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Description of product
What is Yervoy and how is it used?
Yervoy is a prescription medicine used:
- to treat a kind of skin cancer called melanoma. Yervoy may be used:
- in adults and children 12 years of age and older when melanoma has spread or cannot be removed by surgery
- to help prevent melanoma from coming back after it and lymph nodes that contain cancer have been removed by surgery
- in people 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).
- Yervoy in combination with nivolumab may be used when your colon or rectal cancer:
- has spread to other parts of the body (metastatic).
- is microsatellite stability-high (MSI-H) or mismatch repair deficient (dMMR), and
- You have tried treatment with a fluoropyrimidine, oxaliplatin, and irinotecan, and it did not work or is no longer working.
- in people with liver cancer (hepatocellular carcinoma).
- Yervoy may be used in combination with nivolumab if you have previously received treatment with sorafenib.
- in adults with a type of lung cancer called non-small cell lung cancer (NSCLC).
- Yervoy may be used in combination with nivolumab as your first treatment for NSCLC:
- when your lung cancer has spread to other parts of your body (metastatic), and
- your tumors are positive for PD-L1, but do not have an abnormal EGFR or ALK gene.
- Yervoy may be used in combination with nivolumab and 2 cycles of chemotherapy that contains platinum and another chemotherapy medicine, as the first treatment of your NSCLC when your lung cancer:
- has spread or grown, or comes back, and
- your tumor does not have an abnormal EGFR or ALK gene.
- Yervoy may be used in combination with nivolumab as your first treatment for NSCLC:
It is not known if Yervoy is safe and effective in children younger than 12 years of age.
What are the possible side effects of Yervoy?
Yervoy can cause serious side effects, including:
- See “What is the most important information I should know about Yervoy?”
- Severe infusion reactions. Tell your doctor or nurse right away if you get these symptoms during an infusion of Yervoy:
- chills or shaking
- itching or rash
- flushing
- difficulty breathing
- dizziness
- fever
- feeling like passing out
Graft-versus-host disease, a complication that can happen after receiving a bone marrow (stem cell) transplant that uses donor stem cells (allogeneic), may be severe, and can lead to death, if you receive Yervoy either before or after transplant. Your healthcare provider will monitor you for the following signs and symptoms: skin rash, liver inflammation, stomach-area (abdominal) pain, and diarrhea.
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
- rash
- itching
- diarrhea
- pain in muscles, bones, and joints
- cough
- fever
- decreased appetite
- nausea
- stomach-area (abdominal) pain
- headache
- vomiting
- shortness of breath
- dizziness
- low thyroid hormone levels (hypothyroidism)
- decreased weight
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.
DESCRIPTION
Ipilimumab is a recombinant, human monoclonal antibody that binds to the cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4). Ipilimumab is an IgG1 kappa immunoglobulin with an approximate molecular weight of 148 kDa. Ipilimumab is produced in mammalian (Chinese hamster ovary) cell culture.
YERVOY is a sterile, preservative-free, clear to slightly opalescent, colorless to pale-yellow solution for intravenous infusion, which may contain a small amount of visible translucent-towhite, amorphous ipilimumab particulates. It is supplied in single-use vials of 50 mg/10 mL and 200 mg/40 mL. Each milliliter contains 5 mg of ipilimumab and the following inactive ingredients: diethylene triamine pentaacetic acid (DTPA) (0.04 mg), mannitol (10 mg), polysorbate 80 (vegetable origin) (0.1 mg), sodium chloride (5.85 mg), tris hydrochloride (3.15 mg), and Water for Injection, USP at a pH of 7.
INDICATIONS
Unresectable Or Metastatic Melanoma
YERVOY is indicated for the treatment of unresectable or metastatic melanoma in adults and pediatric patients 12 years and older.
YERVOY, in combination with nivolumab, is indicated for the treatment of unresectable or metastatic melanoma in adult patients.
Adjuvant Treatment Of Melanoma
YERVOY is indicated for the adjuvant treatment of patients with cutaneous melanoma with pathologic involvement of regional lymph nodes of more than 1 mm who have undergone complete resection, including total lymphadenectomy.
Advanced Renal Cell Carcinoma
YERVOY, in combination with nivolumab, is indicated for the first-line treatment of patients with intermediate or poor risk advanced renal cell carcinoma (RCC).
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 microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (mCRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan.
This indication is approved under accelerated approval based on overall response rate and duration of response [see Clinical Studies]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
Hepatocellular Carcinoma
YERVOY, in combination with nivolumab, 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 overall response rate and duration of response [see Clinical Studies]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
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-approved test [see DOSAGE AND ADMINISTRATION], 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 patients with metastatic or recurrent NSCLC, with no EGFR or ALK genomic tumor aberrations.
Malignant Pleural Mesothelioma
YERVOY, in combination with nivolumab, is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma.