Sunlenca
Sunlenca (lenacapavir) is the first FDA-approved, twice-yearly injectable medication used for hard-to-treat human immunodeficiency virus (HIV) infections. It's injected under the skin on the belly by a healthcare provider every 6 months (after the starting dose is finished). Sunlenca (lenacapavir) is available as either an injection or a tablet, but the tablet form is only taken at the start of treatment. The most common side effects people experienced with Sunlenca (lenacapavir) involved reactions at the injection site, including swelling, pain, and redness.
What is Sunlenca (lenacapavir)?
What is Sunlenca (lenacapavir) used for?
Human immunodeficiency virus type 1 (HIV-1) infection in people who've received HIV medications in the past, and:
Past HIV medications are no longer working, or
Can't tolerate side effects of past HIV medications, or
Safety concerns about past HIV medication
How Sunlenca (lenacapavir) works
Sunlenca (lenacapavir) is a capsid inhibitor. Capsid is a protein shell that human immunodeficiency viruses use to protect their genetic material. Sunlenca (lenacapavir) attacks the virus by disrupting the capsid. This prevents the virus from making more copies of itself. By blocking the capsids, Sunlenca (lenacapavir) can interfere at multiple points of the viral life cycle.
Drug Facts
What are the side effects of Sunlenca (lenacapavir)?
Common Side Effects
- Swelling (36%)
- Pain (31%)
- Redness (31%)
- Small lump (25%)
- Hardening of skin (15%)
- Itching (6%)
Other Side Effects
- Nausea
- Bruising at injection site
- Ulcer at injection site
Source: DailyMed
The following side effects have also been reported
Side effects that you should report to your care team as soon as possible:
- Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):
Pros and cons of Sunlenca (lenacapavir)
Pros
Injected once every 6 months (after starting dose), so it's convenient for people with a busy schedule
Has few side effects
Might work well for people who didn’t see benefits with other medications for HIV
A possible option for people with kidney or liver problems
Cons
Likely to cause post-injection reactions
Unknown if safe or works well in children
Interacts with a lot of medications such as lovastatin, dexamethasone, and rivaroxaban (Xarelto)
Needs to be taken with other HIV medications
Pharmacist tips for Sunlenca (lenacapavir)
Each Sunlenca (lenacapavir) maintenance treatment contains two injections, which can be injected under the skin on each side of your belly or on the same side (at least 2 inches away from your belly button). Most commonly, you'll receive this medication at a hospital or a provider's office.
Be sure to plan for some extra time after your appointment. Your provider may need to monitor you for post-injection reactions after you've received Sunlenca (lenacapavir). Tell your provider if you experience swelling, pain, redness, small lump, hardening of skin, or itching.
Sunlenca (lenacapavir) can interact with many medications. Let your provider or pharmacist know what medications you're taking, including over-the-counter products and supplements, before you start Sunlenca (lenacapavir).
It's best to get your Sunlenca (lenacapavir) injections around the same time every 6 months. If you miss or are planning to miss a treatment, talk with your provider right away about rescheduling your appointment.
Talk to your provider before stopping Sunlenca (lenacapavir) or any of your HIV medications. Doing so can cause the virus to spread and become harder to treat.
Sunlenca (lenacapavir) can cause your immune system to overreact and attack your own body, which can cause certain autoimmune problems, such as Graves' disease. Sunlenca (lenacapavir) can also cause symptoms of infection to show up. Let your provider know if you develop any new symptoms of infection, such as fever, sore throat, weakness, cough, or trouble breathing.
Frequently asked questions about Sunlenca (lenacapavir)
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What are the risks and warnings for Sunlenca (lenacapavir)?
Sunlenca (lenacapavir) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Overactive immune system
Taking Sunlenca (lenacapavir) can cause changes to your immune system called immune reconstitution syndrome. This is a medical condition where your immune system becomes stronger after you start Sunlenca (lenacapavir) treatment and it begins to fight off different infections (infections your immune system was too weak to fight off before). In rare cases, your immune system may become so strong that it starts to attack normal cells in your body (autoimmune). You can experience immune reconstitution syndrome as early as during the first few weeks of Sunlenca (lenacapavir) treatment, or many months later. Tell your healthcare provider right away if you start having any new symptoms, such as anxiety, hair loss, bulging eyes, or sweating, after starting Sunlenca (lenacapavir).
Injection site reactions
Sunlenca (lenacapavir) commonly causes injection site reactions. While most are mild and get better within a few days, some reactions like hardened skin or small lumps at the injection site can take longer to go away. If you develop injection site reactions, such as swelling, pain, redness, skin hardening, small skin lump, and itching, let your provider know.
