SUNLENCA 300 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Sunlenca 300 mg Film-Coated Tablets

lenacapavir

This medicine is subject to additional monitoring, which will help to quickly identify new safety information. You can help by reporting any side effects you may get. The last section of this leaflet includes information on how to report side effects.

Read all of this leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

1. What is Sunlenca and what is it used for
2. What you need to know before you take Sunlenca
3. How to take Sunlenca
4. Possible side effects
5. Storage of Sunlenca
6. Contents of the pack and other information

1. What is Sunlenca and what is it used for

Sunlenca contains the active substance lenacapavir. It is an antiretroviral medicine known as a capsid inhibitor.

Sunlenca is used in combination with other antiretroviral medicinesto treat human immunodeficiency virus type 1 (HIV-1) infection, the virus that causes acquired immune deficiency syndrome (AIDS).

It is used to treat HIV-1 infection in adults with limited treatment options (for example, when other antiretroviral medicines are not effective enough or are not suitable).

Treatment with Sunlenca in combination with other antiretrovirals reduces the amount of HIV in the body. This improves the function of the immune system (the body's natural defence system) and reduces the risk of developing illnesses associated with HIV infection.

Your doctor will tell you to take Sunlenca tablets before you are given Sunlenca injections for the first time.

2. What you need to know before you take Sunlenca

Do not take Sunlenca

• If you are allergic to lenacapavir or any of the other ingredients of this medicine (listed in section 6).
• If you are taking any of the following medicines:
  • rifampicin, used to treat some bacterial infections such as tuberculosis
  • carbamazepine, phenytoin, used to prevent seizures
  • St John's Wort (Hypericum perforatum), a herbal medicine used for depression and anxiety

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

Warnings and precautions

Tell your doctor before taking Sunlenca

• Tell your doctor or pharmacist if you have or have ever had severe liver disease or if tests have shown liver problems. Your doctor will carefully consider whether to treat you with Sunlenca or not.

While you are taking Sunlenca

Once you start taking Sunlenca, be aware of:

• Signs of inflammation or infection

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

Children and adolescents

Do not give this medicine to children under 18 years of age. The use of Sunlenca in patients under 18 years of age has not been studied yet, so it is not known how safe and effective the medicine is in this age group.

Other medicines and Sunlenca

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Sunlenca may interact with other medicines. This can prevent Sunlenca or other medicines from working properly or make side effects worse. In some cases, your doctor may need to adjust the dose or check your blood levels.

Medicines that must not 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 herbal medicine used for depression and anxiety

?If you are taking any of these medicines, do not take Sunlenca and tell your doctor immediately.

Tell your doctor especially if you are taking:

• antibiotics that contain:
  • rifabutin
• anti-epileptics, used to treat epilepsy and prevent seizures (fits), that contain:
  • oxcarbazepine or phenobarbital
• medicines used to treat HIV, that contain:
  • atazanavir/cobicistat, efavirenz, nevirapine, tipranavir/ritonavir or etravirine
• medicines used to treat migraine headaches, that contain:
  • dihydroergotamine or ergotamine
• medicines used to treat impotence and pulmonary hypertension, that contain:
  • sildenafil or tadalafil
• medicines used to treat impotence, that contain:
  • vardenafil
• corticosteroids (also known as “steroids”) given by mouth or by injection, used to treat allergies, inflammatory bowel diseases and various other diseases that involve inflammation in the body, that contain:
  • dexamethasone or hydrocortisone/cortisone
• medicines used to lower cholesterol, that contain:
  • lovastatin or simvastatin
• anti-arrhythmics used to treat heart problems, that contain:
  • digoxin
• medicines used to help you sleep, that contain:
  • midazolam or triazolam
• anticoagulants used to prevent and treat blood clots, that contain:
  • rivaroxaban, dabigatran or edoxaban

?Tell your doctor if you are taking any of these medicinesor if you start taking any of these medicines during treatment with Sunlenca. Do not stop your treatment without talking to your doctor.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

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

It is recommended that women with HIV-1 infection do not breast-feed their babies, as HIV-1 infection can be passed to the baby through breast milk. If you are breast-feeding or think you might want to breast-feed, talk to your doctor as soon as possible.

Driving and using machines

Sunlenca is not expected to affect your ability to drive or use machines.

Sunlenca contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per tablet, which is essentially “sodium-free”.

3. How to take Sunlenca

Sunlenca is used in combination with other antiretroviral medicinesto treat HIV infection. Your doctor will tell you which other medicines you should take to treat HIV infection and when you should take them.

Treatment with Sunlenca starts with taking tablets by mouth, followed by injections given by your doctor or nurse, as described below.

Talk to your doctor before taking the tablets.Your doctor will tell you when to start taking the tablets and when to schedule your appointment to receive 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 into the abdomen (belly) given at the same time by your doctor or nurse.

Every 6 months:

• Two injections into the abdomen given 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 greater risk of experiencing side effects (see section 4, Possible side effects).

It is important that you do not miss a dose of Sunlenca tablets.

If you miss a dose of tablets,contact your doctor or pharmacist immediately.

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

If you miss an injection of Sunlenca

• It is important that you attend your scheduled appointments every 6 months to receive the Sunlenca injections. This will help to control your HIV infection and prevent your illness from getting worse.
• If you think you will not be able to attend your appointment to receive the injections, call your doctor as soon as possible to discuss your treatment options.

Do not stop taking Sunlenca

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects: tell a doctor immediately

• Any signs 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 weak immune system), signs and symptoms of inflammation due to previous infections may occur soon after starting treatment for HIV. It is thought that these symptoms are due to an improvement in the body's immune response, which enables it to fight off infections that may have been present without obvious symptoms.

• Autoimmune disorders, where the immune system attacks the body's healthy tissues, can also occur after you start taking medicines for HIV infection. Autoimmune disorders can 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 towards the trunk
  • palpitations, tremor or hyperactivity

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

Common side effects

(may affect up to 1 in 10 people)

• Nausea

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Sunlenca

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

Do not use this medicine after the expiry date which is stated on the carton and blister after {CAD}. The expiry date refers to the last day of the month shown.

This medicine does not require any special storage conditions. Keep the blister in the outer carton in order to protect from moisture.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the pack and other information

What Sunlenca contains

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

The other ingredients are

Tablet core

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

Tablet coating

polyvinyl 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 pack contents

Sunlenca film-coated tablets are beige, capsule-shaped, film-coated tablets marked with “GSI” on one face of the tablet and “62L” on the other face of the tablet. Sunlenca is available in a blister pack of 5 film-coated tablets. The blister pack is packaged in an aluminium paper pouch. The aluminium paper pouch contains a silica gel desiccant that should remain in the pouch to help protect the tablets. The silica gel is packaged in a separate sachet or container and should not be swallowed.

Marketing authorisation holder

Gilead Sciences Ireland UC

Carrigtohill

County Cork, T45 DP77

Ireland

Manufacturer

Gilead Sciences Ireland UC

IDA Business & Technology Park

Carrigtohill

County Cork

Ireland

You can ask for more information about this medicine from the local representative of the marketing authorisation holder:

Date of last revision of this leaflet:

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.