Trogarzo Side Effects

Generic name: ibalizumab

Medically reviewed by Drugs.com. Last updated on Apr 17, 2023.

Note: This document contains side effect information about ibalizumab. Some dosage forms listed on this page may not apply to the brand name Trogarzo.

Applies to ibalizumab: intravenous solution.

Serious side effects of Trogarzo

Along with its needed effects, ibalizumab (the active ingredient contained in Trogarzo) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking ibalizumab:

Incidence not known

Back pain
blurred vision
chest tightness
chills
confusion
cough
difficulty swallowing
dizziness
drowsiness
fast heartbeat
fever
flushing
headache
hives, itching, skin rash
nausea and vomiting
puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
seizures
trouble breathing
unusual tiredness or weakness

Other side effects of Trogarzo

Some side effects of ibalizumab may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Diarrhea

For Healthcare Professionals

Applies to ibalizumab: intravenous solution.

General

The primary safety assessment was based on 24 weeks of data from a trial which enrolled 40 heavily therapy-experienced patients with multidrug-resistant HIV-1 on a failing HIV treatment regimen. The most common side effects reported were diarrhea, dizziness, nausea, and rash. Most side effects were mild or moderate in severity.^[Ref]

Renal

Very common (10% or more): Increased creatinine (10%)^[Ref]

Increased creatinine (greater than 1.8 times the upper limit of normal [1.8 x ULN] or 1.5 times baseline) has been reported in 10% of patients.^[Ref]

Gastrointestinal

Common (1% to 10%): Diarrhea, nausea, increased lipase^[Ref]

Increased lipase (greater than 3 x ULN) has been reported in 5% of patients.^[Ref]

Nervous system

Common (1% to 10%): Dizziness^[Ref]

Dermatologic

Common (1% to 10%): Rash (included rash, erythematous rash, generalized rash, macular rash, maculopapular rash, papular rash)

Postmarketing reports: Pruritus^[Ref]

Hematologic

Common (1% to 10%): Decreased leukocytes, decreased neutrophils, decreased hemoglobin, decreased platelets^[Ref]

Decreased leukocytes (less than 1.5 x 10[9] cells/L), neutrophils (less than 0.6 x 10[9] cells/L), hemoglobin (less than 8.5 g/dL), and platelets (less than 50,000/mm3) have been reported in 5%, 5%, 3%, and 3% of patients, respectively.^[Ref]

Hepatic

Common (1% to 10%): Increased bilirubin, increased direct bilirubin^[Ref]

Increased bilirubin (at least 2.6 x ULN) and direct bilirubin (greater than ULN) have been reported in 5% and 3% of patients, respectively.^[Ref]

Metabolic

Common (1% to 10%): Increased blood glucose, increased uric acid^[Ref]

Increased blood glucose (greater than 250 mg/dL) and uric acid (greater than 12 mg/dL) have each been reported in 3% of patients.^[Ref]

Hypersensitivity

Postmarketing reports: Hypersensitivity reactions (including infusion-related reactions, anaphylactic reactions)^[Ref]

Immunologic

Frequency not reported: Immune reconstitution inflammatory syndrome (manifested as exacerbation of progressive multifocal leukoencephalopathy), positive test for anti-ibalizumab (the active ingredient contained in Trogarzo) antibodies^[Ref]

All patients enrolled in the clinical trials were tested for anti-ibalizumab antibodies during their participation; 1 sample tested positive with low titer anti-ibalizumab antibodies. No side effect or reduced efficacy was attributed to the positive sample reported in this patient.^[Ref]