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Sunlenca (Lenacapavir sodium): Uses, Side Effects and Dosage

Updated:
Facts
Status:
Prescription (Rx)
Strength:
300 mg, 463.5 mg/1.5 mL
Other brand names:
Drug class:
Active ingredient:
Similar drugs:

Source: FDA drug labeling via NLM DailyMed · About this document

Patient information: uses, side effects, how to take - Sunlenca

What is SUNLENCA?

SUNLENCA is a prescription medicine that is used with other human immunodeficiency virus-1 (HIV-1) medicines to treat HIV-1 in adults:

  • who have received HIV-1 medicines in the past, and
  • who have HIV-1 virus that is resistant to many HIV-1 medicines, and
  • whose current HIV-1 medicines are failing. Your HIV-1 medicines may be failing because the HIV-1 medicines are not working or no longer work, you are not able to tolerate the side effects, or there are safety reasons why you cannot take them.

OR,

  • SUNLENCA tablets are used in adults when starting treatment with the prescription HIV-1 medicine called BIXLENVO.

HIV-1 is the virus that causes Acquired Immune Deficiency Syndrome (AIDS).

It is not known if SUNLENCA is safe and effective in children.

Do not receive or take SUNLENCA if you take certain other medicines called strong CYP3A inducers. Ask your healthcare provider if you are not sure.

Before receiving or taking SUNLENCA, tell your healthcare provider about all your medical conditions, including if you:

  • are pregnant or plan to become pregnant.

    • Tell your healthcare provider if you become pregnant during treatment with SUNLENCA.
    • Pregnancy Exposure Registry: There is a pregnancy exposure registry for women who receive or take SUNLENCA during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Talk with your healthcare provider about how you can take part in this registry.

  • are breastfeeding or plan to breastfeed. A small amount of SUNLENCA is present in breast milk. Talk with your healthcare provider about the following risks to your baby from breastfeeding during treatment with SUNLENCA:

    • The HIV-1 virus may pass to your baby if your baby does not have HIV-1.
    • The HIV-1 virus may become harder to treat if your baby has HIV-1.
    • Your baby may get side effects from SUNLENCA.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements, including St. John's wort.

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

How should I receive and take SUNLENCA?

If you are receive or take SUNLENCA for the treatment of HIV-1 (not for starting treatment with BIXLENVO):

  • Your SUNLENCA treatment will consist of injections and tablets.

    • SUNLENCA injections will be given to you by your healthcare provider under the skin (subcutaneous injection) in your stomach-area (abdomen).

    • Take SUNLENCA tablets by mouth, with or without food.

  • There are 2 options (Option 1 and Option 2) to start treatment with SUNLENCA. Your healthcare provider will decide which starting option is for you.

    • If Option 1 is chosen:

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

    • If Option 2 is chosen:

      • On Day 1 and Day 2, you will take 2 SUNLENCA tablets each day.
      • On Day 8, you will take 1 SUNLENCA tablet.
      • On Day 15, you will receive 2 SUNLENCA injections.
  • After completing Option 1 or Option 2, you will receive 2 SUNLENCA injections every 6 months (26 weeks) from the date of your last injection.
  • Stay under the care of a healthcare provider during treatment with SUNLENCA. It is important that you attend your planned appointments to receive your injections of SUNLENCA.

  • If you miss or plan to miss your scheduled every 6 months injection of SUNLENCA by more than 2 weeks, contact your healthcare provider right away to discuss your treatment options.

    • If you plan to miss a scheduled SUNLENCA injection, there is the option to temporarily take SUNLENCA tablets. You will take 1 SUNLENCA tablet by mouth 1 time every 7 days for up to 6 months, until your injections resume.
    • It is important to continue SUNLENCA treatment as your healthcare provider tells you. Missing SUNLENCA treatment may cause the HIV-1 virus to change (mutate) and become harder to treat (resistant).
  • Tell your healthcare provider right away if you stop treatment with SUNLENCA or stop treatment with any other HIV-1 medicines. If you stop treatment with SUNLENCA you will need other medicines to treat your HIV-1. If you do not take other HIV-1 medicines, the amount of virus in your blood may increase and the virus may become harder to treat. Contact your healthcare provider right away to discuss your treatment options.
  • If you take too many SUNLENCA tablets, contact your healthcare provider or go to the nearest hospital emergency room right away.

If you take SUNLENCA tablets for starting treatment with BIXLENVO:

  • Your treatment includes SUNLENCA tablets, for the first 2 days only, and another medicine called BIXLENVO tablets.
  • Take BIXLENVO tablets and SUNLENCA tablets by mouth, with or without food.

  • You dosing schedule will start as follows:

    • On Day 1, you will take 1 BIXLENVO tablet and 2 SUNLENCA tablets.
    • On Day 2, you will take 1 BIXLENVO tablet and 2 SUNLENCA tablets.
    • It is very important that you take BIXLENVO with SUNLENCA on these first 2 days. Contact your healthcare provider if you have questions

  • You dosing schedule will then continue as follows:

    • On Day 3 and each day after, you will take 1 BIXLENVO tablet each day.
  • If you miss a dose of SUNLENCA on Day 1 or Day 2, take it as soon as possible. Do not take Day 1 and Day 2 doses of SUNLENCA on the same day.

What are the possible side effects of SUNLENCA?

SUNLENCA may cause serious side effects, including:

  • Changes in your immune system (Immune Reconstitution Syndrome) can happen when you start taking HIV-1 medicines. Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time. Tell your healthcare provider right away if you develop any new symptoms after starting your HIV-1 medicine.
  • Injection site reactions may happen when you receive SUNLENCA injections and may include swelling, pain, redness, skin hardening, small mass or lump, and itching. Hardened skin or lumps at the injection site usually can be felt but not seen. 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. Tell your healthcare provider if you get any injection site reactions.

The most common side effects of SUNLENCA are nausea and injection site reactions.

These are not all of the possible side effects of SUNLENCA.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store SUNLENCA?

  • Store SUNLENCA tablets at room temperature between 68 °F to 77 °F (20 °C to 25 °C).
  • SUNLENCA 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 SUNLENCA tablets in their original bottle or blister pack.
  • Keep the bottle tightly closed.
  • SUNLENCA bottle has a child resistant cap closure.
  • SUNLENCA blister pack has a sealed child resistant flexible laminated pouch.

Keep SUNLENCA and all medicines out of the reach of children.

General information about the safe and effective use of SUNLENCA.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use SUNLENCA for a condition for which it was not prescribed. Do not give SUNLENCA to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about SUNLENCA that is written for health professionals.

What are the ingredients in SUNLENCA?

Active ingredient: lenacapavir sodium

Inactive ingredients:

SUNLENCA 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.

SUNLENCA injection: polyethylene glycol 300 and water for injection.

Manufactured for and distributed by: Gilead Sciences, Inc. Foster City, CA 94404

SUNLENCA and BIXLENVO are trademarks of Gilead Sciences, Inc., or its related companies. All other trademarks referenced herein are the property of their respective owners.

© 2026 Gilead Sciences, Inc. All rights reserved. 215973-GS-007/IFU-002/IFU-WD-001/IFU-WDS-000

For more information, call 1-800-445-3235 or go to www.SUNLENCA.com.

About this document

Source: FDA drug labeling via NLM DailyMed · Application number: NDA 215974 · View the label on DailyMed

Revision date stated in the text: August 2026

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The information on this site does not replace the advice of a doctor or pharmacist.

Drug information for Sunlenca

Rx or OTC
Prescription (Rx)?
  • This drug is available only with a prescription from a licensed healthcare provider.
  • Rx
Drug class Human Immunodeficiency Virus 1 Capsid Inhibitor
Active ingredient Lenacapavir sodium
Dosage form Tablet, film coated, Kit
Route Oral
Marketing status listed in the FDA NDC Directory
Company (applicant) GILEAD SCIENCES INC
FDA approval NDA 215974New Drug Application (NDA) Approved December 22, 2022
Reference listed drug This is the reference listed drug (RLD) that generics are compared with.
Manufacturers 1 labelers list this drug on DailyMed
Packages (NDC)
Package
300 mg – 4 in 1 blister pack / 1 in 1 pouch / 1 in 1 carton NDC 61958-3001-1
300 mg – 5 in 1 blister pack / 1 in 1 pouch / 1 in 1 carton NDC 61958-3001-2
300 mg – 4 in 1 bottle, plastic NDC 61958-3001-3
463.5 mg/1.5 mL – 1 in 1 carton NDC 61958-3002-1
463.5 mg/1.5 mL – 1 in 1 carton NDC 61958-3005-1

Source: FDA drug labeling via NLM DailyMed, data as of October 31, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.