Ibalizumab
22 March 2023. Related: ARVs, Entry inhibitors, monoclonal antibody (mAb).
Ibalizumab is a 200 mg concentrate that is then made up as an infusion.
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Ibalizumab was approved in the US in March 2018 and in Europe in September 2019. However, the marketing license was later withdrawn in Europe due to low use and a high price. It is now only available in Europe in a named-patient programme.
Ibalizumab is a treatment for HIV multidrug resistance. It needs to be used in combination with other active HIV drugs.
- Ibalizumab is a monoclonal antibody given as an IV infusion.
- It is approved for adults who are heavily treatment-experienced and who have multidrug resistant HIV.
- 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 TaiMed under the brand name Trogarzo.
- The named-patient programme is being run by WEP Clinical. Doctors in Europe and the UK can arrange access by email: trogarzo@WEPclinical.com
- For full details please see the full prescribing information.
Further information
The US product information is available at this link.
The European patient information and detailed Product Information for Ibalizumab are posted to this link at the European Medicines Agency (EMA) website.
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.