TEPKINLY 48 mg INJECTABLE SOLUTION

Introduction

Package Leaflet: Information for the Patient

Tepkinly 48 mg Solution for Injection

epcoritamab

This medicine is subject to additional monitoring, which will allow for quick identification of new safety information. You can help by reporting any side effects you may get. The last section of this leaflet includes information on how to report side effects.

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• Your doctor will give you a patient information card. Read it carefully and follow the instructions it contains. Always carry this patient information card with you.
• Always show this patient information card to your doctor, nurse, or if you go to the hospital.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. See section 4.

Contents of the Package Leaflet

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

1. What is Tepkinly and what is it used for

What is Tepkinly

Tepkinly is a cancer medicine that contains the active substance epcoritamab. Tepkinly is used alone (monotherapy) to treat adult patients who have a type of blood cancer called diffuse large B-cell lymphoma (DLBCL) or follicular lymphoma (FL) when the disease has come back or has not responded to previous treatment after at least two previous treatments.

How Tepkinly works

Epcoritamab is designed to help your own immune system attack cancer cells (lymphoma). Epcoritamab works by binding to immune cells and cancer cells in your body, bringing them together, so your immune system can destroy the cancer cells.

2. What you need to know before you use Tepkinly

Do not use Tepkinly

If you are allergic to epcoritamab or any of the other ingredients of this medicine (listed in section 6).

In case of doubt, consult your doctor or nurse before you are given Tepkinly.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before you start using Tepkinly if

• you have or have had problems with your nervous system, such as seizures
• you have an infection
• you need to get a vaccine or know you will need one in the near future.

If any of the above applies to you (or you are not sure), talk to your doctor or nurse before you are given Tepkinly.

Tell your doctor if you experience symptoms of any of the following side effects listed below during or after treatment with Tepkinly. You may need additional medical treatment.

• Cytokine Release Syndrome (CRS):a potentially life-threatening condition that causes fever, vomiting, difficulty breathing/shortness of breath, chills, rapid heartbeat, headache, and dizziness or mild disorientation, associated with medicines that stimulate T-cells.

Or Before each subcutaneous injection, you may be given medicines to help reduce the possible effects of cytokine release syndrome.

• Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS):symptoms may include problems with language use (including speech, understanding, writing, and reading), sleepiness, confusion/disorientation, muscle weakness, seizures, swelling of a part of the brain, and memory loss.
• Infections:you may experience signs of infection, such as fever of 38°C or higher, chills, cough, or pain when urinating, which may vary depending on the location of the infection in the body.
• Tumor Lysis Syndrome (TLS):some people may have unusual levels of certain salts in the blood due to the rapid breakdown of cancer cells during treatment. This is called tumor lysis syndrome (TLS).
• Your doctor or nurse will do blood tests to check if you have this condition. Before each subcutaneous injection, you should be well-hydrated and may be given other medicines that can help reduce high levels of uric acid and reduce the possible effects of tumor lysis syndrome.
• Tumor Flare:as your cancer is destroyed, you may react and seem to worsen - this is called a "tumor flare reaction".

Children and adolescents

Tepkinly is not recommended for children and adolescents under 18 years of age, as there is no information on its 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 plan to become pregnant, consult your doctor or pharmacist before using this medicine. Do not use Tepkinly during pregnancy because it may harm your baby. Your doctor may ask you to have a pregnancy test before starting treatment.

Contraception

If you are a woman who can become pregnant, you must use effective contraceptive methods to avoid becoming pregnant while taking Tepkinly and for at least 4 months after the last dose of Tepkinly. If you become pregnant during this time, you should talk to your doctor immediately.

Talk to your doctor or nurse about suitable contraceptive methods.

Breast-feeding

Do not breast-feed during treatment with Tepkinly and for at least 4 months after the last dose. It is not known if Tepkinly passes into breast milk and if it could affect your baby.

Fertility

The effect of Tepkinly on fertility in men and women is unknown.

Driving and using machines

Due to the possible symptoms of ICANS, you should be cautious when driving, cycling, or using heavy or potentially dangerous machinery. If you currently have such symptoms, avoid these activities and contact your doctor, nurse, or pharmacist. See section 4 for more information on side effects.

Tepkinly contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per vial; this is essentially "sodium-free".

Tepkinly contains sorbitol

This medicine contains 21.9 mg of sorbitol in each vial, equivalent to 27.33 mg/ml.

Tepkinly contains polysorbate

This medicine contains 0.42 mg of polysorbate 80 in each vial, equivalent to 0.4 mg/ml. Polysorbate 80 may cause allergic reactions. Tell your doctor if you have any known allergies.

3. How to use Tepkinly

A doctor with experience in cancer treatment will be in charge of your treatment. Follow the treatment schedule that your doctor explains to you.

Tepkinly will be given to you by a doctor or nurse as a subcutaneous injection. Tepkinly will be given to you in 28-day cycles, according to a dosing schedule that your doctor will provide.

Tepkinly will be given to you according to the following schedule

You may be given other medicines before Tepkinly is given to you. This is to help prevent reactions such as cytokine release syndrome and fever in Cycle 1 (and potentially in future cycles).

These medicines may include

• Corticosteroids: such as prednisolone or equivalent
• An antihistamine: such as diphenhydramine
• Paracetamol

If you have diffuse large B-cell lymphoma (DLBCL)

The first full dose (48 mg) of Tepkinly will be given to you on Day 15 of Cycle 1. Your doctor will monitor how your treatment is working and will ask you to stay in the hospital for hours after the first full dose (48 mg) because this is when reactions such as CRS, ICANS, and fever are most likely to occur.

If you have follicular lymphoma (FL)

The first full dose (48 mg) of Tepkinly will be given to you on Day 22 of Cycle 1.

You will be given Tepkinly as long as your doctor thinks you are benefiting from the treatment.

Your doctor may delay or completely stop treatment with Tepkinly if you experience certain side effects.

If you miss a dose of Tepkinly

If you miss or skip a doctor's appointment, schedule another one immediately. To ensure the treatment is fully effective, it is very important not to miss any doses.

If you stop treatment with Tepkinly

Do not stop treatment with Tepkinly unless you have talked to 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.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects

Tell your doctor immediately if you notice any of the symptoms of the following serious side effects. You may experience only one or some of these symptoms.

Cytokine Release Syndrome (CRS) (Very common:may affect more than 1 in 10 people)

Symptoms may include

• fever
• vomiting
• dizziness or mild disorientation
• chills
• rapid 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 the nervous system, whose symptoms may occur days or even weeks after receiving the injection, can be subtle at first. Some of these symptoms can be signs of a severe immune reaction called "Immune Effector Cell-Associated Neurotoxicity Syndrome" (ICANS). Symptoms may include
• difficulty speaking or writing
• sleepiness
• confusion/disorientation
• muscle weakness
• seizures
• memory loss

Tumor Lysis Syndrome (TLS) (Common:may affect up to 1 in 10 people)

Symptoms may include

• fever
• chills
• vomiting
• confusion/disorientation
• difficulty breathing
• seizures
• irregular heartbeat
• dark or cloudy urine
• unusual tiredness
• muscle or joint pain

Other side effects

Tell your doctor or nurse immediately 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)
• upper respiratory tract infections (infections of the airways)
• decreased appetite
• pain in bones, joints, ligaments, and muscles
• abdominal pain
• headache
• nausea
• diarrhea
• skin rash
• fatigue
• injection site reactions
• fever
• inflammation

Shown in blood tests

• low levels of a type of white blood cell that fights infections (neutropenia)
• low levels of red blood cells, which can cause tiredness, paleness, and shortness of breath (anemia)
• low levels of platelets, which can lead to bleeding and bruising (thrombocytopenia)
• decrease in a type of white blood cell called lymphocyte, which can affect the body's ability to fight infections (lymphopenia)

