Why is this medication prescribed?

Orilissa (generic name: elagolix) is a prescription medication primarily used to treat moderate to severe pain associated with endometriosis. Endometriosis is a condition in which tissue similar to the lining of the uterus grows outside the uterus, leading to pain, inflammation, and other symptoms. Orilissa belongs to a class of drugs called gonadotropin-releasing hormone (GnRH) antagonists.

Orilissa works by reducing the production of certain hormones, specifically luteinizing hormone (LH) and follicle-stimulating hormone (FSH), which are involved in the menstrual cycle. By decreasing these hormone levels, Orilissa suppresses the production of estrogen, a hormone that promotes the growth of endometrial tissue. Lower estrogen levels can help alleviate pain and reduce the progression of endometriosis.

How should this medicine be used?

Orilissa should be taken exactly as prescribed by a healthcare professional. It is available in oral tablet form and is typically taken once or twice daily, depending on the prescribed dosage.

Here are some general guidelines for using Orilissa:

• Follow the instructions provided by your healthcare professional and read the medication guide that comes with the prescription.
• Take Orilissa at the same time(s) each day to maintain a consistent level of the medication in your body.
• Orilissa can be taken with or without food, but it should be taken consistently in the same manner.
• Swallow the tablet whole with a glass of water. Do not crush, chew, or break the tablet.
• If you miss a dose, take it as soon as you remember, unless it is close to the time for your next scheduled dose. In that case, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one.
• It is important to complete the full course of treatment as prescribed by your healthcare professional, even if you start feeling better.

It is crucial to communicate with your healthcare professional about any questions or concerns you may have regarding the use of Orilissa. They can provide you with specific instructions tailored to your condition and monitor your response to the medication.

Other uses for this medicine

Orilissa is primarily used for the treatment of endometriosis-associated pain. However, it may also be prescribed for the management of heavy menstrual bleeding due to uterine fibroids. It is important to note that the use of Orilissa for these conditions should be determined by a healthcare professional based on an individual’s specific situation.

What special precautions should I follow?

Regarding special precautions, here are some important considerations when using Orilissa:

• Pregnancy and breastfeeding: Orilissa is not recommended for use during pregnancy as it may cause harm to the developing fetus. If you become pregnant while taking Orilissa, you should discontinue the medication and consult your healthcare professional. It is also not known whether Orilissa passes into breast milk, so it is advisable to avoid breastfeeding while using this medication.
• Liver problems: Orilissa may cause liver enzyme elevations. Your healthcare professional may order periodic liver function tests while you are taking Orilissa to monitor your liver health. If you have a history of liver disease or experience symptoms such as yellowing of the skin or eyes, dark urine, or persistent nausea, you should inform your healthcare professional.
• Bone loss: Orilissa can cause a decrease in bone mineral density (BMD) with long-term use. Your healthcare professional may evaluate your BMD before starting treatment and periodically during therapy. They may also recommend measures to support bone health, such as calcium and vitamin D supplementation or weight-bearing exercise.
• Drug interactions: Orilissa may interact with other medications, including hormonal contraceptives, certain antifungal drugs, and certain HIV medications. It is important to inform your healthcare professional about all the medications you are taking, including prescription drugs, over-the-counter medications, and herbal supplements.
• Adverse reactions: Orilissa may cause side effects such as hot flashes, night sweats, headache, nausea, and mood changes. If you experience any severe or persistent side effects, you should contact your healthcare professional.

It is crucial to have regular check-ups and follow-up appointments with your healthcare professional while taking Orilissa to monitor your response to the medication and address any concerns that may arise.

What special dietary instructions should I follow?

There are no specific dietary instructions associated with taking Orilissa (elagolix). You can take the medication with or without food according to your preference. However, it is generally recommended to take Orilissa consistently in the same manner, either with or without food, throughout your treatment period. If you have any specific dietary concerns or restrictions, it is advisable to consult with your healthcare professional.

What should I do if I forget a dose?

If you forget to take a dose of Orilissa, follow these general guidelines:

• Take the missed dose as soon as you remember, unless it is close to the time for your next scheduled dose. If it is near the time for your next dose, skip the missed dose and continue with your regular dosing schedule.
• Do not take a double dose to make up for the missed one.

What side effects can this medication cause?

Orilissa (elagolix) may cause side effects in some individuals. It’s important to note that not everyone will experience these side effects, and their severity can vary. If you have concerns about the side effects or experience any severe or persistent symptoms, it is recommended to consult with your healthcare professional.

Common side effects of Orilissa can include:

• Hot flashes: A sudden feeling of warmth or flushing of the face and upper body.
• Headache: Pain or discomfort in the head, ranging from mild to moderate intensity.
• Nausea: A sensation of unease and discomfort in the stomach, often accompanied by an inclination to vomit.
• Insomnia: Difficulty falling asleep or staying asleep.
• Mood changes: Including mood swings, irritability, anxiety, and depression.
• Decreased bone mineral density: Long-term use of Orilissa may lead to a decrease in bone mineral density, which could increase the risk of osteoporosis or bone fractures.

Less common or rare side effects can include:

• Abnormal liver function: Orilissa may cause elevations in liver enzymes, which can be detected through blood tests.
• Decreased libido: A reduced interest in or desire for sexual activity.
• Fatigue: Persistent tiredness or lack of energy.
• Dizziness: A sensation of lightheadedness or unsteadiness.
• Joint pain: Discomfort or pain in the joints.
• Changes in menstrual bleeding: This may include changes in the frequency, duration, or intensity of menstrual periods.

These are not all the possible side effects of Orilissa. If you experience any unusual or concerning symptoms while taking Orilissa, it is important to report them to your healthcare professional for evaluation and guidance. They can provide further information and support based on your specific situation.

What should I know about storage and disposal of this medication?

• Storage: Store Orilissa at room temperature, away from excessive heat, moisture, and direct sunlight. Follow the specific storage instructions provided on the medication packaging or in the medication guide.
• Keep out of reach of children and pets: Orilissa should be stored in a secure place where children and pets cannot access it. Accidental ingestion of the medication can be harmful.
• Disposal: Dispose of unused or expired Orilissa properly. Do not flush it down the toilet or pour it into a drain, unless specifically instructed to do so. The best way to dispose of medications is to take them to a drug take-back program or follow the disposal instructions provided by your local pharmacy or healthcare facility.

In case of emergency/overdose

• If you believe you or someone else may have overdosed on Orilissa, immediately call emergency services or your local poison control center for assistance. Provide them with as much information as possible, including the quantity of medication taken and the time it was ingested.
• Do not induce vomiting or take any other actions unless instructed to do so by a healthcare professional or poison control.
• It is advisable to have the packaging or container of Orilissa readily available to provide accurate information to medical personnel.

What other information should I know?

• Regular monitoring: It is important to attend regular follow-up appointments with your healthcare professional to monitor your response to Orilissa, evaluate any side effects, and discuss any concerns or questions you may have.
• Drug interactions: Inform your healthcare professional about all the medications you are currently taking, including prescription drugs, over-the-counter medications, and herbal supplements. Certain medications may interact with Orilissa and affect its effectiveness or increase the risk of side effects.
• Medical procedures and surgeries: If you are scheduled for any surgical procedures, including dental surgery, inform the healthcare professionals involved about your use of Orilissa. They may provide guidance on whether to continue or temporarily discontinue the medication.
• Compliance: Take Orilissa as prescribed and complete the full course of treatment unless otherwise directed by your healthcare professional. If you have any difficulty or concerns regarding adherence to the medication regimen, discuss it with your healthcare professional.

Always consult your healthcare professional or pharmacist for specific instructions and guidance regarding the storage, disposal, emergencies, and other important information related to Orilissa.