lenacapavir: package leaflet

For patients

Package leaflet, verbatim

Sunlenca

Package leaflet: Sunlenca 464 mg solution for injection

1. What Sunlenca is and what it is used for

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

Sunlenca is a long acting medicine and is used in combination with other antiretroviral medicines to treat type 1 human immunodeficiency virus (HIV), the virus that cause 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 your body. This will improve the function of your immune system (the body’s natural defences) and reduce the risk of developing illnesses linked to HIV infection.

2. What you need to know before you are given Sunlenca

Do not receive 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 these 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 remedy used for depression and anxiety

 Do not receive Sunlenca and tell your doctor immediately if you think this applies to you.

Warnings and precautions

Talk to your doctor before using Sunlenca

Talk to your doctor or pharmacist if you have ever had severe liver disease, or if tests have shown problems with your liver. Your doctor will carefully consider whether to treat you with Sunlenca.

While you are using Sunlenca

Once you start using Sunlenca, look out for:

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.

Reactions where Sunlenca is injected.

 A hardened mass or lump may occur at the injection site. In some cases, such lumps have remained for more than a year and in some cases may not go away. If this has not gone away at the time of the next injection, alert your doctor. For more information, see section 4, Possible side effects.

Regular appointments are important

It is important that you attend your planned appointments to receive your Sunlenca injection, to control your HIV infection, and to stop your illness from getting worse. Talk to your doctor if you are thinking about stopping treatment. If you are late receiving your Sunlenca injection, or if you stop receiving Sunlenca, your will need to take other medicines to treat your HIV infection and to reduce the risk of developing viral resistance.

Children and adolescents

Do not give this medicine to children under 18 years of age. The use of Sunlenca in patients aged under 18 has not yet been studied, so it is not known how safe and effective the medicine is in that 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 may keep Sunlenca or other medicines from working properly, or may make side effects worse. In some cases, your doctor may need to adjust your dose or check your blood levels.

Medicines that must 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 herbal remedy used for depression and anxiety

 If you are taking any of these medicines, do not receive Sunlenca injection and tell your doctor immediately.

Talk to your doctor in particular if you are taking:

antibiotics containing:
rifabutin
anticonvulsants used to treat epilepsy and prevent seizures (fits), 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
medicine used to treat impotence and pulmonary hypertension, containing:
sildenafil or tadalafil
medicine used to treat impotence, containing:
vardenafil
corticosteroids (also known as ‘steroids’) taken orally or given by injection used to treat allergies, inflammatory bowel diseases, and other various illnesses involving inflammations in your body, containing:
dexamethasone or hydrocortisone/cortisone
medicines used to lower cholesterol, containing:
lovastatin or simvastatin
antiarrhythmics used to treat heart problems, containing:
digoxin
medicines used to help you sleep, containing:
midazolam or triazolam.
anticoagulants used to prevent and treat blood clots, containing:
rivaroxaban, dabigatran or edoxaban

 Tell 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 any treatment without contacting your doctor.

Sunlenca is a long-acting medicine. If after talking to your doctor you decide to stop your treatment or switch to another, you should know low levels of lenacapavir (the active substance in Sunlenca) can remain in your system for many months after your last injection. These low remaining levels should not affect other antiretroviral medicines that you take afterwards to treat your HIV infection. Some other medicines however may be affected by the low levels of lenacapavir in your system if you take them within 9 months after your last Sunlenca injection. You should check with your doctor if such medicines are safe for you to take after you stop treatment with Sunlenca.

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 precautionary measure you should avoid the use of Sunlenca during pregnancy unless your doctor tells you otherwise.

Breast-feeding is not recommended in women living with HIV because HIV infection can be passed on to the baby through breast milk. If you are breast-feeding, or thinking about breast-feeding, you should discuss it with your doctor as soon as possible.

Driving and using machines

Sunlenca is not expected to have any effect on your ability to drive or use machines.

Sunlenca contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per injection, that is to say essentially ‘sodium-free’.

3. How Sunlenca is given

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

Your treatment with Sunlenca starts with tablets you take by mouth, followed by injections given by your doctor or nurse, as described below.

Talk to your doctor before taking the tablets. You will be advised when to start your tablets and when your appointment for the first injections will be scheduled.

Day 1 of treatment:
- Two tablets taken by mouth. These can be taken with or without food.

Day 2 of treatment:
- Two tablets taken by mouth. These can be taken with or without food.

Day 8 of treatment:
- One tablet taken by mouth. This can be taken with or without food.

Day 15 of treatment:
- Two injections into your abdomen (tummy) given at the same time by your doctor or nurse.

Every 6 months:
- Two injections into your abdomen given at the same time by your doctor or nurse.

If you are given more Sunlenca injection than you should

Your doctor or a nurse will give this medicine to you, so it is unlikely that you will be given too much.
If you are worried, tell the doctor or a nurse.

If you miss a Sunlenca injection

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

If you miss or vomit the tablets, refer to the package leaflet for Sunlenca tablets.

If you stop receiving Sunlenca

Do not stop receiving Sunlenca without talking to your doctor. Keep receiving Sunlenca injections for as long as your doctor recommends. Stopping Sunlenca can seriously affect how future HIV treatments work.

 Talk to your doctor if you want to stop receiving Sunlenca injections.

4. Possible side effects

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

Possible 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 from previous infections may occur soon after HIV treatment is started. It is thought that these symptoms are due to an improvement in the body’s immune response, enabling the body to fight infections that may have been present with no obvious symptoms.

Autoimmune disorders, when the immune system attacks healthy body tissue, may also occur after you start taking medicines for HIV infection. Autoimmune disorders may occur many months after the start of treatment. Look out for any symptoms of infection or other symptoms such as:
muscle weakness
weakness beginning in the hands and feet and moving up towards the trunk of the body
palpitations, tremor or hyperactivity

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

Very common side effects
(may affect more than 1 in 10 people)
- Reactions where Sunlenca is injected.
Symptoms may include:
- pain and discomfort
- a hardened mass or lump, which may take longer to go away than other reactions at the injection site or may not go away
- inflammatory reaction such as redness, itching, and swelling
- open sore on the skin

Common side effects
(may affect up to 1 in 10 people)
- Feeling sick (nausea)

Reporting of side effects
If you get 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. How to store 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 vial label and carton after EXP.
The expiry date refers to the last day of that month.

This medicine does not require any special temperature storage conditions. Store in the original package in order to protect from light.

6. Contents of the pack and other information

What Sunlenca contains

The active substance is lenacapavir. Each single-use vial contains 463.5 mg of lenacapavir.

The other ingredients are

Macrogol (E1521), water for injections.

What Sunlenca looks like and contents of the pack

Sunlenca solution for injection (injection) is a clear, yellow to brown solution with no visible particles.
Sunlenca comes in two glass vials, each containing 1.5 ml of solution for injection. These vials are included in a dosing kit also containing 2 vial access devices (a device that will allow your doctor or a nurse to withdraw Sunlenca from the vial), 2 disposable syringes and 2 injection needles.

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

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien
Gilead Sciences Belgium SRL-BV
Tél/Tel: + 32 (0) 24 01 35 50

Lietuva
Gilead Sciences Ireland UC
Tel: + 353 (0) 1 686 1888
България
Gilead Sciences Ireland UC
Тел.: + 353 (0) 1 686 1888

Luxembourg/Luxemburg
Gilead Sciences Belgium SRL-BV
Tél/Tel: + 32 (0) 24 01 35 50

Česká republika
Gilead Sciences s.r.o.
Tel: + 420 910 871 986

Magyarország
Gilead Sciences Ireland UC
Tel.: + 353 (0) 1 686 1888

Danmark
Gilead Sciences Sweden AB
Tlf: + 46 (0) 8 5057 1849

Malta
Gilead Sciences Ireland UC
Tel: + 353 (0) 1 686 1888

Deutschland
Gilead Sciences GmbH
Tel: + 49 (0) 89 899890-0

Nederland
Gilead Sciences Netherlands B.V.
Tel: + 31 (0) 20 718 36 98

Eesti
Gilead Sciences Ireland UC
Tel: + 353 (0) 1 686 1888
Norge
Gilead Sciences Sweden AB
Tlf: + 46 (0) 8 5057 1849

Ελλάδα
Gilead Sciences Ελλάς Μ.ΕΠΕ.
Τηλ: + 30 210 8930 100

Österreich
Gilead Sciences GesmbH
Tel: + 43 1 260 830

España
Gilead Sciences, S.L.
Tel: + 34 91 378 98 30

Polska
Gilead Sciences Poland Sp. z o.o.
Tel.: + 48 22 262 8702

France
Gilead Sciences
Tél: + 33 (0) 1 46 09 41 00

Portugal
Gilead Sciences, Lda.
Tel: + 351 21 7928790

Hrvatska
Gilead Sciences Ireland UC
Tel: + 353 (0) 1 686 1888

România
Gilead Sciences (GSR) S.R.L.
Tel: + 40 31 631 18 00

Ireland
Gilead Sciences Ireland UC
Tel: + 353 (0) 214 825 999

Slovenija
Gilead Sciences Ireland UC
Tel: + 353 (0) 1 686 1888

Ísland
Gilead Sciences Sweden AB
Sími: + 46 (0) 8 5057 1849

Slovenská republika
Gilead Sciences Slovakia s.r.o.
Tel: + 421 232 121 210

Italia
Gilead Sciences S.r.l.
Tel: + 39 02 439201

Suomi/Finland
Gilead Sciences Sweden AB
Puh/Tel: + 46 (0) 8 5057 1849

Κύπρος
Gilead Sciences Ελλάς Μ.ΕΠΕ.
Τηλ: + 30 210 8930 100

Sverige
Gilead Sciences Sweden AB
Tel: + 46 (0) 8 5057 1849

Latvija
Gilead Sciences Ireland UC
Tel: + 353 (0) 1 686 1888

This leaflet was last revised in.

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

------------------------------------------------------------------------------------------------------------------------

The following information is intended for healthcare professionals only:

Instructions for Use-Sunlenca 464 mg solution for injection

Your pack contains

2 x vials

2 x vials access devices

2 x syringes

2 x 22G, 13mm injection needles

All the components are for single use.

A complete dose requires two 1.5 mL injections. The use of the vial access device is required.

Make sure that:
- Vial and prepared syringe contain a yellow-to-brown solution with no particles
- Contents are not damaged
- Product is not expired

1. Prepare Vial
Remove cap.
Clean vial stopper with alcohol wipe.
2. Prepare Vial Access Device
Push Down.
Twist off.

3., 4. Attach and Fill Syringe

- Attach syringe and inject 1.5 mL of air into vial.
- Flip upside down and withdraw all contents.
5. Attach 22G Injection Needle to Syringe, Expel Air Bubbles, and Prime to 1.5 mL

6. Clean an Injection Site on Patient’s Abdomen
Injection site options (at least 5 cm from navel)
7. Inject 1.5 mL of Sunlenca Subcutaneously

injection site options
(at least 5 cm from navel)
Grey hub
Insert fully
90° preferred
45° acceptable

8. Administer 2nd Injection

Repeat steps for
2nd injection at least 5 cm from first injection site

Package leaflet: Sunlenca 300 mg film-coated tablets

1. What Sunlenca is and what it is used for

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

Sunlenca is used in combination with other antiretroviral medicines to treat type 1 human immunodeficiency virus (HIV), the virus that cause 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).

Your doctor will advise 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 these 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 remedy used for depression and anxiety

 Do not take Sunlenca and tell your doctor immediately if you think this applies to you.

Warnings and precautions

Talk to your doctor before taking Sunlenca

Talk to your doctor or pharmacist if you have ever had severe liver disease, or if tests have shown problems with your liver. Your doctor will carefully consider whether to treat you with Sunlenca.

While you are using Sunlenca

Once you start using Sunlenca, look out for:

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

Other medicines and Sunlenca

Medicines that must 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 herbal remedy used for depression and anxiety

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

Talk to your doctor in particular if you are taking:

antibiotics containing:
rifabutin
anticonvulsants used to treat epilepsy and prevent seizures (fits), 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
medicine used to treat impotence and pulmonary hypertension, containing:
sildenafil or tadalafil
medicine used to treat impotence, containing:

vardenafil
corticosteroids (also known as ‘steroids’) taken orally or given by injection used to treat allergies, inflammatory bowel diseases, and other various illnesses involving inflammations in your body, containing:
dexamethasone or hydrocortisone/cortisone
medicines used to lower cholesterol, containing:
lovastatin or simvastatin
antiarrhythmics used to treat heart problems, containing:
digoxin
medicines used to help you sleep, containing:
midazolam or triazolam.
anticoagulants used to prevent and treat blood clots, containing:
rivaroxaban, dabigatran or edoxaban

 Tell 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 any treatment without contacting 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 precautionary measure you should avoid the use of Sunlenca during pregnancy unless your doctor tells you otherwise.

Driving and using machines

Sunlenca is not expected to have any effect on your ability to drive or use machines.

Sunlenca contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium- free’.

3. How to take Sunlenca

Your treatment with Sunlenca starts with tablets you take by mouth, followed by injections given by your doctor or nurse, as described below.

Talk to your doctor before taking the tablets. You will be advised when to start your tablets and when your appointment for the first injections will be scheduled.

Day 1 of treatment:
- Two tablets taken by mouth. These can be taken with or without food.

Day 2 of treatment:
- Two tablets taken by mouth. These can be taken with or without food.

Day 8 of treatment:
- One tablet taken by mouth. This can be taken with or without food.

Day 15 of treatment:
- Two injections into your abdomen (tummy) given at the same time by your doctor or nurse.

Every 6 months:
- Two injections into your 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 higher risk of side effects (see section 4, Possible side effects).

It is important not to miss a dose of Sunlenca tablets.

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

If you vomit within 3 hours after 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 more tablets until your next scheduled tablets or injection.

If you miss a Sunlenca injection

It is important that you attend your planned appointments every 6 months to receive your injections of Sunlenca. This will help to control your HIV infection and to stop your illness from getting worse.
If you think you will not be able to attend your appointment for your 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 can seriously affect how future HIV treatments work.

4. Possible side effects

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

Possible 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 from previous infections may occur soon after HIV treatment is started. It is thought that these symptoms are due to an improvement in the body’s immune response, enabling the body to fight infections that may have been present with no obvious symptoms.

Autoimmune disorders, when the immune system attacks healthy body tissue, may also occur after you start taking medicines for HIV infection. Autoimmune disorders may occur many months after the start of treatment. Look out for any symptoms of infection or other symptoms such as:
muscle weakness
weakness beginning in the hands and feet and moving up towards the trunk of the body
palpitations, tremor or hyperactivity

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

Common side effects
(may affect up to 1 in 10 people)
- Feeling sick (nausea)

5. How to store 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 EXP. The expiry date refers to the last day of that month.

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

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help 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 lenacapavir.

The other ingredients are

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

Film-coating
Polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol (E1521), talc (E553b), iron oxide yellow (E172), iron oxide black (E172), iron oxide red (E172).

What Sunlenca looks like and contents of the pack

Sunlenca film-coated tablets are beige, capsule-shaped, film-coated tablets, debossed with “GSI” on one side of the tablet and “62L” on the other side of the tablet. Sunlenca comes in a blister of 5 tablets surrounded by a blister card. The blister is placed within a foil pouch. The foil pouch contains a silica gel desiccant that must be kept in the foil pouch to help protect your tablets. The silica gel is contained in a separate sachet or canister and is not to 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

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien
Gilead Sciences Belgium SRL-BV
Tél/Tel: + 32 (0) 24 01 35 50

Lietuva
Gilead Sciences Ireland UC
Tel: + 353 (0) 1 686 1888

България
Gilead Sciences Ireland UC
Тел.: + 353 (0) 1 686 1888

Luxembourg/Luxemburg
Gilead Sciences Belgium SRL-BV
Tél/Tel: + 32 (0) 24 01 35 50

Česká republika
Gilead Sciences s.r.o.
Tel: + 420 910 871 986

Magyarország
Gilead Sciences Ireland UC
Tel.: + 353 (0) 1 686 1888

Danmark
Gilead Sciences Sweden AB
Tlf: + 46 (0) 8 5057 1849

Malta
Gilead Sciences Ireland UC
Tel: + 353 (0) 1 686 1888

Deutschland
Gilead Sciences GmbH
Tel: + 49 (0) 89 899890-0

Nederland
Gilead Sciences Netherlands B.V.
Tel: + 31 (0) 20 718 36 98

Eesti
Gilead Sciences Ireland UC
Tel: + 353 (0) 1 686 1888
Norge
Gilead Sciences Sweden AB
Tlf: + 46 (0) 8 5057 1849

Ελλάδα
Gilead Sciences Ελλάς Μ.ΕΠΕ.
Τηλ: + 30 210 8930 100

Österreich
Gilead Sciences GesmbH
Tel: + 43 1 260 830

España
Gilead Sciences, S.L.
Tel: + 34 91 378 98 30

Polska
Gilead Sciences Poland Sp. z o.o.
Tel.: + 48 22 262 8702

France
Gilead Sciences
Tél: + 33 (0) 1 46 09 41 00

Portugal
Gilead Sciences, Lda.
Tel: + 351 21 7928790

Hrvatska
Gilead Sciences Ireland UC
Tel: + 353 (0) 1 686 1888

România
Gilead Sciences (GSR) S.R.L.
Tel: + 40 31 631 18 00

Ireland
Gilead Sciences Ireland UC
Tel: + 353 (0) 214 825 999

Slovenija
Gilead Sciences Ireland UC
Tel: + 353 (0) 1 686 1888

Ísland
Gilead Sciences Sweden AB
Sími: + 46 (0) 8 5057 1849

Slovenská republika
Gilead Sciences Slovakia s.r.o.
Tel: + 421 232 121 210

Italia
Gilead Sciences S.r.l.
Tel: + 39 02 439201

Suomi/Finland
Gilead Sciences Sweden AB
Puh/Tel: + 46 (0) 8 5057 1849

Κύπρος
Gilead Sciences Ελλάς Μ.ΕΠΕ.
Τηλ: + 30 210 8930 100

Sverige
Gilead Sciences Sweden AB
Tel: + 46 (0) 8 5057 1849

Latvija
Gilead Sciences Ireland UC
Tel: + 353 (0) 1 686 1888

This leaflet was last revised in

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

Yeytuo

Package leaflet: Yeytuo 464 mg solution for injection

1. Prepare Vial

Remove cap.
Clean vial stopper with alcohol wipe.

2. Attach 18G Withdrawal Needle to Syringe

3. Fill Syringe

• Inject 1.5 mL of air into vial.
• Withdraw all contents.

4. Remove 18G Withdrawal Needle from Syringe

Pink hub
Pink hub

5. Assemble 22G Injection Needle to Syringe, Expel Air Bubbles and Prime to 1.5 mL

6. Select and Clean an Injection Site

Injection site options (at least 5 cm from navel)
7.
Inject 1.5 mL Yeytuo subcutaneously

8.
Administer 2nd Injection

= Injection site options
(at least 5 cm from navel)
Grey hub
90° preferred
45° acceptable
Insert fully
Repeat steps for 2nd injection at least 5 cm from first injection site

Package leaflet: Yeytuo 464 mg solution for injection

1. Prepare Vial

Remove cap.
Clean vial stopper with alcohol wipe.

2. Attach 18G Withdrawal Needle to Syringe

3. Fill Syringe

• Inject 1.5 mL of air into vial.
• Withdraw all contents.

4. Remove 18G Withdrawal Needle from Syringe

5. Assemble 22G Injection Needle to Syringe, Expel Air Bubbles and Prime to 1.5 mL

Pink hub
Pink hub
Gray hub

6. Select and Clean an Injection Site

Injection site options (at least 5 cm from navel)
7.
Inject 1.5 mL Yeytuo subcutaneously

8.
Administer 2nd Injection

= Injection site options
(at least 5 cm from navel)
Repeat steps for 2nd injection at least 5 cm from first injection site
90° preferred
45° acceptable
Insert fully

Package leaflet: Yeytuo 300 mg film-coated tablets

1. What Yeytuo is and what it is used for

Yeytuo contains the active substance lenacapavir. It is a long acting antiretroviral medicine known as a capsid inhibitor. Lenacapavir, the active substance in Yeytuo, binds to proteins of the HIV-1 virus’s outer layer, disrupting its ability to multiply and spread.

Yeytuo is used to help prevent HIV-1 infection in adults and adolescents weighing at least 35 kg who are at an increased risk of getting HIV-1. This is called pre-exposure prophylaxis (PrEP). It should be used in combination with safer sex practices.

Your doctor will advise you to take Yeytuo tablets when you are given Yeytuo injections for the first time.

If you are being given Yeytuo injections, but you plan to miss your scheduled Yeytuo injections, you can take Yeytuo tablets instead, until you can receive the injections again (see section 3).

2. What you need to know before you take Yeytuo

Do not take Yeytuo

If you are allergic to lenacapavir or any of the other ingredients of this medicine (listed in section 6).

If you do not know if you have HIV. You must get tested to make sure that you do not already have HIV before you start treatment with Yeytuo. Yeytuo can only prevent HIV if you don’t already have it.

If you are taking any of these 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 remedy used for depression and anxiety

 Do not take Yeytuo and tell your doctor or nurse immediately if you think any of these apply to you.

Warnings and precautions

Just taking Yeytuo may not stop you from getting HIV. Take extra measures to help prevent HIV while you are receiving Yeytuo
Always practice safer sex. Use condoms to reduce contact with semen, vaginal fluids, or blood.
Do not share or re-use needles or other injection or drug equipment.
Get tested for other sexually transmitted infections such as syphilis and gonorrhoea. These infections make it easier for HIV to infect you.

Get tested for HIV when your doctor or nurse tells you. You must get tested before starting Yeytuo and before every injection to make sure that you stay HIV negative while receiving this medicine.

Keep all your appointments to get your Yeytuo injections on time. Talk to your doctor or nurse if you are thinking about stopping injections: stopping may increase your risk of getting HIV. If you do stop, or miss your scheduled injections, you may need to take other medicines or precautions to reduce your risk of getting HIV and possibly developing viral resistance.

Tell your doctor or nurse straight away if you think you were infected with HIV. They may want to do more tests to make sure you still do not have HIV.

If you get a flu-like illness, it could mean you have recently been infected with HIV. These may be signs of HIV infection:
tiredness
fever
joint or muscle aches
headache
vomiting or diarrhoea
rash
night sweats
enlarged lymph nodes in the neck or groin.

 Tell your doctor or nurse about any flu-like illness, either in the month before starting Yeytuo, or at any time while taking Yeytuo.

Talk to your doctor or nurse if you have any more questions about how to prevent getting HIV.

Children and adolescents

Do not give this medicine to anyone weighing less than 35 kg because it has not been studied in these individuals.

Other medicines and Yeytuo

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

Medicines that must never be taken with Yeytuo:

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

carbamazepine, phenytoin, used to prevent seizures
St. John’s wort (Hypericum perforatum), a herbal remedy used for depression and anxiety

 If you are taking any of these medicines, do not take Yeytuo and tell your doctor or nurse immediately.

