Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - rybrevant

Document Subject

Generated Narrative: MedicinalProductDefinition mpa96793ea13ac1652c4391adeab5c5fd7

identifier: http://ema.europa.eu/identifier/EU/1/21/1594/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Rybrevant 350 mg concentrate for solution for infusion.

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

part

part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-a96793ea13ac1652c4391adeab5c5fd7

identifier: http://ema.europa.eu/identifier/EU/1/21/1594/001

status: Final

type: Package Leaflet

category: Raw

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

author: Organization ACME industry

title: TEST PURPOSES ONLY - rybrevant

Attesters

What is in this leaflet

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

What Rybrevant is Rybrevant is a cancer medicine. It contains the active substance amivantamab , which is an antibody (type of protein) designed to recognise and attach to specific targets in the body. What Rybrevant is used for Rybrevant is used in adults with a type of lung cancer called non-small cell lung cancer . It is used when the cancer has spread to other parts of your body and has gone through certain changes (Exon insertion mutations) in a gene called EGFR . How Rybrevant works The active substance in Rybrevant, amivantamab, targets two proteins found on cancer cells:

epidermal growth factor receptor (EGFR), and

mesenchymal-epithelial transition factor (MET). This medicine works by attaching to these proteins. This may help to slow or stop your lung cancer from growing. It may also help to reduce the size of the tumour.

Do not use Rybrevant if

you are allergic to amivantamab or any of the other ingredients of this medicine (listed in section 6). Do not use this medicine if the above applies to you. If you are not sure, talk to your doctor or nurse before you are given this medicine. Warnings and precautions Tell your doctor or nurse before you are given Rybrevant if:

you have suffered from inflammation of your lungs (a condition called interstitial lung disease or pneumonitis ). Tell your doctor or nurse straight away while taking this medicine if you get any of the following side effects (see section 4 for more information):

Any side effect while the medicine is being given into your vein.

Sudden difficulty in breathing, cough, or fever that may suggest inflammation of the lungs.

Skin problems. To reduce the risk of skin problems, keep out of the sun, wear protective clothing, apply sunscreen, and use moisturisers regularly on your skin and nails while taking this medicine. You will need to continue doing this for 2 months after you stop treatment.

Eye problems. If you have vision problems or eye pain contact your doctor or nurse straight away. If you use contact lenses and have any new eye symptoms, stop using contact lenses and tell your doctor straight away. Children and adolescents Do not give this medicine to children or young people below 18 years of age. This is because it is not known whether the medicine is safe and effective in this age group. Other medicines and Rybrevant Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines. Contraception

If you could become pregnant, you must use effective contraception during Rybrevant treatment and for 3 months after stopping treatment. Pregnancy

Tell your doctor or nurse before you are given this medicine if you are pregnant, think you might be pregnant, or are planning to have a baby.

It is possible that this medicine may harm an unborn baby. If you become pregnant while being treated with this medicine, tell your doctor or nurse straight away. You and your doctor will decide if the benefit of having the medicine is greater than the risk to your unborn baby. Breast-feeding It is not known if Rybrevant passes into breast milk. Ask your doctor for advice before being given this medicine. You and your doctor will decide if the benefit of breast-feeding is greater than the risk to your baby. Driving and using machines If you feel tired, feel dizzy, or if your eyes are irritated or vision is affected after taking Rybrevant, do not drive or use machinery. Rybrevant contains sodium This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially sodium-free . However, before Rybrevant is given to you, it may be mixed with a solution that contains sodium. Talk to your doctor if you are on a low salt diet.

How much is given Your doctor will work out the correct dose of Rybrevant for you. The dose of this medicine will depend on your body weight at the start of your therapy. The recommended dose of Rybrevant is:

1,050 mg if you weigh less than 80 kg.

1,400 mg if you weigh more than or equal to 80 kg. How the medicine is given This medicine will be given to you by a doctor or nurse. It is given as a drip into a vein ( intravenous infusion ) over several hours. Rybrevant is given as follows:

once a week for the first 4 weeks

then once every 2 weeks starting at week 5, for as long as you keep getting benefit from the treatment. In the first week, your doctor will give you the Rybrevant dose split over two days. Medicines given during treatment with Rybrevant Before each infusion of Rybrevant, you will be given medicines which help lower the chance of infusion-related reactions. These may include:

medicines for an allergic reaction (antihistamines)

medicines for inflammation (corticosteroids)

medicines for fever (such as paracetamol). You may also be given additional medicines based on any symptoms you may experience. If you are given more Rybrevant than you should This medicine will be given by your doctor or nurse. In the unlikely event that you are given too much (an overdose), your doctor will check you for side effects. If you forget your appointment to have Rybrevant It is very important to go to all your appointments. If you miss an appointment, make another one as soon as possible. If you have any further questions on the use of this medicine, ask your doctor or nurse.

Like all medicines, this medicine can cause side effects, although not everybody gets them. Serious side effects Tell your doctor or nurse straight away if you notice the following serious side effects: Very common (may affect more than 1 in 10 people):

Signs of a reaction to the infusion - such as chills, feeling short of breath, feeling sick (nausea), flushing, chest discomfort, and vomiting while the medicine is being given. This can happen especially with the first dose. Your doctor may give you other medicines, or the infusion may need to be slowed down or stopped.

Skin problems - such as rash (including acne), infected skin around the nails, dry skin, itching, pain, and redness. Tell your doctor if your skin or nail problems get worse. Common (may affect up to 1 in 10 people):

Eye problems - such as dry eye, swollen eyelid, itchy eyes, problems with vision, growth of eyelashes.

Signs of an inflammation in the lungs - such as sudden difficulty in breathing, cough, or fever. This could lead to permanent damage ( interstitial lung disease ). Your doctor may wish to stop Rybrevant if you get this side effect. Uncommon (may affect up to 1 in 100 people):

inflamed cornea (front part of the eye)

inflammation inside the eye that may affect vision

life-threatening rash with blisters and peeling skin over much of the body (toxic epidermal necrolysis). Other side effects Tell your doctor if you notice any of the following side effects: Very common (may affect more than 1 in 10 people):

low level of the protein 'albumin' in the blood

swelling caused by fluid build up in the body

feeling very tired

sores in the mouth

constipation or diarrhoea

decreased appetite

increased level of the liver enzyme alanine aminotransferase in the blood, a possible sign of liver problems

increased level of the enzyme aspartate aminotransferase in the blood, a possible sign of liver problems

feeling dizzy

increased level of the enzyme alkaline phosphatase in the blood

muscle aches

low level of calcium in the blood. Common (may affect up to 1 in 10 people)

stomach pain

low level of potassium in the blood

low level of magnesium in the blood. Reporting of side effects If you get any side effects, talk to your doctor or nurse. 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.

Rybrevant will be stored at the hospital or clinic. 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 and the vial label after EXP . The expiry date refers to the last day of that month. Chemical and physical in-use stability has been demonstrated for 10 hours at 15 C to 25 C in room light. From a microbiological point of view, unless the method of dilution precludes the risk of microbial contamination, the product should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user. Store in a refrigerator (2 C to 8 C). Do not freeze. Store in the original package in order to protect from light. Medicines should not be disposed of via wastewater or household waste. Your healthcare professional will throw away any medicines that are no longer being used. These measures will help protect the environment.

What Rybrevant contains

The active substance is amivantamab. One mL of concentrate for solution for infusion contains 50 mg of amivantamab. One vial of 7 mL concentrate contains 350 mg of amivantamab.

The other ingredients are ethylenediaminetetraacetic acid (EDTA), L-histidine, L-histidine hydrochloride monohydrate, L-methionine, polysorbate 80, sucrose, and water for injections (see section 2). What Rybrevant looks like and contents of the pack Rybrevant is a concentrate for solution for infusion and is a colourless to pale yellow liquid. This medicine is available in a carton pack containing 1 glass vial of 7 mL of concentrate. Marketing Authorisation Holder Janssen-Cilag International NV Turnhoutseweg B-2340 Beerse Belgium Manufacturer Janssen Biologics B.V. Einsteinweg 2333 CB Leiden The Netherlands For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: Belgi /Belgique/Belgien Janssen-Cilag NV Tel/T l: +32 14 64 94 janssen@jacbe.jnj.com Lietuva UAB JOHNSON & JOHNSON Tel: +370 5 278 68 lt@its.jnj.com

&
.: +359 2 489 94 jjsafety@its.jnj.com Luxembourg/Luxemburg Janssen-Cilag NV T l/Tel: +32 14 64 94 janssen@jacbe.jnj.com 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 Janssen-Cilag GmbH Tel: +49 2137 955 jancil@its.jnj.com Nederland Janssen-Cilag B.V. Tel: +31 76 711 1janssen@jacnl.jnj.com Eesti 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 Janssen-Cilag, S.A. Tel: +34 91 722 81 contacto@its.jnj.com Polska Janssen-Cilag Polska Sp. z o.o. Tel.: +48 22 237 60 France Janssen-Cilag T l: 0 800 25 50 75 / +33 1 55 00 40 medisource@its.jnj.com Portugal Janssen-Cilag Farmac utica, Lda. Tel: +351 214 368 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 Janssen-Cilag SpA Tel: 800.688.777 / +39 02 2510 1 janssenita@its.jnj.com Suomi/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) Janssen Sciences Ireland UC Tel: +44 1 494 567 medinfo@its.jnj.com This leaflet was last revised in. This medicine has been given conditional approval . This means that there is more evidence to come about this medicine. The European Medicines Agency will review new information on this medicine at least every year and this leaflet will be updated as necessary. Other sources of information Detailed information on this medicine is available on the European Medicines Agency web site: