Co-administration increases relugolix exposure and risk of adverse reactions. If unavoidable, separate dosing by at least 6 hours and monitor frequently.
Source: NLP:relugolix
Relugolix Interactions
Brand names: Orgovyx
Gonadotropin Releasing Hormone Receptor Antagonist · Gonadotropin Releasing Hormone Receptor Antagonists · Cytochrome P450 3A Inducers · Cytochrome P450 2B6 Inducers · Breast Cancer Resistance Protein Inhibitors · P-Glycoprotein Inhibitors
Route: Oral
Contraindications
4 CONTRAINDICATIONS ORGOVYX is contraindicated in patients with severe hypersensitivity to relugolix or to any of the product components. Known severe hypersensitivity to relugolix or to any of the product components ( 4 ).
Pregnancy & Breastfeeding
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 to a pregnant female [see Clinical Pharmacology ( 12.1 )] . There are no human data on the use of ORGOVYX in pregnant females to inform the drug-associated risk. In an animal reproduction study, oral administration of relugolix to pregnant rabbits during organogenesis caused embryo-fetal lethality at maternal exposures that were 0.3 times the human exposure at the recommended dose of 120 mg daily based on AUC ( see Data ). Advise patients of the potential risk to the fetus. Data Animal Data In an embryo-fetal development study, oral administration of relugolix to pregnant rabbits during the period of organogenesis resulted in abortion, total litter loss, or decreased number of live fetuses at a dose of 9 mg/kg/day (approximately 0.3 times the human exposure at the recommended dose of 120 mg daily based on AUC).
2 interactions on record
Co-administration decreases relugolix exposure, which may reduce therapeutic effects. If unavoidable, increase ORGOVYX dose to 240 mg once daily.
Source: NLP:relugolix