Ibalizumab-Uiyk: uses, dosing, side effects & brands
Ibalizumab-Uiyk is a medicine sold in the U.S. under one brand, for hiv infections. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Treats
- Hiv Infections
- Available as
- Injectable
- Sold as
- Trogarzo
- Prescription?
- Prescription only
- Generic available?
- Not in our catalog
How ibalizumab-uiyk is dosed
From the FDA label for Trogarzo (application BLA761065). Other ibalizumab-uiyk products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
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…
Ibalizumab-Uiyk 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…
Who shouldn’t take ibalizumab-uiyk
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.
Every ibalizumab-uiyk product we track (1)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
Only one: Trogarzo.
What people report to the FDA about ibalizumab-uiyk
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 8 reports naming ibalizumab-uiyk, and the FDA flagged 63% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:
- blood hiv rna increased3 reports
- dyspepsia3 reports
- genotype drug resistance test positive3 reports
- hepatic cytolysis3 reports
- hepatitis b3 reports
- hepatitis b dna increased3 reports
- pruritus3 reports
- anhedonia2 reports
Read these as a signal, not a rate. A report does not mean ibalizumab-uiyk caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label section above.
Source: openFDA drug/event (FAERS), retrieved July 25, 2026.
Related calculators
Frequently asked questions
What is ibalizumab-uiyk?
Trogarzo (Ibalizumab-Uiyk) is a medication used to treat Hiv Infections.
Can you take ibalizumab-uiyk with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run ibalizumab-uiyk against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What forms does ibalizumab-uiyk come in?
Across the brands we track, ibalizumab-uiyk is currently marketed as injectable, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic ibalizumab-uiyk?
We do not currently list a generic-labelled ibalizumab-uiyk product. That does not always mean none exists — it means none appears under a generic name in the FDA data we track. Ask your pharmacist.
Cite this page
- APA
- pharmaranks. (2026, July 24). Ibalizumab-Uiyk: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/ibalizumab-uiyk
- MLA
- “Ibalizumab-Uiyk: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/ibalizumab-uiyk.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Read the full FDA label for ibalizumab-uiyk on DailyMed (NIH) ↗.