Vocabria

Package leaflet: Information for the patient

Vocabria 400 mg prolonged-release injectable suspension

cabotegravir
This medicinal product is subject to additional monitoring. This will allow rapid identification of new
safety information. You can help by reporting any side effects you experience while taking this
medicinal product. See the end of section 4 for information on how to report side effects.
Please read 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 questions, ask your doctor or nurse.
• If you get any side effects, talk to your doctor or nurse. This includes any side effects not listed in this leaflet. See section 4.

Contents of 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 administered
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 injectable contains the active substance cabotegravir. Cabotegravir belongs to a group of
antiretroviral medicines called integrase inhibitors (INI).
Vocabria injectable is used to treat HIV (human immunodeficiency virus) infection in adults and
adolescents (aged at least 12 years and weighing at least 35 kg) who are also receiving another antiretroviral
medicine called rilpivirine and whose HIV-1 infection is under control.
Vocabria injections do not cure HIV infection, but keep the amount of virus in the body low, which helps
maintain the number of CD4 cells in the blood. CD4 cells are a type of white blood cell that are important in
helping the body fight infection.
Vocabria injectable is always given together with another antiretroviral medicine called
injectable rilpivirine. Please consult the patient leaflet for rilpivirine for information about this medicine.

2 What you need to know before you are given Vocabria
Do not receive a Vocabria injection if:

• you have developed severe skin rash, skin peeling, blisters and/or mouth ulcers.
• you are allergic ( hypersensitive ) to cabotegravir or to any of the other ingredients of this medicine (listed in section 6)
• you are taking any of the following medicines, as they may affect the activity of Vocabria:
  • carbamazepine, oxcarbazepine, phenytoin, phenobarbital (medicines used to treat epilepsy and prevent seizures)
  • rifampicin or rifapentine (medicines used to treat certain bacterial infections such as tuberculosis).

➔ Talk to your doctor if you think any of these conditions apply to you.
Warnings and precautions
Severe skin reaction
Severe, potentially life-threatening skin reactions such as Stevens-Johnson syndrome and toxic epidermal
necrolysis have been reported very rarely with Vocabria. Stop taking Vocabria and contact a doctor
immediately if you notice any symptoms related to these severe skin reactions.
➔ Read the information in section 4 of this leaflet (“Possible side effects”).
Allergic reaction
Vocabria contains cabotegravir, which is an integrase inhibitor. Integrase inhibitors, including
cabotegravir, may cause a serious allergic reaction known as hypersensitivity reaction. You should be
aware of these important signs and symptoms so you can recognise them while taking Vocabria.
➔ Read the information in section 4 of this leaflet.
Liver problems including hepatitis B and/or C
Talk to your doctor if you have or have had liver problems, including hepatitis B and/or C. Your doctor may
assess the severity of your liver disease before deciding whether you can take Vocabria.
Be alert to important symptoms
Some people taking medicines for HIV infection develop other conditions that may be serious. You should
be aware of these important signs and symptoms so you can recognise them while 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 have symptoms of infection or liver damage: ➔ contact your doctor immediately. Do not take other medicines for infection without consulting your doctor.

Regular visits are important
It is important that you attend your scheduled appointments to receive your Vocabria injection, to monitor
your HIV infection and to prevent the disease from worsening. Talk to your doctor if you are considering
stopping treatment. If you are late receiving your Vocabria injection or stop receiving Vocabria, you will
need to take other medicines to treat HIV infection and reduce the risk of developing viral resistance.
Vocabria injectable is a long-acting medicine. If you stop treatment, low levels of cabotegravir (the active
substance in Vocabria) may remain in your body for up to 12 months or more after the last injection. These
low levels of cabotegravir will not protect you from 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 receive monthly
injections, or within two months of your last Vocabria injection if you receive injections every two months.
Children and adolescents
This medicine is not indicated for use in children under 12 years of age or in adolescents weighing less than
35 kg, as it has not been studied in these patients.
Other medicines and Vocabria injectable
Tell your doctor if you are taking, have recently taken, or might take any other medicines, including those
available without a prescription.
Vocabria must not be administered with certain medicines (see “Do not receive a Vocabria injection” at the
beginning of section 2).
Some medicines may affect the activity of Vocabria or make it more likely that you will experience
side effects. Vocabria may also affect the activity of other medicines.
Tell your doctor if you are taking:

• rifabutin (used to treat certain infections such as tuberculosis). ➔ Tell your doctor or pharmacist if you are taking this medicine. Your doctor may decide that you need additional monitoring.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding:
➔ Talk to your doctor before receiving a Vocabria injection.
Pregnancy

• Vocabria is not recommended during pregnancy. If necessary, your doctor will consider the benefit to you and the risk to your baby from Vocabria injections during pregnancy. If you are planning a pregnancy, talk to your doctor in advance.
• If you become pregnant, do not stop your scheduled appointments for Vocabria injections without consulting your doctor.

Breastfeeding
Breastfeeding is not recommended for women who are HIV-positive because HIV infection can be
transmitted to the baby through breast milk.
It is not known whether the components of Vocabria injectable pass into breast milk. However, cabotegravir may still pass into breast milk for up to 12 months after the last Vocabria injection.
If you are breastfeeding or considering breastfeeding, you must talk to your doctor as soon as possible.
Driving and using machines
Vocabria may cause dizziness and other side effects that may reduce your attention.
➔ Do not drive or operate machinery if you are not sure that your alertness is not impaired.
Important information about some of the ingredients of Vocabria
Vocabria injectable contains polysorbate. This medicine contains 40 mg of polysorbate per 2 mL dose.
Inform your doctor if you have known allergies.
3 How Vocabria injections are administered
You will be given Vocabria as an injection, once a month or once every two months, together with another
injection of a medicine called rilpivirine. Your doctor will advise you on the dosing schedule.
A nurse or doctor will administer Vocabria to you as an injection into the muscle of the buttock
( intramuscular injection, IM ).
When starting treatment for the first time with Vocabria, you and your doctor may decide whether to
start treatment with cabotegravir tablets or to start directly with a Vocabria injection:

• if you decide to start with tablets, your doctor will instruct you:
• to take one 30 mg Vocabria tablet and one 25 mg rilpivirine tablet once daily for approximately one month
• after which you will receive injections once a month or every two months.

This initial one-month period of Vocabria and rilpivirine taken as tablets is called the oral lead-in phase
of therapy. This allows your doctor to assess whether it is appropriate to proceed with injections.
Injection schedule for monthly administration
Type of medicine When
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 administration every two months
Type of medicine When
First and second injection, Third injection onwards, every two
one month apart months
Vocabria 600 mg injection 600 mg injection every two months
Rilpivirine 900 mg injection 900 mg injection every two months
If you miss a Vocabria injection
➔ Contact your doctor immediately to reschedule your appointment.
It is important that you attend your regular scheduled appointments to receive your injection to monitor
HIV and prevent the disease from worsening. Talk to your doctor if you are considering stopping treatment.
Talk to your doctor if you think you may not be able to receive your Vocabria injection at the scheduled
time. Your doctor may advise you to take Vocabria tablets or another HIV treatment until you are able to
receive the Vocabria injection again.
If you are given too much Vocabria
A doctor or nurse will administer this medicine, so it is unlikely that you will be given too much. If you are
concerned, talk to your doctor or nurse.
Do not stop receiving Vocabria injections without consulting your doctor.
Continue receiving Vocabria injections for as long as your doctor advises. Do not stop unless your doctor
tells you to. If you stop, your doctor must start another HIV treatment within one month of your last
Vocabria injection if you receive monthly injections, or within two months of your last Vocabria injection if
you receive injections every two months, to reduce the risk of developing viral resistance.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4 Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Vocabria and contact a doctor immediately if you notice any of the following symptoms:

• flat, red target-like or circular spots on the trunk, often with blisters in the centre, skin peeling, mouth, throat, nose, genital or eye ulcers. These severe skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis). These potentially life-threatening skin reactions are very rare (may affect up to 1 in 10,000 people).

Allergic reactions
Vocabria contains cabotegravir, which is an integrase inhibitor. Integrase inhibitors, including
cabotegravir, may cause a serious allergic reaction known as hypersensitivity reaction. These
hypersensitivity reactions are uncommon (may affect up to 1 in 100 people).
If you experience any of the following symptoms:

• skin reaction ( rash, hives )
• high temperature ( fever )
• lack of energy ( fatigue )
• swelling, sometimes of the face or mouth ( angioedema ), causing difficulty breathing
• muscle or joint pain. ➔ Contact your doctor immediately. Your doctor may decide to perform tests to monitor your liver, kidneys or blood and may tell you to stop taking Vocabria.

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

• headache
• injection site reactions. In clinical studies, most were generally mild to moderate in severity and became less frequent over time. Symptoms may include: pain (which rarely may include temporary difficulty walking) and discomfort, a lump or hardened area
• feeling of warmth ( pyrexia ), which may occur within one week after injections.

Common side effects
May affect up to 1 in 10 people:

• depression
• anxiety
• abnormal dreams
• difficulty sleeping ( insomnia )
• dizziness
• nausea
• vomiting
• stomach ache ( abdominal pain )
• flatulence
• diarrhoea
• rash
• muscle pain ( myalgia )
• lack of energy ( fatigue )
• weakness ( asthenia )
• general feeling of being unwell
• weight gain
• injection site reactions. In clinical studies, most were generally mild to moderate in severity and became less frequent over time. Symptoms may include: redness, itching, swelling, warmth, bruising (which may include skin discolouration or blood accumulation under the skin).

Uncommon side effects
May affect up to 1 in 100 people:

• suicide attempt and suicidal thoughts (particularly in patients who have previously had depression or mental health problems)
• allergic reaction ( hypersensitivity )
• hives
• swelling, sometimes of the face or mouth ( angioedema ), causing difficulty breathing
• feeling of tiredness ( drowsiness )
• feeling dizzy, during or after an injection. This may lead to fainting.
• liver damage (signs may include yellowing of the skin and whites of the eyes, loss of appetite, itching, stomach tenderness, pale stools or unusually dark urine)
• changes in liver blood tests (increase in transaminases or increase in bilirubin )
• injection site reactions. In clinical studies, most were generally mild to moderate in severity and became less frequent over time. Symptoms may include: numbness, slight bleeding, an abscess (collection of pus) or cellulitis (warmth, swelling or redness).

Other side effects that may be detected in blood tests

• increase in lipase (a substance produced by the pancreas)

Other possible side effects
People receiving Vocabria and rilpivirine therapy for HIV may experience other side effects.
Pancreatitis
If you experience severe abdominal (stomach) pain, this may be caused by inflammation of the pancreas
(pancreatitis).
➔ Inform your doctor, especially if the pain spreads and worsens.
Symptoms of infection and inflammation
People with advanced HIV infection (AIDS) have a weakened immune system and are more likely to develop
serious infections ( opportunistic infections ). After starting treatment, the immune system becomes stronger
and begins to fight infections.
Symptoms of infection and inflammation may develop due to:

• re-emergence of old “silent” infections as the body fights them
• the immune system attacking the body’s own healthy tissues ( autoimmune disorders ). Symptoms of autoimmune disorders may develop many months after starting HIV treatment. Symptoms may include:
• muscle weakness and/or muscle pain
• pain or swelling of joints
• weakness starting in the hands and feet and spreading to the body trunk
• palpitations or tremor
• hyperactivity (restlessness and excessive movement). If you experience any symptoms of infection: ➔ inform your doctor immediately. Do not take other medicines for infection without consulting your doctor.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or nurse. You
can also report side effects directly via the national reporting system listed in Annex V. 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 stated on the label and on the pack after “Exp.”. The expiry date refers to the last day of that month.
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 of cabotegravir.
The other ingredients are:
Mannitol (E421)
Polysorbate 20 (E432)
Macrogol (E1521)
Water for injections
Description of the appearance of Vocabria and contents of the pack
Cabotegravir prolonged-release injectable suspension is supplied in a brown glass vial with a rubber stopper. The pack also contains 1 syringe, 1 vial adapter and 1 injection needle.
Marketing Authorisation Holder
ViiV Healthcare BV
Van Asch van Wijckstraat 55H,
3811 LP Amersfoort
The Netherlands
Manufacturer
GlaxoSmithKline Manufacturing SpA
Strada Provinciale Asolana, 90
San Polo di Torrile
Parma, 43056
Italy
For further information about this medicine, contact the local representative of the Marketing
Authorisation Holder:
België/Belgique/Belgien Lietuva
ViiV Healthcare srl/bv ViiV Healthcare BV
Tél/Tel: + 32 (0) 10 85 65 00 Tel: + 370 80000334
България Luxembourg/Luxemburg
ViiV Healthcare BV ViiV Healthcare srl/bv
Teл.: + 359 80018205 Belgique/Belgien
Tél/Tel: + 32 (0) 10 85 65 00
Česká republika Magyarország
GlaxoSmithKline, s.r.o. ViiV Healthcare BV
Tel: + 420 222 001 111 Tel.: + 36 80088309
[email protected]
Danmark Malta
GlaxoSmithKline Pharma A/S ViiV Healthcare BV
Tlf.: + 45 36 35 91 00 Tel: + 356 80065004
[email protected]
Deutschland Nederland
ViiV Healthcare GmbH ViiV Healthcare BV
Tel.: + 49 (0)89 203 0038-10 Tel: + 31 (0) 33 2081199
[email protected]
Eesti Norge
ViiV Healthcare BV GlaxoSmithKline AS
Tel: + 372 8002640 Tlf: + 47 22 70 20 00
Ελλάδα Österreich
GlaxoSmithKline Μονοπρόσωπη A.E.B.E. GlaxoSmithKline Pharma GmbH
Τηλ: + 30 210 68 82 100 Tel: + 43 (0)1 97075 0
[email protected]
España Polska
Laboratorios ViiV Healthcare, S.L. GSK Services Sp. z o.o.
Tel: + 34 900 923 501 Tel.: + 48 (0)22 576 9000
[email protected]
France Portugal
ViiV Healthcare SAS VIIVHIV HEALTHCARE, UNIPESSOAL, LDA
Tél.: + 33 (0)1 39 17 69 69 Tel: + 351 21 094 08 01
[email protected] [email protected]
Hrvatska România
ViiV Healthcare BV ViiV Healthcare BV
Tel: + 385 800787089 Tel: + 40 800672524
Ireland Slovenija
GlaxoSmithKline (Ireland) Limited ViiV Healthcare BV
Tel: + 353 (0)1 4955000 Tel: + 386 80688869
Ísland Slovenská republika
Vistor ehf. ViiV Healthcare BV
Sími: +354 535 7000 Tel: + 421 800500589
Italia Suomi/Finland
ViiV Healthcare S.r.l GlaxoSmithKline Oy
Tel: + 39 (0)45 7741600 Puh/Tel: + 358 (0)10 30 30 30
Κύπρος Sverige
ViiV Healthcare BV GlaxoSmithKline AB
Τηλ: + 357 80070017 Tel: + 46 (0)8 638 93 00
[email protected]
Latvija
ViiV Healthcare BV
Tel: + 371 80205045
Other sources of information
More detailed information about this medicine is available on the website of the European Medicines Agency, https://www.ema.europa.eu

---

The following information is intended exclusively for healthcare professionals:
Vocabria 2 mL injectable Instructions for use:
General information
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 require further dilution or reconstitution.
The preparation steps are identical for both medicines. Follow these instructions carefully when preparing the suspension for injection to avoid leakage of liquid.
Cabotegravir and rilpivirine are for intramuscular use only. Both injections must be administered in the gluteal region.

Note: the ventrogluteal site is recommended. The order of administration is not important.
Storage information
Do not freeze.
Contents of the pack

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

Consider the patient’s body build and, based on your clinical judgment, select an injection needle of appropriate length.

Cabotegravir vial Vial adapter
fC i i
Vial cap
( Rubber stopper under the
cap )
Syringe Injection needle

Plunger
Needle safety guard
Needle cap
You will also need

• Non-sterile gloves
• 2 alcohol swabs
• 2 gauze pads
• A sharps container Ensure you have the rilpivirine pack available before starting.

Preparation

1. Inspect the vial

• Check that the expiration date has not

Check the expiration date and the medicine passed.
and inspect the vial immediately.
If foreign particles are visible, do not use the
medicine.
Note: The cabotegravir vial is made of
brown glass.
Do not use if the expiration date has passed.

2. Wait 15 minutes

• If the package has been stored in the

refrigerator, remove it and wait at least
Wait 15 minutes 15 minutes before proceeding with the injection
to allow the medicine to reach
room temperature.

3. Shake vigorously

Hold the vial firmly and shake
10 vigorously for a full 10 seconds, as
shown in the figure.
sec.

4. Check the suspension

Invert the bottle and check the
resuspension. It should have a
uniform appearance. If the suspension is not uniform,
shake the bottle again.

• It is normal to see small air bubbles.

Note: the order of reconstitution of the suspension

is not important.

5. Remove the cap from the vial

• Remove the cap from the vial.

• Wipe the rubber stopper with an alcohol swab.

Do not allow anything to come into
contact with the rubber stopper after
cleaning it.

10. Attach the syringe

• Hold the adapter and vial firmly.

as illustrated in the figure.

• Screw the syringe securely onto the vial adapter.

11. Press the plunger

• Press the plunger all the way down to

push the air into the vial.

12. Slowly draw up the dose

• Invert the syringe and the vial and

slowly draw up all the liquid possible
into the syringe. There may be more liquid in
the vial than the required dose.
Note: Keep the syringe in an upright position
to prevent leakage of liquid.

17. Remove excess liquid

• Hold the syringe with the needle pointing upwards.

Press the plunger up to
the 2 mL mark to
remove excess liquid and any
air bubbles.
2 mL

Note: Disinfect the injection site with
an alcohol swab. Allow the skin to
dry in the air before
proceeding.

18. Stretch the skin

Use the z-track injection technique to

minimize the risk of leakage of
2.5 cm
medication from the injection site.
(1 inch)

• Firmly stretch the skin covering the injection site, displacing it approximately 2.5 cm (1 inch).
• Keep the skin in this position while administering the injection.

19. Insert the needle

• Insert the needle fully or to a sufficient depth to reach the
  muscle.

20. Inject the dose

• While continuing to keep the skin firmly stretched,

slowly press the plunger all the way
down.

• Make sure the syringe is empty.
• Remove the needle and immediately release the stretched skin.

Patient information leaflet

Vocabria 600 mg prolonged-release injectable suspension

cabotegravir
This medicinal product is subject to additional monitoring. This will allow for rapid identification of new safety information. You can help by reporting any side effects you experience while taking this medicine. See the end of section 4 for information on how to report side effects.
Please read this leaflet carefully before you start using this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or nurse.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or nurse. See section 4.

Contents of 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 administered
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 injectable contains the active substance cabotegravir. Cabotegravir belongs to a group of antiretroviral medicines called integrase inhibitors (INI).
Vocabria injectable is used to treat HIV (human immunodeficiency virus) infection in adults and adolescents (aged at least 12 years and weighing at least 35 kg) who are also receiving another antiretroviral medicine called rilpivirine and whose HIV-1 infection is under control.
Vocabria injections do not cure HIV infection, but keep the amount of virus in the body at low levels, which helps maintain the number of CD4 cells in the blood. CD4 cells are a type of white blood cell that are important in helping the body fight infection.
Vocabria injectable is always administered together with another antiretroviral medicine called rilpivirine injectable. Please refer to the package leaflet for rilpivirine for information about this medicine.

2. What you should know before being administered Vocabria

A Vocabria injection must not be given to you:

• if you have developed a severe skin rash, skin peeling, blisters, and/or mouth ulcers.
• if you are allergic ( hypersensitive ) to cabotegravir or to any of the other ingredients of this medicine (listed in section 6).
• if you are taking any of the following medicines, as they may affect the activity of Vocabria:
  • carbamazepine, oxcarbazepine, phenytoin, phenobarbital (medicines used to treat epilepsy and prevent seizures).
  • rifampicin or rifapentine (medicines used to treat certain bacterial infections such as tuberculosis).

➔ Contact your doctor if you think any of these conditions apply to you.
Warnings and precautions
Severe skin reaction
Very rare cases of life-threatening skin reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported in association with Vocabria. Stop taking Vocabria and contact a doctor immediately if you notice any of the symptoms related to these severe skin reactions.
➔ Read the information in section 4 of this leaflet (“Possible side effects”).
Allergic reaction
Vocabria contains cabotegravir, which is an integrase inhibitor. Integrase inhibitors, including cabotegravir, may cause a serious allergic reaction known as hypersensitivity reaction. You should be aware of these important signs and symptoms so that you can recognize them while taking Vocabria.
➔ Read the information in section 4 of this leaflet.
Liver problems, including hepatitis B and/or C
Contact your doctor if you have or have had liver problems, including hepatitis B and/or C. Your doctor may assess the severity of your liver disease before deciding whether you can take Vocabria.
Be aware of important symptoms
Some people taking medicines for HIV infection develop other conditions that may be serious. You should be aware of these important signs and symptoms so that you can recognize them while 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 experience symptoms of infection or liver damage: ➔ contact your doctor immediately . Do not take any other medicines for infection without consulting your doctor.

Regular visits are important
It is important that you attend your scheduled appointments to receive your Vocabria injection, to monitor your HIV infection, and to prevent the disease from worsening. Talk to your doctor if you are considering 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.
Injectable Vocabria is a long-acting medicine . If you stop treatment, low levels of cabotegravir (the active substance in Vocabria) may remain in your body for up to 12 months or longer after the last injection. These low levels of cabotegravir will not protect you from the virus, and the virus may become resistant. You must start a different HIV treatment within one month after your last Vocabria injection if you receive monthly injections, or within two months after your last Vocabria injection if you receive injections every two months.
Children and adolescents
This medicine is not indicated for use in children under 12 years of age or in adolescents weighing less than 35 kg, as it has not been studied in these patient groups.
Other medicines and injectable Vocabria
Inform your doctor if you are taking, have recently taken, or might take any other medicines, including those available without a prescription.
Vocabria must not be administered together with certain medicines (see “A Vocabria injection must not be given to you” at the beginning of section 2).
Some medicines may affect the activity of Vocabria or make it more likely that you will experience side effects . Vocabria may also affect the activity of other medicines.
Inform your doctor if you are taking:

• rifabutin (used to treat certain infections such as tuberculosis) ➔ Inform your doctor or pharmacist if you are taking this medicine. Your doctor may decide that you need additional monitoring.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding:
➔ Talk to your doctor before receiving a Vocabria injection.
Pregnancy

• Vocabria is not recommended during pregnancy . If necessary, your doctor will consider the benefits to you and the risks to your baby associated with Vocabria injections during pregnancy. If you are planning a pregnancy, talk to your doctor in advance .
• If you become pregnant, do not stop attending scheduled appointments for Vocabria injections without consulting your doctor.

Breastfeeding
Breastfeeding is not recommended for women who are HIV-positive, as HIV infection can be transmitted to the infant through breast milk.
It is not known whether the components of injectable Vocabria can pass into breast milk. However, cabotegravir may still pass into breast milk for up to 12 months after the last Vocabria injection.
If you are breastfeeding or considering breastfeeding, you must discuss this with your doctor as soon as possible.
Driving and using machines
Vocabria may cause dizziness and other side effects that may reduce your level of alertness.
➔ Do not drive or operate machinery if you are not sure that your ability to remain alert is not impaired.
Important information about some of the ingredients of Vocabria
Injectable Vocabria contains polysorbate. This medicine contains 60 mg of polysorbate per 3 ml dose.
Inform your doctor if you have known allergies.

3. How Vocabria injections are administered

You will be given Vocabria as an injection, once a month or once every 2 months,
together with another injection of a medicine called rilpivirine. Your doctor will advise you on the dosing schedule.
A nurse or doctor will administer Vocabria to you as an injection into the muscle of the buttock
(intramuscular injection, IM ).
When starting treatment with Vocabria for the first time, you and your doctor may decide whether to
start treatment with Vocabria tablets or to start directly with a Vocabria injection:

• if you decide to start with tablets, your doctor will instruct you:
• to take one 30 mg tablet of Vocabria and one 25 mg tablet of rilpivirine once daily for approximately one month
• after which you will receive injections once a month or every 2 months.

This initial one-month period of Vocabria and rilpivirine taken orally is called the oral initiation phase of therapy.
This allows your doctor to assess whether it is appropriate to proceed with injections.

Injection schedule for monthly administration
Type of medicine When
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 administration every 2 months
Type of medicine When
First and second injection Third injection onwards, every two months
one month apart
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 reschedule your appointment.
It is important that you keep your scheduled appointments to receive the injection, to monitor your HIV and to
prevent the disease from worsening. Talk to your doctor if you are considering stopping treatment.
Talk to your doctor if you think you may be unable to receive your Vocabria injection at the scheduled time.
Your doctor may advise you to take Vocabria tablets or another HIV treatment until you are able to receive the
Vocabria injection again.

If you are given too much Vocabria injection
A doctor or nurse will administer this medicine to you, so it is unlikely that you will receive too much. If you are concerned, speak to your doctor or nurse.

Do not stop receiving Vocabria injections without consulting your doctor.
Continue receiving Vocabria injections for as long as your doctor recommends. Do not stop unless your doctor advises you to. If you stop, your doctor must start another HIV treatment within one month after your last Vocabria injection if you are receiving monthly injections, or within two months after your last Vocabria injection if you are receiving injections every two months, in order to reduce the risk of developing viral resistance.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Stop taking Vocabria and contact a doctor immediately if you notice any of the following symptoms:

• Flat, red spots resembling targets or rings on the trunk, often with blisters in the center, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes. These serious skin reactions may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis). These potentially life-threatening skin reactions are very rare (may affect up to 1 in 10,000 people).

