Rekambys
Authorised
This medicine is authorised for use in the European Union
rilpivirine
MedicineHumanAuthorised
Overview
Rekambys is used together with another medicine called cabotegravir to treat adults infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS). It is used in adults whose infection is under control with other HIV medicines.
Rekambys contains the active substance rilpivirine.
Rekambys is available as a prolonged-release suspension for injection. ‘Prolonged release’ means that the active substance is released slowly over a few weeks after being injected. The medicine is given by injection into the hip or buttock muscle by a doctor or nurse.
Before starting treatment, the doctor ensures that the patient agrees to keep to the schedule of injections, because this is important to keep the virus under control and there is a risk that levels of the virus could increase or the virus could become resistant to treatment if doses are missed.
Rilpivirine and cabotegravir tablets are taken daily by mouth for one month, after which Rekambys and cabotegravir injections are given monthly or every 2 months.
If treatment with Rekambys is stopped, another treatment to supress the virus must be started to minimise the risk that the virus could become resistant to treatment.
Rekambys can only be obtained with a prescription, and treatment should be started by a doctor who has experience in the management of HIV infection.
For more information about using Rekambys, including the schedule for the injections, see the package leaflet or contact your doctor or pharmacist.
Rekambys is a type of HIV medicine called a non-nucleoside reverse transcriptase inhibitor (NNRTI). It blocks the activity of reverse transcriptase, an enzyme produced by HIV-1 that allows it to make more viruses in the cells it has infected. By blocking this enzyme, Rekambys, taken in combination with cabotegravir, reduces the amount of HIV in the blood and keeps it at a low level. Rekambys does not cure HIV infection or AIDS, but it can hold off damage to the immune system and the development of infections and diseases associated with AIDS.
Rekambys, taken together with cabotegravir, was as effective as other HIV medicines in maintaining the HIV-1 level in the blood (viral load) below a defined level (less than 50 HIV-1 RNA copies/ml) in 3 main studies involving patients with HIV-1 infection. The studies involved patients who had not taken HIV medicines before or who had been taking these medicines for at least 6 months.
In two studies, patients were treated with Rekambys and cabotegravir or with combinations of other medicines. After 48 weeks, the HIV-1 level was above the limit in 1.9% of patients (11 out of 591) taking monthly injections of Rekambys and cabotegravir and in 1.7% of patients (10 out of 591) taking other medicines.
One study showed that injections of Rekambys and cabotegravir given monthly or every 2 months were similarly effective. After 48 weeks for patients taking the injections every 2 months, the HIV-1 level was above the limit in 1.7% of patients (9 out of 522) compared with 1% of patients (5 out of 523) who had monthly injections.
The most common side effects with Rekambys (which may affect more than 1 in 10 people) are injection site reactions, headache and fever.
Rekambys must not be used with the following medicines as they may lead to reduced blood levels of the medicine, reducing its effectiveness:
- carbamazepine, oxcarbazepine, phenobarbital, phenytoin (medicines for epilepsy);
- rifabutin, rifampicin, rifapentine (antibiotics);
- systemic dexamethasone (a steroid anti-inflammatory and immunosuppressant medicine), except when used as a single dose treatment;
- St John’s wort (a herbal antidepressant medicine).
For the full list of side effects and restrictions with Rekambys, see the package leaflet.
Injections every month or every 2 months may be more convenient for patients than taking medicines every day. Studies showed that the injections were as effective at keeping the virus level low as other standard medicines. It is important that patients keep to the schedule of injections to avoid the virus becoming resistant to treatment, and further studies will determine whether this is happening once the medicine is on the market. The European Medicines Agency decided that Rekambys’s benefits are greater than its risks and it can be authorised for use in the EU.
The company that markets Rekambys will carry out 2 studies on how the medicine is used and its effectiveness. The outcomes for patients who switch to other treatments after taking Rekambys will also be studied.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Rekambys have also been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Rekambys are continuously monitored. Side effects reported with Rekambys are carefully evaluated and any necessary action taken to protect patients.
Rekambys received a marketing authorisation valid throughout the EU on 17.12.2020.
Product information
Latest procedure affecting product information: II-19
28/09/2023
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- Rekambys
- Active substance
- rilpivirine
- International non-proprietary name (INN) or common name
- rilpivirine
- Therapeutic area (MeSH)
- HIV Infections
- Anatomical therapeutic chemical (ATC) code
- J05AG05
Pharmacotherapeutic group
Antivirals for systemic useTherapeutic indication
Rekambys is indicated, in combination with cabotegravir injection, for the treatment of human immunodeficiency virus type 1 (HIV 1) infection in adults who are virologically suppressed (HIV-1 RNA < 50 copies/mL) on a stable antiretroviral regimen without present or past evidence of viral resistance to, and no prior virological failure with, agents of the NNRTI and INI class.
News on Rekambys
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