Understanding your treatment and the side effects you may experience
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- Magdalene Walker
- 5 years ago
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1 Understanding your treatment and the side effects you may experience What does treat? is a prescription medicine used in combination with YERVOY to treat a type of skin cancer called melanoma that has spread or cannot be removed by surgery (advanced melanoma). in combination with YERVOY was approved based on the amount of time patients lived without their tumors worsening. There is ongoing evaluation of clinical benefit of in combination with YERVOY for this use. It is not known if is safe and effective in children less than 18 years of age. (10 mg/ml) and YERVOY (5 mg/ml) are injections for intravenous (IV) use. + YERVOY will not work for every patient. Individual results may vary. Information provided in this brochure is not a substitute for talking with your healthcare professional. Your healthcare professional is the best source of information about your disease. Please see Important Safety Information on pages 23-24, and accompanying U.S. Full Prescribing Information, including Boxed WARNING for YERVOY regarding immune-mediated side effects, and Medication Guides for and YERVOY at the end of this brochure. All models depicted are used for illustrative purposes. 1
2 Your treatment may cause side effects You may have questions or concerns about potential side effects of the + YERVOY Regimen. This journal provides a detailed look at the kind of side effects that may occur. It also gives you a convenient way to track any changes in your health as you start and continue with treatment. If you experience any difference in the way that you feel, even if you re not sure that it s related to a side effect, call your healthcare provider right away for medical advice. Treating side effects as soon as possible may keep problems from becoming more serious. It s important that you do not try to treat symptoms yourself. Don t hesitate to reach out to your oncology treatment team. Remember that YOU are your best healthcare advocate, and that communication is key when it comes to your treatment. What does treat? is a prescription medicine used in combination with YERVOY to treat a type of skin cancer called melanoma that has spread or cannot be removed by surgery (advanced melanoma). in combination with YERVOY was approved based on the amount of time patients lived without their tumors worsening. There is ongoing evaluation of clinical benefit of in combination with YERVOY for this use. It is not known if is safe and effective in children less than 18 years of age. Select Important Safety Information can cause problems that can sometimes become serious or life-threatening and can lead to death. 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 of YERVOY alone include: nerve problems that can lead to paralysis; and eye problems. Getting medical treatment right away may keep these problems from becoming more serious. Please see additional Important Safety Information on pages 23-24, and accompanying U.S. Full Prescribing Information, including Boxed WARNING for YERVOY regarding immune-mediated side effects, and Medication Guides for and YERVOY at the end of this brochure. 2
3 + YERVOY works with your immune system to fight metastatic melanoma in 2 ways Stimulate + Recognize YERVOY helps increase the activity of the immune system and stimulates more of the cells that help fight cancer. allows these cells to recognize melanoma and attack it. Because of the way the + YERVOY Regimen works, it can cause your immune system to attack normal organs and tissues in many areas 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. Immune cells are activated and directed toward the melanoma. Your oncologist may prescribe the + YERVOY Regimen because these 2 medications work with your immune system to help fight cancer, but they do it in different ways. Put simply, YERVOY stimulates the kind of cells that fight disease, and allows these cells to recognize melanoma and attack it. While doing so, and YERVOY can also affect non-tumor cells. You may experience side effects These problems may happen anytime during treatment or even after your treatment has ended. Some of these problems may happen more often when is used in combination with YERVOY. See a list of potential side effects on page 5. If you experience severe side effects, your doctor may treat you with corticosteroid or hormone replacement medicines. Your healthcare provider may also need to delay or completely stop treatment. Getting your treatment and YERVOY are 2 different medicines that are delivered into your vein through an intravenous (IV) line. Treatment begins with the combination phase a dose of each medicine every 3 weeks for your first 4 doses. After the combination phase, treatment continues with alone, every 2 weeks. Your healthcare provider will decide how many treatments you need and will do blood tests to check you for side effects. Please see Important Safety Information on pages 23-24, and accompanying U.S. Full Prescribing Information, including Boxed WARNING for YERVOY regarding immune-mediated side effects, and Medication Guides for and YERVOY at the end of this brochure. 3
