TEPKINLY 4 mg/0.8 mL Injectable Solution

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).

If in doubt, consult your doctor or nurse before you are given Tepkinly.

Warnings and precautions

Tell 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 are going to have 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), consult your doctor or nurse before you are given Tepkinly.

Tell your doctor immediately if you get 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 can cause fever, vomiting, difficulty breathing/shortness of breath, chills, rapid heartbeat, headache, and dizziness or mild drowsiness, associated with medicines that stimulate T-cells.

• 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), drowsiness, 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 can 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 you 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 get worse – 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, as it may affect the fetus. 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

You should 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 not known.

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 treating cancer 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 you with.

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 dexamethasone, 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 24 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 while 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, make another one immediately. It is very important not to miss any doses for the treatment to be fully effective.

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 other questions about 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 drowsiness
• 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)

• the 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 serious immune reaction called “Immune Effector Cell-Associated Neurotoxicity Syndrome” (ICANS). Symptoms may include
• difficulty speaking or writing
• drowsiness
• 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 infection (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, which can make it difficult to breathe (pleural effusion)
• vomiting
• skin rash
• itching (pruritus)

Shown in blood tests:

• low levels of phosphate, 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 you think they are not related to the medicine. 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 shown.
• 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.
• Tepkinly 4 mg/0.8 ml is a concentrated solution that must be diluted before use.
• • Dilute before subcutaneous use for doses of 0.16 mg and 0.8 mg.
  • No dilution is required for the 3 mg dose.
• 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 4 mg of epcoritamab at a concentration of 5 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 pack 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 medicinal product by contacting the local representative of the marketing authorization holder:

Date of Last Revision of this Prospectus 06/2025

This medicinal product has been authorized with a "conditional approval". This approval mechanism means that further information on this medicinal product is expected.

The European Medicines Agency will review the new information on this medicinal product at least once a year, and this prospectus will be updated as necessary.

Other Sources of Information

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

The most recent and approved summary of product characteristics and patient information leaflet for this medicinal product 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

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

This information is intended solely 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 must be diluted and administered by a healthcare professional using aseptic technique.

It is not necessary to filter the diluted solution.

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

Instructions for preparation of the 0.16 mg dose - 2 dilutions are required

Use a new syringe and needle of suitable size for each transfer step.

1. Prepare the Tepkinly vial

1. Remove a 4 mg/0.8 ml Tepkinly vial with the light blueclosure cap from the refrigerator.
2. Allow the vial to reach room temperature for no more than 1 hour.
3. Gently swirl the Tepkinly vial.

DO NOTshake vigorously or vortex the vial.

1. Perform the first dilution

1. Label an empty vial of suitable size as "dilution A".
2. Transfer 0.8 ml of Tepkinlyto the dilution Avial.
3. Transfer 4.2 ml of sterile sodium chloride 9 mg/ml (0.9%) solutionto the dilution Avial. The initial diluted solution contains 0.8 mg/ml of epcoritamab.
4. Gently swirl the dilution Avial for 30-45 seconds.

1. Perform the second dilution

1. Label an empty vial of suitable size as "dilution B".
2. Transfer 2 ml of solutionfrom the dilution Avial to the dilution Bvial. The dilution Avial is no longer needed and should be discarded.
3. Transfer 8 ml of sterile sodium chloride 9 mg/ml (0.9%) solutionto the dilution Bvial to obtain a final concentration of 0.16 mg/ml.
4. Gently swirl the dilution Bvial for 30-45 seconds.

1. Withdraw the dose

Withdraw 1 ml of diluted epcoritamabfrom the dilution Bvial with a syringe. The dilution Bvial is no longer needed and should be discarded.

1. Label the syringe

Label the syringe with the product name, dose concentration (0.16 mg), date, and time of day.

1. Discard the vial and any unused portion of Tepkinly according to local regulations.

Instructions for preparation of the intermediate dose of 0.8 mg - 1 dilution is required

Use a syringe, vial, and needle of suitable size for each transfer step.

1. Prepare the Tepkinly vial

1. Remove a 4 mg/0.8 ml Tepkinly vial with the light blueclosure cap from the refrigerator.
2. Allow the vial to reach room temperature for no more than 1 hour.
3. Gently swirl the Tepkinly vial.

DO NOTshake vigorously or vortex the vial.

1. Perform the dilution

1. Label an empty vial of suitable size as "dilution A".
2. Transfer 0.8 ml of Tepkinlyto the dilution Avial.
3. Transfer 4.2 ml of sterile sodium chloride 9 mg/ml (0.9%) solutionto the dilution Avial to obtain a final concentration of 0.8 mg/ml.
4. Gently swirl the dilution Avial for 30-45 seconds.

1. Withdraw the dose

Withdraw 1 ml of diluted epcoritamabfrom the dilution Avial with a syringe. The dilution Avial is no longer needed and should be discarded.

1. Label the syringe

Label the syringe with the product name, dose concentration (0.8 mg), date, and time of day.

1. Discard the vial and any unused portion of Tepkinly according to local regulations.

Instructions for preparation of the second intermediate dose of 3 mg (no dilution is required)

The 3 mg dose of epcoritamab is only required for patients with LF.

1. Prepare the Tepkinly vial
   1. Remove a 4 mg/0.8 ml Tepkinly vial with the light blueclosure cap from the refrigerator.
   2. Allow the vial to reach room temperature for no more than 1 hour.
   3. Gently swirl the Tepkinly vial.

DO NOTshake vigorously or vortex the vial.

1. Withdraw the dose

Withdraw 0.6 mlof epcoritamab with a syringe.

1. Label the syringe

Label the syringe with the dose concentration (3 mg), date, and time of day.

1. Discard the vial and any unused portion of Tepkinly according to local regulations.

Traceability

In order to improve the traceability of biological medicinal products, the name and batch number of the administered medicinal product should be clearly recorded.