• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

1. What is REKAMBYS and what it is used for
2. What you need to know before you use REKAMBYS
3. How REKAMBYS is given
4. Possible side effects
5. How to store REKAMBYS
6. Contents of the pack and other information

Talk to your doctor or pharmacist before using REKAMBYS.

REKAMBYS is not a cure for HIV infection. It is part of a treatment to reduce the amount of virus in the blood.

Tell your doctor about your situation

Check the following points and tell your doctor if any of them apply to you.

• You must attend all the planned visits for injections, do not miss any visits, it is very important for the success of your treatment. If you cannot attend a planned visit, inform your doctor as soon as possible.
• Tell your doctor if you have ever had problems with your liver, including hepatitis B or hepatitis C, or problems with your kidneys. Your doctor may check how well your liver or kidneys work to decide if you can use REKAMBYS. See ‘Uncommon side effects’ in section 4 of this leaflet for signs of liver damage.
• Tell your doctor immediately if you notice any symptoms of infections (for example, fever, chills, sweats). In some patients with HIV, inflammation from previous infections may occur soon after starting HIV treatment. It is believed that these symptoms are due to an improvement in the body’s immune response, enabling the body to fight infections that were present previously but caused no obvious symptoms.
• Also tell your doctor straight away if you notice any symptoms such as muscle weakness, weakness beginning in the hands and feet and moving up towards the trunk of the body, palpitations, tremor or hyperactivity. This is because autoimmune disorders (conditions in which the immune system mistakenly attacks healthy body tissue) may also occur after you start taking medicines for the treatment of your HIV infection. Autoimmune disorders may occur many months after the start of treatment.
• Tell your doctor if you are taking any medicines that you have been told may cause a life-threatening irregular heartbeat (torsade de pointes).

Post-injection reaction symptoms have happened within minutes in some people after receiving their rilpivirine injection. Most symptoms resolved within a few minutes after the injection. Symptoms of post-injection reactions may include: difficulty breathing, stomach cramps, rash, sweating, numbness of your mouth, feeling anxious, feeling warm, feeling lightheaded or feeling like you are going to pass out (faint), blood pressure changes, and pain (e.g., back and chest). Tell your healthcare professional if you experience these symptoms after you receive your injections.

It is important that you attend your planned appointments to receive REKAMBYS, to control your HIV infection and to stop your illness from getting worse. Do not miss any visits, it is very important for the success of your treatment. If you cannot attend a planned visit, inform your doctor as soon as possible. Talk to your doctor if you are thinking about stopping treatment. If you are late receiving your REKAMBYS injection, or if you stop receiving REKAMBYS, you will need to take other medicines to treat HIV infection and to reduce the risk of the virus becoming resistant as the drug levels in your body will be too low to treat the HIV infection.

REKAMBYS is not for use in children less than 12 years of age or adolescents weighing less than 35 kg, because it has not been studied in these patients.

Tell your healthcare provider if you are taking, have recently taken or might take any other medicines. Some medicines may affect the levels of REKAMBYS in the blood if you are taking them while being treated with REKAMBYS, or REKAMBYS may affect how well the other medicine works.

REKAMBYS must not be given with some other medicines (see ‘Do not use REKAMBYS’ in section 2).

The effects of REKAMBYS or other medicines might change if you use REKAMBYS together with any of the following medicines:

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

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

Tell your doctor immediately if you are pregnant or if you plan to become pregnant. Your doctor will consider the benefit and the risk to you and your baby of using REKAMBYS while you are pregnant. If you are planning to have a baby, talk to your doctor in advance, as rilpivirine can remain in your body for up to 4 years after the last injection of REKAMBYS.

Breast-feeding is not recommended in women living with HIV because HIV infection can be passed on to the baby in breast milk.

If you are breast-feeding, or thinking about breast-feeding, you should discuss it with your doctor as soon as possible.

Some patients may feel tired, dizzy or drowsy during treatment with REKAMBYS. Do not drive or operate machinery if you have any of these side effects.

This medicine contains less than 1 mmol sodium (23 mg) per 3 mL injection, that is to say essentially ‘sodium-free’.

It is important that you keep your regular planned appointments to receive your injection. If you miss an appointment, contact your doctor immediately to make a new appointment.

Talk to your doctor if you think you will not be able to receive your REKAMBYS injection at the usual time. Your doctor may recommend you take tablets instead, until you are able to have a REKAMBYS injection again.

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.

Use REKAMBYS for as long as your doctor recommends. Don’t stop unless your doctor advises you to.

Low levels of rilpivirine (the active ingredient of REKAMBYS) can remain in your body for up to 4 years after stopping treatment. However, once you received your last REKAMBYS injection, the low levels of rilpivirine that remain will not work well enough against the virus which then can become resistant. To keep your HIV-1 infection under control and to stop the virus becoming resistant, you must start a different HIV treatment by the time your next REKAMBYS injection was planned.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard 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.

• The active substance is rilpivirine. Each 3 mL vial contains 900 mg rilpivirine.
• The excipients are poloxamer 338, citric acid monohydrate (E330), glucose monohydrate, sodium dihydrogen phosphate monohydrate, sodium hydroxide (E524) to adjust pH and ensure isotonicity, and water for injections.

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