Sunlenca
Pronunciation: sun-LEN-kuh
Generic name: lenacapavir
Dosage form: injection 463.5 mg/1.5 mL (309 mg/mL), tablets (300 mg)
Drug class: Miscellaneous antivirals
What is Sunlenca?
Sunlenca injection is used for hard-to-treat HIV-1 infections in adults when used together with other HIV-1 medicines. Sunlenca injection is used for 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 mechanism of action 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 belongs to a class of drugs called capsid inhibitors.
Sunlenca (lenacapavir) injections are given twice a year after a starting dose of Sunlenca pills for a few days.
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 who are failing their current antiretroviral regimen due to resistance intolerance, or safety considerations. Sunlenca FDA approval was granted to Gilead Sciences after positive results from the Phase 2/3 CAPELLA trial, which helped 83% of patients achieve an undetectable viral load (<50 copies/mL) at Week 52 and also achieved a mean increase in CD4 count 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.
Sunlenca side effects
Common Sunlenca side effects
Common Sunlenca side effects may include:
- Injections site reactions (65%), which include swelling (36%), pain (31%), redness (31%), lumps or nodules (25%), thickening and hardening or hardening (15%), itchiness (6%), extravasation (3%) and mass at the injection site (3%).
- Nausea (4%).
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. 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.
Who should not receive or take Sunlenca?
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 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.
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.
How should I receive and take Sunlenca?
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.
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.
Sunlenca Dosing information
Usual Adult Dose for HIV-1 Infection
Initiation with one of two options followed by once every 6-months maintenance dosing.
| Initiation Option 1 | |
| Day 1 | 927 mg by subcutaneous injection (2 x 1.5 mL injections) 600 mg orally (2 x 300 mg tablets) |
| Day 2 | 600 mg orally (2 x 300 mg tablets) |
| Initiation Option 2 | |
| Day 1 | 600 mg orally (2 x 300 mg tablets) |
| Day 2 | 600 mg orally (2 x 300 mg tablets) |
| Day 8 | 300 mg orally (1 x 300 mg tablet) |
| Day 15 | 927 mg by subcutaneous injection (2 x 1.5 mL injections) |
| Maintenance | |
| 927 mg by subcutaneous injection (2 x 1.5 mL injections) every 6 months (26 weeks) from the date of the last injection +/-2 weeks. | |
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.
Related/similar drugs
Truvada, Biktarvy, Descovy, Cabenuva, Atripla, Stribild, Epzicom, Complera
Sunlenca J code
Sunlenca J1961 (1 mg, injection).
J codes are used for medicines that are not taken orally and include injections, inhalations chemotherapies. J codes are important accurate and consistent coding for billing and reimbursement purposes.
Your physician will need Sunlenca J-code when filling out forms for your treatment.
Sunlenca Package Insert
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.
What other drugs will affect this medicine?
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
Storage
- 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.
What are the ingredients in Sunlenca?
Active ingredient: lenacapavir
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.
Company
Sunlenca Gilead Sciences, Inc. Foster City, CA 94404
References
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Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
