Mfd. by :- Myovan (Fulfilled By : Magicine Pharma)
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.
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).
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.
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).
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.
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.
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
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.
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.
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.
Do not drive or operate heavy machinery.
Do not crush or break the tablet.
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).
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