Prospect: information for the patient

Vocabria 600 mg prolonged-release injectable suspension

cabotegravir

This medicine is subject to additional monitoring, which will expedite the detection of new information about its safety. You can contribute by reporting any adverse effects you may experience. The final part of section 4 includes information on how to report these adverse effects.

Read this prospect carefully before starting to use this medicine, as it contains important information for you.

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

Vocabria injectable contains cabotegravir as the active ingredient. Cabotegravir belongs to a group of antiretroviral medications called integrase inhibitors (INI).

Vocabria injectable 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 also receive another injectable antiretroviral medication called rilpivirine and whose HIV-1 infection is under control.

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

The Vocabria injection is always administeredin combination with another injection of another antiretroviral medication calledrilpivirine injectable. Consult the prospectus for rilpivirine for more information about that medication.

Do not receive Vocabria injectable

• if you have ever had a severe skin rash, skin peeling, blisters, and/or mouth sores.
• if you areallergic(hypersensitive) to cabotegravir or any of the other components of this medication (listed in section 6).
• if you are taking any of these medications as they may affect how Vocabria works:
• • carbamazepine, oxcarbazepine, phenytoin, phenobarbital(medications to treat epilepsy and prevent seizures)
  • rifampicinorrifapentine(medications to treat some bacterial infections, such as tuberculosis).

• If you think this affects you, inform your doctor.

Warnings and precautions

Severe skin reaction

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

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

Severe allergic reaction

Vocabria contains cabotegravir, which is an integrase inhibitor. Integrase inhibitors, including cabotegravir, can cause a severe allergic reaction known ashypersensitivity reaction. You need to know the important signs and symptoms to which you should pay attention 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 evaluate the severity of your liver disease before deciding if you can take Vocabria.

Be aware of the important symptoms

Some people taking HIV medications develop other conditions, which can be serious.

You need to know the important signs and symptoms to which you should pay attention 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 medications for infection unless your doctor advises you to.

Regular visits are important

It is essential thatyou attend your scheduled appointmentsto receive the Vocabria injection, to control your HIV infection, and prevent your condition from worsening. Inform your doctor if you are thinking of interrupting treatment. If you delay receiving your Vocabria injection, or if you stop receiving Vocabria, you will need to take other medications to treat HIV infection and reduce the risk of developing viral resistance.

Vocabria injectable is a long-acting medication.If you interrupt treatment, low levels of cabotegravir (the active ingredient 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 against the virus, and the virus may become resistant. You should start a different HIV treatment within a month after the last Vocabria injection, if you receive monthly injections, and within two months after the last Vocabria injection, if you receive injections every two months.

Children and adolescents

This medication should not be used in children under 12 years or adolescents with a weight less than 35 kg, as it has not been studied in these patients.

Other medications and Vocabria injectable

Inform your doctor if you are taking, have taken recently, or may need to take any other medication, including over-the-counter medications.

Vocabria should not be administeredwith other medications (see‘Do not receive Vocabria injectable’ earlier in section 2).

Some medications may affect how Vocabria worksor increase the likelihood of you experiencingside effects. Vocabria may also affect how other medications work.

Inform your doctorif you are taking:

• rifabutine(to treat some bacterial infections, such as tuberculosis).

• Inform your doctor or pharmacist if you are taking this medication. Your doctor may decide that you need additional monitoring.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant or plan to become pregnant:

• Consult your doctor before receiving Vocabria injectable.

Pregnancy

• Vocabria is not recommended during pregnancy.If necessary, your doctorwill consider the benefit for you and the risk to your baby of receiving Vocabria injections while pregnant. If you are planning to become pregnant,talk to your doctor beforehand
• If you become pregnant, do not stop attending your appointments to receive the Vocabria injection without consulting your doctor.

Breastfeeding

It is not recommendedthat women with HIV breastfeed as the infection can be transmitted to the baby through breast milk.

The safety of Vocabria injectable in breastfeeding women has not been established.However, it is possible that cabotegravir may pass into breast milk during the 12 months following the last Vocabria injection.

If you are breastfeeding or plan to breastfeed,you should consult your doctor as soon as possible.

Driving and operating machinery

Vocabria may cause dizzinessand other side effects that may make you less alert.

• Do not drive or operate machinery unless you are sure it will not affect you.

You will be administered Vocabriain the form of an injection, once a month or once every 2 months, along with another injectable medication called rilpivirina.Your doctor will inform you about the dosing schedule.

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

When you start treatmentwith Vocabria,you and your doctor may decideto start treatment with Vocabria tablets or opt directly for Vocabria injections. If you decide to start treatment with the tablets, your doctor will tell you:

• to take one Vocabria 30 mg tablet and one rilpivirina 25 mg tablet, once a day, forapproximatelyone month
• after that, you will receive theinjectionsmonthly or every 2 months.

This first monthof Vocabria and rilpivirina tabletsis called theoral induction period.It will allow your doctor to evaluate if it is appropriate to switch to injections.

Monthly injection schedule

Every 2 months injection schedule

If you miss a Vocabria injection

Contact your doctor immediatelyto schedule a new appointment

It is essentialto control HIV and prevent your condition from worsening,to attend the scheduled regular appointments to receive your injection. Talk to your doctor if you are thinking of interrupting treatment.

Talk to your doctorif you think you will not be able to receive your Vocabria injection at the usual frequency. Your doctor may recommend that you take Vocabria tabletsor another HIV treatmentinstead, until you can receive your Vocabria injection again.

If you are administered more Vocabria injectable than you should

This medication will be administered by a doctor or nurse, so it is unlikely that you will be administered too much. If you are concerned, consult 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 interrupt treatment, your doctor should start another HIV treatment within 1 month of the last Vocabria injection if you are receiving monthly injections, and within 2 months of the last Vocabria injection if you receive injections every 2 months, to reduce the risk of viral resistance.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

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

• flat, red spots, in the shape of a target or circles on the trunk,oftenwith blisters in the center, skin peeling, mouth sores, throat, nose, genital, and eye sores. These severe skin eruptions may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis). These severe skin reactions are very rare (may affectup to 1 in 10,000people).

Allergic reactions

Vocabria contains cabotegravir, which is an integrase inhibitor. Integrase inhibitors, including cabotegravir, can cause a severe allergic reaction known as hypersensitivity reaction.

If you experience any of the following symptoms:

• skin rash (eruption, hives)
• high temperature (fever)
• fatigue (fatigue)
• swelling, sometimes of the face or mouth (angioedema), which causes difficulty breathing
• muscle or joint pain.

• Seek immediate medical attention.Your doctor may consider it necessary to perform tests to monitor your liver, kidneys, or blood and may advise you to stop taking Vocabria.

Very common side effects

These may affectmore than 1 in 10people:

• headache
• reactions at the injection site.In clinical studies, these were generally mild to moderate and became less frequent over time. Symptoms may include:
• • very common: pain (which in rare cases may include temporary difficulty walking) and discomfort, a hardened mass or lump
  • common: redness, itching, swelling, heat, hematomas (which may includediscoloration or accumulation of blood under the skin)
  • uncommon: numbness, mild bleeding, abscess (accumulation of pus) or cellulitis (heat, swelling, or redness).
• sensation of heat (pyrexia), which may occur in the first week after injections.

Common side effects

These may affectup to 1 in 10people:

• depression
• anxiety
• abnormal dreams
• difficulty sleeping (insomnia)
• dizziness
• nausea
• vomiting
• stomach pain (abdominal pain)
• gas (flatulence)
• diarrhea
• eruption
• muscle pain (myalgia)
• fatigue (fatigue)
• sensation of weakness (asthenia)
• general feeling of illness
• weight gain.

Uncommon side effects

These may affectup to 1 in 100people:

• suicidal attempt and suicidal thoughts (especially in patients who have previously had depression or mental health problems)
• allergic reaction (hypersensitivity)
• hives (urticaria)
• swelling, sometimes of the face or mouth (angioedema), which causes difficulty breathing
• sensation of drowsiness
• sensation of dizziness, during or after an injection. This may lead to fainting
• liver damage (the signs may include yellowing of the skin and the white of the eyes, loss of appetite, itching, stomach sensitivity, pale stools, or dark urine)
• changes in liver markers in blood tests (increase intransaminasesor increase inbilirubin).

Other side effects that may appear in blood tests

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

Other possible side effects

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

Pancreatitis

If you have severe abdominal pain (stomach), it may be due to inflammation of the pancreas (pancreatitis).

• Inform your doctor,especially if the pain worsens and spreads.

Symptoms of infection and inflammation

People with advanced HIV infection (AIDS) have a weakened immune system and are more prone to developing severe infections (opportunistic infections). When starting treatment, the immune system strengthens, and the body begins to fight these infections.

Symptoms of infection and inflammation may occur:

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

Symptoms of autoimmune disorders may appear many months after starting treatment for HIV infection.

Symptoms may include:

• muscle weaknessand/ormuscle pain
• joint painorswelling
• weaknessthat begins in the hands and feet and ascends to the body trunk
• palpitationsorshaking
• hyperactivity(excessive restlessness and movement).

If you experience any symptoms of infection:

• Inform your doctor immediately. Do not take other medications for the infection without consulting your doctor first.

Reporting side effects

If you experience any type of side effect, consult your doctor or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the label and the box after CAD. The expiration date is the last day of the month indicated.

This medication does not require any special storage temperature.

Do not freeze.

Composition of Vocabria

• The active ingredient is cabotegravir.

Each vial of 3ml contains 600mg of cabotegravir.

The other components are:

Mannitol (E421)

Polysorbate 20(E432)

Macrogol(E1521)

Water forinjectable preparations

Appearance of the product and contents of the package

Cabotegravirprolonged-release injectable suspensionis presented in a topaz-colored glass vialwith a rubber stopper. The package also contains 1 syringe, 1 vial adapter, and 1 needle for injection.

Marketing Authorization Holder

ViiV Healthcare BV
Van Asch van Wijckstraat 55H

3811 LP Amersfoort
Netherlands

Manufacturer

GlaxoSmithKline Manufacturing SpA

Strada Provinciale Asolana, 90

San Polo di Torrile

Parma, 43056

Italy

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Last update date of this leaflet:

Other sources of informationn

The detailed information about this medication is available on the website of the European Medicines Agency:https://www.ema.europa.eu

------------------------------------------------------------------------------------------------------------------This information is intended solely for healthcare professionals:

Instructions for useof Vocabria injectable 3ml: