Elagolix
What is Elagolix?[edit | edit source]
- Elagolix (Orilissa) is a gonadotropin-releasing hormone (GnRH) receptor antagonist used to treat moderate to severe pain associated with endometriosis.
What are the uses of this medicine?[edit | edit source]
- This medicine is used to treat moderate to severe pain associated with endometriosis.
Limitations of Use
- Limit the duration of use based on the dose and coexisting condition.
How does this medicine work?[edit | edit source]
- An orally bioavailable, second-generation, non-peptide based, small molecule compound and selective gonadotropin-releasing hormone (GnRH; LHRH) receptor antagonist, with potential hormone production inhibitory activity.
- Upon oral administration, elagolix competes with GnRH for receptor binding and inhibits GnRH receptor signaling in the anterior pituitary gland.
- This inhibits the secretion of luteinizing hormone (LH) and follicle-stimulating hormone (FSH).
- In males, the inhibition of LH secretion prevents the release of testosterone.
- In women, inhibition of FSH and LH prevents the production of estrogen by the ovaries.
- Inhibition of GnRH signaling may treat or prevent symptoms of sex hormone-dependent disease states.
Who Should Not Use this medicine ?[edit | edit source]
This medicine cannot be used in patients:
- Who are pregnant
- With known osteoporosis because of the risk of further bone loss
- With severe hepatic impairment
- Taking inhibitors of organic anion transporting polypeptide (OATP)1B1 (a hepatic uptake transporter)
- With known hypersensitivity reaction to Orilissa or any of its inactive components
What drug interactions can this medicine cause?[edit | edit source]
- Concomitant use of Orilissa 200 mg twice daily and strong CYP3A inhibitors for more than 1 month is not recommended. Limit concomitant use of Orilissa 150 mg once daily and strong CYP3A inhibitors to 6 months.
- Co-administration of Orilissa with strong CYP3A inducers may decrease elagolix plasma concentrations and may result in a decrease of the therapeutic effects of Orilissa.
- Concomitant use of Orilissa 200 mg twice daily and rifampin is not recommended. Limit concomitant use of Orilissa 150 mg once daily and rifampin to 6 months.
- The effect of concomitant use of P-gp inhibitors or inducers on the pharmacokinetics of Orilissa is unknown.
Is this medicine FDA approved?[edit | edit source]
- It was approved for use in the United States in 2018.
How should this medicine be used?[edit | edit source]
- Exclude pregnancy before starting Orilissa or start Orilissa within 7 days from the onset of menses.
Recommended Dosage 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.
Moderate hepatic impairment:
- 150 mg once daily for up to 6 months.
Administration
- Take Orilissa exactly as your healthcare provider tells you to take it.
- Your healthcare provider will give you a pregnancy test before you start taking Orilissa or will have you start taking Orilissa within 7 days after you start your period.
If your healthcare provider prescribes:
- Orilissa 150 mg (a pink tablet), take it 1 time each day
- Orilissa 200 mg (an orange tablet), take it 2 times each day
- Take Orilissa at about the same time each day with or without food.
- If you take too much Orilissa, call your healthcare provider or go to the nearest hospital emergency room right away.
If you miss a dose of Orilissa:
- 150 mg (1 time each day), take it as soon as you remember as long as it is on the same day. Do not take more than 1 tablet each day.
- 200 mg (2 times each day), take it as soon as you remember as long as it is on the same day. Do not take more than 2 tablets each day.
What are the dosage forms and brand names of this medicine?[edit | edit source]
This medicine is available in fallowing doasage form:
- As Oral tablets: 150 mg and 200 mg
This medicine is available in fallowing brand namesː
- Orilissa
What side effects can this medication cause?[edit | edit source]
The most common side effects of this medicine include:
- hot flashes and night sweats
- headache
- nausea
- difficulty sleeping
- absence of periods
- anxiety
- joint pain
- depression
- mood changes
Orilissa can cause serious side effects including:
- suicidal thoughts, suicidal behavior, and worsening of mood
- abnormal liver tests
signs and symptoms of liver problems:
- yellowing of the skin or the whites of the eyes (jaundice)
- dark amber-colored urine
- feeling tired (fatigue or exhaustion)
- nausea and vomiting
- generalized swelling
- right upper stomach area (abdomen) pain
- bruising easily
What special precautions should I follow?[edit | edit source]
- Inform patients about the risk of bone loss. Advise patients that supplementary calcium and vitamin D may be beneficial if dietary intake of calcium and vitamin D is not adequate.
