Abatacept (Orencia)

Trade Name : ORENCIA

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

INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

Strength 250 mg/15mL

Storage and handling for ORENCIA

ABATACEPT Decreased Cytokine Activity [PE],Selective T Cell Costimulation Modulator [EPC],Recombinant Fusion Proteins [CS]

Disclaimer

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Abatacept (Orencia) which is also known as ORENCIA and Manufactured by E.R. Squibb & Sons, L.L.C.. It is available in strength of 250 mg/15mL per ml. Read more

Abatacept (Orencia) 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

Delivery Process

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You can fill in a request for your medicine through the form provided. You can access the form by clicking on the ‘Get Price’ button.

Product information is meant for

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

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.

About GNH

No data

ORENCIA is a selective T cell costimulation modulator indicated for:n n
Juvenile Idiopathic Arthritis n
Adult Psoriatic Arthritis (PsA) ()

Intravenous Administration for Adult RA and Adult PsA n
Subcutaneous Administration for Adult RA n
Intravenous Administration for Juvenile Idiopathic Arthritis n
Subcutaneous Administration for Juvenile Idiopathic Arthritis n
Subcutaneous Administration for Adult PsA ()
General Dosing Information for Intravenous Administration and n

Intravenous Infusion
Subcutaneous Injection

None.

u2022
(4)

No data

(5.3n- 8.5)

Because clinical trials are conducted under widely varying and controlled conditions, adverse reaction rates observed in clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not predict the rates observed in a broader patient population in clinical practice.
As with all therapeutic proteins, there is potential for immunogenicity. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to abatacept in the studies described below with the incidence of antibodies in other studies or to other products may be misleading.
Most common adverse events (u226510%) are headache, upper respiratory tract infection, nasopharyngitis, and nausea n
www.fda.gov/medwatch

No data

No data

u2022
(8.1)

Doses up to 50 mg/kg have been administered intravenously without apparent toxic effect. In case of overdosage, it is recommended that the patient be monitored for any signs or symptoms of adverse reactions and appropriate symptomatic treatment instituted.

ORENCIA (abatacept) is a selective T cell costimulation modulator. ORENCIA is a soluble fusion protein that consists of the extracellular domain of human cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) linked to the modified Fc (hinge, CH2, and CH3 domains) portion of human immunoglobulin G1 (IgG1). Abatacept is produced by recombinant DNA technology in a mammalian cell expression system. The apparent molecular weight of abatacept is 92 kilodaltons.
ORENCIA for Injection is a lyophilized powder for intravenous infusion. ORENCIA for Injection is supplied as a sterile, white, preservative-free, lyophilized powder for reconstitution and dilution prior to intravenous administration. Following reconstitution of the lyophilized powder with 10 mL of Sterile Water for Injection, USP, the solution of ORENCIA is clear, colorless to pale yellow, with a pH range of 7.2 to 7.8. Each single-use vial of ORENCIA for Injection provides 250u00a0mg abatacept, maltose (500 mg), monobasic sodium phosphate (17.2 mg), and sodium chloride (14.6 mg) for administration.
ORENCIA Injection is a sterile, preservative-free, clear to slightly opalescent, colorless to pale-yellow solution with a pH range of 6.8 to 7.4 for subcutaneous administration. ORENCIA Injection is supplied as a single-dose prefilled syringe or as a single-dose ClickJect autoinjector (see Table 4).
Unlike the lyophilized formulation for intravenous use, the ORENCIA solutions for subcutaneous administration contain no maltose.

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Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).

U.S. License Number 1713n n n n n n

This Patient Information has been approved by the U.S. Food and Drug Administration.u00a0u00a0u00a0u00a0u00a0u00a0
Rev June/2017u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0n

ORENCIAn n- (abatacept)n- Prefilled Syringe with BD UltraSafe Passive Needle Guard
Step 1:u00a0u00a0Preparing for an ORENCIA Injection
Step 2:u00a0u00a0u00a0Examine the Prefilled Syringe
Step 3:u00a0u00a0Check the Dose on the Prefilled Syringe
Step 4:u00a0u00a0Choose and Prepare an Injection Site
Step 5:u00a0u00a0Inject Your Dose of ORENCIA
Step 6:u00a0u00a0After the Injection
Bristol-Myers Squibb CompanyPrinceton, NJ 08543 USA, U.S. License Number 1713n
This Instructions for Use has been approved by the U.S. Food and Drug Administration.n
ORENCIA is a registered trademark of Bristol-Myers Squibb Company.BD UltraSafe Passive is a trademark of Becton, Dickinson and Company.n
u00a0
u00a0
u00a0

ORENCIAn n- ClickJectu2122n- (abatacept)n- Prefilled Autoinjector
Step 1:u00a0u00a0Prepare Your Autoinjector
Step 2:u00a0u00a0Prepare for Injection
Step 3:u00a0u00a0Inject Your Dose
Step 4:u00a0u00a0After the Injection
Bristol-Myers Squibb CompanyPrinceton, NJ 08543 USA, U.S. License Number 1713
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
ORENCIA is a registered trademark and ClickJect is a trademark of Bristol-Myers Squibb Company.
Revised March 2017
u00a0u00a0u00a0u00a0u00a0u00a0

See section for a complete list of available packages of ORENCIA.
Rx onlyNDC 0003-2187-13ORENCIAn (abatacept)Lyophilized Powder for IV Infusion250 mg/vialONLY USE THE SILICONE-FREE DISPOSABLE SYRINGE INCLUDED IN THE PACKAGE FOR RECONSTITUTIONBristol-Myers Squibb CompanyPrinceton, New Jersey 08543 USAUS License No. 1713

Bristol-Myers SquibbNDC 0003-2814-114 Single-Dose Prefilled Syringes with BD UltraSafe Passiveu2122 Needle GuardORENCIAu00ae(abatacept)Injection50 mg/0.4mLSingle-Dose Prefilled Syringe with BD UltraSafe Passiveu2122 Needle GuardFOR SUBCUTANEOUS USE ONLYWARNING: Keep out of reach of childrenDiscard each syringe after useRx only

Bristol-Myers SquibbNDC 0003-2818-114 Single-Dose Prefilled Syringes with BD UltraSafe Passiveu2122 Needle GuardORENCIAu00ae(abatacept)Injection87.5 mg/0.7mLSingle-Dose Prefilled Syringe with BD UltraSafe Passiveu2122 Needle GuardFOR SUBCUTANEOUS USE ONLYWARNING: Keep out of reach of childrenDiscard each syringe after useRx only

Bristol-Myers SquibbNDC 0003-2188-114 Single-Dose Prefilled Syringes with BD UltraSafe Passive Needle GuardORENCIAn (abatacept)Injection125 mg/mLSingle-Dose Prefilled Syringe with BD UltraSafe Passive Needle GuardFOR SUBCUTANEOUS USE ONLYWARNING: Keep out of reach of childrenDiscard each syringe after useRx only

Bristol-Myers SquibbNDC 0003-2188-514 Single-Dose Prefilled AutoinjectorsORENCIAClickJectn (abatacept)Injection125 mg/mLSingle-Dose AutoinjectorFOR SUBCUTANEOUS USE ONLYRefrigerate immediatelyWARNING: Keep out of reach of childrenDiscard each autoinjector after useOpen from this side u00a0u00a0u00a0u00a0Rx only

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