TM Owner Theratechnologies
Trogarzo 200 mg/1.33 mL Vial (Solution for Injection)
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Indications & Clinical Uses
- Trogarzo 200mg/1.33mL (ibalizumab-uiyk) is a CD4-directed, post-attachment HIV-1 inhibitor given by intravenous infusion or push, only in a clinic - never self-injected at home.
- Its US biologics licence is held by Theratechnologies Inc. of Montreal, Canada (manufactured by TaiMed Biologics USA Corp).
- It is approved in the US for heavily treatment-experienced adults with multidrug-resistant HIV-1 infection, used together with other antiretroviral drugs when a fully suppressive regimen otherwise cannot be built.
- The European Union marketing authorisation for Trogarzo was formally withdrawn by the European Commission on 1 January 2023, at the marketing authorisation holder's own request for commercial reasons; this is a company-requested EU withdrawal, not a safety-related revocation, and Trogarzo remains an active, marketed product in the United States.
- Treatment starts with a single 2,000mg loading dose, then continues with an 800mg maintenance dose every two weeks.
Side Effects
- Trogarzo carries no boxed warning on its current US label.
- The most commonly reported side effects are diarrhoea, dizziness, nausea and rash, most of them mild to moderate.
- Because Trogarzo is a monoclonal antibody given by infusion, hypersensitivity and infusion-related or injection-site reactions can occur during or shortly after dosing, and patients are usually observed for a period afterward.
- Immune reconstitution inflammatory syndrome can occur soon after starting any effective antiretroviral therapy, including a Trogarzo-based regimen, causing inflammatory symptoms from previously hidden infections; report new or worsening symptoms after starting treatment.
- Seek urgent care for hives, facial or throat swelling, difficulty breathing, or a widespread rash with fever, as these can indicate a serious allergic reaction.
Precautions & Warnings
- Trogarzo is given only by intravenous infusion or push by a healthcare professional, as part of a combination antiretroviral regimen - it is not effective, and is not approved, as a stand-alone HIV treatment.
- It should not be used in anyone with known hypersensitivity to ibalizumab or any component of the formulation.
- Because the EU marketing authorisation was withdrawn in January 2023 at the company's request, patients and prescribers in EU/UK markets should check current local availability before assuming continued supply.
- There is limited safety information in pregnancy and breastfeeding, and use should be discussed individually with a specialist.
- No dedicated studies have been done in hepatic or renal impairment, so these patients should be monitored closely.
- Vaccination status and screening for opportunistic infections should be reviewed as part of routine multidrug-resistant HIV care alongside Trogarzo.
Avoid Interactions
- No formal drug-interaction studies have been conducted with Trogarzo, and because it is a monoclonal antibody rather than a small-molecule drug, it is not expected to interact with cytochrome P450 enzymes, so significant interactions with most oral antiretrovirals, antifungals or other small-molecule medicines are not anticipated.
- Trogarzo is always used together with other active antiretroviral agents chosen for the individual's resistance pattern, so the overall regimen - not Trogarzo alone - determines the full interaction profile; each additional drug's own interactions still apply.
- Tell your healthcare provider about every prescription medicine, supplement and other biologic therapy you use, so the whole regimen can be checked for interactions.
References
Frequently Asked Questions
Trogarzo (ibalizumab) treats adults with multidrug-resistant HIV-1 who have already tried many other antiretroviral drugs. It is always combined with other active antiretrovirals to build a fully suppressive regimen when other options have failed.
Trogarzo is given only by intravenous infusion or push in a clinic, never self-injected at home. Treatment starts with a 2,000 mg loading dose, then continues with an 800 mg dose every two weeks, alongside your other HIV medicines.
Trogarzo has no boxed warning. The most common side effects are diarrhoea, dizziness, nausea and rash, usually mild. Seek urgent care for hives, facial swelling, breathing difficulty or a severe rash with fever, as these can signal a serious allergic reaction.
No specific drug interactions have been identified with Trogarzo, but tell your healthcare provider about every other medicine and supplement you take, since Trogarzo is always combined with other antiretrovirals whose own interactions still apply.
A healthcare professional gives Trogarzo by IV infusion or push, then monitors you afterward for reactions. Your first visit includes a larger loading dose; later visits, every two weeks, give the 800 mg maintenance dose alongside your other HIV medicines.
The EU marketing authorisation for Trogarzo was withdrawn on 1 January 2023 at the manufacturer's request for commercial reasons, not for safety concerns. It remains an approved, actively marketed medicine in the United States for multidrug-resistant HIV-1.
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