Description
Elagolix is used to manage moderate to severe pain caused by endometriosis.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Capsule
- Tablet
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of elagolix in the pediatric population. Safety and efficacy have not been established.
Geriatric
No information is available on the relationship of age to the effects of enalapril in geriatric patients.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Cyclosporine
- Darolutamide
- Eltrombopag
- Enasidenib
- Fostemsavir
- Gemfibrozil
- Grazoprevir
- Levoketoconazole
- Lonafarnib
- Mavacamten
- Paritaprevir
- Rifampin
- Tolvaptan
- Velpatasvir
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Abametapir
- Alprazolam
- Amiodarone
- Avacopan
- Bedaquiline
- Benzhydrocodone
- Berotralstat
- Boceprevir
- Buprenorphine
- Capivasertib
- Capmatinib
- Carbamazepine
- Ceftobiprole Medocaril
- Clarithromycin
- Clozapine
- Cobicistat
- Codeine
- Conivaptan
- Dabigatran Etexilate
- Daridorexant
- Desogestrel
- Dienogest
- Digoxin
- Dihydrocodeine
- Drospirenone
- Elexacaftor
- Eliglustat
- Encorafenib
- Entrectinib
- Erdafitinib
- Estetrol
- Estradiol
- Ethinyl Estradiol
- Ethynodiol
- Etonogestrel
- Fedratinib
- Fentanyl
- Fexinidazole
- Finerenone
- Fruquintinib
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Liver disease, severe or
- Osteoporosis (weak bones)—Should not be used in patients with these conditions.
- Mental problems (eg, depression, suicidal thoughts or behavior), history of—Use with caution. May make these conditions worse.
Proper Use
Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.
This medicine comes with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.
Use this medicine within 7 days from the start of your menstrual period.
Take this medicine with or without food.
You may receive other medicines (eg, calcium or vitamin D supplements) to help reduce bone loss.
Dosing
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For oral dosage form (tablets):
- For moderate to severe pain caused by endometriosis:
- Adults—At first, 150 milligrams (mg) once a day for up to 24 months. Your doctor may adjust your dose as needed and tolerated. Some patients may start taking this medicine 200 mg 2 times a day for up to 6 months (for patients with dyspareunia) or 150 mg once a day for up to 6 months (for patients with moderate liver disease). However, the dose is usually not more than 200 mg 2 times a day.
- Children—Use and dose must be determined by your doctor.
- For moderate to severe pain caused by endometriosis:
Missed Dose
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Storage
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Do not flush this medicine down the toilet.
Precautions
It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.
Using this medicine while you are pregnant can harm your unborn baby. Birth control pills may not work as well to prevent pregnancy when used with this medicine. Use another form of birth control (eg, condoms, spermicide) along with your pills. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before starting treatment. Use an effective form of birth control during treatment and for at least 28 days after the last dose. If a pregnancy occurs while using the medicine, tell your doctor right away.
Do not use this medicine together with cyclosporine (Neoral®, Sandimmune®) or gemfibrozil (Lopid®).
This medicine can cause your bone mineral density to decrease, which may lead to osteoporosis or weakened bones. Check with your doctor if you have pain in the back, ribs, arms, or legs, or a decrease in your height.
This medicine may cause changes in menstrual bleeding, which may decrease your ability to recognize a pregnancy from occurring. Talk to your doctor if you have concerns.
Elagolix may cause some people to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. Also tell your doctor if you have sudden or strong feelings, such as feeling nervous, angry, restless, violent, or scared. If you or your caregiver notice any of these side effects, tell your doctor right away.
Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
More common
- Absent, missed, or irregular menstrual periods
- bone loss
- fast heartbeat
- fever
- hives, itching, skin rash
- hoarseness
- irritation
- joint pain, stiffness, or swelling
- mood swings
- redness of the skin
- stopping of menstrual bleeding
- swelling of the eyelids, face, lips, hands, or feet
- tightness in the chest
- trouble breathing or swallowing
Less common
- Anxiety
- bleeding between periods
- change in pattern of monthly periods
- change in the amount of bleeding during periods
- discouragement
- feeling sad or empty
- irritability
- lack of appetite
- loss of interest or pleasure
- tiredness
- trouble concentrating
- trouble sleeping
Rare
- Back pain
- bloating
- nausea
- severe cramping
- stomach or lower abdominal pain
- thoughts or attempts at killing oneself
- vomiting
Incidence not known
- Cough
- dizziness
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- redness of the skin
- unusual tiredness or weakness
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
- Feeling of warmth
- night sweats
Less common
- Constipation
- decreased interest in sexual intercourse
- diarrhea
- difficulty in moving
- muscle pain or stiffness
- weight gain
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
CON-XXXXXXXX
