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with TROGARZO®

TROGARZO® (ibalizumab‑uiyk)
For heavily treatment‑experienced patients with HIV whose current ARV regimen is failing and who need additional support to achieve long‑term suppression.1

TROGARZO®: The first long‑acting ARV for HIV‑11

A fully active agent with a unique MOA1

TROGARZO® is a CD4-directed post‑attachment HIV‑1 inhibitor.1

  • It is a humanized monoclonal antibody that binds to domain 2 of CD4 on the surface of immune cells, blocking viral entry without interfering in normal CD4‑mediated immune functions1
  • TROGARZO® has no baseline resistance, as demonstrated by the high maximum percent inhibition of all the baseline viruses in the Phase 3 TMB‑301 study (median 97%)1
MOA Video

Activity among classes1

  • TROGARZO® is active against HIV‑1 strains resistant to other approved ARVs
  • There is no evidence of cross‑resistance between TROGARZO® and any of the approved classes of ARVs (NRTI, NNRTI, PI, INSTI, CCR5 antagonist, fusion inhibitor, entry inhibitor, capsid inhibitor)

Broad activity1

  • TROGARZO® activity is independent of co‑receptor tropism (CXCR4 vs. CCR5)
  • TROGARZO® is active against all HIV‑1 clades

A powerful virologic response1

At 7 days post‑loading dose, 83% of patients who received TROGARZO® functional monotherapy achieved a virologic response vs. 3% of patients pre‑loading dose (p<0.0001; 95% CI: 67%, 93%).1

Explore the data

The safety and effectiveness of TROGARZO® has been established based on adequate and well‑controlled studies.

TROGARZO® can also be administered as a diluted IV infusion. Consult the TROGARZO® Prescribing Information for complete posology.

Key considerations to help heavily treatment‐experienced patients with HIV achieve durable viral suppression2

DHHS Guidelines Recommendations (March, 2023)2

DEFINE FAILURE: HIV RNA ≥200 copies/mL

Persistent HIV RNA ≥200 copies/mL is considered virologic failure and is associated with accumulation of viral drug‑resistance mutations.2

BE PROACTIVE: MODIFY AS SOON AS POSSIBLE

When a regimen is compromised, it should be modified as soon as possible to avoid progressive accumulation of resistance mutations.2

CHOOSE A FULLY ACTIVE REGIMEN

A new regimen can include two fully active ARV drugs if at least one with a high resistance barrier is included (e.g., dolutegravir QD or boosted darunavir QD). If no fully active drug with a high resistance barrier is available, then every effort should be made to include three fully active drugs.2

CONSIDER DIFFERENT MOAs

The availability of ARTs across various mechanisms of action makes it possible to suppress HIV RNA to <50 copies/mL in most patients.2

Explore the link: Viremia & Vulnerability

V = V

V = V

Viremia = Vulnerability

Patients with persistent viremia ≥200 copies/mL often develop drug resistance, particularly when HIV RNA levels are >500 copies/mL2

  • Viremic patients are at increased risk of HIV‑associated morbidity and mortality3
  • HIV RNA 50‑199 copies/mL and 200‑999 copies/mL have been associated with a 2.2-fold and 2.1-fold increased risk of mortality, respectively, regardless of CD4 count3

There are many reasons why your heavily treatment‑experienced patients may have difficulty reaching viral suppression.

Limited Treatment Options

  • While there may be a small proportion of patients with extensive resistance across and within drug classes, they are in need of novel treatment options4
  • Prevalence of three‑class resistance has decreased, but INSTI resistance is of concern4
  • The most common three‑class resistance combination includes NRTI/NNRTI/INSTI4

Nonadherence

  • Pill burden has been associated with decreased adherence and increased incidence of virologic failure2,5
  • Nonadherence leads to suboptimal drug levels, which results in the development of viral mutations, including the risk of drug‑resistance mutations6,7

Cross- and Baseline‑Resistance

  • Recycling ARVs may lead to the development of resistance mutations and increase the risk of cross‑resistance within a drug class6
  • Studies have shown that in TE patients:
    • 42% of NNRTI‑failing patients had predicted genotypic resistance to doravirine according to the Stanford algorithm8
    • 46% of patients had viral sequence polymorphisms at baseline that have been shown to impact FTR activity, despite no prior exposure to FTR9
    • 48% of those failing FTR displayed viral substitutions in gp120, rendering the virus resistant9

Please see Important Safety Information throughout and the full Prescribing Information.

Important Safety Information

Indication

TROGARZO® (ibalizumab‑uiyk), in combination with other antiretroviral(s), is indicated for the treatment of human immunodeficiency virus type 1 (HIV‑1) infection in heavily treatment‑experienced adults with multidrug resistant HIV‑1 infection failing their current antiretroviral regimen.

Contraindications

TROGARZO® is contraindicated in patients with a prior hypersensitivity reaction to TROGARZO® or any components of the product.

Use in Specific Populations

  • Pregnancy: No adequate human data are available to establish whether or not TROGARZO® poses a risk to pregnancy outcomes. Monoclonal antibodies, such as ibalizumab‑uiyk, are transported across the placenta as pregnancy progresses; therefore, ibalizumab‑uiyk has the potential to be transmitted from the mother to the developing fetus.
  • Lactation: No data are available regarding the presence of TROGARZO® in human milk, the effects on the breastfed child, or the effects on milk production. Because of the potential for HIV‑1 transmission, instruct mothers not to breastfeed if they are receiving TROGARZO®.

Warnings and Precautions

Hypersensitivity Including Infusion‑Related and Anaphylactic Reactions

  • Hypersensitivity reactions including infusion‑related reactions and anaphylactic reactions have been reported following infusion of TROGARZO® during post‑approval use. Symptoms may include dyspnea, angioedema, wheezing, chest pain, chest tightness, cough, hot flush, nausea, and vomiting. If signs and symptoms of an anaphylactic or other clinically significant hypersensitivity reaction occur, immediately discontinue administration of TROGARZO® and initiate appropriate treatment. The use of TROGARZO® is contraindicated in patients with known hypersensitivity with TROGARZO®.

Immune Reconstitution Inflammatory Syndrome

  • Immune Reconstitution Inflammatory Syndrome (IRIS) has been reported in one patient treated with TROGARZO® in combination with other antiretrovirals. During the initial phase of combination antiretroviral therapies, patients whose immune systems respond may develop an inflammatory response to indolent or residual opportunistic infections, which may necessitate further evaluation and treatment.

Embryo-Fetal Toxicity

  • Based on animal data, TROGARZO® may cause reversible immunosuppression (CD4+ T cell and B cell lymphocytopenia) in infants born to mothers exposed to TROGARZO® during pregnancy. Immune phenotyping of the peripheral blood and expert consultation are recommended to provide guidance regarding monitoring and management of exposed infants based on the degree of immunosuppression observed. The safety of administering live or live‑attenuated vaccines in exposed infants is unknown.

Adverse Reactions

  • The most common adverse reactions (all Grades) seen in clinical trial experience, reported in at least 5% of subjects receiving TROGARZO® were diarrhea (8%), dizziness (8%), nausea (5%) and rash (5%).
  • Most (90%) of the adverse reactions reported were mild or moderate in severity. Two subjects experienced severe adverse reactions: one subject had a severe rash and one subject developed IRIS manifested as an exacerbation of progressive multifocal leukoencephalopathy.

To report suspected adverse reactions, contact THERA patient support® at 1‑833‑23THERA (1‑833‑238-4372) or FDA at 1‑800‑FDA-1088 or www.fda.gov/medwatch.