Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - rekambys

Document Subject

Generated Narrative: MedicinalProductDefinition mp9af059b2ba34008a8e3668c3f552d22f

identifier: http://ema.europa.eu/identifier/600 mg: EU/1/20/1482/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: REKAMBYS 600 mg prolonged-release suspension for injection

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

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part: nan

type: Strength part

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type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-9af059b2ba34008a8e3668c3f552d22f

identifier: http://ema.europa.eu/identifier/600 mg: EU/1/20/1482/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - rekambys

Attesters

What is in this leaflet

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

REKAMBYS contains the active ingredient rilpivirine. It is one of a group of medicines called non-nucleoside reverse transcriptase inhibitors (NNRTIs) that are used for the treatment of human immunodeficiency virus type 1 (HIV-1) infection. REKAMBYS works together with other HIV medicines to block the ability of the virus to make more copies of itself. REKAMBYS injections do not cure HIV infection but help reduce the amount of HIV in your body and keeps it at a low level. This holds off damage to the immune system and the development of infections and diseases associated with AIDS. REKAMBYS is always given with another HIV medicine called cabotegravir injection. They are used together in adults aged 18 years and older whose HIV-1 infection is already under control.

Do not use REKAMBYS if you are allergic to rilpivirine or 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 the way REKAMBYS or the other medicine works:

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

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

dexamethasone (a corticosteroid used in a variety of conditions such as inflammation and allergic reactions) as a course of treatment by mouth or injection

products that contain St John s wort (Hypericum perforatum, a herbal remedy used for depression). If you are taking any of the above, ask your doctor about alternatives. Warnings and precautions 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). Reactions to Injections 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. Regular appointments are important 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. Children REKAMBYS is not for use in children and adolescents less than 18 years of age, because it has not been studied in these patients. Other medicines and REKAMBYS 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. Pregnancy and breast-feeding 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. Driving and using machines 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. Important information about some of the ingredients of REKAMBYS This medicine contains less than 1 mmol sodium (23 mg) per 2 mL injection, that is to say essentially sodium-free .

A nurse or doctor will give you REKAMBYS as an injection in the muscle of your buttock (intramuscular, or IM injection). You will be given your injection either once every month or once every 2 months, together with another injectable medicine called cabotegravir. Your doctor will explain how often the medicine will be given. When you start treatment with REKAMBYS, you and your doctor may decide to start with daily treatment of one 25 mg rilpivirine tablet with a meal and one 30 mg cabotegravir tablet for one month before your first REKAMBYS injection. This is called the lead-in period - taking the tablets before you receive REKAMBYS and cabotegravir injections will allow your doctor to test how well these medicines suit you. The other option is that you and your doctor may decide to start directly with REKAMBYS injections. If you are going to be given REKAMBYS every month, your treatment will be as follows: When Medicine First injection Second injection onwards, every month Rilpivirine single injection of 900 mg 600 mg by injection every month Cabotegravir single injection of 600 mg 400 mg by injection every month If you are going to be given REKAMBYS every 2 months, your treatment will be as follows: When Medicine First and second injections, one month apart Third injection onwards, every two months Rilpivirine single injection of 900 mg 900 mg by injection, every 2 months Cabotegravir single injection of 600 mg 600 mg by injection, every 2 months If you miss a REKAMBYS injection 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. If you are given too much REKAMBYS 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. Don t stop using REKAMBYS without advice from your doctor. 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.

Like all medicines, this medicine can cause side effects, although not everybody gets them. The following is a list of side effects that have been reported when REKAMBYS is used with cabotegravir injection. Very common side effects (affects at least 1 in 10 people)

headache

injection site reactions - these are generally mild to moderate and became less frequent over time. Symptoms may include:* very common: pain and discomfort, a hardened mass or lump* common: redness, itching, swelling, warmth or bruising (which may include discolouration or a collection of blood under the skin).* uncommon: numbness, minor bleeding, an abscess (collection of pus) or cellulitis (heat, swelling or redness).

feeling hot/feverish (pyrexia), which may occur within one week after injections. Common side effects (affects less than 1 in 10 people)

depression

anxiety

abnormal dreams

sleeping difficulty (insomnia)

dizziness

feeling sick (nausea)

vomiting

belly pain (abdominal pain)

wind (flatulence)

diarrhoea

rash

muscle pain (myalgia)

tiredness (fatigue)

feeling weak (asthenia)

generally feeling unwell (malaise)

weight gain Uncommon side effects (affects less than 1 in 100 people)

feeling drowsy (somnolence)

feeling lightheaded, during or after an injection. This may lead to fainting.

liver damage (signs may include yellowing of the skin and the whites of the eyes loss of appetite, itching, tenderness in the belly, light-coloured stools or unusually dark urine).

changes in liver blood tests (increase in transaminases)

an increase in bilirubin (a substance produced by the liver) in the blood. Other side effects

Severe abdominal pain caused by inflammation of the pancreas (pancreatitis). The following side effects that can occur with rilpivirine tablets may also occur with REKAMBYS injection: Very Common side effects (affects at least 1 in 10 people)

increase in cholesterol and/or pancreatic amylase in your blood Common side effects (affects less than 1 in 10 people)

decreased appetite

sleep disorders

depressed mood

stomach discomfort

dry mouth

low white blood cell and/or platelet count, decrease in haemoglobin in your blood, increase in triglycerides and/or lipase in your blood Uncommon side effects (affects less than 1 in 100 people)

signs or symptoms of inflammation or infection, for example fever, chills, sweats (immune reactivation syndrome, see section 2 for more details) Reporting of side effects 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 national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month. Store in a refrigerator (2 C - 8 C). Do not freeze. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What REKAMBYS contains

The active substance is rilpivirine. Each 2 mL vial contains 600 mg rilpivirine.

The excipients are poloxamer 338, citric acid monohydrate, glucose monohydrate, sodium dihydrogen phosphate monohydrate, sodium hydroxide to adjust pH and ensure isotonicity, and water for injections. What REKAMBYS looks like and contents of the pack 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. Marketing Authorisation Holder Janssen-Cilag International NV Turnhoutseweg B-2340 Beerse Belgium Manufacturer Janssen Pharmaceutica NV Turnhoutseweg B-2340 Beerse Belgium For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: Belgi /Belgique/Belgien ViiV Healthcare srl/bv T l/Tel: + 32 (0) 10 85 65 Lietuva UAB "JOHNSON & JOHNSON" Tel: +370 5 278 68 lt@its.jnj.com

&
.: +359 2 489 94 jjsafety@its.jnj.com Luxembourg/Luxemburg ViiV Healthcare srl/bv Belgique/Belgien T l/Tel: + 32 (0) 10 85 65 esk republika Janssen-Cilag s.r.o. Tel: +420 227 012 Magyarorsz g Janssen-Cilag Kft. Tel.: +36 1 884 2janssenhu@its.jnj.com Danmark Janssen-Cilag A/S Tlf: +45 4594 8jacdk@its.jnj.com Malta AM MANGION LTD. Tel: +356 2397 6Deutschland ViiV Healthcare GmbH Tel.: + 49 (0)89 203 0038-viiv.med.info@viivhealthcare.com Nederland ViiV Healthcare BV Tel: + 31 (0) 33 2081Eesti UAB "JOHNSON & JOHNSON" Eesti filiaal Tel: +372 617 7ee@its.jnj.com Norge Janssen-Cilag AS Tlf: +47 24 12 65 jacno@its.jnj.com

Janssen-Cilag . . . . T : +30 210 80 90 sterreich Janssen-Cilag Pharma GmbH Tel: +43 1 610 Espa a Laboratorios ViiV Healthcare, S.L. Tel: + 34 900 923 es-ci@viivhealthcare.com Polska Janssen-Cilag Polska Sp. z o.o. Tel.: +48 22 237 60 France ViiV Healthcare SAS T l.: + 33 (0)1 39 17 69 Infomed@viivhealthcare.com Portugal VIIVHIV HEALTHCARE, UNIPESSOAL, LDA Tel: + 351 21 094 08 viiv.fi.pt@viivhealthcare.com Hrvatska Johnson & Johnson S.E. d.o.o. Tel: +385 1 6610 jjsafety@JNJCR.JNJ.com Rom nia Johnson & Johnson Rom nia SRL Tel: +40 21 207 1Ireland Janssen Sciences Ireland UC Tel: 1 800 709 medinfo@its.jnj.com Slovenija Johnson & Johnson d.o.o. Tel: +386 1 401 18 Janssen_safety_slo@its.jnj.com sland Janssen-Cilag AB c/o Vistor hf. S mi: +354 535 7janssen@vistor.is Slovensk republika Johnson & Johnson s.r.o. Tel: +421 232 408 Italia ViiV Healthcare S.r.l Tel: +39 045 7741Suomi/Finland Janssen-Cilag Oy Puh/Tel: +358 207 531 jacfi@its.jnj.com

: +357 22 207 Sverige Janssen-Cilag AB Tfn: +46 8 626 50 jacse@its.jnj.com Latvija UAB "JOHNSON & JOHNSON" fili le Latvij Tel: +371 678 93lv@its.jnj.com United Kingdom (Northern Ireland) ViiV Healthcare BV Tel: + 44 (0)800 221customercontactuk@gsk.com This leaflet was last revised in {MM/YYYY}. Detailed information on this medicine is available on the European Medicines Agency web site: