Lenacapavir
Lenacapavir is a long-acting HIV-1 capsid inhibitor used in combination with other antiretrovirals for the treatment of HIV-1 infection in heavily treatment-experienced adults with multi-drug resistant virus who are failing their current antiretroviral regimen. Administered as subcutaneous injections every six months, it offers an alternative option for patients who have limited treatment choices due to resistance.
Lenacapavir is a long-acting injectable HIV-1 capsid inhibitor for treatment-experienced patients with multi-drug resistant HIV infection.
This medication carries a boxed (black box) warning — the strongest type of FDA warning. Review the full prescribing information before use.
Key facts at a glance
- ATC
- J05AX31
- RxNorm
- 2625651
- Generic
- Lenacapavir
- Class
- atc-j05
- Brands
- Sunlenca, Yeztugo
- Availability
- rx
- Lactation
- unknown
- Routes
- oral
- Forms
- injection, 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 on day 1, 600mg on day 2 (oral loading)
- Maximum
- consult physician
- Frequency
- twice daily for 2 days
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- 300mg
- Maximum
- consult physician
- Frequency
- every 26 weeks (every 6 months)
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- 300mg oral loading then 300mg subcutaneous
- Maximum
- consult physician
- Frequency
- oral weekly for 12 weeks, then injection every 6 months
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
Overdose information
Special Populations
8 groupspregnancy
first trimesteravoid if possible
use only if benefits outweigh potential risks to fetus
regular fetal monitoring recommended
Use with caution and monitor for adverse effects.
pregnancy
second trimesteravoid if possible
continue only if already receiving therapy and benefits outweigh risks
regular prenatal monitoring
Use with caution and monitor for adverse effects.
pregnancy
third trimesteravoid if possible
consider risks versus benefits; discuss with healthcare provider
fetal monitoring and viral load monitoring
Use with caution and monitor for adverse effects.
lactation
breastfeedingavoid
do not breastfeed due to risk of HIV transmission regardless of viral load
infant HIV testing
Use of this medication in this population requires careful consideration of risks and benefits.
geriatric
elderly 65plusno specific adjustment
use with caution; limited clinical trial data in patients over 65
monitor renal and hepatic function
Use with caution and monitor for adverse effects.
pediatric_age
adolescents 12 17not established
not yet approved for patients under 18; clinical trials ongoing (HORIZON study)
awaiting pediatric data
renal_impairment
severeuse with caution
no dose adjustment needed for mild to moderate impairment; use caution in severe
monitor renal function
Use with caution and monitor for adverse effects.
hepatic_impairment
severeno adjustment needed
no dose adjustment for mild to moderate hepatic impairment; use caution in severe
monitor hepatic function
Use with caution and monitor for adverse effects.
Statistics and clinical data
Drug class
Antiretroviral drug class classification
FDA approval year
FDA approval date for Lenacapavir (Sunlenca)
Primary indication
Therapeutic indication for patients with multidrug resistant HIV
Administration route
Route of administration for Lenacapavir
Lenacapavir is indicated for the treatment of HIV-1 infection in adults with multi-drug resistant HIV-1 who are failing their current antiretroviral regimen due to resistance, intolerance, or safety considerations. It is used in combination with other antiretroviral drugs.
Lenacapavir targets the HIV-1 capsid protein, which is essential for multiple steps of the viral lifecycle including viral replication, nuclear import of viral DNA, and virus assembly. By binding to the capsid protein, it disrupts these critical functions, preventing viral replication.
Lenacapavir is administered as subcutaneous injections every 26 weeks (approximately 6 months). Patients must receive oral bridging therapy before starting injections. Common side effects may include injection site reactions. It should not be used as a single agent due to resistance risk. Regular monitoring of HIV viral load and CD4 counts is recommended.
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
WellAlly may earn a referral fee from linked resources at no extra cost to you. Editorial content is never influenced by commercial relationships.
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