“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

Ofatumumab (Arzerra)

Trade Name : ARZERRA

Novartis Pharmaceuticals Corporation

INJECTION, SOLUTION

Strength 20 mg/mL

OFATUMUMAB CD20-directed Cytolytic Antibody [EPC],CD20-directed Antibody Interactions [MoA]

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 Ofatumumab (Arzerra) which is also known as ARZERRA and Manufactured by Novartis Pharmaceuticals Corporation. It is available in strength of 20 mg/mL per ml. Read more

Ofatumumab (Arzerra) 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
  • No data
  • WARNING: HEPATITIS B VIRUS REACTIVATION AND PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY
  • See full prescribing information for complete boxed warning.
  • Hepatitis B Virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death. ()
  • Progressive Multifocal Leukoencephalopathy (PML) resulting in death. ()
  • Arrayn- Chronic Lymphocytic Leukemia (CLL)
  • ARZERRA (ofatumumab) is indicated:
  • ARZERRA (ofatumumab) is a CD20-directed cytolytic monoclonal antibody indicated for the treatment of chronic lymphocytic leukemia (CLL) ():
  • in combination with chlorambucil, for the treatment of previously untreated patients with CLL for whom fludarabine-based therapy is considered inappropriate.
  • in combination with fludarabine and cyclophosphamide for the treatment of patients with relapsed CLL.
  • for extended treatment of patients who are in complete or partial response after at least two lines of therapy for recurrent or progressive CLL.
  • for the treatment of patients with CLL refractory to fludarabine and alemtuzumab.
  • No data
  • Dilute and administer as an intravenous infusion. Do not administer subcutaneously or as an intravenous push or bolus. ()
  • Previously untreated CLL in combination with chlorambucil recommended dosage and schedule is:nttttttt n
  • Relapsed CLL in combination with fludarabine and cyclophosphamide recommended dosage and schedule is:nttttttt n
  • Extended treatment in CLL recommended dosage and schedule is:n n
  • Refractory CLL recommended dosage and schedule is:nttttttt n
  • Administer where facilities to adequately monitor and treat infusion reactions are available. ()
  • Pre-medicate with acetaminophen, antihistamine, and corticosteroid. ()
  • No data
  • 100u00a0mg/5u00a0mL single-use vial for intravenous infusion. ()
  • 1,000u00a0mg/50u00a0mL single-use vial for intravenous infusion. ()
  • None.
  • None. ()
  • No data
  • Infusion Reactions: Pre-medicate with corticosteroid, acetaminophen, and an antihistamine. Monitor patients during infusions. Interrupt infusion if infusion reactions occur. (, , )
  • Tumor Lysis Syndrome: Anticipate TLS in high-risk patients; pre-medicate with anti-hyperuricemics and hydration. ()
  • Cytopenias: Neutropenia, anemia, and thrombocytopenia occur. Late-onset and prolonged neutropenia can also occur. Monitor complete blood counts at regular intervals. ()
  • The following serious adverse reactions are discussed in greater detail in other sections of the labeling:
  • To report SUSPECTED ADVERSE REACTIONS, contact Novartis Pharmaceuticals Corporation at 1-888-669-6682 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
  • Previously Untreated CLL: Common adverse reactions (u226510%) were infusion reactions and neutropenia. ()
  • Relapsed CLL: Common adverse reactions (>10%) were infusion reactions, neutropenia, leukopenia and febrile neutropenia. ()
  • Extended Treatment in CLL: Common adverse reactions (u226510%) were infusion reactions, neutropenia, and upper respiratory tract infection. ()
  • Refractory CLL: Common adverse reactions (u226510%) were neutropenia, pneumonia, pyrexia, cough, diarrhea, anemia, fatigue, dyspnea, rash, nausea, bronchitis, and upper respiratory tract infections. ()
  • No data
  • Pregnancy: May cause fetal B-cell depletion. ()
  • ARZERRA (ofatumumab) is an IgG1u03ba human monoclonal antibody with a molecular weight of approximately 149u00a0kDa. The antibody was generated via transgenic mouse and hybridoma technology and is produced in a recombinant murine cell line (NS0) using standard mammalian cell cultivation and purification technologies.
  • ARZERRA is a sterile, clear to opalescent, colorless, preservative-free liquid concentrate for intravenous administration. ARZERRA is supplied at a concentration of 20u00a0mg/mL in single-use vials. Each single-use vial contains either 100u00a0mg ofatumumab in 5u00a0mL of solution or 1,000u00a0mg ofatumumab in 50u00a0mL of solution.
  • Inactive ingredients include: 10u00a0mg/mL arginine, diluted hydrochloric acid, 0.019u00a0mg/mL edetate disodium, 0.2u00a0mg/mL polysorbateu00a080, 6.8u00a0mg/mL sodium acetate, 2.98u00a0mg/mL sodium chloride, and Water for Injection, USP. The pH is 5.5.
  • No data
  • No carcinogenicity or mutagenicity studies of ofatumumab have been conducted. In a repeat-dose toxicity study, no tumorigenic or unexpected mitogenic responses were noted in cynomolgus monkeys treated for 7 months with up to 3.5 times the maximum human dose (2,000 mg) of ofatumumab. Effects on male and female fertility have not been evaluated in animal studies.
  • No data
  • ARZERRA (ofatumumab) is a sterile, clear to opalescent, colorless, preservative-free liquid concentrate (20u00a0mg/mL) for dilution and intravenous administration provided in single-use glass vials with a rubber stopper (not made with natural rubber latex) and an aluminum overseal. Each vial contains either 100u00a0mg ofatumumab in 5u00a0mL of solution or 1,000u00a0mg ofatumumab in 50u00a0mL of solution.
  • ARZERRA is available as follows:
  • Store ARZERRA refrigerated between 2u00b0 to 8u00b0C (36u00b0 to 46u00b0F). Do not freeze. Vials should be protected from light.
  • Advise patients to contact a healthcare professional for any of the following:
  • Advise patients of the need for:
  • Manufactured by:Novartis Pharmaceuticals CorporationEast Hanover, New Jersey 07936US License 1244AtGlaxo Group LtdBrentford, Middlesex, UK
  • u00a9 Novartis
  • T2016-73August 2016
  • Principal Display Panel
  • NDC 0078-0669-13
  • Arzerran
  • (ofatumumab)
  • Injection, for Intravenous Infusion
  • 100 mg/5 mL(20mg/mL)
  • Rx only
  • For Intravenous Infusion Only.
  • Must Be Diluted Prior To Administration.
  • Contains vials
  • Single-Use Vials - Discard Unused Portion
  • Novartis
  • Principal Display Panel
  • NDC 0078-0690-61
  • Arzerran
  • (ofatumumab)
  • Injection, for Intravenous Infusion
  • 1000 mg/50 mL(20mg/mL)
  • Rx only
  • For Intravenous Infusion Only.
  • Must Be Diluted Prior To Administration.
  • Contains vial
  • Single-Use Vials - Discard Unused Portion
  • Novartis

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.