Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - talvey

Document Subject

Generated Narrative: MedicinalProductDefinition mpf69e07644f479bf7649f8c501a410e55

identifier: http://ema.europa.eu/identifier/EU/1/23/1748/001 (2 mg/ml)

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: TALVEY 2 mg/mL solution for injection

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-f69e07644f479bf7649f8c501a410e55

identifier: http://ema.europa.eu/identifier/EU/1/23/1748/001 (2 mg/ml)

status: Final

type: Package Leaflet

category: Raw

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

author: Organization ACME industry

title: TEST PURPOSES ONLY - talvey

Attesters

What is in this leaflet

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

Talvey is a cancer medicine that contains the active substance talquetamab. Talquetamab is an antibody, a type of protein that recognises and attaches to specific targets in your body. It has been designed to attach to the protien GPRC5D (G Protein-coupled receptor family C group 5 member D), which is found on multiple myeloma cancer cells, and to CD3, a protein on T cells (a type of white blood cell). T cells are a part of the body s natural defences and help protect the body from infection. They can also destroy cancer cells. When this medicine attaches to these cells, it brings the cancer cells and T cells together. This encourages the T cells to destroy the multiple myeloma cancer cells. Talvey is used to treat adults with multiple myeloma, a cancer of the bone marrow. It is used when patients have had at least three other types of treatment that have not worked or have stopped working.

You must not be given Talvey

if you are allergic to talquetamab or any of the other ingredients of this medicine (listed in section 6). Do not use Talvey if the above applies to you. If you are not sure, talk to your doctor or nurse before you are given Talvey. Warnings and precautions Talk to your doctor or nurse before you are given Talvey. Serious side effects There are serious side effects that may occur after you start taking Talvey. You need to tell your doctor or nurse straight away if these occur, as they may require that you get immediate medical attention. Tell your doctor or nurse right away if you experience any of the following:

signs of a condition known as cytokine release syndrome (CRS). CRS is a serious immune reaction with symptoms such as fever, low blood pressure, chills, difficulty breathing, fatigue, headache, fast heart beat and increased level of liver enzymes in the blood.

effects on your nervous system. Symptoms include feeling confused, feeling disoriented, feeling sleepy, feeling less alert, slow or difficulty thinking, altered thinking or decreased conciousness, confusion, difficulty speaking and understanding speech. Some of these may be signs of a serious immune reaction called immune effector cell-associated neurotoxicity syndrome
(ICANS).

problems with the mouth, such as a loss of taste, dry mouth, difficulty swallowing and inflammation of the lining of the mouth.

skin problems such as rash, redness and nail problems.

feeling warm, fever, chills or shivering, sore throat or mouth ulcers may be signs of an infection. Talvey and vaccines Talk to your doctor or nurse before you are given Talvey if you have had a recent vaccination or are going to have a vaccination. Your immune system (the body s natural defences) may not respond as well to vaccination when you are taking this medicine. You should not receive live vaccines, a specific type of vaccine, from at least 4 weeks before starting your treatment with Talvey until at least 4 weeks after you have taken your last dose. Tests and checks Before you are given Talvey your doctor will check your blood to look at the levels of different blood cells and to test for signs of infection. Infections will be treated before you start taking this medicine. After you have Talvey your doctor will monitor you for side effects. They will also regularly check your blood counts, as the number of blood cells and other blood components may decrease when you use this medicine. Children and adolescents Talvey should not be used in children or young people below 18 years of age, because the medicine has not been studied in this age group and it is not known how this medicine will affect them. Other medicines and Talvey Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines. This includes medicines you can get without a prescription and herbal medicines. Pregnancy, contraception and breast-feeding Pregnancy and contraception Talvey has the potential to be transmitted from the mother to the developing foetus. The effects of Talvey on the developing foetus are unknown and a risk to newborns/infants cannot be excluded. If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or nurse for advice before you are given this medicine. If you become pregnant while being treated with this medicine, tell your doctor or nurse straight away. If you could become pregnant, you must use effective contraception during treatment and for 3 months after stopping treatment with Talvey. Your doctor will check if you are pregnant before starting treatment. If your partner becomes pregnant while you are taking this medicine, tell your doctor straight away. If you have taken this medicine during pregnancy, your newborn baby should not be given any live vaccines until he or she is at least four weeks old. Breast-feeding It is not known if Talvey passes into breast milk. There may be a risk to breastfed newborns/infants. Ask your doctor for advice before starting this medicine. You and your doctor will decide if the benefit of breast-feeding is greater than the risk to your baby. If you and your doctor decide to stop taking this medicine, you should not breast-feed for 3 months after stopping treatment. Driving and using machines Some people may feel tired, dizzy, or confused while taking Talvey. Do not drive, use tools or machines from recieving your first dose until at least 48 hours after receiving your first treatment dose of Talvey or as instructed by your doctor. Talvey contains sodium Talvey contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially sodium-free .

How much is given Talvey will be given to you under supervision by a doctor experienced in treating patients with multiple myeloma. Your doctor will decide how much Talvey you are given. The dose of Talvey will depend on your body weight. Talvey is given either once a week or once every 2 weeks, depending on the dose, as follows: 0.4 mg/kg once a week:

For your first dose, you will receive 0.01 mg per kilogram of bodyweight.

For your second dose, which will be given 2-4 days later, you will receive 0.06 mg per kilogram of bodyweight.

For your third dose, you will receive a Treatment dose of 0.4 mg per kilogram of bodyweight 2-4 days after your second dose.

After your third dose, you will then receive a Treatment dose once a week thereafter.

Treatment will continue for as long as you benefit from having Talvey. Your doctor will monitor you for side effects after each of your first three doses. They will do this for 2 days after each dose. You should stay close to a healthcare facility after each of the first three doses in case you have side effects. If you experience side effects after any of your first two doses, your doctor may decide to wait up to 7 days before giving you your next dose. 0.8 mg/kg once every 2 weeks:

For your first dose, you will receive 0.01 mg for each kilogram of bodyweight.

For your second dose, which will be given 2-4 days later, you will receive 0.06 mg per kilogram of bodyweight.

For your third dose, which will be given 2-4 days later, you will receive 0.4 mg per kilogram of bodyweight

For your fourth dose, you will then receive a Treatment dose of 0.8 mg per kilogram of bodyweight 2-4 days after your third dose.

After your fourth dose, you will then receive a Treatment dose once every 2 weeks thereafter.

Treatment will continue for as long as you benefit from having Talvey. Your doctor will monitor you for side effects after each of your first four doses. They will do this for 2 days after each dose. You should stay close to a healthcare facility after each of the first four doses in case you have side effects. If you experience side effects after any of your first three doses, your doctor may decide to wait up to 7 days before giving you your next dose. The decision to use either the 0.4 mg/kg once weekly or 0.8 mg/kg every two weeks should be made in consultation with your doctor. How the medicine is given Talvey will be given to you by a doctor or nurse as an injection under your skin ( subcutaneous
injection). It is given in the stomach area (abdomen) or thigh. Medicines given during treatment with Talvey Before the first three doses (if you are given 0.4 mg/kg bodyweight) or the first four doses (if you are given 0.8 mg/kg bodyweight) of Talvey, you will be given medicines which help to lower the chance of side effects. These may include:

medicines to reduce an allergic reaction (antihistamines)

medicines to reduce inflammation (corticosteroids)

medicines to reduce fever (such as paracetamol) You may also be given these medicines for when you take later doses of Talvey based on any symptoms you have. You may also be given additional medicines based on any symptoms you experience or your medical history. If you are given more Talvey than you should This medicine will be given by your doctor or nurse. In the event that you are given too much (an overdose) your doctor will check you for side effects. If you forget your appointment to have Talvey It is very important to go to all your appointments to make sure your treatment works. 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 Get medical help straight away if you get any of the following serious side effects which may be severe and can be fatal. Very Common (may affect more than 1 in 10 people):

Immune effector cell-associated neurotoxicity syndrome (ICANS), a serious immune reaction that may affect your nervous system. Some of the symptoms are:* feeling confused* being less alert or aware* feeling disoriented* feeling sleepy* low energy* slow and difficulty thinking.

Cytokine release syndrome (CRS), a serious immune reaction. CRS may cause symptoms such as:* fever* low blood pressure* chills* low level of oxygen in the blood* headache * fast heart beat* increased level of liver enzymes in the blood

low levels of neutrophils (neutropenia), a type of white blood cell that helps fight infection

low number of blood platelets (thrombocytopenia), which help blood to clot Tell your doctor right away if you notice any of the above listed serious side effects. 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):

nail problems

pain in the muscles and bones (musculoskeletal pain)

low number of red blood cells (anaemia)

feeling tired

chills

weight loss

abnormally dry skin or membranes such as the mouth and eyes (xerosis)

low number of lymphocytes (lymphopenia), a type of white blood cell

problem being able to produce or control movement (motor dysfunction)

feeling dizzy

nerve damage that may cause tingling, numbness, pain or loss of pain sensation (sensory neuropathy)

damage or disease affecting brain function (encephalopathy)

diarrhoea

nausea

constipation

stomach pain

vomiting

infected nose, sinuses or throat (upper respiratory tract infection)

itching (pruritus)

decreased appetite

pain

low number of white blood cells (leukopenia)

low levels of potassium in the blood (hypokalaemia)

low levels of phosphate in the blood (hypophosphataemia)

low levels of magnesium in the blood (hypomagnesaemia)

low level of immunoglobulins, a type of antibody in the blood (hypogammaglobulinaemia), which may make infections more likely

swelling caused by fluid build up in the body (oedema)

irritation or pain where the injection is given

increased level of liver enzymes in the blood

COVID-19 infection

blood tests may show it takes longer for blood to clot (fibrinogen decreased, INR increased and PTT prolongation)

bacterial infection

mouth pain

fungal infection

fever (pyrexia)

headache

shortness of breath (dyspnea)

cough

problems with the mouth and swallowing, such as change in sense of taste (dysgeusia), dry mouth, difficulty swallowing (dysphagia), and inflammation of the lining of the mouth (stomatitis)

skin problems, including skin rash Common (may affect up to 1 in 10 people)

hair loss

bleeding, which can be severe (haemorrhage)

infection of the lungs (pneumonia)

viral infection

blood poisoning (sepsis)

low number of a type of white blood cell (neutrophils), with a fever 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.

Talvey will be stored at the hospital or clinic by your doctor. The following information is therefore mainly intended for healthcare professionals. 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 vial label after EXP . The expiry date refers to the last day of that month. Store in a refrigerator (2 C to 8 C). Do not freeze. Store in the original carton in order to protect from light. Before using the medicine, check the solution for particles or discolouration. The solution should be colourless to light yellow. Do not use this medicine if it is cloudy, discoloured, or contains visible particles. 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 Talvey contains

The active substance is talquetamab. Talvey comes in two different strengths:* 2 mg/mL one 1.5 mL vial contains 3 mg talquetamab* 40 mg/mL one 1 mL vial contains 40 mg talquetamab

The other ingredients are EDTA disodium salt dihydrate, glacial acetic acid, polysorbate 20, sodium acetate trihydrate, sucrose, water for injection (see Talvey contains sodium in section 2). What Talvey looks like and contents of the pack Talvey is a solution for injection (injection) and is a colourless to light yellow liquid. Talvey is supplied as a carton pack containing 1 glass vial. 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: