Chemistry:Vonicog alfa
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| Trade names | Vonvendi, Veyvondi |
| Other names | BAX-111 |
| AHFS/Drugs.com | Monograph |
| License data | |
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| Routes of administration | Intravenous |
| Drug class | Hemostatic |
| ATC code | |
| Legal status | |
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| Formula | C9712H15373N2737O3032S210 |
| Molar mass | 225725.54 g·mol−1 |
Vonicog alfa, sold under the brand names Vonvendi and Veyvondi, is a medication used to control bleeding in adults with von Willebrand disease (an inherited bleeding disorder).[4][6][7][8] It is a recombinant von Willebrand factor.[4][6]
The most common adverse reactions are generalized itching, vomiting, nausea, dizziness, and vertigo.[4]
Vonicog alfa should not be used in the treatment of Hemophilia A.[6]
Vonicog alfa was approved for medical use in the United States in December 2015, in the European Union in August 2018, and in Australia in April 2020.[5][4][6][9] It was granted orphan drug designations in both the United States and the European Union.[6][1]
Medical uses
In the EU, vonicog alfa is indicated in adults with von Willebrand Disease (VWD), when desmopressin (DDAVP) treatment alone is ineffective or not indicated for the treatment of hemorrhage and surgical bleeding;[6] and the prevention of surgical bleeding.[6]
In September 2025, the US Food and Drug Administration expanded the indication for von Willebrand factor (recombinant) for the routine preventative (prophylactic) use in adults with all types of von Willebrand disease and on-demand and treatment of bleeding episodes and perioperative use in children with von Willebrand disease.[10] It is indicated in people with von Willebrand disease for the on-demand treatment and control of bleeding episodes;[4] and for the perioperative management of bleeding.[4] It is indicated in adults for the routine prophylaxis to reduce the frequency of bleeding episodes.[4]
Adverse effects
The following side effects may occur during treatment with vonicog alfa: hypersensitivity (allergic) reactions, thromboembolic events (problems due to the formation of blood clots in the blood vessels), development of inhibitors (antibodies) against von Willebrand factor, causing the medicine to stop working and resulting in a loss of bleeding control.[6] The most common side effects with vonicog alfa (which may affect up to 1 in 10 patients) are dizziness, vertigo (a spinning sensation), dysgeusia (taste disturbances), tremor, rapid heartbeat, deep venous thrombosis (blood clot in a deep vein, usually in the leg), hypertension (high blood pressure), hot flush, vomiting, nausea (feeling sick), pruritus (itching), chest discomfort, sensations like numbness, tingling, pins and needles at the site of infusion, and an abnormal reading on the electrocardiogram (ECG).[6]
References
- ↑ 1.0 1.1 1.2 "Veyvondi Australian prescription medicine decision summary". 29 April 2020. https://www.tga.gov.au/apm-summary/veyvondi.
- ↑ "Summary Basis of Decision (SBD) for Vonvendi". 23 October 2014. https://hpr-rps.hres.ca/reg-content/summary-basis-decision-detailTwo.php?linkID=SBD00434&lang=en.
- ↑ "Vonvendi 650 IU powder and solvent for solution for injection - Summary of Product Characteristics (SmPC)". 7 May 2020. https://www.medicines.org.uk/emc/product/11222/smpc.
- ↑ 4.0 4.1 4.2 4.3 4.4 4.5 4.6 4.7 "Vonvendi (von willebrand factor- recombinant kit". 13 February 2019. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=53b6d198-6175-4a26-8606-dc0d2a0f12d6.
- ↑ 5.0 5.1 "Vonvendi". 9 May 2018. https://www.fda.gov/vaccines-blood-biologics/approved-blood-products/vonvendi.
- ↑ 6.00 6.01 6.02 6.03 6.04 6.05 6.06 6.07 6.08 6.09 "Veyvondi EPAR". 20 September 2018. https://www.ema.europa.eu/en/medicines/human/EPAR/veyvondi. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
- ↑ "Veyvondi-epar product information". European Medicines Agency. https://www.ema.europa.eu/en/documents/product-information/veyvondi-epar-product-information_en.pdf.
- ↑ "Vonicog alfa for the management of von Willebrand disease: a comprehensive review and single-center experience". Journal of Thrombosis and Thrombolysis 49 (3): 431–440. April 2020. doi:10.1007/s11239-019-02018-1. PMID 31902122.
- ↑ "Vonvendi". 13 April 2018. http://www.fda.gov/vaccines-blood-biologics/approved-blood-products/vonvendi.
- ↑ "FDA Approves Expanded Use of Vonvendi for von Willebrand Disease, Including for Certain Uses for Children". 5 September 2025. https://www.fda.gov/news-events/press-announcements/fda-approves-expanded-use-vonvendi-von-willebrand-disease-including-certain-uses-children.
This article incorporates text from this source, which is in the public domain.
Further reading
- AusPAR: Vonicog alfa (Report). October 2020. https://www.tga.gov.au/auspar/auspar-vonicog-alfa.
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