- Advise women that Orilissa may delay the recognition of pregnancy because it may reduce the amount, intensity, or duration of menstrual bleeding. Advise patients to use effective non-hormonal contraception while taking Orilissa and to discontinue Orilissa if pregnancy is confirmed.
- Advise patients that suicidal ideation and exacerbation of mood disorders may occur with Orilissa use.
- Advise patients to promptly seek medical attention in case of signs or symptoms that may reflect liver injury, such as jaundice.
- Use non-hormonal contraception during treatment and for 28 days after discontinuing Orilissa. Coadministration of Orilissa 200 mg twice daily with an estrogen-containing contraceptive is not recommended because of the potential for increased estrogen-associated risks. Coadministration of Orilissa with an estrogen-containing contraceptive may reduce the efficacy of Orilissa. Coadministration with progestin-containing oral contraceptives may reduce the efficacy of the contraceptive.
What to do in case of emergency/overdose?[edit | edit source]
Management for overdosage:
- In case of overdose, monitor the patient for any signs or symptoms of adverse reactions and initiate appropriate symptomatic treatment, as needed.
Can this medicine be used in pregnancy?[edit | edit source]
- 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.
- There is a pregnancy registry that monitors outcomes in women who become pregnant while treated with Orilissa. Pregnant patients should be encouraged to enroll by calling 1-833-782-7241.
Can this medicine be used in children?[edit | edit source]
- Safety and effectiveness of Orilissa in pediatric patients have not been established.
What are the active and inactive ingredients in this medicine?[edit | edit source]
- Active ingredient: elagolix
- Inactive ingredients 150 mg tablets: mannitol, sodium carbonate monohydrate, pregelatinized starch, povidone, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, and carmine high tint.
- Inactive ingredients 200 mg tablets: mannitol, sodium carbonate monohydrate, pregelatinized starch, povidone, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, and iron oxide red.
Who manufactures and distributes this medicine?[edit | edit source]
Manufactured by AbbVie Inc. North Chicago
What should I know about storage and disposal of this medication?[edit | edit source]
- Store Orilissa between 36°F to 86°F (2°C to 30°C).
- Do not keep medicine that is out of date or that you no longer need.
- Throw away (dispose of) unused medicines through community take-back disposal programs when available. If no community take-back disposal program is available go to www.fda.gov/drugdisposal for more information on how to dispose of Orilissa the right way.
- Do not flush Orilissa down the toilet.
- Keep Orilissa and all medicines out of the reach of children.
Elagolix Resources | ||
---|---|---|
|
|
Translate to: East Asian
中文,
日本,
한국어,
South Asian
हिन्दी,
Urdu,
বাংলা,
తెలుగు,
தமிழ்,
ಕನ್ನಡ,
Southeast Asian
Indonesian,
Vietnamese,
Thai,
မြန်မာဘာသာ,
European
español,
Deutsch,
français,
русский,
português do Brasil,
Italian,
polski
Navigation: Wellness - Encyclopedia - Health topics - Disease Index - Drugs - World Directory - Gray's Anatomy - Keto diet - Recipes
Search WikiMD
Ad.Tired of being Overweight? Try W8MD's physician weight loss program.
Semaglutide (Ozempic / Wegovy and Tirzepatide (Mounjaro) available.
Advertise on WikiMD
WikiMD is not a substitute for professional medical advice. See full disclaimer.
Credits:Most images are courtesy of Wikimedia commons, and templates Wikipedia, licensed under CC BY SA or similar.Contributors: Admin, Deepika vegiraju, Prab R. Tumpati, MD