ORGOVYX 

Mfd. by :- Myovan (Fulfilled By : Magicine Pharma)

Orgovyx 

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Magicine Pharma is registered with the Government Of NCT, India, Ministry Of Health in Government of Delhi, India, registration number DL-RAJ-122372 and as a wholesale distributor, department file No. 44208.

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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 

Dosage

  • 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 and Precautions

  • ORGOVYX can cause fetal harm and loss of pregnancy when administered to a pregnant female. 

Ques-1 What is ORGOVYX? 

Ans-1 ORGOVYX is a medicine used in adults to treat advanced prostate cancer. 

Ques-2 How should I take ORGOVYX? 

Ans-2 Take ORGOVYX as your healthcare provider tells you. Take 3 tablets of Orgovyx on the first day of treatment, followed by 1 tablet of Orgovyx daily. Swallow the tablet; do not chew or crush. Don't change your dose or stop taking ORGOVYX without consulting your healthcare provider. 

Ques-3 What are the possible side effects of ORGOVYX? 

Ans-3 Following are the serious side effects of ORGOVYX:- 

  • Changes in the electrical activity of heart 

  • Chest pain 

  • Dizziness 

  • Fainting  

  • Heart palpitations 

Following are the common side effects of ORGOVYX:- 

  • 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 

Ques-4 In what strength is it available? 

Ans-4 It is available in the strength of 120mg. 

Ques-5 What happens if I miss a dose? 

Ans-5 If the dose gets missed by 12 hours, you should not take the missed dose and resume with the next scheduled dose.  

Ques-6 What should I avoid while consuming this medicine? 

Ans-6 Follow your doctor’s instructions regarding restrictions on food and others. 

Ques-7 What are self care tips? 

Ans-7 Ask your healthcare provider for detailed prescription and tips. 

Ques-8 Can I take this medicine during pregnancy? 

Ans-8 It can harm the unborn baby and cause loss of pregnancy. Please ask your healthcare provider before consumption in such cases. 

Ques-9 Can I drive after taking this medicine? 

Ans-9 If you have any symptom of loss of vision, avoid driving and ask your healthcare provider. 

Ques-10 What are the storage conditions? 

Ans-10 Store at room temperature. Don’t store above 30°C (86°F). 

Above Content has been reviewed by Professionals