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What Is Orilissa (Elagolix Sodium) Tablet?
Orilissa is an FDA-approved medication used for the treatment of moderate to severe pain due to endometriosis. It contains the active ingredient elagolix and is taken orally in either once or twice daily doses. Clinical studies have demonstrated that Orilissa can be effective at reducing endometriosis-related pain.
How Is Orilissa Used for and How Does It Work?
Orilissa is a medication that contains elagolix as the active ingredient. It is used to treat moderate to severe pain caused by endometriosis. This condition involves the growth of tissue resembling the uterine lining outside of the uterus. Elagolix works by blocking the release of certain hormones, such as follicle-stimulating hormone and luteinizing hormone, that stimulate the growth of this tissue. By reducing the levels of these hormones, elagolix can shrink the tissue and relieve the pain associated with endometriosis.
Some of the benefits of taking Orilissa are:
- It can lower the estrogen levels in women, which helps prevent the tissue from growing outside the uterus.
- It can inhibit the hormones that trigger the symptoms of endometriosis, such as pelvic pain, painful periods, and pain during sex.
- It can provide relief from moderate to severe pain for women who have endometriosis.
Orilissa should not be taken for more than 24 months or 6 months if taken twice daily or if you have liver problems. It may take up to three months for the effects of Orilissa to be noticeable. It is not suitable for women who are pregnant or breastfeeding, as it may harm the baby.
It may also affect your fertility and your ability to use hormonal birth control, so you should use non-hormonal methods of contraception while taking this medication. You should talk to your doctor before starting Orilissa and follow their instructions carefully. If you have any questions or concerns about taking Orilissa, you should consult your doctor or pharmacist.
Guidelines for Orilissa Dosages
Dosage Forms and Strengths
- Orilissa 150 mg Tablet: Oblong, light pink, film-coated tablets with “EL 150” debossed on one side. Each tablet contains 155.2 mg of elagolix sodium, equivalent to 150 mg of elagolix.
- Orilissa 200 mg Tablet: Light orange, oblong, film-coated tablets with “EL 200” debossed on one side. Each tablet contains 207.0 mg of elagolix sodium, equivalent to 200 mg of elagolix.
How to Take Orilissa 150 mg Tablet & Orilissa 200 mg Tablet?
Orilissa is a medication that requires careful dosing and administration. Please follow these important instructions when taking Orilissa:
- Before you start taking Orilissa, make sure you are not pregnant or start Orilissa within 7 days from the onset of your menstrual period.
- Take Orilissa once or twice a day, depending on your prescribed dose, and try to take it at the same time every day. You can take Orilissa with or without food.
- Use the lowest effective dose of Orilissa that can reduce your symptoms and meet your treatment goals. Do not take more than the recommended dose or for longer than the prescribed duration.
- Limit the duration of use of Orilissa to avoid bone loss, which is a serious side effect of this medication. Your doctor will monitor your bone health and advise you on how long you can take Orilissa safely.
Recommended Dosage and Duration of Use:
For general endometriosis treatment:
- Initiate treatment with Orilissa 150 mg tablet once daily
- Maximum treatment duration is of 24 months
For endometriosis treatment with coexisting dyspareunia (painful sexual intercourse):
- Consider initiating treatment with Orilissa 200 mg tablet twice daily
- Maximum treatment duration is of 6 months
For endometriosis treatment with moderate hepatic impairment (Child-Pugh Class B):
- Initiate treatment with Orilissa 150 mg once daily
- Use of 200 mg twice daily is not recommended
- Maximum treatment duration is of 6 months
Orilissa dosage adjustments are necessary based on the degree of hepatic impairment in women:
- Mild Hepatic Impairment (Child-Pugh A): No dosage adjustment is required.
- Moderate Hepatic Impairment (Child-Pugh B): Orilissa 150 mg tablet once daily is recommended. The treatment duration should not exceed 6 months. Orilissa 200 mg tablet twice daily is not recommended for women with moderate hepatic impairment.
- Severe Hepatic Impairment (Child-Pugh C): Orilissa is contraindicated.
In women with moderate hepatic impairment, the exposure to elagolix is approximately 3-fold higher compared to those with normal liver function. For women with severe hepatic impairment, the exposure is approximately 7-fold higher. Due to these increased exposures and the associated risk of bone loss, specific dosage recommendations are essential to ensure patient safety.
Patients should be advised on what to do in case of a missed dose:
- If a dose of Orilissa is missed, instruct the patient to take the missed dose on the same day as soon as one remembers and then resume the regular dosing schedule.
- For the Orilissa 150 mg tablet, patients should take no more than 1 tablet each day.
- For the Orilissa 200 mg tablet, patients should take no more than 2 tablets each day.
This information is crucial for patients to adhere to the prescribed dosage regimen, ensuring the effectiveness and safety of Orilissa treatment.
Important Warnings and Precautions for Orilissa Use
Bone Health Concerns: Orilissa may cause a decrease in bone mineral density (BMD), which becomes more significant with prolonged use. The extent of BMD loss might not be fully reversible after discontinuing treatment. It is contraindicated in women with known osteoporosis. Physicians should assess BMD in patients with a history of low-trauma fractures or other osteoporosis risk factors. To mitigate bone loss, limit the duration of Orilissa use. Although calcium and vitamin D supplementation effectiveness was not studied, it may be beneficial for all patients.
Changes in Menstrual Bleeding and Pregnancy Recognition: Women taking Orilissa might experience reduced menstrual bleeding intensity, duration, or amount, potentially hindering timely pregnancy recognition. If pregnancy is suspected, perform pregnancy testing promptly. Orilissa should be discontinued if pregnancy is confirmed.
Suicidal Ideation, Behavior, and Mood Disorders: Suicidal thoughts and behavior, including one completed suicide, were reported in Orilissa-treated subjects during endometriosis clinical trials. Subjects taking Orilissa exhibited higher rates of depression and mood changes compared to the placebo group. Patients with a history of suicidality or depression had elevated depression incidence.
Clinicians should thoroughly evaluate patients showing depressive symptoms to assess the balance between risks and benefits. Those with new or worsening depression, anxiety, or mood changes should be referred to mental health professionals. Immediate medical attention is necessary for patients experiencing suicidal thoughts. Continuation of Orilissa should be reevaluated in such cases.
Hepatic Transaminase Elevations: Clinical trials observed dose-dependent elevations of serum alanine aminotransferase (ALT) levels at least three times the upper limit of the reference range in Orilissa users. Physicians should prescribe the lowest effective dose and instruct patients to seek medical help promptly if symptoms or signs suggestive of liver injury, like jaundice, appear. Patients with elevated liver tests should be evaluated promptly to assess the risk-benefit ratio of continuing Orilissa therapy.
Breastfeeding Safety: The safety of breastfeeding while using Orilissa is uncertain. Patients should consult their doctors regarding potential risks associated with breastfeeding during Orilissa use. It is essential for healthcare providers and patients to be aware of these warnings and precautions to ensure the safe and informed use of Orilissa.
Side Effects of Orilissa
Some individuals may experience the following side effects while taking this medication: Nausea, difficulty sleeping, hot flashes, night sweats, headaches, or changes in menstrual periods. If any of these effects persist or worsen, it is advisable to promptly inform your healthcare provider or pharmacist.
It’s important to remember that your healthcare provider has prescribed this medication because they have determined that the potential benefits outweigh the risks associated with side effects. The majority of people using this medication do not experience severe adverse effects.
Serious Side Effects
Contact your healthcare provider immediately if you encounter any of the following serious side effects:
- Mental or mood changes, such as new or worsening depression, anxiety, or unusual changes in behavior.
- Indications of liver damage include persistent nausea or vomiting, loss of appetite, stomach or abdominal pain, yellowing of the eyes or skin, and dark-colored urine.
- If you experience any of the following very serious side effects, seek immediate medical attention:
- Thoughts of suicide.
Bone Health Considerations
This medication reduces estrogen levels in your body, which can lead to bone loss. The risk of bone loss is greater with higher doses or extended use of this medication. Some degree of bone loss may be irreversible, so it is recommended to take this medication at the lowest effective dose. Consult your healthcare provider to discuss the risks and benefits of using this medication and inquire about the possibility of calcium supplements and vitamin D for maintaining bone health.
While extremely rare, a severe allergic reaction to this medication can occur. If you notice any signs of a serious allergic reaction, such as a rash, itching, swelling (particularly of the face, tongue, or throat), severe dizziness, or breathing difficulties, seek immediate medical assistance.
This list does not encompass all possible side effects. If you experience any effects that are not mentioned above, don’t hesitate to get in touch with your healthcare provider or pharmacist.
Drug Interactions and Important Information
Drug interactions have the potential to alter the effectiveness of your medications or increase the risk of severe side effects. Please be aware that this document may not cover all possible drug interactions. To ensure your safety, maintain a comprehensive list of all products you use, including prescription and nonprescription drugs, as well as herbal products. Share this list with both your doctor and pharmacist. It is crucial not to initiate, discontinue, or adjust the dosage of any medicines without obtaining approval from your doctor.
Interactions with Elagolix
Certain medications can influence the elimination of elagolix from your system, thereby impacting its efficacy. Examples of such medications include cyclosporine and gemfibrozil, among others.
Furthermore, elagolix can expedite the removal of other drugs from your body, potentially affecting their functionality. Examples of affected drugs include daridorexant, elacestrant, specific hepatitis C medications like asunaprevir and ombitasvir/paritaprevir/ritonavir, as well as quizartinib, among others.
Interaction with Hormonal Birth Control
For women of childbearing age, it is imperative to discuss the use of reliable non-hormonal birth control methods with your doctor, as hormonal birth control might interact with this medication.
In conclusion, your proactive communication with healthcare professionals regarding your medication regimen is crucial to ensuring your well-being and the effectiveness of your treatment.
Orilissa Cost and Coverage
The cost of Orilissa can fluctuate based on the patient’s insurance coverage and the pharmacy of choice. Patients without insurance or with inadequate coverage might incur higher out-of-pocket expenses. Medicaid options and financial assistance programs are available in certain cases to aid with the cost of Orilissa.
Regarding insurance coverage, many health plans may cover a portion or the entirety of the Orilissa cost. However, it is crucial for patients to verify their coverage with their healthcare provider before initiating treatment. Without insurance, the out-of-pocket expenses for Orilissa can range from $100 to $500 per month, contingent upon the pharmacy and prescribed dosage strength.
It is important to note that generic versions of elagolix are not currently available in the United States, eliminating the typical discounts associated with generic medications. Nevertheless, there are avenues for individuals seeking financial assistance. Reduced co-pays can be accessed through manufacturer’s coupon programs, and government subsidies are available for low-income individuals. Additionally, PolarBearMeds.com offers large discounts and Orilissa costs for people who are paying out of pocket.
Frequently Asked Questions
How long does it take for Orilissa to start working?
Orilissa starts working swiftly, reducing estrogen levels within the body within 24 hours. However, it takes some time for pain relief to be noticeable. Clinical studies have demonstrated that Orilissa provides pain relief after 3 months of use. Orilissa offers two dosing options: 150 mg taken once daily or 200 mg taken twice a day.
Can I take Orilissa while pregnant or breastfeeding?
When dealing with endometriosis symptoms, it’s crucial to consider the risks associated with taking Orilissa during pregnancy or breastfeeding. Orilissa has not been tested in pregnant women, so it should not be used during these times. It’s advisable for women to explore alternative methods to manage pain, like home remedies or surgery, and to thoroughly research available safety information before considering Orilissa. Reliable sources for this information include healthcare professionals and the manufacturer’s website, which offers a video library featuring patient stories and reviews.
Can I take Orilissa if I have osteoporosis?
Osteoporosis, marked by decreased bone density and a higher risk of fractures, requires caution with medications. Orilissa, used for severe endometriosis pain, hasn’t been specifically studied in osteoporosis patients. It’s crucial to consult your doctor before taking Orilissa if you have osteoporosis. Besides medical options, lifestyle changes and alternative therapies can help manage symptoms for both conditions. Additionally, consider the long-term effects of Orilissa and other prescribed medications, staying informed about your health choices.
Are there any other treatments for endometriosis pain besides Orilissa?
Absolutely, endometriosis is a condition causing significant pain due to the growth of uterine tissue outside the uterus, offering various treatment avenues beyond Orilissa. These options encompass alternative therapies like yoga or acupuncture, lifestyle adjustments such as regular exercise and sufficient sleep, dietary changes focusing on anti-inflammatory foods or avoiding triggers worsening symptoms. Additionally, hormonal therapies, including oral contraceptives and GnRH analogs, help regulate estrogen levels. For more invasive approaches, surgeries like laparoscopic excision or laser ablation remove misplaced endometrial tissue. It’s crucial for patients to consult their doctors about these options to determine the best fit for their needs.
Can Orilissa interact with other medications, including over-the-counter products or supplements?
Yes, it’s crucial to talk to your healthcare professional about potential interactions between Orilissa and other medications. These interactions can occur with over-the-counter products, vitamins, minerals, or herbal supplements. Apart from drug interactions, lifestyle changes and personal experiences can also impact how effective Orilissa is in relieving pain caused by endometriosis. There are various treatment options for endometriosis pain, including hormonal and nonhormonal therapies like surgery or home remedies. It’s always best to discuss all these options with your doctor before starting any new regimen for endometriosis pain relief.
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