Drug Uses

Evista is a prescription medicine used by women after menopause to treat or prevent a condition called osteoporosis. You should take calcium and vitamin D along with Evista if you do not get enough calcium and vitamin D in your diet.

How Taken

The recommended dosage is one 60-mg Evista tablet daily, which may be administered any time of day without regard to meals.

Warnings/Precautions

Before taking this medication, tell your doctor if you have a history of blood clots; stroke; cancer; increased triglycerides (a type of fat in the blood); or liver disease. You may not be able to take Evista, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above. Evista is in the FDA pregnancy category X. This means that Evista is known to cause birth defects in an unborn baby. Do not take Evista if you are pregnant or if you could become pregnant during treatment. It is not known whether Evista passes into breast milk. Do not take this medication without first talking to your doctor if you are breast-feeding a baby.

Missed Dose

Take the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and take only the next regularly scheduled dose. Do not take a double dose of this medication.

Possible Side Effects

An infrequent but serious side effect of taking Evista is the development of blood clots in the veins. These blood clots can stop blood flow and cause serious medical problems, disability or death. Call your doctor right away if you have or have had any of the following signs of blood clots in the legs, lungs or eyes: leg pain or a feeling of warmth in the calves, swelling of the legs, hands or feet, sudden chest pain, shortness of breath or coughing up blood, sudden change in your vision, such as loss of vision or blurred vision. Most of the side effects of Evista are mild and usually do not cause women to stop taking Evista. The most common side effects of Evista are hot flashes and leg cramps. Hot flashes are more common during the first 6 months after starting treatment. If you have any problems or questions that concern you while taking Evista, ask your doctor or pharmacist for more information.

Storage

Store at controlled room temperature, 20o to 25oC (68o to 77oF); allows excursions between 15o and 30oC (59o and 86oF).

Overdose

Incidents of overdose in humans have not been reported. There is no specific antidote for Evista.

More Information

Before having any surgery, tell your doctor that you are taking Evista. Treatment with Evista may need to be stopped temporarily if you require an extended period of bed rest. Avoid sitting still for long periods of time during travel while taking Evista. Alcohol and cigarette smoking may cause increased bone loss. Discuss with your doctor the use of these products.

Disclaimer

This drug information is for your information purposes only, it is not intended that this information covers all uses, directions, drug interactions, precautions, or adverse effects of your medication. This is only general information, and should not be relied on for any purpose. It should not be construed as containing specific instructions for any particular patient. We disclaim all responsibility for the accuracy and reliability of this information, and/or any consequences arising from the use of this information, including damage or adverse consequences to persons or property, however such damages or consequences arise. No warranty, either expressed or implied, is made in regards to this information.

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A: Sorry we ship only within the U.S, we cannot ship Internationally at this time.


July 24, 2007 -- An expert panel gave its OK for expanded use of the osteoporosis drug Evista Tuesday, telling the FDA that the drug appears effective in preventing some breast cancer.
If the agency follows the panel's advice, it would clear the way for the drug, also called raloxifene, to be legally sold as a cancer prevention agent to millions of women.
It would also position the drug as an alternative to the anti-estrogen drug tamoxifen, which has long been used to help fight breast cancer's return. In 1998, the FDA approved tamoxifen for use by women who hadn't had breast cancer but were at high risk of developing the disease.
Breast cancer is the second leading cause of cancer death among women, and about 40,500 American women will die from breast cancer in 2007, according to the American Cancer Society. About 13% of women are estimated to develop breast cancer in their lifetime, according to the National Cancer Institute.
"Postmenopausal women at high risk for invasive breast cancer, I think now should have a choice," says George Sledge, MD, a professor of medicine at Indiana University. Sledge is also a consultant for Eli Lilly & Co, the maker of Evista.
Experts voted 10-4, with one abstaining, to recommend that Lilly be allowed to market Evista's ability to cut the likelihood of breast cancer in postmenopausal women at high risk for tumors. A company study showed that raloxifene and tamoxifen are equally effective at reducing the risk of cancer in those women.
"I do believe raloxifene is effective in reducing breast cancer," says panelist Otis Brawley, MD, a professor of oncology at Emory University School of Medicine.
Close Decision
The panel voted 8 to 6, with one abstention, on whether Lilly should be allowed to promote Evista's possible cancer-fighting abilities to all postmenopausal women with osteoporosis.
Three studies filed by the company all showed that women who took Evista for up to five years developed fewer invasive breast cancers than women who took a placebo. But women who took the drug also had a higher risk of serious blood clots and fatal stroke.
An FDA analysis of the three studies was inconclusive as to whether Evista's potential benefits outweighed its risks. Agency officials said they were troubled because Lilly had not submitted any data showing whether women who take Evista actually live longer than those who don't.
"It is uncertain if the balance of benefits and risk factors for women at high risk is favorable because the magnitude of benefits is unknown," says Patricia Cortazar, MD, an FDA safety official.
Potential Risks
Several breast cancer advocacy groups opposed the approval. Carolina Hinestrosa, executive vice president of the Breast Cancer Coalition, says the government should boost efforts to find causes of breast cancer rather than approving drugs with relatively small benefits.
"Considering that most women will not develop breast cancer in their lifetimes ... taking raloxifene and tamoxifen as a risk reduction measure will be unnecessary for most," she says.
Some panelists urged the FDA to restrict the drug's marketing, particularly to keep it out of the hands of women at risk for cardiovascular disease. One panelist even suggested issuing a "black box" warning for Evista.
"There should be a strong effort to limit potential harm," says Curt D. Furburg, MD, a Wake Forest University professor of public health who voted to approve the new use for Evista.
Lilly paid $36 million in fines in 2005 after pleading guilty to illegally promoting Evista as a cancer-fighting drug. Critics said approving the new use for the drug would clear the way for the company to promote the drug with direct-to-consumer advertising.
Gwen Krivi, PhD, vice president of Lilly Research Laboratories, says the company will "continue working with the FDA to make this important option a reality for patients."

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