Država: Združene države Amerike
Jezik: angleščina
Source: NLM (National Library of Medicine)
IPILIMUMAB (UNII: 6T8C155666) (IPILIMUMAB - UNII:6T8C155666)
E.R. Squibb & Sons, L.L.C.
IPILIMUMAB
IPILIMUMAB 5 mg in 1 mL
INTRAVENOUS
PRESCRIPTION DRUG
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. 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. 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). 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 [
YERVOY (ipilimumab) injection is a sterile, preservative-free, clear to slightly opalescent, colorless to pale-yellow solution. YERVOY is available as follows: Carton Contents NDC One 50 mg/10 mL (5 mg/mL), single-dose vial NDC 0003-2327-11 One 200 mg/40 mL (5 mg/mL), single-dose vial NDC 0003-2328-22 Store YERVOY under refrigeration at 2°C to 8°C (36°F to 46°F). Protect YERVOY from light by storing in the original carton until time of use. Do not freeze or shake.
Biologic Licensing Application
E.R. Squibb & Sons, L.L.C. ---------- MEDICATION GUIDE YERVOY® (yur-voi) (ipilimumab) injection Read this Medication Guide before you start receiving YERVOY and before each infusion. There may be new information. If your healthcare provider prescribes YERVOY in combination with nivolumab (OPDIVO®), also read the Medication Guide that comes with nivolumab. This Medication Guide does not take the place of talking with your healthcare provider about your medical condition or your treatment. What is the most important information I should know about YERVOY? 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 Preberite celoten dokument
YERVOY- IPILIMUMAB INJECTION E.R. SQUIBB & SONS, L.L.C. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE YERVOY SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR YERVOY. YERVOY (IPILIMUMAB) INJECTION, FOR INTRAVENOUS USE INITIAL U.S. APPROVAL: 2011 RECENT MAJOR CHANGES Indications and Usage (1) 2/2023 Dosage and Administration (2) 5/2022 INDICATIONS AND USAGE YERVOY is a human cytotoxic T-lymphocyte antigen 4 (CTLA-4)-blocking antibody indicated for: Melanoma • • Renal Cell Carcinoma (RCC) • Colorectal Cancer • Hepatocellular Carcinoma • Non-Small Cell Lung Cancer (NSCLC) • • Malignant Pleural Mesothelioma • Esophageal Cancer ® Treatment of unresectable or metastatic melanoma in adults and pediatric patients 12 years and older as a single agent or in combination with nivolumab. (1.1) 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. (1.2) Treatment of adult patients with intermediate or poor risk advanced renal cell carcinoma, as first-line treatment in combination with nivolumab. (1.3) Treatment of adult and pediatric patients 12 years and older 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, in combination with nivolumab. 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. (1.4) Treatment of adult patients with hepatocellular carcinoma who have been previously treated with sorafenib, in combination with nivolumab. This indication is approved under accelerated approval based on overall response rate and duration of response. Preberite celoten dokument