YERVOY- ipilimumab injection

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

IPILIMUMAB (UNII: 6T8C155666) (IPILIMUMAB - UNII:6T8C155666)

متاح من:

E.R. Squibb & Sons, L.L.C.

INN (الاسم الدولي):

IPILIMUMAB

تركيب:

IPILIMUMAB 5 mg in 1 mL

طريقة التعاطي:

INTRAVENOUS

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

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 [

ملخص المنتج:

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.

الوضع إذن:

Biologic Licensing Application

نشرة المعلومات

E.R. Squibb & Sons, L.L.C.
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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

خصائص المنتج

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.