trogarzo
Trogarzo (Ibalizumab-Uiyk) is a medication used to treat Hiv Infections.
Ibalizumab-Uiyk · by Theratechnologies
Key facts
- Active ingredient
- Ibalizumab-Uiyk
- Form
- Injectable
- Strength
- IBALIZUMAB-UIYK 150MG/ML
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- May treat
- hiv infections
- Manufacturer
- Theratechnologies
- FDA application
- BLA761065
What is Trogarzo?
From the FDA label: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.
How to use
The recommended dosage regimen is a single loading dose of 2,000 mg followed by a maintenance dose of 800 mg every 2 weeks administered as a diluted intravenous infusion (IV infusion) or undiluted intravenous push (IV push). ( 2.1 , 2.2 , 2.3 ) Duration of IV Infusion or IV Push IV Infusion (Diluted) IV Push (Undiluted) Loading Dose 2,000 mg Over at least 30 minutes Over at least 90 seconds Maintenance Dose 800 mg Over at least 15 minutes Over at least 30 seconds 2.1 Recommended Dosage The recommended dosage regimen is a single loading dose of 2,000 mg followed by a maintenance dose of 800 mg every 2 weeks administered as a diluted intravenous infusion (IV infusion) or undiluted intravenous push (IV push) [ see Dosage and Administration ( 2.2 , 2.3 ) ]. TROGARZO is available in a single-dose, 2 mL vial containing 150 mg/mL of ibalizumab-uiyk. Each vial delivers approximately 1.33 mL containing 200 mg of ibalizumab-uiyk. Dose modifications of TROGARZO are not required when administered with any other antiretroviral or any other treatments. 2.2 Preparation Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Discard vial if solution is cloudy, if there is pronounced discoloration or if there is foreign particulate matter. See Table 1 for the appropriate number of vials…
Side effects
The following adverse drug reactions are discussed in other sections of the labeling: Immune Reconstitution Inflammatory Syndrome [see Warnings and Precautions ( 5.2 )] The most common adverse reactions (incidence ≥ 5%) were diarrhea, dizziness, nausea, and rash. ( 6.1 ) 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. 6.1 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 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) [see Clinical Pharmacology ( 12.3 )]. 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…
Warnings
Important safety information
Hypersensitivity reactions including infusion-related reactions and anaphylactic reactions have been reported following infusion of TROGARZO. ( 5.1 ) Immune Reconstitution Inflammatory Syndrome (IRIS) has been reported in patients treated with combination antiretroviral therapies. ( 5.2 ) Embryo-Fetal Toxicity: Monitor infants exposed to TROGARZO in utero for signs and symptoms of immunosuppression. ( 5.3 , 8.1 ) 5.1 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 [see Contraindications ( 4 ), Adverse Reactions ( 6.2 )]. 5.2 Immune Reconstitution Inflammatory Syndrome Immune reconstitution inflammatory syndrome 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. 5.3 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. [see Use In Specific Populations ( 8.1 )]
Who should not take Trogarzo
TROGARZO is contraindicated in patients with a prior hypersensitivity reaction to TROGARZO or any components of the product [see Warnings and Precautions ( 5.1 )]. Prior hypersensitivity reaction to TROGARZO or any components of the product.
May treat (source: NIH RxClass)
Dosage forms
Injectable
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
Same active ingredient, far cheaper. Is there a generic? →
Request a 90-day supply
Bulk fills usually lower the per-dose price vs monthly refills.
Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
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Frequently asked questions
- What does Trogarzo treat?
- Trogarzo (Ibalizumab-Uiyk) may be used to treat HIV infections, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- Is there a coupon or discount for Trogarzo?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Trogarzo. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Trogarzo?
- Trogarzo is marketed by Theratechnologies. You can see Theratechnologies's full profile, rating, and other products on pharmaranks.
- Is Trogarzo a brand-name or generic drug?
- Trogarzo is a brand-name product with the active ingredient Ibalizumab-Uiyk.
- Is Trogarzo available over the counter?
- No. Trogarzo is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Trogarzo come in?
- Trogarzo is currently marketed as injectable, per the FDA's National Drug Code Directory.
- Is Trogarzo FDA-registered?
- Trogarzo is on record with the U.S. FDA under application number BLA761065. You can verify this on its official FDA label.
- Is Trogarzo safe?
- There's no single safe-or-not verdict, and we don't yet have a composite recall-safety score for Trogarzo. Review its FDA-label side effects and warnings below, and always consult a licensed professional.
- What are the side effects of Trogarzo?
- Trogarzo's side effects are taken directly from its FDA label. From the label: The following adverse drug reactions are discussed in other sections of the labeling: Immune Reconstitution Inflammatory Syndrome [see Warnings and Precautions ( 5.2 )] The most common adverse reactions (incidence ≥ 5%) were diarrhea, dizziness, nausea, and rash.… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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