ORGOVYX Film-coated tablet (2021)
Βιβλιογραφική αναφορά
Συγγραφείς
Myovant Sciences, Inc.
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1. Indications and Usage
ORGOVYX is indicated for the treatment of adult patients with advanced prostate cancer.
2. Dosage and Administration
2.1 Recommended Dosage Initiate treatment of ORGOVYX with a loading dose of 360 mg on the first day and continue treatment with a 120 mg dose taken orally once daily at approximately the same time each ...
3. Dosage Forms and Strengths
<u>Tablets:</u> 120 mg, light red, almond-shaped, film-coated, and debossed with R on one side and 120 on the other side.
4. Contraindications
None.
5. Warnings and Precautions
5.1 QT/QTc Interval Prolongation Androgen deprivation therapy, such as ORGOVYX may prolong the QT/QTc interval. Providers should consider whether the benefits of androgen deprivation therapy outweigh the ...
6. Adverse Reactions
The following clinically significant adverse reactions are described elsewhere in the labeling: QT/QTc Interval Prolongation <em>[see Warnings and Precautions (5.1)]</em>.
6.1. Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another ...
7. Drug Interactions
7.1 Effect of Other Drugs on ORGOVYX P-gp Inhibitors Co-administration of ORGOVYX with a P-gp inhibitor increases the AUC and the maximum concentration (C<sub>max</sub>) of relugolix <em>[see Clinical ...
8.1. Pregnancy
Risk Summary The safety and efficacy of ORGOVYX have not been established in females. Based on findings in animals and mechanism of action, ORGOVYX can cause fetal harm and loss of pregnancy when administered ...
8.2. Lactation
Risk Summary The safety and efficacy of ORGOVYX at the recommended dose of 120 mg daily have not been established in females. There are no data on the presence of relugolix in human milk, the effects on ...
8.3. Females and Males of Reproductive Potential
Contraception Males Based on findings in animals and mechanism of action, advise male patients with female partners of reproductive potential to use effective contraception during treatment and for 2 weeks ...
8.4. Pediatric Use
The safety and efficacy of ORGOVYX in pediatric patients have not been established.
8.5. Geriatric Use
Of the 622 patients who received ORGOVYX in the HERO study, 81% were 65 years of age or older, while 35% were 75 years of age or older. No overall differences in safety or effectiveness were observed between ...
11. Description
Relugolix is a nonpeptide small molecule, GnRH receptor antagonist. The chemical name is N-(4-{1-[(2,6-difluorophenyl)methyl]5[(dimethylamino)methyl]3(6-methoxypyridazin-3-yl)-2,4-dioxo-1,2,3,4-tetrahydrothieno[2,3-d]pyrimidin-6-yl}phenyl)-N'-methoxyurea. ...
12.1. Mechanism of Action
Relugolix is a nonpeptide GnRH receptor antagonist that competitively binds to pituitary GnRH receptors, thereby, reducing the release of luteinizing hormone (LH) and follicle-stimulating hormone (FSH), ...
12.2. Pharmacodynamics
Pituitary and Gonadal Hormones Relugolix reduced LH, FSH (Figure 1), and testosterone concentrations after oral administration of the recommended loading dose of 360 mg and a 120 mg dose once daily. Out ...
12.3. Pharmacokinetics
After administration of single doses ranging from 60 mg to 360 mg (0.17 to 1 times the recommended loading dose), the AUC from time zero extrapolated to infinity (AUC<sub>0-inf</sub>) and the maximum observed ...
13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility
Two-year carcinogenicity studies were conducted in mice at oral relugolix doses up to 100 mg/kg/day and in rats at doses up to 600 mg/kg/day. Relugolix was not carcinogenic in mice or rats at exposures ...
13.2. Animal Toxicology and/or Pharmacology
Phospholipidosis (intracellular phospholipid accumulation) was observed in multiple organs and tissues (e.g., liver, pancreas, spleen, kidney, lymph nodes, lung, bone marrow, gastrointestinal tract or ...
14. Clinical Studies
HERO Study The safety and efficacy of ORGOVYX was evaluated in HERO (NCT03085095), a randomized, open label study in men with advanced prostate cancer requiring at least 1 year of androgen deprivation ...
16.1. How Supplied
The 120 mg tablets are film-coated, light red, almond shaped, and debossed with R on one side and 120 on the other side and are supplied in two configurations, bottles and blister packs. Each bottle (NDC ...
16.2. Storage and Handling
Store ORGOVYX at room temperature. Do not store above 30°C (86°F). Dispense to patients in original container only. For bottles, keep container tightly closed after first opening. Keep out of reach of ...
17. Patient Counseling Information
Advise the patient to read the FDA-approved patient labeling (Patient Information). <u>QT/QTc Interval Prolongation:</u> Advise patients that androgen deprivation therapy treatment with ORGOVYX may prolong ...