Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - apretude

Document Subject

Generated Narrative: MedicinalProductDefinition mp4a43236fb582d17d10a1516a86f60348

identifier: http://ema.europa.eu/identifier/EU/1/23/1760/002

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Apretude 600 mg prolonged-release suspension for injection

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

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part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-4a43236fb582d17d10a1516a86f60348

identifier: http://ema.europa.eu/identifier/EU/1/23/1760/002

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - apretude

Attesters

What is in this leaflet

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

Apretude contains the active ingredient cabotegravir. Cabotegravir belongs to a group of anti- retroviral medicines called integrase inhibitors (INIs).

Apretude is used to help prevent HIV-1 infection in adults and adolescents weighing at least 35kg who are at an increased risk of infection. This is called pre-exposure prophylaxis: PrEP (see section 2).
It should be used in combination with safer sex practices, such as use of condoms.

Do not use Apretude:
if you are allergic (hypersensitive) to cabotegravir or any of the other ingredients of this medicine (listed in section 6). If you are HIV positive or you do not know if you are HIV positive. Apretude can only help reduce your risk of getting HIV before you are infected. You must get tested to make sure you are HIV negative before taking Apretude. if you are taking any of the following medicines: *carbamazepine, oxcarbazepine, phenytoin, phenobarbital (medicines to treat epilepsy and prevent fits). *rifampicin or rifapentine (medicines to treat some bacterial infections such as tuberculosis).

These medicines reduce the effectiveness of Apretude by decreasing the amount of Apretude in the blood. If you think these apply to you, or if you are not sure, tell your doctor.

Warnings and precautions

Just taking Apretude may not prevent HIV infection.

HIV infection is spread by sexual contact with someone who is HIV positive or by transfer of infected blood. Although Apretude lowers the risk of becoming infected, you can still get HIV when taking this medicine.
Other measures should be taken to further reduce your risk of getting HIV:

• Get tested for other sexually transmitted infections when your doctor tells you to. These infections make it easier for HIV to infect you.
• Use a condom when you have oral or penetrative sex.
• Do not share or re-use needles or other injection or drug equipment.
• Do not share personal items that may have blood or body fluids on them (such as razor blades or toothbrushes).
  Discuss with your doctor the additional precautions needed to further decrease the risk of getting HIV.

Reduce the risk of getting HIV: There is a risk of resistance to this medicine if you get infected with HIV. This means that the medicine will not prevent HIV infection. To minimise this risk and to prevent infection with HIV, it is important that you:
attend your planned appointments to receive your Apretude injection. Talk to your doctor if you are thinking about stopping injections, as this may increase your risk of getting a HIV infection. If you do stop, or are late receiving your Apretude injection, you will need to take other medicines or precautions to reduce your risk of getting HIV and possibly developing viral resistance.
get tested for HIV when your doctor tells you. You must be regularly tested to make sure that you remain HIV-1 negative while taking Apretude. tell your doctor straight away if you think you have been infected with HIV (you may get a flu- like illness). They may want to do more tests to make sure you are still HIV negative. Apretude injection is a long-acting medicine If you stop Apretude injections, cabotegravir will remain in your system for up to a year or more after your last injection, but this will not be enough to protect you from becoming infected.
It is important that you attend your planned appointments to receive Apretude injection. Talk to your doctor if you are thinking about stopping PrEP.
Once you stop Apretude injections you may need to take other medicines to reduce the risk of getting HIV infection or use other safe sex precautions.
Liver problems Let your doctor know if you have liver problems. You may need to be more closely monitored. (See also Uncommon side effects in section 4). Adolescents
Your doctor will discuss your mental health with you before and while receiving Apretude. Let your doctor know if you have mental health problems. You may need to be more closely monitored (See also section 4).

Allergic reaction
Apretude contains cabotegravir, which is an integrase inhibitor. Integrase inhibitors, including cabotegravir, can cause a serious allergic reaction known as a hypersensitivity reaction. You need to know about important signs and symptoms to look out for while you re receiving Apretude.

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

Children and adolescents This medicine should not be used in children or adolescents weighing less than 35 kg, because it has not been studied in these individuals.

Other medicines and Apretude
Tell your doctor if you are taking, have recently taken or might take any other medicines, including other medicines bought without a prescription.

Some medicines can affect how Apretude works or make it more likely that you will have side effects. Apretude can also affect how some other medicines work.

Apretude must not be given with some other medicines that may affect how well the medicine works
. (see Do not use Apretude in section 2). These include: *carbamazepine, oxcarbazepine, phenytoin, phenobarbital (medicines to treat epilepsy and prevent fits). *rifampicin or rifapentine (medicines to treat some bacterial infections such as tuberculosis).

Tell your doctor if you are taking: rifabutin (to treat some bacterial infections such as tuberculosis). You may need to receive Apretude injections more often.

Tell your doctor or pharmacist if you are taking this medicine. Your doctor may decide that you need extra check-ups.

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 for advice before receiving this medicine.

Pregnancy Apretude is not recommended during pregnancy. The effect of Apretude on pregnancy is unknown. Talk to your doctor: if you could get pregnant, if you are planning to have a baby or if you become pregnant. Do not stop attending your appointments to receive Apretude without consulting your doctor. Your doctor will consider the benefit to you and the risk to your baby of starting/continuing Apretude.

Breast-feeding It is not known whether the ingredients of Apretude can pass into breast milk. However, cabotegravir, may pass into breast milk for up to 12 months after the last injection of Apretude. If you are breast- feeding, or thinking about breast-feeding, check with your doctor. Your doctor will consider the benefit and risks of breast-feeding for you and your baby.

Driving and using machines

Apretude can make you dizzy and have other side effects that make you less alert.
Don t drive or use machines unless you are sure you re not affected.

This medicine is given as a 600 mg injection. A nurse or doctor will give you Apretude in the muscle of your buttock.

You must have a HIV-negative test before being given Apretude.

You will be given your first and second dose of Apretude one month apart. After the second dose, you will be given Apretude as a single injection once every 2 months.

Before starting treatment with Apretude injections, you and your doctor may decide first take cabotegravir tablets (called oral lead-in period). The lead-in period allows you and your doctor to assess whether it s appropriate to proceed with injections. If you decide to start treatment with tablets: *You should take one 30 mg Apretude tablet once a day, for approximately one month. *You should have your first injection on the same day as your last tablet or no later than 3 days after. *You will then receive an injection every 2 months Injection Schedule for every 2 month dosing
When Which medicine First and second injection one month apart Apretude 600 mg Third injection onwards, every two months Apretude 600 mg

If you are given too much Apretude injection A doctor or 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 nurse and you will be treated as needed.

If you miss a Apretude injection Contact your doctor immediately to make a new appointment.
It is important that you keep your regular planned appointments to receive your injection and reduce the risk of getting HIV (see section 2). Talk to your doctor if you are thinking about stopping Apretude.

Talk to your doctor if you think you will not be able to receive your Apretude injection at the usual time. Your doctor may recommend you take cabotegravir tablets instead, until you are able to receive an Apretude injection again.

Don t stop receiving Apretude injections without advice from your doctor. Keep receiving Apretude injections for as long as your doctor recommends. Don t stop unless your doctor advises you to. If you stop and you are still at risk of getting HIV your doctor must start you on another PrEP medicine within 2 months of your last Apretude injection.

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

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

Allergic reactions

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

If you get any of the following symptoms: skin rash a high temperature (fever) lack of energy (fatigue) swelling, sometimes of the face or mouth (angioedema), causing difficulty in breathing muscle or joint aches.

See a doctor straight away. Your doctor may decide to carry out tests to check your liver, kidneys or blood, and may tell you to stop taking Apretude.

Very common side effects (may affect more than 1 in 10 people)
headache diarrhoea injection site reactions: * very common: pain and discomfort, a hardened mass (induration), or lump (nodule) * common: redness (erythema), itching (pruritus), swelling, warmth, numbness (aneasthesia) or bruising, (which may include discolouration or a collection of blood under the skin) * uncommon: collection of pus (abscess)

• feeling hot (pyrexia)
• changes in liver function (transaminase increased), as measured in blood tests

Common side effects (may affect up to 1 in 10 people)

• depression
• anxiety
• abnormal dreams
• difficulty in sleeping (insomnia)
• dizziness
• feeling sick (nausea)
• vomiting
• stomach pain (abdominal pain)
• wind (flatulence)
• rash
• muscle pain (myalgia)
• lack of energy (fatigue)
• generally feeling unwell (malaise)

Uncommon side effects (may affect up to 1 in 100 people)

• suicide attempt
• suicidal thoughts (particularly in individuals who have had depression or mental health problems before)
• allergic reaction (hypersensitivity)
• hives (urticaria)
• swelling (angioedema), sometimes of the face or mouth, which can cause difficulty in breathing
• feeling drowsy (somnolence)
• weight gain.
• feeling lightheaded, during or following an injection (vasovagal reactions). This may lead to fainting.
• liver damage (hepatotoxicity). Signs may include yellowing of the skin and the whites of the eyes, loss of appetite, itching, tenderness of the stomach, light-coloured stools or unusually dark urine.
• Increase in blood bilirubin, a breakdown product of red blood cells, as measured in blood tests.

