Antihemophilic Factor (Recombinant) (Kovaltry)

Trade Name

Kovaltry

Active Ingredient

Power

Type / form

Tablets

Status

Manufacturer

Bayer HealthCare LLC

Storage and handling for Kovaltry

Disclaimer

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Antihemophilic Factor (Recombinant) (Kovaltry) which is also known as Kovaltry and Manufactured by Bayer HealthCare LLC. It is available in strength of per ml. Read more

Antihemophilic Factor (Recombinant) (Kovaltry) 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

About GNH

GNH India a Global Orphan Drug specialist renowned for its adherence to stringent quality standards. GNH India holds ISO 9001:2015 certification and WHO Good Storage and Distribution Practices (GSDP) compliance, ensuring the highest levels of safety and reliability in our operations.

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  • No data
  • KOVALTRY is not indicated for the treatment of von Willebrand disease.
  • For intravenous use after reconstitution only.
  • For intravenous use after reconstitution only.
  • Control of bleeding episodes and perioperative management ()
  • Routine prophylaxis ()
  • Children u226412 years old: 25-50 IU/kg 2 times per week, 3u00a0times per week or every other day.
  • KOVALTRY is available as a lyophilized powder in single-use glass vials containing nominally 250, 500, 1000, 2000, or 3000 IU of recombinant Factor VIII per vial.
  • Each vial of KOVALTRY is labeled with actual Factor VIII potency expressed in IU determined using a chromogenic substrate assay. This potency assignment employs a Factor VIII concentrate standard that is referenced to the current WHO International Standard for Factor VIII concentrate, and is evaluated by appropriate methodology to ensure accuracy of the results.
  • u00a0
  • 3
  • KOVALTRY is contraindicated in patients who have a history of hypersensitivity reactions to the active substance, to any of the excipients, or to mouse or hamster proteins n
  • Do not use in patients who have history of hypersensitivity reactions to the active substance, mouse or hamster protein, or other constituents of the product ().
  • No data
  • 5.2n- 5.5
  • The most frequently reported adverse reactions in clinical trials (u22653%) were headache, pyrexia, and pruritus (see ).
  • Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in clinical trials of another drug and may not reflect the rates observed in clinical practice.
  • The safety profile of KOVALTRY was evaluated in 193 previously treated patients (PTPs) (inclusive of 51 pediatric patients <12 years of age) with at least three months of exposure to KOVALTRY. The safety analysis was done using a pooled database from three multi-center, prospective, open-label clinical studies. The median time on study for patients u226512 years of age was 372 days with a median of 159 exposure days (EDs). The median time on study for patients <12 years of age was 182 days with a median of 73 EDs. Subjects who received KOVALTRY for perioperative management (n=5) with treatment period of 2 to 3 weeks and those who received single doses of KOVALTRY for PK studies (n=6) were excluded from safety analysis. lists the adverse reactions reported during clinical studies. The frequency, type, and severity of adverse reactions in children are similar to those in adults.
  • Immunogenicity
  • All clinical trial subjects were monitored for neutralizing antibodies (inhibitors) to Factor VIII by the modified Bethesda assay using blood samples obtained prior to the first infusion of KOVALTRY, at defined intervals during the studies and at the completion visit.
  • Clinical trials (Phases 1 through 3) with KOVALTRY evaluated a total of 204 pediatric and adult patients diagnosed with severe hemophilia A (Factor VIII <1%) with previous exposure to Factor VIII concentrates u226550u00a0EDs, and no history of inhibitors.
  • In the completed studies, no PTP developed neutralizing antibodies to Factor VIII. In an ongoing extension study, a 13 year old PTP had a titer of 0.6 BU after 550 EDs concurrent with an acute infection and positive IgG anticardiolipin antibodies. The Factor VIII recovery was 2.2 IU/dL per IU/kg, annualized bleeding rate (ABR) was zero, and no change in therapy was required.
  • In an actively enrolling clinical trial in PUPs, 6 of 14 treated subjects (42.9% with a 95% Confidence Interval of 17.7-71.1%) developed an inhibitor. Of these, 3 subjects (21.4%) had high titer inhibitors, and 3 subjects (21.4%) had transient low titer inhibitors for which no change in therapy was required.
  • The detection of antibody formation is 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, it may be misleading to compare the incidence of antibodies to KOVALTRY with the incidence of antibodies to other products.
  • The most frequently reported adverse reactions in clinical trials (u22653%) were headache, pyrexia, and pruritus ().
  • No data
  • u00a0
  • 8.4
  • KOVALTRY, Antihemophilic Factor (Recombinant), is a sterile, non-pyrogenic, white to slightly yellow powder for reconstitution contained in a single-use vial. The final product does not contain any preservative. The reconstituted product is indicated for intravenous administration. The product is available in 250 IU, 500 IU, 1000 IU, 2000 IU, or 3000 IU nominal potencies; however, for each dosage strength the actual, assayed Factor VIII potency is directly printed on each vial label. The container closure system consists of a 10 mL, Type I glass vial sealed with a bromobutyl grey stopper and an aluminum crimp seal with plastic flip-off cap plus vial adapter. The vial adapter was designed to connect with the sterile water for injection (sWFI), prefilled diluent syringe. KOVALTRY is formulated with the following excipients: 2.2% glycine, 1% sucrose, 30 mM sodium chloride, 2.5 mM calcium chloride, 20 mM histidine and 80 ppm polysorbate 80. The pH of the reconstituted product is 6.6 to 7.0. Intravenous administration of sucrose contained in KOVALTRY will not affect blood glucose level.
  • The active substance in KOVALTRY is the unmodified full length recombinant Factor VIII glycoprotein comprising the human derived amino acid sequence. Post-translational modifications are similar to those of endogenous Factor VIII including glycosylation sites and sulfation of tyrosine sites. Manufacturing and quality controls ensure that both galactose-alpha-1,3-galactose (alpha-Gal) and N-glycolyl neuraminic acid (NGNA) content are below the 1% limit of detection established for each analytical method.
  • KOVALTRY is produced by a genetically engineered Baby Hamster Kidney (BHK) cell line into which the human Factor VIII gene was introduced together with the human heat shock protein 70 (HSP 70) gene. HSP 70 is an intracellular protein that improves proper folding of the Factor VIII protein. While KOVALTRY and Kogenate FS have the same protein backbone, human- and animal-derived raw materials are not added to the cell culture, purification, or formulation processes for KOVALTRY. In the manufacturing process for KOVALTRY, recombinant Factor VIII is secreted into cell culture medium and is purified from process- and product-related impurities using a series of chromatography and filtration steps. The production process incorporates two dedicated viral clearance steps: (1) a detergent treatment step for inactivation and (2) a 20 nanometer filtration step for removal of viruses and potential protein aggregates.
  • No data
  • Long-term studies in animals to evaluate the carcinogenic potential of KOVALTRY or other studies to determine the effects of KOVALTRY on fertility have not been performed. KOVALTRY was negative in the modified (Mammalian Mutation and Chromosome Aberration Assay with Mouse Lymphoma Cells) genotoxicity test. KOVALTRY is expected to have no mutagenic potential.
  • The safety and efficacy of KOVALTRY for on-demand treatment and control of bleeding episodes, perioperative management of bleeding, and routine prophylaxis in subjects with severe hemophilia A (<1% Factor VIII) was evaluated in three international (including U.S.) clinical studies. Immunocompetent subjects with severe hemophilia A (Factor VIII activity u22641%) and no history of Factor VIII inhibitors were eligible for the trials.
  • Study 1: a multi-center, open-label, cross-over, uncontrolled, study in adolescent and adult (age u226512 years to <65 years) PTPs (u2265150 EDs) evaluated the pharmacokinetics, efficacy and safety of routine prophylaxis, and perioperative management of bleeding of KOVALTRY (see ). The primary efficacy variable was ABR. The prophylactic regimen was 20 to 50 IU/kg two or three times per week in which the dosing frequency was assigned by the investigator based on the subjectu2019s individual requirements.
  • Study 2: a multi-center, open-label, cross-over, uncontrolled, randomized study in adolescent and adult (age u226512 years to <65 years) PTPs (u2265150 EDs) evaluated the superiority of prophylaxis over on-demand treatment with KOVALTRY over a one-year treatment period (see ). The primary efficacy variable was ABR. The prophylactic regimen was 20 to 30 IU/kg two times per week or 30 to 40 IU/kg three times per week and the treatment group was assigned by randomization.
  • Study 3: a multi-center, open-label, uncontrolled study in pediatric (age u226412 years) PTPs (u226550 EDs) evaluated the pharmacokinetics, efficacy and safety of routine prophylaxis, and perioperative management of bleeding of KOVALTRY (see ). The primary efficacy variable was annualized number of total bleeds during routine prophylaxis that occurred within 48 hours following previous prophylaxis infusion. ABR during prophylaxis, independent of time of infusion, was also analyzed. The prophylactic regimen was 25 to 50 IU/kg at frequencies of either 2 times per week, 3 times per week or every other day and could be adapted to individual subjectu2019s need by the investigator.
  • In all studies, treatments of breakthrough bleeds and perioperative management were at the investigatoru2019s discretion based on standard of care.
  • A total of 204 subjects were enrolled in the completed clinical trials, 153 subjects u226512 years of age and 51 subjects <12 years of age. One hundred-forty (140) subjects were treated for at least 12 months, and 43 of these subjects were treated for 24 months.
  • How Supplied
  • KOVALTRY is available as a lyophilized powder in single-use glass vials, one vial per carton. It is supplied with a sterile vial adapter with 15-micrometer filter and a prefilled diluent glass barrel syringe, which together serve as a needleless reconstitution system. The prefilled diluent syringe contains Sterile Water for Injection, USP. An administration set is also provided in the package. Available sizes:
  • Actual Factor VIII activity in IU is stated on the label of each KOVALTRY vial.
  • The product vial and diluent syringe are not made with natural rubber latex.
  • Storage and Handling
  • Product as Packaged for Sale
  • Product After Reconstitution
  • No data
  • FDA-Approved Patient Labeling
  • Patient Information
  • KOVALTRY (KOH-vahl-tree)
  • Antihemophilic Factor (Recombinant)
  • This leaflet summarizes important information about KOVALTRY with vial adapter. Please read it carefully before using this medicine. This information does not take the place of talking with your healthcare provider, and it does not include all of the important information about KOVALTRY. If you have any questions after reading this, ask your healthcare provider.
  • Do not attempt to self-infuse unless you have been taught how by your healthcare provider or hemophilia center.
  • What is KOVALTRY?
  • KOVALTRY is a medicine used to replace clotting factor (Factor VIII or antihemophilic factor) that is missing in people with hemophilia A (also called u201cclassicu201d hemophilia). Hemophilia A is an inherited bleeding disorder that prevents blood from clotting normally.
  • KOVALTRY is used to treat and control bleeding in adults and children with hemophilia A. Your healthcare provider may give you KOVALTRY when you have surgery. KOVALTRY can reduce the number of bleeding episodes in adults and children with hemophilia A when used regularly (prophylaxis).
  • KOVALTRY is not used to treat von Willebrand Disease.
  • Who should not use KOVALTRY?
  • You should not use KOVALTRY if you
  • What should I tell my healthcare provider before I use KOVALTRY?
  • What are the possible side effects of KOVALTRY?
  • The common side effects of KOVALTRY are headache, fever and itchy rash.
  • Allergic reactions may occur with KOVALTRY. Call your healthcare provider right away and stop treatment if you get tightness of the chest or throat, dizziness, decrease in blood pressure, and nausea.
  • Your body can also make antibodies, called u201cinhibitors,u201d against KOVALTRY, which may stop KOVALTRY from working properly. Consult with your healthcare provider to make sure you are carefully monitored with blood tests for the development of inhibitors to Factor VIII.
  • These are not all the possible side effects with KOVALTRY. You can ask your healthcare provider for information that is written for healthcare professionals.
  • Tell your healthcare provider about any side effect that bothers you or that does not go away.
  • What are the KOVALTRY dosage strengths?
  • KOVALTRY with 2.5 mL or 5 mL Sterile Water for Injection (SWFI) comes in five different dosage strengths labeled as International Units (IU): 250 IU, 500 IU, 1000 IU, 2000 IU, and 3000 IU. The five different strengths are color-coded as follows:
  • How do I store KOVALTRY?
  • Do not freeze KOVALTRY.
  • Store KOVALTRY at +2u00b0C to +8u00b0C (36u00b0F to 46u00b0F) for up to 30 months from the date of manufacture. Within this period, KOVALTRY may be stored for a period of up to 12 months at temperatures up to +25u00b0C or 77u00b0F.
  • Record the starting date of room temperature storage clearly on the unopened product carton. Once stored at room temperature, do not return the product to the refrigerator. The product then expires after storage at room temperature for 12 months, or after the expiration date on the product vial, whichever is earlier. Store vials in their original carton and protect them from extreme exposure to light.
  • Administer reconstituted KOVALTRY as soon as possible. If not, store at room temperature for no longer than 3 hours.
  • Throw away any unused KOVALTRY after the expiration date.
  • Do not use reconstituted KOVALTRY if it is not clear.
  • What else should I know about KOVALTRY and hemophilia A?
  • Finding veins for injections may be difficult in young children. When frequent injections are required, your healthcare provider may propose to have a device surgically placed under the skin to facilitate access to the bloodstream. These devices may result in infections.
  • Medicines are sometimes prescribed for purposes other than those listed here. Do not use KOVALTRY for a condition for which it is not prescribed. Do not share KOVALTRY with other people, even if they have the same symptoms that you have.
  • This leaflet summarizes the most important information about KOVALTRY. If you would like more information, talk to your healthcare provider. You can ask your healthcare provider or pharmacist for information about KOVALTRY that was written for healthcare professionals.
  • Instructions for Use
  • KOVALTRY (KOH-vahl-tree)
  • Antihemophilic Factor (Recombinant)
  • Do not attempt to self-infuse unless you have been taught how by your healthcare provider or hemophilia center.
  • You should always follow the specific instructions given by your healthcare provider. The steps listed below are general guidelines for using KOVALTRY. If you are unsure of the procedures, please call your healthcare provider before using.
  • Call your healthcare provider right away if bleeding is not controlled after using KOVALTRY.
  • Your healthcare provider will prescribe the dose that you should take.
  • Your healthcare provider may need to take blood tests from time to time.
  • Talk to your healthcare provider before traveling. You should plan to bring enough KOVALTRY for your treatment during this time.
  • See the step-by-step instructions below for reconstituting KOVALTRY with vial adapter. Follow the specific infusion instruction leaflet included with the infusion set provided.
  • Carefully handle KOVALTRY. Dispose of all materials, including any leftover reconstituted KOVALTRY product, in an appropriate container.
  • Reconstitution
  • Always work on a clean surface and wash your hands before performing the following procedure. Use only the components for reconstitution and administration that are provided with each package of KOVALTRY. If a package is opened or damaged, do not use this component. If these components cannot be used, please contact your healthcare provider.
  • Prepare a clean flat surface and gather all the materials needed for the infusion.
  • Pooling
  • If the dose requires more than one vial, reconstitute each vial as described above with the diluent syringe provided. To combine the content of the vials, use a larger plastic syringe (not provided) to pool the solution into the syringe and administer as usual.
  • Rate of Administration
  • The entire dose of KOVALTRY can usually be infused within 1 to 15 minutes. Your healthcare provider will determine the rate of administration that is best for you.
  • Resources at Bayer available to the patient:
  • For Adverse Reaction Reporting, contact Bayer Medical Communications 1-888-84-BAYER (1-888-842-2937)
  • To receive more product information, contact KOVALTRY Customer Service 1-888-606-3780
  • Bayer Reimbursement HELPline 1-800-288-8374
  • For more information, visit n
  • Bayer HealthCare LLCWhippany, NJ 07981 USA
  • U.S. License No. 8
  • NDC 0026-3821-25Kovaltry 250 IU RangeAntihemophilic Factor (Recombinant)Recombinant Factor VIII
  • with Vial Adapter
  • For Intravenous Use Only
  • Needleless Reconstitution Set
  • NDC 0026-3822-25Kovaltry 500 IU RangeAntihemophilic Factor (Recombinant)Recombinant Factor VIII
  • with Vial Adapter
  • For Intravenous Use Only
  • Needleless Reconstitution Set
  • NDC 0026-3824-25Kovaltry 1000 IU RangeAntihemophilic Factor (Recombinant)Recombinant Factor VIII
  • with Vial Adapter
  • For Intravenous Use Only
  • Needleless Reconstitution Set
  • NDC 0026-3826-50Kovaltry 2000 IU RangeAntihemophilic Factor (Recombinant)Recombinant Factor VIII
  • with Vial Adapter
  • For Intravenous Use Only
  • Needleless Reconstitution Set
  • NDC 0026-3828-50Kovaltry 3000 IU RangeAntihemophilic Factor (Recombinant)Recombinant Factor VIII
  • with Vial Adapter
  • For Intravenous Use Only
  • Needleless Reconstitution Set

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