What is/are Toremifene?
Toremifene citrate is an oral selective estrogen receptor modulator (SERM) which helps oppose the actions of estrogen in the body. Licensed in the United States under the brand name Fareston, toremifene citrate is FDA-approved for use in advanced (metastatic) breast cancer. It is also being evaluated for prevention of prostate cancer under the brand name Acapodene.
In 2007 the pharmaceutical company GTx, Inc was conducting two different phase 3 clinical trials; First, a pivotal Phase clinical trial for the treatment of serious side effects of androgen deprivation therapy (ADT) (especially vertebral/spine fractures and hot flashes, lipid profile, and gynecomastia) for advanced prostate cancer, and second, a pivotal Phase III clinical trial for the prevention of prostate cancer in high risk men with high grade prostatic intraepithelial neoplasia, or PIN. Results of these trials are expected by first quarter of 2008
An NDA for the first application (relief of prostate cancer ADT side effects) was submitted in Feb 2009, and in Oct 2009 the FDA said they would need more clinical data, e.g. another phase III trial.
- Severe dizziness, fainting, fast or pounding heartbeats, seizure (convulsions);
- Nausea, vomiting, stomach pain, loss of appetite, constipation, increased thirst or urination, muscle pain or weakness, joint pain, confusion, and feeling tired or restless;
- Easy bruising, unusual bleeding, purple or red pinpoint spots under your skin;
- Vaginal bleeding or discharge;
- Chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
- Sudden numbness or weakness, especially on one side of the body;
- Chest pain, sudden cough, wheezing, rapid breathing, coughing up blood;
- Pain, swelling, warmth, or redness in one or both legs;
- Blurred vision, eye pain, or seeing halos around lights;
- Jaundice (yellowing of the skin or eyes);
- Tremor; or
- Loss of movement in any part of your body.
Less serious side effects of toremifene may include:
- Sweating, hot flashes;
- Mild nausea, constipation;
- Dizziness, spinning sensation;
- Depressed mood;
- Swelling in your hands or feet;
- Itching, skin discoloration; or
- Hair loss.
This article uses material from the Wikipedia article Toremifene, which is released under the Creative Commons Attribution-Share-Alike License 3.0.