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Preparing For A Conversation About Metastatic Melanoma

San Diego, California (NAPSI) - Dealing with a new cancer diagnosis can be overwhelming. But talking to your medical team about the disease treatment options available and personal goals may help best address your specific case.

 

When Jim Murch went for a chest X-ray, his doctor discovered a mass that turned out to be melanoma, a form of skin cancer in which cells that produce the skin’s pigment grow out of control. Murch was shocked to learn that his cancer had already developed into metastatic melanoma, the deadliest form of the disease.

“When my doctor found the mass, my wife and I were in denial,” Murch said. “But an open discussion with my medical team helped me understand my diagnosis and learn more about the available treatment options.”

If you or a loved one is faced with a diagnosis of metastatic melanoma, you may feel overwhelmed with questions about the disease and next steps. It is important to have an open dialogue with your medical team to help get the information you need. Here are some important topics you may want to discuss with your medical team following a metastatic melanoma diagnosis.

1. Understanding Your Diagnosis

Your medical team may talk about melanoma in terms of “stages,” starting at stage 0 and going up to stage IV. The stages are determined by how thick the tumor is and whether the cancer has spread to lymph nodes or other parts of your body. For metastatic melanoma, you may have a diagnosis of stage IV, meaning the cancer has spread to one or more distant sites.

2. Choosing Your Treatment Plan

Depending on your diagnosis, your medical team may discuss with you potential treatment options for metastatic melanoma. This may include immunotherapy, targeted therapy, or other treatment approaches. It is important to discuss with your medical team the potential risks and benefits of a treatment, based on a product’s FDA-approved label.

3. Achieving Treatment Goals

It is also important to discuss your personal treatment goals with your medical team, as this may help inform treatment decisions.

A metastatic melanoma diagnosis can be a difficult experience for patients and their loved ones. Fortunately, in recent years, additional therapies have become available to help fight the disease. One of these treatment options is Yervoy, also known as ipilimumab. Upon approval by the U.S. FDA in 2011, it became the first treatment for metastatic melanoma to significantly extend survival for patients in a phase III study.

Yervoy is approved for the treatment of patients with melanoma that has spread (metastatic) or cannot be removed through surgery (unresectable), and works through the immune system. Yervoy (ipilimumab) may not work in all patients and may affect healthy cells, too, which could result in serious side effects in many parts of the body. Some of these side effects may lead to death. A phase III clinical study showed that some patients taking Yervoy lived much longer than patients who did not receive it. People treated with Yervoy lived a median of 10 months, compared to a median of six months for those who were treated with an experimental drug alone.

As follow-up of these patients continued, it was estimated that 46 percent of patients taking Yervoy alone were alive at one year and 24 percent were alive at two years. By comparison, 25 percent of patients taking the experimental drug alone were alive at one year and 14 percent at two years.

Of the 676 patients in this trial, 137 patients (20 percent) received Yervoy alone, 136 patients (20 percent) received another experimental drug alone, and 403 patients (60 percent) received both treatments. In the trial, patients were previously treated with one or more of the following: aldesleukin, dacarbazine, temozolomide, fotemustine, or carboplatin. The primary goal was to measure how long patients lived with Yervoy in combination with the experimental drug compared to the experimental drug alone. Over the course of the study, treatment with Yervoy decreased the risk of death by about one-third compared to patients who received the experimental drug. Individual results will vary.

The serious side effects of Yervoy (ipilimumab) may include: inflammation of the intestines (colitis) that can cause tears or holes (perforation) in the intestines; inflammation of the liver (hepatitis) that can lead to liver failure; inflammation of the skin that can lead to severe skin reaction (toxic epidermal necrolysis); inflammation of the nerves that can lead to paralysis; inflammation of hormone glands (especially the pituitary, adrenal, and thyroid glands) that may affect how these glands work; and inflammation of the eyes. In addition to the serious side effects, the most common side effects of Yervoy are tiredness, diarrhea, itching, and rash.

These side effects are most likely to begin during treatment; however, side effects can show up months after the last infusion. Healthcare providers should perform blood tests, such as liver and thyroid function tests, before starting and during treatment with Yervoy. The oncologist may decide to delay or stop Yervoy.

Patients should call their healthcare provider if they have any signs or symptoms or they get worse. Even seemingly mild symptoms can lead to severe or even life-threatening conditions if not addressed. Patients should not try to treat symptoms themselves.

These are not all of the possible side effects of Yervoy. Please see the Important Safety Information below for additional information.

Talk to your healthcare provider about any questions you may have about your health or Yervoy. To learn more, visit www.Yervoy.com.

 

Important Safety Information

Yervoy (ipilimumab) can cause serious side effects in many parts of your body which can lead to death. These serious side effects may include: inflammation of the intestines (colitis) that can cause tears or holes (perforation) in the intestines; inflammation of the liver (hepatitis) that can lead to liver failure; inflammation of the skin that can lead to severe skin reaction (toxic epidermal necrolysis); inflammation of the nerves that can lead to paralysis; inflammation of hormone glands (especially the pituitary, adrenal, and thyroid glands) that may affect how these glands work; and inflammation of the eyes.

These side effects are most likely to begin during treatment; however, side effects can show up months after your last infusion. Your healthcare provider should perform blood tests, such as liver and thyroid function tests, before starting and during treatment with Yervoy. Your oncologist may decide to delay or stop Yervoy.

Call your healthcare provider if you have any signs or symptoms or they get worse. Even seemingly mild symptoms can lead to severe or even life-threatening conditions if not addressed. Do not try to treat symptoms yourself.

Serious side effects may include:

• Inflammation of the intestines (colitis) that can cause tears or holes (perforation) in the intestines. Signs and symptoms of colitis may include:

o diarrhea (loose stools) or more bowel movements than usual

o blood in your stools or dark, tarry, sticky stools

o stomach pain (abdominal pain) or tenderness

• Inflammation of the liver (hepatitis) that can lead to liver failure. Signs and symptoms of hepatitis may include:

o yellowing of your skin or the whites of your eyes

o dark urine (tea colored)

o nausea or vomiting

o pain on the right side of your stomach

o bleeding or bruise more easily than normal

• Inflammation of the skin that can lead to severe skin reaction (toxic epidermal necrolysis). Signs and symptoms of severe skin reactions may include:

o skin rash with or without itching

o sores in your mouth

o your skin blisters and/or peels

• Inflammation of the nerves that can lead to paralysis. Symptoms of nerve problems may include:

o unusual weakness of legs, arms, or face

o numbness or tingling in hands or feet

• Inflammation of hormone glands (especially the pituitary, adrenal, and thyroid glands) that may affect how these glands work. Signs and symptoms that your glands are not working properly may include:

o persistent or unusual headaches

o unusual sluggishness, feeling cold all the time, or weight gain

o changes in mood or behavior such as decreased sex drive, irritability, or forgetfulness

o dizziness or fainting

• Inflammation of the eyes. Symptoms may include:

o blurry vision, double vision, or other vision problems

o eye pain or redness

Pregnancy and Nursing:

• Tell your healthcare provider if you are pregnant or plan to become pregnant. Yervoy (ipilimumab) may cause stillbirth, premature delivery, and/or death of your unborn baby. Before starting Yervoy, tell your healthcare provider if you are breast-feeding. It is advised that nursing mothers do not breast-feed while taking Yervoy.

Tell your healthcare provider about:

• Your health problems if you:

o have an active condition where your immune system attacks your body (autoimmune disease), such as ulcerative colitis, Crohn’s disease, lupus, or sarcoidosis.

o had an organ transplant, such as a kidney transplant

o have liver damage from diseases or drugs

o have any other medical conditions

• All the medicines you take including:

o all prescription and non-prescription medicines

o steroids or other medicines that lower your immune response

o vitamins

o herbal supplements

You should not start a new medicine before you talk with your healthcare provider who prescribes you Yervoy (ipilimumab).

Most Common Side Effects:

The most common side effects of Yervoy include: tiredness, diarrhea, itching, and rash.

These are not all of the possible side effects of Yervoy. If you have any questions about your health or medicines, talk to your healthcare provider.

Please visit www.Yervoy.com for U.S. Full Prescribing Information, including Boxed WARNING regarding immune-mediated side effects, and Medication Guide for Yervoy.