Talk to your doctor or nurse in particular if you are taking:

medicines used to treat some bacterial infections, such as tuberculosis, containing:
rifabutin or rifapentine
anticonvulsants used to treat epilepsy and prevent seizures, containing:
oxcarbazepine or phenobarbital
medicines used to treat migraine, containing:
dihydroergotamine or ergotamine
medicines used to treat impotence and pulmonary hypertension, containing:
sildenafil or tadalafil
medicine used to treat impotence, containing:
vardenafil
corticosteroids (also known as ‘steroids’) taken orally or given by injection used to treat allergies, inflammatory bowel diseases, and other illnesses involving inflammation in your body, containing:
dexamethasone or hydrocortisone/cortisone
medicines used to lower cholesterol, containing:
lovastatin or simvastatin
antiarrhythmics used to treat heart problems, containing:
digoxin
medicines used to help you sleep, containing:
midazolam or triazolam.
anticoagulants used to prevent and treat blood clots, containing:
rivaroxaban, dabigatran or edoxaban

 Tell your doctor or nurse if you are taking any of these medicines or if you start taking any of these medicines while receiving Yeytuo. Do not stop any treatment without contacting your doctor or nurse.

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, nurse or pharmacist for advice before taking this medicine.

If you are breast-feeding, or thinking about breast-feeding, you should discuss it with your doctor or nurse.

Driving and using machines

Yeytuo is not expected to have any effect on your ability to drive or use machines.

Yeytuo contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium- free’.

3. How to take Yeytuo

You must have a negative HIV test before starting Yeytuo and before every injection.

You will take tablets by mouth and your doctor or nurse will give you injections under the skin (subcutaneously) when you start Yeytuo. After that you will have injections every 6 months.

Day 1:
- Two tablets taken by mouth. These can be taken with or without food.
- Two injections given by your doctor or nurse. The two injections will be given at the same time at least 5 centimetres apart from each other and may be given into your abdomen (tummy) or thigh.

Day 2:
- Two tablets taken by mouth, as above.

Every 6 months:
- Two injections given by your doctor or nurse, as above.

If you have difficulty swallowing the tablet whole, you can split it in half. Take both halves of the tablet one after the other to get the full dose. Do not store the split tablet.

It is important that you attend your planned appointments every 6 months (26 weeks) to receive your injections of Yeytuo. This will continue to help protect you from getting HIV.
- Schedule your appointment with your doctor or nurse to make sure you will receive your next injections on time.
- You must receive your next injections within 28 weeks of your last injection.

If you take more Yeytuo than you should

Contact your doctor, nurse or pharmacist immediately for advice. If you take more than the recommended dose of Yeytuo, you may be at higher risk of side effects (see section 4, Possible side effects).

It is important not to miss a dose of Yeytuo tablets.

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

If you vomit within 3 hours after taking Yeytuo tablets, contact your doctor or nurse immediately and take another two tablets. If you vomit more than 3 hours after taking Yeytuo you do not need to take more tablets until your next scheduled tablets or injection.

If you miss a Yeytuo injection appointment

If you think you will not be able to attend an appointment for your injections, contact your doctor or nurse as soon as possible to discuss your options. If you need to miss a scheduled injection appointment, there is the option to temporarily take Yeytuo tablets instead.
Using Yeytuo tablets if you have to miss an injection appointment
Take one tablet by mouth, every 7 days until your injections resume. Tablets can be taken with or without food.
It is important to continue Yeytuo as your doctor or nurse recommends.

Do not stop taking Yeytuo without talking to your doctor or nurse.
Take Yeytuo for as long as your doctor recommends. Don’t stop unless your doctor advises you to.
Missing Yeytuo injections or tablets increases your risk of getting HIV.

4. Possible side effects

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

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. 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. How to store Yeytuo

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 bottle label after EXP.
The expiry date refers to the last day of that month.

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

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Yeytuo contains

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

The other ingredients are

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

Film-coating
Polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol (E1521), talc (E553b), iron oxide yellow (E172), iron oxide black (E172), iron oxide red (E172).

What Yeytuo looks like and contents of the pack

Yeytuo film-coated tablets are beige, capsule-shaped, film-coated tablets, debossed with “GSI” on one side of the tablet and “62L” on the other side of the tablet. Yeytuo comes in a bottle of 4 tablets. Each bottle contains a silica gel desiccant that must be kept in the bottle to help protect your tablets. The silica gel desiccant is contained in a separate packet and should not be swallowed.