Yeztugo® (lenacapavir)
How should I take YEZTUGO?
Gilead Sciences, Inc. is providing this letter in response to your unsolicited request for medical information. It is not promotional. It is intended for a US audience 18 years or older.
Gilead Sciences, Inc. is providing this letter in response to your unsolicited request for medical information. It is not promotional. It is intended for a US audience 18 years or older.
YEZTUGO® (lenacapavir)
How should I take YEZTUGO?
This information is provided in response to your question. It is not treatment advice on how to use YEZTUGO. Please discuss this question and others you have about your medical condition or treatment with your healthcare provider.
Download the YEZTUGO Patient Information for more details, including approved use(s) and important warnings: https://www.gilead.com/-/media/files/pdfs/medicines/hiv/yeztugo/yeztugo_patient_pi.pdf
The short answer1
- YEZTUGO is given as injections and tablets.
- On Day 1, you will get 2 injections and take 2 tablets of YEZTUGO.
- On Day 2, you will take 2 tablets of YEZTUGO.
- Then you will get 2 injections of YEZTUGO every 6 months.
- You must be HIV-negative before you start and while taking YEZTUGO. Get tested for HIV-1 when your healthcare provider tells you.
- Follow the dosing plan for YEZTUGO. Missing injections or tablets may increase your chance of getting HIV-1.
- YEZTUGO does not prevent other sexually transmitted infections, or STIs. Practice safe sex to help prevent STIs.
Who is YEZTUGO for?1
YEZTUGO is a prescription medicine that is used for HIV-1 PrEP to reduce the chance of getting HIV-1 from sex in adults and teenagers who weigh at least 77 pounds (35 kg). HIV-1 is the virus that causes Acquired Immune Deficiency Syndrome (AIDS).
| You must be HIV-negative before you start and while taking YEZTUGO. Do not take YEZTUGO if you already have HIV-1 or you do not know your HIV-1 status. |
| Talk to a healthcare provider about your chance of getting HIV and if YEZTUGO is right for you. If you do not have a healthcare provider, the PrEP Locator website (https://www.PrEPLocator.org) can help you find a healthcare provider in your area who has experience prescribing PrEP medications. |
How is YEZTUGO dosed and given?1
YEZTUGO is given as injections and tablets.
Your healthcare provider will give you injections under your skin. You will get the injections in your stomach area (abdomen) or upper leg (thigh). You will take the tablets by mouth, with or without food.
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What is expected of me when receiving YEZTUGO?1
While receiving YEZTUGO:
| Stay under the care of a healthcare provider. |
| Get tested for HIV-1 when your healthcare provider tells you. |
| Tell your healthcare provider right away if you think you were exposed to HIV-1. They may want to do more tests to be sure you do not have HIV-1. |
| Follow the dosing plan. Return to your healthcare provider for your planned injections of YEZTUGO every 6 months. Missing injections or tablets increases your chance of getting HIV-1. If you are not able to visit your healthcare provider to get the injections as planned, call them right away to discuss your PrEP options. |
| 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 does not prevent other STIs. Practice safe sex by using latex or polyurethane condoms to reduce the risk of getting STIs. |
Talk to your healthcare providers if you stop receiving YEZTUGO. They can tell you about other options to reduce the chance of getting HIV-1.
If you take too many YEZTUGO tablets, call your healthcare provider or go to the nearest hospital emergency room right away.
What if I miss my Day 2 tablets of YEZTUGO?1
If you miss the Day 2 tablets, take it as soon as possible. Do not take Day 1 and Day 2 tablets on the same day.
What if I miss my planned injections of YEZTUGO?1
It is important that you get your injections of YEZTUGO every 6 months. If you miss or plan to miss your scheduled injection by more than 2 weeks, talk with your healthcare provider right away to discuss your PrEP options.
- You may be able to take YEZTUGO tablets until you can restart injections.
- You may need to repeat the starting doses of YEZTUGO tablets and injections. Your health care provider will let you know.
| It is important to continue receiving YEZTUGO as scheduled. Missing YEZTUGO injections or tablets may increase your chance of getting HIV-1. |
What if I start a medication that may interact with YEZTUGO?
It is important to tell your health care provider about all the medications you are currently taking. Tell your healthcare provider of any medication or supplement that you plan to start while taking YEZTUGO. Depending on the medication, your healthcare provider may need to supplement your YEZTUGO dose.
What do I need to know before I am given YEZTUGO?1
You must get tested to make sure that you do not have HIV-1. You must be HIV‑negative before you start and while receiving YEZTUGO. YEZTUGO is not approved for treatment of HIV-1.
Some HIV tests can miss HIV-1 status in a person who has only recently gotten HIV. If you have flu-like symptoms, you could have recently gotten 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 it.
Tell your healthcare provider about all the medicines you take, including
- Prescription medicines
- Over-the-counter medicines
- Vitamins
- Herbal supplements, including St. John’s wort
YEZTUGO may affect some medicines for up to 9 months after your last YEZTUGO injection.
Glossary
AIDS (Acquired Immunodeficiency Syndrome): most advanced stage of HIV infection.
HIV (Human Immunodeficiency Virus): HIV is a virus that attacks the body’s immune system. If HIV is not treated, it can lead to AIDS (acquired immunodeficiency syndrome).
Pre-exposure prophylaxis (PrEP): means routinely taking prescription medicine before you're exposed to HIV to help reduce your chances of getting it.
Sexually transmitted infection (STI): A sexually transmitted infection which can be spread through skin-to-skin contact and body fluids during oral, vaginal, and anal sex.
Reference
- Enclosed, Gilead Sciences Inc. YEZTUGO® (lenacapavir) tablets, for oral use. YEZTUGO® (lenacapavir) injection, for subcutaneous use. U.S. Prescribing Information. Foster City, CA.
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More information about YEZTUGO
If you would like more detailed information about YEZTUGO, please visit: https://www.gilead.com/-/media/files/pdfs/medicines/hiv/yeztugo/yeztugo_pi.pdf
This is the US FDA-approved Prescribing Information, including the Patient Labeling, for YEZTUGO. It will tell you about the uses, warnings, and other important safety information about YEZTUGO.
Important note
Gilead Sciences, Inc. is providing this letter in response to your unsolicited request for medical information. Some of the information included in this letter may not be covered in the US FDA- approved Prescribing Information for YEZTUGO. Gilead Sciences, Inc. does not intend this letter to be used as medical advice and does not promote use of YEZTUGO in a way that has not been approved by the FDA. Please discuss this question and others you may have about your medical condition or treatment with your healthcare provider.
Follow-Up
For any additional questions, please contact Gilead Medical Information at:
☎1‐866‐MEDI‐GSI (1‐866‐633‐4474) or https://www.patient.askgileadmedical.com/
Reporting side effects
Please report all adverse events to:
Gilead Global Patient Safety ☎ 1-800-445-3235, option 3 or
www.gilead.com/utility/contact/report-an-adverse-event
FDA MedWatch Program by ☎ 1-800-FDA-1088 or MedWatch, FDA, 5600 Fishers Ln, Rockville, MD 20852 or www.accessdata.fda.gov/scripts/medwatch
Data Privacy
The Medical Information service at Gilead Sciences may collect, store, and use your personal information to provide a response to your medical request. We may share your information with other Gilead Sciences colleagues to ensure that your request is addressed appropriately. If you report an adverse event or concern about the quality of a Gilead or Kite product, we will need to use the information you have given us in order to meet our regulatory requirements in relation to the safety of our medicines.
It may be necessary for us to share your information with Gilead’s affiliates, business partners, service providers, and regulatory authorities located in countries besides your own. Gilead Sciences has implemented measures to protect the personal information you provide. Please see the Gilead Privacy Statement (www.gilead.com/privacy-statements) for more information about how Gilead handles your personal information and your rights. If you have any further questions about the use of your personal information, please contact privacy@gilead.com.
YEZTUGO, GILEAD, and the GILEAD logo are registered trademarks of Gilead Sciences, Inc., or its related companies.
© 2025 Gilead Sciences, Inc.
Do you want to report a side effect or other concern about a Gilead medicine?
Report side effects
To report a side effect or unexpected reaction (sometimes called an “adverse event”) please call 1-800-445-3235 (option #3), available 24 hours a day, 7 days a week.
Product complaints
To report issues with our products, like defects or package errors, please call 1-800-445-3235 (option #2) available Monday – Friday, 8am – 5pm PT, or email QualityComplaints@gilead.com.
FDA MedWatch
To report a side effect or product quality concern directly to the U.S. Food and Drug Administration (FDA), please call 1-800-FDA-1088 or email www.fda.gov/MedWatch.
You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns at 1-800-FDA-1088 or www.fda.gov/MedWatch.