"The U.S. Food and Drug Administration today granted accelerated approval to Ibrance (palbociclib) to treat advanced (metastatic) breast cancer.
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IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
TAMOXIFEN - ORAL
COMMON BRAND NAME(S): Nolvadex, Soltamox
WARNING: Tamoxifen has rarely caused very serious (possibly fatal) strokes, blood clots in the lungs/legs, and cancer of the uterus. If you are taking tamoxifen to reduce the risk of breast cancer, or if your cancer is limited to the milk ducts (ductal carcinoma in situ-DCIS), then discuss the benefits and risks of taking this medication with your doctor. However, if you are taking tamoxifen to treat breast cancer, then the benefits of taking tamoxifen are greater than the risks of side effects.
Seek immediate medical attention if you develop symptoms of a stroke or blood clots in the lungs/legs, such as weakness on one side of the body, slurred speech, sudden vision changes, confusion, shortness of breath, chest pain, or calf pain/swelling.
Tell your doctor immediately if you develop symptoms of cancer of the uterus, such as unusual changes in your monthly period (e.g., amount or timing of bleeding), unusual vaginal discharge, or pain/pressure below your "belly button" (navel).
USES: Tamoxifen is used to treat breast cancer that has spread to other parts of the body (metastatic breast cancer), to treat breast cancer in certain patients after surgery and radiation therapy, and to reduce the chances of breast cancer in high-risk patients.
This medication can block the growth of breast cancer. It works by interfering with the effects of estrogen in the breast tissue.
HOW TO USE: Read the Medication Guide provided by your pharmacist before you start using tamoxifen and each time you get a refill. If you have any questions, consult your doctor or pharmacist.
Take this medication by mouth with or without food, usually once or twice daily for 5 years, or as directed by your doctor. Daily dosages greater than 20 milligrams are usually divided in half and taken twice a day, in the morning and evening, or as directed by your doctor. If you are using the liquid, measure the dose carefully using a special measuring device/spoon. Do not use a household spoon because you may not get the correct dose.
Dosage is based on your medical condition and response to therapy.
Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time(s) each day.
If you have breast cancer that has spread to other parts of the body, you may experience increased bone/cancer pain and/or disease flare-up as you start taking tamoxifen. In some cases, this may be a sign of a good response to the medication. Symptoms include increased bone pain, increased tumor size, or even new tumors. These symptoms usually disappear quickly. In any case, report these symptoms immediately to your doctor.
Since this drug can be absorbed through the skin and lungs, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the tablets. (See also Precautions section.)
Inform your doctor immediately if your condition worsens (e.g., you get new breast lumps).
Additional Soltamox Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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