Sunlenca: Uses, Side Effects and Dosage

What is Sunlenca used for?

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

• people living with HIV-1 aged 18 years or older, and
• who have received HIV-1 medicines in the past, and
• have HIV-1 virus that is resistant to many HIV-1 medicines, and
• need to change their current HIV-1 medicines. You may need to change HIV-1 medicines because they are not working or no longer work, you are not able to tolerate the side effects, or there are other safety reasons why you cannot take them.

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

How does Sunlenca work?

• Sunlenca contains the active ingredient lenacapavir, a long-acting medicine to treat HIV-1 infection. This is an antiretroviral medicine known as a capsid inhibitor. It works by binding to the virus, and at multiple steps of the virus lifecycle, stops the HIV from making more copies of itself in the body.
• Sunlenca reduces the amount of HIV in your body and keeps it at a low level.
• Sunlenca also increases the CD4+ (T) cell count in your blood. CD4 cells are white blood cells that are important in helping your body to fight infection. This will improve the immune system and reduce the risk of developing illnesses linked to HIV infection.

What are the ingredients in Sunlenca?

Sunlenca injection

Medicinal ingredients: lenacapavir (as lenacapavir sodium)

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

Sunlenca tablets

Medicinal ingredients: lenacapavir (as lenacapavir sodium)

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.

Sunlenca is available as:

• Solution for injection, 463.5 mg/1.5 mL (309 mg/mL) of lenacapavir (equivalent to 473.1 mg/1.5 mL of lenacapavir sodium). The solution is clear and yellow to brown with no visible particles.
• Tablets, 300 mg of lenacapavir (equivalent to 306.8 mg lenacapavir sodium). The tablets are beige and capsule shaped.

Do not use Sunlenca if:

• you are allergic to lenacapavir or any of the other ingredients of this medicine (listed in What are the ingredients in Sunlenca?)
• you are currently taking rifampin (Rifadin^®, Rifater^®, Rofact^®) used to treat some bacterial infections such as tuberculosis.
• 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.
• you are currently taking rifapentine, an antibiotic.

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

• have liver problems
• have kidney problems

• are pregnant or plan to become pregnant. It is not known if Sunlenca can harm your unborn baby. Tell your health professional if you become pregnant during treatment with Sunlenca.

  Pregnancy Registry: There is a pregnancy registry for women who take Sunlenca during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Talk with your health professional about how you can take part in this registry.

• are breastfeeding or plan to breastfeed. Do not breastfeed if you take Sunlenca.

  • You should not breastfeed if you have HIV-1 because of the risk of passing HIV-1 to your baby.
  • It is not known if Sunlenca can pass to your baby in your breast milk. Talk with your health professional about the best way to feed your baby.

Other warnings you should know about:

Injection Site Reactions: Your health professional will administer Sunlenca injections. Improper administration of this product may result in serious injections site reactions such as:

• More pain, tenderness and discomfort than expected
• Change in skin color (bluish or purple)
• Developing a sore that takes a long time to heal
• Infection

Talk to your health professional if you experience signs of serious injection site reactions.

Changes in your immune system (Immune Reconstitution Inflammatory 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. Autoimmune disorders (when the immune system attacks healthy body tissue), may also occur after you start taking medicines for HIV infection. Examples of this include: Grave's disease (which affects the thyroid gland), Guillain-Barré syndrome (which affects the nervous system), or polymyositis (which affects the muscles). Autoimmune disorders may occur many months after the start of treatment.

Sunlenca is a long-acting medicine. If after talking to your health professional you decide to stop your treatment or switch to another, you should know low levels of lenacapavir can remain in your system for many months after your last injection. These low remaining levels should not affect other antiretroviral medicines that you take afterwards to treat your HIV infection. Some other medicines however may be affected by the low levels of lenacapavir in your system if you take them within 9 months after your last Sunlenca injection. You should check with your health professional if such medicines are safe for you to take after you stop treatment with Sunlenca.

Regular appointments are important

It is important that you attend your planned appointments every 6 months to receive your Sunlenca injection to control your HIV infection, and to stop your illness from getting worse.

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

Sunlenca may interact with other medicines. As a result, the amounts of Sunlenca 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 health professional may need to adjust your dose or check your blood levels.

The following may interact with Sunlenca:

• antibiotics containing:

  • rifabutin

• anticonvulsants used to treat epilepsy and prevent seizures (fits), containing:

  • oxcarbazepine or phenobarbital

• medicines used to treat HIV, containing:

  • atazanavir/cobicistat, efavirenz, nevirapine or tipranavir/ritonavir

• 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

How to take Sunlenca:

Talk to your health professional before taking Sunlenca tablets. Your health professional will tell you when to take Sunlenca tablets.

Treatment starts with Sunlenca tablets that you take by mouth and Sunlenca injections given by your health professional. Treatment then continues with Sunlenca injections twice a year (every 6 months) given by your health professional.

• You need to take Sunlenca with other HIV-1 medications.

Stay under the care of a health professional during treatment with Sunlenca. It is important that you attend your planned appointments to receive your injections of Sunlenca once every 6 months (26 weeks).

If you miss your scheduled injection appointment, call your health professional right away to discuss your treatment options.

If you stop treatment with Sunlenca you will need other medicines to treat your HIV-1 infection. 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. Call your health professional right away to discuss your treatment options.

Usual dose:

• The usual dose of Sunlenca tablets is two tablets (600 mg) by mouth on treatment Day 1 and Day 2, followed by one tablet (300 mg) by mouth on treatment Day 8. You may take Sunlenca tablets with or without food.

• The usual dose of Sunlenca injection is two injections (927 mg) into your abdomen (stomach) given by your health professional on treatment Day 15 and then every 6 months (26 weeks) from the date of the last injection.

Overdose:

Missed Dose:

If you miss a Sunlenca injection

• It is important that you attend your planned appointments to receive your injections of Sunlenca every 6 months. This will help to control your HIV infection and to stop your illness getting worse.
• If you think you will not be able to attend your injection appointment, call your health professional as soon as possible to discuss your treatment options.

If you miss a Sunlenca tablet

• It is important not to miss a dose of Sunlenca tablets.
• If you forget to take your tablets on Day 1, Day 2, or Day 8, contact your health professional or pharmacist immediately.
• If you vomit (throw up) within 3 hours after taking Sunlenca tablets, contact your health professional immediately. If you vomit more than 3 hours after taking Sunlenca, you do not need to take more tablets to replace the dose.

What are possible side effects from using Sunlenca?

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

The most common side effects of Sunlenca are nausea (feeling sick) and side effects at the injection site (including pain and inflammatory reactions such as redness, swelling and itching).

Less common side effects include:

• Diarrhea
• Vomiting
• Muscle aches and pain
• Headache
• Sleepiness
• Rash

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 health professional.

Reporting Side Effects

Storage:

Sunlenca tablets: Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of that month.

Sunlenca injection: Do not use this medicine after the expiry date which is stated on the vial label and carton after EXP. The expiry date refers to the last day of that month.

Store in the original package. Store below 30 °C. Protect from light.

Keep out of reach and sight of children.

If you want more information about Sunlenca:

• Talk to your health professional
• Find the full product monograph that is prepared for health professionals and includes this Patient Medication Information by visiting the Health Canada 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: 2026-08-12

Gilead Sciences, Inc.

Foster City, CA 94404

USA

Gilead Sciences Canada, Inc.

Mississauga, ON L5N 7K2

Sunlenca^® is a trademark of Gilead Sciences, Inc. or its related companies.

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

© 2026 Gilead Sciences, Inc. All rights reserved.

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