Baby Health in Winter
In the winter, the risks associated with sun exposure may be far from your mind. But did you know that ultraviolet (UV) rays – like those from the sun – can affect your skin health throughout the year?
Living in upstate New York, where wintery weather can last most of the year, Dave Janicki* didn’t often think about the risks of sun exposure, which include melanoma (skin cancer), before he was diagnosed with an advanced form of the disease. “While I did spend time outdoors in the summer playing golf, I thought I was doing enough to cover myself, and I never thought much about sun safety the rest of the year,” said Janicki.
The road to Janicki’s diagnosis started when he noticed an odd growth – which he describes as looking like a pimple – on his face. He planned to visit a dermatologist, but it was difficult to get an appointment. Since he did not feel any other symptoms, he brushed it off for a while.
After some time had passed, the growth was still there, and so another doctor recommended a biopsy. That’s when Janicki received the shocking news that changed his life forever: he had cancer.
“I didn’t know anything about melanoma at that time, but you learn very quickly,” he added.
Ultraviolet (UV) rays are a primary cause of skin cancer. Melanoma is the most dangerous form of the disease and its incidence has been increasing over the last 30 years. While melanoma can form anywhere on the body and at any age, risk increases as people age.
“More than 96,000 people will be diagnosed with melanoma in the United States this year,” said Sigrun Hallmeyer, M.D., of Advocate Medical Group and Advocate Lutheran General Hospital, Chicago, IL. “Melanoma that has spread beyond the skin or cannot be removed by surgery is known as advanced melanoma and historically was associated with a very poor prognosis.”
Janicki underwent two surgeries, but his cancer had spread, and he was diagnosed with advanced melanoma. He recalls that he wasn’t ready to give up.
“You look back, and realize you can’t change the past, but you can change the future. With the help of my family and friends, I began dealing with it – doing research and talking to several different doctors. I was relieved to hear there were treatment options.”
Dave and his physician agreed that the next step would be treatment with a combination of immunotherapies – treatments that work with the body’s own immune system to fight cancer. This combination, Opdivo® (nivolumab) + Yervoy® (ipilimumab), is the first and only dual immunotherapy approved by the U.S. Food and Drug Administration for people diagnosed with melanoma that has spread or cannot be removed by surgery (advanced melanoma). Because immunotherapies may help the body’s immune system find and fight cancer cells, they might also cause the immune system to harm healthy cells. In addition, a Boxed WARNING is associated with YERVOY regarding immune-mediated side effects.
Indication
OPDIVO® (nivolumab) is a prescription medicine and may be used alone or in combination with YERVOY® (ipilimumab) to treat melanoma, a type of skin cancer, that has spread or cannot be removed by surgery (advanced melanoma).
It is not known if OPDIVO is safe and effective in children younger than 18 years of age.
OPDIVO (10 mg/mL) and YERVOY (5 mg/mL) are injections for intravenous use.
Serious Side Effects
OPDIVO and YERVOY are associated with a number of serious risks that may impact a patient’s ability to work, function, and participate in activities of daily living. Some of these risks include problems that can sometimes become serious or life-threatening and can lead to death. These problems may happen anytime during treatment or even after your treatment has ended. Some of these problems may happen more often when OPDIVO is used in combination with YERVOY. Serious side effects may include lung problems (pneumonitis); intestinal problems (colitis) that can lead to tears or holes in your intestine; liver problems (hepatitis); hormone gland problems (especially the thyroid, pituitary, adrenal glands, and pancreas); kidney problems, including nephritis and kidney failure; skin problems; inflammation of the brain (encephalitis); problems in other organs; and severe infusion reactions. Additional serious side effects observed during a separate study of YERVOY alone include: nerve problems that can lead to paralysis; and eye problems.
Study Design and Results
OPDIVO, used in combination with YERVOY or as a single agent, was approved by the FDA for this use based on a clinical trial of 945 patients with previously untreated, unresectable or metastatic melanoma, in which 314 patients received treatment with OPDIVO + YERVOY, 316 patients received OPDIVO alone and 315 patients received YERVOY alone.
In the primary analysis of the trial, OPDIVO + YERVOY and OPDIVO reduced the risk of the cancer spreading, growing, or getting worse by 58% and 43%, respectively, compared to YERVOY at 9 months. Half of the patients on OPDIVO + YERVOY went 11.5 months and half of the patients on OPDIVO went 6.9 months without the cancer spreading, growing, or getting worse versus 2.9 months with YERVOY.
In the primary analysis, OPDIVO + YERVOY and OPDIVO reduced the risk of dying by 45% and 37% compared to YERVOY at 28 months. In a follow-up analysis of this trial at five years, 52% of patients treated with OPDIVO + YERVOY and 44% of patients treated with OPDIVO alone were alive, compared to 26% of patients treated with YERVOY alone. Half of patients treated with YERVOY were alive at 19.9 months, while half the patients treated with OPDIVO were alive at 36.9 months and more than half of the patients treated with OPDIVO + YERVOY were alive at the time of the analysis.
In this follow-up analysis, data were also assessed across patient subtypes. In BRAF-mutant (MT) and wild-type (WT) patients, 60% of MT and 48% of WT patients in the OPDIVO + YERVOY arm were alive at five years, respectively.
OPDIVO + YERVOY and OPDIVO have also been shown to reduce or shrink tumors in the primary analysis. Among patients treated with OPDIVO + YERVOY or OPDIVO, respectively, 50% and 40% of all tumors shrank or disappeared completely (41% of tumors shrank while 9% disappeared completely with OPDIVO + YERVOY; 31% of tumors shrank while 9% disappeared completely with OPDIVO) at 9 months compared to 14% for patients treated with YERVOY (12% of tumors shrank while 2% disappeared completely).
The efficacy of OPDIVO + YERVOY cannot be compared to OPDIVO.
OPDIVO + YERVOY will not work for everyone. Individual results may vary.
Common Side Effects
The most common side effects of OPDIVO, when used in combination with YERVOY, include: feeling tired; rash; diarrhea; nausea; fever; pain in muscles, bones, and joints; upper respiratory tract infection; itching; abdominal pain; vomiting; cough; decreased appetite; and shortness of breath. The most common side effects of OPDIVO when used alone include: feeling tired; rash; pain in muscles, bones, and joints; itchy skin; diarrhea; nausea; weakness; cough; vomiting; shortness of breath; constipation; decreased appetite; back pain; upper respiratory tract infection; fever; headache; abdominal pain. The most common side effects of YERVOY include: feeling tired; diarrhea; nausea; itching; rash; vomiting; headache; weight loss; fever; decreased appetite; and difficulty falling or staying asleep.
Please see additional safety information below.
In Janicki’s case, his tumor completely disappeared while undergoing treatment. This result is not typical of every patient.
“As a doctor, I hear stories like Dave’s and I am inspired. A melanoma diagnosis may have a different meaning today,” Dr. Hallmeyer added. “The fact that some patients are living longer is incredibly exciting.”
For Dave, who is now four years out from his initial diagnosis, maintaining an optimistic outlook is important. He visits his doctor every other week for treatment, something he believes is not “too much to ask.”
“My cancer diagnosis was eye-opening,” Janicki said. “I’m more determined than ever to live life to the fullest, stay positive and take care of myself.”
Janicki’s experience affected his loved ones, too. Outdoor activities in any season have now taken on a new meaning: quality time together and increased vigilance about the sun. “For one thing, my daughter reminds everyone to wear sunscreen all year long, even when it’s cold outside,” he said.
Janicki was recently able to walk his daughter down the aisle at her wedding. “By sharing my story, I want to inspire other people to take action and learn more about the risks for melanoma, and to remember to not ever lose hope.”
To learn more about Opdivo + Yervoy for advanced melanoma, please click here.
*Dave Janicki is a Bristol-Myers Squibb Patient Ambassador.
INDICATIONS
OPDIVO® (nivolumab) is a prescription medicine used to treat people with a type of skin cancer called melanoma that has spread or cannot be removed by surgery (advanced melanoma).
OPDIVO® (nivolumab) is a prescription medicine used in combination with YERVOY® (ipilimumab) to treat people with a type of skin cancer called melanoma that has spread or cannot be removed by surgery (advanced melanoma).
It is not known if OPDIVO is safe and effective in children younger than 18 years of age.
Important Safety Information for OPDIVO® (nivolumab) and the OPDIVO+YERVOY® (ipilimumab) Regimen
OPDIVO is a medicine that may treat certain cancers by working with your immune system. OPDIVO can cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work. These problems can sometimes become serious or life-threatening and can lead to death. These problems may happen anytime during treatment or even after your treatment has ended. Some of these problems may happen more often when OPDIVO is used in combination with YERVOY.
YERVOY can cause serious side effects in many parts of your body which can lead to death. These problems may happen anytime during treatment with YERVOY or after you have completed treatment.
Serious side effects may include:
● Lung problems (pneumonitis). Symptoms of pneumonitis may include: new or worsening cough; chest pain; and shortness of breath.
● Intestinal problems (colitis) that can lead to tears or holes in your intestine. Signs and symptoms of colitis may include: diarrhea (loose stools) or more bowel movements than usual; blood in your stools or dark, tarry, sticky stools; and severe stomach area (abdomen) pain or tenderness.
● Liver problems (hepatitis). Signs and symptoms of hepatitis may include: yellowing of your skin or the whites of your eyes; severe nausea or vomiting; pain on the right side of your stomach area (abdomen); drowsiness; dark urine (tea colored); bleeding or bruising more easily than normal; feeling less hungry than usual; and decreased energy.
● Hormone gland problems (especially the thyroid, pituitary, adrenal glands, and pancreas). Signs and symptoms that your hormone glands are not working properly may include: headaches that will not go away or unusual headaches; extreme tiredness; weight gain or weight loss; dizziness or fainting; changes in mood or behavior, such as decreased sex drive, irritability, or forgetfulness; hair loss; feeling cold; constipation; voice gets deeper; and excessive thirst or lots of urine.
● Kidney problems, including nephritis and kidney failure. Signs of kidney problems may include: decrease in the amount of urine; blood in your urine; swelling in your ankles; and loss of appetite.
● Skin Problems. Signs of these problems may include: rash; itching; skin blistering; and ulcers in the mouth or other mucous membranes.
● Inflammation of the brain (encephalitis). Signs and symptoms of encephalitis may include: headache; fever; tiredness or weakness; confusion; memory problems; sleepiness; seeing or hearing things that are not really there (hallucinations); seizures; and stiff neck.
● Problems in other organs. Signs of these problems may include: changes in eyesight; severe or persistent muscle or joint pains; severe muscle weakness; and chest pain.
Additional serious side effects observed during a separate study of YERVOY alone include:
● Nerve problems that can lead to paralysis. Symptoms of nerve problems may include: unusual weakness of legs, arms, or face; and numbness or tingling in hands or feet.
● Eye problems. Symptoms may include: blurry vision, double vision, or other vision problems; and eye pain or redness.
Getting medical treatment right away may keep these problems from becoming more serious.
Your healthcare provider will check you for these problems during treatment. Your healthcare provider may treat you with corticosteroid or hormone replacement medicines. Your healthcare provider may also need to delay or completely stop treatment, if you have severe side effects.
OPDIVO can cause serious side effects, including:
● Severe infusion reactions. Tell your doctor or nurse right away if you get these symptoms during an infusion of OPDIVO: chills or shaking; itching or rash; flushing; difficulty breathing; dizziness; fever; and feeling like passing out.
Pregnancy and Nursing:
● Tell your healthcare provider if you are pregnant or plan to become pregnant. OPDIVO and YERVOY can harm your unborn baby. Females who are able to become pregnant should use an effective method of birth control during and for at least 5 months after the last dose of OPDIVO. Talk to your healthcare provider about birth control methods that you can use during this time. Tell your healthcare provider right away if you become pregnant or think you are pregnant during treatment. You or your healthcare provider should contact Bristol-Myers Squibb at 1-800-721-5072 as soon as you become aware of the pregnancy.
● Pregnancy Safety Surveillance Study: Females who become pregnant during treatment with YERVOY are encouraged to enroll in a Pregnancy Safety Surveillance Study. The purpose of this study is to collect information about the health of you and your baby. You or your healthcare provider can enroll in the Pregnancy Safety Surveillance Study by calling 1-844-593-7869.
● Before receiving treatment, tell your healthcare provider if you are breastfeeding or plan to breastfeed. It is not known if either treatment passes into your breast milk. Do not breastfeed during treatment and for 3 months after the last dose of YERVOY.
Tell your healthcare provider about:
● Your health problems or concerns if you: have immune system problems such as autoimmune disease, Crohn’s disease, ulcerative colitis, lupus, or sarcoidosis; have had an organ transplant; have lung or breathing problems; have liver problems; or have any other medical conditions.
● All the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
The most common side effects of OPDIVO when used alone include: feeling tired; rash; pain in muscles, bones, and joints; itchy skin; diarrhea; nausea; weakness; cough; vomiting; shortness of breath; constipation; decreased appetite; back pain; upper respiratory tract infection; fever; headache; and abdominal pain.
The most common side effects of OPDIVO, when used in combination with YERVOY, include: feeling tired; rash; diarrhea; nausea; fever; pain in muscles, bones, and joints; upper respiratory tract infection; itching; abdominal pain; vomiting; cough; decreased appetite; and shortness of breath. The most common side effects of YERVOY include: feeling tired; diarrhea; nausea; itching; rash; vomiting; headache; weight loss; fever; decreased appetite; and difficulty falling or staying asleep.
These are not all the possible side effects. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Please see U.S. Full Prescribing Information and Medication Guide for OPDIVO and YERVOY including Boxed WARNING regarding immune-mediated side effects for YERVOY.
© 2019 Bristol-Myers Squibb Company.
OPDIVO® and YERVOY® are registered trademarks of Bristol-Myers Squibb Company.
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