Sunlenca

Sunlenca is a prescription medicine used to treat HIV-1 infections in adults. Sunlenca injection is used together with other HIV-1 medicines for hard-to-treat HIV-1 when you have received HIV-1 medicines in the past, your HIV-1 virus is resistant to HIV-1 medicines, and the medicines you are currently using are failing. They could be failing as they are no longer working, you have bad side effects, or there is a safety reason why you can not take them. Sunlenca tablets are also used in adults when starting treatment with the prescription HIV-1 medicine called Bixlenvo.

Sunlenca (lenacapavir) injections are given twice a year after a starting dose of Sunlenca pills for a few days.

Sunlenca belongs to a class of drugs called capsid inhibitors.

Sunlenca mechanism of action (MOA) is by interfering with HIV capsid, a protein shell that protects the genetic material of the HIV virus and the enzymes needed for replication. It 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 FDA approval was received on December 22, 2022, for the treatment of human immunodeficiency virus-1 (HIV-1) in adult patients who are:

• heavily treatment-experienced with multidrug-resistant HIV-1 infection and
• are failing their current antiretroviral regimen due to resistance intolerance, or safety considerations.

Sunlenca's FDA approval was granted to Gilead Sciences after positive results from the Phase 2/3 CAPELLA trial (Cohort 1). Key Outcomes at Week 52:

• 83% of patients achieved undetectable viral load (<50 copies/mL)
• Mean CD4 count increased of 82 cells/µL

These results are from patients with multi-drug resistant HIV-1 who were heavily treatment-experienced and evaluated after being on lenacapavir in combination with a background antiretroviral(s) (ARV) regimen.

Lenacapavir for PrEP (prevention of HIV as pre-exposure prophylaxis) has had positive results in clinical trials PURPOSE 1 (NCT04994509) and PURPOSE 2 (NCT04925752). Lenacapavir injections were used twice yearly for HIV prevention among a broad and geographically diverse range of cisgender men and gender-diverse people.

• Lenacapavir reduced HIV infections by 96% compared to background HIV incidence (bHIV).

The FDA has accepted Gilead's New Drug Application (NDA) submissions for lenacapavir to be used for the prevention of HIV as pre-exposure prophylaxis (PrEP). Lenacapavir PDUFA date is June 19, 2025.

If lenacapavir is approved for this use, it will be the first-ever twice-yearly HIV prevention medication.

The start of Sunlenca treatment will consist of injections and tablets. There are two starting options (Option 1 and Option 2), and your healthcare provider will decide which starting option is for you.

Along with Sunlenca treatment, you should continue to take all of your other HIV-1 medicines as prescribed by your doctor.

Take tablets by mouth, with or without food.

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

Starting treatment Instructions

Option 1:

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

Option 2:

• 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.

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.
• 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. On Day 3 and each day after, you will take 1 Bixlenvo tablet each day.

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 or plan to miss your scheduled injection appointment by more than 2 weeks, call your healthcare provider right away to discuss your treatment options. If you plan to miss a scheduled 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. 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.

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 this medicine, tell your healthcare provider about all your medical conditions.

Pregnancy

Tell your healthcare provider if you are pregnant, plan to become pregnant, or become pregnant, as it is not known if Sunlenca can harm your unborn baby. 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.

Breastfeeding

Tell your healthcare provider if you 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.

A small amount of this medicine is present in breast milk.

Talk with your healthcare provider about the best way to feed your baby during treatment.

Common Sunlenca side effects

Common Sunlenca side effects may include:

• Injections site reactions (65%)
• Nausea (4%)

These common side effects occurred in 3% or more of Sunlenca patients in the Phase 2/3 CAPELLA trial (Week 52 Analysis).

Serious Sunlenca side effects

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 these injections and may include swelling, pain, redness, skin hardening, small mass or lump, and itching. Improper administration can cause serious injection site reactions, including tissue death (necrosis) and ulcers. 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.

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.

Usual Adult Dose for HIV-1 Infection

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

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.

Sunlenca J Code J1961 (1 mg, injection).J codes are used for medicines not taken orally and include injections, inhalations, and chemotherapies. J codes are important, accurate and consistent coding for billing and reimbursement purposes.

Your physician will need the Sunlenca J-code when filling out forms for your treatment.

Review the Sunlenca Package Insert for more detailed information about this medicine. The Sunlenca PI contains more detailed information on Indications and Usage, Dosage and Administration, Clinical Pharmacology, Clinical Studies, Drug Interaction, and more. Discuss any medical questions you have with your doctor or other health care provider. This is not all the information you need to know about this medicine for safe and effective use, and it does not take the place of talking to your doctor about your treatment.

The Package Insert is sometimes called Sunlenca Prescribing Information (PI) or FDA label.

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.
• This medicine 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

• Store at room temperature between 68 °F to 77 °F (20 °C to 25 °C).
• The 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 the tablets in their original blister pack.
• Keep all medicines out of the reach of children and pets.

Active ingredient: lenacapavir sodiumInactive ingredients:Sunlenca tablets: copovidone, croscarmellose sodium, magnesium stearate, mannitol, microcrystalline cellulose, and poloxamer 407.Tablet Film-coating: 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.

Sunlenca Gilead Sciences, Inc. Foster City, CA 94404