Antihemophilic Factor (Recombinant), Porcine Sequence (Obizur)

Trade Name : OBIZUR

Baxalta US Inc.

KIT, PLASMA DERIVATIVE

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Antihemophilic Factor (Recombinant), Porcine Sequence (Obizur) which is also known as OBIZUR and Manufactured by Baxalta US Inc.. It is available in strength of per ml. Read more

Antihemophilic Factor (Recombinant), Porcine Sequence (Obizur) 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

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About GNH

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OBIZUR, Antihemophilic Factor (Recombinant), Porcine Sequence, is a recombinant DNA derived, antihemophilic factor indicated for the treatment of bleeding episodes in adults with acquired hemophilia A.
Limitations of Use:
OBIZUR, Antihemophilic Factor (Recombinant), Porcine Sequence, is an antihemophilic factor indicated for the treatment of bleeding episodes in adults with acquired hemophilia A. ()
Limitations of Use:

Safety and efficacy of OBIZUR has not been established in patients with a baseline anti-porcine factor VIII inhibitor titer of greater than 20 BU. ()
OBIZUR is not indicated for the treatment of congenital hemophilia A or von Willebrand disease. ()

For intravenous use after reconstitution only
For intravenous use after reconstitution only ()

Initial dose of OBIZUR is 200 units per kg. ()
Titrate dose and frequency of administration based on factor VIII recovery levels and individual clinical response. ()

OBIZUR is available as a white lyophilized powder in single-use glass vials containing nominally 500 units per vial.
OBIZUR is available as lyophilized powder for solution in single-use vials containing nominally 500 units per vial. ()

OBIZUR is contraindicated in patients who have had life-threatening hypersensitivity reactions to OBIZUR or its components (including traces of hamster proteins).
Do not use in patients who have had life-threatening hypersensitivity reactions to OBIZUR or its components, including hamster protein. ()

No data

Hypersensitivity reactions, including anaphylaxis, may occur. Should symptoms occur, discontinue OBIZUR and administer appropriate treatment. ()
Development of inhibitory antibodies to OBIZUR has occurred. 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 porcine factor VIII inhibitor concentration. ()

Common adverse reactions observed in greater than 5% of subjects in the clinical trial were development of inhibitors to porcine factor VIII.
Common adverse reaction observed in greater than 5% of subjects in the clinical trial were development of inhibitors to porcine factor VIII. ()
To report SUSPECTED ADVERSE REACTIONS, contact Takeda at 1-800-828-2088 or FDA at 1-800-FDA-1088 or .

No data

The active ingredient in OBIZUR is a recombinant (r) analogue of porcine factor VIII (pFVIII) with an approximate molecular weight of 170 kDa. The rpFVIII molecule in OBIZUR is a glycoprotein containing a 90 kDa heavy chain and a 80 kDa light chain. The B-domain normally present in naturally occurring porcine factor VIII has been replaced with a twenty-four amino acid linker. Once activated, the resulting rpFVIIIa has a comparable activity to the endogenous human FVIIIa.
OBIZUR is expressed in a genetically engineered baby hamster kidney (BHK) cell line which secretes rpFVIII into the cell culture medium, and the rpFVIII protein is purified using a series of chromatography and filtration steps. The production process includes two dedicated viral clearance steps - a solvent/detergent treatment step for viral inactivation and a nanofiltration step through a series of two 15-nm filters for removal of viruses. No additives of human or animal origin are used in the formulation of OBIZUR.
OBIZUR is formulated as a sterile, non-pyrogenic, lyophilized powder for intravenous injection after reconstitution with the diluent (Sterile Water for Injections). OBIZUR is available in single-use vials that nominally contain 500 units (U) per vial. When reconstituted with the diluent, the product contains the following components per mL: 8.8 mg sodium chloride, 0.04 mg Tris-base, 0.73 mg Tris-HCl, 1.47 mg tri-sodium citrate dehydrate, 0.15 mg calcium chloride dehydrate, 1.9 mg sucrose, and 0.05 mg polysorbate 80.
Each vial of OBIZUR is labeled with the actual rpFVIII activity expressed in units determined by a one-stage clotting assay, using a reference rpFVIII material calibrated against the World Health Organization (WHO) 8 International Standard for human FVIII concentrates. The specific activity of OBIZUR is in the range of 11000 to 18000 U per milligram of protein. The potency values of OBIZUR determined by the chromogenic assay vary and are approximately 20 to 50 % lower than those of the one-stage clotting assay.

No data

Long-term studies in animals to evaluate the carcinogenic potential of OBIZUR, or studies to determine genotoxicity and the effects of OBIZUR on fertility, have not been performed.

The efficacy of OBIZUR for the treatment of serious bleeding episodes in subjects with acquired hemophilia A was investigated in a prospective, open-label trial (N=29). The trial was conducted in 18 Caucasian, 6 African-American, and 5 Asian subjects diagnosed with acquired hemophilia A (AHA), having auto-immune inhibitory antibodies to human factor VIII, and experiencing serious bleeding episodes that required hospitalization. Subjects with a prior history of bleeding disorders other than AHA, anti-porcine factor VIII antibody titer > 20 Bethesda Units (BU), or in whom the bleeding episode was judged likely to resolve on its own were excluded. One subject was considered evaluable at study entry; however, it was later determined that this subject did not have AHA, leaving 28 subjects evaluable for efficacy.
An initial dose of 200 units per kg OBIZUR was administered to subjects for the treatment of life- or limb-threatening initial bleeding episodes. Patients were treated with OBIZUR until resolution of bleeding or dosing was continued at the physician's discretion according to the clinical assessment. These bleeding episodes included 19 intramuscular or joint bleeding episodes, 4 post-surgical bleeding episodes, 2 intracranial episodes, 2 surgeries, 1 retroperitoneal hemorrhage, and 1 periorbital bleed. Hemostatic response was assessed by the study site investigator at specified time points after initiation of OBIZUR treatment using a pre-specified rating scale that was based on subjective clinical assessments combined with objective factor VIII activity levels achieved. An assessment of effective or partially effective was considered as a positive response (see for definitions).
Of the 28 subjects evaluable for efficacy, all subjects had a positive response to treatment for the initial bleeding episodes at 24 hours after dosing. A positive response was observed in 95% (19/20) of subjects evaluated at 8 hours and 100% (18/18) at 16 hours.
In addition to response to treatment, the overall treatment success was determined by the investigator based on his/her ability to discontinue or reduce the dose and/or dosing frequency of OBIZUR. A total of 24/28 (86%) had successful treatment of the initial bleeding episode. Of those subjects treated with OBIZUR as first-line therapy, defined as no immediate previous use of anti-hemorrhagic agents prior to the first OBIZUR treatment, 16/17 (94%) had eventual treatment success reported. Eleven subjects were reported to have received anti-hemorrhagics (e.g. rFVIIa, activated prothrombin-complex concentrate, tranexamic acid) prior to first treatment with OBIZUR. Of these 11 subjects, eight had eventual successful treatment (73%).
The median dose per infusion to successfully treat the primary bleeding episode was 133 units per kg and a median total dose of 1523 units per kg. In the initial 24 hour period, a median of 3 infusions (median dose 200 U/kg) were utilized in the clinical study. When treatment was required beyond 24 hours, a median of 10.5 infusions (median dose 100 U/kg) were given for a median of 6 days to control a bleeding episode.

No data

Inform patients:

OBIZUR is a trademark of Baxalta Incorporated, a Takeda company.
SHIRE and the Shire Logo are trademarks or registered trademarks of members of the Shire group of companies, now part of Takeda.
Manufactured by:
Baxalta US Inc.

OBIZUR Antihemophilic Factor (Recombinant), Porcine Sequence
Single-use vial, lyophilized powder for solution
For Intravenous Administration AfterReconstitution Only
Rx Onlyn
NDC 0944-5001-01
500 units range*
* Refer to actual potency

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Antihemophilic Factor (Recombinant), Porcine Sequence (Obizur)

Trade Name : OBIZUR

KIT, PLASMA DERIVATIVE

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

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Antihemophilic Factor (Recombinant), Porcine Sequence (Obizur)

Trade Name : OBIZUR

KIT, PLASMA DERIVATIVE

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

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

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

Browse Our Services And Processes

Disclaimer

Browse from other international pharmaceuticals

General

US NDC

Canadian DIN

Swiss Drugs

NZ Drugs

FAQ

Can’t find what you’re looking for?

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CONTACT US

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