Applies to elagolix / estradiol / norethindrone: oral capsule.
Warning
Oral route (Capsule)
Thrombolic Disorders and Vascular EventsEstrogen and progestin combinations, including elagolix, estradiol, and norethindrone acetate plus elagolix, increase the risk of thrombotic or thromboembolic disorders, especially in women at increased risk for these events.Elagolix, estradiol, and norethindrone acetate plus elagolix is contraindicated in women with current or a history of thrombotic or thromboembolic disorders and in women at increased risk for these events including women over 35 years of age who smoke or women with uncontrolled hypertension.
Serious side effects
Along with its needed effects, elagolix/estradiol/norethindrone 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 while taking elagolix / estradiol / norethindrone:
Less common
- Blurred vision
- bone loss
- chest pain
- dark urine
- discouragement
- dizziness
- feeling sad or empty
- general feeling of tiredness or weakness
- headache
- irritability
- lack of appetite
- light-colored stools
- longer or heavier menstrual periods
- loss of interest or pleasure
- mood swings
- nervousness
- normal menstrual bleeding occurring earlier, possibly lasting longer than expected
- pounding in the ears
- slow or fast heartbeat
- stomach pain
- tenderness, pain, swelling, warmth, skin discoloration, and prominent superficial veins over the calf
- thoughts or attempts at killing oneself
- trouble concentrating
- trouble sleeping
- vomiting
- yellow eyes or skin
Rare
- Anxiety
- cough
- fainting
- trouble with breathing
Other side effects
Some side effects of elagolix / estradiol / norethindrone 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
- redness of the face, neck, arms, and occasionally, upper chest
Less common
- Chills
- decreased interest in sexual intercourse
- diarrhea
- difficulty in moving
- fever
- full or bloated feeling
- general feeling of discomfort or illness
- increased weight
- joint pain
- loss in sexual ability, desire, drive, or performance
- muscle pain or stiffness
- nausea
- pressure in the stomach
- runny nose
- shivering
- sore throat
- sweating
- swelling of the stomach area
- thinning or loss of hair
For Healthcare Professionals
Applies to elagolix / estradiol / norethindrone: oral capsule.
General
The more commonly reported adverse reactions have included hot flush, headache, fatigue, and metrorrhagia.[Ref]
Cardiovascular
Very common (10% or more): Hot flush (22%)
Common (1% to 10%): Hypertension
Uncommon (0.1% to 1%): Thrombotic events[Ref]
During clinical trials, 2 thrombotic events were reported (n=453). A woman with obesity developed thrombosis in her left calf after 30 days of treatment. A second woman developed a pulmonary embolism 8 months into treatment.
During clinical trials, maximum mean increases in systolic and diastolic blood pressure were 5.1 and 2.1 mmHg, respectively occurring at month 5 and month 4, respectively.[Ref]
Musculoskeletal
During clinical trials, BMD was assessed by dual-energy X-ray absorptiometry (DXA). At 6 months, the percent change in lumbar spine BMD was -0.7% in women receiving this drug compared with -0.1% for placebo. For women treated with this drug for 12 months, 27% experienced a decline in lumbar spine BMD of greater than 3%; 1.7% experienced a decline of 8% or greater. Following cessation of therapy, continued bone loss was observed at the lumbar spine, total hip, and femoral neck in 24%, 32%, and 40% of women, respectively; partial recovery occurred in 46%, 33%, and 38% and full recovery was observed in 30%, 35%, and 22% at these same sites.[Ref]
Very common (10% or more): Loss of bone mineral density (BMD) in lumbar spine (27%)
Common (1% to 10%): Arthralgia[Ref]
Metabolic
Common (1% to 10%): Increased weight
Psychiatric
During clinical trials, depression, depressed mood, and/or tearfulness were reported in 3% of women receiving this drug compared to 1% of placebo-treated women. In clinical trials for elagolix, a woman treated with lower dose elagolix alone completed suicide 2 days after elagolix discontinuation.[Ref]
Common (1% to 10%): Decreased libido; adverse mood changes including depression, depressed mood, tearfulness
Elagolix:
Frequency not reported: Suicide[Ref]
Genitourinary
Common (1% to 10%): Metrorrhagia[Ref]
Dermatologic
Common (1% to 10%): Alopecia[Ref]
Hepatic
Common (1% to 10%): Transaminase elevations[Ref]
During clinical trials, ALT and AST elevations of up to 3 times the upper limit of normal (3 x ULN) occurred in 1.1% and 1.3% of women treated with this drug, respectively compared with 0% receiving placebo. Peak elevation in AST of almost 8 x ULN and ALT of 6 x ULN was reported.[Ref]
Oncologic
In phase 3 trials, 2 cases of breast cancer were reported among 453 women receiving this drug.[Ref]
Uncommon (0.1% to 1%): Breast Cancer[Ref]
Nervous system
Common (1% to 10%): Headache[Ref]
Other
Common (1% to 10%): Fatigue[Ref]
Gastrointestinal
Common (1% to 10%): Abdominal distension, vomiting[Ref]
Respiratory
Common (1% to 10%): Upper respiratory tract infection[Ref]
Immunologic
Common (1% to 10%): Influenza
