Prospect: information for the patient

Sunlenca 300 mg film-coated tablets

lenacapavir

This medicine is subject to additional monitoring, which will speed up the detection of new information about its safety. You can 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, because it contains important information for you.

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

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

-This medicine has been prescribed only for you, and you should not give it to other people even if they have the same symptoms as you, as it may harm them.

-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 before starting to take Sunlenca

3.How to take Sunlenca

4.Possible adverse effects

5.Storage of Sunlenca

6.Contents of the pack and additional information

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

Sunlencais 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.

Your doctor will instruct you to take Sunlenca tablets before they administer Sunlenca injections for the first time.

Do not take 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, phenitoin, 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 take Sunlenca and inform your doctor immediately.

Warnings and precautions

Consult your doctor before taking 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

?If you notice any of these symptoms, inform your doctor immediately.For more information, see section 4, Possible side effects.

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 side effects. 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, phenitoin, 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 take Sunlenca 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 (seizures), 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

•sleeping medications, 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 medications or if you start taking any of these medications during treatment with Sunlenca. Do not stop your treatment without consulting your doctor.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be 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.

Women with HIV infection are advised not to breastfeed their babies, as HIV-1 infection can be transmitted to the baby through breast milk. If you are breastfeeding or plan to breastfeed, speak with 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) per tablet; 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.

The Sunlenca treatment starts with taking tablets by mouth, followed by injections administered by your doctor or nurse, as described below.

Consult your doctor before taking the tablets.Your doctor will tell you when to start taking the tablets and when to schedule your appointment for the first injections.

Day 1 of treatment:

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

Day 2 of treatment:

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

Day 8 of treatment:

• One tablet by mouth. 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 take more Sunlenca than you should

Contact your doctor or pharmacist immediately for advice. If you take more than the recommended dose of Sunlenca, you may be at a higher risk of experiencing adverse effects (see section 4, Adverse effects).

It is essential not to forget to take a Sunlenca tablet dose.

If you forget to take the tablets,contact your doctor or pharmacist immediately.

If you vomitwithin 3 hours of taking Sunlenca tablets, contact your doctor immediately and take two more tablets. If you vomit more than 3 hours after taking Sunlenca, do not take any more tablets until your next scheduled dose, either as tablets or injections.

If you forget a Sunlenca injection

•It is essential thatyou attend your scheduled appointments every 6 monthsto receive 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 for injections, call your doctor as soon as possible to discuss your treatment options.

Do not interrupt Sunlenca treatment

Do not stop taking Sunlenca tablets without talking to your doctor. Stopping Sunlenca may severely affect the functioning of future HIV treatments.

Like all medications, this medication may produce adverse effects, although not all people may experience them.

Severe Adverse Effects: Inform Your 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 the body's healthy tissues, after starting treatment for HIV infection. Autoimmune disorders may occur many months after starting treatment. 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,inform your doctor immediately.

Frequent Adverse Effects

(may affect up to 1 in 10 people)

•Nausea

Reporting Adverse Effects

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

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

Do not use this medication after the expiration date that appears on the box and the blister pack 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 moisture.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. In this way, you will help protect the environment.

Composition of Sunlenca

The active ingredient is lenacapavir. Each tablet contains lenacapavir sodium equivalent to 300 mg of lenacapavir.

The other components are

Tablet core

Manitol (E421), microcrystalline cellulose (E460), sodium croscarmellose (E468), copovidone, magnesium stearate (E572), poloxamer (see section 2, Sunlenca contains sodium).

Coating with a film

Polivinil alcohol (E1203), titanium dioxide (E171), macrogol (E1521), talc (E553b), yellow iron oxide (E172), black iron oxide (E172), red iron oxide (E172).

Appearance of Sunlenca and contents of the package

Sunlenca film-coated tablets are beige-colored, capsule-shaped tablets, marked on one face of the tablet with “GSI” and on the other face of the tablet with “62L”. Sunlenca is presented in a blister pack of 5 film-coated tablets covered by a laminated blister. The blister pack is packed inside an aluminum foil pouch. The aluminum foil pouch contains a desiccant of silica gel that must remain inside the aluminum foil pouch to help protect the tablets. The silica gel is packed in a separate envelope or container and should not be taken.

Marketing Authorization Holder

Gilead Sciences Ireland UC

Carrigtohill

County Cork, T45 DP77

Ireland

Responsible Person

Gilead Sciences Ireland UC

IDA Business & Technology Park

Carrigtohill

County Cork

Ireland

For more information about this medicine, please contact the local representative of the marketing authorization holder:

Last update of this leaflet:

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