Elagolix (1 brand name, 1 dosage form, 1 route)
Available dosage forms: TABLET.
Routes of administration: FILM COATED.
Brand Names
- ELAGOLIX
Indications and Usage
ORILISSA is indicated for the management of moderate to severe pain associated with endometriosis. Limitation s of Use: Limit the duration of use based on the dose and coexisting condition (see Table 1) [see D osage and Administration ( 2.1 ) and Warnings and Precautions ( 5.1 ) ].
Contraindications
ORILISSA is contraindicated in women: Who are pregnant [see Use in Specific Populations ( 8.1 )]. Exposure to ORILISSA early in pregnancy may increase the risk of early pregnancy loss. With known osteoporosis because of the risk of further bone loss [see Warnings and Precautions ( 5.1 )] With severe hepatic impairment [see Use in Specific Populations ( 8.7 ), Clinical Pharmacology ( 12.3 )] Taking inhibitors of organic anion transporting polypeptide (OATP)1B1 (a hepatic uptake transporter) that are known or expected to significantly increase elagolix plasma concentrations [see Drug Interactions ( 7.2 )] With known hypersensitivity reaction to ORILISSA or any of its inactive components. Reactions have included anaphylaxis and angioedema [see Adverse Reactions ( 6.2 )].
Adverse Reactions
The following serious adverse reactions are discussed elsewhere in labeling: Bone loss [see Warnings and Precautions ( 5.1 )] Change in menstrual bleeding pattern and reduced ability to recognize pregnancy [see Warnings and Precautions ( 5.2 )] Suicidal ideation, suicidal behavior, and exacerbation of mood disorders [see Warnings and Precautions ( 5.3 )] Hepatic transaminase elevations [see Warnings and Precautions ( 5.4 )]
Mechanism of Action
ORILISSA is a GnRH receptor antagonist that inhibits endogenous GnRH signaling by binding competitively to GnRH receptors in the pituitary gland. Administration of ORILISSA results in dose-dependent suppression of luteinizing hormone (LH) and follicle-stimulating hormone (FSH), leading to decreased blood concentrations of the ovarian sex hormones, estradiol and progesterone.
Overdosage
In case of overdose, monitor the patient for any signs or symptoms of adverse reactions and initiate appropriate symptomatic treatment, as needed.