Rekambys 900 mg prolonged-release injectable suspension

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

REKAMBYS 900 mg prolonged-release injectable suspension

rilpivirine

This medicinal product is subject to additional monitoring, which will enable rapid identification of new safety information. You can help by reporting any side effects you may experience. Information on how to report side effects is provided at the end of section 4.

Read this entire 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 pharmacist.

• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.

• If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What REKAMBYS is and what it is used for

2. What you need to know before using REKAMBYS

3. How REKAMBYS is administered

4. Possible side effects

5. How to store REKAMBYS

6. Contents of the pack and other information

1. What REKAMBYS is and what it is used for

REKAMBYS contains the active substance rilpivirine. It belongs to a group of medicines called non-nucleoside reverse transcriptase inhibitors (NNRTIs) used in the treatment of human immunodeficiency virus type 1 (HIV-1).

REKAMBYS works together with other anti-HIV medicines by blocking the virus' ability to make more copies of itself. Injectable REKAMBYS does not cure HIV infection, but helps reduce the amount of HIV in your body and keeps it at a low level. This slows down damage to the immune system and the development of AIDS-related infections and diseases.

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

2. What you need to know before using REKAMBYS

Do not use REKAMBYS if you are allergic to rilpivirine or to any of the other ingredients of this medicine (listed in section 6).

Do not use REKAMBYS if you are taking any of the following medicines, as they may affect how REKAMBYS or the other medicines work:

• carbamazepine, oxcarbazepine, phenobarbital, phenytoin (medicines used to treat epilepsy and prevent seizures)

• rifabutin, rifampicin, rifapentine (medicines used to treat bacterial infections such as tuberculosis)

• dexamethasone (a corticosteroid used to treat various conditions, such as inflammation and allergic reactions) administered in an oral or injectable treatment course

• products containing St. John’s wort or Hypericum (Hypericum perforatum, a herbal remedy used for depression).

If you are taking any of the above medicines, consult your doctor about alternative treatments.

Warnings and precautions

Talk to your doctor or pharmacist before starting to use REKAMBYS.

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

Inform your doctor about your condition

Review the following points and inform your doctor if any of the following apply to you.

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

• Inform your doctor if you have or have ever had liver disease, including hepatitis B or hepatitis C, or kidney disease. Your doctor will likely check how well your liver and kidneys are functioning to determine whether you can use REKAMBYS. See the signs of liver damage in section 4 of this leaflet, “Uncommon adverse effects”.

• Inform your doctor immediately if you notice any signs of infection (for example, fever, chills, sweating). In some HIV patients, inflammation due to prior infections may occur shortly after starting HIV treatment. These symptoms are believed to result from improved immune response, enabling the body to fight previously asymptomatic infections.

• Inform your doctor immediately if you experience any symptoms such as muscle weakness, weakness starting in the hands and feet and progressing upward toward the trunk, palpitations, tremor, or hyperactivity. These may be due to autoimmune disorders (conditions in which the immune system mistakenly attacks healthy body tissue), which may also occur after you have started taking medicines for HIV infection. Autoimmune disorders may appear many months after treatment initiation.

• Inform your doctor if you are taking any medicine that has been reported to cause potentially life-threatening irregular heartbeats (torsade de pointes).

Reactions to injections

Some people have experienced symptoms of post-injection reactions within minutes of receiving the rilpivirine injection. Most symptoms resolved within minutes after the injection. Symptoms of post-injection reactions may include: difficulty breathing, stomach cramps, sweating, numbness of the mouth, feeling anxious, feeling hot, feeling dizzy or like you might faint (or pass out), and changes in blood pressure. Inform your healthcare provider if you experience these symptoms after receiving your injections.

It is important to attend appointments on time

It is important that you attend your scheduled appointments to receive REKAMBYS to control your HIV infection and prevent the disease from worsening. Do not miss any visits, as this is crucial for treatment effectiveness. If you cannot attend a scheduled appointment, inform your doctor as soon as possible. Inform your doctor if you are considering stopping treatment. If administration of REKAMBYS is delayed, or if you stop receiving REKAMBYS, you will need to take other medicines to treat HIV infection and reduce the risk of the virus becoming resistant, as drug levels in your body will be too low to treat HIV infection.

Children

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

Other medicines and REKAMBYS

Inform your healthcare provider if you are taking, have recently taken, or might need to take any other medicine. Some medicines may affect the level of REKAMBYS in the blood when taken during treatment with REKAMBYS, or REKAMBYS may affect the effectiveness of other medicines.

Do not use REKAMBYS if you are taking any of the following medicines, as they may affect how REKAMBYS or the other medicines work:

• carbamazepine, oxcarbazepine, phenobarbital, phenytoin (medicines used to treat epilepsy and prevent seizures)

• rifabutin, rifampicin, rifapentine (medicines used to treat bacterial infections such as tuberculosis)

• dexamethasone (a corticosteroid used to treat various conditions, such as inflammation and allergic reactions) administered in an oral or injectable treatment course

• products containing St. John’s wort or Hypericum (Hypericum perforatum, a herbal remedy used for depression).

If you are taking any of the above medicines, consult your doctor about alternative treatments.

The effect of REKAMBYS or other medicines may change if you use REKAMBYS with any of the following medicines:

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

Pregnancy and breastfeeding

Inform your doctor immediately if you are pregnant or plan to become pregnant. Your doctor will assess the benefits and risks to you and your baby of using REKAMBYS during pregnancy. If you plan to become pregnant, consult your doctor in advance, as rilpivirine may remain in the body for up to 4 years after the last REKAMBYS injection.

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

Consult your doctor or pharmacist before taking any medicine.

Driving and using machines

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

Important information about some of the ingredients of REKAMBYS

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

3. How REKAMBYS is administered

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

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

Before starting treatment with REKAMBYS, your doctor will prescribe a daily treatment with rilpivirine and cabotegravir tablets for one month. This is known as oral lead-in dosing; taking the tablets before receiving the injections of REKAMBYS and cabotegravir will allow your doctor to check whether these medicines 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 important that you attend your scheduled appointments regularly to receive your injection. If you miss an appointment, contact your doctor immediately to arrange another one.

Tell your doctor if you think you will be unable to receive your 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 doctor or nurse will administer this medicine, so it is unlikely that you will be given too much. If you are concerned, tell your doctor or nurse.

Do not stop using REKAMBYS unless your doctor advises you to do so.

Use REKAMBYS for as long as your doctor tells you to. Do not stop treatment unless advised by your doctor.

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

4. Possible adverse effects

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

Below is a list of adverse effects that have been reported with the use of REKAMBYS and injectable cabotegravir.

Very common adverse effects (affect at least 1 in 10 people)

• headache

• injection site reactions – usually mild to moderate, and their frequency decreases over time. Symptoms may include:

  o very common: pain and discomfort, hard masses or lumps

  o common: redness, itching, swelling, bruising, warmth, or skin discoloration

  o uncommon: numbness, minor bleeding, abscess formation (collection of pus), or cellulitis (with sensation of warmth, swelling, or redness)

• Feeling hot/feverish (pyrexia)

Common adverse effects (affect less than 1 in 10 people)

• depression
• anxiety
• abnormal dreams
• difficulty sleeping (insomnia)
• dizziness
• feeling unwell (nausea)
• vomiting
• stomach pain (abdominal pain)
• gas (flatulence)
• diarrhea
• rash
• muscle pain (myalgia)
• tiredness (fatigue)
• feeling of weakness (asthenia)
• general malaise
• weight gain

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

• drowsiness (somnolence)
• 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, abdominal tenderness, pale stools, or abnormally dark urine)
• changes in blood tests indicating liver function (increase in transaminases)
• increased bilirubin (a substance produced by the liver) in blood

Other adverse effects

• Severe abdominal pain caused by inflammation of the pancreas (pancreatitis)

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

Very common adverse effects

• increased cholesterol and/or pancreatic amylase in blood

Common adverse effects (affect less than 1 in 10 people)

• loss of appetite
• sleep disorders
• depressive state
• stomach discomfort
• dry mouth
• low white blood cell count and/or platelets, decreased hemoglobin in blood, increased triglycerides and/or lipase in blood

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

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

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, 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 REKAMBYS

Keep out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

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

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This helps protect the environment.

6. Contents of the pack and other information

Composition of REKAMBYS

• The active substance is rilpivirine. Each 3 ml vial contains 900 mg of rilpivirine.

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

Appearance of the product and contents of the pack

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

Marketing Authorization Holder

Janssen-Cilag International NV

Turnhoutseweg 30

B-2340 Beerse

Belgium

Manufacturer

Janssen Pharmaceutica NV

Turnhoutseweg 30

B-2340 Beerse

Belgium

More information about this medicine is available upon request by contacting the local representative of the Marketing Authorization Holder:

Date of the most recent review of this leaflet: {MM/YYYY}.

Detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu/.

This information is intended only for doctors or healthcare professionals and should be read together with the complete prescribing information (Summary of Product Characteristics).

Instructions for use of REKAMBYS 3 ml injectable: