Sunlenca 300 mg film-coated tablets

Patient Information Leaflet

Introduction

Package leaflet: Information for the patient

Sunlenca 300 mg film-coated tablets

lenacapavir

This medicinal product is subject to additional monitoring, which will allow quicker identification of new safety information. You can help by reporting any side effects you may experience. Information on how to report side effects is provided at the end of section 4.

Read the entire leaflet carefully before you start using this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, since it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Sunlenca is and what it is 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 medicines to 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 medicines are not sufficiently effective or are not suitable).

Treatment with Sunlenca in combination with other antiretrovirals reduces the amount of HIV in the body. This will improve the function of the immune system (the body's natural defenses) and reduce the risk of developing HIV-related illnesses.

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

2. What you need to know before taking Sunlenca

Do not take Sunlenca

• If you are allergic to lenacapavir or to 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 certain 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 inform your doctor immediately.

Warnings and precautions

Talk to your doctor before taking Sunlenca

• Consult 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 or not to treat you with Sunlenca.

While using Sunlenca

Once you start using Sunlenca, be alert for:

• 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 give this medicine 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 medicine is in this age group.

Other medicines and Sunlenca

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

Medicines that must never be taken with Sunlenca:

• rifampicin, used to treat certain 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 inform your doctor immediately.

Talk to your doctor especially if you are taking:

• antibiotics containing:
  • rifabutin
• antiepileptic medicines, used to treat epilepsy and prevent seizures (convulsions), containing:
  • oxcarbazepine or phenobarbital
• medicines used to treat HIV, containing:
  • atazanavir/cobicistat, efavirenz, nevirapine, tipranavir/ritonavir or etravirine
• medicines used to treat migraine headache, containing:
  • dihydroergotamine or ergotamine
• medicines used to treat impotence and pulmonary hypertension, containing:
  • sildenafil or tadalafil
• medicines used to treat impotence, containing:
  • vardenafil
• corticosteroids (also known as “steroids”) taken orally or by injection, used to treat allergies, inflammatory bowel diseases and other conditions involving inflammation in the body, containing:
  • dexamethasone or hydrocortisone/cortisone
• medicines used to lower cholesterol, containing:
  • lovastatin or simvastatin
• antiarrhythmic medicines used to treat heart problems, containing:
  • digoxin
• medicines used to help you sleep, containing:
  • midazolam or triazolam
• anticoagulant medicines used to prevent and treat blood clots, containing:
  • rivaroxaban, dabigatran or edoxaban

?Inform your doctor if you are taking any of these medicines or if you start taking any of these medicines during treatment with Sunlenca. Do not stop your treatment without consulting your doctor.

Pregnancy and breastfeeding

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

As a precautionary measure, you should avoid using Sunlenca during pregnancy unless your doctor advises otherwise.

Women with HIV infection are advised not to breastfeed their babies, since HIV-1 infection can be transmitted to the baby through breast milk. If you are breastfeeding or planning to breastfeed, 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 of sodium (23 mg) per tablet; this is essentially “sodium-free”.

3. How to take Sunlenca

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

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

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

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 (the belly) administered at the same time by your doctor or nurse.

Every 6 months:

• Two injections into 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 have an increased risk of experiencing adverse effects (see section 4, Possible side effects).

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

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

If you vomit within 3 hours after taking Sunlenca tablets, contact your doctor immediately and take two more 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, whether 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 Sunlenca injections. This will help control your HIV infection and prevent your condition from worsening.
• If you think you cannot attend your appointment for the injections, call your doctor as soon as possible to discuss your treatment options.

Do not stop treatment with Sunlenca

Do not stop treatment with Sunlenca tablets without speaking to your doctor. Stopping Sunlenca may seriously affect the effectiveness of future HIV treatments.

4. Possible adverse effects

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

Serious possible adverse effects: tell 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 anti-HIV treatment. These symptoms are believed to result from an improved immune response, enabling the body to fight infections that may have been present without obvious symptoms.

• Autoimmune disorders, in which the immune system attacks the body's healthy tissues, may also occur after starting treatment for HIV infection. Autoimmune disorders may occur several months after treatment has begun. Be alert for any signs of infection or other symptoms such as:

  • muscle weakness
  • body weakness starting in the hands and feet and moving towards the trunk
  • palpitations, tremors, or hyperactivity

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

Frequent adverse effects

(may affect up to 1 in 10 people)

• Nausea

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system detailed in Appendix V. By reporting adverse 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 stated on the carton and blister after {CAD}. The expiry date is the last day of the month indicated.

This medicine does not require any special storage temperature. Store in the original packaging to protect from moisture.

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

6. Contents of the container and other information

Composition of Sunlenca

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

The other components are

Tablet core

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

Film 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 contents of the container

Sunlenca film-coated tablets are beige, capsule-shaped, film-coated tablets, marked on one side of the tablet with “GSI” and on the other side of the tablet with “62L”. Sunlenca is supplied in a 5-tablet blister pack sealed with a blister foil. The blister pack is enclosed within an aluminum foil pouch. The aluminum foil pouch contains a silica gel desiccant which should remain inside the pouch to help protect the tablets. The silica gel is packed in a separate sachet or container and must not be swallowed.

Marketing Authorization Holder

Gilead Sciences Ireland UC
Carrigtohill
County Cork, T45 DP77
Ireland

Manufacturer

Gilead Sciences Ireland UC
IDA Business & Technology Park
Carrigtohill
County Cork
Ireland

For further information about this medicine, please contact the local representative of the Marketing Authorization Holder:

Date of the most recent review of this leaflet:

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