Femtrace

Femtrace is a prescription medication used after menopause to reduce moderate to severe hot flashes. Femtrace contains the hormone, estradiol, and belongs to a group of drugs called estrogens. Femtrace works as a hormone replacement to relieve issues caused by hormonal changes. 

Femtrace comes in tablet form and is usually taken once daily, with or without food. 

Common side effects of Femtrace include headache, breast pain, and irregular vaginal bleeding or spotting.

Serious side effects have been reported with Femtrace including the following:

• heart attack
• stroke
• blood clots
• dementia
• breast cancer
• cancer of the lining of the uterus (womb)
• cancer of the ovary
• high blood pressure
• high blood sugar
• gallbladder disease
• liver problems
• changes in your thyroid hormone levels
• enlargement of benign tumors of the uterus (“fibroids”)

Call your healthcare provider right away if you get any of the following warning signs or any other unusual symptoms that concern you:

• new breast lumps
• unusual vaginal bleeding. Vaginal bleeding after menopause may be a warning sign of cancer of the uterus (womb). Your healthcare provider should check any unusual vaginal bleeding to find out the cause. 
• changes in vision or speech
• sudden new severe headaches
• severe pains in your chest or legs with or without shortness of breath, weakness, and fatigue

What can I do to lower my chances of a serious side effect with Femtrace?

• Talk with your healthcare provider regularly about whether you should continue taking Femtrace.
• If you have a uterus, talk with your healthcare provider about whether the addition of a progestin is right for you.
• The addition of a progestin is generally recommended for a woman with a uterus to reduce the chance of getting cancer of the uterus (womb).
• See your healthcare provider right away if you get vaginal bleeding while taking Femtrace.
• Have a pelvic exam, breast exam and mammogram (breast x-ray) every year unless your healthcare provider tells you something else.
• If members of your family have had breast cancer or if you have ever had breast lumps or an abnormal mammogram, you may need to have breast exams more often.
• If you have high blood pressure, high cholesterol (fat in the blood), diabetes, are overweight, or use tobacco, you may have a higher chance of getting heart disease.
• Ask your healthcare provider for ways of lowering your chances of getting heart disease.

Do not take Femtrace if you:

• are allergic to Femtrace or to any of its ingredients
• have unusual vaginal bleeding
• currently have or have had certain cancers. Estrogens may increase the chance of getting certain types of cancers, including cancer of the breast and uterus. If you have or have had cancer, talk with your healthcare provider about whether you should take Femtrace.
• had a stroke or heart attack
• currently have or have had blood clots
• currently have or have had liver problems
• have been diagnosed with a bleeding disorder
• think you may be pregnant

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to medicines in this group 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.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of estrogens and progestins in the elderly with use in other age groups.

Pregnancy

Estrogens and progestins are not recommended for use during pregnancy or right after giving birth. Becoming pregnant or maintaining a pregnancy is not likely to occur around the time of menopause.

Breast Feeding

Estrogens and progestins pass into the breast milk and can change the content or lower the amount of breast milk. Use of this medicine is not recommended in nursing mothers.

Interactions with Medicines

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 any of these medicines, 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 medicines in this class with any of the following medicines is not recommended. Your doctor may decide not to treat you with a medication in this class or change some of the other medicines you take.

• Boceprevir
• Dasabuvir
• Ombitasvir
• Paritaprevir
• Ritonavir
• Tranexamic Acid

Using medicines in this class 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.

• Anagrelide
• Aprepitant
• Boceprevir
• Bosentan
• Bupropion
• Carbamazepine
• Ceritinib
• Conivaptan
• Dabrafenib
• Darunavir
• Dasabuvir
• Dexamethasone
• Donepezil
• Efavirenz
• Eliglustat
• Enzalutamide
• Fosphenytoin
• Griseofulvin
• Idelalisib
• Isotretinoin
• Lesinurad
• Lixisenatide
• Lumacaftor
• Mitotane
• Modafinil
• Netupitant
• Oxcarbazepine
• Paclitaxel
• Paclitaxel Protein-Bound
• Phenytoin
• Piperaquine
• Pitolisant
• Pixantrone
• Prednisone
• Rifabutin
• Rifampin
• St John's Wort
• Sugammadex
• Theophylline
• Tizanidine
• Topiramate
• Ulipristal
• Valproic Acid

Interactions with Food/Tobacco/Alcohol

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 medicines in this class. Make sure you tell your doctor if you have any other medical problems, especially:

• Asthma or
• Calcium, too much or too little in blood or
• Diabetes mellitus (sugar diabetes)
• Epilepsy (seizures) or
• Heart problems or
• Kidney problems or
• Liver tumors, benign or
• Lupus erythematosus, systemic or
• Migraine headaches or
• Porphyria—Estrogens may worsen these conditions.

• Blood clotting problems (or history of during previous estrogen therapy)—Estrogens usually are not used until blood clotting problems stop; using estrogens is not a problem for most patients without a history of blood clotting problems due to estrogen use.

• Breast cancer or
• Bone cancer or
• Cancer of the uterus or
• Fibroid tumors of the uterus—Estrogens may interfere with the treatment of breast or bone cancer or worsen cancer of the uterus when these conditions are present.

• Changes in genital or vaginal bleeding of unknown causes—Use of estrogens may delay diagnosis or worsen condition. The reason for the bleeding should be determined before estrogens are used.

• Endometriosis or
• Gallbladder disease or gallstones (or history of) or
• High cholesterol or triglycerides (or history of) or
• Liver disease or
• Pancreatitis (inflammation of pancreas)—Estrogens may worsen these conditions; while estrogens can improve blood cholesterol, they may worsen blood triglycerides for some people.

• Hypothyroid (too little thyroid hormone)—Dose of thyroid medicine may need to be increased.

• Vision changes, sudden onset including
• Bulging eyes or
• Double vision or
• Migraine headache or
• Vision loss, partial or complete—Estrogens may cause these problems. Tell your doctor if you have had any of these problems, especially while taking estrogen or oral contraceptives (“birth control pills”).

Women rarely have severe side effects from taking estrogens to replace estrogen. Discuss these possible effects with your doctor:

The prolonged use of estrogens has been reported to increase the risk of endometrial cancer (cancer of the lining of the uterus) in women after menopause. This risk seems to increase as the dose and the length of use increase. When estrogens are used in low doses for less than 1 year, there is less risk. The risk is also reduced if a progestin (another female hormone) is added to, or replaces part of, your estrogen dose. If the uterus has been removed by surgery (total hysterectomy), there is no risk of endometrial cancer, and no need to take an estrogen and progestin combination.

It is not yet known whether the use of estrogens increases the risk of breast cancer in women. Although some large studies show an increased risk, most studies and information gathered to date do not support this idea.

Check with your doctor immediately if any of the following side effects occur:

Check with your doctor as soon as possible if any of the following side effects occur:

• Breast pain or tenderness
• dizziness or light-headedness
• headache
• rapid weight gain
• swelling of feet and lower legs
• vaginal bleeding

• Breast lumps
• change in vaginal discharge
• discharge from nipple
• nausea and vomiting
• pains in chest, groin, or leg, especially calf
• pains in stomach, side, or abdomen
• pain or feeling of pressure in pelvis
• severe or sudden headache
• sudden and unexplained shortness of breath
• sudden loss of coordination
• sudden slurred speech
• sudden vision changes
• weakness or numbness in arm or leg
• yellow eyes or skin

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:

• Back pain
• bloating or gas
• dizziness
• general feeling of tiredness
• flu-like symptoms
• mental depression
• muscle aches
• nausea—taking tablet with food may decrease
• vaginitis

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.

Femtrace therapy is indicated in the treatment of moderate to severe vasomotor symptoms associated with the menopause.

Femtrace (estradiol) is a form of estrogen, a female sex hormone produced by the ovaries. Estrogen is necessary for many processes in the body.

Femtrace is used to treat symptoms of menopause such as hot flashes, and vaginal dryness, burning, and irritation. Other uses include prevention of osteoporosis in postmenopausal women, and replacement of estrogen in women with ovarian failure or other conditions that cause a lack of natural estrogen in the body. Femtrace is sometimes used as part of cancer treatment in women and men.

Femtrace may also be used for other purposes not listed in this medication guide.

Femtrace can harm an unborn baby or cause birth defects. Do not use Femtrace if you are pregnant. You should not take Femtrace if you have abnormal vaginal bleeding, liver disease, breast or uterine cancer, hormone-dependent cancer, a recent history of heart attack or stroke, if you are pregnant, if you have ever had a blood clot (especially in your lung or your lower body), or if you are allergic to any medicines or food dyes. Taking hormones can increase your risk of blood clots, stroke, or heart attack, especially if you have diabetes, high blood pressure, high cholesterol or triglycerides, if you smoke, or if you are overweight.

Long-term Femtrace treatment may increase your risk of breast cancer, ovarian cancer, or uterine cancer. Talk with your doctor about your individual risks before using Femtrace long-term. Your doctor should check your progress every 3 to 6 months to determine whether you should continue this treatment.

Taking progestin while using Femtrace may lower your risk of uterine cancer. If your uterus has not been removed, your doctor may prescribe a progestin for you to take while you are using Femtrace.

Femtrace should not be used to prevent heart disease, stroke, or dementia, because this medication may actually increase your risk of developing these conditions.

Have regular physical exams and mammograms, and self-examine your breasts for lumps on a monthly basis while using Femtrace.

Take Femtrace exactly as it was prescribed for you. Do not use the medication in larger amounts, or use it for longer than recommended by your doctor.

Long-term Femtrace treatment may increase your risk of breast cancer, ovarian cancer, or uterine cancer. Talk with your doctor about your individual risks before using Femtrace long-term.

Taking progestin while using Femtrace may lower your risk of uterine cancer. If your uterus has not been removed, your doctor may prescribe a progestin for you to take while you are using Femtrace.

Have regular physical exams and mammograms, and self-examine your breasts for lumps on a monthly basis while using Femtrace. Your doctor should check your progress every 3 to 6 months to determine whether you should continue this treatment.

If you need medical tests or surgery, or if you will be on bed rest, you may need to stop using this medication for a short time. Any doctor or surgeon who treats you should know that you are taking Femtrace.

Store Femtrace at room temperature away from moisture, heat, and light.

Do not smoke while using Femtrace. Smoking can increase your risk of blood clots, stroke, or heart attack caused by estradiol.

Tell your doctor about all other medicines you use, especially:

• a blood thinner such as warfarin (Coumadin);

• cimetidine (Tagamet);

• carbamazepine (Carbatrol, Tegretol);

• phenobarbital (Luminal, Solfoton);

• phenytoin (Dilantin);

• rifampin (Rifadin, Rifater, Rifamate, Rimactane); or

• ritonavir (Norvir);

• St. John's wort;

• an antibiotic such as clarithromycin (Biaxin) or erythromycin (E-Mycin, E.E.S., Erythrocin, Ery-Tab); or

• antifungal medication such as ketoconazole (Extina, Ketozole, Nizoral, Xolegal).

This list is not complete and other drugs may interact with Femtrace. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.