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ORGOVYX is a brand name for Relugolix, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: ORGOVYX (relugolix tablets, 120 mg) is indicated for the treatment of adult patients with advanced prostate cancer. 1.1 Pediatrics Pediatrics (<18 years of age): Safety and effectiveness of ORGOVYX in patients less than 18 years of age has not been established, therefore, Health Canada has not authorized an indication…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations • Because treatment with relugolix, does not cause an increase in testosterone concentrations, it is not necessary to add an anti-androgen as mitigation to avoid the associated clinical flare after initiation of therapy.
• In patients treated with ORGOVYX for prostate cancer, treatment is usually continued upon development of nonmetastatic or metastatic castration-resistant prostate cancer. 2 Recommended Dose and Dosage Adjustment • Initiate treatment of ORGOVYX with a loading dose of 360 mg (three tablets) on the first day and continue treatment with a 120 mg (one tablet) taken orally once daily at approximately the same time each day.
• Dose Modification for Use with Oral P-gp Inhibitors: Co-administration of ORGOVYX with an oral Serious Warnings and Precautions The following are clinically significant adverse events: QT prolongation (see 7 WARNINGS AND PRECAUTIONS Cardiovascular and Monitoring and Laboratory Tests section below and 9 DRUG INTERACTIONS sections).
ORGOVYX (relugolix tablets 120 mg) Page 5 of 27 permeability glycoprotein (P-gp) inhibitor should be avoided. If co-administration is unavoidable, take ORGOVYX first and dosing separated by at least 6 hours (see 9 DRUG INTERACTIONS and 10 CLINICAL PHARMACOLOGY).
Treatment with ORGOVYX may be interrupted for up to two weeks if a short course of treatment with an oral P-gp inhibitor is required. • Dose Modification for Use with Combined P-gp and Strong CYP3A Inducers: Co-administration of ORGOVYX with combined P-gp and strong CYP3A inducers should be avoided.
If co-administration is unavoidable, increase the dose of ORGOVYX to 240 mg once daily. After discontinuation of the combined P-gp and strong CYP3A inducer, resume the recommended 120-mg dose of ORGOVYX once daily (see 9 DRUG INTERACTIONS and 10 CLINICAL PHARMACOLOGY).
1 Pediatrics). 2 Geriatrics and 10 CLINICAL PHARMACOLOGY). • Dose Modification for Renal Impairment No dose adjustment in patients with mild, moderate or severe renal impairment is required. The effects of end-stage renal disease with or without hemodialysis have not been evaluated (see 10 CLINICAL PHARMACOLOGY).
• Dose Modification for Hepatic Impairment No dose adjustment in patients with mild or moderate hepatic impairment is required. The effects of severe hepatic impairment on the pharmacokinetics of relugolix have not been evaluated (see 10 CLINICAL PHARMACOLOGY).
1 Adverse Reaction Overview In total, 2871 patients have been exposed to at least one dose of relugolix monotherapy, including 935 patients with prostate cancer, of whom 796 patients were exposed to ORGOVYX for at least 6 months and of whom 543 patients received ORGOVYX for at least 12 months.
ORGOVYX was studied primarily in an active-controlled trial (N=930) and in uncontrolled trials evaluating safety and tolerability. The safety of ORGOVYX was evaluated in HERO, a randomized (2:1), open-label, clinical study in patients with advanced prostate cancer (see 14 CLINICAL TRIALS).
Among patients who received ORGOVYX, 90% were exposed for at least 48 weeks. 6 days, respectively. 9% of patients (99 patients) received radiotherapy while taking ORGOVYX and a total of 65 patients were randomized to ORGOVYX once daily for 24 weeks following a single loading dose of 320 mg.
6% or less. Serious adverse reactions occurred in 12% of patients receiving ORGOVYX. 5%). 2%). 7% of patients receiving ORGOVYX. 5% of patients. 3%). 7% of patients. 3%). The most commonly observed adverse reactions during treatment with ORGOVYX in the HERO study were hot flush (54%), musculoskeletal pain (30%), fatigue (26%), and weight increase (8%).
Diarrhea and constipation were also very commonly reported (12% each). 2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions. Adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use. Adverse events reported in 5% of patients or more regardless of causality in the HERO study are shown in Table 2.
Cardiovascular and Monitoring and Laboratory Tests section below and 9 DRUG INTERACTIONS sections). ORGOVYX (relugolix tablets 120 mg) Page 5 of 27 permeability glycoprotein (P-gp) inhibitor should be avoided. If co-administration is unavoidable, take ORGOVYX first and dosing separated by at least 6 hours (see 9 DRUG INTERACTIONS and 10 CLINICAL PHARMACOLOGY).
Treatment with ORGOVYX may be interrupted for up to two weeks if a short course of treatment with an oral P-gp inhibitor is required. • Dose Modification for Use with Combined P-gp and Strong CYP3A Inducers: Co-administration of ORGOVYX with combined P-gp and strong CYP3A inducers should be avoided.
If co-administration is unavoidable, increase the dose of ORGOVYX to 240 mg once daily. After discontinuation of the combined P-gp and strong CYP3A inducer, resume the recommended 120-mg dose of ORGOVYX once daily (see 9 DRUG INTERACTIONS and 10 CLINICAL PHARMACOLOGY).
1 Pediatrics). 2 Geriatrics and 10 CLINICAL PHARMACOLOGY). • Dose Modification for Renal Impairment No dose adjustment in patients with mild, moderate or severe renal impairment is required. The effects of end-stage renal disease with or without hemodialysis have not been evaluated (see 10 CLINICAL PHARMACOLOGY).
• Dose Modification for Hepatic Impairment No dose adjustment in patients with mild or moderate hepatic impairment is required. The effects of severe hepatic impairment on the pharmacokinetics of relugolix have not been evaluated (see 10 CLINICAL PHARMACOLOGY).
4 Administration Oral use. 3 Pharmacokinetics). Instruct patients to swallow tablets whole and not to crush or chew tablets. 5 Missed Dose Advise patients to take a missed dose of ORGOVYX 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 ORGOVYX is interrupted for greater than 7 days, restart ORGOVYX with a loading dose of 360 mg on the first day, and continue with a dose of 120 mg once daily. 5 OVERDOSAGE There is no known specific antidote for ORGOVYX overdose.
In patients with known hypersensitivity to relugolix or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing (see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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4 Administration Oral use. 3 Pharmacokinetics). Instruct patients to swallow tablets whole and not to crush or chew tablets. 5 Missed Dose Advise patients to take a missed dose of ORGOVYX 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 ORGOVYX is interrupted for greater than 7 days, restart ORGOVYX with a loading dose of 360 mg on the first day, and continue with a dose of 120 mg once daily.
Table 2 – Adverse Reactions ( ≥ 5%) of Patients with Advanced Prostate Cancer Who Received ORGOVYX in the HERO Study Adverse Reaction ORGOVYX N = 622 Leuprolide Acetate N = 308 All Grades (%) All Grades (%) Gastrointestinal disorders Diarrheaa 12 7 Constipation 12 10 Nausea 6 4 General Fatigueb 26 24 Investigations Weight increased 8 7 Musculoskeletal and connective tissue disorders Musculoskeletal painc 30 29 Nervous system disorders Dizziness 6 6 Headache 6 4 Psychiatric disorders ORGOVYX (relugolix tablets 120 mg) Page 10 of 27 Adverse Reaction ORGOVYX N = 622 Leuprolide Acetate N = 308 All Grades (%) All Grades (%) Insomnia 7 5 Vascular disorders Hot flush 54 52 Hypertension 8 12 a Includes diarrhea and colitis.
b Includes fatigue and asthenia. c Includes arthralgia, back pain, pain in extremity, musculoskeletal pain, myalgia, bone pain, neck pain, arthritis, musculoskeletal stiffness, non-cardiac chest pain, musculoskeletal chest pain, spinal pain, and musculoskeletal discomfort.
3 Less Common Clinical Trial Adverse Reactions The following less common (<5%) adverse reactions were reported in the HERO study. 4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data Clinical Trial Findings Table 3 summarizes the laboratory abnormalities in the HERO study.
6 ORGOVYX (relugolix tablets 120 mg) Page 11 of 27 a The denominator used to calculate the rate varied from 611 to 619 in the ORGOVYX arm and from 301 to 306 in the leuprolide arm based on the number of patients with a baseline value and at least one post-treatment value.
b Included in group though values <15%. 5 Post-Market Adverse Reactions The following adverse reactions have been identified during post-approval use of ORGOVYX. Because these adverse reactions are reported voluntarily from a population of uncertain size, the frequency of these adverse reactions is not known.
• Skin and subcutaneous tissue disorders: angioedema, urticaria
In the event of an overdose, stop ORGOVYX and undertake general supportive measures until any clinical toxicity has diminished or resolved. It is not known if relugolix is removed by hemodialysis. ORGOVYX (relugolix tablets 120 mg) Page 6 of 27 For management of a suspected drug overdose, contact your regional poison control centre.
6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING Table 1 – Dosage Forms, Strengths, Composition and Packaging Each tablet of ORGOVYX contains 120 mg relugolix. The tablets are light red, almond-shaped, film- coated, and debossed with “R” on one side and “120” on the other side.
Supplied in bottles of 30 tablets with desiccant. 7 WARNINGS AND PRECAUTIONS Please see 3 SERIOUS WARNINGS AND PRECAUTIONS BOX. General Relugolix is a P-gp substrate. Co-administration of ORGOVYX with an oral P-gp inhibitor or a combined P-gp and strong cytochrome P450 (CYP) 3A inducer may increase or decrease the exposure to relugolix, respectively (see 4 DOSAGE and ADMINISTRATION and 9 DRUG INTERACTIONS).
Cardiovascular Androgen deprivation therapy can prolong the QT interval. 1), respectively, for degarelix. The proportion of patients who were observed to have one or more QTcF value >480 ms was 5% in the relugolix group and 3% in the degarelix group.
The proportion of patients who were observed to have one or more QTcF value >500 ms was 2% in the relugolix group and 3% in the degarelix group. , hypokalemia, hypomagnesemia, hypocalcemia), congestive heart failure, uncontrolled hypothyroidism, and concomitant treatment with QT-prolonging drugs (see 9 DRUG INTERACTIONS).
Periodic monitoring of electrocardiograms and serum electrolyte levels should be considered (see 7 WARNING AND PRECAUTIONS, Monitoring and Laboratory Tests). Electrolyte Route of Administration Dosage Form / Strength/Composition Non-medicinal Ingredients Oral tablet 120 mg relugolix carnauba wax, hydroxypropyl cellulose, hypromellose, iron oxide red, magnesium stearate, mannitol, sodium starch glycolate, and titanium dioxide ORGOVYX (relugolix tablets 120 mg) Page 7 of 27 abnormalities should be corrected.
Advise patients that androgen deprivation therapy treatment can prolong the QT interval. Inform patients of the signs and symptoms of QT prolongation and torsade de pointes, as well as risk mitigation strategies. Advise patients to contact a healthcare professional immediately regarding signs or symptoms of QT prolongation or torsade de pointes or changes in or new use of other medications.
Monitoring and Laboratory Tests Therapy with ORGOVYX results in suppression of the pituitary gonadal system. Results of diagnostic tests of the pituitary gonadotropic and gonadal functions conducted during and after ORGOVYX may be affected.
The therapeutic effect of ORGOVYX should be monitored by measuring serum […]