Apretude 30 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Apretude 30 mg film-coated tablets

cabotegravir

This medicine is subject to additional monitoring, which will allow for quicker detection of new information on its safety. You can help by reporting any adverse reactions you may experience. Information on how to report adverse reactions is included at the end of section 4.

Read the entire leaflet carefully before you start taking 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Apretude tablets are and what they are used for

Apretude contains cabotegravir as the active substance. Cabotegravir belongs to a group of antiretroviral medicines called integrase inhibitors (INI).

Apretude is used to help prevent HIV-1 infection in adults and adolescents weighing at least 35 kg who are at higher risk of infection. This is known as pre-exposure prophylaxis: PrEP (see section 2).

It should be used in combination with safer sex practices, such as using condoms.

Your doctor may advise you to take Apretude tablets before receiving injectable Apretude for the first time (called the oral lead-in period, see section 3).

If you are already receiving injectable Apretude but are unable to receive your injection, your doctor may also recommend that you take Apretude tablets instead, until you can receive the injection again (see section 3).

2. What you need to know before taking Apretude tablets

Do not take Apretude

• if you have ever developed a severe skin rash, skin peeling, blisters, and/or mouth sores.

• if you are allergic (hypersensitive) to cabotegravir or to any of the other ingredients of this medicine (listed in section 6).

• If you are HIV positive or do not know whether you are HIV positive. Apretude can only help reduce the risk of acquiring HIV before infection occurs. You must be tested to ensure you are HIV negative before taking Apretude.

• if you are taking any of the following medicines:

• carbamazepine, oxcarbazepine, phenytoin, phenobarbital (medicines used to treat epilepsy and prevent seizures).

• rifampicin or rifapentine (medicines used to treat certain bacterial infections such as tuberculosis).

These medicines reduce the effectiveness of Apretude by decreasing the amount of Apretude in the blood.

If you think this applies to you, or if you are unsure, inform your doctor.

Warnings and precautions

Taking Apretude alone may not be sufficient to prevent HIV infection.

HIV infection is transmitted through sexual contact with someone who is HIV positive or through transfer of infected blood. Although Apretude reduces the risk of infection, you may still become infected with HIV despite receiving this medicine.

Other measures should be taken to further reduce the risk of HIV infection:

• Get tested for other sexually transmitted infections when your doctor advises. These infections make it easier for you to become infected with HIV.
• Use condoms during oral or penetrative sex.
• Do not share or reuse needles or other injection equipment or medical devices.
• Do not share personal items that may contain blood or body fluids (such as razors or toothbrushes).

Talk to your doctor about what additional precautions are necessary to further reduce the risk of HIV infection.

Reducing the risk of HIV infection:

There is a risk of developing resistance to this medicine if you become infected with HIV. This means the medicine may no longer protect you from becoming infected with HIV. To minimize this risk and prevent HIV infection, it is important that:

• take Apretude tablets every day as directed to reduce your risk, not only when you think you may have been exposed to HIV. Do not miss any doses of Apretude or stop taking it. Missing a dose may increase the risk of acquiring HIV infection.
• get tested for HIV when your doctor advises. You should be tested regularly to ensure you remain HIV-1 negative while taking Apretude.
• inform your doctor immediately if you think you may have become infected with HIV (you may have flu-like illness). You may need additional testing to confirm you remain HIV negative.

Liver problems

Inform your doctor if you have liver problems. You may need closer monitoring. (See also "Uncommon adverse effects" in section 4).

Adolescents

Your doctor will discuss your mental health with you before and during treatment with Apretude. Inform your doctor if you have mental health problems. You may need closer monitoring (see also section 4).

Severe skin reaction

Severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been very rarely reported in association with Apretude. If you notice any symptoms related to these severe skin reactions, stop taking Apretude and seek immediate medical attention.

Read the information in section 4 of this leaflet (“Possible side effects”).

Allergic reaction

Apretude contains cabotegravir, which is an integrase inhibitor. Integrase inhibitors, including cabotegravir, can cause a serious allergic reaction known as hypersensitivity reaction. You need to know the important signs and symptoms to watch for while taking Apretude.

Read the information in 'Possible side effects' in section 4 of this leaflet.

Children and adolescents

This medicine must not be used in children or adolescents under 12 years of age or weighing less than 35 kg, as it has not been studied in these populations.

Other medicines and Apretude

Inform your doctor if you are taking, have recently taken, or might need to take any other medicines, including medicines purchased without a prescription.

Some medicines may affect how Apretude works or increase the likelihood of you experiencing side effects. Apretude may also affect how other medicines work.

Apretude must not be administered with other medicines that may affect the efficacy of the medicine (see "Do not use Apretude" in section 2). These include:

• carbamazepine, oxcarbazepine, phenobarbital, or phenytoin (medicines used to treat epilepsy and prevent seizures).
• rifampicin or rifapentine (medicines used to treat certain bacterial infections, such as tuberculosis).

Inform your doctor if you are taking:

• antacids (medicines used to treat indigestion and heartburn). Antacids may prevent Apretude tablets from being absorbed into your body. Do not take these medicines within 2 hours before or at least 4 hours after taking Apretude.

Inform your doctor or pharmacist if you are taking any of these medicines. Your doctor may decide you need additional monitoring.

Pregnancy and breastfeeding

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

Pregnancy

Apretude is not recommended during pregnancy. The effect of Apretude on pregnancy is unknown. Consult your doctor if you may be pregnant, if you are planning to have a baby, or if you become pregnant. Your doctor will consider the benefit to you and the risk to your baby before starting or continuing Apretude.

Breastfeeding

It is unknown whether the components of Apretude pass into breast milk.

If you are breastfeeding or planning to breastfeed, consult your doctor. Your doctor will consider the benefits and risks of breastfeeding for you and your baby.

Driving and use of machines

Apretude may cause dizziness and other side effects that may reduce your alertness.

Do not drive or operate machinery unless you are certain it does not affect you.

Apretude contains lactose

If your doctor has informed you that you have an intolerance to certain sugars, consult with them before taking this medicine.

Apretude contains sodium

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

3. How to take Apretude tablets

Follow exactly the instructions given by your doctor for administering this medicine. If you are unsure, consult your doctor or pharmacist again.

You must be tested for HIV and receive a negative result before starting to take Apretude.

Before beginning treatment with injectable Apretude, you and your doctor may decide to start treatment first with cabotegravir tablets (called the oral lead-in period). This will allow your doctor to assess whether it is appropriate to switch to the injections.

If you decide to start treatment with tablets for the oral lead-in:

• You must take one 30 mg Apretude tablet once daily for approximately one month.
• After one month of tablets, you should receive your first injection on the same day you take your last tablet, or no more than 3 days after.
• Afterwards, you will receive an injection every 2 months.

Oral lead-in schedule

If you are unable to receive your Apretude injection, your doctor may recommend that you take Apretude tablets instead, until you can resume your injection schedule.

How to take the tablets

Apretude tablets should be swallowed with some water. They may be taken with or without food.

Do not take antacids (medicines used to treat indigestion and stomach acidity) during the 2 hours before or at least 4 hours after taking an Apretude tablet, as this may prevent the Apretude tablets from being absorbed by your body and reduce their effectiveness.

If you take more Apretude than you should

If you take too many Apretude tablets, contact your doctor or pharmacist immediately; you will receive the necessary treatment. If possible, show them the Apretude tablet bottle.

If you forget to take Apretude

If less than 12 hours have passed since the time you usually take Apretude, take the missed tablet as soon as possible. If more than 12 hours have passed, skip the missed dose and take the next dose at the usual time.

Do not take a double dose to make up for a missed dose.

If you vomit within 4 hours of taking Apretude, take another tablet. If you vomit more than 4 hours after taking Apretude, you do not need to take another tablet until your next scheduled dose.

Do not stop taking Apretude without consulting your doctor

Continue taking Apretude for as long as your doctor recommends. Do not stop taking it unless instructed by your doctor.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Stop taking Apretude and seek immediate medical attention if you notice any of the following symptoms:

• red, non-elevated spots, target-shaped or circular rashes on the trunk, often with blisters in the center, skin peeling, sores in the mouth, throat, nose, genitals, and eyes. These severe skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis). These serious skin reactions are very rare (may affect up to 1 in 10,000 people).

Allergic reactions

Apretude contains cabotegravir, which is an integrase inhibitor. Integrase inhibitors, including cabotegravir, can cause a serious allergic reaction known as hypersensitivity reaction.

If you experience any of the following symptoms:

• skin rash
• high temperature (fever)
• lack of energy (fatigue)
• swelling, sometimes of the face or mouth (angioedema), causing difficulty breathing
• muscle or joint pain

Seek medical advice immediately. Your doctor may consider it necessary to run tests to monitor your liver, kidneys, or blood and may instruct you to stop taking Apretude.

Very common side effects

(may affect more than 1 in 10 people)

• headache
• diarrhoea
• feeling hot (pyrexia)
• changes in liver function (increased transaminases), detected in blood tests.

Common side effects

(may affect up to 1 in 10 people)

• depression
• anxiety
• abnormal dreams
• difficulty sleeping (insomnia)
• dizziness
• feeling sick (nausea)
• vomiting
• stomach ache (abdominal pain)
• gas (flatulence)
• rash
• muscle pain (myalgia)
• lack of energy (fatigue)
• general malaise.

Uncommon side effects

(may affect up to 1 in 100 people)

• suicide attempt and suicidal thoughts (especially in users with a history of depression or mental health problems)
• allergic reaction (hypersensitivity)
• hives (urticaria)
• swelling, sometimes of the face or mouth (angioedema), which may cause difficulty breathing
• feeling drowsy (somnolence)
• weight gain
• liver damage (hepatotoxicity). Signs may include yellowing of the skin and whites of the eyes, loss of appetite, itching, stomach tenderness, pale-coloured stools, or abnormally dark urine
• increased bilirubin in the blood, a breakdown product of red blood cells, detected in blood tests.

Reporting of side effects

If you experience any type of side effect, talk to your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through 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 Apretude tablets

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

Do not use this medicine after the expiry date stated on the label of the bottle and the carton after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage temperature.

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

6. Contents of the pack and other information

Composition of Apretude

• The active substance is cabotegravir. Each tablet contains 30 mg of cabotegravir.

The other components are:

Tablet core

Lactose monohydrate
Microcrystalline cellulose (E460)
Hypromellose (E464)
Sodium carboxymethylstarch
Magnesium stearate

Tablet coating

Hypromellose (E464)
Titanium dioxide (E171)
Macrogol (E1521)

Appearance of the product and contents of the pack

Apretude film-coated tablets are white, oval-shaped, and marked with 'SV CTV' on one side.

Film-coated tablets are supplied in bottles with child-resistant closures.

Each bottle contains 30 film-coated tablets.

Marketing Authorization Holder

ViiV Healthcare BV
Van Asch van Wijckstraat 55H,
3811 LP Amersfoort
The Netherlands

Manufacturer

Glaxo Wellcome S.A.
Avenida de Extremadura 3
09400 Aranda de Duero (Burgos)
Spain

Further information on this medicinal product is available from the local representative of the Marketing Authorization Holder:

Date of the most recent review of this leaflet: {MM/YYYY}.

Other sources of information

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