Prospect: information for the patient

Sunlenca 464 mg injectable solution

lenacapavir

This medicine is subject to additional monitoring, which will expedite the detection of new information about its safety. You may contribute by reporting any adverse effects you may experience. The final part of section 4 includes information on how to report these adverse effects.

Read this prospect carefully before starting to use this medicine, as it contains important information for you.

-Keep this prospect, as you may need to refer to it again.

-If you have any questions, consult your doctor or pharmacist.

-If you experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

1.What is Sunlenca and what it is used for

2.What you need to know beforeyou are administered Sunlenca

3.How Sunlenca is administered

4.Possible adverse effects

5.Storage of Sunlenca

6.Contents of the package and additional information

Sunlenca contains the active ingredient lenacapavir. It is an antiretroviral medication known as a capsid inhibitor.

Sunlenca is a long-acting medication andis used in combination with other antiretroviral medicationsto treat human immunodeficiency virus type 1 (HIV), the virus that causes acquired immunodeficiency syndrome (AIDS).

It is used to treat HIV infection in adults with limited treatment options (for example, when other antiretroviral medications are not sufficiently effective or are not suitable).

Treatment with Sunlenca in combination with other antiretrovirals reduces the amount of HIV present in the body. This will improve the function of the immune system (the body's natural defenses) and decrease the risk of developing diseases associated with HIV infection.

Do not receive Sunlenca

•If you are allergic to lenacapavir or any of the other components of this medication (listed in section 6).

•If you are taking any of the following medications:

-rifampicin, used to treat some bacterial infections such as tuberculosis

-carbamazepine, phenytoin, used to prevent seizures

-St. John's Wort(Hypericum perforatum), a plant-based medication used to treat depression and anxiety

?If you think this applies to you,do not receive Sunlenca and inform your doctor immediately.

Warnings and precautions

Consult your doctor before using Sunlenca

•Consult your doctor or pharmacist if you have or have had severe liver disease or if tests have shown liver problems.Your doctor will carefully evaluate whether to treat you with Sunlenca.

While using Sunlenca

Once you start using Sunlenca, be aware of:

•Signs of inflammation or infection.

?Inform your doctor immediately if you notice any of these symptoms.For more information, see section 4,Adverse reactions.

Scheduled appointments are important

It is essential thatyou attend your scheduled appointmentsto receive the Sunlenca injection to control HIV infection and prevent your condition from worsening. Talk to your doctor if you are considering interrupting treatment. If there is a delay in administering your injection or if you stop receiving Sunlenca, you will need to take other medications to treat HIV infection and reduce the risk of developing viral resistance.

Children and adolescents

Do not administer this medication to children under 18 years of age. Sunlenca has not yet been studied in patients under 18 years of age, so it is unknown how safe and effective the medication is in this age group.

Other medications and Sunlenca

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. Sunlenca may interact with other medications. This may prevent Sunlenca or other medications from working correctly or worsen adverse reactions. In some cases, your doctor may need to adjust the dose or check your blood concentrations.

Medications that should never be taken with Sunlenca:

•rifampicin, used to treat some bacterial infections such as tuberculosis

•carbamazepine, phenytoin, used to prevent seizures

•St. John's Wort (Hypericum perforatum), a plant-based medication used to treat depression and anxiety

?.If you are taking any of these medications,do not receive Sunlenca injectable and inform your doctor immediately.

Consult your doctor especially if you are taking:

•antibiotics containing:

-rifabutin

•antiepileptic medications, used to treat epilepsy and prevent seizures (convulsions), containing:

-oxcarbazepine or phenobarbital

•medications used to treat HIV, containing:

-atazanavir/cobicistat, efavirenz, nevirapine, tipranavir/ritonavir, or etravirine

•medications used to treat migraines, containing:

-dihydroergotamine or ergotamine

•medications used to treat erectile dysfunction and pulmonary hypertension, containing:

-sildenafil or tadalafil

•medications used to treat erectile dysfunction, containing:

-vardenafil

•corticosteroids (also known as "steroids") administered orally or by injection, used to treat allergies, inflammatory bowel diseases, and other conditions involving inflammation in the body, containing:

-dexamethasone or hydrocortisone/cortisone

•cholesterol-lowering medications, containing:

-lovastatin or simvastatin

•antiarrhythmic medications used to treat heart problems, containing:

-digoxin

•sleep aids, containing:

-midazolam or triazolam

•blood thinners used to prevent and treat blood clots, containing:

-rivaroxaban, dabigatran, or edoxaban

?Inform your doctor if you are taking any of these medicationsor if you start taking any of these medications during treatment with Sunlenca. Do not interrupt your treatment without consulting your doctor.

Sunlenca is a long-acting medication. You should know that, if you decide to interrupt or change your treatment after consulting with your doctor, low concentrations of lenacapavir (the active ingredient in Sunlenca) may remain in your body for several months after your last injection. It is not anticipated that the presence of these remaining low concentrations will affect other antiretroviral medications you take later to treat HIV infection. However, the presence of low concentrations of lenacapavir in your body may affect other medications you take in the 9 months following your last Sunlenca injection. Ask your doctor if those medicationsare safe for you after interrupting treatment with Sunlenca.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant or plan to become pregnant, consult your doctor or pharmacist before using this medication.

As a precaution, you should avoid using Sunlenca during pregnancy unless your doctor tells you otherwise.

It is recommended that women with HIV infection do not breastfeed their babies, as HIV-1 infection can be transmitted to the baby through breast milk. If you are breastfeeding or plan to breastfeed,talk to your doctor as soon as possible..

Driving and operating machinery

Sunlenca is not expected to affect your ability to drive or operate machinery.

Sunlenca contains sodium

This medication contains less than 1 mmol of sodium (23 mg) perinjection; it is essentially "sodium-free".

Sunlencais used in combination with other antiretroviral medicationsto treat HIV infection. Your doctor will tell you which other medications you should take to treat HIV infection and when to take them.

Sunlenca treatment begins with taking oral tablets, followed by injections administered by your doctor or nurse, as described below.

Consult your doctor before taking the tablets.Your doctor will inform you when to start taking the tablets and when your appointment will be scheduled to receive the first injections.

Day 1 of treatment:

• Two tablets taken orally. These can be taken with or without food.

Day 2 of treatment:

• Two tablets taken orally. These can be taken with or without food.

Day 8 of treatment:

• One tablet taken orally. This can be taken with or without food.

Day 15 of treatment:

• Two injections in the abdomen (stomach) administered at the same time by your doctor or nurse.

Every 6 months:

• Two injections in the abdomen administered at the same time by your doctor or nurse.

If you are administered more Sunlenca injectable than prescribed

Your doctor or a nurse will administer this medication, so it is unlikely that you will receive too much. Inform your doctor or nurse if you are concerned.

If you forgot a Sunlenca injection

•It is essential thatyou attend your scheduled appointments every 6 monthsto receive the Sunlenca injections. This will help control HIV infection and prevent your condition from worsening.

•If you think you will be unable to attend your appointment to receive the injections, call your doctor as soon as possible to discuss your treatment options.

See the Sunlenca tablets package insert if you forgot to take or vomit the tablets.

Do not interrupt Sunlenca treatment

Do not stop Sunlenca treatment without talking to your doctor. Continue treatment with Sunlenca injections as recommended by your doctor. Stopping Sunlenca may severely affect the functioning of future HIV treatments.

?Speak with your doctor if you want to stop treatment with Sunlenca injections.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Severe side effects: report to a doctor immediately

•Any sign of inflammation or infection.In some patients with advanced HIV infection (AIDS) and a history of opportunistic infections (infections that occur in people with a weakened immune system), signs and symptoms of inflammation from previous infections may occur shortly after starting HIV treatment. It is believed that these symptoms are due to an improvement in the body's immune response, which allows it to fight off infections that may have been present without obvious symptoms.

•Autoimmune disordersmay also occur, in which the immune system attacks healthy tissues in the body, after starting treatment for HIV infection. Autoimmune disorders can occur many months after treatment begins. Be aware of any symptoms of infection or other symptoms, such as:

-Muscle weakness

-Weakness of the body that starts in the hands and feet and moves to the trunk

-Palpitations, tremors, or hyperactivity

?If you notice any of these symptoms or any symptoms of inflammation or infection,report to your doctor immediately.

Frequent side effects

(may affect more than 1 in 10 people)

• Reactions at the Sunlenca injection site.

The symptoms may include:

• Pain and discomfort
• A lump or hardened mass
• Inflammatory reaction such as redness, itching, and swelling

Common side effects

(may affect up to 1 in 10 people)

• Nausea

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through thenational notification system included in theAppendix V.By reporting side effects, you can contribute to providing more information about the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the vial label and the box after {CAD}. The expiration date is the last day of the month indicated.

This medication does not require any special storage temperature. Store in the original packaging to protect it from light.

Composition of Sunlenca

The active ingredient is lenacapavir. Each single-dose vial contains 463.5 mg of lenacapavir.

The other components are

Macrogol (E1521), water for injectable preparations.

Appearance of Sunlenca and contents of the package

Sunlenca injectable solution (injectable) is a transparent, yellow to brown solution, without visible particles. Sunlenca is presented in two glass vials containing 1.5 ml of injectable solution each. These vials come included in an administration kit that also contains 2 vial access devices (a device that will allow your doctor or nurse to extract Sunlenca from the vial), 2 disposable syringes, and 2 injection needles.

Marketing Authorization Holder

Gilead Sciences Ireland UC

Carrigtohill

County Cork, T45 DP77

Ireland

Responsible for manufacturing

Gilead Sciences Ireland UC

IDA Business & Technology Park

Carrigtohill

County Cork

Ireland

You can request more information about this medication by contacting the local representative of the marketing authorization holder:representative local of the marketing authorization holder:

Last review date of this leaflet:

The detailed information about this medicine is available on the website of the European Medicines Agency:http://www.ema.europa.eu.

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This information is intended solely for healthcare professionals:

Instructions for use-Sunlenca 464 mg injectable solution

The kit contains

All components are for single use.

Two injections of 1.5 ml are needed for a complete dose. It is necessary to use thevial access device.

Check that:

• The vial contains ayellow to brown solution, without particles
• The contentsare not damaged
• The medicinehas not expired