Ibalizumab Side Effects

Medically reviewed by Drugs.com. Last updated on Sep 25, 2024.

Applies to ibalizumab: intravenous solution.

Precautions

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Using this medicine could harm unborn baby while you are pregnant. Use an effective form of birth control to keep from getting pregnant. Tell your doctor right away if you think you have become pregnant.

This medicine may cause infusion-related reactions and serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Tell your doctor right away if you have a back pain, chest tightness, fever or chills, flushing, rash, itching, headache, hoarseness, nausea and vomiting, trouble breathing or swallowing, or any swelling of your hands, face, or mouth after using this medicine.

Your immune system may get stronger when you start taking HIV medicines. This could cause a hidden infection in your body to become active. Tell your doctor right away if you notice any changes in your health, including any symptoms of infection (eg, fever, chills, cough, hoarseness, lower back or side pain, or painful or difficult urination).

This medicine will not keep you from giving HIV to your partner during sex. Make sure you understand this and practice safe sex, even if your partner also has HIV, by using a latex condom or other barrier method. This medicine will also not keep you from giving HIV to other people if they are exposed to your blood. Do not re-use or share needles with anyone.

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:

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:

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]

See also:

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