Sunlenca is a prescription medicine that is used with other human immunodeficiency virus-1 (HIV-1) medicines to treat HIV-1 infection in adults. HIV-1 is the virus that causes Acquired Immune Deficiency Syndrome (AIDS).

Sunlenca belongs to a new class of drugs called capsid inhibitors. Capsid inhibitors work by interfering with HIV capsid, a protein shell that protects the genetic material of the HIV virus and the enzymes needed for replication.

Sunlenca is designed to inhibit HIV-1 at multiple stages of its lifecycle and may work against HIV strains that are resistant to other HIV drugs.

Sunlenca is currently the only HIV-1 treatment option to be administered twice-yearly.

What is Sunlenca used to treat?

Sunlenca is used to HIV-1 infection in heavily treatment-experienced (HTE) adults with multi-drug resistant (MDR) HIV-1 infection. This means people 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.

HIV-1 medicines may be considered to be failing when your HIV-1 medicines are not working or no longer work, or you are not able to tolerate the side effects, or there are safety reasons why you cannot take them.

It is not known if this medicine is safe and effective in children.

• 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 two options (Option 1 and Option 2) to start treatment. Your healthcare provider will decide which starting option is for you.
  • If Option 1 is chosen:
    • On Day 1, you will receive 2 injections and take 2 tablets.
    • On Day 2, you will take 2 tablets.
  • If Option 2 is chosen:
    • On Day 1 and Day 2, you will take 2 tablets each day.
    • On Day 8, you will take 1 tablet.
    • On Day 15, you will receive 2 injections.
• After completing Option 1 or Option 2, you will receive 2 injections every 6 months (26 weeks) from the date of your last injection.
• Stay under the care of a healthcare provider during treatment. It is important that you attend your planned appointments to receive your injections.
• If you miss your scheduled injection appointment, call your healthcare provider right away to discuss your treatment options. Missing an injection may cause the HIV-1 virus to change (mutate) and become harder to treat (resistant).
• Tell your healthcare provider right away if you stop receiving Sunlenca or stop taking any other antiretroviral medicines. 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 healthcare provider right away to discuss your treatment options.
• If you take too many tablets, call your healthcare provider or go to the nearest hospital emergency room right away.

Usual Adult Dose for HIV-1 Infection

Initiation with one of two options followed by once every 6-months maintenance dosing.

Comment: Missed dose - If more than 28 weeks since last injection and clinically appropriate to continue Sunlenca, restart initiation from Day 1, using either Option 1 or Option 2.

Use: in combination with other antiretroviral(s) for the treatment of HIV-1 infection in heavily treatment-experienced adults with multidrug resistant HIV-1 infection failing their current antiretroviral regimen due to resistance, intolerance, or safety considerations

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

Before receiving or taking Sunlenca

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

• are pregnant or plan to become pregnant. It is not known if Sunlenca can harm your unborn baby. Tell your healthcare provider if you become pregnant during treatment.
  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 healthcare provider 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 this medicine can pass to your baby in your breast milk.
  • Talk with your healthcare provider about the best way to feed your baby during treatment.

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 start having 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 have any injection site reactions.

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

These are not all of the possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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 complete 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 take Sunlenca with other medicines.
• Sunlenca may affect certain other medicines for up to 9 months after your last injection.

Do not receive or take Sunlenca if you also take certain other medicines called strong CYP3A inducers.

Examples of strong CYP3A inducers include:

• carbamazepine
• dexamethasone
• enzalutamide
• fosphenytoin
• ivosidenib
• lumacaftor and lumacaftor/ivacaftor
• mitotane
• phenobarbital
• phenytoin
• primidone
• rifampin
• rifabutin
• St. John’s wort