Patient Medication Information: uses, side effects, how to take - Yeytuo

Serious warnings and precautions box

What is Yeytuo used for:

Yeytuo is used to reduce the risk of getting HIV-1 in adults and adolescents who weigh at least 35 kg. This is called pre-exposure prophylaxis (PrEP).

How Yeytuo works:

Yeytuo contains the active ingredient lenacapavir, a long-acting medicine that belongs to a group of antiretroviral medicines called capsid inhibitors. It works by binding to the HIV-1 virus proteins and disrupting the virus from making more copies and spreading.

After injection, Yeytuo forms a collection of drug under the skin in an area known as a “drug depot”. From this site, Yeytuo will release slowly into your bloodstream to reduce your risk of getting HIV-1.

The ingredients in Yeytuo are:

Yeytuo injection

Medicinal ingredients: lenacapavir (as lenacapavir sodium)

Non-medicinal ingredients: polyethylene glycol 300, water for injection

Yeytuo tablets

Medicinal ingredients: lenacapavir (as lenacapavir sodium)

Risk of drug resistance with use of Yeytuo in undiagnosed HIV-1 Infection
Use of Yeytuo in individuals with HIV-1 increases the risk of developing resistance to lenacapavir, the active ingredient in Yeytuo. Your healthcare professional will run tests to confirm that you are HIV-1 negative before starting and while receiving Yeytuo. If you acquire HIV-1 while receiving Yeytuo, your healthcare professional will switch you to other medicines to treat HIV-1.

Non-medicinal ingredients: copovidone, croscarmellose sodium, iron oxide black, iron oxide red, iron oxide yellow, magnesium stearate, mannitol, microcrystalline cellulose, poloxamer 407, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide.

Yeytuo comes in the following dosage forms:

Solution for injection, 463.5 mg/1.5 mL (309 mg/mL).
Beige tablets, 300 mg.

Do not use Yeytuo if:

you do not know your HIV-1 status or you already have HIV-1 infection. Yeytuo can only reduce your risk of getting HIV-1 before you get it. You must get tested to make sure you do not have HIV-1 before receiving Yeytuo and you must stay HIV-1 negative to keep receiving Yeytuo. If you get HIV-1, you will need to immediately take other medicines to treat HIV-1.
you are allergic to lenacapavir or any of the other ingredients of this medicine (listed in The ingredients in Yeytuo are)
you are currently taking carbamazepine (Epitol^®, Mazepine^®, Novocarbamaz^®, Tegretol^®) and phenytoin (Dilantin^®, Tremytoin^®) used to treat epilepsy and prevent seizures (fits).
you are currently taking St. John’s wort, an herbal remedy used for depression and anxiety.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Yeytuo. Talk about any health conditions or problems you may have, including if you:

are pregnant or plan to become pregnant. Tell your healthcare professional if you become pregnant while or after receiving Yeytuo. Pregnancy Registry: There is a pregnancy registry for individuals who receive Yeytuo during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Talk with your healthcare professional about how you can take part in this registry.
are breastfeeding or plan to breastfeed. A small amount of Yeytuo is present in breast milk. Talk with your healthcare professional about the best way to feed your baby.

Other warnings you should know about:

Yeytuo does not prevent other sexually transmitted infections (STIs). Get tested for other STIs such as syphilis, chlamydia, and gonorrhea.
You must stay HIV-1 negative to keep receiving Yeytuo. Get tested for HIV-1 as recommended by your healthcare professional.
If you think you might have HIV-1 (you may get a flu-like illness), talk to your healthcare professional right away. They may want to do more tests to make you do not have HIV-1.
Regular appointments are important. It is important that you attend your planned appointments every 6 months (26 weeks) to receive your Yeytuo injections. Missing your Yeytuo injections increases your risk of getting HIV-1.
Yeytuo is a long-acting medicine. If after talking to your healthcare professional you decide to stop Yeytuo, you should know that low levels of lenacapavir may remain in your body for up to a year or more after your last injection, but the amount of drug in your body may be too low to reduce your risk of getting HIV-1. If you are thinking about
- stopping PrEP, you may need to take other medicines to reduce your risk of getting HIV-1.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

Yeytuo may interact with other medicines. As a result, the amounts of Yeytuo or other medicines in your blood may change. This may stop your medicines from working properly, or it may make side effects worse. In some cases, your healthcare professional may need to adjust your dose or check your blood levels.

The following may interact with Yeytuo:

antibiotics containing:
- rifabutin, rifampin, or rifapentine
anticonvulsants used to treat epilepsy and prevent seizures (fits), containing:
- oxcarbazepine or phenobarbital
medicines used to treat migraine headache, containing:
- dihydroergotamine, ergotamine or methylergonovine
medicine used to treat impotence and pulmonary hypertension, containing:
- tadalafil
medicine used to treat impotence, containing:
- sildenafil or vardenavil
corticosteroids (also known as ‘steroids’) taken orally or given by injection used to treat allergies, inflammatory bowel diseases, and other various illnesses involving inflammations in your body, containing:
- dexamethasone or hydrocortisone/cortisone
medicines used to lower cholesterol, containing:
- lovastatin or simvastatin
antiarrhythmics used to treat heart problems, containing:
- digoxin
medicines used to help you sleep, containing:
- midazolam or triazolam
anticoagulants used to prevent and treat blood clots, containing:
- rivaroxaban, betrixaban, dabigatran or edoxaban

Yeytuo is a long-acting medicine and may affect certain other medicines if you take them within 9 months after your last injection. You should check with your healthcare professional if such medicines are safe for you to take after you stop Yeytuo.

How to take Yeytuo:

Yeytuo consists of tablets and injections.

You start with Yeytuo tablets that you take by mouth and Yeytuo injections given by your healthcare professional.
You will then continue with Yeytuo injections twice a year (every 6 months from the date of your last injection) given by your healthcare professional.
You must be tested and have a negative HIV-1 status before starting and while receiving Yeytuo. Your healthcare professional will order the HIV-1 test for you to confirm your negative status.

Stay under the care of a healthcare professional while receiving Yeytuo. It is important that you attend your planned appointments to receive your injections of Yeytuo every 6 months. Your healthcare professional will discuss safer sex practices to reduce the risk of STIs and recommend you get tested for STIs.

Usual dose:

Yeytuo consists of tablets and injections.

Day 1:

Two tablets by mouth. You may take Yeytuo tablets with or without food.
Two injections given to you by your healthcare professional into your abdomen (stomach).

Day 2:

Two tablets by mouth. You may take Yeytuo tablets with or without food.

Every 6 months:

Two injections given to you by your healthcare professional into your abdomen (stomach) every 6 months (26 weeks) from the date of your last injection.

It is important that you attend your planned appointments to receive your Yeytuo injections every 6 months. Missing your Yeytuo injections increases your risk of getting HIV-1.

Overdose:

If you think you, or a person you are caring for, have taken too much Yeytuo, contact a healthcare professional, hospital emergency department, regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms.

Missed dose:

If you miss a Yeytuo injection

If you will be unable to attend your next planned appointment to receive your every 6 months injection of Yeytuo, call your healthcare professional as soon as possible to discuss your options. Your healthcare professional may recommend that you temporarily take Yeytuo tablets until you can receive the injection again.
Using Yeytuo tablets if you have to miss an injection appointment: Take one tablet (300 mg) by mouth, once every 7 days until your injections resume.
If you have missed your planned injection appointment, talk to your healthcare professional right away.

Possible side effects from using Yeytuo:

These are not all the possible side effects you may have when taking Yeytuo. If you experience any side effects not listed here, tell your healthcare professional.

The most common side effect of Yeytuo is injection site reactions. It is expected that injectable products may cause injection site reactions. These may include a bump, pain, redness, skin hardening, swelling, bruising, itching, or warmth. Other side effects include headaches.

As Yeytuo injections forms a collection of medicine under the skin that is slowly released over time, you may develop a bump at the injection site.

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

Reporting Side Effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

Visiting the Web page on Adverse Reaction Reporting (canada.ca/drug-device-reporting) for information on how to report online, by mail or by fax; or
Calling toll-free at 1-866-234-2345.

NOTE: Contact your healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

Storage:

Store Yeytuo injections and Yeytuo tablets below 30 °C in their original package. Protect from light.
The expiry date refers to the last day of that month. Do not use this medicine after the listed expiry date.

Keep out of reach and sight of children.

If you want more information about Yeytuo:

Talk to your healthcare professional.
Find the full product monograph that is prepared for healthcare professionals and includes the Patient Medication Information by visiting the Health Canada Drug Product Database website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website (www.gilead.ca), or by calling 1-866-207-4267.

Date of Authorization: 2026-04-09

Gilead Sciences Canada, Inc.

Mississauga, ON L5N 7K2

YEYTUO^TM, DESCOVY^®, TRUVADA^®are trademarks of Gilead Sciences, Inc. or its related companies.

All other marks referenced herein are the property of their respective owners.

e292258-GS-000

Yeytuo: Uses, Side Effects and Dosage