Rexilo Tablet
Relugolix
120 mg
Incepta Pharmaceuticals Ltd.
| Pack size | 10's Pack |
|---|---|
| Unite Price | 250.00 BDT |
Indications
Rexilo Tablet is used for:
Prostate Cancer
Adult Dose
Prostate Cancer
Indicated for advanced prostate cancer
Day 1 loading dose: 360 mg PO
Maintenance dose: 120 mg PO once a Day
Hepatic impairment
Mild-to-moderate (Child-Pugh A or B): No dosage adjustment required
Severe (Child-Pugh C): Not studied
Child Dose
Renal Dose
Renal impairment
Mild-to-severe (CrCl 15-89 mL/min): No dosage adjustment required
End-stage renal disease with or without hemodialysis: Not studied
Administration
Take at approximately the same time each day
May take with or without food
Contra Indications
Precautions
Based animal studies and mechanism of action, fetal harm may occur
Therapy suppresses pituitary gonadal system; results of diagnostic tests conducted during and after treatment may be affected; monitor therapeutic effect of relugolix by measuring serum concentrations of prostate specific antigen (PSA) periodically; if PSA increases, measure serum testosterone concentrations
QT/QTc interval prolongation
Androgen deprivation therapy may prolong QT/QTc interval
Consider benefits and risks in patients with congenital long QT syndrome, congestive heart failure, or frequent electrolyte abnormalities, and those taking drugs known to prolong QT interval
Correct electrolyte abnormalities
Consider periodic ECG and electrolyte monitoring
Pregnancy-Lactation
Pregnancy
Based on findings in animals and mechanism of action, can cause fetal harm and loss of pregnancy when administered to pregnant females
Human data are unavailable
Animal studies
Administration to pregnant rabbits during organogenesis caused embryofetal lethality at maternal exposures that were 0.3 times the human exposure at the recommended dose of 120 mg daily based on AUC
Contraception
Males with female partners of reproductive potential: Use effective contraception during treatment and for 2 weeks after last dose
Infertility
Based on findings in animals and mechanism of action, may impair fertility in males of reproductive potential
Lactation
Data are unavailable on presence in human milk, effects on breastfed children, or effects on milk production
Relugolix and/or its metabolites were present in milk of lactating rats at concentrations up to 10-fold higher than in plasma at 2 hr post dose
Interactions
Side Effects
Side effects of Relugolix :
>10%
All grades
Hot flush (54%)
Glucose increased (44%)
Triglycerides increased (35%)
Musculoskeletal pain (30%)
Hemoglobin decreased (28%)
ALT increased (27%)
Fatigue (26%)
AST increased (18%)
Diarrhea (12%)
Constipation (12%)
1-10%
All grades
Increased weight (<10%)
Insomnia (<10%)
Gynecomastia (<10%)
Hyperhidrosis (<10%)
Depression (<10%)
Decreased libido (<10%)
Grade 3-4
Glucose increased (2.9%)
Triglycerides increased (2%)
Musculoskeletal pain (1.1%)
<1%
Grade 3-4
Hot flush
Fatigue
Diarrhea
ALT increased
Hemoglobin increased
Mode of Action
Gonadotropin-releasing hormone (GnRH) receptor antagonist; binds to and blocks GnRH receptors in the anterior pituitary gland
Blocking GnRH receptors decreases the release of gonadotropins (ie, luteinizing hormone, follicle stimulating hormone), thereby decreasing the downstream production of testosterone by the testes in men
Note
Rexilo 120 mg Tablet generic name is Relugolix. Rexilo 120 mg Tablet is manufactured by Incepta Pharmaceuticals Ltd.Rexilo is availble in all over Bangladesh.
Mes BD drug index information on Rexilo Tablet is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.