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Ipilimumab (Yervoy)

Trade Name : YERVOY

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

INJECTION

Strength 5 mg/mL

IPILIMUMAB CTLA-4-directed Blocking Antibody [EPC],CTLA-4-directed Antibody Interactions [MoA],Increased T Lymphocyte Activation [PE]

Delivery Process

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Wholesalers Suppliers Exporters Doctors MOH Tender Supplies Hospitals Brand CROs Comparator Supplies Generic Cooperate Sourcing Individual Patients Indian Institutional Buyers

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Ipilimumab (Yervoy) which is also known as YERVOY and Manufactured by E.R. Squibb & Sons, L.L.C.. It is available in strength of 5 mg/mL per ml. Read more

Ipilimumab (Yervoy) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

Packaging and Delivery

Validated Cold Chain Shipment

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • Warnings and Precautions, Immune-Mediated Enterocolitis/Colitis u00a0u00a0u00a0u00a0u00a09/2019
  • Warnings and Precautions, Other Immune-Mediated Adverse Reactions u00a0u00a0u00a0u00a0u00a05/2019
  • 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 .
  • 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 .
  • WARNING: IMMUNE-MEDIATED ADVERSE REACTIONS
  • See full prescribing information for complete boxed warning.
  • 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.
  • YERVOY is a human cytotoxic T-lymphocyte antigen 4 (CTLA-4)-blocking antibody indicated for:
  • No data
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  • Injection: 50 mg/10 mL (5 mg/mL) and 200 mg/40 mL (5 mg/mL) as a clear to slightly opalescent, colorless to pale-yellow solution in a single-use vial.
  • Injection: 50 mg/10 mL (5 mg/mL) and 200 mg/40 mL (5 mg/mL) in a single-use vial. n
  • None.
  • None. n
  • YERVOY can result in severe and fatal immune-mediated reactions .
  • Immune-mediated adverse reactions: Permanently discontinue for severe reactions. Withhold dose for moderate immune-mediated adverse reactions until return to baseline, improvement to mild severity, or complete resolution, and patient is receiving less than 7.5 mg prednisone or equivalent per day. Administer systemic high-dose corticosteroids for severe, persistent, or recurring immune-mediated reactions. , , , , , , , , , n
  • Immune-mediated hepatitis
  • Immune-mediated endocrinopathies
  • Immune-mediated pneumonitis
  • Immune-mediated nephritis and renal dysfunction
  • Immune-mediated encephalitis
  • Infusion reactions
  • Embryo-Fetal toxicity
  • The following adverse reactions are discussed in greater detail in other sections of the labeling.
  • In patients receiving YERVOY 3 mg/kg for unresectable or metastatic melanoma in MDX010-20, 15% of patients receiving monotherapy and 12% of patients treated in combination with gp100 peptide vaccine experienced Grade 3 to 5 immune-mediated reactions. In patients receiving YERVOY 10 mg/kg for adjuvant treatment of melanoma in CA184-029, 41% experienced Grade 3 to 5 immune-mediated reactions.
  • Most common adverse reactions (u22655%) with YERVOY as a single agent are fatigue, diarrhea, pruritus, rash, and colitis. Additional common adverse reactions at the 10 mg/kg dose (u22655%) include nausea, vomiting, headache, weight loss, pyrexia, decreased appetite, and insomnia. n
  • Most common adverse reactions (u226520%) with YERVOY in combination with nivolumab are fatigue, rash, diarrhea, nausea, pyrexia, musculoskeletal pain, pruritus, abdominal pain, vomiting, cough, arthralgia, decreased appetite, dyspnea. n
  • www.fda.gov/medwatch
  • No formal pharmacokinetic drug interaction studies have been conducted with YERVOY.
  • No data
  • u2022
  • (8.2)
  • There is no information on overdosage with 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 pale-yellow 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.
  • No data
  • The carcinogenic potential of ipilimumab has not been evaluated in long-term animal studies, and the genotoxic potential of ipilimumab has not been evaluated.
  • Fertility studies have not been performed with ipilimumab.
  • No data
  • YERVOY (ipilimumab) Injection is available as follows:
  • Store YERVOY under refrigeration at 2u00b0C to 8u00b0C (36u00b0F to 46u00b0F). Protect YERVOY from light by storing in the original carton until time of use. Do not freeze or shake.
  • Advise the patient to read the FDA-approved patient labeling (Medication Guide).
  • This Medication Guide has been approved by the U.S. Food and Drug Administration.Revised: May 2019
  • See section for a complete list of available packages of YERVOY.
  • NDC 0003-2327-11Rx onlyYERVOYn (ipilimumab)Injection50 mg/10 mL(5 mg/mL)For Intravenous Infusion OnlySingle-use vial; Discard unused portionDISPENSE ENCLOSED MEDICATION GUIDE TO EACH PATIENTBristol-Myers Squibb
  • NDC 0003-2328-22Rx onlyYERVOYn (ipilimumab)Injection200 mg/40 mL(5 mg/mL)For Intravenous Infusion OnlySingle-use vial; Discard unused portion DISPENSE ENCLOSED MEDICATION GUIDE TO EACH PATIENTBristol-Myers Squibb

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