Vocabria 600 mg prolonged-release injectable suspension

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the patient

Vocabria 600 mg prolonged-release injectable suspension

cabotegravir

This medicinal product is subject to additional monitoring, which will allow for rapid identification of new safety information. You can help by reporting any adverse reactions you may experience. Section 4 at the end contains information on how to report these adverse reactions.

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or nurse.
• If you experience any adverse reactions, consult your doctor or nurse, even if they are not listed in this leaflet. See section 4.

Contents of the 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 injectable is 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 for injection contains cabotegravir as the active substance. Cabotegravir belongs to a group of antiretroviral medicines called integrase inhibitors (INI).

Vocabria for injection is 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 receiving another injectable 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 the blood. CD4+ cells are a type of white blood cell important in helping your body fight infections.

Vocabria injection is always administered in combination with another injection of an antiretroviral medicine called rilpivirine for injection. Please refer to the rilpivirine package leaflet for more information about that medicine.

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

Do not receive Vocabria injection

• if you have ever developed a severe skin rash, peeling of the skin, blisters, and/or mouth sores.

• 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 how Vocabria works:

• 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).

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

Warnings and precautions

Severe skin reaction

Very rarely, severe skin reactions, Stevens-Johnson syndrome, and toxic epidermal necrolysis have been reported in association with Vocabria. If you notice any of the symptoms related to these severe skin reactions, do not receive the next Vocabria injection and seek immediate medical attention.

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 need to be aware of the important signs and symptoms to watch for while receiving Vocabria.

Read the information in section 4 of this leaflet.

Liver problems including hepatitis B and/or C

Inform your doctor if you have or have had liver problems, including hepatitis B and/or C. Your doctor will assess the severity of your liver disease before deciding whether you can take Vocabria.

Be alert to important symptoms

Some people who take medicines for HIV infection develop other disorders, which may be serious.

You need to know the important signs and symptoms to watch for while being treated with Vocabria. These include:

• symptoms of infection
• 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:

Inform your doctor immediately. Do not take other medicines for infection unless advised by 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 prevent your condition from worsening. Inform your doctor if you are considering stopping treatment. If you delay 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 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 against 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 are receiving monthly injections, or within two months after your last Vocabria injection if you are receiving injections every two months.

Children and adolescents

This medicine should not be used 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 injection

Inform your doctor if you are taking, have recently taken, or might need to take any other medicines, including medicines obtained without a prescription.

Vocabria should not be administered with other medicines (see 'Do not receive Vocabria injection' above in section 2).

Some medicines may affect how Vocabria works or increase the likelihood that you will experience side effects. Vocabria may also affect how other medicines work.

Inform your doctor if you are taking:

• 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 or breastfeeding, think you may be pregnant, or are planning to become pregnant:

Consult your doctor before receiving 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 of receiving Vocabria injections while pregnant. If you are planning to become pregnant, discuss this with your doctor in advance.
• If you become pregnant, do not stop attending your appointments for Vocabria injections without consulting your doctor.

Breastfeeding

It is not recommended that women living with HIV breastfeed because HIV infection can be transmitted to the baby through breast milk.

It is unknown whether the components of Vocabria injection can pass into breast milk. However, cabotegravir may pass into breast milk for up to 12 months after the last Vocabria injection.

If you are breastfeeding or considering breastfeeding, you must consult your doctor as soon as possible.

Driving and use of machines

Vocabria may make you feel dizzy and cause other side effects that may reduce your alertness.

Do not drive or operate machinery unless you are certain it does not affect you.

Important information about some of the ingredients of Vocabria

The Vocabria injection contains polysorbate. This medicine contains 60 mg of polysorbate per 3 ml dose. Inform your doctor if you have any known allergy.

3. How Vocabria injectable is administered

Vocabria will be administered to you as an injection, once a month or once every 2 months, together with another injectable medicine called rilpivirine. Your doctor will inform you about the dosing schedule.

A nurse or doctor will administer Vocabria to you by injecting it into the muscle of your buttock (intramuscular injection, or IM).

When you start treatment with Vocabria, you and your doctor may decide to begin treatment with Vocabria tablets or to start directly with Vocabria injections. If it is decided to begin with tablets, your doctor will instruct you to:

• take one Vocabria 30 mg tablet and one rilpivirine 25 mg tablet once daily for approximately one month
• after this, you will receive the injections either monthly or every 2 months.

This initial one-month period of taking Vocabria and rilpivirine tablets is called the oral induction period. It will allow your doctor to assess whether it is appropriate to switch to the injections.

Monthly injection schedule

Injection schedule every 2 months

If you miss an injection of Vocabria

Contact your doctor immediately to schedule a new appointment.

It is important for controlling HIV and preventing your condition from worsening that you attend your scheduled appointments to receive your injection. Speak with 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 usual frequency. Your doctor may recommend that you take Vocabria tablets or another HIV treatment instead, until you can receive your Vocabria injection again.

If you are given more Vocabria injectable than you should

This medicine will be administered by a doctor or nurse, so it is unlikely that you will be given too much. If you are concerned, speak to the 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 tells you to. If you discontinue treatment, your doctor should start you on another HIV treatment within one month after your last Vocabria injection if you were receiving monthly injections, or within two months after your last Vocabria injection if you were receiving 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 adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Do not receive the next Vocabria injection and seek immediate medical attention if you notice any of the following symptoms:

• red, flat, target-shaped or circular rashes on the trunk, often with blisters in the center, peeling skin, sores in the mouth, throat, nose, genitals, and eyes. These serious skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis). These serious 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 your doctor immediately. Your doctor may consider it necessary to perform tests to monitor your liver, kidneys, or blood and may instruct you to stop taking Vocabria.

Very common adverse effects

These may affect more than 1 in 10 people:

• headache

• injection site reactions. In clinical studies, most were generally mild to moderate and became less frequent over time. Symptoms may include:

• pain (which in rare cases may include temporary difficulty walking) and discomfort, a mass or hardened lump

• feeling of warmth (pyrexia), which may occur during the first week after injections.

Common adverse effects

These may affect up to 1 in 10 people:

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

Uncommon adverse effects

These may affect up to 1 in 100 people:

• suicide attempt and suicidal thoughts (especially in patients who previously had depression or mental health problems)
• allergic reaction (hypersensitivity)
• hives (urticaria)
• swelling, sometimes of the face or mouth (angioedema), causing difficulty breathing
• feeling of drowsiness
• 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 upset, pale stools, or abnormally dark urine)
• changes in liver markers in blood tests (increase in transaminases or increase in bilirubin)
• injection site reactions. In clinical studies, most were generally mild to moderate in intensity and became less frequent over time. Symptoms may include: numbness, minor bleeding, an abscess (collection of pus), or cellulitis (warmth, swelling, or redness).

Other adverse effects that may appear in blood tests

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

Other possible adverse effects

People receiving HIV treatment with Vocabria and rilpivirine may experience other adverse effects.

Pancreatitis

If you have severe abdominal pain (stomach), this may be due to 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). When they start treatment, the immune system strengthens, so the body begins to fight these infections.

Symptoms of infection and inflammation may develop, caused by:

• reactivation of old latent infections as the body fights them
• the immune system attacking healthy tissues (autoimmune disorders).

Symptoms of autoimmune disorders may appear many months after starting treatment with HIV medicines.

Symptoms may include:

• muscle weakness and/or muscle pain
• pain or swelling of the joints
• weakness beginning in the hands and feet and moving upward toward the trunk
• palpitations or tremors
• hyperactivity (excessive restlessness and movement).

If you have any symptoms of infection:

Inform your doctor immediately. Do not take any other medicines for infection without consulting your doctor first.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of 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 the carton after EXP. The expiry date is the last day of the month indicated.

Do not freeze.

6. Contents of the pack and other information

Composition of Vocabria

• The active substance is cabotegravir.

Each 3 ml vial contains 600 mg of cabotegravir.

The other components are:

Mannitol (E421)

Polysorbate 20 (E432)

Macrogol (E1521)

Water for injections

Nature of the product and contents of the pack

Cabotegravir prolonged-release injectable suspension is supplied in a topaz glass vial with a rubber stopper. The pack also contains 1 syringe, 1 vial adapter, and 1 injection needle.

Marketing Authorization 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

Further information about this medicinal product is available upon request from the local representative of the Marketing Authorization Holder:

Date of last review of this leaflet: <{MM/YYYY}>.

Other sources of information

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

This information is intended for healthcare professionals only:

Instructions for use of Vocabria injectable 3 ml: