Trade Name: AFSTYLA

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.
  3. Read more
  • No data
  • No data
  • AFSTYLA, Antihemophilic Factor (Recombinant), Single Chain is a recombinant, antihemophilic factor indicated in adults and children with hemophilia A (congenital Factor VIII deficiency) for:
  • Limitation of Use
  • AFSTYLA is not indicated for the treatment of von Willebrand disease.
  • AFSTYLA, Antihemophilic Factor (Recombinant), Single Chain, is a recombinant, antihemophilic factor indicated in adults and children with hemophilia A (congenital Factor VIII deficiency) for:
  • Limitation of Use
  • AFSTYLA is not indicated for the treatment of von Willebrand disease ().
  • On-demand treatment and control of bleeding episodes,
  • Routine prophylaxis to reduce the frequency of bleeding episodes,
  • Perioperative management of bleeding.
  • For intravenous use after reconstitution only.
  • For intravenous use after reconstitution only.
  • Calculating Required Dose:
  • Dose (IU) = Body Weight (kg) u00d7 Desired Factor VIII Rise (IU/dL or % of normal) u00d7 0.5 (IU/kg per IU/dL)
  • Routine Prophylaxis:
  • Perioperative Management:
  • Ensure the appropriate Factor VIII activity level is achieved and maintained.
  • AFSTYLA is available as a white or slightly yellow lyophilized powder supplied in single-use vials containing nominally 250, 500, 1000, 1500, 2000, 2500, or 3000 IU. The actual potency is labeled on each AFSTYLA vial and carton.
  • AFSTYLA is available as a white or slightly yellow lyophilized powder supplied in single-use vials containing nominally 250, 500, 1000, 1500, 2000, 2500, or 3000 International Units (IU). ()
  • AFSTYLA is contraindicated in patients who have had life-threatening hypersensitivity reactions, including anaphylaxis to AFSTYLA or its excipients (e.g., polysorbate 80) , or hamster proteins .
  • Do not use in patients who have had life-threatening hypersensitivity reactions, including anaphylaxis to AFSTYLA or its excipients, or hamster proteins. ()
  • No data
  • Hypersensitivity reactions, including anaphylaxis, are possible. Should symptoms occur, immediately discontinue AFSTYLA and administer appropriate treatment. ()
  • Formation of neutralizing antibodies (inhibitors) to Factor VIII has been reported following administration of AFSTYLA; previously untreated patients (PUPs) are at greater risk.. If expected plasma Factor VIII activity levels are not attained, or if bleeding is not controlled with an appropriate dose, perform an assay that measures Factor VIII inhibitor concentration. ()
  • If the one-stage clotting assay is used, multiply the result by a conversion factor of 2 to determine the patient's Factor VIII activity level. ()
  • The most common adverse reactions (>0.5% of subjects) reported in clinical trials were dizziness and hypersensitivity.
  • To report SUSPECTED ADVERSE REACTIONS, contact the CSL Behring Pharmacovigilance Department at 1-866-915-6958 or FDA at 1-800-FDA-1088 or
  • www.fda.gov/medwatch
  • .
  • The most common adverse reactions reported in clinical trials (>0.5% of subjects) were dizziness and hypersensitivity. ()
  • No data
  • Pediatric: Clearance (based on per kg body weight) is higher in pediatric patients 0 to <12 years of age. Higher and/or more frequent dosing may be needed. ()
  • AFSTYLA is a single-chain recombinant Factor VIII produced in chinese hamster ovary (CHO) cells. It is a construct where the B-domain occurring in wild type full-length Factor VIII has been truncated and 4 amino acids of the adjacent acidic a3 domain were removed (amino acids 765 to 1652 of full-length Factor VIII). AFSTYLA is expressed as a single-chain Factor VIII molecule with covalent linkage between heavy and light chains; thereby keeping the molecule in the single-chain form resulting in increased stability and increased von Willebrand Factor (VWF) affinity. Except for a new N-glycosylation site at the junction between heavy and light chains, the post-translational modifications are comparable to endogenous Factor VIII.
  • AFSTYLA is purified by a controlled multi-step process including two virus reduction steps complementing each other in their mode of action. No human or animal derived proteins are used in the purification or formulation processes.
  • AFSTYLA is a preservative-free, sterile, non-pyrogenic, lyophilized powder to be reconstituted with sterile water for injection (sWFI) for intravenous injection. AFSTYLA is available in single-use vials containing the labeled amount of Factor VIII activity, expressed in IU. Each vial contains nominally 250, 500, 1000, 1500, 2000, 2500, or 3000 IU of AFSTYLA. The actual potency is labeled on each AFSTYLA vial and carton. After reconstitution of the lyophilized powder, all dosage strengths yield an almost colorless to slightly opalescent solution. The concentrations of excipients based on the vial size, as well as the amount of sWFI for reconstitution are provided in Table 4 below.
  • The number of units of Factor VIII administered is expressed in IU, which are related to the current WHO standard for Factor VIII products. One IU of Factor VIII activity in plasma is equivalent to that quantity of Factor VIII in 1 mL of normal plasma. Factor VIII activity in plasma is expressed either as a percentage (relative to normal human plasma) or in IU (relative to an International Standard for Factor VIII in plasma).
  • No data
  • Long-term animal studies investigating the carcinogenic effects of AFSTYLA have not been conducted. In vitro and in vivo testing of AFSTYLA for mutagenicity or effects on fertility were not performed.
  • The safety and efficacy of AFSTYLA were evaluated in two studies: an Open-label, Multicenter, Crossover Safety, Efficacy and Pharmacokinetic Study in adults/adolescents as well as in an Open Label Pharmacokinetic, Efficacy and Safety study in children. These studies characterized the PK of AFSTYLA and determined hemostatic efficacy in the control of bleeding events, the prevention of bleeding events in prophylaxis and in the adult/adolescent study determined hemostatic efficacy during perioperative management of bleeding in subjects undergoing surgical procedures.
  • The adult/adolescent study enrolled a total of 175 previously treated male subjects with severe hemophilia A (<1% endogenous Factor VIII activity). Subjects ranged in age from 12 to 65 years, including 14 adolescent subjects (u226512 to <18 years). Of the 175 enrolled subjects, 174 received at least one dose of AFSTYLA and 173 (99%) were evaluable for efficacy. A total of 161 subjects (92.5%) completed the study. A total of 120 (69.0%) subjects were treated for at least 50 EDs and 52 (29.9%) of those subjects were treated for at least 100 EDs. Subjects received a total of 14,592 injections with a median of 67.0 (range 1 to 395) injections per subject.
  • The pediatric study enrolled 84 previously treated male subjects with severe hemophilia A (35 subjects 0 to <6 years and 49 subjects u22656 to <12 years). Of the 84 enrolled subjects, all received at least one dose of AFSTYLA and 83 (99%) were evaluable for efficacy. A total of 65 (77.4%) subjects were treated for at least 50 EDs and 8 (9.5%) of those subjects were treated for at least 100 EDs. Subjects received a total of 5,313 injections with a median of 59 (range 4 to 145) injections per subject.
  • ttttttt1. Zollner S, Raquet E, Claar Ph, Mu00fcller-Cohrs J, Metzner HJ, Weimer Th, Pragst I, Dickneite G, Schulte S. Non-clinical pharmacokinetics and pharmacodynamics of rVIII-SingleChain, a novel recombinant single-chain factor VIII, Thrombosis Research 2014; 134: 125-131.
  • AFSTYLA is supplied in a kit containing a lyophilized powder in a single-use vial labeled with the amount of Factor VIII activity, expressed in international units (IU). Actual Factor VIII activity in International Units (IU) is stated on the AFSTYLA carton and vial label.
  • AFSTYLA is packaged with Sterile Water for Injection, USP (2.5 mL for reconstitution of 250, 500 or 1000 IU or 5 mL for reconstitution of 1500, 2000, 2500, or 3000 IU AFSTYLA), one Mix2Vial filter transfer set, and one sterile alcohol swab. Components are not made of natural rubber latex.
  • Storage and Handling
  • Advise patients to:
  • Manufactured by:n n 35041 Marburg, Germany
  • for:n n Industriestrasse 112543 Lengnau, SwitzerlandUS License No. 2009
  • Distributed by:n n Kankakee, IL 60901 USA
  • Mix2Vial is a registered trademark of West Pharma. Services IL, Ltd., a subsidiary of West Pharmaceuticals Services, Inc.
  • FDA-Approved Patient Labeling u2013 Patient Product Information (PPI)
  • AFSTYLA / af styu0306 u030dlah /
  • Antihemophilic Factor (Recombinant), Single Chain
  • Freeze-Dried Powder for Reconstitution
  • This leaflet summarizes important information about AFSTYLA. Please read it carefully before using AFSTYLA. This information does not take the place of talking with your healthcare provider, and it does not include all of the important information about AFSTYLA. If you have any questions after reading this, ask your healthcare provider.
  • What is the most important information I need to know about AFSTYLA?
  • What is AFSTYLA?
  • Who should not use AFSTYLA?
  • You should not use AFSTYLA if you:
  • Tell your healthcare provider if you are pregnant or breastfeeding because AFSTYLA may not be right for you.
  • What should I tell my healthcare provider before using AFSTYLA?
  • Tell your healthcare provider if you:
  • How should I use AFSTYLA?
  • What are the possible side effects of AFSTYLA?
  • What are the AFSTYLA dosage strengths?
  • AFSTYLA comes in seven different dosage strengths: 250, 500, 1000, 1500, 2000, 2500, or 3000 International Units (IU) as provided in Table 1. The actual strength is printed on the carton and vial label.
  • 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 AFSTYLA?
  • What else should I know about AFSTYLA?
  • Arrayn- Instructions for Use of AFSTYLA
  • For intravenous use after reconstitution only
  • This medicine is infused into a vein. Your healthcare provider or hemophilia treatment center should teach you how to do infusions on your own.
  • Always follow the specific instructions given by your healthcare provider. The steps listed below are general guidelines for using AFSTYLA. If you are unsure of the instructions, call your healthcare provider before using AFSTYLA. Call your healthcare provider right away if bleeding is not controlled after using AFSTYLA. Your healthcare provider will prescribe the dose that you should take. You may need to take 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.
  • AFSTYLA 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.AFSTYLA.com
  • Manufactured by:n n 35041 Marburg, Germany
  • for:n n Industriestrasse 112543 Lengnau, SwitzerlandUS License No. 2009
  • Distributed by:n n Kankakee, IL 60901 USA
  • Mix2Vial is a registered trademark of West Pharma. Services IL, Ltd., a subsidiary of West Pharmaceuticals Services, Inc.
  • Revised: 4/2020
  • NDC 69911-474-02
  • 250 IU Range
  • AFSTYLAn Antihemophilic Factor (Recombinant),Single Chain
  • One single-use vial containing lyophilized powder for reconstitution.
  • For Intravenous Administration Only
  • CSL Behring
  • NDC 69911-475-02
  • 500 IU Range
  • AFSTYLAn
  • Antihemophilic Factor (Recombinant),Single Chain
  • One single-use vial containing lyophilized powder for reconstitution.
  • For Intravenous Administration Only
  • CSL Behring
  • NDC 69911-476-02
  • 1000 IU Range
  • AFSTYLAn Antihemophilic Factor (Recombinant),Single Chain
  • One single-use vial containing lyophilized powder for reconstitution.
  • For Intravenous Administration Only
  • CSL Behring
  • NDC 69911-477-02
  • 2000 IU Range
  • AFSTYLAn Antihemophilic Factor (Recombinant),Single Chain
  • One single-use vial containing lyophilized powder for reconstitution.
  • For Intravenous Administration Only
  • CSL Behring
  • NDC 69911-478-02
  • 3000 IU Range
  • AFSTYLAn Antihemophilic Factor (Recombinant),Single Chain
  • One single-use vial containing lyophilized powder for reconstitution.
  • For Intravenous Administration Only
  • CSL Behring
  • NDC 69911-480-02
  • 1500 IU Range
  • AFSTYLAn
  • Antihemophilic Factor (Recombinant),Single Chain
  • One single-use vial containing lyophilized powder for reconstitution.
  • For Intravenous Administration Only
  • CSL Behring
  • NDC 69911-481-02
  • 2500 IU Range
  • AFSTYLAn Antihemophilic Factor (Recombinant),Single Chain
  • 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 ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT - Antihemophilic Factor (Recombinant), Single Chain (AFSTYLA) which is also known as AFSTYLA and Manufactured by CSL Behring Lengnau AG. It is available in strength of .

ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT - Antihemophilic Factor (Recombinant), Single Chain (AFSTYLA) 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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