ORGOVYX

DESCRIPTION

  • Composition : relugolix
  • Manufacturer: Myovan
  • Indication: Prostate Cancer
  • Packaging: Bottle
  • Dosage Form: Tablet

PACKAGE

  • 0.5mg
  • 1 mg
  • 40mg

Brand name- Orgovyx

Generic name- relugolix

Manufactured by: Bushu Pharmaceuticals, Ltd, Kawagoe, Saitama, Japan

Manufactured for: Myovant Sciences, Inc., Brisbane, CA 94005

Dosage Form- oral or tablet

Strength- 120mg

Composition- relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg

Packaging- 120 mg tablets, film-coated, light red, almond-shaped; supplied in two configurations, bottles and blister packs.

Indication- Approved for the treatment of adult patients with advanced prostate cancer.

Storage- Store at room temperature. Don’t store above 30°C (86°F).

Description:

Relugolix is a nonpeptide small molecule, GnRH receptor antagonist. The molecular weight is 623.63 daltons and the molecular formula is C29H27F2N7O5S.

The GnRH receptor regulates the production of hormones. It is mainly responsible for making follicle-stimulating hormone (FSH) and luteinizing hormone (LH). These hormones are vital for producing and controlling the levels of testosterone in the human body.

Pharmacodynamics

Pituitary and Gonadal Hormones- Relugolix reduced LH, FSH, and testosterone concentrations after oral administration of the recommended loading dose of 360 mg and a 120 mg dose once daily. Out of 622 patients, 56% had testosterone concentrations at castrate levels (< 50 ng/dL) by the first sampling time point at Day 4, and 97% maintained castrate levels of testosterone through 48 weeks. In a substudy of 137 patients who did not receive subsequent androgen deprivation therapy for at least 90 days after discontinuation of relugolix, the cumulative incidence rate of achieving testosterone concentrations above the lower limit of the normal range (> 280 ng/dL) or baseline at 90 days was 55%.

Cardiac Electrophysiology- In a randomized, double-blind, placebo- and positive-controlled (open-label moxifloxacin), parallel group thorough QT/QTc study, no increase in mean QTc interval > 10 ms was identified after administration of single 60 or 360 mg doses of relugolix (0.2 or 1 times the recommended loading dose, respectively).

Ingredients

The active ingredient of Orgovyx is relugolix, where relugolix is a gonadotropin-releasing hormone antagonist (GnRH receptor antagonist) medication. The inactive ingredients of Orgovyx are mannitol, sodium starch glycolate, hydroxypropyl cellulose, magnesium stearate, hypromellose, titanium dioxide, ferric oxide red and carnauba wax.

Usage Of Medicine

As announced by Myovant Sciences, OrgovyxTM is the First and Only Oral Gonadotropin-Releasing Hormone (GnRH) Receptor Antagonist, approved by the US Food and Drug Administration for the treatment of adult patients with Advanced Prostate Cancer.

 

Common Side Effects

  • Constipation
  • Hot flushes
  • Increase in blood fat (triglyceride) levels
  • Muscle and joint pain
  • Decrease in blood hemoglobin levels
  • Increase in liver enzymes
  • Feeling of tiredness
  • Increase in blood sugar levels

Serious Side Effects

  • Changes in the electrical activity of heart
  • Chest pain
  • Dizziness
  • Fainting
  • Heart palpitations

 

Missed dose

If the dose gets missed by more than 12 hours, patients should not take the missed dose and resume with the next scheduled dose.

Normal dose

Initiate treatment with a loading dose of 360 mg on the first day. Continue treatment with a 120 mg oral dose once daily at approximately the same time.

WARNING

  • Before starting treatment with Orgovyx, please inform your doctor about your previous medical history. If you experience any symptoms while receiving this medication, do not ignore those symptoms because it may lead to higher risk.
    •  Contraception
      • Use effective methods of contraception while taking this medicine.
    • Children and adolescents
      • This medicine is not advisable for use in children and adolescents.

    General Warning And Precaution  

    • This medicine may cause drowsiness.
    • Orgovyx tablet may increase the risk of breathing difficulties, low blood pressure, fever, etc.
    • Close monitoring of blood cell count is required during treatment with this medicine.
    • This medicine is highly unsafe in children.
    • This medicine may cause bone marrow suppression.
    • Do not receive any vaccines while having treatment with this medicine.

    Cautions

    • Do not drive or operate heavy machinery.
    • Do not crush or break the tablet.

DESCRIPTION

  • Composition : relugolix
  • Manufacturer: Myovan
  • Indication: Prostate Cancer
  • Packaging: Bottle
  • Dosage Form: Tablet

PACKAGE

  • 0.5mg
  • 1 mg
  • 40mg
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