4 My Health Right Now / / Date Weight lbs Temperature Number of bowel movements daily Number of times you urinate daily Energy level: high medium low Appetite: good average poor Difficulty sleeping? yes no Any shortness of breath? yes no If yes, explain here Assessing how you feel now may make it easier to track side effects moving forward Everyone s body is different, and you know yours better than anyone else. Assessing how your body is feeling right now may make it easier for you to see if you are experiencing any side effects during treatment. Take a few minutes to think about your overall health, and complete the assessment above. Potential side effects are listed on page 5, and there are a number of Side Effects Check-ins throughout the journal. Together with your health baseline, this information provides an important way to monitor your health as your treatment progresses. Please see Important Safety Information on pages 23-24, and accompanying U.S. Full Prescribing Information, including Boxed WARNING for YERVOY regarding immune-mediated side effects, and Medication Guides for (nivolumab) and YERVOY (ipilimumab) at the end of this brochure. 4
5 Possible side effects of the (nivolumab) + YERVOY (ipilimumab) Regimen The + YERVOY Regimen can cause your immune system to attack normal organs and tissues in many areas 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. The most common side effects of, when used in combination with YERVOY include: feeling tired; diarrhea; fever; shortness of breath; rash; nausea; and vomiting. The most common side effects of YERVOY include: tiredness; diarrhea; itching; rash; nausea; vomiting; headache; weight loss; fever; decreased appetite; and difficulty falling or staying asleep. Call or see your healthcare provider right away if you have any of these signs or symptoms or if they get worse: Brain n headache n fever n tiredness or weakness n confusion n memory problems n sleepiness n seeing or hearing things that are not really there (hallucinations) n seizures n stiff neck Liver n yellowing of your skin or the whites of your eyes n severe nausea or vomiting n pain on the right side of your stomach area (abdomen) n drowsiness n dark urine (tea colored) n bleeding or bruise more easily than normal n feeling less hungry than usual Intestines n colitis that can lead to tears or holes in your intestine n diarrhea (loose stools) or more bowel movements than usual n blood in your stools or dark, tarry, sticky stools n severe stomach area (abdomen) pain or tenderness Severe Infusion Reactions Tell your doctor or nurse right away if you get these symptoms during an infusion of : n chills or shaking n itching or rash n flushing n difficulty breathing n dizziness n fever n feeling like passing out Other Organs n changes in eyesight n severe or persistent muscle or joint pains n severe muscle weakness Hormone Glands (especially the thyroid, pituitary, adrenal glands, and pancreas) n headaches that will not go away or unusual headaches n extreme tiredness n weight gain or weight loss n dizziness or fainting n changes in mood or behavior, such as decreased sex drive, irritability, or forgetfulness n hair loss n feeling cold n constipation n voice gets deeper n excessive thirst or lots of urine Lungs n new or worsening cough n chest pain n shortness of breath Kidneys including nephritis and kidney failure n decrease in the amount of urine n blood in your urine n swelling in your ankles n loss of appetite Skin n rash n itching n skin blistering n ulcers in mouth or other mucous membranes Please see additional Important Safety Information on pages 23-24, and accompanying U.S. Full Prescribing Information, including Boxed WARNING for YERVOY regarding immune-mediated side effects, and Medication Guides for and YERVOY at the end of this brochure. 5
6 Side Effects Check-in Combination Phase FIRST DOSE / / Date Check where you are experiencing any side effect Weight lbs Temperature Number of bowel movements daily Number of times you urinate daily Brain Liver Hormone Glands Lungs Energy level: high medium low Appetite: good average poor Kidneys Difficulty sleeping? yes no Any shortness of breath? yes no If yes, explain here Intestines Severe Infusion Reactions Skin Other Organs If you are experiencing any of the side effects listed on page 5, use the chart below to keep track of them. All side effects, even those that may seem mild, such as diarrhea or nausea, should be discussed with your healthcare team right away. This may help keep your side effects from becoming more serious. Use this ranking based on how severe you think your side effects are: Mild Moderate Severe Very Severe Date Side effect(s) you are experiencing How severe? Notes Please see Important Safety Information on pages 23-24, and accompanying U.S. Full Prescribing Information, including Boxed WARNING for YERVOY regarding immune-mediated side effects, and Medication Guides for (nivolumab) and YERVOY (ipilimumab) at the end of this brochure. 6
7 Side Effects Check-in Combination Phase SECOND DOSE / / Date Check where you are experiencing any side effect Weight lbs Temperature Number of bowel movements daily Number of times you urinate daily Brain Liver Hormone Glands Lungs Energy level: high medium low Appetite: good average poor Kidneys Difficulty sleeping? yes no Any shortness of breath? yes no If yes, explain here Intestines Severe Infusion Reactions Skin Other Organs If you are experiencing any of the side effects listed on page 5, use the chart below to keep track of them. All side effects, even those that may seem mild, such as diarrhea or nausea, should be discussed with your healthcare team right away. This may help keep your side effects from becoming more serious. Use this ranking based on how severe you think your side effects are: Mild Moderate Severe Very Severe Date Side effect(s) you are experiencing How severe? Notes Please see Important Safety Information on pages 23-24, and accompanying U.S. Full Prescribing Information, including Boxed WARNING for YERVOY regarding immune-mediated side effects, and Medication Guides for (nivolumab) and YERVOY (ipilimumab) at the end of this brochure. 7
8 Side Effects Check-in Combination Phase THIRD DOSE / / Date Check where you are experiencing any side effect Weight lbs Temperature Number of bowel movements daily Number of times you urinate daily Brain Liver Hormone Glands Lungs Energy level: high medium low Appetite: good average poor Kidneys Difficulty sleeping? yes no Any shortness of breath? yes no If yes, explain here Intestines Severe Infusion Reactions Skin Other Organs If you are experiencing any of the side effects listed on page 5, use the chart below to keep track of them. All side effects, even those that may seem mild, such as diarrhea or nausea, should be discussed with your healthcare team right away. This may help keep your side effects from becoming more serious. Use this ranking based on how severe you think your side effects are: Mild Moderate Severe Very Severe Date Side effect(s) you are experiencing How severe? Notes Please see Important Safety Information on pages 23-24, and accompanying U.S. Full Prescribing Information, including Boxed WARNING for YERVOY regarding immune-mediated side effects, and Medication Guides for (nivolumab) and YERVOY (ipilimumab) at the end of this brochure. 8
9 Side Effects Check-in Combination Phase FOURTH DOSE / / Date Check where you are experiencing any side effect Weight lbs Temperature Number of bowel movements daily Number of times you urinate daily Brain Liver Hormone Glands Lungs Energy level: high medium low Appetite: good average poor Kidneys Difficulty sleeping? yes no Any shortness of breath? yes no If yes, explain here Intestines Severe Infusion Reactions Skin Other Organs If you are experiencing any of the side effects listed on page 5, use the chart below to keep track of them. All side effects, even those that may seem mild, such as diarrhea or nausea, should be discussed with your healthcare team right away. This may help keep your side effects from becoming more serious. Use this ranking based on how severe you think your side effects are: Mild Moderate Severe Very Severe Date Side effect(s) you are experiencing How severe? Notes Please see Important Safety Information on pages 23-24, and accompanying U.S. Full Prescribing Information, including Boxed WARNING for YERVOY regarding immune-mediated side effects, and Medication Guides for (nivolumab) and YERVOY (ipilimumab) at the end of this brochure. 9
10 Side Effects Check-in Alone FIRST DOSE / / Date Check where you are experiencing any side effect Weight lbs Temperature Number of bowel movements daily Number of times you urinate daily Brain Liver Hormone Glands Lungs Energy level: high medium low Appetite: good average poor Kidneys Difficulty sleeping? yes no Any shortness of breath? yes no If yes, explain here Intestines Severe Infusion Reactions Skin Other Organs If you are experiencing any of the side effects listed on page 5, use the chart below to keep track of them. All side effects, even those that may seem mild, such as diarrhea or nausea, should be discussed with your healthcare team right away. This may help keep your side effects from becoming more serious. Use this ranking based on how severe you think your side effects are: Mild Moderate Severe Very Severe Date Side effect(s) you are experiencing How severe? Notes Please see Important Safety Information on pages 23-24, and accompanying U.S. Full Prescribing Information, including Boxed WARNING for YERVOY regarding immune-mediated side effects, and Medication Guides for (nivolumab) and YERVOY (ipilimumab) at the end of this brochure. 10
11 Side Effects Check-in Alone SECOND DOSE / / Date Check where you are experiencing any side effect Weight lbs Temperature Number of bowel movements daily Number of times you urinate daily Brain Liver Hormone Glands Lungs Energy level: high medium low Appetite: good average poor Kidneys Difficulty sleeping? yes no Any shortness of breath? yes no If yes, explain here Intestines Severe Infusion Reactions Skin Other Organs If you are experiencing any of the side effects listed on page 5, use the chart below to keep track of them. All side effects, even those that may seem mild, such as diarrhea or nausea, should be discussed with your healthcare team right away. This may help keep your side effects from becoming more serious. Use this ranking based on how severe you think your side effects are: Mild Moderate Severe Very Severe Date Side effect(s) you are experiencing How severe? Notes Please see Important Safety Information on pages 23-24, and accompanying U.S. Full Prescribing Information, including Boxed WARNING for YERVOY regarding immune-mediated side effects, and Medication Guides for (nivolumab) and YERVOY (ipilimumab) at the end of this brochure. 11
12 Side Effects Check-in Alone THIRD DOSE / / Date Check where you are experiencing any side effect Weight lbs Temperature Number of bowel movements daily Number of times you urinate daily Brain Liver Hormone Glands Lungs Energy level: high medium low Appetite: good average poor Kidneys Difficulty sleeping? yes no Any shortness of breath? yes no If yes, explain here Intestines Severe Infusion Reactions Skin Other Organs If you are experiencing any of the side effects listed on page 5, use the chart below to keep track of them. All side effects, even those that may seem mild, such as diarrhea or nausea, should be discussed with your healthcare team right away. This may help keep your side effects from becoming more serious. Use this ranking based on how severe you think your side effects are: Mild Moderate Severe Very Severe Date Side effect(s) you are experiencing How severe? Notes Please see Important Safety Information on pages 23-24, and accompanying U.S. Full Prescribing Information, including Boxed WARNING for YERVOY regarding immune-mediated side effects, and Medication Guides for (nivolumab) and YERVOY (ipilimumab) at the end of this brochure. 12
13 Side Effects Check-in Alone FOURTH DOSE / / Date Check where you are experiencing any side effect Weight lbs Temperature Number of bowel movements daily Number of times you urinate daily Brain Liver Hormone Glands Lungs Energy level: high medium low Appetite: good average poor Kidneys Difficulty sleeping? yes no Any shortness of breath? yes no If yes, explain here Intestines Severe Infusion Reactions Skin Other Organs If you are experiencing any of the side effects listed on page 5, use the chart below to keep track of them. All side effects, even those that may seem mild, such as diarrhea or nausea, should be discussed with your healthcare team right away. This may help keep your side effects from becoming more serious. Use this ranking based on how severe you think your side effects are: Mild Moderate Severe Very Severe Date Side effect(s) you are experiencing How severe? Notes Please see Important Safety Information on pages 23-24, and accompanying U.S. Full Prescribing Information, including Boxed WARNING for YERVOY regarding immune-mediated side effects, and Medication Guides for (nivolumab) and YERVOY (ipilimumab) at the end of this brochure. 13
14 Side Effects Check-in Alone FIFTH DOSE / / Date Check where you are experiencing any side effect Weight lbs Temperature Number of bowel movements daily Number of times you urinate daily Brain Liver Hormone Glands Lungs Energy level: high medium low Appetite: good average poor Kidneys Difficulty sleeping? yes no Any shortness of breath? yes no If yes, explain here Intestines Severe Infusion Reactions Skin Other Organs If you are experiencing any of the side effects listed on page 5, use the chart below to keep track of them. All side effects, even those that may seem mild, such as diarrhea or nausea, should be discussed with your healthcare team right away. This may help keep your side effects from becoming more serious. Use this ranking based on how severe you think your side effects are: Mild Moderate Severe Very Severe Date Side effect(s) you are experiencing How severe? Notes Please see Important Safety Information on pages 23-24, and accompanying U.S. Full Prescribing Information, including Boxed WARNING for YERVOY regarding immune-mediated side effects, and Medication Guides for (nivolumab) and YERVOY (ipilimumab) at the end of this brochure. 14
15 Side Effects Check-in Alone SIXTH DOSE / / Date Check where you are experiencing any side effect Weight lbs Temperature Number of bowel movements daily Number of times you urinate daily Brain Liver Hormone Glands Lungs Energy level: high medium low Appetite: good average poor Kidneys Difficulty sleeping? yes no Any shortness of breath? yes no If yes, explain here Intestines Severe Infusion Reactions Skin Other Organs If you are experiencing any of the side effects listed on page 5, use the chart below to keep track of them. All side effects, even those that may seem mild, such as diarrhea or nausea, should be discussed with your healthcare team right away. This may help keep your side effects from becoming more serious. Use this ranking based on how severe you think your side effects are: Mild Moderate Severe Very Severe Date Side effect(s) you are experiencing How severe? Notes Please see Important Safety Information on pages 23-24, and accompanying U.S. Full Prescribing Information, including Boxed WARNING for YERVOY regarding immune-mediated side effects, and Medication Guides for (nivolumab) and YERVOY (ipilimumab) at the end of this brochure. 15
16 Side Effects Check-in Alone SEVENTH DOSE / / Date Check where you are experiencing any side effect Weight lbs Temperature Number of bowel movements daily Number of times you urinate daily Brain Liver Hormone Glands Lungs Energy level: high medium low Appetite: good average poor Kidneys Difficulty sleeping? yes no Any shortness of breath? yes no If yes, explain here Intestines Severe Infusion Reactions Skin Other Organs If you are experiencing any of the side effects listed on page 5, use the chart below to keep track of them. All side effects, even those that may seem mild, such as diarrhea or nausea, should be discussed with your healthcare team right away. This may help keep your side effects from becoming more serious. Use this ranking based on how severe you think your side effects are: Mild Moderate Severe Very Severe Date Side effect(s) you are experiencing How severe? Notes Please see Important Safety Information on pages 23-24, and accompanying U.S. Full Prescribing Information, including Boxed WARNING for YERVOY regarding immune-mediated side effects, and Medication Guides for (nivolumab) and YERVOY (ipilimumab) at the end of this brochure. 16
17 Side Effects Check-in Alone EIGHTH DOSE / / Date Check where you are experiencing any side effect Weight lbs Temperature Number of bowel movements daily Number of times you urinate daily Brain Liver Hormone Glands Lungs Energy level: high medium low Appetite: good average poor Kidneys Difficulty sleeping? yes no Any shortness of breath? yes no If yes, explain here Intestines Severe Infusion Reactions Skin Other Organs If you are experiencing any of the side effects listed on page 5, use the chart below to keep track of them. All side effects, even those that may seem mild, such as diarrhea or nausea, should be discussed with your healthcare team right away. This may help keep your side effects from becoming more serious. Use this ranking based on how severe you think your side effects are: Mild Moderate Severe Very Severe Date Side effect(s) you are experiencing How severe? Notes Please see Important Safety Information on pages 23-24, and accompanying U.S. Full Prescribing Information, including Boxed WARNING for YERVOY regarding immune-mediated side effects, and Medication Guides for (nivolumab) and YERVOY (ipilimumab) at the end of this brochure. 17
18 Side Effects Check-in Alone NINTH DOSE / / Date Check where you are experiencing any side effect Weight lbs Temperature Number of bowel movements daily Number of times you urinate daily Brain Liver Hormone Glands Lungs Energy level: high medium low Appetite: good average poor Kidneys Difficulty sleeping? yes no Any shortness of breath? yes no If yes, explain here Intestines Severe Infusion Reactions Skin Other Organs If you are experiencing any of the side effects listed on page 5, use the chart below to keep track of them. All side effects, even those that may seem mild, such as diarrhea or nausea, should be discussed with your healthcare team right away. This may help keep your side effects from becoming more serious. Use this ranking based on how severe you think your side effects are: Mild Moderate Severe Very Severe Date Side effect(s) you are experiencing How severe? Notes Please see Important Safety Information on pages 23-24, and accompanying U.S. Full Prescribing Information, including Boxed WARNING for YERVOY regarding immune-mediated side effects, and Medication Guides for (nivolumab) and YERVOY (ipilimumab) at the end of this brochure. 18
19 Side Effects Check-in Alone TENTH DOSE / / Date Check where you are experiencing any side effect Weight lbs Temperature Number of bowel movements daily Number of times you urinate daily Brain Liver Hormone Glands Lungs Energy level: high medium low Appetite: good average poor Kidneys Difficulty sleeping? yes no Any shortness of breath? yes no If yes, explain here Intestines Severe Infusion Reactions Skin Other Organs If you are experiencing any of the side effects listed on page 5, use the chart below to keep track of them. All side effects, even those that may seem mild, such as diarrhea or nausea, should be discussed with your healthcare team right away. This may help keep your side effects from becoming more serious. Use this ranking based on how severe you think your side effects are: Mild Moderate Severe Very Severe Date Side effect(s) you are experiencing How severe? Notes Please see Important Safety Information on pages 23-24, and accompanying U.S. Full Prescribing Information, including Boxed WARNING for YERVOY regarding immune-mediated side effects, and Medication Guides for (nivolumab) and YERVOY (ipilimumab) at the end of this brochure. 19
20 Side Effects Check-in Alone ELEVENTH DOSE / / Date Check where you are experiencing any side effect Weight lbs Temperature Number of bowel movements daily Number of times you urinate daily Brain Liver Hormone Glands Lungs Energy level: high medium low Appetite: good average poor Kidneys Difficulty sleeping? yes no Any shortness of breath? yes no If yes, explain here Intestines Severe Infusion Reactions Skin Other Organs If you are experiencing any of the side effects listed on page 5, use the chart below to keep track of them. All side effects, even those that may seem mild, such as diarrhea or nausea, should be discussed with your healthcare team right away. This may help keep your side effects from becoming more serious. Use this ranking based on how severe you think your side effects are: Mild Moderate Severe Very Severe Date Side effect(s) you are experiencing How severe? Notes Please see Important Safety Information on pages 23-24, and accompanying U.S. Full Prescribing Information, including Boxed WARNING for YERVOY regarding immune-mediated side effects, and Medication Guides for (nivolumab) and YERVOY (ipilimumab) at the end of this brochure. 20
21 Side Effects Check-in Alone Additional Chart as Needed / / Date Check where you are experiencing any side effect Weight lbs Temperature Number of bowel movements daily Number of times you urinate daily Brain Liver Hormone Glands Lungs Energy level: high medium low Appetite: good average poor Kidneys Difficulty sleeping? yes no Any shortness of breath? yes no If yes, explain here Intestines Severe Infusion Reactions Skin Other Organs If you are experiencing any of the side effects listed on page 5, use the chart below to keep track of them. All side effects, even those that may seem mild, such as diarrhea or nausea, should be discussed with your healthcare team right away. This may help keep your side effects from becoming more serious. Use this ranking based on how severe you think your side effects are: Mild Moderate Severe Very Severe Date Side effect(s) you are experiencing How severe? Notes Please see Important Safety Information on pages 23-24, and accompanying U.S. Full Prescribing Information, including Boxed WARNING for YERVOY regarding immune-mediated side effects, and Medication Guides for (nivolumab) and YERVOY (ipilimumab) at the end of this brochure. 21
22 Important Contact Information Oncologist s name Phone number address Nurse s name Phone number address Other healthcare provider s name Phone number address Health insurance provider Phone number Keep the lines of communication open + YERVOY combination therapy may offer you a way to fight advanced melanoma, but there is the very real potential for side effects. The important thing is to keep the lines of communication open with your oncology team. Personalized Care Counselor Support Patients can sign up for the option to speak with a registered nurse who can respond to questions about treatment and help you to be an informed partner with your doctor. Care Counselors cannot offer medical advice. Your healthcare professional is the best source of information about your health. For more information, visit or call ( ). Please see Important Safety Information on pages 23-24, and accompanying U.S. Full Prescribing Information, including Boxed WARNING for YERVOY regarding immune-mediated side effects, and Medication Guides for and YERVOY at the end of this brochure. 22
23 Important Safety Information Important Safety Information about (nivolumab) in combination with YERVOY (ipilimumab) is a medicine that may treat your melanoma by working with your immune system. can cause your immune system to attack normal organs and tissues in many areas 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 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: n Lung problems (pneumonitis). Symptoms of pneumonitis may include: new or worsening cough; chest pain; and shortness of breath. n 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. n 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; and feeling less hungry than usual. n 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. n 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. n Skin problems. Signs of these problems may include: rash; itching; skin blistering; and ulcers in the mouth or other mucous membranes. n 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. n Problems in other organs. Signs of these problems may include: changes in eyesight; severe or persistent muscle or joint pains; and severe muscle weakness. Additional serious side effects observed during a separate study of YERVOY alone include: n 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. n 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. (continued on next page) Please see accompanying U.S. Full Prescribing Information, including Boxed WARNING for YERVOY regarding immune-mediated side effects, and Medication Guides for and YERVOY at the end of this brochure. 23
24 Important Safety Information (continued) can cause serious side effects, including: n Severe infusion reactions. Tell your doctor or nurse right away if you get these symptoms during an infusion of : chills or shaking; itching or rash; flushing; difficulty breathing; dizziness; fever; and feeling like passing out. Pregnancy and Nursing: n Tell your healthcare provider if you are pregnant or plan to become pregnant. 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. 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 as soon as you become aware of the pregnancy. n 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 n 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: n 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. n All the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. The most common side effects of, when used in combination with YERVOY include: feeling tired; diarrhea; fever; shortness of breath; rash; nausea; and vomiting. The most common side effects of YERVOY include: tiredness; diarrhea; itching; rash; nausea; 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 or call FDA You may also report side effects to Bristol-Myers Squibb at Please see accompanying U.S. Full Prescribing Information, including Boxed WARNING for YERVOY regarding immune-mediated side effects, and Medication Guides for and YERVOY at the end of this brochure. 24
25 For more information, call or visit Bristol-Myers Squibb is committed to helping patients throughout their + YERVOY Regimen treatment., YERVOY, and the related logos are trademarks of Bristol-Myers Squibb Company Bristol-Myers Squibb Company. All rights reserved. Printed in USA. 7356US /18 Please see Important Safety Information on pages 23-24, and accompanying U.S. Full Prescribing Information, including Boxed WARNING for YERVOY regarding immune-mediated side effects, and Medication Guides for and YERVOY at the end of this brochure. 25
26 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use safely and effectively. See full prescribing information for. (nivolumab) injection, for intravenous use Initial U.S. Approval: RECENT MAJOR CHANGES Indications and Usage (1) 12/2017 Dosage and Administration (2) 1/2018 Warnings and Precautions, Immune-Mediated Hepatitis (5.3) 9/2017 Warnings and Precautions, Other Immune-Mediated Adverse Reactions (5.8) 9/2017 Warnings and Precautions, Infusion Reactions (5.9) 1/ INDICATIONS AND USAGE is a programmed death receptor-1 (PD-1) blocking antibody indicated for the treatment of: patients with BRAF V600 wild-type unresectable or metastatic melanoma, as a single agent. (1.1) patients with BRAF V600 mutation-positive unresectable or metastatic melanoma, as a single agent. a (1.1) patients with unresectable or metastatic melanoma, in combination with ipilimumab. a (1.1) patients with melanoma with lymph node involvement or metastatic disease who have undergone complete resection, in the adjuvant setting. (1.2) patients with metastatic non-small cell lung cancer and progression on or after platinum-based chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving. (1.3) patients with advanced renal cell carcinoma who have received prior antiangiogenic therapy. (1.4) adult patients with classical Hodgkin lymphoma that has relapsed or progressed after b : (1.5) autologous hematopoietic stem cell transplantation (HSCT) and brentuximab vedotin, or 3 or more lines of systemic therapy that includes autologous HSCT. patients with recurrent or metastatic squamous cell carcinoma of the head and neck with disease progression on or after a platinum-based therapy. (1.6) patients with locally advanced or metastatic urothelial carcinoma who b : have disease progression during or following platinum-containing chemotherapy have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. (1.7) adult and pediatric (12 years and older) patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dmmr) metastatic colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. b (1.8) patients with hepatocellular carcinoma who have been previously treated with sorafenib. b (1.9) a This indication is approved under accelerated approval based on progression-free survival. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. b This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials DOSAGE AND ADMINISTRATION Administer as an intravenous infusion. Unresectable or metastatic melanoma 240 mg every 2 weeks. (2.1) with ipilimumab: 1 mg/kg, followed by ipilimumab on the same day, every 3 weeks for 4 doses, then 240 mg every 2 weeks. (2.1) Adjuvant treatment of melanoma 240 mg every 2 weeks. (2.2) Metastatic non-small cell lung cancer 240 mg every 2 weeks. (2.3) Advanced renal cell carcinoma 240 mg every 2 weeks. (2.4) FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE 1.1 Unresectable or Metastatic Melanoma 1.2 Adjuvant Treatment of Melanoma 1.3 Metastatic Non-Small Cell Lung Cancer 1.4 Renal Cell Carcinoma 1.5 Classical Hodgkin Lymphoma 1.6 Squamous Cell Carcinoma of the Head and Neck 1.7 Urothelial Carcinoma 1.8 Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dmmr) Metastatic Colorectal Cancer 1.9 Hepatocellular Carcinoma Classical Hodgkin lymphoma (nivolumab) 3 mg/kg every 2 weeks. (2.5) Recurrent or metastatic squamous cell carcinoma of the head and neck 3 mg/kg every 2 weeks. (2.6) Locally advanced or metastatic urothelial carcinoma 240 mg every 2 weeks (2.7) Microsatellite instability-high (MSI-H) or mismatch repair deficient (dmmr) metastatic colorectal cancer 240 mg every 2 weeks. (2.8) Hepatocellular carcinoma 240 mg every 2 weeks. (2.9) DOSAGE FORMS AND STRENGTHS Injection: 40 mg/4 ml, 100 mg/10 ml, and 240 mg/24 ml solution in a single-dose vial. (3) CONTRAINDICATIONS None. (4) WARNINGS AND PRECAUTIONS Immune-mediated pneumonitis: Withhold for moderate and permanently discontinue for severe or life-threatening pneumonitis. (5.1) Immune-mediated colitis: Withhold when given as a single agent for moderate or severe and permanently discontinue for life-threatening colitis. Withhold when given with ipilimumab for moderate and permanently discontinue for severe or life-threatening colitis. (5.2) Immune-mediated hepatitis: Monitor for changes in liver function. Withhold for moderate and permanently discontinue for severe or life-threatening transaminase or total bilirubin elevation. (5.3) Immune-mediated endocrinopathies: Withhold for moderate or severe and permanently discontinue for life-threatening hypophysitis. Withhold for moderate and permanently discontinue for severe or life-threatening adrenal insufficiency. Monitor for changes in thyroid function. Initiate thyroid hormone replacement as needed. Monitor for hyperglycemia. Withhold for severe and permanently discontinue for life-threatening hyperglycemia. (5.4) Immune-mediated nephritis and renal dysfunction: Monitor for changes in renal function. Withhold for moderate or severe and permanently discontinue for life-threatening serum creatinine elevation. (5.5) Immune-mediated skin adverse reactions: Withhold for severe and permanently discontinue for life-threatening rash. (5.6) Immune-mediated encephalitis: Monitor for changes in neurologic function. Withhold for new-onset moderate to severe neurological signs or symptoms and permanently discontinue for immune-mediated encephalitis. (5.7) Infusion reactions: Discontinue for severe and life-threatening infusion reactions. Interrupt or slow the rate of infusion in patients with mild or moderate infusion reactions. (5.9) Complications of allogeneic HSCT after : Monitor for hyperacute graftversus-host-disease (GVHD), grade acute GVHD, steroid-requiring febrile syndrome, hepatic veno-occlusive disease, and other immune-mediated adverse reactions. Transplant-related mortality has occurred. (5.10) Embryo-fetal toxicity: Can cause fetal harm. Advise of potential risk to a fetus and use of effective contraception. (5.11, 8.1, 8.3) ADVERSE REACTIONS Most common adverse reactions ( 20%) in patients were: as a single agent: fatigue, rash, musculoskeletal pain, pruritus, diarrhea, nausea, asthenia, cough, dyspnea, constipation, decreased appetite, back pain, arthralgia, upper respiratory tract infection, pyrexia, headache, and abdominal pain. (6.1) with ipilimumab: fatigue, rash, diarrhea, nausea, pyrexia, vomiting, and dyspnea. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Bristol-Myers Squibb at or FDA at FDA-1088 or USE IN SPECIFIC POPULATIONS Lactation: Discontinue breastfeeding. (8.2) See 17 for PATIENT COUNSELING INFORMATION and Medication Guide. Revised: 1/ DOSAGE AND ADMINISTRATION 2.1 Recommended Dosage for Unresectable or Metastatic Melanoma 2.2 Recommended Dosage for Adjuvant Treatment of Melanoma 2.3 Recommended Dosage for NSCLC 2.4 Recommended Dosage for RCC 2.5 Recommended Dosage for chl 2.6 Recommended Dosage for SCCHN 2.7 Recommended Dosage for Urothelial Carcinoma 2.8 Recommended Dosage for CRC 2.9 Recommended Dosage for HCC 2.10 Dose Modifications 2.11 Preparation and Administration (Continued)
