Sunlenca

Generic name: Lenacapavir
Dosage form: tablets and injection
Drug class: Miscellaneous antivirals

Usage of Sunlenca

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.

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 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.

Before taking 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.

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How to use Sunlenca

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.

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

What other drugs will affect Sunlenca

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

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