Vonicog alfa

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Vonicog alfa
Clinical data
Trade namesVonvendi, Veyvondi
Other namesBAX-111
AHFS/Drugs.comMonograph
License data
Pregnancy
category
Routes of
administration
Intravenous
Drug classHemostatic
ATC code
Legal status
Legal status
  • AU: S4 (Prescription only) [1]
  • CA: Rx-only / Schedule D [2]
  • UK: POM (Prescription only) [3]
  • US: ℞-only [4]
  • EU: Rx-only [5]
  • In general: ℞ (Prescription only)
Identifiers
CAS Number
DrugBank
UNII
KEGG
Chemical and physical data
FormulaC9712H15373N2737O3032S210
Molar mass225725.54 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).[6][5][7][8] It is a recombinant von Willebrand factor.[6][5]

The most common adverse reactions are generalized itching, vomiting, nausea, dizziness, and vertigo.[6]

Vonicog alfa should not be used in the treatment of Hemophilia A.[5]

In the UK it is available only via a named patient access program.[9]

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.[4][6][5][10] It was granted orphan drug designations in both the United States and the European Union.[5][1]

Medical uses[edit]

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 haemorrhage and surgical bleeding[5]
  • Prevention of surgical bleeding.[5]

Adverse effects[edit]

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.[5] 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).[5]

References[edit]

  1. ^ a b c "Veyvondi Australian prescription medicine decision summary". Therapeutic Goods Administration (TGA). 29 April 2020. Retrieved 16 August 2020.
  2. ^ "Summary Basis of Decision (SBD) for Vonvendi". Health Canada. Retrieved 29 May 2022.
  3. ^ "Vonvendi 650 IU powder and solvent for solution for injection - Summary of Product Characteristics (SmPC)". (emc). 7 May 2020. Retrieved 16 August 2020.
  4. ^ a b "Vonvendi". U.S. Food and Drug Administration (FDA). 9 May 2018. Archived from the original on 23 April 2019. Retrieved 15 April 2020.{{cite web}}: CS1 maint: unfit URL (link)
  5. ^ a b c d e f g h i j "Veyvondi EPAR". European Medicines Agency (EMA). 20 September 2018. Retrieved 27 March 2020. Text was copied from this source which is © European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  6. ^ a b c d "Vonvendi (von willebrand factor- recombinant kit". DailyMed. 13 February 2019. Retrieved 27 March 2020.
  7. ^ "Veyvondi-epar product information" (PDF). European Medicines Agency.
  8. ^ Tran T, Arnall J, Moore DC, Ward L, Palkimas S, Man L (April 2020). "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. doi:10.1007/s11239-019-02018-1. PMID 31902122. S2CID 209673044.
  9. ^ "Vonicog alfa". Specialist Pharmacy Service. 15 January 2020. Retrieved 27 March 2020.
  10. ^ "Vonvendi". U.S. Food and Drug Administration (FDA). 13 April 2018. STN: 125577. Retrieved 27 March 2020.

Further reading[edit]

External links[edit]

  • "Vonicog alfa". Drug Information Portal. U.S. National Library of Medicine.