Lenacapavir (PrEP)
YEZTUGO
What it isLong-acting HIV capsid inhibitor; preexposure prophylaxis against sexually acquired HIV.
Why this oneIt provides the longest-interval PrEP option, replacing daily adherence with infrequent subcutaneous injections.
What limits itConfirm HIV-negative status before and during therapy; breakthrough infection risks capsid resistance, and injection nodules can persist.
FDA label
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| FDA dosing | Population | Start | Target | Max |
|---|---|---|---|---|
| Pre-exposure prophylaxis (PrEP) to reduce risk of sexually acquired HIV-1 | Adults and adolescents weighing >=35 kg | Initiation: Day 1 - 927 mg SC (2 x 1.5 mL) + 600 mg orally (2 x 300 mg); Day 2 - 600 mg orally | Continuation: 927 mg SC every 6 months (26 weeks) +/- 2 weeks |
Renal No adjustment for mild, moderate, or severe renal impairment (CrCl >=15 mL/min); not studied in ESRD (CrCl <15)
Hepatic No adjustment for mild or moderate (Child-Pugh A/B); not studied in severe (Child-Pugh C)
Continuation injection every 6 months (26 weeks); if delayed >2 weeks, interim weekly oral 300 mg for up to 6 months; if >28 weeks and no tablets taken, restart initiation
Instructions
- Screen for HIV-1 before initiating and before each injection
- SC injection into abdomen (thigh alternative) by healthcare provider; do NOT administer intradermally (serious injection site reactions)
- Oral tablets may be taken with or without food
- Supplemental doses recommended when initiating strong or moderate CYP3A inducers
- Residual concentrations may persist up to 12 months after last dose
Contraindications
- Unknown or positive HIV-1 status
Cautions
- Comprehensive management to reduce HIV-1 acquisition risk
- Potential risk of resistance if HIV-1 acquired before/during use or after discontinuation
- Long-acting properties: residual concentrations up to 12 months or longer
- Serious injection site reactions with improper (intradermal) administration
Adverse reactions
- Injection site reactions (nodule, pain)
- Headache
- Nausea
Pregnancy Available data (PURPOSE 1) have not identified a drug-associated risk; APR registry available.
Lactation Lenacapavir present in human milk at low levels; no adverse effects observed in breastfed infants.
NO BOXED WARNINGS
Classes and tags
Clinical profile
Mechanism of action: Lenacapavir (PrEP) ballicule
