"Today the U.S. Food and Drug Administration expanded the approved use of Yervoy (ipilimumab) to include a new use as adjuvant therapy for patients with stage III melanoma, to lower the risk that the melanoma will return following surgery.
(ipilimumab) Intravenous Infusion
IMMUNE-MEDIATED ADVERSE REACTIONS
YERVOY can result in severe and fatal immune-mediated adverse reactions. These immune-mediated reactions may involve any organ system; however, the most common severe immune-mediated adverse reactions are enterocolitis, hepatitis, dermatitis (including toxic epidermal necrolysis), neuropathy, and endocrinopathy. The majority of these immune-mediated reactions initially manifested during treatment; however, a minority occurred weeks to months after discontinuation of YERVOY.
Permanently discontinue YERVOY and initiate systemic high-dose corticosteroid therapy for severe immune-mediated reactions [see DOSAGE AND ADMINISTRATION].
Assess patients for signs and symptoms of enterocolitis, dermatitis, neuropathy, and endocrinopathy, and evaluate clinical chemistries including liver function tests, adrenocorticotropic hormone (ACTH) level, and thyroid function tests, at baseline and before each dose [see WARNINGS AND PRECAUTIONS].
YERVOY (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 paleyellow solution for intravenous infusion, which may contain a small amount of visible translucent-to-white, 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.
What are the possible side effects of ipilimumab (Yervoy)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Serious and sometimes fatal reactions may occur during treatment with ipilimumab or months after stopping. Contact your doctor right away if you have symptoms such as:
- diarrhea, increased bowel movements, black or bloody stools, stomach tenderness;
- pain in your upper stomach, dark urine, jaundice (yellowing of the skin or eyes), easy bruising or bleeding;
- unusual muscle weakness, numbness or...
What are the precautions when taking ipilimumab injection (Yervoy)?
Before using ipilimumab, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: history of organ transplant.
This medication may worsen certain types of immune system disorders (autoimmune type). Before using this medication, tell your doctor or pharmacist if you have any of the following disorders, among others: certain bowel diseases (Crohn's disease, ulcerative colitis), Guillain-Barre syndrome, lupus, sarcoidosis.
Before having surgery, tell your doctor or dentist about all the products...
Last reviewed on RxList: 11/5/2015
This monograph has been modified to include the generic and brand name in many instances.
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