Ibalizumab is a 200 mg concentrate that is then made up as an infusion.
Ibalizumab was approved in the US in March 2018 and was given a positive opinion (indicating approval soon) in Europe in July 2019.
- Ibalizumab is a monoclonal antibody given as an IV infusion.
- It is approved in the US for heavily treatment-experienced adults with multidrug resistant HIV who are failing their current ART.
- Ibalizumab is first given in a loading dose of 2,000 mg and then as a maintenance dose of 800 mg every two weeks.
- The most common side effects are diarrhoea, dizziness, nausea and rash.
- Ibalizumab is manufactured by Theratechnologies with the brand name Trogarzo..
- For full details please see the full prescribing information.
The US product information is available at this link.
The European patient information and detailed Product Information for Ibalizumab are not yet available but will be posted to this link (TO BE ADDED] at the European Medicines Agency (EMA) website after approval.
The Patient Information is a simplified summary: what the drug is, why it is used, results from studies and cautions including side effects.
The Product Information is a detailed technical summary that you can access as a PDF file by clicking the ‘Product Information’ tab. It describes more precisely how the drug works and how it is processed by your body. This includes, for example, reported food interaction studies in terms of calories or fat content. It includes more details of the study results and a full list of side effects and drug interactions.