“We use cookies on this website to enhance your user experience and to personalise content. By clicking any link or continuing to use our Website you agree to our cookies as per our Privacy Policy. Read More” Ok, I agree

Elotuzumab (Empliciti)

Trade Name : EMPLICITI

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

INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

Strength 300 mg/1

ELOTUZUMAB SLAMF7-directed Immunostimulatory Antibody [EPC],SLAMF7-directed Antibody Interactions [MoA],Antibodies, Monoclonal [CS]

Delivery Process

Submit a Request

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.

We’ll Get in Touch

Once we review your request, we’ll send you an estimated price for the medicine within 2-5 days.

Confirmation and Payment

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.

Submit a Request

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

Disclaimer

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 Elotuzumab (Empliciti) which is also known as EMPLICITI and Manufactured by E.R. Squibb & Sons, L.L.C.. It is available in strength of 300 mg/1 per ml. Read more

Elotuzumab (Empliciti) 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.

Inquire directly from our website and get 5% off on any medicine!

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.

Read more

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.

Read more
  • No data
  • Indications and Usage u00a0u00a0u00a0u00a0u00a0u00a011/2018Dosage and Administration , ,u00a0u00a0u00a0u00a0u00a0u00a011/2018Warnings and Precautions , , , u00a0u00a0u00a0u00a0u00a0u00a011/2018
  • EMPLICITI is a SLAMF7-directed immunostimulatory antibody indicated in
  • No data
  • For injection: 300 mg or 400 mg of elotuzumab as a white to off-white lyophilized powder in a single-dose vial for reconstitution.
  • For Injection: 300 mg or 400 mg lyophilized powder in a single-dose vial for reconstitution. n
  • None.
  • None n
  • No data
  • (n- 2.3n- 2.4n- 5.1)
  • The following clinically significant adverse reactions are described in detail in other sections of the label:
  • Most common adverse reactions (20% or higher)
  • No data
  • Pregnancy: Embryo-fetal toxicity in combination with lenalidomide and dexamethasone or pomalidomide and dexamethasone. n
  • The dose of EMPLICITI at which severe toxicity occurs is not known. EMPLICITI does not appear to be removed by dialysis as determined in a study of patients with renal impairment.
  • In case of overdosage, monitor patients closely for signs or symptoms of adverse reactions and institute appropriate symptomatic treatment.
  • Elotuzumab is a humanized recombinant monoclonal antibody directed to SLAMF7, a cell surface glycoprotein. Elotuzumab consists of the complementary determining regions (CDR) of the mouse antibody, MuLuc63, grafted onto human IgG1 heavy and kappa light chain frameworks. Elotuzumab is produced in NS0 cells by recombinant DNA technology. Elotuzumab has a theoretical mass of 148.1u00a0kDa for the intact antibody.
  • EMPLICITI (elotuzumab) is a sterile, nonpyrogenic, preservative-free lyophilized powder that is white to off-white, whole or fragmented cake in single-dose vials. EMPLICITI for Injection is supplied as 300 mg per vial and 400 mg per vial and requires reconstitution with Sterile Water for Injection, USP (13 mL and 17 mL, respectively) to obtain a solution with a concentration of 25u00a0mg/mL. After reconstitution, each vial contains overfill to allow for withdrawal of 12 mL (300 mg) and 16 mL (400 mg). The reconstituted solution is colorless to slightly yellow, clear to slightly opalescent. Prior to intravenous infusion, the reconstituted solution is diluted with either 0.9%u00a0Sodium Chloride Injection, USP or 5%u00a0Dextrose Injection, USP [n ].
  • Each 300 mg single-dose vial of EMPLICITI also contains the following inactive ingredients: citric acid monohydrate (2.44 mg), polysorbate 80 (3.4 mg), sodium citrate (16.6 mg), and sucrose (510u00a0mg).
  • Each 400 mg single-dose vial of EMPLICITI also contains the following inactive ingredients: citric acid monohydrate (3.17 mg), polysorbate 80 (4.4 mg), sodium citrate (21.5 mg), and sucrose (660 mg).
  • No data
  • No carcinogenicity or mutagenicity data are available for elotuzumab in animals or humans. Fertility studies have not been performed for elotuzumab.
  • ELOQUENT-2 (NCT01239797)
  • The efficacy and safety of EMPLICITI in combination with lenalidomide and dexamethasone were evaluated in ELOQUENT-2, a randomized, open-label trial in patients with multiple myeloma who had received one to three prior therapies and had documented progression following their most recent therapy.
  • Eligible patients were randomized in a 1:1 ratio to receive either EMPLICITI in combination with lenalidomide and low-dose dexamethasone or lenalidomide and low-dose dexamethasone. Treatment was administered in 4-week cycles until disease progression or unacceptable toxicity. EMPLICITI 10 mg/kg was administered intravenously each week for the first 2u00a0cycles and every 2 weeks thereafter. Prior to EMPLICITI infusion, dexamethasone was administered as a divided dose: an oral dose of 28 mg and an intravenous dose of 8 mg. In the control group and on weeks without EMPLICITI, dexamethasone 40 mg was administered as a single oral dose weekly. Lenalidomide 25 mg was taken orally once daily for the first 3u00a0weeks of each cycle. Assessment of tumor response was conducted every 4u00a0weeks.
  • A total of 646 patients were randomized to receive treatment: 321 to EMPLICITI in combination with lenalidomide and low-dose dexamethasone and 325 to lenalidomide and low-dose dexamethasone.
  • Demographics and baseline disease characteristics were balanced between treatment arms. The median age was 66 years (range, 37-91); 57% of patients were 65 years or older; 60% of patients were male; whites comprised 84% of the study population, Asians 10%, and blacks 4%. The ECOG performance status was 0 in 47%, 1 in 44%, and 2 in 9% of patients, and ISS Stage was I in 43%, II in 32%, and III in 21% of patients. The cytogenetic categories of delu00a017p and t(4;14) were present in 32% and 9% of patients, respectively. The median number of prior therapies was 2. Thirty-five percent (35%) of patients were refractory (progression during or within 60 days of last therapy) and 65% were relapsed (progression after 60 days of last therapy). Prior therapies included stem cell transplant (55%), bortezomib (70%), melphalan (65%), thalidomide (48%), and lenalidomide (6%).
  • The efficacy of EMPLICITI was evaluated by progression-free survival (PFS) as assessed by hazard ratio, and overall response rate (ORR) as determined by a blinded Independent Review Committee using the European Group for Blood and Marrow Transplantation (EBMT) response criteria. Efficacy results are shown in Table 12 and Figure 1. The median number of treatment cycles was 19 for the EMPLICITI group and 14 for the comparator arm with a minimum follow-up of two years.
  • A pre-planned final overall survival (OS) analysis was performed after at least 427 deaths occurred. The minimum follow-up was 70.6u00a0months. The OS results at final analysis reached statistical significance. A significantly longer OS was observed in patients in the E-Ld arm compared to patients in Ld arm, representing an 18% reduction in the risk of death. Efficacy results are presented in Table 12 and Figure 2.
  • Figure 1:u00a0u00a0u00a0ELOQUENT-2 Progression-Free Survival
  • The 1- and 2-year rates of PFS for EMPLICITI in combination with lenalidomide and dexamethasone treatment were 68% and 41%, respectively, compared with 57% and 27%, respectively, for lenalidomide and dexamethasone treatment.
  • Figure 2:u00a0u00a0u00a0ELOQUENT-2 Overall Survival
  • ELOQUENT-3 (NCT02654132)n- Array
  • The efficacy and safety of EMPLICITI in combination with pomalidomide and dexamethasone were evaluated in ELOQUENT-3, a randomized, open-label trial in patients with relapsed or refractory multiple myeloma.
  • Eligible patients were randomized in a 1:1 ratio to receive either EMPLICITI in combination with pomalidomide and low-dose dexamethasone or pomalidomide and low-dose dexamethasone. Treatment was administered in 4-week cycles until disease progression or unacceptable toxicity. EMPLICITI 10 mg/kg was administered intravenously each week for the first 2u00a0cycles and 20 mg/kg every 4 weeks thereafter.
  • Prior to EMPLICITI infusion, dexamethasone was administered. Dexamethasone was administered on day 1, 8, 15 and 22 of each cycle. On weeks with EMPLICITI infusion, dexamethasone was administered as a divided dose: subjects 75 years or younger, an oral dose of 28 mg and an intravenous dose of 8 mg, and in subjects older than 75 years an oral dose of 8 mg and an intravenous dose of 8 mg. On weeks without an EMPLICITI infusion and in the control group, dexamethasone was administered in subjects 75 years or younger as an oral dose of 40 mg and in subjects older than 75 years as an oral dose of 20 mg dexamethasone was administered orally. Assessment of tumor response was conducted every 4u00a0weeks.
  • A total of 117 patients were randomized to receive treatment: 60 to EMPLICITI in combination with pomalidomide and low-dose dexamethasone and 57 to pomalidomide and low-dose dexamethasone.
  • Demographics and baseline disease characteristics were balanced between treatment arms. The median age was 67 years (range, 36-81); 62% of patients were 65 years or older; 57% of patients were male; whites comprised 77% of the study population, Asians 21%, and blacks 1%. The ECOG performance status was 0 in 44%, 1 in 46%, and 2 in 10% of patients, and ISS Stage was I in 50%, II in 38%, and III in 12% of patients. The chromosomal lab abnormalities as determined by FISH of delu00a017p and t(4;14) were present in 5% and 11% of patients, respectively. The median number of prior therapies was 3. Eighty-seven percent (87%) of patients were refractory to lenalidomide, 80% refractory to a proteasome inhibitor, 70% were refractory to both lenalidomide and a proteasome inhibitor. Prior therapies included stem cell transplant (55%), bortezomib (100%), lenalidomide (99%), cyclophosphamide (66%), melphalan (63%), carfilzomib (21%), and daratumumab (3%).
  • The efficacy of EMPLICITI was evaluated by progression-free survival (PFS) and overall response rate (ORR) as determined by the investigator. Efficacy results are shown in Table 13 and Figure 3. The median number of treatment cycles was 9 for the EMPLICITI group and 5 for the comparator arm with a minimum follow-up of 9.1 months.
  • Figure 3:u00a0u00a0u00a0ELOQUENT-3 Progression-Free Survival
  • EMPLICITI (elotuzumab) is white to off-white lyophilized powder available as follows:
  • Store EMPLICITI under refrigeration at 2u00b0C to 8u00b0C (36u00b0F-46u00b0F). Protect EMPLICITI from light by storing in the original package until time of use. Do not freeze or shake.
  • Advise the patient to read the FDA-approved patient labeling .
  • This Patient Information has been approved by the U.S. Food and Drug Administration.
  • Revised: 11/2018
  • NDC 0003-2291-11Rx onlyn- For intravenous Infusion OnlyReconstitute and Further Dilute Prior to UseSingle-Dose Vial. Discard Unused Portion.
  • TM

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Desogestrel And Ethinyl Estradiol (Emoquette)

Manufacturer: REMEDYREPACK INC.

Presentation: KIT

Strength:

Pack Size:

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Manufacturer: REMEDYREPACK INC.

Presentation: TABLET

Strength: 2.5; .025 mg/1; mg/1

Pack Size:

Fluoxetine Hydrochloride (Fluoxetine)

Fluoxetine Hydrochloride (Fluoxetine)

Manufacturer: REMEDYREPACK INC.

Presentation: CAPSULE

Strength: 40 mg/1

Pack Size:

Metoprolol Succinate (Metoprolol Succinate)

Metoprolol Succinate (Metoprolol Succinate)

Manufacturer: REMEDYREPACK INC.

Presentation: TABLET, EXTENDED RELEASE

Strength: 25 mg/1

Pack Size:

Losartan Potassium (Losartan Potassium)

Losartan Potassium (Losartan Potassium)

Manufacturer: REMEDYREPACK INC.

Presentation: TABLET, FILM COATED

Strength: 25 mg/1

Pack Size:

Browse Our Services And Processes

Comparator Sourcing for Clinical Trials

Comparator Sourcing for Clinical Trials

GNH India brings over 10 years of experience in Comparator

Read More

Name Patient Supply

Name Patient Supply

Today, the exact cause for many rare diseases remains unknown

Read More

Validated Cold Chain Shipment

Validated Cold Chain Shipment

With shifting of pharma industry from synthetic molecules to biologic

Read More

Clinical Trials Supply

Clinical Trials Supply

STOP SOURCING..... START SMART SOURCING...... COME STRAIGHT TO THE SOURCE

Read More

Pharmaceutical Contract Manufacturing

Pharmaceutical Contract Manufacturing

GNH Provides Contract Manufacturing services for: Generic Medicines with following

Read More

Pricing

Pricing

PRICING POLICY Terms of sales are typically prepaid, unless otherwise

Read More

Disclaimer

Please see the Legal Notice for detailed terms and disclaimers. The Legal Notice governs the use of this Website and by accessing and using this Website you agree to be bound by and accept the Legal Notice.

Browse from other international pharmaceuticals

General

64020 Products

GNH India Brings to over 64036 Product SKUs from India all at 1 place with easy access and global deliveries.

US NDC

71245 Products

GNH India Brings to over 71252 Product SKUs from India all at 1 place with easy access and global deliveries.

Canadian DIN

51046 Products

GNH India Brings to over 51047 Product SKUs from India all at 1 place with easy access and global deliveries.

Swiss Drugs

150 Products

GNH India Brings to over 150 Product SKUs from India all at 1 place with easy access and global deliveries.

NZ Drugs

13296 Products

GNH Brings to over 13298 Product SKUs from India all at 1 place with easy access and global deliveries.

FAQ

Check out our delivery process

Can’t find what
you’re looking for?

Contact US
Get Price

Are you an existing customer or a vendor of GNH India? Log in here to

View your Transaction
COMPANY
SERVICES
QUICK LINKS
CONTACT US
Registered Office Address:

Unit # G- 14, 15, 16, 17, Ground Floor, Prabhadevi Industrial Estate, Enterprises Industrial Premises, 408, Veer Sawarkar Road, Prabhadevi,
Mumbai 400025 India

US Office Address:

GNH Pharmaceuticals USA LLC,
Suite E # 499, 1235 EAST BLVD,
Charlotte, NC, 28203, U.S.A
TEL: +1 704 557 0412

Pharmexcil
DB
FIEO-2016
SiteLock

Copyright © 2024 GNHIndia .com. All Rights Reserved. Please read Legal Notice for further details.

Disclaimer: Product names, logos, brands and other trademarks featured or referred to are the property of their respective trademark holders.