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Trogarzo

Generic Name: ibalizumab-uiyk
Brand Names: Trogarzo
Trogarzo (ibalizumab-uiyk) is used to treat multidrug resistant HIV. Includes Trogarzo side effects, interactions and indications.
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Drug Information:
Trogarzo (ibalizumab-uiyk) is an antiviral medicine that prevents human immunodeficiency virus (HIV) from multiplying in your body. Trogarzo is used to treat HIV, the virus that can cause acquired immunodeficiency syndrome (AIDS). Ibalizumab-uiyk is not a cure for HIV or AIDS. Trogarzo is usually given after other treatments have failed. Trogarzo affects your immune system. Tell your doctor if you have signs of a new infection such as fever, night sweats, swollen glands, cough, diarrhea, or weight loss. Learn more

Trogarzo Side Effects

Trogarzo Side Effects

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

For the Consumer

Applies to ibalizumab: intravenous solution

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
  • confusion
  • dizziness
  • drowsiness
  • fever
  • headache
  • seizures
  • severe rash
  • unusual tiredness or weakness

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

Less common

  • Nausea
  • rash

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.

Renal

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.

Very common (10% or more): Increased creatinine (10%)

Gastrointestinal

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

Common (1% to 10%): Diarrhea, nausea, increased lipase

Nervous system

Common (1% to 10%): Dizziness

Dermatologic

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

Hematologic

Common (1% to 10%): Decreased leukocytes, decreased neutrophils, decreased hemoglobin, decreased platelets

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.

Hepatic

Common (1% to 10%): Increased bilirubin, increased direct bilirubin

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

Metabolic

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

Common (1% to 10%): Increased blood glucose, increased uric acid

Immunologic

All patients enrolled in the clinical trials were tested for anti-ibalizumab (the active ingredient contained in Trogarzo) 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.

Frequency not reported: Immune reconstitution inflammatory syndrome (manifested as exacerbation of progressive multifocal leukoencephalopathy), positive test for anti-ibalizumab antibodies

Editorial References and Review

Medically reviewed by BestRx Medical Team Last updated on 1/1/2020.

Source: Drugs.com Trogarzo