Abigale
Abigale is combination hormone replacement therapy (HRT) that contains estradiol (an estrogen) and norethindrone (a progestin). It’s used to treat hot flashes and vaginal symptoms caused by menopause, and it can also help prevent bone thinning (osteoporosis) after menopause. You take it by mouth once a day. The tablet is available in two strengths: Abigale (1 mg/0.5 mg) and Abigale Lo (0.5 mg/0.1 mg). Common effects include breast tenderness, headache, and irregular vaginal bleeding.
Abigale is a branded generic of Activella, the brand name medication.
What is Abigale?
What is Abigale used for?
In women who have a healthy uterus:
- Moderate-to-severe vasomotor symptoms of menopause, like hot flashes and night sweats - Abigale and Abigale Lo
- Moderate-to-severe vaginal dryness, burning, and irritation caused by menopause - Abigale only
- Prevention of osteoporosis after menopause - Abigale and Abigale Lo
How Abigale works
Abigale is a hormone replacement therapy (HRT) that replaces estrogen and progesterone hormones during menopause:
- Estradiol is an estrogen. It replaces estrogen levels that naturally decrease after menopause to relieve symptoms such as hot flashes and vaginal dryness. It can also help to lower the risk of bone loss.
- Norethindrone is a progestin. It helps protect the lining of the uterus from changes caused by estrogen therapy.
Drug facts
| Common Brands | Abigale, Abigale Lo |
|---|---|
| Drug Class | Estrogen replacement / Progestin |
| Controlled Substance Classification | Not a controlled medication |
| Generic Status | Lower-cost generic available |
| Availability | Prescription only |
Side effects of Abigale
The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.
Common Side Effects
Vasomotor symptoms (hot flashes) — Abigale
- Breast pain (21%)
- Headache (17%)
- Vaginal bleeding (10%)
- Upper respiratory tract infection (10%)
- Nausea (10%)
- Sinus inflammation (7%)
- Ovarian cyst (7%)
Vaginal symptoms — Abigale
- Breast pain (24%)
- Upper respiratory tract infection (18%)
- Headache (16%)
- Sinus inflammation (7%)
- Back Pain (6%)
- Trouble sleeping (6%)
- Vaginal bleeding (5%)
- Uterine fibroid (5%)
Prevention of bone loss — Abigale
- Breast pain (17%)
- Accidental injury (17%)
- Upper respiratory tract infection (15%)
- Sinus inflammation (15%)
- Vaginal bleeding (11%)
- Headache (11%)
- Nausea (11%)
- Weight gain (9%)
Abigale Lo
- Vaginal bleeding (26%)
- Headache (22%)
- Nose and throat inflammation (21%)
- Back pain (10%)
- Uterine lining thickening (10%)
- Diarrhea (6%)
- Nausea (5%)
- Pain in arms or legs (5%)
Less Common Side Effects
- Mood changes
- Migraine
- Holding on to more fluid
- Rash
- Dark patches on skin
- Stomach pain
- Stomach infection
- Weight changes
- Viral infection
- Yeast infection
- Dizziness
- Nervousness
- Leg cramps
- Tiredness
- Changes to sex drive
Abigale serious side effects
Contact your healthcare provider immediately if you experience any of the following.
- Blood clots: trouble breathing, chest pain, leg pain or swelling, skin that's warm to the touch
- Heart attack: chest pain, arm pain, shortness of breath, cold sweats, lightheadedness
- Stroke: sudden weakness on one side of your body, drooping face, changes in your speech or vision, confusion, headache
- High calcium levels: tiredness, muscle weakness, nausea, vomiting, constipation
- Low calcium levels: muscle spasms or twitching, numbness and tingling in your fingers, toes, or around your mouth
- Unusual vaginal bleeding, vaginal discharge, or pelvic pain
The following Abigale side effects have also been reported
Side effects that you should report to your care team as soon as possible:
- Allergic reactions or angioedema—skin rash, itching or hives, swelling of the face, eyes, lips, tongue, arms, or legs, trouble swallowing or breathing
- Blood clot—pain, swelling, or warmth in the leg, shortness of breath, chest pain
- Breast tissue changes, new lumps, redness, pain, or discharge from the nipple
- Gallbladder problems—severe stomach pain, nausea, vomiting, fever
- Heart attack—pain or tightness in the chest, shoulders, arms, or jaw, nausea, shortness of breath, cold or clammy skin, feeling faint or lightheaded
- Increase in blood pressure
- Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
- Stroke—sudden numbness or weakness of the face, arm, or leg, trouble speaking, confusion, trouble walking, loss of balance or coordination, dizziness, severe headache, change in vision
- Sudden eye pain or change in vision such as blurry vision, seeing halos around lights, vision loss
- Unusual vaginal discharge, itching, or odor
- Vaginal bleeding after menopause, pelvic pain
Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):
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Pros and cons of Abigale
Pros
- Taken by mouth once daily
- Helps relieve menopause symptoms
- Contains both estrogen and progestin in one tablet
- Available in two strengths
Cons
- Raises the risk of blood clots, stroke, and heart attack
- Can cause vaginal bleeding or spotting
- Needs regular check‑ins
- Interacts with certain medications and supplements
Pharmacist tips for Abigale
- Take Abigale at the same time every day. This keeps hormone levels steady and helps reduce spotting and other side effects. Set an alarm or use the calendar on the package to keep track.
- Tell your care team about all medications and supplements before starting Abigale. Some products (like St. John’s wort, and carbamazepine can lower estrogen levels and make Abigale work less well. Others (like clarithromycin and grapefruit juice) can raise levels and side effects.
- Watch for blood clot warning signs while taking Abigale. Get medical help right away if you have chest pain, shortness of breath, or a painful, swollen leg.
- Your prescriber might ask you to stop Abigale 4 to 6 weeks before major surgery or during long periods of minimal movement to lower clot risk.
- Tell your care team if you have unusual vaginal bleeding while taking Abigale. Light spotting can happen at first, but heavy or ongoing bleeding should be checked.
- If you get new or worse migraines, vision changes, or sudden severe headaches, stop Abigale and get medical attention.
- Abigale can raise your blood sugar or blood pressure. If you have diabetes or high blood pressure, your care team might ask you to check these levels more often.
- Because of the risk of serious side effects, take Abigale for the shortest time needed to treat your symptoms. Check in with your prescriber every 3 to 6 months to see if you still need treatment.
Risks and warnings for Abigale
Abigale can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Blood clots, heart attacks, and strokes
- Risk factors: Personal or family history of blood clots | High blood pressure | Diabetes | High cholesterol | Smoking | People who identify as obese | Systemic lupus erythematosus (SLE)
Estrogen/progestin HRTs like Abigale can increase your risk of blood clots. Sometimes, these blood clots can be very dangerous and lead to a heart attack, stroke, or pulmonary embolism (blood clot in the lungs).
Tell your prescriber about your full medical history so they can check your risk for blood clots. Also tell your prescriber about any planned procedures or long periods of bedrest. Your prescriber will let you know when to stop Abigale before your procedure and when to restart it afterwards to lessen your risk for blood clots. In general, you should take the lowest dose of Abigale for the shortest period of time possible to lower your risk for blood clots.
Be aware of the signs and symptoms of a blood clot and related complications.
- Blood clot in arm or leg: swelling or pain in the arm or leg
- Blood clot in the lung: chest pain, trouble breathing
- Blood clot in the eye: sudden partial or complete vision loss, bulging eyes, double vision
- Heart attack (blood clot near the heart): chest pain, arm pain, shortness of breath, a cold sweat, lightheadedness
- Stroke (blood clot in the brain): sudden weakness on one side of the body, drooping face, trouble breathing, bad headache, changes in speech or vision
Get medical help right away if you have any signs or symptoms of a blood clot.
Breast cancer
- Risk factors: Personal or family history of breast cancer | Using hormonal therapy for a long period of time
Estrogen/progestin combination HRTs, such as Abigale, can raise your risk of breast cancer. This risk might be higher than with estrogen-only hormone therapy, especially if you take the medication for a long time.
To help lower your risk of breast cancer, your prescriber will usually recommend the lowest dose of Abigale for the shortest time needed. Check your breasts regularly for changes and get mammograms as recommended. Tell your care team if you notice a new lump or changes in the size, shape, or appearance of your breasts.
Uterine (endometrial) cancer
- Risk factors: Estrogen therapy without additional progestin | People with a healthy uterus | Using estrogen therapy for more than 1 year | High estrogen dose
Abigale contains estradiol, which works like estrogen in your uterus. Estrogen can cause the lining of the uterus (endometrium) to grow too much, which can raise the risk of uterine (endometrial) cancer. This risk is lower with Abigale than with estrogen-only therapy because it also contains a progestin, which helps protect the uterine lining.
Even so, it’s important to watch for warning signs of uterine cancer. Tell your care team right away if you have unusual vaginal bleeding, especially if it doesn’t go away or keeps coming back. If you have concerns about your risk of uterine cancer, talk with your prescriber.
Dementia
- Risk factors: Age 65 years or older
People aged 65 years and older who take medications with estrogen, such as Abigale, might have a higher risk of developing dementia. Estrogen therapy shouldn't be used to prevent dementia.