Worsening of HIV infection with missed doses
It's very important to get your Sunlenca (lenacapavir) injections regularly according to your provider's treatment plan. Missing doses frequently can make it easier for HIV virus to change form, causing Sunlenca (lenacapavir) to stop working. It can also lead to a higher amount of HIV virus in your body and your infection getting worse. Tell your provider right away if you miss or plan to miss a scheduled appointment to receive your injections so that they can let you know about other options. If you choose to stop receiving Sunlenca (lenacapavir) or if the amount of HIV virus in your blood has gone up, your provider can help you decide on a new HIV treatment plan.
Interaction with other medications
Some medications can interfere with how your body removes Sunlenca (lenacapavir). This can affect the amount of Sunlenca (lenacapavir) in your body, how well it works, and the risk of side effects. It's important to know that this medication can stay in your body for 9 months or longer after your last dose.
Taking certain medications for seizures (e.g., carbamazepine (Tegretol), phenytoin (Dilantin)), St John’s wort, or antibiotics (e.g., rifampin (Rifadin), Priftin (rifapentine)) along with Sunlenca (lenacapavir) should also be avoided. This is because these medications can lower the amount of Sunlenca (lenacapavir) in your body and cause it to not work as well.
Sunlenca (lenacapavir) also interferes with how your body removes other medications. For example, taking this medication with tramadol (Ultram) or midazolam can raise the amount of these medications in your body, which can cause severe dizziness, sleepiness, and slowed breathing.
Sunlenca (lenacapavir) dosage forms
Typical dosing for Sunlenca (lenacapavir)
Sunlenca (lenacapavir) is available in both injection (463.5 mg) and tablet (300 mg) form. The injection is usually given in a hospital setting or at your provider's office by a healthcare professional. There are two dosing options for this medication and your healthcare provider will determine the best option for you.
Dosing option 1:
Starting dose Day 1: Your provider will inject 927 mg under the skin once. You'll take 600 mg by mouth once.
Starting dose Day 2: Take 600 mg by mouth once.
Maintenance dose: After you complete the starting dose, your provider will inject 927 mg under the skin once every 6 months (starting from the date of your last injection).
Dosing option 2:
Starting dose Day 1: Take 600 mg by mouth once.
Starting dose Day 2: Take 600 mg by mouth once.
Starting dose Day 8: Take 300 mg by mouth once.
Starting dose Day 15: Your provider will inject 927 mg under the skin once.
Maintenance dose: After you complete the starting dose, your provider will inject 927 mg under the skin once every 6 months (starting from the date of your last injection).
Sunlenca (lenacapavir) contraindications
Certain medications called CYP3A inducers that lower the levels of Sunlenca (lenacapavir) in your body, such as carbamazepine (Tegretol), rifampin (Rifadin), or phenobarbital
What are alternatives to Sunlenca (lenacapavir)?
Human immunodeficiency virus type 1 (HIV-1) infection in people who've received HIV medications in the past, and:
Past HIV medications are no longer working, or
Can't tolerate side effects of past HIV medications, or
Safety concerns about past HIV medication
What is the latest news about Sunlenca (lenacapavir)?
Sunlenca (lenacapavir) images
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References
Best studies we foundCenters for Disease Control and Prevention. (2023). Human immunodeficiency virus (HIV).
Clinical Info HIV.gov. (n.d.). Capsid inhibitor(s).
Clinical Info HIV.gov. (n.d.). Immune reconstitution inflammatory syndrome (IRIS).
Gilead Sciences, Inc. (n.d.). Sunlenca is a long-acting SC injectable administered only twice a year1.
Gilead Sciences, Inc. (n.d.). Sunlenca® demonstrated rapid and long-acting antiviral activity1.
Gilead Sciences, Inc. (2022). Sunlenca® (lenacapavir) receives FDA approval as a first-in-class, twice-yearly treatment option for people living with multi-drug resistant HIV. Business Wire.
Gilead Sciences, Inc. (2023). Sunlenca- lenacapavir sodium tablet, film coated; lenacapavir sodium kit [package insert]. DailyMed.
HIV.gov. (2023). Taking your HIV medicine as prescribed.
HIV.gov. (2023). What are HIV and AIDS?
HIVinfo.NIH.gov. (2021). The HIV life cycle.
Segal-Maurer, S., et al. (2022). Capsid inhibition with lenacapavir in multidrug-resistant HIV-1 infection. The New England Journal of Medicine.
Thapa, S., et al. (2023). Immune reconstitution inflammatory syndrome. StatPearls.
U.S. Food and Drug Administration. (2023). Drug development and drug interactions | Table of substrates, inhibitors and inducers.
World Health Organization. (2022). HIV drug resistance.
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