Vonicog alfa
Vonicog alfa Uses, Dosage, Side Effects, Food Interaction and all others data.
Vonicog alfa is a recombinant von Willebrand factor manufactured by Baxalta. It was FDA approved in December 2015. The gen of von Willebrand factor was first cloned in 1985 by Stuart Orkin and David Ginsburg. By the EMA, vonicog alfa is still under clinical analysis.
Vonicog alfa does not present a risk of transmission of blood-borne pathogens as it is a recombinant, plasma- and albumin-free protein. The two first clinical trials showed an effective reduction of bleeding episodes in different sites of the body. This effect was observed even after the first infusion in 81% of the cases.
| Trade Name | Vonicog alfa |
| Generic | Vonicog alfa |
| Vonicog alfa Other Names | Von willebrand factor (recombinant), Von willebrand factor, recombinant, human, Vonicog alfa |
| Type | |
| Weight | 20000000.0 Da (Contains all multimers and ultra-large multimers) |
| Protein binding | Vonicog alfa presents a very high plasma protein binding as its main function is performed in the blood. |
| Groups | Approved, Investigational |
| Therapeutic Class | |
| Manufacturer | |
| Available Country | |
| Last Updated: | September 19, 2023 at 7:00 am |
Uses
Vonicog alfa is indicated for the on-demand treatment and control of bleeding episodes in adults previously diagnosed with von Willebrand disease. Vonicog alfa contains only the vWF and thus, its administration offers the flexibility to administer the coagulation factor VIII if needed. The von Willebrand disease is an inherited disorder characterized by the deficiency or misfunction of the von Willebrand factor (vWF). Due to this deficiency, the blood cannot clot properly and the patients that present this disease are prone to prolonged or excessive bleeding. There are three types of this disease, and type 3 is an autosomal recessive inherited disorder marked by very low or absent levels of vWF.
Vonicog alfa is also used to associated treatment for these conditions: Bleeding
How Vonicog alfa works
Von Willebrand factor (vWF) is an important piece of the blood coagulation cascade and it acts by stabilizing the coagulation factor VIII. It also binds to collagen and platelets in blood vessel walls which helps with the formation of a platelet plug during clotting process. The presence of different mutations in vWF causes a common bleeding disorder named von Willebrand disease. The bleeding episodes were usually treated with plasma-derived vWF/factor VIII concentrates which required high doses and long treatment duration. The use of vonicog alfa allows a separate administration of vWF without the presence of the Factor VIII. This separate dosing allows the personalization of the dosage according to the patient's needs. On the same note, the plasma-derived vWF concentrates variably lack ULM due to an in vivo exposure to plasma ADAMTS13 and granulocyte elastases. Vonicog alfa can be delivered as an unaltered vWF and it functions as a replacement of vWF. Thus, it mediates platelet adhesion and aggregation as well as stabilization of the procoagulant factor VIII.
Toxicity
Studies performed in vitro and in vivo have indicated no mutagenic potential. Carcinogenic or fertility studies have not been performed.
Food Interaction
No interactions found.Volume of Distribution
In phase 3 clinical trials, the volume of distribution of vonicog alfa is reported to be of 0.80 L.
Elimination Route
In pharmacokinetic studies, the Cmax, AUC and mean residence time of vonicog alfa are reported to be 90.7 mcg, 1877 h.U/dL and 29.8 hours, respectively.
Half Life
Clinical trials have shown a terminal half-life of 21.9 hours for vonicog alfa which can be modified by the coadministration of the factor VIII.
Clearance
In phase 3 clinical trials, the clearance rate of vonicog alfa is reported to be of 0.29 dL/kg/h.
Elimination Route
The majority of vonicog alfa is targeted to the liver and spleen which indicates an active regulatory elimination mechanism. It seems to be uptaken mainly by macrophages.
Innovators Monograph
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