Elagolix
Generic Name: elagolix
Brand Names:
Orilissa
11 DESCRIPTION ORILISSA (elagolix) tablets for oral administration contain elagolix sodium, the sodium salt of the active moiety elagolix. Elagolix sodium is a nonpeptide small molecule, GnRH receptor antagonist. Elagolix sodium is chemically described as sodium 4-({(1 R )-2-[5-(2-fluoro-3-methoxyphenyl)-3-{[2-fluoro-6-(trifluoromethyl)phenyl]methyl}-4-methyl-2,6-dioxo-3,6-dihydropyrimidin-1(2 H )-yl]-1-phenylethyl}amino)butanoate.
Overview
11 DESCRIPTION ORILISSA (elagolix) tablets for oral administration contain elagolix sodium, the sodium salt of the active moiety elagolix. Elagolix sodium is a nonpeptide small molecule, GnRH receptor antagonist. Elagolix sodium is chemically described as sodium 4-({(1 R )-2-[5-(2-fluoro-3-methoxyphenyl)-3-{[2-fluoro-6-(trifluoromethyl)phenyl]methyl}-4-methyl-2,6-dioxo-3,6-dihydropyrimidin-1(2 H )-yl]-1-phenylethyl}amino)butanoate.
Uses
1 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 ) ] . ORILISSA is a gonadotropin-releasing hormone (GnRH) receptor antagonist indicated for the management of moderate to severe pain associated with endometriosis. ( 1 ) Limitation s of Use: Limit the duration of use based on the dose and coexisting condition (see Table 1 ). ( 1 )
Dosage
2 DOSAGE AND ADMINISTRATION Normal liver function or mild hepatic impairment : 150 mg once daily for up to 24 months or 200 mg twice daily for up to 6 months. ( 2.1 ) Moderate hepatic impairment : 150 mg once daily for up to 6 months. ( 2.1 ) 2.1 Important Dosing Information Exclude pregnancy before starting ORILISSA or start ORILISSA within 7 days from the onset of menses. Take ORILISSA at approximately the same time each day, with or without food. Use the lowest effective dose, taking into account the severity of symptoms and treatment objectives [see Warnings and Precautions ( 5.1 , 5.3 , 5.4 ) and Clinical Studies ( 14 )] . Limit the duration of use because of bone loss ( Table 1 ) [see Warnings and Precautions ( 5.1 )] . Table 1.
Side Effects
6 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 )] Most common adverse reactions (>5%) in clinical trials included hot flushes and night sweats, headache, nausea, insomnia, amenorrhea, anxiety, arthralgia, depression-related adverse reactions and mood changes ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact AbbVie Inc.
Interactions
7 DRUG INTERACTIONS See full prescribing information for a list of clinically important drug interactions ( 7 ). 7.1 Potential for ORILISSA to Affect Other Drugs Elagolix is: A weak to moderate inducer of cytochrome P450 (CYP) 3A. Co-administration with ORILISSA may decrease plasma concentrations of drugs that are substrates of CYP3A (see Table 7). A weak inhibitor of CYP 2C19. Co-administration with ORILISSA may increase plasma concentrations of drugs that are substrates of CYP2C19 (see Table 7). An inhibitor of efflux transporter P-glycoprotein (P-gp). Co-administration with ORILISSA may increase plasma concentrations of drugs that are substrates of P-gp (see Table 7).
Warnings
5 WARNINGS AND PRECAUTIONS Bone Loss : Dose- and duration-dependent decreases in bone mineral density (BMD) that may not be completely reversible. Assess BMD in women with additional risk factors for bone loss ( 5.1 ) Reduced Ability to Recognize Pregnancy : ORILISSA may alter menstrual bleeding, which may reduce the ability to recognize pregnancy. Perform testing if pregnancy is suspected. Discontinue if pregnancy is confirmed ( 5.2 ) Suicidal Ideation and Mood Disorders : Advise patients to seek medical attention for suicidal ideation, suicidal behavior, new onset or worsening depression, anxiety, or other mood changes ( 5.3 ) Hepatic Transaminase Elevations : Dose-dependent elevations in serum alanine aminotransferase (ALT). 4 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.
Pregnancy
8.1 Pregnancy Risk Summary Use of ORILISSA is contraindicated in pregnant women. Exposure to ORILISSA early in pregnancy may increase the risk of early pregnancy loss. Discontinue ORILISSA if pregnancy occurs during treatment. The limited human data with the use of ORILISSA in pregnant women are insufficient to determine whether there is a risk for major birth defects or miscarriage. Although two cases of congenital malformations were reported in clinical trials with ORILISSA, no pattern was identified and miscarriages were reported at a similar incidence across treatment groups (see Data ) .
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING ORILISSA tablets are available in two strengths: 150 mg and 200 mg, which are equivalent to 155.2 mg and 207.0 mg of elagolix sodium, respectively. ORILISSA 150 mg tablets are light pink, oblong, film-coated tablets with “EL 150” debossed on one side. ORILISSA 150 mg tablets are packaged in weekly blister packs.
Frequently Asked Questions
What is Elagolix used for?▼
1 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 ) ] . ORILISSA is a gonadotropin-releasing hormone (GnRH) receptor antagonist indicated for the management of moderate to severe pain associated with endometriosis. ( 1 ) Limitation s of Use: Limit the duration of use based on the dose and coexisting condition (see Table 1 ). ( 1 )
What are the side effects of Elagolix?▼
6 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 )] Most common adverse reactions (>5%) in clinical trials included hot flushes and night sweats, headache, nausea, insomnia, amenorrhea, anxiety, arthralgia, depression-related adverse reactions and mood changes ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact AbbVie Inc.
Can I take Elagolix during pregnancy?▼
8.1 Pregnancy Risk Summary Use of ORILISSA is contraindicated in pregnant women. Exposure to ORILISSA early in pregnancy may increase the risk of early pregnancy loss. Discontinue ORILISSA if pregnancy occurs during treatment. The limited human data with the use of ORILISSA in pregnant women are insufficient to determine whether there is a risk for major birth defects or miscarriage. Although two cases of congenital malformations were reported in clinical trials with ORILISSA, no pattern was identified and miscarriages were reported at a similar incidence across treatment groups (see Data ) .
What are the important warnings for Elagolix?▼
5 WARNINGS AND PRECAUTIONS Bone Loss : Dose- and duration-dependent decreases in bone mineral density (BMD) that may not be completely reversible. Assess BMD in women with additional risk factors for bone loss ( 5.1 ) Reduced Ability to Recognize Pregnancy : ORILISSA may alter menstrual bleeding, which may reduce the ability to recognize pregnancy. Perform testing if pregnancy is suspected. Discontinue if pregnancy is confirmed ( 5.2 ) Suicidal Ideation and Mood Disorders : Advise patients to seek medical attention for suicidal ideation, suicidal behavior, new onset or worsening depression, anxiety, or other mood changes ( 5.3 ) Hepatic Transaminase Elevations : Dose-dependent elevations in serum alanine aminotransferase (ALT). 4 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.
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.