Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - tepkinly

Document Subject

Generated Narrative: MedicinalProductDefinition mp8e3bfdaa73d1dfe2a558d763f021c01e

identifier: http://ema.europa.eu/identifier/EU/1/23/1759/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Tepkinly 4 mg/0.8 ml concentrate for 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-8e3bfdaa73d1dfe2a558d763f021c01e

identifier: http://ema.europa.eu/identifier/EU/1/23/1759/001

status: Final

type: Package Leaflet

category: Raw

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

author: Organization ACME industry

title: TEST PURPOSES ONLY - tepkinly

Attesters

What is in this leaflet

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

What Tepkinly is Tepkinly is a cancer medicine that contains the active substance epcoritamab. Tepkinly is used on its own (monotherapy) to treat adult patients who have a blood cancer called diffuse large B-cell lymphoma (DLBCL) when the disease has come back or did not respond to previous treatment after at least two prior therapies. How Tepkinly works Epcoritamab is specifically designed to help your own immune system to attack cancer (lymphoma) cells. Epcoritamab acts by attaching to your body s immune cells and cancer cells, bringing them together, so that your immune system can destroy the cancer cells.

Do not use Tepkinly If you are allergic to epcoritamab or any of the other ingredients of this medicine (listed in section 6). If you are not sure, talk to your doctor or nurse before you are given Tepkinly. Warnings and precautions Talk to your doctor, pharmacist or nurse before using Tepkinly if you

have current or past problems with your nervous system such as seizures

have an infection

are due to have a vaccine or you know you may need to have one in the near future. If any of the above apply to you (or you are not sure), talk to your doctor or nurse before you are given Tepkinly. Tell your doctor straight away if you get symptoms of any of the side effects listed below, during or after treatment with Tepkinly. You may need additional medical treatment.

Cytokine release syndrome a life-threatening condition causing fever, vomiting, difficulty breathing/shortness of breath, chills, rapid heartbeat, headache and dizziness or light- headedness associated with medicines that stimulate T cells. Before each injection under the skin, you may be given medicines which help reduce possible effects of cytokine release syndrome.

ICANS (immune effector cell-associated neurotoxicity syndrome)- Symptoms may include problems with use of language (including speech, understanding, writing and reading), drowsiness, confusion/disorientation, muscle weakness, seizures, swelling of a part of the brain, and memory loss.

Tumour lysis syndrome some people may get unusual levels of some salts in the blood
caused by the fast breakdown of cancer cells during treatment. This is called tumour lysis syndrome (TLS).* Your doctor or nurse will do blood tests to check for this condition. Before each injection under the skin, you should be well-hydrated and may be given other medicines that can help reduce high levels of uric acid and help reduce possible effects of tumour lysis syndrome.

Tumour flare as your cancer is destroyed, it may react and appear to get worse this is called tumour flare reaction .

Infections you may get signs of infection, such as fever of 38 C or above, chills, cough, or pain with urination which can vary depending on where in the body the infection is. Children and adolescents Tepkinly is not recommended in children and adolescents under 18 years, as there is no information about use in this age group. Other medicines and Tepkinly Tell your doctor or pharmacist if you are taking or using, have recently taken or used, or might take or use any other medicines. This includes medicines obtained without a prescription and herbal medicines. Pregnancy If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Do not use Tepkinly during pregnancy, as it may affect your unborn baby. Your doctor may ask you to take a pregnancy test before starting treatment. Contraception If you are a woman who is able to have children, you must use effective contraception to avoid becoming pregnant while taking Tepkinly and for at least 4 months after your last dose of Tepkinly. If you become pregnant during this time, you must talk to your doctor straight away. Talk to your doctor or nurse about suitable methods of contraception. Breast-feeding You must not breast-feed during treatment with Tepkinly and for at least 4 months after the last dose. It is not known whether Tepkinly passes into breast milk and whether it could affect your baby. Fertility The effect of Tepkinly on male and female fertility is unknown. Driving and using machines Due to the possible symptoms of ICANS, you should be careful while driving, cycling or using heavy or potentially dangerous machines. If you currently have such symptoms, avoid these activities and contact your doctor, nurse, or pharmacist. See section 4 for more information about side effects. Tepkinly contains sodium This medicine contains less than 1 mmol sodium (23 mg) per vial, that is to say essentially sodium-free . Tepkinly contains sorbitol This medicine contains 21.9 mg sorbitol in each vial, which is equivalent to 27.33 mg/ml.

A doctor experienced in treating cancer will take care of your treatment. Follow the treatment schedule explained to you by your doctor. Tepkinly will be given to you by a doctor or nurse as an injection under your skin. Tepkinly will be given to you in cycles of 28 days, on a dosing schedule given to you by your doctor. You will be given Tepkinly according to the following schedule Cycle Dosing schedule Cycles 1 to 3 Weekly Cycles 4 to 9 Every two weeks Cycles 10 and beyond Every four weeks You may be given other medicines before you are given Tepkinly. This is to help prevent reactions such as cytokine release syndrome and fever in Cycle 1 (and potentially future cycles). These medicines may include

Corticosteroids such as prednisolone or equivalent

An antihistamine such as diphenhydramine

Paracetamol The first full dose (48 mg) of Tepkinly will be given to you on Cycle 1 Day 15. Your doctor will monitor how your treatment is working and ask you to stay in a hospital for 24 hours after the first full dose (48 mg) because this is when reactions such as CRS, ICANS and fever are most likely to happen. You will be given Tepkinly for as long as your doctor thinks you are benefitting from the treatment. Your doctor may delay or completely stop your treatment with Tepkinly if you have certain side effects. If you forget to use Tepkinly If you forget or miss your medical appointment, make another one straight away. For the treatment to be fully effective, it is very important not to miss a dose. If you stop using Tepkinly Do not stop treatment with Tepkinly unless you have discussed this with your doctor. This is because stopping treatment may make your condition worse. If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

Like all medicines, this medicine can cause side effects, although not everybody gets them. Serious side effects Tell your doctor straight away if you notice any of the symptoms of the following serious side effects. You may only get one or some of these symptoms. Cytokine release syndrome (CRS) (Very common: may affect more than 1 in 10 people) Symptoms can include

fever

vomiting

dizziness or light-headedness

chills

fast heartbeat

difficulty breathing/shortness of breath

headache Immune effector cell-associated neurotoxicity syndrome (ICANS) (Common: may affect up to 1 in 10 people)

effects on your nervous system, the symptoms of which can occur days or weeks after you receive the injection, may initially be subtle. Some of these symptoms may be signs of a serious immune reaction called immune effector cell-associated neurotoxicity syndrome
(ICANS). Symptoms can include

difficulty speaking or writing

drowsiness

confusion/disorientation

muscle weakness

seizures

memory loss Tumour lysis syndrome (TLS) (Common: may affect up to 1 in 10 people) Symptoms can include

fever

chills

vomiting

confusion

shortness of breath

seizures

irregular heartbeat

dark or cloudy urine

unusual tiredness

muscle or joint pain
Other side effects Tell your doctor or nurse straight away if you notice any of the following side effects or if they get worse: Very common: may affect more than 1 in 10 people

viral infection

pneumonia (lung infection)

decreased hunger

irregular heartbeat

pain in bones, joints, ligaments and muscles

pain in the belly area

headache

nausea

diarrhoea

vomiting

tiredness

injection site reactions

fever

swelling Shown in blood tests

low levels of a type of white blood cells that fight infection (neutropenia)

low levels of red blood cells, which can cause tiredness, pale skin, and shortness of breath (anaemia)

low levels of blood platelets, which can lead to bleeding and bruising (thrombocytopenia) Common: may affect up to 1 in 10 people

fever due to infection when you have low levels of white blood cells (febrile neutropenia)

upper respiratory tract infections (infection of the airways)

tender swollen lymph nodes, chest pain, cough or difficulty breathing, pain at the site of the tumour (tumour flare)

fungal infections (caused by a type of germ called a fungus)

skin infections

life-threatening reaction the body has to an infection (sepsis)

decrease in a type of white blood cell called a lymphocyte, that may affect the body s ability to fight infection (lymphopenia)

a rapid breakdown of tumour cells resulting in chemical changes in the blood and damage to organs, including the kidneys, heart, and liver (tumour lysis syndrome)

extra fluid around the lungs that can make it difficult to breathe (pleural effusion)

rash

itching (pruritus) Shown in blood tests

low level of phosphates in the blood, potassium, magnesium or sodium

increased blood level of creatinine, a breakdown product from muscle tissue

increased blood level of liver proteins, which may show problems with the liver Reporting of side effects If you get any side effects, talk to your doctor, pharmacist 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.

Tepkinly will be stored by the doctor, nurse, or pharmacist at the hospital or clinic. To correctly store Tepkinly

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 vial label and carton after EXP. The expiry date refers to the last day of that month.

Store and transport refrigerated (2 C to 8 C).

Do not freeze.

Keep the vial in the outer carton in order to protect from light.

Tepkinly 4 mg/0.8 ml is a concentrated solution and must be diluted prior to use.

If not used immediately, the prepared solution may be stored for up to 24 hours at 2 C to 8 C from the time of preparation.

Within these 24 hours, the prepared solution can be stored for up to 12 hours at room temperature (20 C - 25 C) from the start of dose preparation to administration.

Allow the dilution solution to warm to room temperature before using. Your doctor, nurse or pharmacist will throw away any unused medicine following local requirements. These measures will help protect the environment.

What Tepkinly contains

The active substance is epcoritamab. Each 0.8 ml vial contains 4 mg of epcoritamab at a concentration of 5 mg/ml.

The other excipients are sodium acetate trihydrate, acetic acid, sorbitol (E420), polysorbate 80, water for injections (see section 2 Tepkinly contains sodium and Tepkinly contains sorbitol ). What Tepkinly looks like and contents of the pack Tepkinly is a concentrate for solution for injection. It is a colourless to slightly yellow solution provided in a glass vial. Each carton contains 1 vial. Marketing Authorisation Holder AbbVie Deutschland GmbH & Co. KG Knollstrasse 67061 Ludwigshafen Germany Manufacturer AbbVie S.r.l. S.R. 148 Pontina, km 52 SNC 04011 Campoverde di Aprilia (LT) Italy For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: Belgi /Belgique/Belgien AbbVie SA T l/Tel: +32 10 477Lietuva AbbVie UAB Tel: +370 5 205 3

: +359 2 90 30 430{ Luxembourg/Luxemburg AbbVie SA Belgique/Belgien T l/Tel: +32 10 477 esk republika AbbVie s.r.o. Tel: +420 233 098 Magyarorsz g AbbVie Kft. Tel: +36 1 455 8Danmark AbbVie A/S Tlf: +45 72 30-20-Malta V.J.Salomone Pharma Limited Tel: +356 22983Deutschland AbbVie Deutschland GmbH & Co. KG Tel: 00800 222843 33 (geb hrenfrei) Tel: +49 (0) 611 / 1720-0 Nederland AbbVie B.V. Tel: +31 (0)88 322 2Eesti AbbVie O Tel: +372 623 1Norge AbbVie AS Tlf: +47 67 81 80
AbbVie . . : +30 214 4165 sterreich AbbVie GmbH Tel: +43 1 20589-0 Espa a AbbVie Spain, S.L.U. Tel: +34 91 384 09 Polska AbbVie Sp. z o.o. Tel: +48 22 372 78 France AbbVie T l: +33 (0) 1 45 60 13 Portugal AbbVie, Lda. Tel: +351 (0)21 1908Hrvatska AbbVie d.o.o. Tel: +385 (0)1 5625 Ireland AbbVie Limited Tel: +353 (0)1 4287Rom nia AbbVie S.R.L. Tel: +40 21 529 30 Slovenija AbbVie Biofarmacevtska dru ba d.o.o. Tel: +386 (1)32 08 sland Vistor hf. Tel: +354 535 7Slovensk republika AbbVie s.r.o. Tel: +421 2 5050 0Italia AbbVie S.r.l. Tel: +39 06 928Suomi/Finland AbbVie Oy Puh/Tel: +358 (0)10 2411
Lifepharma (Z.A.M.) Ltd : +357 22 34 74 Sverige AbbVie AB Tel: +46 (0)8 684 44 Latvija AbbVie SIA Tel: +371 67605United Kingdom (Northern Ireland) AbbVie Deutschland GmbH & Co. KG Tel: +44 (0)1628 561This 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: