Fostemsavir
Fostemsavir (Rukobia) is an HIV-1 attachment inhibitor used in combination with other antiretroviral medications for the treatment of HIV-1 infection in adults with limited therapeutic options. It works by binding to the gp120 protein on the surface of HIV-1, preventing the virus from attaching to host CD4+ T-cells. This medication is specifically indicated for treatment-experienced patients who have multi-drug resistant HIV-1 and cannot form an effective suppressive regimen with other available agents.
Fostemsavir is an HIV-1 attachment inhibitor prescribed for treatment-experienced adults with multi-drug resistant HIV who need a new antiretroviral option.
Key facts at a glance
- ATC
- J05AX29
- RxNorm
- 2380373
- Generic
- Fostemsavir
- Class
- atc-j05
- Brands
- Rukobia
- Availability
- rx
- Lactation
- unknown
- Routes
- oral
- Forms
- tablet
- 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
- 600mg twice daily
- Maximum
- consult physician
- Frequency
- every 12 hours
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- 400mg twice daily
- Maximum
- consult physician
- Frequency
- every 12 hours
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- 600mg twice daily
- Maximum
- consult physician
- Frequency
- every 12 hours
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
Overdose information
Special Populations
7 groupspregnancy
all trimestersuse only if benefits outweigh risks
limited data available; use only when clearly needed
regular prenatal monitoring
Use with caution and monitor for adverse effects.
lactation
breastfeedingnot recommended
HIV-positive mothers should not breastfeed to prevent HIV transmission to infant
none specific
Use of this medication in this population requires careful consideration of risks and benefits.
pediatric_age
under 18 yearsnot recommended
safety and efficacy not established in patients under 18 years of age
not applicable
geriatric
over 65 yearsno dose adjustment required
use with caution due to limited data in elderly population
monitor renal and hepatic function
Use with caution and monitor for adverse effects.
renal_impairment
severeno dose adjustment required
no dosage adjustment needed for any degree of renal impairment including end-stage renal disease
standard monitoring
hepatic_impairment
severeno dose adjustment required
use with caution in severe hepatic impairment due to limited data
monitor liver function tests
Use with caution and monitor for adverse effects.
hepatic_impairment
mild moderateno dose adjustment required
no dosage adjustment needed for mild or moderate hepatic impairment
standard monitoring
Statistics and clinical data
FDA approval year
FDA approval date for Fostemsavir (Rukobia)
Drug class
Antiretroviral drug class classification
Primary indication
Approved therapeutic indication
Mechanism of action
Pharmacological mechanism of action
Treatment of HIV-1 infection in adults with limited therapeutic options due to resistance, intolerance, or safety considerations. Specifically indicated for patients who cannot construct a suppressive regimen from other antiretroviral agents.
Fostemsavir is a prodrug that is metabolized to temsavir, which binds directly to the gp120 subunit on the HIV-1 envelope glycoprotein. This binding blocks the initial interaction between HIV-1 and CD4+ T-cell receptors, preventing viral attachment and subsequent infection of host cells.
Should be used in combination with other antiretroviral drugs. Not recommended for patients with known hypersensitivity to temsavir or fostemsavir. May cause immune reconstitution syndrome in some patients. Safety and effectiveness in children have not been established.
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