Lenacapavir

What is Lenacapavir?

• Lenacapavir (Sunlenca),is a human immunodeficiency virus type 1 (HIV-1) capsid inhibitor.

Lenacapavir

What are the uses of this medicine?

Lenacapavir (Sunlenca) is a prescription medicine that is used with other human immunodeficiency virus-1 (HIV-1) medicines to treat HIV-1 infection in adults:

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

How does this medicine work?

• Sunlenca is an HIV-1 antiretroviral agent.
• Lenacapavir is a multistage, selective inhibitor of HIV-1 capsid function that directly binds to the interface between capsid protein (p24) subunits in hexamers.
• Lenacapavir inhibits HIV-1 replication by interfering with multiple essential steps of the viral lifecycle, including capsid-mediated nuclear uptake of HIV-1 proviral DNA (by blocking nuclear import proteins binding to capsid), virus assembly and release (by interfering with Gag/Gag-Pol functioning, reducing production of capsid protein subunits), and capsid core formation (by disrupting the rate of capsid subunit association, leading to malformed capsids).

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• take certain other medicines called strong CYP3A inducers.

What drug interactions can this medicine cause?

• Tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.

Be sure to mention any of the following:

• St. John's Wort. Be sure to let your doctor and pharmacist know that you are taking these medications before you start taking lenacapavir.
• 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.

Is this medicine FDA approved?

• Lenacapavir was approved for medical use in the United States in December 2022.
• The US Food and Drug Administration (FDA) considers it to be a first-in-class medication.

How should this medicine be used?

Recommended dosage: The fallowing two options followed by once every 6-months maintenance dosing as fallows:

Option 1:

• Day 1:

927 mg by subcutaneous injection (2 × 1.5 mL injections) 600 mg orally (2 × 300 mg tablets)

• Day 2:

600 mg orally (2 × 300 mg tablets)

Option 2:

• Day 1:
• 600 mg orally (2 × 300 mg tablets)
• Day 2:
• 600 mg orally (2 × 300 mg tablets)
• Day 8:
• 300 mg orally (1 × 300 mg tablet)
• Day 15:
• 927 mg by subcutaneous injection (2 × 1.5 mL injections)

Maintenance Dose:

• 927 mg by subcutaneous injection (2 × 1.5 mL injections) every 6 months (26 weeks) from the date of the last injection +/-2 weeks.

Administration:

• 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 with Sunlenca. Your healthcare provider will decide which starting option is for you.

If Option 1 is chosen:

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

If Option 2 is chosen:

• On Day 1 and Day 2, you will take 2 Sunlenca tablets each day.
• On Day 8, you will take 1 Sunlenca tablet.
• On Day 15, you will receive 2 Sunlenca injections.

• After completing Option 1 or Option 2, you will receive 2 Sunlenca injections every 6 months (26 weeks) from the date of your last injection.
• If you miss your scheduled injection appointment, call your healthcare provider right away to discuss your treatment options.
• Missing an injection of Sunlenca may cause the HIV-1 virus to change (mutate) and become harder to treat (resistant).
• If you take too many Sunlenca tablets, call your healthcare provider or go to the nearest hospital emergency room right away.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Tablets: 300 mg
• Injection: 463.5 mg/1.5 mL (309 mg/mL) in single-dose vials

This medicine is available in fallowing brand namesː

• Sunlenca

What side effects can this medication cause?

The most common side effects of this medicine may include:

• nausea and injection site reactions

Less common, but serious side effects may include:

• Immune Reconstitution Syndrome
• Injection site reactions

What special precautions should I follow?

• Immune reconstitution syndrome has been reported in patients treated with combination antiretroviral therapy. Advise patients to inform their healthcare provider immediately of any symptoms of infection, as in some patients with advanced HIV infection (AIDS), signs and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment is started.
• Residual concentrations of lenacapavir may remain in the systemic circulation of patients for prolonged periods. If Sunlenca is discontinued, advise patients that Sunlenca may remain in the body and affect certain other drugs for up to 9 months after receiving their last injection.
• Administration of Sunlenca may result in local injection site reactions (ISRs). Inform patients that injection site reactions (ISRs), such as swelling, pain, erythema, nodule, induration, pruritus, extravasation or mass, may occur. Nodules and indurations at the injection site may take longer to resolve than other ISRs and may be persistent. Instruct patients when to contact their healthcare provider about these reactions.
• 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 Sunlenca can pass to your baby in your breast milk.
• Talk with your healthcare provider about the best way to feed your baby during treatment with Sunlenca.
• If discontinued, initiate an alternative, fully suppressive antiretroviral regimen where possible no later than 28 weeks after the final injection of Sunlenca. If virologic failure occurs, switch to an alternative regimen if possible.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• It is not known if Sunlenca can harm your unborn baby.
• Tell your healthcare provider if you become pregnant during treatment with Sunlenca.
• 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.

Can this medicine be used in children?

• The safety and effectiveness of Sunlenca have not been established in pediatric patients.

What are the active and inactive ingredients in this medicine?

• 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.

Who manufactures and distributes this medicine?

Manufactured and distributed by:

• Gilead Sciences, Inc. Foster City, CA
• Sunlenca is a trademark of Gilead Sciences, Inc., or its related companies.

What should I know about storage and disposal of this medication?

Sunlenca tablets:

• Store Sunlenca tablets at room temperature between 68 °F to 77 °F (20 °C to 25 °C).
• Keep Sunlenca tablets in their original blister pack.

Sunlenca injection:

• Store at 20 °C – 25 °C (68 °F – 77 °F), excursions permitted to 15 °C – 30 °C (59 °F – 86 °F).
• Keep the vials in the original carton until just prior to preparation of the injections in order to protect from light.
• Once the solution has been drawn into the syringes, the injections should be administered as soon as possible.
• Discard any unused portion of the solution.

• Dailymed label info on Lenacapavir
• FDA Lenacapavir

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