Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - vocabria

Document Subject

Generated Narrative: MedicinalProductDefinition mp1e7f57f62efba41459076aa92d00da1a

identifier: http://ema.europa.eu/identifier/EU/1/20/1481/002

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: 400 mg

type: Full name

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part: nan

type: Invented name part

part

part: nan

type: Scientific name part

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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-1e7f57f62efba41459076aa92d00da1a

identifier: http://ema.europa.eu/identifier/EU/1/20/1481/002

status: Final

type: Package Leaflet

category: Raw

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

author: Organization ACME industry

title: TEST PURPOSES ONLY - vocabria

Attesters

What is in this leaflet

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

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

Vocabria injection is used to treat HIV (human immunodeficiency virus) infection in adults aged years and over, who are also receiving another antiretroviral medicine called rilpivirine and whose HIV-1 infection is under control.

Vocabria injections do not cure HIV infection; they keep the amount of virus in your body at a low level. This helps maintain the number of CD4 cells in your blood. CD4 cells are a type of white blood cells that are important in helping your body to fight infection.

Vocabria injection is always given in combination with another injection of an anti-retroviral medicine called rilpivirine injection. Refer to the rilpivirine package leaflet for information on that medicine.

Do not receive a Vocabria injection:
if you are allergic (hypersensitive) to cabotegravir or any of the other ingredients of this medicine (listed in section 6). if you are taking any of these medicines as they may affect the way Vocabria works:

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

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

  If you think this applies to you, tell your doctor.

Warnings and precautions

Allergic reaction
Vocabria 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 Vocabria.

Read the information in section 4 of this leaflet.

Liver problems including hepatitis B and/or C Tell your doctor if you have or have had problems with your liver, including hepatitis B and/or C. Your doctor may evaluate how severe your liver disease is before deciding if you can take Vocabria.

Look out for important symptoms Some people taking medicines for HIV infection develop other conditions, which can be serious.
You need to know about important signs and symptoms to look out for while you re taking Vocabria. These include:

• symptoms of infections

• symptoms of liver damage.

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

If you get any symptoms of infection or liver damage:

Tell your doctor immediately. Don t take other medicines for the infection without your doctor s advice.

Regular appointments are important It is important that you attend your planned appointments to receive your Vocabria 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 Vocabria injection, or if you stop receiving Vocabria, you will need to take other medicines to treat HIV infection and to reduce the risk of developing viral resistance.

Vocabria injection is a long acting medication. If you stop treatment, low levels of cabotegravir (the active ingredient of Vocabria) can remain in your system for up to 12 months or more after your last injection. These low levels of cabotegravir will not protect you against the virus and the virus may become resistant. You must start a different HIV treatment within one month of your last Vocabria injection if you are having monthly injections, and within two months of your last Vocabria injection if you are having injections every two months.

Children and adolescents This medicine is not for use in children or adolescents less than 18 years of age, because it has not been studied in these patients.

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

Vocabria must not be given with some other medicines. (see Do not receive a Vocabria injection
earlier in section 2).

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

Tell your doctor if you are taking:

rifabutin (to treat some bacterial infections such as tuberculosis).

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby:

Talk to your doctor before receiving a Vocabria injection

Pregnancy

• Vocabria is not recommended during pregnancy. If needed, your doctor will consider the benefit to you and the risk to your baby of receiving Vocabria injections while you're pregnant. If you are planning to have a baby, talk to your doctor in advance
• If you have become pregnant, do not stop attending your appointments to receive a Vocabria injection without consulting your doctor.

Breast-feeding Breast-feeding is not recommended in women living with HIV because HIV infection can be passed on to the baby in breast milk.

It is not known whether the ingredients of Vocabria injection can pass into breast milk. However, it is possible that cabotegravir may still pass into breast milk for 12 months after the last injection of Vocabria.

If you re breast-feeding, or thinking about breast-feeding, you should discuss it with your doctor as soon as possible.

Driving and using machines

Vocabria 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.

You will be given Vocabria as an injection, either once every month or once every 2 months, together with another injection of medicine called rilpivirine. Your doctor will advise you of your dosing schedule.

A nurse or doctor will give you Vocabria through an injection in the muscle of your buttock (intramuscular, or IM, injection).

• When you first start treatment with Vocabria you and your doctor may decide to either start treatment with cabotegravir tablets or start treatment directly with a Vocabria injection: If you decide to start treatment with tablets, your doctor will tell you:
• to take one 30 mg Vocabria tablet and one 25 mg rilpivirine tablet, once a day, for approximately one month
• after that receive monthly or every 2 month injections.

This first month of Vocabria and rilpivirine tablets is called the oral lead-in period. It allows your doctor to assess whether it s appropriate to proceed with injections.

Injection schedule for monthly dosing

When Which medicine First injection Second injection onwards, every month Vocabria 600 mg injection 400 mg injection every month Rilpivirine 900 mg injection 600 mg injection every month

Injection Schedule for every 2 month dosing
Which medicine When First and second injections, one month apart Third injection onwards, every two months
Vocabria 600 mg injection 600 mg injection every 2 months Rilpivirine 900 mg injection 900 mg injection every 2 months

If you miss a Vocabria injection

Contact your doctor immediately to make a new appointment

It is important that you keep your regular planned appointments to receive your injection to control your HIV and to stop your illness from getting worse. Talk to your doctor if you are thinking about stopping treatment.

Talk to your doctor if you think you will not be able to receive your Vocabria injection at the usual time. Your doctor may recommend you take Vocabria tablets or another HIV treatment instead, until you are able to receive Vocabria injection again.

If you are given too much Vocabria 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.

Don t stop receiving Vocabria injections without advice from your doctor. Keep receiving Vocabria injections for as long as your doctor recommends. Don t stop unless your doctor advises you to. If you stop, your doctor must start you on another HIV treatment within a month of your last Vocabria injection if you are having monthly injections, and within two months of your last Vocabria injection if you are having injections every two months, to reduce the risk of developing viral resistance.

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 Vocabria 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 reaction (rash, hives) 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 Vocabria.

Very common side effects
These may affect more than 1 in 10 people:

• headache
• injection site reactions. In clinical studies, these were generally mild to moderate and became less frequent over time. Symptoms may include: * very common: pain and discomfort, a hardened mass or lump * common: redness, itching, swelling, warmth, bruising, (which may include discolouration or a collection of blood under the skin) * uncommon: numbness, minor bleeding, an abscess (collection of pus) or cellulitis (heat, swelling or redness).
• feeling hot (pyrexia), which may occur within one week after injections.

Common side effects
These 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)
• diarrhoea
• rash
• muscle pain (myalgia)
• lack of energy (fatigue)
• feeling weak (asthenia)
• generally feeling unwell (malaise)
• weight gain.

Uncommon side effects
These may affect up to 1 in 100 people:

• suicide attempt and suicidal thoughts (particularly in patients who have had depression or mental health problems before)
• allergic reaction (hypersensitivity)
• hives (urticaria)
• swelling, sometimes of the face or mouth (angioedema), causing difficulty in breathing
• feeling drowsy (somnolence)
• feeling lightheaded, during or following an injection. This may lead to fainting
• liver damage (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)
• changes in liver blood tests (increase in transaminases or increase in bilirubin).

Other side effects that may show up in blood tests

• an increase in lipases (a substance produced by the pancreas)

Other possible side effects

People receiving Vocabria and rilpivirine therapy for HIV may get other side effects.

Pancreatitis

If you get severe pain in the abdomen (tummy), this may be caused by inflammation of your pancreas (pancreatitis).

Tell your doctor, especially if the pain spreads and gets worse.

Symptoms of infection and inflammation

People with advanced HIV infection (AIDS) have weak immune systems and are more likely to develop serious infections (opportunistic infections). When they start treatment, the immune system becomes stronger, so the body starts to fight infections. Symptoms of infection and inflammation may develop, caused by either: old, hidden infections flaring up again as the body fights them
the immune system attacking healthy body tissue (autoimmune disorders).

The symptoms of autoimmune disorders may develop many months after you start taking medicine to treat your HIV infection.

Symptoms may include: muscle weakness and/or muscle pain joint pain or swelling weakness beginning in the hands and feet and moving up towards the trunk of the body palpitations or tremor hyperactivity (excessive restlessness and movement).

If you get any symptoms of infection:

Tell your doctor immediately. Don t take other medicines for the infection without your doctor s advice.

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.

This medicine does not require any special temperature storage conditions.

Do not freeze.

What Vocabria contains

• The active substance is cabotegravir.

Each 2 ml vial contains 400 mg cabotegravir.

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

What Vocabria looks like and contents of the pack Cabotegravir prolonged release suspension for injection is presented in a brown glass vial with a rubber stopper. The pack also contains 1 syringe, 1 vial adaptor, and 1 injection needle.

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

Manufacturer GlaxoSmithKline Manufacturing SpA Strada Provinciale Asolana, San Polo di Torrile Parma, 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. S mi: +354 535 7Slovensk republika ViiV Healthcare BV
Tel: + 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: