VOCABRIA 600 MG PROLONGED-RELEASE SUSPENSION FOR INJECTION - patient leaflet, side effects, dosage

Package leaflet: Information for the patient

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 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

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

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

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 is called the lead-in period. It allows your doctor to assess whether it’s appropriate to proceed with injections.

Injection schedule for monthly dosing

Injection Schedule for every 2 month dosing

If you miss a Vocabria injection

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, bruising, warmth or discolouration, which may include 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).

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:

• 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

If you get any symptoms of infection

• ■^ Tell your doctor immediately. Don’t take other medicines for the infection without your doctor’s advice.

Reporting of side effects

If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme Website: or search for MHRA Yellow Card in the Google Play or Apple App Store. 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-     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 UK Limited

980 Great West Road

Brentford

Middlesex

TW8 9GS

United Kingdom

Manufacturer

Glaxo Operations UK Limited (trading as Glaxo Wellcome Operations)

Harmire Road

Barnard Castle

County Durham DL12 8DT

UK

GlaxoSmithKline Manufacturing SpA

Strada Provinciale Asolana, 90

San Polo di Torrile

Parma, 43056

Italy

This leaflet was last revised in April 2021.

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.

11. Attach needle

• 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.

• 18. Assess the injection site

  
  
  • 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.

Repeat for 2nd medicine

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