Allergic reactions
Vocabria contains cabotegravir, which is an integrase inhibitor. Integrase inhibitors, including cabotegravir, can cause a serious allergic reaction known as hypersensitivity reaction. These hypersensitivity reactions are uncommon (may affect up to 1 in 100 people).
If you experience any of the following symptoms:

• skin reaction ( rash, hives )
• high temperature ( fever )
• lack of energy ( fatigue )
• swelling, sometimes of the face or mouth ( angioedema ), causing difficulty breathing
• muscle or joint pain ➔ Contact a doctor immediately. The doctor may decide to run tests to monitor liver, kidney, or blood function and may instruct you to stop taking Vocabria.

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

• headache
• injection site reactions. In clinical studies, most were generally mild to moderate in severity and became less frequent over time. Symptoms may include: pain (which rarely may include temporary difficulty walking), discomfort, a lump or hardened mass
• feeling of warmth ( pyrexia ), which may occur within one week after injections

Common side effects
May affect up to 1 in 10 people:

• depression
• anxiety
• abnormal dreams
• difficulty sleeping ( insomnia )
• dizziness
• nausea
• vomiting
• stomach ache ( abdominal pain )
• flatulence
• diarrhoea
• rash
• muscle pain ( myalgia )
• lack of energy ( fatigue )
• weakness ( asthenia )
• general feeling of being unwell
• weight gain
• injection site reactions. In clinical studies, most were generally mild to moderate in severity and became less frequent over time. Symptoms may include: redness, itching, swelling, warmth, bruising (which may include skin discoloration or blood accumulation under the skin).

Uncommon side effects
May affect up to 1 in 100 people:

• suicide attempt and suicidal thoughts (particularly in patients who previously had depression or mental health problems)
• allergic reaction ( hypersensitivity )
• hives
• swelling, sometimes of the face or mouth ( angioedema ), causing difficulty breathing
• feeling of tiredness ( somnolence )
• feeling of dizziness, during or after an injection. This may lead to fainting.
• liver damage (signs may include yellowing of the skin and whites of the eyes, loss of appetite, itching, stomach tenderness, pale stools or unusually dark urine)
• changes in liver blood tests (increase in transaminases or increase in bilirubin )
• injection site reactions. In clinical studies, most were generally mild to moderate in severity and became less frequent over time. Symptoms may include: numbness, slight bleeding, an abscess (collection of pus), or cellulitis (warmth, swelling, or redness).

Other side effects that may be detected in blood tests

• increase in lipase (a substance produced by the pancreas)

Other possible side effects
People receiving Vocabria and rilpivirine therapy for HIV may experience other side effects.
Pancreatitis
If you experience severe abdominal pain, this may be caused by inflammation of the pancreas (pancreatitis).
➔ Inform your doctor, especially if the pain spreads and worsens.
Symptoms of infection and inflammation
People with advanced HIV infection (AIDS) have a weakened immune system and are more likely to develop serious infections ( opportunistic infections ). After starting treatment, the immune system becomes stronger and begins to fight existing infections.
Symptoms of infection and inflammation may develop due to:

• re-emergence of previous "silent" infections as the body starts fighting them
• the immune system attacking the body's healthy tissues ( autoimmune disorders ). Symptoms of autoimmune disorders may develop several months after starting treatment for HIV infection.

Symptoms may include:

• muscle weakness and/or muscle pain
• pain or swelling of the joints
• weakness starting in the hands and feet and spreading to the body's trunk
• palpitations or tremor
• hyperactivity (agitation and excessive movement)
  If you experience any symptoms of infection: ➔ inform your doctor immediately. Do not take any other medicines for infection without consulting your doctor.

Reporting of side effects
If you get any side effects, including ones not listed in this leaflet, talk to your doctor or nurse. You can also report side effects directly via the national reporting system listed in Annex V. 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 stated on the label and carton after "Exp.".
The expiry date refers to the last day of that month.
Do not freeze.

6. Package contents and other information

What Vocabria contains

• The active substance is cabotegravir.

Each 3 mL vial contains 600 mg of cabotegravir.
The excipients are:
Mannitol (E421)
Polysorbate 20 (E432)
Macrogol (E1521)
Water for injections
Description of the appearance of Vocabria and contents of the pack
Cabotegravir prolonged-release injectable suspension is supplied in a brown glass vial with a rubber stopper. The pack also contains 1 syringe, 1 vial adapter, and 1 injection needle.
Marketing Authorisation Holder
ViiV Healthcare BV
Van Asch van Wijckstraat 55H,
3811 LP Amersfoort
The Netherlands
Manufacturer
GlaxoSmithKline Manufacturing S.p.A.
Strada Provinciale Asolana, 90
San Polo di Torrile
Parma, 43056
Italy
For further information about this medicinal product, please contact the local representative of the marketing authorisation holder:
België/Belgique/Belgien Lietuva
ViiV Healthcare srl/bv ViiV Healthcare BV
Tél/Tel: + 32 (0) 10 85 65 00 Tel: + 370 80000334
България Luxembourg/Luxemburg
ViiV Healthcare BV ViiV Healthcare srl/bv
Teл.: + 359 80018205 Belgique/Belgien
Tél/Tel: + 32 (0) 10 85 65 00
Česká republika Magyarország
GlaxoSmithKline, s.r.o. ViiV Healthcare BV
Tel: + 420 222 001 111 Tel.: + 36 80088309
[email protected]
Danmark Malta
GlaxoSmithKline Pharma A/S ViiV Healthcare BV
Tlf.: + 45 36 35 91 00 Tel: + 356 80065004
[email protected]
Deutschland Nederland
ViiV Healthcare GmbH ViiV Healthcare BV
Tel.: + 49 (0)89 203 0038-10 Tel: + 31 (0) 33 2081199
[email protected]
Eesti Norge
ViiV Healthcare BV GlaxoSmithKline AS
Tel: + 372 8002640 Tlf: + 47 22 70 20 00
Ελλάδα Österreich
GlaxoSmithKline Μονοπρόσωπη A.E.B.E. GlaxoSmithKline Pharma GmbH
Τηλ: + 30 210 68 82 100 Tel: + 43 (0)1 97075 0
[email protected]
España Polska
Laboratorios ViiV Healthcare, S.L. GSK Services Sp. z o.o.
Tel: + 34 900 923 501 Tel.: + 48 (0)22 576 9000
[email protected]
France Portugal
ViiV Healthcare SAS VIIVHIV HEALTHCARE, UNIPESSOAL, LDA
Tél.: + 33 (0)1 39 17 69 69 Tel: + 351 21 094 08 01
[email protected] [email protected]
Hrvatska România
ViiV Healthcare BV ViiV Healthcare BV
Tel: + 385 800787089 Tel: + 40 800672524
Ireland Slovenija
GlaxoSmithKline (Ireland) Limited ViiV Healthcare BV
Tel: + 353 (0)1 4955000 Tel: + 386 80688869
Ísland Slovenská republika
Vistor ehf. ViiV Healthcare BV
Sími: +354 535 7000 Tel: + 421 800500589
Italia Suomi/Finland
ViiV Healthcare S.r.l GlaxoSmithKline Oy
Tel: + 39 (0)45 7741600 Puh/Tel: + 358 (0)10 30 30 30
Κύπρος Sverige
ViiV Healthcare BV GlaxoSmithKline AB
Τηλ: + 357 80070017 Tel: + 46 (0)8 638 93 00
[email protected]
Latvija
ViiV Healthcare BV
Tel: + 371 80205045
Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency, https://www.ema.europa.eu >

---

The following information is intended for healthcare professionals only:
Vocabria 3 mL injectable Instructions for use:
General information
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 require further dilution or reconstitution.
The preparation steps are identical for both medicines. Follow these instructions carefully during preparation of the suspension for injection to avoid leakage.
Cabotegravir and rilpivirine are for intramuscular use only. Both injections must be administered into the gluteal region.

Note: The ventrogluteal site is recommended. The order of administration is not important.

Storage instructions
Do not freeze.
Contents of the pack

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

Consider the patient's body habitus and, based on clinical judgment, select an injection needle of appropriate length.

You will also need

• Non-sterile gloves
• 2 alcohol-impregnated swabs
• 2 gauze pads
• A sharps container Ensure that the rilpivirine pack is available before starting.

Preparation

1. Inspect the vial

• Check that the expiration date has not

been exceeded.
Check the expiration date and the medicine.

• Inspect the vial immediately. If foreign particles are visible, do not use the medicine.

Note: The cabotegravir vial is made of brown glass.
Do not use if the expiration date has passed.

2. Wait 15 minutes

• If the pack has been stored in the

refrigerator, remove it and wait at least
Wait 15 minutes
15 minutes before proceeding with the injection
to allow the medicine to reach
room temperature.

3. Shake vigorously

Hold the vial firmly and shake
vigorously for a full 10 seconds as
10
shown in the figure.
sec.

4. Check the suspension

• Invert the bottle and check the

resuspension. It should have a uniform
appearance. If the suspension is not uniform,
shake the bottle again.

• It is normal to see small air bubbles

Note: The order of preparing the
bottle is not important.

5. Remove the vial cap

• Remove the cap from the vial.

• Wipe the rubber stopper with an alcohol-soaked swab.

Do not allow anything to come into
contact with the rubber stopper after
cleaning it.

6. Open the vial adapter container

• Peel off the protective paper from the

vial adapter container.
Note: do not remove the adapter from its

container for the next step.
The adapter will not fall out even if the
package is inverted.

10. Attach the syringe

• Hold the adapter and the vial firmly

as shown in the figure.

• Screw the syringe securely onto the vial adapter.

11. Press the plunger

• Press the plunger all the way through to

push air into the vial.

12. Slowly draw up the dose

• Invert the syringe and the vial and

slowly draw up all the liquid possible
into the syringe. There may be more liquid in
the vial than the required dose.
Note: keep the syringe in an upright position
to avoid leakage of liquid.

13. Unscrew the syringe

• Hold the syringe plunger firmly in position as shown in the figure to prevent leakage of liquid. It is normal to feel some resistance.
• Unscrew the syringe from the vial adapter, holding the adapter as illustrated in the figure.

Note: Check that the cabotegravir suspension is uniform and ranges in color from white to pale pink.

2. Why is it necessary to inject air into the vial?

Introducing 1 mL of air into the vial facilitates the subsequent withdrawal of the dose into the syringe.
Without the air, some of the liquid may inadvertently flow back into the vial, leaving less liquid in the syringe than required.

3. Does the order in which the medicines are administered matter?

No, the order is not important.

4. If the pack has been stored in the refrigerator, is it safe to warm the vial more quickly to reach room temperature? The best way is to allow the vial to reach room temperature naturally. However, you may use the warmth of your hands to speed up the warming process. Do not use any other methods of heating.

5. Why is the ventrogluteal approach the recommended route of administration?

The ventrogluteal approach, into the gluteus medius muscle, is recommended because this site is located far from major nerves and blood vessels. The dorsogluteal approach or injection into the gluteus maximus muscle is acceptable if preferred by the healthcare provider. The injection must not be administered at any other site.

Patient information leaflet

Vocabria 30 mg film-coated tablets

cabotegravir
This medicinal product is under additional monitoring. This will allow for rapid identification of new safety information. You can help by reporting any side effects you experience while taking this medicine. See the end of section 4 for information on how to report side effects.
Please read this leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What Vocabria is and what it is used for
2. What you need to know before taking Vocabria
3. How to take Vocabria
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 tablets contain the active substance cabotegravir. Cabotegravir belongs to a group of antiretroviral medicines called integrase inhibitors (INI).
Vocabria tablets are used to treat HIV (human immunodeficiency virus) infection in adults and adolescents (at least 12 years of age and weighing at least 35 kg) who are also taking another antiretroviral medicine called rilpivirine and in whom HIV-1 infection is under control.
Vocabria tablets do not cure HIV infection, but help keep the amount of virus in the body low. This helps maintain the number of CD4 cells in the blood. CD4 cells are a type of white blood cell that play an important role in helping the body fight infection.
Your doctor will advise you to take Vocabria tablets before you receive the first injection of injectable Vocabria.
If you are being treated with injectable Vocabria but are unable to receive the injection, your doctor may also advise you to take Vocabria tablets until you can receive the injection again.
Vocabria tablets are always prescribed together with another antiretroviral medicine called rilpivirine tablets for the treatment of HIV infection. Vocabria and rilpivirine tablets will replace the antiretroviral medicines you are currently taking. Please consult the package leaflet for rilpivirine for information about this medicine.

2. What you need to know before taking Vocabria

Do not take Vocabria tablets:

• if you have developed a severe skin rash, skin peeling, blisters and/or mouth ulcers.
• if you are allergic ( hypersensitive ) to cabotegravir or to any of the other ingredients of this medicine (listed in section 6).
• if you are taking any of the following medicines, as they may affect the activity of Vocabria:
• carbamazepine, oxcarbazepine, phenytoin, phenobarbital (medicines used to treat epilepsy and prevent seizures).
• rifampicin or rifapentine (medicines used to treat certain bacterial infections such as tuberculosis). ➔ Consult your doctor if you think any of these conditions apply to you.

Warnings and precautions
Severe skin reaction:
Severe, potentially life-threatening skin reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis, have very rarely been reported with Vocabria. Stop taking Vocabria and contact a doctor immediately if you notice any symptoms associated with these serious skin reactions.
➔ Read the information in section 4 of this leaflet (“Possible side effects”).
Allergic reaction
Vocabria contains cabotegravir, which is an integrase inhibitor. Integrase inhibitors, including cabotegravir, may cause a serious allergic reaction known as hypersensitivity reaction. You should be aware of these important signs and symptoms so that you can recognize them while taking Vocabria.
➔ Read the information in section 4 of this leaflet.
Liver problems, including hepatitis B and/or C
Consult your doctor if you have or have had liver problems, including hepatitis B and/or C. Your doctor may assess the severity of your liver disease before deciding whether you can take Vocabria.
Be alert for important symptoms
Some people taking medicines for HIV infection develop other conditions that may be serious. You should be aware of these important signs and symptoms so that you can recognize them while taking Vocabria. These include:

• signs of infections
• signs of liver damage ➔ Read the information in section 4 of this leaflet (“Possible side effects”)

If you experience symptoms of infection or liver damage:
➔ Contact your doctor immediately. Do not take any other medicines for infection without consulting your doctor.
Children and adolescents
This medicine is not indicated for use in children under 12 years of age or in adolescents weighing less than 35 kg, as it has not been studied in these patient groups.
Other medicines and Vocabria tablets
Inform your doctor if you are taking, have recently taken, or might take any other medicines, including those without a prescription.
Vocabria must not be taken with certain medicines (see “Do not take Vocabria tablets” at the beginning of section 2).
Some medicines may affect the activity of Vocabria or make it more likely that you will experience side effects. Vocabria may also affect the activity of other medicines.
Inform your doctor if you are taking any of the following medicines:

• medicines called antacids used to treat indigestion and heartburn. Antacids may interfere with the absorption of Vocabria tablets by the body. Do not take these medicines within 2 hours before or at least 4 hours after taking Vocabria.
• rifabutin (used to treat certain bacterial infections such as tuberculosis). ➔ Inform your doctor or pharmacist if you are taking this medicine. Your doctor may decide that you need additional monitoring.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding:
➔ Talk to your doctor before taking Vocabria.
Pregnancy

• Vocabria is not recommended during pregnancy. If necessary, your doctor will evaluate the benefit to you and the risk to the unborn child of taking Vocabria during pregnancy. If you are planning a pregnancy, talk to your doctor in advance.
• If you become pregnant, do not stop taking Vocabria without first consulting your doctor.

Breastfeeding
Breastfeeding is not recommended for HIV-positive women, as HIV infection can be transmitted to the infant through breast milk.
It is not known whether the components of Vocabria tablets pass into breast milk.
If you are breastfeeding or considering breastfeeding, you must discuss this with your doctor as soon as possible.
Driving and using machines
Vocabria may cause dizziness and other side effects that may reduce alertness.
➔ Do not drive or operate machinery if you are not sure that your level of alertness is not impaired.
Important information about some ingredients of Vocabria
If your doctor has informed you that you have an intolerance to certain sugars, talk to your doctor before taking this medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet; therefore, it is essentially "sodium-free".

3. How to take Vocabria

Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
Vocabria tablets must always be taken together with another HIV medicine (rilpivirine tablets).
You must also carefully follow the instructions for rilpivirine. The package leaflet is provided in the
rilpivirine packaging.
Dosing schedule for Vocabria tablets after monthly injections

Dosing schedule for Vocabria tablets after every 2-month injections

When starting treatment with Vocabria for the first time, you and your doctor may decide whether to
start treatment with Vocabria tablets or to begin directly with an injection of
Vocabria:
if you decide to start treatment with tablets, your doctor will instruct you to:

• take one 30 mg Vocabria tablet and one 25 mg rilpivirine tablet once daily for approximately one month
• after that, you will receive injections once a month or every two months.

The first month of treatment with Vocabria and rilpivirine tablets is called the oral initiation phase of therapy.
This allows your doctor to assess whether continuing with injections is appropriate.
How to take the tablets
Vocabria tablets must be swallowed with a small amount of water.
Vocabria may be taken with or without food. However, when Vocabria is taken together with rilpivirine,
both tablets must be taken with a meal.
If you cannot receive the Vocabria injection
If you are unable to receive the Vocabria injection, your doctor may recommend that you take Vocabria tablets
or another HIV treatment until you are able to receive an injection again.
Antacid medicines
Antacids used to treat indigestion and heartburn may interfere with the absorption of
Vocabria tablets into your body, making the medicine less effective.
Do not take an antacid within 2 hours before or at least
4 hours after taking the Vocabria tablet. Speak with your doctor for further advice on taking medicines that reduce
stomach acid (antacids) together with Vocabria tablets.
If you take more Vocabria than you should
If you take too many Vocabria tablets, contact your doctor or pharmacist for advice. If possible,
show them the Vocabria tablet bottle.
If you forget to take Vocabria
If you realize you have missed a dose of Vocabria within 12 hours of your usual dosing time, take the missed tablet as soon as possible. If you realize after 12 hours, skip the missed dose and take the next dose at the usual time.
➔ Do not take a double dose to make up for a forgotten tablet.
If you vomit within 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 regularly scheduled dose.
Do not stop taking Vocabria without consulting your doctor
Take Vocabria for the entire duration prescribed by your doctor. Do not discontinue treatment unless instructed to do so by your doctor.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Vocabria and contact a doctor immediately if you notice any of the following symptoms:

• Flat, red spots resembling targets or circles on the trunk, often with blisters in the center, skin peeling, mouth, throat, nose, genital or eye ulcers. These severe skin reactions may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis). These life-threatening skin reactions are very rare (may affect up to 1 in 10,000 people).

Allergic reactions
Vocabria contains cabotegravir, which is an integrase inhibitor. Integrase inhibitors, including cabotegravir, can cause a serious allergic reaction known as hypersensitivity reaction. These hypersensitivity reactions are uncommon (may affect up to 1 in 100 people).
If you experience any of the following symptoms:

• Skin reaction ( rash, hives )
• High temperature ( fever )
• Lack of energy ( fatigue )
• Swelling, sometimes of the face or mouth ( angioedema ), causing breathing difficulties
• Muscle or joint pain ➔ Contact your doctor immediately. The doctor may decide to run tests to monitor your liver, kidneys or blood and may instruct you to stop taking Vocabria.

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

• Headache
• Feeling of warmth ( pyrexia )

Common side effects
May affect up to 1 in 10 people:

• Depression
• Anxiety
• Abnormal dreams
• Difficulty sleeping ( insomnia )
• Dizziness
• Nausea
• Vomiting
• Stomach ache ( abdominal pain )
• Flatulence
• Diarrhoea
• Rash
• Muscle pain ( myalgia )
• Lack of energy ( fatigue )
• Weakness ( asthenia )
• General feeling of being unwell
• Weight gain

Uncommon side effects
May affect up to 1 in 100 people:

• Suicide attempt and suicidal thoughts (particularly in patients who have previously had depression or mental health problems)
• Allergic reaction ( hypersensitivity )
• Hives
• Swelling, sometimes of the face or mouth ( angioedema ), causing breathing difficulties
• Feeling of tiredness ( somnolence )
• Liver damage (signs may include yellowing of the skin and whites of the eyes, loss of appetite, itching, stomach sensitivity, pale stools or unusually dark urine)
• Changes in liver blood tests (increase in transaminases or increase in bilirubin ).

Other side effects that may be detected in blood tests

• Increase in lipase (a substance produced by the pancreas)

Other possible side effects
People receiving Vocabria and rilpivirine therapy for HIV may experience other side effects.
Pancreatitis
If you experience severe abdominal pain, this may be caused by inflammation of the pancreas (pancreatitis).
➔ Inform your doctor, especially if the pain spreads and worsens.
Symptoms of infection and inflammation
People with advanced HIV infection (AIDS) have a weakened immune system and are more likely to develop serious infections ( opportunistic infections ). After starting treatment, the immune system becomes stronger and begins to fight existing infections.
Symptoms of infection and inflammation may develop due to:

• Old "silent" infections that reappear as the body starts fighting them
• The immune system attacking the body's healthy tissues ( autoimmune disorders ). Symptoms of autoimmune disorders may develop several months after starting treatment for HIV infection.

Symptoms may include:

• Muscle weakness and/or muscle pain
• Pain or swelling of the joints
• Weakness starting in the hands and feet and spreading to the trunk
• Palpitations or tremor
• Hyperactivity (excessive agitation and movement) If you experience any symptoms of infection or inflammation or notice any of the symptoms listed above: ➔ Contact your doctor immediately. Do not take any other medicines for infection without consulting your doctor.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or nurse. You can also report side effects directly via the national reporting system listed in Annex V. Reporting side effects 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 stated on the carton and vial after "Exp".
The expiry date refers to the last day of that month.
This medicine does not require any specific storage temperature.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Vocabria contains
The active substance is cabotegravir. Each tablet contains 30 mg of cabotegravir.
The other components are:
Tablet core
Lactose monohydrate
Microcrystalline cellulose (E460)
Hypromellose (E464)
Sodium starch glycolate
Magnesium stearate
Tablet film coating
Hypromellose (E464)
Titanium dioxide (E171)
Macrogol (E1521)

Description of the appearance of Vocabria and contents of the pack
Vocabria film-coated tablets are white, oval, film-coated tablets, marked on one side with the code 'SV CTV'.
The film-coated tablets are supplied in bottles with child-resistant closures.
Each bottle contains 30 film-coated tablets.

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

Manufacturer
Glaxo Wellcome, S.A.
Avda. Extremadura, 3
Aranda De Duero
Burgos 09400
Spain

For further information about this medicine, please contact the local representative of the Marketing Authorization Holder:

België/Belgique/Belgien Lietuva
ViiV Healthcare srl/bv ViiV Healthcare BV
Tél/Tel: + 32 (0) 10 85 65 00 Tel: + 370 80000334

България Luxembourg/Luxemburg
ViiV Healthcare BV ViiV Healthcare srl/bv
Teл.: + 359 80018205 Belgique/Belgien
Tél/Tel: + 32 (0) 10 85 65 00

Česká republika Magyarország
GlaxoSmithKline, s.r.o. ViiV Healthcare BV
Tel: + 420 222 001 111 Tel.: + 36 80088309
[email protected]

Danmark Malta
GlaxoSmithKline Pharma A/S ViiV Healthcare BV
Tlf.: + 45 36 35 91 00 Tel: + 356 80065004
[email protected]

Deutschland Nederland
ViiV Healthcare GmbH ViiV Healthcare BV
Tel.: + 49 (0)89 203 0038-10 Tel: + 31 (0) 33 2081199
[email protected]

Eesti Norge
ViiV Healthcare BV GlaxoSmithKline AS
Tel: + 372 8002640 Tlf: + 47 22 70 20 00

Ελλάδα Österreich
GlaxoSmithKline Μονοπρόσωπη A.E.B.E. GlaxoSmithKline Pharma GmbH
Τηλ: + 30 210 68 82 100 Tel: + 43 (0)1 97075 0
[email protected]

España Polska
Laboratorios ViiV Healthcare, S.L. GSK Services Sp. z o.o.
Tel: + 34 900 923 501 Tel.: + 48 (0)22 576 9000
[email protected]

France Portugal
ViiV Healthcare SAS VIIVHIV HEALTHCARE, UNIPESSOAL, LDA
Tél.: + 33 (0)1 39 17 69 69 Tel: + 351 21 094 08 01
[email protected] [email protected]

Hrvatska România
ViiV Healthcare BV ViiV Healthcare BV
Tel: + 385 800787089 Tel: + 40 800672524

Ireland Slovenija
GlaxoSmithKline (Ireland) Limited ViiV Healthcare BV
Tel: + 353 (0)1 4955000 Tel: + 386 80688869

Ísland Slovenská republika
Vistor ehf. ViiV Healthcare BV
Sími: +354 535 7000 Tel: + 421 800500589

Italia Suomi/Finland
ViiV Healthcare S.r.l GlaxoSmithKline Oy
Tel: + 39 (0)45 7741600 Puh/Tel: + 358 (0)10 30 30 30

Κύπρος Sverige
ViiV Healthcare BV GlaxoSmithKline AB
Τηλ: + 357 80070017 Tel: + 46 (0)8 638 93 00
[email protected]

Latvija
ViiV Healthcare BV
Tel: + 371 80205045

Other sources of information
More detailed information on this medicine is available on the website of the European Medicines Agency: https://www.ema.europa.eu