Medical Editor: John P. Cunha, DO, FACOEP
What Is Trogarzo?
Trogarzo (ibalizumab-uiyk) injection is a CD4-directed post-attachment HIV-1 inhibitor, used 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.
What Are Side Effects of Trogarzo?
Common side effects of Trogarzo include:
- nausea, and
Dosage for Trogarzo
Trogarzo is administered intravenously (IV) as a single loading dose of 2,000 mg followed by a maintenance dose of 800 mg every 2 weeks after dilution in 250 mL of 0.9% sodium chloride injection.
What Drugs, Substances, or Supplements Interact with Trogarzo?
Trogarzo may interact with other drugs. Tell your doctor all medications and supplements you use.
Trogarzo During Pregnancy and Breastfeeding
Tell your doctor if you are pregnant or plan to become pregnant before using Trogarzo; it is unknown how it would affect a fetus. There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to Trogarzo during pregnancy. Women infected with HIV should not breastfeed due to the potential for HIV transmission.
Our Trogarzo (ibalizumab-uiyk) injection Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
The following adverse drug reactions are discussed in other sections of the labeling:
- Immune Reconstitution Inflammatory Syndrome [see WARNINGS AND PRECAUTIONS]
Clinical Trial Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
A total of 292 patients with HIV-1 infection have been exposed to TROGARZO IV infusion.
The primary safety assessment of TROGARZO is based on 24 weeks of data from Trial TMB-301. TMB-301 was a single-arm trial of TROGARZO which enrolled 40 heavily treatment-experienced subjects with multidrug resistant HIV-1 on a failing HIV treatment regimen. Subjects received a single 2,000 mg IV loading dose of TROGARZO followed seven days later by the initiation of an optimized background regimen (OBR) including at least one agent to which the subject’s virus was susceptible. Two weeks after the TROGARZO loading dose, 800 mg of TROGARZO was administered IV. The IV administration of TROGARZO 800 mg was continued every 2 weeks through Week 25.
The most common adverse reactions (all Grades) reported in at least 5% of subjects were diarrhea, dizziness, nausea, and rash. Table 2 shows the frequency of adverse reactions occurring in 5% or more of subjects.
Table 2. Adverse Reactions (All Grades) Reported in ≥ 5% of Subjects Receiving TROGARZO and Optimized Background Regimen for 23 Weeks in Trial TMB-301
|*Includes pooled terms “rash”, “rash erythematous”, “rash generalized”, “rash macular”, “rash maculopapular”, and “rash papular”|
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 immune reconstitution inflammatory syndrome manifested as an exacerbation of progressive multifocal leukoencephalopathy.
Table 3 shows the frequency of laboratory abnormalities (≥ Grade 3) in Trial TMB-301.
Table 3. Selected Laboratory Abnormalities (≥ Grade 3) in Trial TMB-301
|Bilirubin (≥ 2.6 x ULN)||5%|
|Direct Bilirubin (> ULN)||3%|
|Creatinine (> 1.8x ULN or 1.5x baseline)||10%|
|Blood Glucose (> 250 mg/dL)||3%|
|Lipase (> 3.0 x ULN)||5%|
|Uric Acid (> 12 mg/dL)||3%|
|Hemoglobin (< 8.5 g/dL)||3%|
|Platelets (< 50,000/mm3)||3%|
|Leukocytes (< 1.5 109 cells/L)||5%|
|Neutrophils (< 0.6 109 cells/L)||5%|
As with all therapeutic proteins, there is potential for immunogenicity. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to ibalizumab-uiyk in the studies described below with the incidence of antibodies in other studies or to other products may be misleading.
All subjects enrolled in clinical trial TMB-301 and trial TMB-202 (a Phase 2b clinical trial that studied TROGARZO administered intravenously as 2,000 mg every 4 weeks or 800 mg every 2 weeks; the safety and effectiveness of this dosing regimen has not been established), were tested for the presence of anti-ibalizumab antibodies throughout their participation. One sample tested positive with low titer anti-ibalizumab antibodies. No adverse reaction or reduced efficacy was attributed to the positive sample reported in this subject.
Read the entire FDA prescribing information for Trogarzo (Ibalizumab-uiyk Injection)