Orgovyx is the world's first oral gonadotropin-releasing hormone (GnRH) receptor antagonist, approved by the FDA in 2021 for the treatment of advanced prostate cancer.

1、 Drug name

1. Common name: Relugolix

2. Product Name: Orgovyx

2、 Indications

This product is suitable for treating adult patients with advanced prostate cancer.

3、 Specifications and characteristics

1. Specification: Each tablet contains 120mg of Reglek.

2. Appearance: Light red, almond shaped film coated tablets.

4、 Main components

1. Active ingredient: Relugolix.

2. Non active ingredients: mannitol, sodium starch glycolate, hydroxypropyl cellulose, magnesium stearate, hydroxypropyl methylcellulose, titanium dioxide, iron oxide red, Brazilian palm wax.

5、 Usage and dosage

1. Initial dose: On the first day of treatment, the oral loading dose is 360mg (3 tablets).

2. Maintenance dose: Starting from the second day, take 120mg (1 tablet) orally approximately once a day at the same time.

3. Usage: This product can be taken with food or on an empty stomach. It should be swallowed whole and should not be crushed or chewed.

4. Leakage treatment: If one dose is missed, it should be replenished as soon as possible. But if the missed dose exceeds 12 hours, it should not be taken again, and the next regular dose should be taken directly according to the plan.

5. Discontinuation treatment: If the treatment is interrupted for more than 7 days, the loading dose (360mg, first day) should be restarted, followed by a daily maintenance dose of 120mg.

6、 Dose adjustment

1. Combined with P-gp inhibitors:

Combination therapy with oral P-glycoprotein (P-gp) inhibitors should be avoided.

If unavoidable, Orgovyx should be taken first, followed by P-gp inhibitors at least 6 hours later, and adverse reactions should be closely monitored.

If short-term use of P-gp inhibitors is required, Orgovyx can be discontinued for up to two weeks. Resume using Orgovyx after discontinuation of medication.

2. Combined use with P-gp and potent CYP3A inducers:

Combination use with P-gp and potent CYP3A4 inducers should be avoided.

If unavoidable, the daily dose of Orgovyx should be increased to 240mg (2 tablets) once daily. After discontinuing the inducer, return to the standard dose of 120mg once daily.

7、 Medication precautions

1. Before and after meals: can be taken with food or on an empty stomach.

2. Missed dose: Supplement within 12 hours, skip if it exceeds 12 hours, and take the next dose according to the original plan.

1. Vomiting: The instructions do not explicitly mention the treatment method for vomiting after taking medication. If vomiting occurs quickly after taking medication, the medication may not be fully absorbed, and it is not recommended to take it immediately. You should wait for the next scheduled medication time.

8、 Medication for special populations

1. Pregnant women: Based on animal studies and mechanisms of action, this product may cause harm to the fetus and lead to pregnancy failure. This product is not suitable for women.

2. Breastfeeding women: Regleck can enter human breast milk, but its impact on infants is unknown. This product is not suitable for women.

3. Women and men with fertility:

Contraception: It is recommended that male patients with female partners of childbearing age use effective contraceptive measures during treatment and within 2 weeks after the last dose.

Infertility: This product may impair male fertility.

4. Child patients: Safety and efficacy have not been determined yet.

5. Elderly patients: No clinically significant effect of age on pharmacokinetics was observed in male patients aged 45 to 91 years, and there is no need to adjust dosage based on age.

9、 Adverse reactions

1. Common adverse reactions (≥ 10%): hot flashes (54%), elevated blood sugar (44%), elevated triglycerides (35%), musculoskeletal pain (30%), decreased hemoglobin (28%), elevated alanine aminotransferase (27%), fatigue (26%), elevated aspartate aminotransferase (18%), constipation (12%), diarrhea (12%).

2. Other important adverse reactions: weight gain, insomnia, male breast development, excessive sweating, depression, decreased libido, vascular edema.

3. Serious adverse reactions: including myocardial infarction (0.8%), acute kidney injury (0.6%), arrhythmia (0.6%), etc. Allergic reactions (including angioedema and urticaria) were detected after listing.

10、 Contraindications

Patients with a history of severe hypersensitivity reactions to Regleck or any of its ingredients are contraindicated.

11、 Drug interactions

1. P-gp inhibitors (such as certain oral medications): can increase the blood concentration of regorak and increase the risk of adverse reactions. Combination use or dosage adjustment should be avoided.

2. P-gp and potent CYP3A inducers (such as rifampicin): can reduce the blood concentration of regorak and weaken its therapeutic effect. Combination use or increasing Orgovyx dosage according to dosage adjustment requirements should be avoided.

3. Combining P-gp and moderate CYP3A inhibitors (such as erythromycin) can significantly increase the exposure to regorak (AUC increased by 3.5 times).

12、 Storage method

1. Storage temperature: Store at room temperature. Cannot be stored above 30 ° C (86 ° F).

2. Packaging requirements: Only original packaging can be used to send to patients. After the first opening, please keep the bottle cap tightly closed.

3. Solution: It is recommended to dispose of unused drugs through a drug recycling plan. If this condition is not met, please follow the FDA household waste disposal guidelines and do not flush into the toilet.

4. Child safety: Please keep this product out of reach of children.

Orgovyxinformation