Patient Information Leaflet

REKAMBYS 900 mg prolonged-release injectable suspension

rilpivirina

This medicine is subject to additional monitoring, which will speed up the detection of any 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 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 doubts, consult your doctor or pharmacist.

• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What you need to know before you start using REKAMBYS
2. How to administer REKAMBYS
3. Adverse effects

1. Storage of REKAMBYS
2. Contents of the pack and additional information

REKAMBYS contains the active ingredient rilpivirina. It is part of a group of medications known as non-nucleoside reverse transcriptase inhibitors (NNRTIs) used in the treatment of human immunodeficiency virus type 1 (HIV-1).

REKAMBYS works together with other HIV medications to block the virus's ability to make more copies of itself. REKAMBYS injectable does not cure HIV infection, but it helps to reduce the amount of HIV in the body and keep it at a low level. This slows down the damage to the immune system and the development of infections and diseases associated with AIDS.

REKAMBYS is always administered with another HIV medication called cabotegravir injectable. They are administered together in adults aged 18 years and older whose HIV-1 infection is already controlled.

Do not use REKAMBYSif you are allergic to rilpivirina or any of the other components of thismedication (listed in section 6).

Do not use REKAMBYS if you are taking any of the following medications, as they mayaffect the way REKAMBYS or other medications work:

• carbamazepine, oxcarbazepine, phenobarbital, phenytoin (medications for treating epilepsy and preventing seizures)
• rifabutin, rifampicin, rifapentine (medications for treating bacterial infections such as tuberculosis)
• dexamethasone (a corticosteroid used to treat various conditions, such as inflammation and allergic reactions) administered in a treatment cycle via oral or injectable route

• products containing St. John's Wort or Hypericum (Hypericum perforatum,a medicinal plant used for depression).

If you are taking any of the above medications, consult your doctor about alternatives.

Warnings and precautions

Consult your doctor or pharmacist before starting to use REKAMBYS.

REKAMBYS does not cure HIV infection. It is part of a treatment to reduce the amount of virus in the blood. While using this medication, you may still transmit HIV to others, although the risk is reduced by effective antiviral treatment. Consult your doctor about precautions to avoid infecting others.

Inform your doctor about your situation

Review the following points and inform your doctor if you are in any of the following cases.

• You must attend all scheduled injection visits, do not miss any visits, it is very important for the success of your treatment. If you cannot attend a scheduled visit, inform your doctor as soon as possible.

• Inform your doctor if you have or have had any timeliver diseases, including hepatitis B or hepatitis C, orkidney diseases. Your doctor will probably check how well your liver and kidneys are functioning to decide if you can use REKAMBYS. See the signs of liver damage in section 4 of this prospectus “Adverse reactions”.

• Inform your doctor immediately if you observe anysymptoms of infection(for example, fever, chills, sweating). In some patients with HIV, inflammation may occur due to previous infections shortly after starting HIV treatment. It is believed that these symptoms are due to the improvement of the body's immune response, allowing it to fight previously present infections that had not manifested evident symptoms.

• Inform your doctor immediately if you observe any symptoms such as muscle weakness, weakness starting in hands and feet and ascending to the body trunk, palpitations, tremor, or hyperactivity. This is due to autoimmune disorders (conditions in which the immune system attacks healthy body tissue by mistake) that may also occur after starting HIV treatment medications. Autoimmune disorders may appear many months after treatment initiation.
• Inform your doctor if you are taking any medication that has been told to cause potentially fatal irregular heartbeat (torsade de pointes).

Reactions to injections

Some people have experienced symptoms of post-injection reactions a few minutes after receiving the rilpivirina injection. Most symptoms resolved a few minutes after the injection. Symptoms of post-injection reactions may include: difficulty breathing, stomach cramps, sweating, numbness of the mouth, feeling of anxiety, feeling of heat, feeling of dizziness, or feeling of fainting and changes in blood pressure. Inform your healthcare professional if you experience these symptoms after receiving your injections.

It is essential to attend appointments punctually

It is essential thatyou attend your scheduled appointmentsto receive REKAMBYS to control your HIV infection and avoid the disease from worsening. Do not miss any of the visits, it is very important for the treatment to be effective. If you cannot attend a scheduled visit, inform your doctor as soon as possible. Inform your doctor if you are thinking of stopping treatment. If the administration of REKAMBYS is delayed, or if you stop receiving REKAMBYS, you will need to take other medications to treat HIV infection and reduce the risk of the virus becoming resistant, as the medication levels in your body will be too low to treat HIV infection.

Children

REKAMBYS is not for use in children or adolescents under 18 years of age, as it has not been studied in these patients.

Other medications and REKAMBYS

Inform your healthcare professional if you are taking, have taken recently, or may need to take any other medication. Some medications may affect the level of REKAMBYS in the blood if taken during REKAMBYS treatment, or REKAMBYS may affect the efficacy of other medications.

Do not use REKAMBYS if you are taking any of the following medications, as they mayaffect the way REKAMBYS or other medications work:

• carbamazepine, oxcarbazepine, phenobarbital, phenytoin (medications for treating epilepsy and preventing seizures)
• rifabutin, rifampicin, rifapentine (medications for treating bacterial infections such as tuberculosis)
• dexamethasone (a corticosteroid used to treat various conditions, such as inflammation and allergic reactions) administered in a treatment cycle via oral or injectable route

• products containing St. John's Wort or Hypericum (Hypericum perforatum,a medicinal plant used for depression).

If you are taking any of the above medications, consult your doctor about alternatives.

The effect of REKAMBYS or other medications may changeif you use REKAMBYS withany of the following medications:

• clarithromycin, erythromycin (antibiotics)
• methadone (used to treat withdrawal syndrome and dependence)

Pregnancy and breastfeeding

Inform your doctor immediately if you are pregnant or intend to become pregnant. Your doctor will evaluate the benefit and risk, for you and your baby, of using REKAMBYS during pregnancy. If you intend to become pregnant, consult your doctor beforehand, as rilpivirina may remain in the body for up to 4 years after the last REKAMBYS injection.

Women with HIV should not breastfeed as HIV can be transmitted through breast milk and infect the baby.

Consult your doctor or pharmacist before taking any medication.

Driving and operating machinery

Some patients may feel fatigue, dizziness, or somnolence during REKAMBYS treatment. Do not drive or operate machinery if you experience any of these adverse effects.

Important information about some of the components of REKAMBYS

This medication contains less than 1 mmol of sodium (23 mg) per 3 ml of injection; it is essentially “sodium-free”.

A nurse or doctor will administer REKAMBYS as an injection into the muscle of your buttock (intramuscular injection, or IM).

The injection will be administeredonce a month or once every 2 months,along with another injectable medication called cabotegravir. Your doctor will explain how often you will receive the medication.

Before starting treatment with REKAMBYS, your doctor will prescribe a daily treatmentwith tablets of rilpivirina and cabotegravir for a month. This is known asinitial oral dosing;taking the tablets before receiving the injections of REKAMBYS and cabotegravirwill allow your doctor to check if these medications are suitable for you.

If you are to receive REKAMBYS once a month, your treatment will be as follows:

If you are to receive REKAMBYS every 2 months, your treatment will be as follows:

If you miss a REKAMBYS injection

It is essential that you attend your scheduled appointments to receive your injection. If you miss an appointment, contact your doctor immediately to reschedule.

Inform your doctorif you think you will not be able to receive the REKAMBYS injection on the scheduled date. Your doctor may recommend that you take tablets until you can receive another REKAMBYS injection.

If you are given too much REKAMBYS

A nurse or doctor will administer this medication, so it is unlikely that you will be given too much. If you are concerned, tell the nurse or doctor.

Do not stop using REKAMBYS without consulting your doctor.

Use REKAMBYS as directed by your doctor. Do not interrupt treatment unless your doctor advises you to.

After interrupting treatment, low levels of rilpivirina (the active ingredient in REKAMBYS) may remain in your body for up to 4 years. However, after your last REKAMBYS injection, the remaining low levels of rilpivirina will not be sufficient to fight the virus, and you may become resistant. To keep your HIV-1 infection under control and prevent the virus from becoming resistant, you must start a different HIV treatment on the date when your next REKAMBYS injection was scheduled.

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

Below, you will find a list of side effects that have been described with the use of REKAMBYS and cabotegravir injectable.

Frequent side effects (affect at least 1 in 10 people)

• Headache
• Reactions at the injection site - usually mild to moderate and decreasing in frequency over time. Symptoms may include:

orFrequent: pain and discomfort, masses or hard lumps

orCommon: redness, itching, swelling, bruises, heat, or change in color.

orUncommon: numbness, mild bleeding, abscess formation (accumulation of pus) or cellulitis (with a sensation of heat, swelling, or redness).

• Sensation of heat/fever (pyrexia)

Frequent side effects (affect less than 1 in 10 people)

• Depression
• Anxiety
• Abnormal dreams
• Difficulty sleeping (insomnia)
• Dizziness
• Sensation of discomfort (nausea)
• Vomiting
• Abdominal pain (abdominal pain)
• Gas (flatulence)
• Diarrhea
• Urticaria
• Muscle pain (mialgia)
• Fatigue
• Sensation of weakness (asthenia)
• General feeling of illness
• Weight gain

Uncommon side effects (affect less than 1 in 100 people)

• Drowsiness (somnolence)
• Sensation of dizziness during or after an injection. This may cause fainting.
• Liver damage (its signs may include yellowing of the skin and the white part of the eye, loss of appetite, itching, abdominal pain, pale stools, or dark urine).
• Changes in liver function test results (elevated transaminases)
• Increased bilirubinin the blood.

Other side effects

• Intense abdominal pain caused by pancreatitis (pancreatitis).

The following side effects that can occur with rilpivirine tablets may also occur with REKAMBYS injectable:

Frequent side effects

• Increased cholesterol and/or pancreatic amylase in the blood

Frequent side effects (affect less than 1 in 10 people)

• Loss of appetite
• Sleep disorders
• Depressive state
• Abdominal discomfort
• Dry mouth
• Low white blood cell and/or platelet count, decreased hemoglobin in the blood, increased triglycerides and/or lipase in the blood

Uncommon side effects (affect less than 1 in 100 people)

• Signs or symptoms of inflammation or infection, for example fever, chills, sweating (immune reconstitution syndrome, for more information see section 2)

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the national reporting system included in theAppendix V. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep out of sight and reach of children.

Do not use this medication after the expiration date found on the packaging after CAD. The expiration date is the last day of the month indicated.

Store in refrigerator (between 2°C and 8°C). Do not freeze.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

Composition of REKAMBYS

• The active ingredient is rilpivirina. Each vial of 3 ml contains 900 mg of rilpivirina.

• The excipients are poloxamer 338, citric acid monohydrate, glucose monohydrate, sodium dihydrogen phosphate monohydrate, sodium hydroxide for pH adjustment and to ensure isotonicity, and water for injection.

Appearance of the product and contents of the package

Prolonged-release injectable suspension. REKAMBYS is presented in a glass vial. The package also contains 1 syringe, 1 vial adapter, and 1 injection needle.

Marketing authorization holder

Janssen-Cilag International NV

Turnhoutseweg 30

B-2340 Beerse

Belgium

Responsible for manufacturing

Janssen Pharmaceutica NV

Turnhoutseweg 30

B-2340 Beerse

Belgium

For more information about this medicine, please contact the local representative of the marketing authorization holder:

Last date of revision of this leaflet: {MM/AAAA}.

For more detailed information about this medicine, please visit the website of the European Medicines Agency:http://www.ema.europa.eu/.

This information is intended solely for healthcare professionals who should read it together with the complete prescribing information (Summary of Product Characteristics).

Instructions for use of REKAMBYS 3 ml injectable: