Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - carvykti

Document Subject

Generated Narrative: MedicinalProductDefinition mp155f96d6fa2a1acb6bbe985e5b890f92

identifier: http://ema.europa.eu/identifier/EU/1/22/1648/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: CARVYKTI 3.2 × 106 – 1 × 108 cells dispersion 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-155f96d6fa2a1acb6bbe985e5b890f92

identifier: http://ema.europa.eu/identifier/EU/1/22/1648/001

status: Final

type: Package Leaflet

category: Raw

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

author: Organization ACME industry

title: TEST PURPOSES ONLY - carvykti

Attesters

What is in this leaflet

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

CARVYKTI is a type of medicine called a genetically modified cell therapy which is made especially for you from your own white blood cells, called T cells.

CARVYKTI is used to treat adult patients with cancer of the bone marrow called multiple myeloma. It is given when at least three other kinds of treatment have not worked. How CARVYKTI works

The white blood cells taken from your blood are modified in the laboratory to insert a gene that allows them to make a protein called chimeric antigen receptor (CAR).

The CAR can attach to a specific protein on the surface of myeloma cells allowing your white blood cells to recognise and attack the myeloma cells.

You must not be given CARVYKTI

if you are allergic to any of the ingredients of this medicine (listed in section 6).

if you are allergic to any of the ingredients in the medicines you will be given to reduce the number of white blood cells in your blood (lymphodepleting therapy) before treatment with CARVYKTI (see also section 3, How CARVYKTI is given). If you think you may be allergic, ask your doctor for advice. Warnings and precautions Tell your doctor before you are given CARVYKTI if you have:

current or past problems with your nervous system - such as fits, stroke, new or worsening memory loss

any lung, heart or blood pressure (low or raised) problems

liver or kidney problems.

signs or symptoms of graft-versus-host disease. This happens when transplanted cells attack your body, causing symptoms such as rash, nausea, vomiting, diarrhoea and bloody stools. If any of the above apply to you (or you are not sure), talk to your doctor before you are given CARVYKTI. Tests and checks Before you are given CARVYKTI your doctor will:

check the levels of blood cells in your blood

check your lungs, heart and blood pressure

look for signs of infection - an infection will be treated before you have CARVYKTI

check if your cancer is getting worse

check for hepatitis B, hepatitis C or HIV infection

check if you had a vaccination in the last 6 weeks or plan to have one in the next few months. After treatment with CARVYKTI your doctor will:

regularly check your blood, as the number of blood cells and other blood components may decrease. Tell your doctor right away if you get a fever, chills or any signs or symptoms of an infection, are feeling tired, or have bruising or bleeding. Look out for serious side effects There are serious side effects which you need to tell your doctor or nurse about straight away and which may require you to get immediate medical attention. See section 4 under Serious side effects . Children and adolescents CARVYKTI should not be used in children and adolescents below 18 years of age as the medicine has not been studied in this age group and it is not known if it is safe and effective. Other medicines and CARVYKTI Before you are given CARVYKTI tell your doctor or nurse if you are taking, have recently taken, or might take any other medicines. In particular, tell your doctor or nurse if you are taking:

medicines that weaken your immune system such as corticosteroids. These medicines may interfere with the effect of CARVYKTI. Vaccines and CARVYKTI You must not be given certain vaccines called live vaccines:

in the 6 weeks before you are given the short course of chemotherapy (called lymphodepleting chemotherapy) to prepare your body for the CARVYKTI cells.

after CARVYKTI treatment while your immune system is recovering. Talk to your doctor if you need to have any vaccinations. Pregnancy and breast-feeding If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before being given this medicine.

This is because the effects of CARVYKTI in pregnant or breast-feeding women are not known.

CARVYKTI may harm your unborn baby or your breast-fed child. If you are pregnant or think you may be pregnant after treatment with CARVYKTI, talk to your doctor immediately. You have to do a pregnancy test before treatment starts. CARVYKTI should only be given if the results show you are not pregnant. If you have had CARVYKTI treatment, you should discuss any plans to have future pregnancies with your doctor. Driving and using tools or machines CARVYKTI can severely affect your ability to drive or use tools or machines causing side effects that may make you:

feel tired

have balance and coordination problems

feel confused, weak or dizzy. Do not drive or use tools or machines until at least 8 weeks after having CARVYKTI and if these symptoms return. CARVYKTI contains dimethyl sulfoxide (DMSO) and kanamycin This medicine contains DMSO (a substance used to preserve frozen cells) and may contain traces of kanamycin (an aminoglycoside antibiotic), both of which can sometimes cause allergic reactions. Your doctor will monitor you for any signs of a possible allergic reaction.

CARVYKTI will always be given to you by a healthcare professional at a qualified treatment centre. Making CARVYKTI from your own blood cells CARVYKTI is made from your own white blood cells. Your blood cells will be collected from you to prepare your medicine.

Your doctor will take some of your blood using a catheter (tube) placed in your vein.

Some of your white blood cells are separated from your blood - the rest of your blood is returned to your vein. This process is called leukapheresis .

This process can take 3 to 6 hours and may need to be repeated.

Your white blood cells are sent to the manufacturing centre where they are modified to make CARVYKTI. This process takes about 4 weeks.

While CARVYKTI is made you may get other medicines to treat the multiple myeloma. This is so it does not get worse. Medicines given before CARVYKTI treatment A few days before - you will be given treatment called lymphodepleting therapy to prepare your body to receive CARVYKTI. This treatment reduces the number of white blood cells in your blood, so the genetically modified white blood cells in CARVYKTI can grow in numbers when they are returned to your body. 30 to 60 minutes before - you may be given other medicines. These may include:

Antihistamine medicines for an allergic reaction - such as diphenhydramine

medicines for fever - such as paracetamol. Your doctor or nurse will check carefully that the CARVYKTI treatment you are given is from your own white blood cells. How you are given CARVYKTI CARVYKTI is a one-time treatment. It will not be given to you again.

Your doctor or nurse will give you CARVYKTI by a drip into your vein. This is called an intravenous infusion and is usually less than 60 minutes. CARVYKTI is the genetically modified version of your white blood cells.

Your healthcare professional handling CARVYKTI will take appropriate precautions to prevent the chance of transfer of infectious diseases.

They will also follow local guidelines to clean up or dispose of any material that has been in contact with CARVYKTI. After you are given CARVYKTI

Plan to stay near the hospital where you were treated for at least 4 weeks after you are given CARVYKTI.

You will need to return to the hospital every day for at least 14 days after you are given CARVYKTI. This is so your doctor can check if your treatment is working and treat you if you get any side effects. If you do develop serious side effects, you may need to stay in the hospital until your side effects are under control and it is safe for you to leave.

If you miss any appointments, call your doctor or qualified treatment centre as soon as possible to make a new appointment.

You will be asked to enrol in a registry for at least 15 years in order to monitor your health and better understand the long-term effects of CARVYKTI.

Having CARVYKTI in your blood may cause some commercial HIV tests to incorrectly give you a HIV positive result even though you may be HIV negative.

Do not donate blood, organs, tissues or cells for transplants after you have had CARVYKTI.

Like all medicines, this medicine can cause side effects, although not everybody gets them. CARVYKTI can cause side effects that may be serious or life-threatening. Serious side effects Get medical help straight away if you get any of the following serious side effects which may be severe and can be fatal.

A serious immune reaction known as cytokine release syndrome (CRS) , some signs include: Very common (may affect more than 1 in 10 people):* chills, fever (38 C or higher).* fast heart beat, difficulty breathing,* low blood pressure which can make you feel dizzy or lightheaded.

Effects on your nervous system, symptoms of which can occur days or weeks after you receive the infusion, and may initially be subtle. Some of these symptoms may be signs of a serious immune reaction called immune effector cell associated neurotoxicity syndrome (ICANS) or may be signs and symptoms of parkinsonism: Very common (may affect more than 1 in 10 people):* feeling confused,* less alert, disorientated, anxious, memory loss,* difficulty speaking or slurred speech,* slower movements, changes in handwriting Common (may affect up to 1 in 10 people):* loss of coordination, affecting movement and balance,* difficulty reading, writing and understanding words,* personality changes, which may include being less talkative, disinterest in activities and reduced facial expression

CARVYKTI may increase the risk of life-threatening infections that may lead to death. If you notice any of the above side effects, get medical help straight away. Other side effects Other side effects are listed below. Tell your doctor or nurse if you get any of these side effects. Very common (may affect more than 1 in 10 people):

infected nose, sinuses or throat (a cold)

bacterial infection

cough, being short of breath

headache

pain, including muscle and joint pain

stomach pain

swelling caused by fluid build up in the body

feeling very tired

nausea (feeling sick), decreased appetite, constipation, vomiting, diarrhoea

problems with movement including muscle spasms, muscle tightness

nerve damage that may cause tingling, numbness, pain or loss of pain sensation

low levels of antibodies called immunoglobulins in the blood which may lead to infections

low level of oxygen in the blood causing shortness of breath, coughing, headache, and confusion

increased blood pressure

abnormal blood tests indicating:

low number of white blood cells (including neutrophils and lymphocytes) which can occur with infection and fever

low levels of platelets (cells that help blood to clot) and red blood cells

low levels of calcium, sodium, potassium, magnesium, phosphate in the blood

low levels of albumin a type of protein in the blood

low levels of fibrinogen , a type of protein in the blood, making it more difficult to form clots

increased levels of a protein called ferritin in the blood

increased levels of enzymes in the blood called alkaline phosphatase , lactate dehydrogenase , gamma-glutamyltransferase and transaminases
Common (may affect up to 1 in 10 people):

pneumonia (lung infection)

viral infection

fungal infection

severe infection throughout the body (sepsis)

a type of herpes virus infection called cytomegalovirus

kidney failure

abnormal heart beat

bleeding, which can be severe, called a haemorrhage

serious immune reaction involving the blood cells - may lead to an enlarged liver and spleen, called haemophagocytic lymphohistiocytosis

muscle tremor

difficulty sleeping

mild muscle weakness caused by nerve damage

severe confusion

tingling, numbness, and pain of hands and feet, difficulty walking, leg and/or arm weakness, and difficulty breathing

facial numbness, difficulty moving muscles of face and eyes

high level of bilirubin in the blood

blood clot

skin rash

increased level of a protein called C-reactive protein in the blood that may indicate an infection or inflammation Tell your doctor or nurse if you get any of the side effects listed above. Do not try to treat your symptoms with other medicines on your own. 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.

The following information is intended for doctors only. Do not use this medicine after the expiry date which is stated on the container label and infusion bag after EXP . Store frozen in vapour phase of liquid nitrogen ( -120 C) until thawed for use. Do not refreeze.

What CARVYKTI contains The active substance is ciltacabtagene autoleucel. Each CARVYKTI infusion bag contains ciltacabtagene autoleucel cell dispersion containing 3.2 106 to 1 108 CAR-positive viable T cells suspended in a cryopreservative solution. An infusion bag contains 30 mL or 70 mL of dispersion for infusion. The other ingredients are a solution (Cryostor CS5) used to preserve frozen cells (see section 2, CARVYKTI contains DMSO and kanamycin). This medicine contains genetically modified human cells. What CARVYKTI looks like and contents of the pack CARVYKTI is a colourless to white, including shades of white, yellow, and pink, 30 ml or 70 ml cell dispersion for infusion, supplied in either a 50 mL or a 250 mL infusion bag respectively, individually packed in an aluminium cryo cassette. 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 MM/YYYY. 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: