Trade Name: IDELVION

Following information is meant for : Wholesalers, Suppliers, Exporters, Doctors, CROs, Comparator Supplies, Hospitals, MOH Tender Supplies, Generic, Brand, Cooperate Sourcing, India, Institutional Buyers.

Manufacturer: CSL Behring Lengnau AG

Presentation: KIT, PLASMA DERIVATIVE

Storage and handling

Disclaimer:
  1. These products are NOT FOR SALE in US territories. We offer them for Exports outside of US Territories to Trade Professionals or patients with a valid prescription.
  2. Trademark shown are property of their respective owners and GNH India does not lay any claim on them.
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  • IDELVION, Coagulation Factor IX (Recombinant), Albumin Fusion Protein (rIX-FP), a recombinant DNA-derived coagulation Factor IX concentrate, is indicated in children and adults with Hemophilia B (congenital Factor IX deficiency) for: tttttt
  • Limitations of Use:
  • IDELVION is not indicated for immune tolerance induction in patients with Hemophilia B.
  • IDELVION, Coagulation Factor IX (Recombinant), Albumin Fusion Protein (rIX-FP), a recombinant DNA-derived coagulation Factor IX concentrate, is indicated in children and adults with Hemophilia B (congenital Factor IX deficiency) for:
  • Limitations of Use:
  • IDELVION is not indicated for immune tolerance induction in patients with Hemophilia B. ()
  • On-demand treatment and control of bleeding episodes
  • Perioperative management of bleeding
  • Routine prophylaxis to reduce the frequency of bleeding episodes
  • For intravenous use after reconstitution only.
  • For intravenous use after reconstitution only.
  • On-demand treatment and control of bleeding episodes and perioperative management:
  • Routine prophylaxis:
  • IDELVION is a pale yellow to white lyophilized powder supplied in single-dose vials containing nominally 250, 500, 1000, 2000, or 3500 IU of Factor IX potency. The actual factor IX potency is labeled on each vial and carton.
  • IDELVION is available as a lyophilized powder in single-dose vials containing nominally 250, 500, 1000, 2000, or 3500 IU. ()
  • IDELVION is contraindicated in patients who have had life-threatening hypersensitivity reactions to IDELVION, or its components, including hamster proteins .
  • Do not use in patients who have had life-threatening hypersensitivity reactions to IDELVION or its components, including hamster proteins. ()
  • No data
  • Hypersensitivity reactions, including anaphylaxis, are possible. Should symptoms occur, discontinue IDELVION and administer appropriate treatment. ()
  • The formation of neutralizing antibodies (inhibitors) to Factor IX has been reported with IDELVION. If expected Factor IX plasma recovery in patient plasma is not attained, or if bleeding is not controlled with an appropriate dose, perform an assay that measures Factor IX inhibitor concentration. (, )
  • Thromboembolism (e.g., pulmonary embolism, venous thrombosis, and arterial thrombosis) may occur when using Factor IX-containing products. ()
  • Nephrotic syndrome has been reported following immune tolerance induction with Factor IX-containing products in hemophilia B patients with Factor IX inhibitors and a history of allergic reactions to Factor IX. ()
  • Factor IX activity assay results may vary with the type of activated partial thromboplastin time reagent used. ()
  • The most common adverse reaction (incidence u22651%) reported in clinical trials was headache.
  • The most common adverse reaction (incidence u22651%) reported in clinical trials was headache. ()
  • To report SUSPECTED ADVERSE REACTIONS, contact CSL Behring Pharmacovigilance Department at 1-866-915-6958 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatchn
  • Pediatric: Higher dose per kilogram body weight or more frequent dosing may be needed. ()
  • IDELVION, Coagulation Factor IX (Recombinant), Albumin Fusion Protein (rIX-FP) is a sterile, non-pyrogenic, lyophilized powder to be reconstituted with sterile Water for Injection (sWFI) for intravenous administration. IDELVION is available in single-dose vials containing nominally 250, 500, 1000, 2000, or 3500 IU of Factor IX formulated with sodium citrate, polysorbate 80, mannitol and sucrose. The actual amount of Factor IX activity in IU is labeled on each vial. After reconstitution of the lyophilized powder, all dosage strengths yield a clear, yellow to colorless solution. IDELVION contains no preservatives.
  • The active ingredient in IDELVION, recombinant human coagulation Factor IX albumin fusion protein, is a purified protein produced by recombinant DNA technology. It is generated by the genetic fusion of recombinant albumin to recombinant coagulation Factor IX. The genetic fusion of the cDNA of human albumin to the cDNA of human coagulation Factor IX enables the gene product to be expressed as a single recombinant protein designated as rIX-FP. The Factor IX portion of IDELVION is identical to the Thr148 allelic form of human plasma-derived Factor IX. The cleavable linker between the Factor IX and albumin moieties is derived from the endogenous activation peptide in native Factor IX. rIX-FP remains intact in the circulation until Factor IX is activated, whereupon albumin is cleaved from Factor IX, releasing activated Factor IX (FIXa) when it is needed for coagulation.
  • IDELVION is manufactured without the addition of proteins derived from human or animal source materials. IDELVION is a glycoprotein consisting of 1018 amino acids secreted by a genetically engineered Chinese hamster ovary (CHO) cell line. The CHO cell line secretes rIX-FP into a defined cell culture medium and the rIX-FP protein is purified by a process that does not require the use of a monoclonal antibody reagent. The manufacturing process incorporates three validated virus clearance steps, including virus inactivation by solvent/detergent treatment and virus removal by filtration.
  • The potency expressed in International Units is determined using an in vitro aPTT-based one-stage clotting assay against CSL Behring's manufacturing reference standard. This internal potency standard has been calibrated against the World Health Organization (WHO) International Standard for Factor IX concentrate by a one-stage clotting assay using synthetic silica and synthetic phospholipid-based reagents.
  • No data
  • Nonclinical studies evaluating the carcinogenic potential of IDELVION have not been conducted.
  • No macroscopic or microscopic pathologies in reproductive organs were observed in animals dosed every day for 28 days with 6.7 times the maximum recommended prophylactic clinical dose of 75 IU/kg IDELVION. No animal studies regarding impairment of fertility following IDELVION dosing were conducted.
  • The safety and efficacy of IDELVION were evaluated in a prospective, open-label, multicenter clinical study of 63 male previously treated patients (PTPs) with hemophilia B (u22642% endogenous Factor IX activity) who received at least one infusion of IDELVION as part of on-demand treatment and control of bleeding episodes, perioperative management of major and minor surgical, dental, or other invasive procedures, routine prophylaxis once every 7-, 10- or 14-day intervals, or pharmacokinetic evaluation. Subjects were aged 12 to 61 years; including 7 adolescent subjects aged 12 to 17. Subjects were treated for up to 27 months.
  • No data
  • IDELVION is supplied as a lyophilized powder in single-dose vials containing the labeled amount of Factor IX activity, expressed in international units (IU).
  • IDELVION is packaged with 2.5 mL (for reconstitution of 250, 500 or 1000 IU vials) or 5 mL (for reconstitution of 2000 or 3500 IU vials) of Sterile Water for Injection, USP, one Mix2Vial filter transfer set, and one sterile alcohol swab. Components are not made with natural rubber latex.
  • Storage and Handling
  • No data
  • Manufactured by:n n 35041 Marburg, Germany
  • for:n n Industriestrasse 11 2543 Lengnau, SwitzerlandUS License No. 2009
  • Distributed by:n n Kankakee, IL 60901 USA
  • IDELVION is manufactured under a license by Novozymes Biopharma A/S, Bagsvaerd, Denmark (US patents pending).
  • Mix2Vial is a registered trademark of West Pharma. Services IL, Ltd., a subsidiary of West Pharmaceutical Services, Inc.
  • IDELVION (eye del' vee onn- ,Coagulation Factor IX (Recombinant), Albumin Fusion Protein
  • This leaflet summarizes important information about IDELVION. Please read it carefully before using IDELVION. This information does not take the place of talking with your healthcare provider, and it does not include all of the important information about IDELVION. If you have any questions after reading this, ask your healthcare provider.
  • What is IDELVION?
  • IDELVION, Coagulation Factor IX (Recombinant), Albumin Fusion Protein is an injectable medicine used to replace clotting factor (Factor IX) that is missing in people with hemophilia B (also called congenital Factor IX deficiency or Christmas disease). Hemophilia B is an inherited bleeding disorder that prevents blood from clotting normally. IDELVION is used in children and adults with hemophilia B to control and prevent bleeding episodes. Your healthcare provider may give you IDELVION when you have surgery. IDELVION can reduce the number of bleeding episodes when used regularly (prophylaxis).
  • Who should not use IDELVION?
  • You should not use IDELVION if you:
  • Tell your healthcare provider if you have had an allergic reaction to any Factor IX product prior to using IDELVION.
  • Tell your healthcare provider if you are pregnant or breast-feeding because IDELVION may not be right for you.
  • What should I tell my healthcare provider before using IDELVION?
  • You should tell your healthcare provider if you:
  • How should I administer IDELVION?
  • What are the possible side effects of IDELVION?
  • Allergic reactions may occur with IDELVION. Call your healthcare provider right away and stop treatment if you get a rash or hives, itching, tightness of the chest or throat, difficulty breathing, light-headedness, dizziness, nausea, or decrease in blood pressure.
  • Your body can make antibodies, called inhibitors, against Factor IX which may stop IDELVION from working properly. Your healthcare provider may need to test your blood for inhibitors from time to time.
  • IDELVION may increase the risk of forming abnormal blood clots in your body, especially if you have risk factors for developing blood clots. Call your healthcare provider if you have chest pain, difficulty breathing, leg tenderness or swelling.
  • A common side effect of IDELVION is headache.
  • This is not the only side effect possible with IDELVION. To learn more, talk to your healthcare provider or pharmacist. Tell your healthcare provider about any side effect that bothers you or does not go away.
  • What are the IDELVION dosage strengths?
  • IDELVION comes in five different dosage strengths: 250, 500, 1000, 2000, or 3500 IU. The actual strength of IDELVION is printed on the carton and vial label. The labeling of the five dosage strengths are color-coded asprovided in Table 1 below.
  • Always check the actual dosage strength printed on the label to make sure you are using the strength prescribed by your healthcare provider.
  • How should I store IDELVION?
  • What else should I know about IDELVION?
  • For intravenous use after reconstitution only.
  • Do not attempt to do an intravenous injection unless you have been taught how by your healthcare provider or hemophilia center.
  • Always follow the specific instructions given by your healthcare provider. The steps listed below are general guidelines for using IDELVION. If you are unsure of the instructions, call your healthcare provider before using IDELVION. Call your healthcare provider right away if bleeding is not controlled after using IDELVION. Your healthcare provider will prescribe the dose that you should take. You may need to have blood tests from time to time. Talk to your healthcare provider before traveling. Dispose of all unused solution, empty vial(s), and other used medical supplies in an appropriate medical waste container.
  • IDELVION Reconstitution Instructions
  • Administration (intravenous injection)
  • Resources at CSL Behring available to the patient:
  • Contact CSL Behring to receive more product information:
  • For more information, visit www.IDELVION.com
  • Manufactured by:n n 35041 Marburg, Germany
  • for:n n Industriestrasse 11 2543 Lengnau, SwitzerlandUS License No. 2009
  • Distributed by:n n Kankakee, IL 60901 USA
  • IDELVION is manufactured under a license by Novozymes Biopharma A/S, Bagsvaerd, Denmark (US patents pending).
  • Mix2Vial is a registered trademark of West Pharma. Services IL, Ltd., a subsidiary of West Pharmaceutical Services, Inc.
  • Revised: 7/2020
  • NDC 69911-864-02
  • 250 IU Range
  • IDELVIONn
  • Coagulation Factor IX (Recombinant), Albumin Fusion Protein
  • One single-use vial containing lyophilized powder for reconstitution.
  • For Intravenous Administration Only
  • CSL Behring
  • NDC 69911-865-02
  • 500 IU Range
  • IDELVIONn
  • Coagulation Factor IX (Recombinant), Albumin Fusion Protein
  • One single-use vial containing lyophilized powder for reconstitution.
  • For Intravenous Administration Only
  • CSL Behring
  • NDC 69911-866-02
  • 1000 IU Range
  • IDELVIONn
  • Coagulation Factor IX (Recombinant), Albumin Fusion Protein
  • One single-use vial containing lyophilized powder for reconstitution.
  • For Intravenous Administration Only
  • CSL Behring
  • NDC 69911-867-02
  • 2000 IU Range
  • IDELVIONn
  • Coagulation Factor IX (Recombinant), Albumin Fusion Protein
  • One single-use vial containing lyophilized powder for reconstitution.
  • For Intravenous Administration Only
  • CSL Behring
  • NDC 69911-869-02
  • 3500 IU Range
  • IDELVIONn
  • Coagulation Factor IX (Recombinant), Albumin Fusion Protein
  • One single-use vial containing lyophilized powder for reconstitution.
  • For Intravenous Administration Only
  • CSL Behring

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler, Supplier, Exporters from India of Coagulation Factor IX Recombinant Human (IDELVION) which is also known as IDELVION and Manufactured by CSL Behring Lengnau AG. It is available in strength of .

Coagulation Factor IX Recombinant Human (IDELVION) 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.

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