Lenacapavir (PrEP)

YEZTUGO

Open Lenacapavir (PrEP) in the interactive console ↗

Pronunciation: len-a-KAP-a-veer (yez-TOO-goe)

Lenacapavir (PrEP) ballicule: receptor binding, kinetics and half-life diagram — Mechanism of action: Lenacapavir (PrEP) ballicule

Lenacapavir (PrEP) YEZTUGO mascot mnemonic cartoon — Visual mnemonic: Lenacapavir (PrEP) mascot
**“Lenny cap o’ virus? Yes, to go!”**

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.

Lenacapavir (PrEP) molecular structure (skeletal formula) — Molecular structure: Lenacapavir (PrEP)

FDA label

Read the full label on DailyMed ↗

BOXED WARNING Risk of drug resistance with use for HIV-1 PrEP in undiagnosed HIV-1 infection. Must test for HIV-1 before initiating and before each injection using an FDA-approved test for acute/primary HIV-1. Do not initiate unless negative status confirmed; those who acquire HIV-1 must transition to a complete treatment regimen.

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

Available strengths

inj 463.5 mg/1.5 mL (SC q6mo (Yeztugo))

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.

Cost

Lenacapavir (PrEP) (YEZTUGO)

Strength		#/mo	generic $/unit	CostPlus
463.5 mg/1.5 mL	inj	per unit		not offered

NADAC is a voluntary CMS survey of what retail community pharmacies pay for the drugs they stock. Lenacapavir (PrEP) is administered under clinical supervision and dispensed outside retail pharmacies, so it rarely appears on surveyed invoices.

Other forms: Lenacapavir (SUNLENCA)

⚠ BOXED WARNING