Orilissa

The recommended dose of Orilissa (Elagolix) is either 150 mg taken by mouth once a day or 200 mg taken by mouth two times a day. Your doctor will determine the best dose for you based on the severity of your endometriosis symptoms. Orilissa (Elagolix) may be taken with food or on an empty stomach and should be taken at the same time every day.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important to take Orilissa (Elagolix) exactly as prescribed by your doctor.

If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost 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 a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store Orilissa (Elagolix) at room temperature, protect it from light and moisture, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

In addition to its desired action, this medication may cause some adverse effects, notably: menstruation may stop during treatment with this medication; it may cause hot flashes; it may cause headaches; it may cause dizziness - use caution when getting up from a lying or sitting position and use caution if driving; it may cause sleep disturbances or insomnia; it may affect your mood. Each person may react differently to a treatment. If you think this medication may be causing adverse effects (including those described here, or others), talk to your health care professional. He or she can help you to determine whether or not the medication is the source of the problem.

150 mg
Each light pink, oblong tablet, debossed with EL 150 on one side, contains 155.2 mg of Orilissa (Elagolix) sodium, equivalent to 150 mg Orilissa (Elagolix). Nonmedicinal ingredients: armine high tint, magnesium stearate, mannitol, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, sodium carbonate monohydrate, talc, and titanium dioxide.

200 mg
Each light orange, oblong tablet, debossed with EL 200 on one side, contains 207 mg of Orilissa (Elagolix) sodium, equivalent to 200 mg Orilissa (Elagolix). Nonmedicinal ingredients: iron oxide red, magnesium stearate, mannitol, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, sodium carbonate monohydrate, talc, and titanium dioxide.

Do not take Orilissa (Elagolix) if you:

• are allergic to Orilissa (Elagolix) or any ingredients of the medication
• are or may become pregnant
• have unexplained vaginal bleeding
• have Osteoporosis
• have severely decreased liver function
• are taking certain medications such as Cyclosporine or Gemfibrozil

There may be an interaction between Orilissa (Elagolix) and any of the following:

• Aliskiren
• Amiodarone
• "azole" antifungals (e.g., itraconazole, ketoconazole, Voriconazole)
• antihistamines (e.g. bilastine, cetirizine, Loratadine)
• birth control pills
• calcium channel blockers (e.g., Amlodipine, Diltiazem, Nifedipine, Verapamil)
• Carbamazepine
• Carvedilol
• certain cancer medications (e.g., brentuximab, Daunorubicin, Doxorubicin, Etoposide, Idarubicin, Methotrexate, Mitotane, Vinblastine, Vincristine)
• Cimetidine
• Clobazam
• Clozapine
• Cobicistat
• Colchicine
• conivaptan
• cyclosporine
• dabigatran
• Dexamethasone
• Digoxin
• Dronedarone
• Edoxaban
• Eltrombopag
• estrogens (e.g., conjugated estrogen, Estradiol, ethinyl estradiol)
• Everolimus
• gemfibrozil
• "gliptin" Diabetes medications (e.g., Linagliptin, Saxagliptin, Sitagliptin)
• grapefruit juice
• Hepatitis C antivirals (e.g. daclatasvir, glecaprevir, grazoprevir ledipasvir, ombitasvir, paritaprevir, velpatasvir, voxilaprevir)
• HIV non-nucleoside reverse transcriptase inhibitors (NNRTIs; e.g., efavirenz, etravirine, nevirapine)
• HIV protease inhibitors (atazanavir, darunavir, lopinavir, ritonavir)
• Hydrocortisone
• Idelalisib
• Leflunomide
• lumacaftor and Ivacaftor
• macrolide antibiotics (e.g., clarithromycin, erythromycin)
• midazolam
• mifepristone
• Omeprazole
• Nadolol
• Naloxegol
• Paliperidone
• Phenobarbital
• Phenytoin
• primidone
• protein kinase inhibitors (e.g., Bosutinib, Crizotinib, Dabrafenib, imatinib, Pazopanib)
• Prucalopride
• quinidine
• quinine
• rifampin
• Risperidone
• Romidepsin
• Silodosin
• Sirolimus
• "statin" anti-cholesterol medications (e.g., Atorvastatin, Lovastatin, Simvastatin)
• Stiripentol
• Tacrolimus
• Teriflunomide
• Tolvaptan

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Orilissa (Elagolix). Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Orilissa (Elagolix).

Birth control: It is possible to become pregnant while taking Orilissa (Elagolix). Women taking Orilissa (Elagolix) should use effective methods of birth control that do not contain estrogen while taking Orilissa (Elagolix) and for at least 1 week after the last dose.

Bone health: Orilissa (Elagolix) can cause a decrease in the density of bones. Higher doses taken for longer periods of time increase the amount of bone lost. The lowest dose of Orilissa (Elagolix) to control the symptoms, taken for the shortest period of time, is less likely to cause these problems. If you have risk factors for osteoporosis, such as previous use of other medications that decrease bone density, metabolic bone disease, anorexia, long term use of alcohol or tobacco, or family history of osteoporosis, discuss with your doctor whether any special monitoring is needed.

Depression and suicidal behaviour: Orilissa (Elagolix) can cause mood swings and symptoms of depression. People taking Orilissa (Elagolix) may feel agitated (restless, anxious, aggressive, emotional, and feeling not like themselves), or they may want to hurt themselves or others. Symptoms of depression such as poor concentration, changes in weight, changes in sleep, and decreased interest in activities may also occur. If you experience these side effects or notice them in a family member who is taking Orilissa (Elagolix), contact your doctor immediately. Your doctor should closely monitor your emotional and behavioural changes while taking Orilissa (Elagolix).

If you have depression or a history of depression, discuss with your doctor how Orilissa (Elagolix) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Orilissa (Elagolix), and whether any special monitoring is needed.
Liver function: Liver disease or reduced liver function may cause Orilissa (Elagolix) to build up in the body, causing side effects. Orilissa (Elagolix) may also reduce liver function and can cause liver damage. If you have liver problems, discuss with your doctor how Orilissa (Elagolix) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Orilissa (Elagolix), and whether any special monitoring is needed. Your doctor may want to test your liver function regularly with blood tests while you are taking Orilissa (Elagolix).

If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately.

Pregnancy: The use of Orilissa (Elagolix) may cause miscarriage or other complications if the mother takes it during pregnancy. If you become pregnant while taking Orilissa (Elagolix), contact your doctor immediately.

Breast-feeding: It is not known if Orilissa (Elagolix) passes into breast milk. If you are a breast-feeding mother and are taking Orilissa (Elagolix), it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using Orilissa (Elagolix) have not been established for children.

Seniors: Orilissa (Elagolix) has not been studied in women over 65 years of age. It is not intended for use by women who have reached Menopause.

This medication is typically used only once a day. However, your pharmacist may have suggested a different schedule that is more appropriate for you. Important: Follow the instructions on the label. Do not use more of this product, or more often, than prescribed. It must be used regularly and continuously to maintain its beneficial effects. Be sure to keep an adequate supply on hand. If you forget a dose, take it as soon as you remember, but do not take two doses the same day. This medication may be taken with or without food.