Be aware of the early signs and symptoms of dementia, such as becoming confused or more forgetful, getting lost, and having trouble doing familiar things at home or at work. Speak with your prescriber if the risk for dementia worries you.
Ovarian cancer
Estrogen/progestin hormone replacement therapies (HRTs) like Abigale could raise your risk of ovarian cancer. Although this risk is small, it’s important to be aware of possible symptoms.
Tell your care team if you notice unusual vaginal bleeding, abnormal vaginal discharge, pelvic pain, bloating, or a feeling of fullness that doesn’t go away. These can be signs of ovarian cancer and should be checked by your care team.
Liver or gallbladder problems
- Risk factors: History of liver problems or jaundice
The risk for gallbladder problems is higher for people who've gone through menopause and are taking estrogen therapy like Abigale. Sometimes, these gallbladder problems require surgery. Let your prescriber know if you've previously had jaundice (yellowing of your skin or whites of the eyes). And tell your care team if you start having jaundice, stomach pain that doesn't go away, nausea, or vomiting while you're taking this medication. These can be signs of liver damage or gallbladder problems.
Changes in calcium levels in the blood
- Risk factors: Breast cancer | Cancer that has spread to the bones | Low parathyroid hormone levels Estrogen therapy, such as Abigale, can change the calcium levels in the blood. People with breast cancer and people with cancer that's spread to the bones are at higher risk of dangerously high calcium levels while they're taking estrogens. Tell your care team if you have any symptoms of high calcium levels, including tiredness, muscle weakness, bone pain, nausea, constipation, and thirst.
On the other hand, estrogen therapy can make calcium levels drop in people with low parathyroid hormone levels. Contact your care team if you have symptoms of low calcium levels, such as muscle cramps; brittle nails; and tingling in your fingers, toes, or lips.
Vision problems
Although very rare, some people taking estrogens have had vision problems due to clot formation in the eyes. If you have sudden partial or complete vision loss, bulging eyes, double vision, or migraines, stop Abigale and tell your care team.
High triglyceride (fat) levels
- Risk factors: History of high triglyceride levels in the blood
Let your prescriber know if you have a history of having high triglyceride levels. It's possible that the estrogen in Abigale can raise the amount of triglycerides (fat) in the blood. And having too much in the blood can lead to swelling of the pancreas (pancreatitis). Tell your care team right away if you have symptoms of pancreatitis, like sudden stomach or back pain, nausea, vomiting, fever, or weakness.
Low thyroid hormone levels
- Risk factors: Conditions that cause low thyroid hormone levels
The estrogen in Abigale can cause changes to the thyroid hormone levels in the body. It's harder for the body to adjust to these changes for people with low thyroid hormone levels (hypothyroidism) than for an average person. If you take thyroid replacement medication for your thyroid condition, you might need a higher dose of your thyroid medication. Work with your prescriber to adjust the dose of your thyroid medication.
Buildup of fluids in your body (fluid retention)
- Risk factors: Certain heart conditions | Kidney problems
Estrogen/progestin combination therapies like Abigale can make your body hold onto extra fluids. This can sometimes cause swelling of your hands and feet. Fluid retention can worsen symptoms of certain heart conditions, like heart failure, and kidney damage. Tell your healthcare team if you notice any signs of worsening fluid retention (e.g., swelling, sudden weight gain) while you're taking Abigale if you have heart or kidney problems.
Worsening of certain other health conditions
Before you start Abigale, speak with your care team about your medical history. Taking estrogen-containing medications can worsen certain health conditions and you might require closer follow up. These health conditions include diabetes, asthma, migraine, lupus, seizures, and hereditary angioedema.
Abigale dosage
| Dosage | Quantity | Price as low as | Price per unit |
|---|---|---|---|
| 28 tablets of 1mg/0.5mg | 3 cartons | $54.33 | $18.11 |
Typical dosage for Abigale
The tablets come in two different strengths:
- Abigale: 1 mg estradiol / 0.5 mg norethindrone
- Abigale Lo: 0.5 mg estradiol / 0.1 mg norethindrone
The typical dose is 1 tablet by mouth once daily.
How much does Abigale cost?
Abigale contraindications
Contraindications are specific health conditions or situations in which a person should not take a medication due to safety concerns. If you have any of the following conditions or if any of the following apply to you, let your healthcare provider know because Abigale will not be safe for you to take.
- Abnormal vaginal bleeding that a healthcare professional hasn't diagnosed yet
- Currently have or have had breast cancer
- Currently have or have had a tumor that depends on estrogen for growth
- Currently have or have had a blood clot (e.g., DVT, PE)
- History of stroke or heart attack
- Blood-clotting conditions
- Liver damage or liver problems
