Ibalizumab
Ibalizumab is a monoclonal antibody antiretroviral medication used to treat HIV-1 infection in heavily treatment-experienced adults with multi-drug resistant virus who are failing their current antiretroviral regimen. It is administered intravenously and is typically used in combination with other antiretrovirals when other treatment options have been exhausted.
Ibalizumab is an HIV monoclonal antibody used for treatment-experienced patients with drug-resistant HIV who need new treatment options.
Key facts at a glance
- ATC
- J05AX23
- RxNorm
- 2043283
- Generic
- Ibalizumab
- Class
- atc-j05
- Brands
- Trogarzo
- Availability
- rx
- Lactation
- unknown
- Routes
- —
- Forms
- injection
- Regions
- US, EU, CN, JP
- Monitoring
- —
This page is for informational purposes only.
Do not use this information to diagnose yourself or to replace a physician's advice. Always consult a qualified healthcare provider before starting, stopping, or changing any medication. If you believe you are experiencing a medical emergency, call your local emergency number immediately.
Dosage and administration
- Usual dose
- 800mg every 2 weeks
- Maximum
- consult physician
- Frequency
- every 2 weeks (after 2000mg loading dose)
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
Overdose information
Special Populations
10 groupspregnancy
first trimesteravoid if possible
use only if benefits outweigh potential risks to fetus; consider alternative antiretroviral therapy if possible
regular fetal monitoring, ultrasound assessments
Use with caution and monitor for adverse effects.
pregnancy
second trimesterno specific adjustment
continue therapy if HIV suppression required; weigh benefits vs risks with healthcare provider
regular prenatal monitoring, viral load tracking
Use with caution and monitor for adverse effects.
pregnancy
third trimesterno specific adjustment
may continue through delivery; consider timing of last dose
viral load monitoring near delivery
Use with caution and monitor for adverse effects.
lactation
breastfeedingnot applicable
HIV-positive mothers should not breastfeed regardless of antiretroviral therapy due to risk of HIV transmission
not applicable
Use of this medication in this population requires careful consideration of risks and benefits.
pediatric_age
under 18 yearsnot established
not approved for pediatric use; safety and efficacy not established in patients under 18 years
not applicable
geriatric
65 years and olderno specific adjustment
use with caution; no dose adjustment required based on age alone; consider comorbidities
routine monitoring of renal function and overall health
Use with caution and monitor for adverse effects.
renal_impairment
mild to moderateno adjustment needed
no dose adjustment required; ibalizumab is not renally cleared as it is a monoclonal antibody
routine monitoring
renal_impairment
severeno adjustment needed
no dose adjustment required; monitor as clinically indicated
routine monitoring
hepatic_impairment
mild to moderateno specific adjustment
use with caution; limited data available; monitor liver function
monitor liver function tests regularly
Use with caution and monitor for adverse effects.
hepatic_impairment
severeno specific adjustment established
use only if benefits outweigh risks; limited clinical data
close monitoring of liver function and clinical status
Use with caution and monitor for adverse effects.
Statistics and clinical data
Drug class
Monoclonal antibody HIV entry inhibitor
FDA approval year
First FDA approval date for Ibalizumab
Common uses
Therapeutic indication
Route of administration
Dosage form and route
Ibalizumab is indicated for the treatment of HIV-1 infection in heavily treatment-experienced adults with limited treatment options due to documented or suspected resistance to multiple antiretroviral agents. It is used in combination with other antiretrovirals.
Ibalizumab is a monoclonal antibody that binds to the CD4 receptor on host T-cells, distinct from the binding site used by HIV. This blocks the entry of HIV into cells by preventing the conformational changes required for viral fusion and entry, thereby reducing viral replication.
Administered as an intravenous infusion every 2 weeks after an initial loading dose. Common side effects may include diarrhea, dizziness, nausea, and rash. Since it targets host cells rather than the virus directly, it has a low potential for cross-resistance with other antiretrovirals. Patients must be monitored for potential immune reconstitution inflammatory syndrome (IRIS).
Contraindications
Conditions and patient states where this medication should be avoided or used with caution.
Do not use (1)
Known allergy to this medication or its components
Use caution (1)
Consult healthcare provider for benefits vs risks assessment
Official drug label
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This information is for educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment.
This content is for general informational and educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the guidance of a qualified healthcare provider with any questions you have about a medical condition, and never disregard professional medical advice or delay seeking it because of something you read here.
If you think you may have a medical emergency, call your local emergency number or go to the nearest emergency department immediately.
Medically reviewed by WellAlly Editorial Team Last reviewed July 26, 2026. · Read our editorial policy