Drug Uses

Vaniqa (Cream) is a prescription medication applied to the skin for the reduction of unwanted facial hair in women. Vaniqa interferes with an enzyme found in the hair follicle of the skin needed for hair growth. This results in slower hair growth and improved appearance where Vaniqa is applied. Vaniqa does not permanently remove hair or "cure" unwanted facial hair. It is not a depilatory. Your treatment program should include continuation of any hair removal technique you are currently using. Vaniqa will help you manage your condition and improve your appearance.

How Taken

Apply a thin layer of Vaniqa Cream to affected areas of the face and adjacent involved areas under the chin and rub in thoroughly. Do not wash treated area for at least 4 hours. Use twice daily at least 8 hours apart or as directed by a physician. You should continue to use hair removal techniques as needed in conjunction with Vaniqa. (Vaniqa should be applied at least 5 minutes after hair removal). Cosmetics or sunscreens may be applied over treated areas after cream has dried.

Warnings/Precautions

Do not use Vaniqa if you have had an allergic reaction to it in the past. Vaniqa is in the FDA pregnancy category C. This means that it is not known whether Vaniqa will harm an unborn baby. Do not use this medication without first talking to your doctor if you are pregnant. It is also not known whether Vaniqa passes into breast milk. Do not use Vaniqa without first talking to your doctor if you are breast-feeding a baby. Vaniqa has not been approved for use by children younger than 12 years of age.

Missed Dose

If you forget or miss a dose of Vaniqa do not try to "make it up". Return to your normal application schedule as soon as you can.

Possible Side Effects

Vaniqa may cause temporary redness, stinging, burning, tingling or rash on areas of the skin where it is applied. Hair bumps may also occur. If these persist, consult your doctor. Treatment related skin adverse events that occurred in less than 1% of the subjects treated with Vaniqa are: bleeding skin, cheilitis, and contact dermatitis, swelling of lips, herpes simplex, numbness and rosacea. Adverse events were primarily mild in intensity and generally resolved without medical treatment or discontinuation of Vaniqa.

Storage

Store at 25° C (77° F); excursions permitted to 15° C-30° C (59° F-86° F). Do not freeze. See tube crimp and carton end for expiration date and lot number.

Overdose

An overdose of Vaniqa is not likely to occur. If the cream has been ingested, or if you suspect an overdose has occurred, contact your doctor, hospital emergency room, or poison control center for advice.

More Information

Avoid getting this medication in your eyes, nose, or mouth. If this occurs, wash the area with water. If Vaniqa gets in your eyes, rinse thoroughly with water and contact your doctor.

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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Q: How does the online consultation for Vaniqa work?
A: Online consultations utilizes the Internet to improve patient access to the physician. The patient no longer needs to receive a traditional physical exam by the physician. Now he simply completes an online questionnaire for Vaniqa, and this questionnaire is then submitted to the physician using our secure order system. The online consultations can never take the place of traditional medicine, they do provide a valid means for patients to receive treatment for a number of conditions that, in many circumstances, do not actually require a physical exam.


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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