Drug information
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What are the most important things to know about lenacapavir? What are the most important things to know about lenacapavir?
What are the most important things to know about lenacapavir?
Lenacapavir can cause serious side effects. These include changes in your immune system, called immune reconstitution syndrome or IRIS. IRIS is a condition that sometimes occurs when the immune system begins to recover after treatment with an HIV medicine. As the immune system gets stronger, it may have an increased response to a previously hidden infection.
Contact your health care provider right away if you start having any new symptoms after starting lenacapavir.
While taking lenacapavir, it is important to keep all of your appointments with your health care provider.
What is lenacapavir?What is lenacapavir?
What is lenacapavir?
Lenacapavir (brand name: Sunlenca) is a prescription medicine approved by the U.S. Food and Drug Administration (FDA) for the treatment of HIV infection in adults for whom other HIV medicines have not worked and who meet certain requirements, as determined by a health care provider. Lenacapavir is always used in combination with other HIV medicines.
For more information on the use of lenacapavir in people with HIV, please refer to the Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents with HIV.
HIV medicines cannot cure HIV/AIDS, but taking HIV medicines every day helps people with HIV live longer, healthier lives. HIV medicines also reduce the risk of HIV transmission. If you are taking HIV medicines, do not cut down on, skip, or stop taking them unless your health care provider tells you to.
What should I tell my health care provider before using lenacapavir?What should I tell my health care provider before using lenacapavir?
What should I tell my health care provider before using lenacapavir?
Before using lenacapavir, tell your health care provider:
- If you are allergic to lenacapavir or any other medicines.
- If you have any other medical conditions.
- If you are pregnant or plan to become pregnant. Talk to your health care provider about the risks and benefits of using lenacapavir during pregnancy.
- If you are breast/chestfeeding or plan to breast/chestfeed. For people with HIV in the United States, the Guideline recommends speaking with your health care provider to discuss options for feeding your baby. People with suppressed viral load have a less than 1% chance of transmitting HIV to their baby via their own milk.
- If you are using hormone-based birth control (such as pills, implants, or vaginal rings). For more information about using birth control and HIV medicines at the same time, view the HIVinfo HIV and Birth Control infographic.
- About other prescription and nonprescription medicines, vitamins, nutritional supplements, and herbal products (including St. John's wort) you are taking or plan to take. Lenacapavir may affect the way other medicines or products work, and other medicines or products may affect how lenacapavir works. Using lenacapavir together with certain medicines or products may cause serious side effects.
How should I use lenacapavir?How should I use lenacapavir?
How should I use lenacapavir?
Lenacapavir comes in the following forms and strengths:
- 300 mg tablets
- 463.5-mg/1.5-mL single-dose vials of injectable solution
Use lenacapavir according to your health care provider's instructions. Do not miss a dose of lenacapavir, and do not change your dose or stop using lenacapavir without first talking with your health care provider.
Take lenacapavir tablets with or without food.
Initially, treatment with lenacapavir involves taking oral tablets in addition to receiving subcutaneous (SC) injections of lenacapavir given by a health care provider. There are two options for starting treatment with lenacapavir. A health care provider will decide which option is for you. After initiation, you will then receive lenacapavir SC injections every 6 months.
It is important that you attend your planned appointments to receive your injections of lenacapavir. If you miss a scheduled injection appointment, call your health care provider right away to discuss treatment options. If you stop treatment with lenacapavir, you will need to take other medicines to treat your HIV infection and reduce the risk of developing resistance.
If lenacapavir is discontinued, it may remain in your body and affect certain other drugs for up to 9 months after receiving your last injection.
Always use lenacapavir in combination with other HIV medicines.
If you have taken too much lenacapavir, contact your health care provider or local poison control center (1-800-222-1222 or online) right away, or go to the nearest hospital emergency room.
For more information on how to use lenacapavir, see the FDA drug label.
What should I do if I forget a dose?What should I do if I forget a dose?
What should I do if I forget a dose?
If you miss a dose of lenacapavir oral tablets, take the missed dose as soon as you remember it. But if it is almost time for your next dose, skip the missed dose and just take your next dose at the regular time. Do not take two doses at the same time to make up for a missed dose.
If you miss your scheduled lenacapavir injection appointment, call your health care provider right away to discuss your treatment options.
What side effects can lenacapavir cause?What side effects can lenacapavir cause?
What side effects can lenacapavir cause?
Lenacapavir may cause side effects. Some side effects of lenacapavir can be serious as noted above. Many side effects from HIV medicines, such as nausea or occasional dizziness, are manageable. See the HIVinfo fact sheet on HIV Medicines and Side Effects for more information.
Other possible side effects of lenacapavir injections include injection site reactions. This can cause swelling, redness, pain or discomfort, itching, hardened skin, or a small mass or lump. If you develop hardened skin or a lump, it may take longer than other reactions at the injection site to go away, and the injection site may not completely heal on its own. If the injection site reaction is severe or if you have an injection site reaction that does not go away within a few days or gets worse, contact your health care provider right away.
Tell your health care provider if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of lenacapavir. To learn more about possible side effects of lenacapavir, read the drug label or package insert or talk to your health care provider or pharmacist.
You can report side effects to FDA at 1-800-FDA-1088 (1-800-332-1088) or online.
How should lenacapavir be stored?How should lenacapavir be stored?
How should lenacapavir be stored?
- Store lenacapavir tablets at room temperature, 68°F to 77°F (20°C to 25°C).
- Keep lenacapavir tablets in their original blister pack. The blister pack is packaged with a small packet of drying agent (called a desiccant); do not remove it. The desiccant protects the medicine from moisture.
- Do not use lenacapavir if the original seal over the blister pack opening is broken or missing.
- Throw away lenacapavir that is no longer needed or expired (out of date). Follow FDA guidelines on how to safely dispose of unused medicine.
- Keep lenacapavir and all medicines out of reach of children.
Where can I find more information about lenacapavir?Where can I find more information about lenacapavir?
Where can I find more information about lenacapavir?
- For more information on the use of lenacapavir in people with HIV, please refer to the Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents with HIV.
- This Patient Version drug summary is based on the following FDA label(s): Tablet (film coated), kit. The Patient Package Insert includes information for people using lenacapavir.
- The American Hospital Formulary Service (AHFS) Patient Medication Information for lenacapavir oral and lenacapavir injection available from MedlinePlus.
- Lenacapavir-related research studies, from ClinicalTrials.gov. (The ClinicalTrials.gov search can be modified so that you can get results that better match your interests.)
- A list of FDA-approved HIV medicines, from HIVinfo.
Manufacturer Information
Gilead Sciences, Inc.
Main number: 800-445-3235
Patient assistance: 800-226-2056
Last Reviewed: January 7, 2024