Vocabria - patient leaflet, side effects, dosage

B. PACKAGE LEAFLET

Package leaflet: Information for the patient

Vocabria 400 mg prolonged-release suspension for injection cabotegravir

This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• – Keep this leaflet. You may need to read it again.

• – If you have any further questions, ask your doctor or nurse.

• – If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

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

1. What Vocabria is and what it is used for

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

Vocabria injection is used to treat HIV (human immunodeficiency virus) infection in adults aged 18 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.

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

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. Other integrase inhibitors 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 ‘Other possible side effects’ 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.

Protect other people

HIV infection is spread by sexual contact with someone who has the infection, or by transfer of infected blood (for example, by sharing injection needles). You can still pass on HIV when receiving this medicine, although the risk is lowered by effective antiretroviral therapy. Discuss with your doctor the precautions needed to avoid infecting other people.

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

Women who are HIV-positive must not breast feed , 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:

• ■ ^ Talk to your doctor immediately.

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.

• 3. How Vocabria injections are given

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 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.

4. Possible side effects

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

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:

o very common: pain and discomfort, a hardened mass or lump

o common: redness, itching, swelling, warmth, bruising, (which may include discolouration or a collection of blood under the skin)

o 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)
• 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.

Allergic reactions

Vocabria contains cabotegravir, which is an integrase inhibitor. Other integrase inhibitors can cause a serious allergic reaction known as a hypersensitivity reaction, although this has not been seen with Vocabria.

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 Vocabria.

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. Y ou can also report side effects directly via the national reporting system listed in By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Vocabria

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.

6. Contents of the pack and other information

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, 90

San Polo di Torrile

Parma, 43056

Italy

For any information about this medicine, please

Authorisation Holder:

België/Belgiqu­e/Belgien

ViiV Healthcare srl/bv

Tél/Tel: + 32 (0) 10 85 65 00

Efc^rapufl

ViiV Healthcare BV

Ten.: + 359 80018205

contact the local representative of the Marketing

Lietuva

ViiV Healthcare BV

Tel: + 370 80000334

Luxembourg/Lu­xemburg

ViiV Healthcare srl/bv

Belgique/Belgien

Tel/Tel: + 32 (0) 10 85 65 00

Česká republika GlaxoSmithKline, s.r.o. Tel: + 420 222 001 111	Magyarország ViiV Healthcare BV Tel.: + 36 80088309
Danmark GlaxoSmithKline Pharma A/S Tlf: + 45 36 35 91 00	Malta ViiV Healthcare BV Tel: + 356 80065004

Deutschland ViiV Healthcare GmbH Tel.: + 49 (0)89 203 0038–10	Nederland ViiV Healthcare BV Tel: + 31 (0) 33 2081199
Eesti ViiV Healthcare BV Tel: + 372 8002640	Norge GlaxoSmithKline AS Tlf: + 47 22 70 20 00
EXÀàôa GlaxoSmithKline Movonpôoœnn A.E.B.E. Tql: + 30 210 68 82 100	Österreich GlaxoSmithKline Pharma GmbH Tel: + 43 (0)1 97075 0
España Laboratorios ViiV Healthcare, S.L. Tel: + 34 900 923 501	Polska GSK Services Sp. z o.o. Tel.: + 48 (0)22 576 9000

France ViiV Healthcare SAS Tél.: + 33 (0)1 39 17 69 69	Portugal VIIVHIV HEALTHCARE, UNIPESSOAL, LDA Tel: + 351 21 094 08 01
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Italia ViiV Healthcare S.r.l Tel: + 39 (0)45 7741600	Suomi/Finland GlaxoSmithKline Oy Puh/Tel: + 358 (0)10 30 30 30
Kùnpoç ViiV Healthcare BV Tql: + 357 80070017	Sverige GlaxoSmithKline AB Tel: + 46 (0)8 638 93 00

United Kingdom (Northern Ireland)

ViiV Healthcare BV

Tel: + 44 (0)800 221441

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:

.

The following information is intended for healthcare professionals only:

Vocabria 2 mL injection Instructions for use:

Overview

A complete dose requires two injections: VOCABRIA and rilpivirine

• 2 mL of cabotegravir and 2 mL of rilpivirine.

Cabotegravir and rilpivirine are suspensions that do not need further dilution or reconstitution. The preparation steps for both medicines are the same.

Cabotegravir and rilpivirine are for intramuscular use only. Both injections must be administered to the gluteal sites. The administration order is not important.

| Note: The ventrogluteal site is recommended.

Storage information

• This medicine does not require any special storage conditions.

| Do not freeze.

Your pack contains

• 1 vial of cabotegravir
• 1 vial adaptor
• 1 syringe
• 1 injection needle (0.65 mm, 38 mm [23 gauge, 1.5 inches])

Consider the patient’s build and use medical judgment to select an appropriate injection needle length.

You will also need

• Non-sterile gloves
• 2 alcohol swabs
• 2 gauze pads
• A suitable sharps container
• 1 rilpivirine 2 mL pack

Make sure to have the rilpivirine pack close by before starting.

Preparation 1. Inspect vial

• Check that the expiry date has not passed.
• Inspect the vial immediately. If you can see foreign matter, do not use the product.

I Note: The cabotegravir vial has a brown tint to the glass.

Do not use if the expiry date has passed.

• 2. Wait 15 minutes

  
  

If the pack has been stored in a fridge, remove and wait at least 15 minutes before you are ready to give the injection to allow the medicine to come to room temperature.

• 3. Shake vigorously

  
  

• Hold the vial firmly and vigorously shake for a full 10 seconds as shown.
• Invert the vial and check the resuspension. It should look uniform. If the suspension is not uniform, shake the vial again.
• It is also normal to see small air bubbles.

• Remove the cap from the vial.
• Wipe the rubber stopper with an alcohol swab.

I Do not allow anything to touch the rubber stopper after wiping it.

• Peel off the paper backing from the vial adaptor packaging.

I Note: Keep the adaptor in place in its packaging for the next step.

• Press the vial adaptor straight down onto the vial using the packaging, as shown.

The vial adaptor should snap securely into place.

• When you are ready, lift off the vial adaptor packaging as shown.
• Remove the syringe from its packaging.
• Draw 1 mL of air into the syringe. This will make it easier to draw up the liquid later.
• Hold the vial adaptor and vial firmly, as shown.
• Screw the syringe firmly onto the vial adaptor.
• Press the plunger all the way down to push the air into the vial.
• Invert the syringe and vial, and slowly withdraw as much of the liquid as possible into the syringe. There might be more liquid than the dose amount.
• Screw the syringe off the vial adaptor, holding the vial adaptor as shown.

I Note: Keep the syringe upright to avoid leakage. Check that the cabotegravir suspension looks uniform and white to light pink.

• Peel open the needle packaging part way to expose the needle base.
• Keeping the syringe upright, firmly twist the syringe onto the needle.
• Remove the needle packaging from the needle.
• life’
• Ventrogluteal (recommended)
• Dorsogluteal (upper outer quadrant)

Note: For gluteal intramuscular use only. Do not inject intravenously.

13. Remove cap

• Fold the needle guard away from the needle.
• Pull off the injection needle cap.

14. Remove extra liquid

2^ ■– 2 mL

• Hold the syringe with the needle pointing up. Press the plunger to the 2 mL dose to remove extra liquid and any air bubbles.

Note: Clean the injection site with an alcohol swab. Allow the skin to air dry before continuing.

15. Stretch skin

1 inch (2.5 cm) ^11

Use the z-track injection technique to minimise medicine leakage from the injection site.

• Firmly drag the skin covering the injection site, displacing it by about an inch (2.5 cm).
• Keep it held in this position for the injection.

• Fold the needle guard over the needle.
• Gently apply pressure using a hard surface to lock the needle guard in place.
• The needle guard will make a click when it locks.
• Dispose of used needles, syringes, vials and vial adaptors according to local health and safety laws.

• 1. How long can the medicine be left in the syringe?

Once the suspension has been drawn into the syringe, the injection should be used immediately, from a microbiological point of view.

Chemical and physical in-use stability has been demonstrated for 2 hours at 25 °C.

• 2. Why do I need to inject air into the vial?

Injecting 1 mL of air into the vial makes it easier to draw up the dose into the syringe.

Without the air, some liquid may flow back into the vial unintentionally, leaving less than intended in the syringe.

• 3. Does the order in which I give the medicines matter?

No, the order is unimportant.

• 4. If the pack has been stored in the fridge, is it safe to warm the vial up to room temperature more quickly?

It is best to let the vial come to room temperature naturally. However, you can use the warmth of your hands to speed up the warm up time, but make sure the vial does not get above 30°C.

Do not use any other heating methods.

• 5. Why is the ventrogluteal administration approach recommended?

The ventrogluteal approach, into the gluteus medius muscle, is recommended because it is located away from major nerves and blood vessels. A dorso-gluteal approach, into the gluteus maximus muscle, is acceptable, if preferred by the health care professional. The injection should not be administered in any other site.

Package leaflet: Information for the patient

Vocabria 600 mg prolonged-release suspension for injection

cabotegravir

This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• – Keep this leaflet. You may need to read it again.

• – If you have any further questions, ask your doctor or nurse.

• – If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

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

1. What Vocabria is and what it is used for

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

Vocabria injection is used to treat HIV (human immunodeficiency virus) infection in adults aged 18 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.

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

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. Other integrase inhibitors 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 ‘Other possible side effects’ 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.

Protect other people

HIV infection is spread by sexual contact with someone who has the infection, or by transfer of infected blood (for example, by sharing injection needles). You can still pass on HIV when receiving this medicine, although the risk is lowered by effective antiretroviral therapy. Discuss with your doctor the precautions needed to avoid infecting other people.

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

Women who are HIV-positive must not breast feed , 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:

• ■ ^ Talk to your doctor immediately.

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.

• 3. How Vocabria injections are given

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 Vocabria 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 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.

4. Possible side effects

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

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:

o very common: pain and discomfort, a hardened mass or lump

o common: redness, itching, swelling, warmth, bruising, (which may include discolouration or a collection of blood under the skin)

o 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)
• 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.

Allergic reactions

Vocabria contains cabotegravir, which is an integrase inhibitor. Other integrase inhibitors can cause a serious allergic reaction known as a hypersensitivity reaction, although this has not been seen with Vocabria.

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 Vocabria.

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. Y ou can also report side effects directly via the national reporting system listed in By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Vocabria

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.

6. Contents of the pack and other information

What Vocabria 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 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, 90

San Polo di Torrile

Parma, 43056

Italy

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

Belgie/Belgiqu­e/Belgien ViiV Healthcare srl/bv Tél/Tel: + 32 (0) 10 85 65 00	Lietuva ViiV Healthcare BV Tel: + 370 80000334
Etnrapufl ViiV Healthcare BV Ten.: + 359 80018205	Luxembourg/Lu­xemburg ViiV Healthcare srl/bv Belgique/Belgien Tél/Tel: + 32 (0) 10 85 65 00
Česká republika GlaxoSmithKline, s.r.o. Tel: + 420 222 001 111	Magyarország ViiV Healthcare BV Tel.: + 36 80088309
Danmark GlaxoSmithKline Pharma A/S	Malta ViiV Healthcare BV

Tlf: + 45 36 35 91 00	Tel: + 356 80065004
Deutschland ViiV Healthcare GmbH Tel.: + 49 (0)89 203 0038–10	Nederland ViiV Healthcare BV Tel: + 31 (0) 33 2081199
Eesti ViiV Healthcare BV Tel: + 372 8002640	Norge GlaxoSmithKline AS Tlf: + 47 22 70 20 00
EXÀàôa GlaxoSmithKline Movonpôoœnn A.E.B.E. Tql: + 30 210 68 82 100	Österreich GlaxoSmithKline Pharma GmbH Tel: + 43 (0)1 97075 0
España Laboratorios ViiV Healthcare, S.L. Tel: + 34 900 923 501	Polska GSK Services Sp. z o.o. Tel.: + 48 (0)22 576 9000
France ViiV Healthcare SAS Tél.: + 33 (0)1 39 17 69 69	Portugal VIIVHIV HEALTHCARE, UNIPESSOAL, LDA Tel: + 351 21 094 08 01
Hrvatska ViiV Healthcare BV Tel: + 385 800787089	Romania ViiV Healthcare BV Tel: + 40 800672524
Ireland GlaxoSmithKline (Ireland) Limited Tel: + 353 (0)1 4955000	Slovenija ViiV Healthcare BV Tel: + 386 80688869
Ísland Vistor hf. Sími: +354 535 7000	Slovenská republika ViiV Healthcare BV Tel: + 421 800500589
Italia ViiV Healthcare S.r.l Tel: + 39 (0)45 7741600	Suomi/Finland GlaxoSmithKline Oy Puh/Tel: + 358 (0)10 30 30 30
Kùnpoç ViiV Healthcare BV Tql: + 357 80070017	Sverige GlaxoSmithKline AB Tel: + 46 (0)8 638 93 00
Latvija ViiV Healthcare BV Tel: + 371 80205045	United Kingdom (Northern Ireland) ViiV Healthcare BV Tel: + 44 (0)800 221441

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:.

The following information is intended for healthcare professionals only:

Vocabria 3 mL injection Instructions for use:

Overview

A complete dose requires two injections: VOCABRIA and rilpivirine

• 3 mL of cabotegravir and 3 mL of rilpivirine.

Cabotegravir and rilpivirine are suspensions that do not need further dilution or reconstitution. The preparation steps for both medicines are the same.

Cabotegravir and rilpivirine are for intramuscular use only. Both injections must be administered to the gluteal sites. The administration order is not important.

| Note: The ventrogluteal site is recommended.

Storage information

• This medicine does not require any special storage conditions.

| Do not freeze.

Cabotegravir vial Vial adaptor

Your pack contains

• 1 vial of cabotegravir
• 1 vial adaptor
• 1 syringe
• 1 injection needle (0.65 mm, 38 mm [23 gauge, 1.5 inches])

Consider the patient’s build and use medical judgment to select an appropriate injection needle length.

You will also need

• Non-sterile gloves
• 2 alcohol swabs
• 2 gauze pads
• A suitable sharps container
• 1 rilpivirine 3 mL pack

Make sure to have the rilpivirine pack close by before starting.

Preparation 1. Inspect vial

• Check that the expiry date has not passed.
• Inspect the vial immediately. If you can see foreign matter, do not use the product.

I Note: The cabotegravir vial has a brown tint to the glass.

Do not use if the expiry date has passed.

• 2. Wait 15 minutes

  
  

If the pack has been stored in a fridge, remove and wait at least 15 minutes before you are ready to give the injection to allow the medicine to come to room temperature.

• 3. Shake vigorously

  
  

• Hold the vial firmly and vigorously shake for a full 10 seconds as shown.
• Invert the vial and check the resuspension. It should look uniform. If the suspension is not uniform, shake the vial again.
• It is also normal to see small air bubbles.

• Remove the cap from the vial.
• Wipe the rubber stopper with an alcohol swab.

I Do not allow anything to touch the rubber stopper after wiping it.

• Peel off the paper backing from the vial adaptor packaging.

I Note: Keep the adaptor in place in its packaging for the next step.

• Press the vial adaptor straight down onto the vial using the packaging, as shown.

The vial adaptor should snap securely into place.

• When you are ready, lift off the vial adaptor packaging as shown.
• Remove the syringe from its packaging.
• Draw 1 mL of air into the syringe. This will make it easier to draw up the liquid later.
• Hold the vial adaptor and vial firmly, as shown.
• Screw the syringe firmly onto the vial adaptor.
• Press the plunger all the way down to push the air into the vial.
• Invert the syringe and vial, and slowly withdraw as much of the liquid as possible into the syringe. There might be more liquid than the dose amount.
• Screw the syringe off the vial adaptor, holding the vial adaptor as shown.

Note: Keep the syringe upright to avoid leakage. Check that the cabotegravir suspension looks uniform and white to light pink.

• Peel open the needle packaging part way to expose the needle base.
• Keeping the syringe upright, firmly twist the syringe onto the needle.
• Remove the needle packaging from the needle.

Injection ________________

12. Prepare injection site

Injections must be administered to the gluteal sites.

Select from the following areas for the injection:

• Ventrogluteal (recommended)
• Dorsogluteal (upper outer quadrant)

I Note: For gluteal intramuscular use only.

Do not inject intravenously.

• Fold the needle guard away from the needle.
• Pull off the injection needle cap.

• Hold the syringe with the needle pointing up. Press the plunger to the 3 mL dose to remove extra liquid and any air bubbles.

I Note: Clean the injection site with an alcohol swab. Allow the skin to air dry before continuing.

Use the z-track injection technique to minimise medicine leakage from the injection site.

• Firmly drag the skin covering the injection site, displacing it by about an inch (2.5 cm).
• Keep it held in this position for the injection.
• Insert the needle to its full depth, or deep enough to reach the muscle.
• Still holding the skin stretched – slowly press the plunger all the way down.
• Ensure the syringe is empty.
• Withdraw the needle and release the stretched skin immediately.
• Apply pressure to the injection site using a gauze.
• A small bandage may be used if a bleed occurs.

| Do not massage the area.

• Fold the needle guard over the needle.
• Gently apply pressure using a hard surface to lock the needle guard in place.
• The needle guard will make a click when it locks.
• Dispose of used needles, syringes, vials and vial adaptors according to local health and safety laws.

• 1. How long can the medicine be left in the syringe?

Once the suspension has been drawn into the syringe, the injection should be used immediately, from a microbiological point of view.

Chemical and physical in-use stability has been demonstrated for 2 hours at 25 ° C.

• 2. Why do I need to inject air into the vial?

Injecting 1 mL of air into the vial makes it easier to draw up the dose into the syringe.

Without the air, some liquid may flow back into the vial unintentionally, leaving less than intended in the syringe.

• 3. Does the order in which I give the medicines matter?

No, the order is unimportant.

• 4. If the pack has been stored in the fridge, is it safe to warm the vial up to room temperature more quickly?

It is best to let the vial come to room temperature naturally. However, you can use the warmth of your hands to speed up the warm up time, but make sure the vial does not get above 30°C.

Do not use any other heating methods.

• 5. Why is the ventrogluteal administration approach recommended?

The ventrogluteal approach, into the gluteus medius muscle, is recommended because it is located away from major nerves and blood vessels. A dorso-gluteal approach, into the gluteus maximus muscle, is acceptable, if preferred by the health care professional. The injection should not be administered in any other site.

Package leaflet: Information for the patient

Vocabria 30 mg film-coated tablets

cabotegravir

V This medicine is subject to additional monitoring. This will allow quick identification of new safety nformation. You canhelp by reporting any side effects you may get. See the end of section 4 forhow to report side effects.

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• – Keep this leaflet. You may need to read it again.

• – If you have any further questions, ask your doctor or pharmacist.

• – This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

• – If you get any side effects, talk to your doctor or pharmacist.This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

• 1. What Vocabria tablets are and what they are used for

• 2. What you need to know before you take Vocabria tablets

• 3. How to take Vocabria tablets

• 4. Possible side effects

• 5. How to store Vocabria tablets

• 6. Contents of the pack and other information

1. What Vocabria is and what it is used for

Vocabria tablets contain the active ingredient cabotegravir. Cabotegravir belongs to a group of antiretroviral medicines called integrase inhibitors (INIs).

Vocabria tablets are used to treat HIV (human immunodeficiency virus) infection in adults aged 18 years and over who are also taking another antiretroviral medicine called rilpivirine and whose HIV-1 infection is under control.

Vocabria tablets do not cure HIV infection; they keep the amount of virus in your body at a low level. his 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.

Your doctor will advise you to take Vocabria tablets before you are given a Vocabria injection for the first time.

If you are being given Vocabria injection, but you are not able to receive your injection, your doctor may also recommend that you take Vocabria tablets instead, until you can receive the injection again.

Vocabria tablets are always given in combination with another anti-retroviral medicine called rilpivirine tablets to treat HIV infection. Vocabria and rilpivirine tablets will replace your current antiretroviral medicines. Refer to the rilpivirine package leaflet for information on that medicine.

2. What you need to know before you take Vocabria

Do not take Vocabria tablets:

• – – 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. Other integrase inhibitors 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 taking Vocabria.

■ ^ Read the information in ‘Other possible side effects’ 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.

Protect other people

HIV infection is spread by sexual contact with someone who has the infection, or by transfer of infected blood (for example, by sharing injection needles). You can still pass on HIV when taking this medicine, although the risk is lowered by effective antiretroviral therapy. Discuss with your doctor the precautions needed to avoid infecting other people.

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 tablets

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 taken with some other medicines (see ‘Do not take Vocabria tablets’ 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 any of the medicines in the following list:

• Medicines called antacids, to treat indigestion and heartburn. Antacids can stop the medicine in Vocabria tablets from being absorbed into your body.

Do not take these medicines in the 2 hours before you take Vocabria or for at least 4 hours after you take it.

• rifabutin (to treat some bacterial injections such as tuberculosis).

• ■ ^ Tell your doctor or pharmacist if you are taking any of these. 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 taking Vocabria.

Pregnancy

• Vocabria is not recommended during pregnancy. If needed, your doctor will consider the benefit to you and the risk to your baby of taking Vocabria 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 taking Vocabria without consulting your doctor.

Breast-feeding

Women who are HIV-positive must not breast feed , because HIV infection can be passed on to the baby in breast milk.

It is not known whether the ingredients of Vocabria tablets can pass into breast milk.

If you’re breast-feeding, or thinking about breast-feeding:

• ■ ^ Talk to your doctor immediately.

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.

Important information about some of the ingredients of Vocabria

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

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

3. How to take Vocabria

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Vocabria tablets must always be taken with another HIV medicine (rilpivirine tablets). You should also follow the instructions for rilpivirine carefully. The leaflet is supplied in the rilpivirine carton.

Dosing schedule for Vocabria tablets followed by monthly injections

Which medicine

When

	During month 1 (at least 28 days)	At month 2 following one month of tablets	Month 3 onwards
Vocabria	30 mg tablet once daily	600 mg injection	400 mg injection monthly
Rilpivirine	25 mg tablet once daily	900 mg injection	600 mg injection monthly

Dosing schedule for Vocabria tablets followed by every 2 month injections

Which medicine	When
	Month 1 (at least 28 days)	At Month 2 and Month 3 following one month of tablets	Month 5 onwards
Vocabria	30 mg tablet once a day	600 mg injection	600 mg injection every 2 months
Rilpivirine	25 mg tablet once a day	900 mg injection	900 mg injection every 2 months

When you first start treatment with Vocabria, you and your doctor may decide to either start treatment with Vocabria 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.

The 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.

How to take the tablets

Vocabria tablets should be swallowed with a small amount of water.

Vocabria can be taken with or without food. However, when Vocabria is taken at the same time as rilpivirine, both tablets should be taken with a meal.

If you cannot receive your Vocabria injection

If you are not able to receive your Vocabria injection, your doctor may recommend you take Vocabria tablets instead, until you can receive an injection again.

Antacid medicines

Antacids, to treat indigestion and heartburn, can stop Vocabria tablets being absorbed into your body and make it less effective.

Do not take an antacid during the 2 hours before you take a Vocabria tablet or for at least 4 hours after you take it. Talk to your doctor for further advice on taking acid-lowering (antacid) medicines with Vocabria tablets.

If you take more Vocabria than you should

If you take too many tablets of Vocabria, contact your doctor or pharmacist for advice. If possible, show them the Vocabria tablet bottle.

If you forget to take Vocabria

If you notice within 12 hours of the time you usually take Vocabria, take the missed tablet as soon as possible. If you notice after 12 hours, then skip that dose and take the next dose as usual.

^ Do not take a double dose to make up for a forgotten tablet.

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

Don’t stop taking Vocabria without advice from your doctor

Take Vocabria for as long as your doctor recommends. Don’t stop unless your doctor advises you to.

If you have any further questions on 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 everybody gets them.

Very common side effects

These may affect more than 1 in 10 people:

• headache
• feeling hot (pyrexia).

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)
• feeling drowsy (somnolence)
• 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 taking Vocabria and rilpivirine therapy for HIV may get other side effects.

Allergic reactions

Vocabria contains cabotegravir, which is an integrase inhibitor. Other integrase inhibitors can cause a serious allergic reaction known as a hypersensitivity reaction, although this has not been seen with Vocabria.

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 Vocabria.

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).

5. How to store Vocabria

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

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

This medicine does not require any special temperature storage conditions.

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 Vocabria contains

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

The other ingredients are:

Tablet core

Lactose Monohydrate

Microcrystalline Cellulose (E460)

Hypromellose (E464)

Sodium Starch Glycolate

Magnesium Stearate

Tablet coating

Hypromellose (E464)

Titanium Dioxide (E171)

Macrogol (E1521)

What Vocabria looks like and contents of the pack

Vocabria film-coated tablets are white, oval, film-coated tablets, debossed with ‘SV CTV’ on one side.

The film-coated tablets are provided in bottles closed with child-resistant closures.

Each bottle contains 30 film-coated tablets.

Marketing Authorisation Holder

ViiV Healthcare BV

Van Asch van Wijckstraat 55H,

3811 LP Amersfoort

Netherlands

Manufacturer

Glaxo Wellcome, S.A.

Avda. Extremadura, 3

Aranda De Duero

Burgos 09400

Spain

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

België/Belgiqu­e/Belgien

ViiV Healthcare srl/bv Tél/Tel: + 32 (0) 10 85 65 00

Lietuva

ViiV Healthcare BV

Tel: + 370 80000334

Etnrapua

ViiV Healthcare BV

Ten.: + 359 80018205

Česká republika

GlaxoSmithKline, s.r.o.

Tel: + 420 222 001 111

Danmark

GlaxoSmithKline Pharma A/S

Tlf: + 45 36 35 91 00

Deutschland

ViiV Healthcare GmbH

Tel.: + 49 (0)89 203 0038–10

Eesti

ViiV Healthcare BV Tel: + 372 8002640

EMáSa

GlaxoSmithKline Movonpóoonn A.E.B.E.

Tql: + 30 210 68 82 100

España

Laboratorios ViiV Healthcare, S.L.

Tel: + 34 900 923 501

France

ViiV Healthcare SAS

Tél.: + 33 (0)1 39 17 69 69

Hrvatska

ViiV Healthcare BV

Tel: + 385 800787089

Ireland

GlaxoSmithKline (Ireland) Limited

Tel: + 353 (0)1 4955000

Ísland

Vistor hf.

Sími: +354 535 7000

Luxembourg/Lu­xemburg

ViiV Healthcare srl/bv Belgique/Belgien

Tél/Tel: + 32 (0) 10 85 65 00

Magyarország

ViiV Healthcare BV

Tel.: + 36 80088309

Malta

ViiV Healthcare BV

Tel: + 356 80065004

Nederland

ViiV Healthcare BV

Tel: + 31 (0) 33 2081199

Norge

GlaxoSmithKline AS

Tlf: + 47 22 70 20 00

Österreich

GlaxoSmithKline Pharma GmbH

Tel: + 43 (0)1 97075 0

Polska

GSK Services Sp. z o.o.

Tel.: + 48 (0)22 576 9000

Portugal

VIIVHIV HEALTHCARE, UNIPESSOAL, LDA

Tel: + 351 21 094 08 01

Romania

ViiV Healthcare BV

Tel: + 40 800672524

Slovenija

ViiV Healthcare BV

Tel: + 386 80688869

Slovenská republika

ViiV Healthcare BV

Tel: + 421 800500589

Italia

ViiV Healthcare S.r.l

Tel: + 39 (0)45 7741600

Suomi/Finland

GlaxoSmithKline Oy

Puh/Tel: + 358 (0)10 30 30 30

Kûnpoç

ViiV Healthcare BV

Tql: + 357 80070017

Sverige

GlaxoSmithKline AB

Tel: + 46 (0)8 638 93 00

Latvija

ViiV Healthcare BV

Tel: + 371 80205045

United Kingdom (Northern Ireland)

ViiV Healthcare BV

Tel: + 44 (0)800 221441

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:

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Annex IV

Scientific conclusions and grounds for the variation to the terms of the marketing authorisation(s)

Scientific conclusions

Taking into account the PRAC Assessment Report on the PSUR(s) for cabotegravir, the scientific conclusions of CHMP are as follows:

In view of available data including in some cases a close temporal relationship, and in view of a plausible mechanism of action, the PRAC considers a causal relationship between cabotegravir and “suicidal ideation” as well as “suicide attempt” at least a reasonable possibility.

Consequently, the PRAC concluded that the PTs “suicidal ideation” and “suicide attempt” should be included in SmPC section 4.8 of the product information for all Cabotegravir-containing products, with a frequency “uncommon” based on the number of events from clinical trials, which is endorsed by the PRAC Rapporteur. The Package leaflet should be updated accordingly.

Since five of the nine patients already had a pre-existing history of depression or psychiatric illness, the following should be included in addition to the two PTs: – “particularly in patients with a preexisting history of psychiatric illness”.

The CHMP agrees with the scientific conclusions made by the PRAC.

Grounds for the variation to the terms of the marketing authorisation(s)

On the basis of the scientific conclusions for cabotegravir the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing cabotegravir is unchanged subject to the proposed changes to the product information

The CHMP recommends that the terms of the marketing authorisation(s) should be varied.

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