Your schedule is important
Sticking to your injection schedule is key for the medication to keep working.
What to know as you go
Understand what to expect before, during, and after your YEZTUGO® (lenacapavir) appointments so you can be prepared all along the way.
Talk to your healthcare provider to learn more about YEZTUGO.
Quick overview of the YEZTUGO experience
YEZTUGO is a prescription medicine used as HIV-1 PrEP to reduce the risk of getting HIV-1 in adults and adolescents who weigh at least 77 pounds. You must be HIV negative before and while receiving YEZTUGO.
PrEP stands for pre-exposure prophylaxis. It's a prescription medicine you take before you come in contact with HIV. Routinely taking PrEP helps protect against HIV through sex.
YEZTUGO is given every 6 months
YEZTUGO is given by your healthcare provider every 6 months (2 injections per visit, after starter dosing). When you first start YEZTUGO, starter dosing includes 2 pills and 2 injections at your provider's office and 2 more pills the next day at home. (No pills after initial 2-day dosing).
Support is available
The Ready to Go™ program is available to help you stay informed and ready throughout your YEZTUGO experience.
Keep your provider informed
Sharing updates about your latest health, any side effects, and any medication changes with your healthcare provider helps them understand your experience and support your care.
Get ready with this pre-appointment checklist
Whether you're just starting YEZTUGO or returning for ongoing injections, make sure you are prepared with the following information:
Your insurance card, or cards
if your medical and prescription benefits are separate, especially if your coverage has changed since your last appointment.
Recent negative HIV test result.
Before each injection visit, talk to your healthcare provider about HIV testing. You must be HIV-1 negative to receive YEZTUGO.
A list of all the medicines
and supplements you are currently taking. Some medicines may interact with YEZTUGO. Also be prepared to share your sexual health history and overall health with your provider.
A date that works best
for your next injection appointment in 6 months. Your next appointment can be scheduled up to 2 weeks before—or 2 weeks after—your 6-month mark.
More helpful reminders
Your healthcare team may request additional information before your next appointment. During or after your appointments, you can ask your provider any questions you have about your YEZTUGO injection experience or follow-up care.
If you think you may miss your next scheduled appointment,
contact your healthcare provider right away to discuss your options.
What happens on injection days
YEZTUGO dosing
When you start YEZTUGO, your first doses include:
- 2 pills and 2 injections at your healthcare provider’s office
- 2 more pills the next day at home
After that, you’ll receive injections every 6 months
Starter doses are required when you begin YEZTUGO and pills should be taken as your healthcare provider tells you. If you miss taking your pills on Day 2, take them as soon as possible. Your Day 1 and Day 2 pills should not be taken on the same day. Talk to your healthcare provider if you have any questions or concerns.
It is important to continue receiving YEZTUGO as scheduled. Missing YEZTUGO injections or pills may increase your chance of getting HIV-1.
Starter & ongoing appointments
1
You check in at the office
Your healthcare provider will make sure you’re ready, confirm your HIV-negative status, and answer any questions you may have.
2
Your dose is prepared
Your care team gets everything prepared for you to receive YEZTUGO.
If this is your starter appointment (first YEZTUGO visit), you will take 2 pills and receive 2 injections. Your healthcare provider will give you 2 more pills to be taken at home the next day.
If this is an ongoing appointment and you already had your starter dosing, you will only get 2 injections given by your healthcare provider.
3
Injection sites are selected
You and your healthcare provider will choose the injection site together. The injections reach a short distance under your skin (subcutaneous injection) and are given in your abdomen or thigh.
4
You receive your injections
Your healthcare provider will give you 2 injections. You may experience some discomfort where the injection is given. You should talk to your healthcare provider about ways to help address this before and after your injections, which could include the use of ice packs and/or pain relief medications.
Please note, these considerations are not specific to YEZTUGO.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
Be sure to schedule your next appointment
Before you leave the office, it’s a great idea to schedule your next 6-month appointment, including HIV testing.
After each appointment
Not everyone will have the same experience with YEZTUGO injections. A bump is one possible injection site reaction—the body's response to an injection. Some people may feel a bump at the injection site, and some people may see it. This is part of how the long-acting medicine works. Talk to your healthcare provider if you have any questions or concerns.
The most common side effects* among people taking YEZTUGO in clinical trials
PURPOSE 1 and PURPOSE 2 were two randomized, double-blinded studies where more than 6400 people were given either YEZTUGO or a daily PrEP pill (FTC/TDF). The most common side effects in ≥2% of people taking YEZTUGO through one year include†:
Side Effect
PURPOSE 1
YEZTUGO (N=2140)
A daily PrEP pill (FTC/TDF)‡(N=1070)
PURPOSE 2
YEZTUGO (N=2183)
A daily PrEP pill (FTC/TDF)‡(N=1088)
Injection site reactions
69%
34%
83%
69%
Headache
7%
8%
2%
2%
Nausea
5%
11%
2%
4%
Dizziness
4%
6%
<1%
1%
Vomiting
4%
7%
<1%
1%
Diarrhea
4%
4%
2%
2%
PURPOSE 1
Side effect
YEZTUGO(N=2140)
A daily PrEP pill (FTC/TDF)‡(N=1070)
Injection site reactions
69%
34%
Headache
7%
8%
Nausea
5%
11%
Dizziness
4%
6%
Vomiting
4%
7%
Diarrhea
4%
4%
PURPOSE 2
Side effect
YEZTUGO(N=2183)
A daily PrEP pill (FTC/TDF)‡(N=1088)
Injection site reactions
83%
69%
Headache
2%
2%
Nausea
2%
4%
Dizziness
<1%
1%
Vomiting
<1%
1%
Diarrhea
2%
2%
Injection site reactions in ≥2% of people taking YEZTUGO included a bump, pain, skin hardening, swelling, itching, redness, bruising, or warmth.
There were no serious injection site reactions.
In each of the 2 studies:
About 1 out of 3 people who received YEZTUGO did not feel or see a bump
- PURPOSE 1: 64% of people who received YEZTUGO noticed a bump vs 17% with placebo injections
- PURPOSE 2: 63% of people who received YEZTUGO noticed a bump vs 39% with placebo injections
These bumps (and other injection site reactions) became less common with later shots of YEZTUGO.
*These are not the only possible side effects.
†Researchers looked at how well YEZTUGO worked in a planned early analysis once 50% of the people had been in the study for a year.
‡FTC/TDF=emtricitabine/tenofovir disoproxil fumarate. People taking FTC/TDF also received placebo injections.
§<1% of people in each study stopped FTC/TDF due to side effects.
Things to keep in mind
after each appointment
Be sure to follow your YEZTUGO dosing schedule every 6 months. Missing scheduled doses can increase your chances of getting HIV.
If you miss or need to delay
your scheduled YEZTUGO appointment by more than 2 weeks, call your healthcare provider right away to discuss your options
IMPORTANT SAFETY INFORMATION
YEZTUGO (lenacapavir) injection, 463.5 mg/1.5 mL, is a prescription medicine that is used as HIV-1 PrEP (pre-exposure prophylaxis) to reduce the risk of getting HIV-1 in adults and adolescents who weigh at least 77 pounds (at least 35 kg). You must be HIV negative before and while receiving YEZTUGO.
What is the most important information I should know about YEZTUGO?
Before and while receiving YEZTUGO:
- You must be HIV negative before you start and while receiving YEZTUGO. Get an HIV test before starting, before each injection, and when your healthcare provider tells you. If you think you were exposed to HIV while receiving YEZTUGO, talk to your healthcare provider as you may need an HIV test.
- Some HIV tests may not detect HIV in a person who recently acquired HIV. Tell your healthcare provider if you had a flu-like illness within the last month before starting or while receiving YEZTUGO. Symptoms of new HIV infection include tiredness, fever, joint or muscle aches, headache, sore throat, vomiting or diarrhea, rash, night sweats, and/or enlarged lymph nodes in the neck or groin.
- YEZTUGO does not prevent other sexually transmitted infections (STIs). Get tested for other STIs and practice safer sex by using condoms to reduce the risk of getting STIs.
- YEZTUGO is not approved to treat HIV. You must immediately take other medicines if you get HIV. If you have HIV and only receive YEZTUGO, your HIV may become harder to treat.
- Follow the YEZTUGO dosing schedule, which includes returning to a healthcare provider for your scheduled injections every 6 months. Missing scheduled injections or tablets can increase your chances of getting HIV.
- To further help reduce your risk of getting HIV:
- Know your HIV status and the HIV status of your partner(s). If they are living with HIV, your risk of getting HIV is lower if they are taking effective HIV treatment.
- Talk to your healthcare provider about all the ways to help reduce the risk of getting HIV.
Who should not receive or take YEZTUGO?
- Do not receive YEZTUGO if you already have HIV or do not know your HIV status. If you have HIV, you will need to take other medicines to treat it. YEZTUGO is not approved to treat HIV and is only for reducing the risk of getting HIV before you get it.
What are the possible side effects of YEZTUGO?
- The most common side effects of YEZTUGO are injection site reactions, headache, and nausea. These are not the only possible side effects.
- Reactions at the injection site may include a lump or bump, pain, skin hardening, swelling, itching, redness, bruising, or warmth.
- Rarely, if YEZTUGO is injected incorrectly, serious injection site reactions, like severe damage of the skin or open sores, can occur.
- Tell your healthcare provider if you have any injection site reactions or other side effects that bother you or don’t go away.
What should I tell my healthcare provider before receiving YEZTUGO?
- All your medical conditions.
- If you are pregnant or plan to become pregnant. Tell your healthcare provider if you become pregnant while or after receiving YEZTUGO.
- If you are breastfeeding or plan to breastfeed. Talk to your healthcare provider about the best way to feed your baby while you are receiving YEZTUGO.
- All the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. YEZTUGO can remain in your body for up to 9 months after your last injection and can affect other medicines. Keep a list of all your medicines and show it to your healthcare provider and pharmacist. Do not start a new medicine without telling your healthcare provider.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
Please see Important Facts about YEZTUGO, including important warnings.
YEZTUGO (lenacapavir) injection, 463.5 mg/1.5 mL, is a prescription medicine that is used as HIV-1 PrEP (pre-exposure prophylaxis) to reduce the risk of getting HIV-1 in adults and adolescents who weigh at least 77 pounds (at least 35 kg). You must be HIV negative before and while receiving YEZTUGO.