For Women with Ductal Carcinoma in Situ (DCIS) and Women at High Risk for Breast Cancer: Serious and life-threatening events associated with tamoxifen citrate in the risk reduction setting (women at high risk for cancer and women with DCIS) include uterine malignancies, stroke and pulmonary embolism. Incidence rates for these events were estimated from the National Surgical Adjuvant Breast and Bowel Project's P-1 (NSABP P-1) trial. Uterine malignancies consist of both endometrial adenocarcinoma (incidence rate per 1,000 women-years of 2.20 for tamoxifen citrate versus 0.71 for placebo) and uterine sarcoma (incidence rate per 1,000 women-years of 0.17 for tamoxifen citrate versus 0.4 for placebo). For stroke, the incidence rate per 1,000 women-years was 1.43 for tamoxifen citrate versus 1 for placebo. For pulmonary embolism, the incidence rate per 1,000 women-years was 0.75 for tamoxifen citrate versus 0.25 for placebo.
Some of the strokes, pulmonary emboli, and uterine malignancies were fatal.
Health care providers should discuss the potential benefits versus the potential risks of these serious events with women at high risk of breast cancer and women with DCIS considering tamoxifen citrate to reduce their risk of developing breast cancer.
The benefits of tamoxifen citrate outweigh its risks in women already diagnosed with breast cancer .
Serious and life-threatening uterine malignancies, stroke, and pulmonary embolism have been associated with tamoxifen use in the risk reduction setting (women with Ductal Carcinoma in Situ (DCIS) and women at high risk for breast cancer). Some of these adverse events were fatal. Health care providers should discuss the potential benefits versus the potential risks of these serious events with women at high risk of breast cancer and women with DCIS considering tamoxifen to reduce their risk of developing breast cancer. The benefits of tamoxifen outweigh its risks in women already diagnosed with breast cancer .
Commonly used brand name(s):
In the U.S.
Available Dosage Forms:
Therapeutic Class: Antiestrogen
Tamoxifen is a medicine that blocks the effects of the estrogen hormone in the body. It is used to treat breast cancer in women or men. It may also be used to treat other kinds of cancer, as determined by your doctor.
Tamoxifen also may be used to reduce the risk of developing breast cancer in women who have a high risk of developing breast cancer. Women at high risk for developing breast cancer are at least 35 years of age and have a combination of risk factors that make their chance of developing breast cancer 1.67% or more over the next 5 years. Your doctor will help to determine your risk of developing breast cancer.
The exact way that tamoxifen works against cancer is not known, but it may be related to the way it blocks the effects of estrogen on the body.
Before you begin treatment with tamoxifen, you and your doctor should talk about the good tamoxifen will do as well as the risks of using it.
Tamoxifen is available only with your doctor's prescription.
Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, tamoxifen is used in certain patients with the following medical conditions:
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 tamoxifen, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to tamoxifen 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.
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. Although there is no specific information comparing use of tamoxifen in the elderly with use in other age groups, tamoxifen is not expected to cause different side effects or problems in older people than it does in younger adults.
|All Trimesters||D||Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.|
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.
Using tamoxifen 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.
Using tamoxifen 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.
Using tamoxifen with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
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.
The presence of other medical problems may affect the use of tamoxifen. Make sure you tell your doctor if you have any other medical problems, especially:
Use tamoxifen only as directed by your doctor. Do not use more or less of it, and do not use it more often than your doctor ordered. The exact amount of medicine you need has been carefully worked out. Taking too much may increase the chance of side effects, while taking too little may not improve your condition.
Tamoxifen sometimes causes mild nausea and vomiting. However, it may have to be taken for several weeks or months to be effective. Even if you begin to feel ill, do not stop using tamoxifen without first checking with your doctor. Ask your health care professional for ways to lessen these effects.
Swallow the tablets whole with a drink of water. You can take the tablets with or without food.
If you vomit shortly after taking a dose of tamoxifen, check with your doctor. You will be told whether to take the dose again or to wait until the next scheduled dose.
The dose of tamoxifen 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 tamoxifen. 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.
If you miss a dose of tamoxifen, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Call your doctor or pharmacist for instructions.
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.
It is very important that your doctor check your progress at regular visits to make sure that tamoxifen is working properly and to check for unwanted effects.
A woman should contact her doctor right away if she develops:
If you seek medical attention for any reason, be sure to tell your doctor that you take tamoxifen or have taken tamoxifen.
For women: Tamoxifen may make you more fertile. It is best to use some type of birth control while you are taking it. However, do not use oral contraceptives (“the Pill”) since they may change the effects of tamoxifen. Tell your doctor right away if you think you have become pregnant while taking tamoxifen.
Because of the way tamoxifen acts on the body, there is a chance that it might cause unwanted effects that may not occur until months or years after the medicine is used. Tamoxifen increases the chance of cancer of the uterus (womb) in some women taking it. Tamoxifen may cause blockages to form in a vein, lung, or brain. In women, tamoxifen may cause cancer or other problems of the uterus (womb). It also causes liver cancer in rats. In addition, tamoxifen has been reported to cause cataracts and other eye problems. Discuss these possible effects with your doctor.
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:Less common or rare
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
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.
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