Elagolix
الاگولیکس
🧬 Systemic Hormonal Preparations, Excl. Sex Hormones And InsulinsOral GnRH antagonist
Market / country: 🇺🇸 USA
Orilissa (US)
🧮 Dose calculator
Endometriosis · Regimen source: FDA Orilissa · 2.1, Table 1
- • Exclude pregnancy or start within 7 days of menses. Moderate hepatic impairment: 150 mg only, max 6 months. FDA Orilissa · 2.1FDA Orilissa · 2.2
Enter age (weight is optional for this regimen).
🛡️ Safety & information
Contraindications
- ⛔ Pregnancy; osteoporosis; severe hepatic impairment; strong OATP1B1 inhibitors; hypersensitivity. FDA Orilissa · 4
Warnings
- • Dose- and duration-dependent bone loss; limit duration of use. FDA Orilissa · 2.1
Formulations
- 150 mg tablet — tablet 🇺🇸 USA FDA Orilissa · 3
- 200 mg tablet — tablet 🇺🇸 USA FDA Orilissa · 3
👥 Special populations
- 🤰 PregnancyContraindicated
Label: contraindicated in pregnancy. FDA Orilissa · 4
“ORILISSA is contraindicated in women: Who are pregnant [see Use in Specific Populations ( 8.1 )] .”
- 🤱 BreastfeedingUse with caution
Label: use with caution while breastfeeding; see the label text. FDA Orilissa · 8.2
“Risk Summary There is no information on the presence of elagolix or its metabolites in human milk, the effects on the breastfed child, or the effects on milk production.”
- 👶 ChildrenSafety not established
Label: safety and effectiveness in children have not been established. FDA Orilissa · 8.4
“Safety and effectiveness of ORILISSA in pediatric patients have not been established.”
- 👴 Older adultsNo data
The source for this drug has no section for this group.
- ⚥ Females & males of reproductive potentialUse with caution
Label has advice on pregnancy testing, contraception or fertility for females and males. FDA Orilissa · 8.3
“Contraception Advise women to use effective non-hormonal contraception during treatment with ORILISSA and for 28 days after discontinuing ORILISSA [see Warnings and Precautions ( 5.5 )] .”
🔗 Reference links
- FDA (approval record)NDA210450
- DailyMed (FDA label)FDA Orilissa
- MedlinePlus (NIH)Elagolix
- WHO ATC/DDDH01CC03
- Darooyab (Iran)Elagolix
🇮🇷 Not found in Iran list Darooyab · G-5571/Elagolix
Darooyab lists no registered dosage form or brand for this drug. This does not prove it is unavailable.
📚 Reference status for this drug
Shows which sources have references recorded for this drug and which do not.
- FDA label (DailyMed)✅ PresentFDA Orilissa · 3FDA Orilissa · 2.1, Table 1FDA Orilissa · 2.1FDA Orilissa · 2.2FDA Orilissa · 4FDA Orilissa · 8.2FDA Orilissa · 8.4FDA Orilissa · 8.3FDA Orilissa · SPL approval / marketing category
- UK SmPC (eMC / MHRA)❌ Not present
- Published guideline❌ Not present
- Licensed reference (medical school)❌ Not present
- Iranian leaflet (IFDA)❌ Not present
- Pharmacy website (secondary, unreliable)✅ PresentDarooyab · G-5571/Elagolix
- Clinical review⚠ Unverified