Relupros

Relupros120 mg

Tablet

Relugolix

Renata Limited

Product Code : 19993
MRP 7400.00
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Medicine overview

Indications of Relupros 120 mg

Relupros 120 mg tablet is a gonadotropin-releasing hormone (GnRH) receptor antagonist indicated for the treatment of adult patients with advanced prostate cancer.

Dosage of Relupros 120 mg

A loading dose of 360 mg on the first day of treatment followed by 120 mg taken once daily, at approximately the same time each day. Relupros 120 mg Tablet can be taken with or without food. Advise patients to take a missed dose of Relupros 120 mg as soon as they remember. If the dose was missed by more than 12 hours, patients should not take the missed dose and resume with the next scheduled dose. If treatment with Relupros 120 mg is interrupted for greater than 7 days, restart Relupros 120 mg with a loading dose of 360 mg on the first day, and continue with a dose of 120 mg once daily.Pediatric Use: The safety and efficacy of Relupros 120 mg in pediatric patients have not been established.Geriatric Use: No overall differences in safety or effectiveness were observed between older and younger subjects.

Interaction of Relupros 120 mg

P-gp Inhibitors: Avoid co-administration. If unavoidable, take Relupros 120 mg first, separate dosing by at least 6 hours, and monitor patients more frequently for adverse reactions. Combined P-gp andStrong CYP3A Inducers: Avoid co-administration. If unavoidable, increase the Relupros ® dose to 240 mg once daily.

Side Effects of Relupros 120 mg

Adverse Reactions: The most common adverse reactions (≥10%) and laboratory abnormalities (≥15%) were hot flushes, glucose increased, triglycerides increased, musculoskeletal pain, haemoglobin decreased, alanine aminotransferase (ALT) increased, fatigue, aspartate aminotransferase (AST) increased, constipation, and diarrhea.Common Side Effects: Hot flushes, Increased blood sugar levels, Increased blood fat (triglyceride) levels, Muscle and joint pain, Decreased hemoglobin levels, Increased liver enzymes, Tiredness, Constipation, DiarrhoeaRare Side Effects: Relupros 120 mg may cause rare side effects, including Changes in the electrical activity of your heart (QT prolongation), Dizziness, Fainting, Feeling that your heart is pounding or racing (palpitations), Chest pain. Other side effects include weight gain, decreased sex drive, and erectile function problems.

Precautions & Warnings

QT/QTc Interval Prolongation: Androgen deprivation therapy may prolong the QT interval.Embryo-Fetal Toxicity: Relupros 120 mg can cause fetal harm. Advise males with female partners of reproductive potential to use effective contraception.

Overdose Effects of Relupros 120 mg

There is no specific experience in the management of Relupros 120 mg overdose in patients.

Storage Conditions

Store in a cool and dry place, protect from light & moisture. Keep all medicines out of the reach of children.

Drug Classes

Gonadotropin-releasing hormone (GnRH) antagonist

Mode Of Action

Relupros 120 mg is a non-peptide small molecule, GnRH receptor antagonist. Relupros 120 mg competitively binds to pituitary GnRH receptors, thereby, reducing the release of luteinizing hormone (LH) and follicle-stimulating hormone (FSH), and consequently testosterone.Absorption: Relupros 120 mg is a substrate for intestinal P-gp. The mean (CV%) absolute bioavailability of Relupros 120 mg is approximately 12%. The median (range) Tmax of Relupros 120 mg is 2.25 hours.Effect of Food: No clinically meaningful differences in the pharmacokinetics of Relupros 120 mg were observed following consumption of a high-calorie, high-fat meal.Distribution: Plasma protein binding of Relupros 120 mg is 68 to 71%, primarily to albumin and to a lesser extent to α1- acid glycoprotein. The mean blood-to-plasma ratio is 0.78.Elimination: The mean effective half-life of Relupros 120 mg is 25 hours and the mean (CV %) terminal elimination half-life is 60.8 (11%) hours. The mean (CV %) total clearance of Relupros 120 mg is 29.4 (15%) L/h and the renal clearance is 8 L/h.Metabolism: Relupros 120 mg is metabolized primarily by CYP3A and to a lesser extent by CYP2C8 in vitro.Excretion: After oral administration of a single 80mg radiolabeled dose of Relupros 120 mg, approximately 81% of the radioactivity was recovered in feces (4.2% as unchanged) and 4.1% in urine (2.2% as unchanged).

Pregnancy

The safety and efficacy of Relupros 120 mg at the recommended dose of 120 mg daily have not been established in females. Females and Males of Reproductive Potential. Based on findings in animals and mechanism of action, Relupros 120 mg may impair fertility in males of reproductive potential.
Disclaimer

The information provided is accurate to our best practices, but it does not replace professional medical advice. We cannot guarantee its completeness or accuracy. The absence of specific information about a drug should not be seen as an endorsement. We are not responsible for any consequences resulting from this information, so consult a healthcare professional for any concerns or questions.