Brand Name
Trogarzo
Generic Name
Ibalizumab
View Brand Information FDA approval date: April 20, 2018
Classification: CD4-directed Blocking Antibody
Form: Injection
What is Trogarzo (Ibalizumab)?
TROGARZO, in combination with other antiretroviral, is indicated for the treatment of human immunodeficiency virus type 1 infection in heavily treatment-experienced adults with multidrug resistant HIV-1 infection failing their current antiretroviral regimen. TROGARZO, a CD4-directed post-attachment HIV-1 inhibitor, in combination with other antiretroviral, is indicated for the treatment of human immunodeficiency virus type 1 infection in heavily treatment-experienced adults with multidrug resistant HIV-1 infection failing their current antiretroviral regimen.
Approved To Treat
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Brand Information
TROGARZO (ibalizumab)
1INDICATIONS AND USAGE
TROGARZO, 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.
2DOSAGE FORMS AND STRENGTHS
Injection: 200 mg/1.33 mL (150 mg/mL) colorless to slightly yellow and clear to slightly opalescent solution with no visible particles in a single-dose vial.
3CONTRAINDICATIONS
TROGARZO is contraindicated in patients with a prior hypersensitivity reaction to TROGARZO or any components of the product
4ADVERSE REACTIONS
The following adverse drug reactions are discussed in other sections of the labeling:
- Immune Reconstitution Inflammatory Syndrome
4.1Clinical 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 350 subjects have been exposed to TROGARZO in the ibalizumab clinical development program, including 45 subjects who received TROGARZO through expanded access programs. A total of 19 subjects received TROGARZO via IV push. The safety profile of TROGARZO administered via IV push (Trial TMB-302) was similar to that seen with IV infusion administration (Trial TMB-301)
Trial TMB-301
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 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 3 shows the frequency of adverse reactions occurring in 5% or more of subjects.
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.
Laboratory Abnormalities
Table 4 shows the frequency of laboratory abnormalities (≥ Grade 3) in Trial TMB-301.
Table 4 shows the frequency of laboratory abnormalities (≥ Grade 3) in Trial TMB-301.
4.2Postmarketing Experience
The following adverse reactions have been identified during post‐approval use of TROGARZO. Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
- Immune system disorders: hypersensitivity reactions including infusion-related reactions and anaphylactic reactions have been reported
- Skin and subcutaneous tissue disorders: pruritus
5DESCRIPTION
TROGARZO is a CD4-directed post-attachment HIV-1 inhibitor.
Ibalizumab-uiyk is a CD4 domain 2-directed humanized monoclonal antibody of immunoglobulin G (IgG) isotype 4 with a molecular weight of approximately 150 kDa. Ibalizumab-uiyk is produced by recombinant DNA technology in murine myeloma non-secreting 0 (NS0) cells.
TROGARZO Injection is a sterile, colorless to slightly yellow and clear to slightly opalescent solution with no visible particles in a single-dose vial for intravenous administration (by IV infusion or IV push). Each single-dose vial delivers approximately 1.33 mL containing 200 mg of ibalizumab-uiyk, and contains the following inactive ingredients: 10 mM L-histidine (2.06 mg), 0.045% polysorbate 80 (0.60 mg), 52 mM sodium chloride (4.04 mg) and 5.2% sucrose (69.2 mg). TROGARZO solution has a pH of 6.0 and contains no preservative.
6PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information).
Hypersensitivity
Advise patients of the risk of hypersensitivity reactions including anaphylaxis. Instruct patients to seek immediate medical attention if signs or symptoms of hypersensitivity occur or are suspected. Advise patients who have had clinically significant hypersensitivity reactions to TROGARZO that they should not receive TROGARZO [see Contraindications (.
Advise patients of the risk of hypersensitivity reactions including anaphylaxis. Instruct patients to seek immediate medical attention if signs or symptoms of hypersensitivity occur or are suspected. Advise patients who have had clinically significant hypersensitivity reactions to TROGARZO that they should not receive TROGARZO [see Contraindications (.
Immune Reconstitution Syndrome
Immune Reconstitution Inflammatory Syndrome: Advise patients that immune reconstitution syndrome has been reported in a patient receiving TROGARZO and to inform their health care provider immediately of any symptoms of infection [see Warnings and Precautions (.
Immune Reconstitution Inflammatory Syndrome: Advise patients that immune reconstitution syndrome has been reported in a patient receiving TROGARZO and to inform their health care provider immediately of any symptoms of infection [see Warnings and Precautions (.
Important Administration Information
Advise the patient it is important to receive TROGARZO injections every two weeks as recommended by their healthcare professional and not to change the dosing schedule of TROGARZO or any antiretroviral medication without consulting their healthcare provider. Advise the patient to contact their healthcare provider immediately if they stop taking TROGARZO or any other drug in their antiretroviral regimen [see Dosage and Administration (. Advise the patient that they may receive TROGARZO loading dose by IV infusion over at least 30 minutes or by IV push over 90 seconds and they may receive TROGARZO maintenance doses by IV infusion over 15 minutes or IV push over 30 seconds. Also, advise the patient to seek counsel of the healthcare provider regarding the most appropriate route of administration
Advise the patient it is important to receive TROGARZO injections every two weeks as recommended by their healthcare professional and not to change the dosing schedule of TROGARZO or any antiretroviral medication without consulting their healthcare provider. Advise the patient to contact their healthcare provider immediately if they stop taking TROGARZO or any other drug in their antiretroviral regimen [see Dosage and Administration (. Advise the patient that they may receive TROGARZO loading dose by IV infusion over at least 30 minutes or by IV push over 90 seconds and they may receive TROGARZO maintenance doses by IV infusion over 15 minutes or IV push over 30 seconds. Also, advise the patient to seek counsel of the healthcare provider regarding the most appropriate route of administration
Embryo-fetal Toxicity
Advise pregnant individuals and females of reproductive potential of the potential risk of reversible immunosuppression in infants exposed to TROGARZO during pregnancy and to inform their healthcare provider of a known or suspected pregnancy [see Warning and Precautions ( and Use in Specific Populations (.
Advise pregnant individuals and females of reproductive potential of the potential risk of reversible immunosuppression in infants exposed to TROGARZO during pregnancy and to inform their healthcare provider of a known or suspected pregnancy [see Warning and Precautions ( and Use in Specific Populations (.
Lactation
Instruct women with HIV-1 infection not to breastfeed because HIV-1 can be passed to the baby in breast milk [see Use in Specific Populations (.
Instruct women with HIV-1 infection not to breastfeed because HIV-1 can be passed to the baby in breast milk [see Use in Specific Populations (.