Yeztugo

Pronunciation: Yez-TOO-go
Generic name: lenacapavir
Brand name: Yeztugo
Dosage form: tablets for oral use (300 mg), injection for subcutaneous use in a single-dose vial (463.5 mg/1.5 mL)
Drug class: Miscellaneous antivirals

Medically reviewed by Carmen Pope, BPharm. Last updated on Jun 23, 2025.

What is Yeztugo?

Yeztugo is used for HIV-1 PrEP to reduce the risk of getting HIV-1 in adults and adolescents who weigh at least 77 pounds (at least 35 kg). The initial dose consists of 2 Yeztugo injections (day 1) and 2 Yeztugo tablets (day 1 and day 2). After completing the initial dose, you will receive 2 Yeztugo injections every 6 months.

Do not receive Yeztugo if you:

Already have HIV-1. If you already have HIV-1, you will need to take other medicines to treat HIV-1. Yeztugo is not approved for the treatment of HIV-1.
Do not know your HIV-1 status. You may already have HIV-1. If you have HIV-1, you will need to take other medicines to treat it. Yeztugo can only help reduce your risk of getting HIV-1 before you get it.

Yeztugo works by binding to capsid protein subunit interfaces with high affinity (KD=1.4nM). Its mechanism involves disrupting multiple viral lifecycle stages, including blocking the nuclear import of proviral DNA, interfering with virus assembly/release by reducing capsid production, and preventing proper capsid core formation through malformed capsid assembly. Yeztugo belongs to the drug class called selective HIV-1 capsid inhibitors.

Yeztugo (lenacapavir) gained FDA approval on June 18, 2025, as the first HIV PrEP to offer 6 months of protection. Approval was based on positive results from two Phase 3 clinical trials: Purpose 1 (NCT04994509, cisgender women) and Purpose 2 (NCT04925752, cisgender men, transgender women, transgender men, and gender nonbinary people ≥ 16 years of age who have sex with male partners and are at risk for HIV infection).

At least 99.9% of people receiving Yeztugo in these clinical trials remained HIV negative.

Side effects

The most common side effects of Yeztugo injection are:

injection site reactions (a lump or bump, pain, skin hardening, swelling, itching, redness, bruising, or warmth at the injection site. This may be felt but not seen, and may take longer to go away than other injection site reactions)
headache
nausea.

Serious injection site reactions. Rarely, some Yeztugo injection site reactions caused by improper technique by a healthcare provider can lead to serious injection site reactions like severe skin damage (necrosis) or open sores (ulcer). Tell your healthcare provider if you have any injection site reactions or other side effects.

Warnings and serious side effects

Yeztugo carries a Boxed Warning for the risk of drug resistance with use in people with undiagnosed HIV-1 infection.

Undiagnosed HIV-1 infection

Before receiving Yeztugo to reduce your risk of getting HIV-1, you must be HIV-1 negative to start Yeztugo. You must get tested to make sure that you do not already have HIV-1.

Do not receive Yeztugo unless you are confirmed to be HIV-1 negative.
Some HIV-1 tests can miss HIV-1 infection in a person who has recently acquired HIV-1. If you have flu-like symptoms, you could have recently acquired HIV-1. Tell your healthcare provider if you had a flu-like illness within the last month before starting Yeztugo or at any time while receiving Yeztugo. Symptoms of a new HIV-1 infection include:
- tiredness
- joint or muscle aches
- sore throat
- rash
- enlarged lymph nodes in the neck or groin
- fever
- headache
- vomiting or diarrhea
- night sweats.

Risk of other sexually transmitted infections (STIs)

Yeztugo does not prevent other sexually transmitted infections (STIs).

Practice safer sex by using a latex or polyurethane condom to reduce the risk of getting STIs.
Get tested for other STIs such as syphilis, chlamydia, and gonorrhea.

You must stay HIV-1 negative to keep receiving Yeztugo.

Know your HIV-1 status and the HIV-1 status of your partners.

Ask your partners with HIV-1 if they are taking anti-HIV-1 medicine and have an undetectable viral load.

An undetectable viral load is when the amount of virus in the blood is too low to be measured in a lab test. To maintain an undetectable viral load, your partners must keep taking HIV-1 medicine as prescribed. Your risk of getting HIV-1 is lower if your partners with HIV-1 are taking effective treatment.

Get tested for HIV-1 with each Yeztugo injection or when your healthcare provider tells you. You should not miss any HIV-1 tests. If you get HIV-1 and continue receiving Yeztugo because you do not know you have HIV-1, the HIV-1 may become harder to treat.

If you think you were exposed to HIV-1, tell your healthcare provider right away. They may want to do more tests to be sure you do not have HIV-1.

Get information and support to help reduce sexual behaviors associated with the risk of getting HIV-1.

Follow the Yeztugo dosing schedule, which includes returning to a healthcare provider for your scheduled injections every 6 months. Missing Yeztugo injections or tablets increases your risk of getting HIV-1.

If you get HIV-1, you will need to immediately take other medicines to treat HIV-1. Yeztugo is not approved for the treatment of HIV-1.

If you have HIV-1 and receive only Yeztugo, over time your HIV-1 may become harder to treat.

Other warnings

It is not known if Yeztugo is safe and effective in children weighing less than 77 pounds (less than 35 kg).

These are not all of the possible side effects of Yeztugo. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Before receiving

Do not receive or take Yeztugo if you have HIV-1 or your HIV status is unknown.

Before receiving Yeztugo, tell your healthcare provider about all your medical conditions, including if you:

Are pregnant or plan to become pregnant
Are breastfeeding or plan to breastfeed.

Pregnancy

Tell your healthcare provider if you become pregnant while or after receiving Yeztugo.

Pregnancy Registry: There is a pregnancy registry for individuals who receive Yeztugo during pregnancy. The purpose of this registry is to collect information about you and your baby's health. Talk with your healthcare provider about how you can take part in this registry.

Breastfeeding

A small amount of Yeztugo will transfer into breast milk. Talk to your healthcare provider about the best way to feed your baby while you are receiving Yeztugo.

How will I receive and take Yeztugo?

Yeztugo consists of injections and tablets.

Yeztugo injections will be given to you by a healthcare provider under the skin (subcutaneous injection).
- The injection can be given in your stomach area (abdomen) or upper leg (thigh).
Take Yeztugo tablets by mouth, with or without food.

Your dosing schedule will start as follows:

On Day 1, you will receive 2 Yeztugo injections and take 2 Yeztugo tablets.
On Day 2, you will take 2 Yeztugo tablets.

After completing the start of your dosing schedule, you will receive 2 Yeztugo injections every 6 months (26 weeks) from the date of your last injection.

Stay under the care of a healthcare provider while receiving Yeztugo. You must attend your scheduled appointments to receive your injections of Yeztugo.

If you miss taking your tablets on Day 2, take them as soon as possible. Your Day 1 and Day 2 tablets should not be taken on the same day.

What happens if I miss a dose?

If you miss or need to delay your scheduled every 6 months injection of Yeztugo by more than 2 weeks, call your healthcare provider right away to discuss your PrEP options.

If you need to delay your scheduled Yeztugo injection appointment, there is the option to temporarily take Yeztugo tablets. You will take 1 Yeztugo tablet by mouth 1 time every 7 days, until your injections resume.

If more than 28 weeks have elapsed since your last injection and tablets have not been taken, your healthcare provider will restart the initiation schedule from Day 1 if clinically appropriate.

It is important to continue receiving Yeztugo as scheduled. Missing Yeztugo injections or tablets may increase your risk of getting HIV-1.

If you stop receiving Yeztugo, talk to your healthcare provider about other options to reduce the risk of getting HIV-1.

What happens if I take too many Yeztugo tablets?

If you take too many Yeztugo tablets, call your healthcare provider or go to the nearest hospital emergency room right away.

Dosing information

Dose of Yeztugo for HIV-1 PrEP in adults

Day 1: 927 mg by subcutaneous (SC) injection (2 x 1.5 mL injections) and 600 mg orally (2 x 300 mg tablets)
Day 2: 600 mg orally (2 x 300 mg tablets)
6 months (26 weeks) thereafter from the date of the last injection (+/-2 weeks): 927 mg by SC injection (2 x 1.5 mL injections)

Note: Yeztugo injection is for subcutaneous administration only. Two 1.5 mL injections are required for the complete dose.

Scheduled injection delay

If scheduled injection is anticipated to be delayed by more than 2 weeks, Yeztugo tablets may be used on an interim basis (for up to 6 months if needed) until injections resume.

The dosing schedule for delayed injection is 300 mg orally once every 7 days.

What other medicines affect Yeztugo?

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Some medicines may interact with Yeztugo. Keep a list of your medicines and show it to your healthcare provider and pharmacist when you get a new medicine. You can ask your healthcare provider or pharmacist for a list of medicines that interact with Yeztugo.

Supplemental doses of Yeztugo are recommended for individuals initiating therapy with either strong CYP3A inducers (such as rifampin, phenytoin, or phenobarbital) or moderate CYP3A inducers (such as efavirenz, dexamethasone, or St. John's Wort).

Strong CYP3A inducers may be started at least 2 days after Yeztugo is first initiated, while moderate CYP3A inducers may be started any time after Yeztugo is initiated.

Combined P-gp, UGT1A1, and strong CYP3A inhibitors (such as cobicistat, darunavir, voriconazole, atazanavir) may significantly increase the plasma concentrations of Yeztugo. Concomitant administration of Yeztugo with these inhibitors is not recommended.

Do not start a new medicine without telling your healthcare provider. Your healthcare provider can tell you if it is safe to receive Yeztugo with other medicines. Yeztugo may affect certain other medicines for up to 9 months after your last injection.

Storage

Store Yeztugo tablets at room temperature between 68°F and 77°F (20 °C to 25 °C).

The tablet bottle contains a desiccant packet to help keep your medicine dry (protect it from moisture). Keep the desiccant packet in the bottle. Do not eat the desiccant packet.

Keep the tablets in their original bottle, with its child-resistant cap closure.

Keep the bottle tightly closed.

Keep out of reach of children.

What are the ingredients in Yeztugo?

Active ingredient: lenacapavir sodium

Inactive ingredients (Yeztugo tablets): copovidone, croscarmellose sodium, magnesium stearate, mannitol, microcrystalline cellulose, and poloxamer 407. The tablets are film-coated with a coating material containing iron oxide black, iron oxide red, iron oxide yellow, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide.

Inactive ingredients (Yeztugo injection): polyethylene glycol 300 and water for injection.