Ibalizumab Side Effects

Medically reviewed by Drugs.com. Last updated on Aug 29, 2024.

Applies to ibalizumab: intravenous solution.

Common side effects of ibalizumab

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 side effects

• diarrhea

Serious side effects of ibalizumab

Along with its needed effects, ibalizumab 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

For healthcare professionals

Applies to ibalizumab: intravenous solution.

General adverse events

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 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]

Frequently asked questions

• How well does Trogarzo work to treat multidrug-resistant (MDR) HIV-1?
• How is Trogarzo used in the treatment of HIV?
• What are the side effects with HIV treatment Trogarzo?

Further information

Ibalizumab side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer