Orilissa

Orilissa is a prescription medication used for managing moderate-to-severe pain associated with endometriosis. It works by reducing estrogen levels, which can help alleviate symptoms such as painful periods, pelvic pain, and pain during sex. The typical dosage starts at 150 mg once daily, with adjustments for specific conditions and coexisting issues like dyspareunia or hepatic impairment. Orilissa can cause side effects like bone density loss, mood changes, and liver damage. It is not recommended during pregnancy and requires careful consideration of birth control methods while in use. Always consult a healthcare provider for personalized advice and treatment plans.

Product Overview

Orilissa (elagolix) is a medication specifically designed for women suffering from endometriosis, a condition characterized by the growth of endometrial tissue outside the uterus, causing pain and discomfort. The main ingredient, elagolix, acts as a gonadotropin-releasing hormone (GnRH) receptor antagonist, reducing the production of estrogen, a hormone that can exacerbate endometriosis symptoms. Orilissa is used to manage moderate-to-severe pain associated with endometriosis, including painful periods, pelvic pain between periods, and pain during sexual intercourse. It works by targeting the hormonal imbalance that contributes to the condition, providing relief from the discomfort and pain caused by endometriosis.

Orilissa is available in two strengths: 150 milligrams (mg) and 200 mg. The recommended dosage varies depending on the severity of the symptoms and the presence of coexisting conditions. For moderate-to-severe endometriosis pain, the starting dose is typically 150 mg once daily for up to 24 months. In cases of dyspareunia, a higher dose of 200 mg twice daily for up to 6 months may be considered. It’s important to note that Orilissa can be taken with or without food, and the tablets should be swallowed whole.

While Orilissa can be effective in managing endometriosis symptoms, it may also cause side effects such as bone density loss, changes in mood and menstrual bleeding, liver damage, and interactions with hormonal birth control. Patients with a history of osteoporosis, liver problems, or mental/mood disorders should exercise caution when using this medication. It is contraindicated in pregnant women and those with severe liver impairment. To minimize risks, patients should follow their healthcare provider’s instructions, use non-hormonal birth control methods during treatment, and store Orilissa tablets at a temperature range of 36°F to 86°F (2°C to 30°C) away from damp or wet areas.

Uses of Orilissa

• Painful periods (endometriosis)
• Pelvic pain in between periods
• Pain with sex

How to Use Orilissa?

Dosage

It comes in the form of an oral tablet and has 2 strengths:

• 150 milligrams (mg)
• 200 mg

Recommended Dosage for Different Patients

Endometriosis Management: For moderate-to-severe pain, start with 150 mg orally once daily for up to 24 months.

Coexisting Conditions:

• For dyspareunia, consider starting with 200 mg twice daily for up to 6 months.
• For moderate hepatic impairment (Child-Pugh B), start with 150 mg once daily for up to 6 months. The 200 mg twice daily dosage is not recommended.

Dosage Modifications:

• Renal Impairment: No adjustment is needed for any degree of renal impairment or end-stage renal disease (including dialysis).
• Hepatic Impairment:
  • Mild (Child-Pugh A): No dosage adjustment is required.
  • Moderate (Child-Pugh B): Only the 150-mg once-daily regimen is recommended, limited to 6 months.
  • Severe (Child-Pugh C): Contraindicated.

Dosing Considerations:

• Confirm that the patient is not pregnant before starting, or begin elagolix within 7 days from the start of menstruation.
• Use the lowest effective dose based on the severity of symptoms and treatment goals.
• Limit the duration of use due to the risk of bone loss.

[Note: Remember, these recommendations may vary from person to person. Discuss it with your doctor, and they’ll customize your dosage accordingly.]

How to Take It?

• Take Orilissa exactly as prescribed by your healthcare provider.
• The usual dosage is one tablet taken orally once or twice daily, depending on your specific condition and treatment plan.
• Orilissa can be taken with or without food. Choose a consistent time of day to take your dose to help you remember.
• Swallow the tablet whole with a glass of water. Do not crush, chew, or break the tablet.
• Keep regular appointments with your doctor to monitor your progress and make any necessary adjustments to your treatment.
• Do not stop taking Orilissa without consulting your healthcare provider, as it may worsen your condition.

[Note: Your doctor will decide the right amount for you based on your condition, following guidelines and studies on the drug. They’ll adjust it as needed over time.]

How Does Orilissa Work?

Orilissa (elagolix) works by reducing the production of estrogen, a hormone that can contribute to the development of endometriosis symptoms. It acts as a gonadotropin-releasing hormone (GnRH) receptor antagonist, which helps to decrease the levels of estrogen and alleviate symptoms such as pelvic pain associated with endometriosis. By targeting the hormonal imbalance, Orilissa can provide relief from the discomfort and pain caused by this condition.

Important Safety Information

Side Effects

Common side effects may include:

• Night sweats
• Hot flashes
• Headache
• Nausea
• Insomnia (trouble sleeping)
• Joint pain
• Diarrhea
• Stopped periods
• Weight gain

Adverse/Serious side effects may include:

• Bone Density Loss
• Mood Changes and Depression
• Liver Problems
• Changes in Menstrual Bleeding
• Allergic Reactions

[Note: Remember, this list may not cover all possible side effects. Always consult with your healthcare giver for medical advice about side effects.]

Warnings

• Bone Loss: Risk increases with a history of osteoporosis or higher doses of Orilissa. May cause irreversible bone loss. Use may be limited to 6 or 24 months to reduce the risk. Consider calcium and vitamin D supplements during treatment.

• Changes in Menstrual Bleeding: Orilissa can alter bleeding patterns during periods. May require pregnancy tests before and during treatment. Monitor for other pregnancy signs and stop Orilissa if pregnancy is suspected.

• Suicidal Thoughts and Mood Changes: Higher risk for those with a history of depression or suicidal behavior. Monitor for new or worsening mood changes and suicidal thoughts. Consult your healthcare provider if you notice unusual mood or behavior changes.

• Liver Damage: Increased risk with higher doses or existing liver problems. Regular lab monitoring is recommended. Seek immediate medical help if symptoms of liver problems occur.

• Interactions with Hormonal Birth Control: Orilissa may reduce the effectiveness of birth control containing estrogen. Hormonal birth controls might also reduce Orilissa’s effectiveness. Discuss alternative birth control options with your provider while taking Orilissa.

Precautions

• Inform your doctor or pharmacist if you are allergic to elagolix or have any other allergies, as this medication may contain inactive ingredients that could cause allergic reactions.
• Disclose your medical history to your healthcare provider, particularly if you have liver problems, bone loss (osteoporosis), or mental/mood disorders like depression.
• Before undergoing surgery, notify your doctor or dentist about all the medications you’re taking, including prescription and over-the-counter drugs, as well as herbal products.
• Do not use elagolix during pregnancy, as it may harm the unborn baby. Discuss reliable non-hormonal birth control methods, such as condoms or spermicide, to use while on this medication and for 4 weeks after stopping treatment. Due to the impact of elagolix on menstruation, it may be challenging to detect pregnancy. Inform your doctor immediately if you suspect you are pregnant.
• The safety of elagolix during breastfeeding is uncertain. Consult your doctor before breastfeeding while taking this medication.

Contraindications

Orilissa should not be used in patients who:

• Are pregnant
• Have osteoporosis
• Have severe liver impairment
• Are taking strong inhibitors of the organic anion transporting polypeptide (OATP) 1B1, such as cyclosporine and gemfibrozil

Missed Dose

• If you remember the missed dose later in the day, go ahead and take it. 
• If it’s almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. 
• Do not take two doses at the same time.

[Note: If you have missed a dose of your medication and are unsure about when to take the next one, immediately consult your doctor or pharmacist.]

Overdose 

If you have unused Orilissa medication and no longer need it, it’s crucial to dispose of it properly. Safe disposal prevents accidental ingestion by children or pets and avoids environmental harm.

[Note: If you consumed more than recommended dose, get medical help right away, or call the Poison Help line at 1-800-222-1222.]

Storage

• The shelf life of a medication can vary based on various factors, including storage conditions.
• Orilissa tablets should be stored at a temperature range of 36°F to 86°F (2°C to 30°C).
• Avoid storing Orilissa in damp or wet areas, such as bathrooms, to maintain its effectiveness.

[Note: Discuss with your healthcare professional about the proper disposal of any unused medicine and any questions you may have regarding its storage.]

Orilissa Interactions

• Lupron Depot (leuprolide acetate)
• Zoladex (goserelin acetate)
• Synarel (nafarelin acetate)
• Danocrine (danazol)
• Visanne (dienogest)
• Aygestin (norethindrone acetate)

[Note: This isn’t a complete list, and there could be other drugs that interact with (drug name). Make sure to tell your doctor any prescription, over-the-counter medicines, and herbal products you’re taking.]

Orilissa Alternatives

• Lupron Depot (leuprolide acetate)
• Zoladex (goserelin acetate)
• Synarel (nafarelin acetate)
• Danocrine (danazol)
• Aygestin (norethindrone acetate)
• Visanne (dienogest)

[Note: Your doctor will choose what’s best for you. Don’t use any of these alternative medications without consulting your healthcare provider. Taking them by yourself may cause serious side effects.] 

Frequently Asked Questions

How soon does Orilissa begin to take effect?

Orilissa (elagolix) begins to reduce hormone levels within 6 hours of taking your dose, although you might not experience immediate relief from symptoms. It may take a few months of continued use before you notice significant relief from endometriosis pain. It’s important to keep taking your medication as prescribed and discuss any concerns with your healthcare provider.

When is the right time to begin taking Orilissa?

Your healthcare provider will advise you to start taking Orilissa (elagolix) within the first 7 days of your menstrual cycle. If you begin the medication outside of this time frame, your provider will ask you to take a pregnancy test to ensure you are not pregnant before starting Orilissa.

Can I conceive after discontinuing Orilissa?

Discontinuing Orilissa (elagolix) does not permanently affect your ability to have children. However, it’s important to note that taking Orilissa during pregnancy can be harmful to your unborn baby, which is why your healthcare provider will confirm you’re not pregnant before starting the medication. Your estrogen levels will normalize one to two days after you stop taking Orilissa, but you should continue using non-hormonal birth control for 28 days after discontinuing the medication to ensure safety.

Are there any withdrawal symptoms when discontinuing Orilissa?

Discontinuing Orilissa is not associated with withdrawal symptoms, which typically occur when ceasing a medication your body has become dependent on for normal functioning. However, it’s possible for endometriosis symptoms to worsen after stopping Orilissa treatment. If you have concerns about stopping Orilissa, it’s important to discuss them with your doctor. Do not cease taking the medication without your doctor’s approval.

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