27 FULL PRESCRIBING INFORMATION: CONTENTS* (Continued) 3 DOSAGE FORMS AND STRENGTHS 4 CONTRAINDICATIONS 5 WARNINGS AND PRECAUTIONS 5.1 Immune-Mediated Pneumonitis 5.2 Immune-Mediated Colitis 5.3 Immune-Mediated Hepatitis 5.4 Immune-Mediated Endocrinopathies 5.5 Immune-Mediated Nephritis and Renal Dysfunction 5.6 Immune-Mediated Skin Adverse Reactions 5.7 Immune-Mediated Encephalitis 5.8 Other Immune-Mediated Adverse Reactions 5.9 Infusion Reactions 5.10 Complications of Allogeneic HSCT after 5.11 Embryo-Fetal Toxicity 6 ADVERSE REACTIONS 6.1 Clinical Trials Experience 6.2 Immunogenicity 7 DRUG INTERACTIONS 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 8.2 Lactation 8.3 Females and Males of Reproductive Potential 8.4 Pediatric Use 8.5 Geriatric Use 8.6 Renal Impairment 8.7 Hepatic Impairment 10 OVERDOSAGE 11 DESCRIPTION 12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action 12.2 Pharmacodynamics 12.3 Pharmacokinetics 13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility 13.2 Animal Toxicology and/or Pharmacology 14 CLINICAL STUDIES 14.1 Unresectable or Metastatic Melanoma 14.2 Adjuvant Treatment of Melanoma 14.3 Metastatic Non-Small Cell Lung Cancer (NSCLC) 14.4 Renal Cell Carcinoma 14.5 Classical Hodgkin Lymphoma 14.6 Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN) 14.7 Urothelial Carcinoma 14.8 Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dmmr) Metastatic Colorectal Cancer 14.9 Hepatocellular Carcinoma 16 HOW SUPPLIED/STORAGE AND HANDLING 17 PATIENT COUNSELING INFORMATION *Sections or subsections omitted from the full prescribing information are not listed. FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE 1.1 Unresectable or Metastatic Melanoma (nivolumab) as a single agent is indicated for the treatment of patients with BRAF V600 wild-type unresectable or metastatic melanoma [see Clinical Studies (14.1)]. as a single agent is indicated for the treatment of patients with BRAF V600 mutation-positive unresectable or metastatic melanoma [see Clinical Studies (14.1)]. This indication is approved under accelerated approval based on progression-free survival. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials., in combination with ipilimumab, is indicated for the treatment of patients with unresectable or metastatic melanoma [see Clinical Studies (14.1)]. This indication is approved under accelerated approval based on progression-free survival. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. 1.2 Adjuvant Treatment of Melanoma is indicated for the adjuvant treatment of patients with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection [see Clinical Studies (14.2)]. 1.3 Metastatic Non-Small Cell Lung Cancer is indicated for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving [see Clinical Studies (14.3)]. 1.4 Renal Cell Carcinoma is indicated for the treatment of patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy [see Clinical Studies (14.4)]. 1.5 Classical Hodgkin Lymphoma is indicated for the treatment of adult patients with classical Hodgkin lymphoma (chl) that has relapsed or progressed after: autologous hematopoietic stem cell transplantation (HSCT) and brentuximab vedotin, or 3 or more lines of systemic therapy that includes autologous HSCT. This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials [see Clinical Studies (14.5)]. 1.6 Squamous Cell Carcinoma of the Head and Neck is indicated for the treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) with disease progression on or after platinum-based therapy [see Clinical Studies (14.6)]. 1.7 Urothelial Carcinoma (nivolumab) is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who: have disease progression during or following platinum-containing chemotherapy have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials [see Clinical Studies (14.7)]. 1.8 Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dmmr) Metastatic Colorectal Cancer is indicated for the treatment of adult and pediatric patients 12 years and older with microsatellite instability-high (MSI-H) or mismatch repair deficient (dmmr) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan [see Clinical Studies (14.8)]. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. 1.9 Hepatocellular Carcinoma is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials [see Clinical Studies (14.9)]. 2 DOSAGE AND ADMINISTRATION 2.1 Recommended Dosage for Unresectable or Metastatic Melanoma The recommended dose of as a single agent is 240 mg administered as an intravenous infusion over 30 minutes every 2 weeks until disease progression or unacceptable toxicity. The recommended dose of is 1 mg/kg administered as an intravenous infusion over 30 minutes, followed by ipilimumab on the same day, every 3 weeks for 4 doses [see Clinical Studies (14.1)]. The recommended subsequent dose of, as a single agent, is 240 mg administered as an intravenous infusion over 30 minutes every 2 weeks until disease progression or unacceptable toxicity. Review the Full Prescribing Information for ipilimumab prior to initiation. 2.2 Recommended Dosage for Adjuvant Treatment of Melanoma The recommended dose of is 240 mg administered as an intravenous infusion over 60 minutes every 2 weeks until disease recurrence or unacceptable toxicity for up to 1 year. 2.3 Recommended Dosage for NSCLC The recommended dose of is 240 mg administered as an intravenous infusion over 30 minutes every 2 weeks until disease progression or unacceptable toxicity.
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