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Indications & Uses
Orili is indicated for:
Pharmacology
Elagolix is a GnRH receptor antagonist. It blocks the body's own GnRH signalling by binding competitively to the GnRH receptors in the pituitary gland. When Elagolix is given, it suppresses luteinizing hormone (LH) and follicle-stimulating hormone (FSH) in a dose-dependent way. This in turn lowers the blood levels of the ovarian sex hormones, estradiol and progesterone.
Dosage Reference
Reference Information Only
Dosages shown are general references from official sources. Always consult your doctor or pharmacist for personalized dosing.
Adults:
Rule out pregnancy before starting Elagolix, and begin Elagolix within 7 days of the onset of menses.
Initial treatment with Elagolix 150 mg is 150 mg once daily for up to 24 months. If the patient has moderate hepatic impairment, the limit is up to 6 months.
Initial treatment with Elagolix 200 mg is 200 mg twice daily for up to 6 months (when dyspareunia is also present). Don't continue Elagolix 200 mg beyond 6 months, because it may decrease bone mineral density (BMD). In moderate to severe hepatic impairment, Elagolix 200 mg is not recommended.
Use in children and adolescents: not established in those under 18 years.
Side Effects
Elagolix Sodium most commonly causes hot flushes, night sweats, headache, nausea, amenorrhea, arthralgia, mood changes and bone loss. Less common effects are insomnia, anxiety and raised hepatic transaminase levels.
Cautions & Contraindications
Warnings & Precautions
Bone Loss Bone mineral density (BMD) can fall when Elagolix Sodium is used, and the fall depends on the dose and on how long the medicine is taken. The loss may not be completely reversible. Assess BMD in women who have additional risk factors for bone loss. Reduced Ability to Recognize Pregnancy The medicine may alter menstrual bleeding, and that may reduce the ability to recognize pregnancy. Perform testing if pregnancy is suspected. Discontinue if pregnancy is confirmed. 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. Hepatic Transaminase Elevations Serum alanine aminotransferase (ALT) shows elevations that depend on the dose. Counsel patients on the signs and symptoms of liver injury. Potential for Reduced Efficacy with Estrogen-Containing Contraceptives Use non-hormonal contraception during treatment and for one week after discontinuing Elagolix Sodium.
Contraindications
Elagolix Sodium must not be given to pregnant women, because exposure to Elagolix early in pregnancy may increase the risk of early pregnancy loss. It is also contraindicated in women with known osteoporosis, since it can increase the risk of further bone loss. People with severe hepatic impairment should not take it either. The same applies when it is used together with strong organic anion transporting polypeptide OATP1B1 inhibitors (e.g. cyclosporine and gemfibrozil).
Pregnancy & Breastfeeding
There isn't much human data on Elagolix in pregnant women, and what exists is too limited to say whether it carries a risk of major birth defects or miscarriage. Exposure to Elagolix early in pregnancy may raise the risk of early pregnancy loss. For this reason, it must not be used by pregnant women. If pregnancy occurs during treatment, Elagolix has to be stopped.
For breastfeeding, nothing is known about whether elagolix or its metabolites pass into human milk. The effects on the breastfed child and on milk production are also unknown.
⚠️ Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
Use in Special Populations
Women with any degree of renal impairment or end-stage renal disease, including those on dialysis, don't need a dose adjustment of Elagolix Sodium. The same applies to women with mild hepatic impairment, where no dosage adjustment of Elagolix Sodium is needed. Safety and effectiveness have not been established in patients under 18 years of age.
Overdose
If someone takes too much Elagolix Sodium, watch them for any signs or symptoms of adverse reactions. Start symptomatic treatment if it's needed.
⚠️ In an emergency call 999 or go to the nearest hospital emergency department.
Storage
Keep Elagolix Sodium in a cool, dry place, away from light and moisture. Keep all medicines out of reach of children.
Drug Interactions
Common questions about Orili 150 mg
What is Orili 150 mg Tablet?
Orili 150 mg Tablet is a medicine that contains Elagolix Sodium. It is made by Square Pharmaceuticals PLC, Pabna. It belongs to the Gonadotropin-releasing hormone (GnRH) antagonist group of medicines.
What is Orili used for?
Orili is used for: Pain.
What are the side effects of Orili?
Elagolix Sodium most commonly causes hot flushes, night sweats, headache, nausea, amenorrhea, arthralgia, mood changes and bone loss. Less common effects are insomnia, anxiety and raised hepatic transaminase levels.
Can I take Orili during pregnancy or while breastfeeding?
There isn't much human data on Elagolix in pregnant women, and what exists is too limited to say whether it carries a risk of major birth defects or miscarriage. Exposure to Elagolix early in pregnancy may raise the risk of early pregnancy loss. Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
What happens if I take too much Orili?
If someone takes too much Elagolix Sodium, watch them for any signs or symptoms of adverse reactions. Start symptomatic treatment if it's needed. In an emergency call 999 or go to the nearest hospital emergency department.
How should I store Orili?
Keep Elagolix Sodium in a cool, dry place, away from light and moisture. Keep all medicines out of reach of children.
Can I take other medicines with Orili?
Some medicines can interact with Elagolix Sodium, for example: Rosuvastatin, Omeprazole, Midazolam, Digoxin. Tell your doctor or pharmacist about every medicine you take.
Is there a cheaper medicine with the same ingredient?
Orili is already among the lowest-priced brands of Elagolix Sodium at this strength.
Do I need a prescription for Orili?
Orili is a prescription (Rx) medicine. Take it as your doctor advises.