Common:may affect up to 1 in 10 people

• fever due to infection when you have low levels of white blood cells (febrile neutropenia)
• painful swelling of the lymph nodes, chest pain, cough, or difficulty breathing, pain in the tumor area (tumor flare)
• fungal infections (caused by a type of fungus called candida)
• skin infections
• body's reaction to an infection (sepsis)
• rapid breakdown of cancer cells in the blood resulting in chemical changes in the blood and damage to organs, including the kidneys, heart, and liver (tumor lysis syndrome)
• irregular heartbeat
• fluid around the lungs that can make it difficult to breathe (pleural effusion)
• vomiting
• itching (pruritus)
• increased levels of liver proteins in the blood, which can indicate liver problems

Shown in blood tests:

• low levels of phosphates, potassium, magnesium, or sodium
• increased levels of creatinine in the blood, a waste product of muscle tissue
• increased levels of liver proteins in the blood, which can indicate liver problems

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. You can also report side effects directly through the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Tepkinly

Your doctor, nurse, or pharmacist will store Tepkinly in the hospital or medical center. To store Tepkinly correctly

• 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 on the carton after EXP. The expiry date is the last day of the month stated.
• Store and transport refrigerated (between 2°C and 8°C).
• Do not freeze.
• Keep the vial in the outer carton to protect it from light.
• If not used immediately, the prepared solution can be stored at 2°C to 8°C for a maximum of 24 hours from the time of preparation.
• Within these 24 hours, the prepared solution can be stored at room temperature (20°C-25°C) for a maximum of 12 hours from the start of preparation to administration.
• Allow the solution to reach room temperature before using it.

Your doctor, nurse, or pharmacist will dispose of any unused medicine in accordance with local regulations. This will help protect the environment.

6. Container Contents and Additional Information

Tepkinly Composition

• The active ingredient is epcoritamab. Each 0.8 ml vial contains 48 mg of epcoritamab at a concentration of 60 mg/ml.
• The other excipients are sodium acetate trihydrate, acetic acid, sorbitol (E420), polysorbate 80, and water for injectable preparations (see section 2 "Tepkinly contains sodium" and "Tepkinly contains sorbitol").

Appearance of Tepkinly and Container Contents

Tepkinly is an injectable solution. It is a colorless to slightly yellowish solution supplied in a glass vial.

Each package contains 1 vial.

Marketing Authorization 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

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Date of Last Revision of this Prospectus

This medication has been authorized with a "conditional approval". This type of approval means that more information about this medication is expected to be obtained.

The European Medicines Agency will review the new information about this medication at least once a year and this prospectus will be updated as necessary.

Other Sources of Information

Detailed information about this medication is available on the European Medicines Agency website: http://www.ema.europa.eu. There are also links to other websites about rare diseases and orphan medicines.

The most recent and approved patient information leaflet and prospectus for this medication are available by scanning the QR code included in this prospectus and on the outer packaging with a smartphone. The same information is also available at the following URL: www.tepkinly.eu

QR Code to be included

To listen to or request a copy of this prospectus in , , or

The prospectus can be found on the European Medicines Agency website in all languages of the European Union/European Economic Area.

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This information is intended only for healthcare professionals:

Epcoritamab is prepared and administered as a subcutaneous injection.

Each vial of epcoritamab is for single use only.

Each vial contains an overfill that allows the withdrawal of the indicated amount.

Epcoritamab should be prepared and administered by a healthcare professional using aseptic technique - no dilution is required.

The Tepkinly 48 mg vial is supplied as a ready-to-use solution that does not require dilution before administration.It is not necessary to filter the solution.

Epcoritamab should be visually inspected for particles and color changes before administration. The concentrate should be a colorless to slightly yellowish solution. Do not use if the solution shows color changes, is turbid, or contains foreign particles.

Storage of Prepared Tepkinly

• Use the Tepkinly solution immediately or store it in a refrigerator and protect it from light at a temperature between 2 °C and 8 °C for a maximum of 24 hours from the time of preparation.
• Within these 24 hours, the Tepkinly solution can be stored for a maximum of 12 hours at room temperature from the start of preparation to administration.
• Minimize exposure to natural light.
• Allow the Tepkinly solution to reach room temperature before administration.
• Discard the Tepkinly solution that has not been used after the allowed storage time.

Traceability

In order to improve the traceability of biological medicines, the name and batch number of the administered medicine must be clearly recorded.