Reporting of side effects
If you get any side effects, talk to your doctor 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.

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

The doctor or nurse is responsible for storing this medicine correctly.

Do not freeze.

What Apretude contains
The active substance is cabotegravir.

Each 3 ml vial contains 600 mg cabotegravir.

The other ingredients are:
Mannitol (E421) Polysorbate 20 (E432) Macrogol (E1521) Water for injections

What Apretude looks like and contents of the pack Cabotegravir is a white to light pink suspension, presented in a brown glass vial with a rubber stopper and an aluminium overseal with a plastic flip-cap.

Marketing Authorisation Holder ViiV Healthcare BV Van Asch van Wijckstraat 55H,
3811 LP Amersfoort
Netherlands

Manufacturer GlaxoSmithKline Manufacturing S.p.A. Strada Provinciale Asolana Torrile PR 43Italy

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

Belgi /Belgique/Belgien ViiV Healthcare srl/bv
T l/Tel: + 32 (0) 10 85 65 Lietuva ViiV Healthcare BV
Tel: + 370 80000
ViiV Healthcare BV
Te .: + 359 80018Luxembourg/Luxemburg ViiV Healthcare srl/bv
Belgique/Belgien T l/Tel: + 32 (0) 10 85 65 esk republika GlaxoSmithKline, s.r.o. Tel: + 420 222 001 cz.info@gsk.com

Magyarorsz g ViiV Healthcare BV
Tel.: + 36 80088Danmark GlaxoSmithKline Pharma A/S Tlf: + 45 36 35 91 dk-info@gsk.com

Malta ViiV Healthcare BV
Tel: + 356 80065Deutschland ViiV Healthcare GmbH
Tel.: + 49 (0)89 203 0038-viiv.med.info@viivhealthcare.com

Nederland ViiV Healthcare BV Tel: + 31 (0) 33 2081Eesti ViiV Healthcare BV
Tel: + 372 8002Norge GlaxoSmithKline AS Tlf: + 47 22 70 20
GlaxoSmithKline A.E.B.E. : + 30 210 68 82 sterreich GlaxoSmithKline Pharma GmbH Tel: + 43 (0)1 97075 0 at.info@gsk.com

Espa a Laboratorios ViiV Healthcare, S.L. Tel: + 34 900 923 es-ci@viivhealthcare.com

Polska GSK Services Sp. z o.o. Tel.: + 48 (0)22 576 9France ViiV Healthcare SAS T l.: + 33 (0)1 39 17 69 Infomed@viivhealthcare.com

Portugal VIIVHIV HEALTHCARE, UNIPESSOAL, LDA Tel: + 351 21 094 08 viiv.fi.pt@viivhealthcare.com

Hrvatska ViiV Healthcare BV
Tel: + 385 800787Rom nia ViiV Healthcare BV
Tel: + 40 800672Ireland GlaxoSmithKline (Ireland) Limited Tel: + 353 (0)1 4955Slovenija ViiV Healthcare BV
Tel: + 386 80688 sland Vistor hf.

Slovensk republika ViiV Healthcare BV
S mi: +354 535 7Tel: + 421 800500Italia ViiV Healthcare S.r.l Tel: + 39 (0)45 7741Suomi/Finland GlaxoSmithKline Oy Puh/Tel: + 358 (0)10 30 30
ViiV Healthcare BV : + 357 80070Sverige GlaxoSmithKline AB Tel: + 46 (0)8 638 93 info.produkt@gsk.com

Latvija ViiV Healthcare BV
Tel: + 371 80205United Kingdom (Northern Ireland) ViiV Healthcare BV
Tel: + 44 (0)800 221customercontactuk@gsk.com

This leaflet was last revised in {MM/YYYY}

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: