle

In case of grade 3 or higher severe adverse reactions (e.g., severe systemic reactions) or intolerable adverse effects, treatment should be suspended. Medication may be resumed at the original dose, or at a reduced dose (160 mg or 80 mg) as appropriate, after the symptoms have improved to grade 1 or returned to the baseline level.

Contraindications

1.Patients with hypersensitivity to the active ingredient or any excipients of this drug.

2.Pregnant women or women planning to become pregnant.

Adverse Reactions

The adverse reactions observed in clinical trials are categorized by body systems as follows:

Pain-related Reactions

May occur in the teeth, gums, tongue, anus, face, armpits, injection sites, urethra, kidneys (possibly accompanied by colic), sciatic nerve, skin, oropharynx, larynx, incision sites, traumatic sites, breasts, perineum, prostate, testicles, pelvis, scrotum, penis, gallbladder, eyes, ears, etc. Cancer-related pain may also occur.

Edema-related Reactions

May occur in the extremities, face, whole body, lips, or eyelids.

Fatigue Symptoms

Including general malaise and lassitude.

Abnormal Blood Pressure

May present as increased blood pressure or hypertension.

Musculoskeletal Pain

May occur in the extremities, bones, muscles, spine, pectoral muscles, groin, neck, or lumbocostal region.

Urinary Abnormalities

May include hematuria, positive occult blood test, or presence of red blood cells in urine.

Voiding Dysfunction

Including dysuria, urinary retention, decreased urine stream force and velocity, and urinary hesitation.

Respiratory Tract Infections

May include upper respiratory tract infection, nasopharyngitis, sinusitis, influenza, pharyngitis, tonsillitis, etc..

Urinary Tract Infections

May include urinary tract infection, cystitis, bacteriuria, kidney infection, etc..

Gastrointestinal Disorders

Common symptoms include constipation or dyschezia.

Abdominal Discomfort

Pain may occur in the upper abdomen, lower abdomen, or the entire abdomen.

Skin Reactions

May include rash, eczema, urticaria, acne, erythema, and other skin conditions; some may occur in the genital area.

Cardiac Abnormalities

Including arrhythmia, bradycardia, tachycardia, atrial fibrillation, and other cardiac rhythm disorders.

Sleep Disturbances

May include insomnia, poor sleep quality, or sleep rhythm disorders.

Special Populations

Pregnant Women

Use of this drug is prohibited throughout pregnancy. The drug may impair fetal development.

Lactating Women

There is no clear research evidence confirming whether the drug can be excreted in human milk, but potential risks exist. Therefore, this drug is prohibited during lactation.

Pediatric and Adolescent Patients

The safety and efficacy of this drug in patients under 18 years of age have not been established.

Elderly Patients

No dosage adjustment is required.

If you are pregnant, planning a pregnancy, or breastfeeding, you must inform your doctor immediately to determine the appropriate treatment plan.

For more detailed drug information, please consult the official package leaflet.

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