Ipilimumab

What it is used for

YERVOY is a human cytotoxic T-lymphocyte antigen 4 (CTLA-4)-blocking antibody indicated for: Melanoma Treatment of unresectable or metastatic melanoma in adults and pediatric patients 12 years and older as a single agent or in combination with nivolumab. Adjuvant treatment of adult patients with cutaneous melanoma with pathologic involvement of regional lymph nodes of more than 1 mm who have undergone complete resection, including total lymphadenectomy.

Renal Cell Carcinoma (RCC) Treatment of adult patients with intermediate or poor risk advanced renal cell carcinoma, as first-line treatment in combination with nivolumab. Colorectal Cancer Treatment of adults and pediatric patients 12 years and older with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (CRC) as determined by an FDA-authorized test in combination with nivolumab.

Hepatocellular Carcinoma adult patients with unresectable or metastatic hepatocellular carcinoma (HCC) as first-line treatment in combination with nivolumab. in combination with nivolumab in adult patients with unresectable or metastatic HCC who have been previously treated with sorafenib. Non-Small Cell Lung Cancer (NSCLC) Treatment of adult patients with metastatic non-small cell lung cancer expressing PD-L1 (≥1%) as determined by an FDA-authorized test, with no EGFR or ALK genomic tumor aberrations, as first-line treatment in combination with nivolumab.

Treatment of adult patients with metastatic or recurrent non-small cell lung cancer with no EGFR or ALK genomic tumor aberrations as first-line treatment, in combination with nivolumab and 2 cycles of platinum-doublet chemotherapy. Malignant Pleural Mesothelioma Treatment of adult patients with unresectable malignant pleural mesothelioma, as first-line treatment in combination with nivolumab.

Esophageal Cancer Treatment of adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma, as first line treatment in combination with nivolumab whose tumors express PD-L1 (≥1). 1.1 Unresectable or Metastatic Melanoma YERVOY, as a single agent or in combination with nivolumab, is indicated for the treatment of unresectable or metastatic melanoma in adult and pediatric patients 12 years and older.

1.2 Adjuvant Treatment of Melanoma YERVOY is indicated for the adjuvant treatment of adult patients with cutaneous melanoma with pathologic involvement of regional lymph nodes of more than 1 mm who have undergone complete resection, including total lymphadenectomy. 1.3 Advanced Renal Cell Carcinoma YERVOY, in combination with nivolumab, is indicated for the first-line treatment of adult patients with intermediate or poor risk advanced renal cell carcinoma (RCC).

1.4 Microsatellite Instability-High or Mismatch Repair Deficient Metastatic Colorectal Cancer YERVOY, in combination with nivolumab, is indicated for the treatment of adult and pediatric patients 12 years and older with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (CRC) as determined by an FDA-authorized test.

1.5 Hepatocellular Carcinoma YERVOY, in combination with nivolumab, is indicated for the first-line treatment of adult patients with unresectable or metastatic hepatocellular carcinoma (HCC). YERVOY, in combination with nivolumab, is indicated for the treatment of adult patients with unresectable or metastatic HCC who have been previously treated with sorafenib.

1.6 Metastatic Non-Small Cell Lung Cancer YERVOY, in combination with nivolumab, is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 (≥1%) as determined by an FDA-authorized test, with no EGFR or ALK genomic tumor aberrations. YERVOY, in combination with nivolumab and 2 cycles of platinum-doublet chemotherapy, is indicated for the first-line treatment of adult

The most important thing to know

YERVOY is a medicine that may treat certain cancers by working with your immune system. YERVOY 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 severe or life-threatening and can lead to death. You may have more than one of these problems at the same time.

These problems may happen anytime during treatment or even after your treatment has ended. Some of these problems may happen more often when YERVOY is used in combination with nivolumab. Call or see your healthcare provider right away if you develop any new or worse signs or symptoms, including: Intestinal problems. diarrhea (loose stools) or more frequent bowel movements than usual stools that are black, tarry, sticky, or have blood or mucus severe stomach-area (abdominal) pain or tenderness Liver problems.

yellowing of your skin or the whites of your eyes severe nausea or vomiting pain on the right side of your stomach-area (abdomen) dark urine (tea colored) bleeding or bruising more easily than normal Skin problems. rash itching skin blistering or peeling painful sores in mouth or nose, throat, or genital area Hormone gland problems.

headache that will not go away or unusual headaches eye sensitivity to light eye problems rapid heartbeat increased sweating extreme tiredness weight gain or weight loss feeling more hungry or thirsty than usual urinating more often than usual hair loss feeling cold constipation your voice gets deeper dizziness or fainting changes in mood or behavior, such as decreased sex drive, irritability, or forgetfulness Lung problems.

new or worsening cough shortness of breath chest pain Kidney problems. decrease in your amount of urine blood in your urine swelling of your ankles loss of appetite Eye problems. blurry vision, double vision, or other vision problems eye pain or redness Problems can also happen in other organs and tissues. These are not all of the signs and symptoms of immune system problems that can happen with YERVOY.

Call or see your healthcare provider right away for any new or worsening signs or symptoms. Chest pain, irregular heartbeat, shortness of breath or swelling of ankles Confusion, sleepiness, memory problems, changes in mood or behavior, stiff neck, balance problems, tingling or numbness of the arms or legs Double vision, blurry vision, sensitivity to light, eye pain, changes in eyesight Persistent or severe muscle pain or weakness, muscle cramps Low red blood cells, bruising Getting medical treatment right away may help keep these problems from becoming more serious.

Your healthcare provider will check you for these problems during your treatment with YERVOY. Your healthcare provider may treat you with corticosteroid or hormone replacement medicines. Your healthcare provider may also need to delay or completely stop treatment with YERVOY if you have severe side effects. What is YERVOY?

YERVOY is a prescription medicine used: to treat a kind of skin cancer called melanoma. o YERVOY may be used alone or in combination with nivolumab in adults and children 12 years of age and older when melanoma has spread or cannot be removed by surgery. o YERVOY may be used alone in adults to help prevent melanoma from coming back after it and lymph nodes that contain cancer have been removed by surgery.

in adults with kidney cancer (renal cell carcinoma). YERVOY may be used in combination with nivolumab in certain people when their cancer has spread. in adults and children 12 years of age and older, with a type of colon or rectal cancer (colorectal cancer). o YERVOY may be used in combination with nivolumab when your colon or rectal cancer: ▪ cannot be removed with surgery, or has spread, and ▪ is microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR).

in adults with liver cancer (hepatocellular carcinoma). o YERVOY may be

Side effects, and when to stop

YERVOY can cause serious side effects, including: Severe infusion-related reactions. Tell your healthcare provider or nurse right away if you get these symptoms during an infusion of YERVOY: o chills or shaking o itching or rash o flushing o shortness of breath or wheezing o dizziness o feel like passing out o fever o back or neck pain Complications, including graft-versus-host disease (GVHD), in people who have received a bone marrow (stem cell) transplant that uses donor stem cells (allogeneic).

These complications can be severe and can lead to death. These complications may happen if you underwent transplantation either before or after being treated with YERVOY. Your healthcare provider will monitor you for these complications. The most common side effects of YERVOY when used alone include: feeling tired diarrhea nausea itching rash vomiting headache weight loss fever decreased appetite difficulty falling or staying asleep The most common side effects of YERVOY when used in combination with nivolumab include: feeling tired diarrhea rash itching nausea pain in muscles, bones, and joints fever cough decreased appetite vomiting stomach-area (abdominal) pain shortness of breath upper respiratory tract infection headache low thyroid hormone levels (hypothyroidism) constipation decreased weight dizziness The most common side effects of YERVOY when used in combination with nivolumab and chemotherapy include: feeling tired pain in muscles, bones, and joints nausea diarrhea rash decreased appetite constipation itching These are not all of the possible side effects of YERVOY.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.