Tepkinly 4 mg/0.8 ml concentrate for solution for injection – patient leaflet, side effects, dosage

1. What Tepkinly is and what it is used for

What Tepkinly is

Tepkinly contains the active substance epcoritamab, which is a type of protein called an antibody designed to kill cancer cells. Tepkinly is used on its own (monotherapy) to treat adult patients who have a blood cancer called diffuse large B-cell lymphoma (DLBCL) or follicular lymphoma (FL) when the disease has come back or did not respond to previous treatment and who have received at least two prior therapies.

Tepkinly is used together (in combination) with other cancer medicines called lenalidomide and rituximab to treat adult patients who have follicular lymphoma (FL) that has come back or did not respond to previous treatment.

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.

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 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.

Your doctor or nurse will do blood tests, prior and during your treatment with epcoritamab, to check your antibody levels, which may indicate your risk of infection and the need for specific treatment.

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. The symptoms of each side effect are listed in section 4.

• CRS (cytokine release syndrome)

  • A condition associated with medicines that stimulate

    T cells.

  • Before each injection under the skin, you may be given

    medicines, which help reduce possible side effects of cytokine release syndrome.

• Haemophagocytic lymphohistiocytosis (HLH)

  • a rare condition in which the immune system makes too

    many of otherwise normal infection fighting cells called histiocytes and lymphocytes. It can lead to enlarged liver and/or spleen, heart problems and kidney abnormalities. Symptoms may include fever, skin rash, swollen lymph glands, breathing problems and easy bruising. Tell your doctor immediately if you experience these symptoms at the same time.

• ICANS (immune effector cell associated neurotoxicity syndrome)

  • Symptoms may be difficulty speaking and/or writing,

    drowsiness, confusion/disorientation, muscle weakness, seizures, and memory loss.

• 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.

• Progressive multifocal leukoencephalopathy (PML)

  • Symptoms of this serious and potentially fatal brain

    condition may include blurred vision, loss of vision or double vision, difficulty speaking, weakness or clumsiness of an arm or a leg, a change in the way you walk or problems with your balance, personality changes, changes in thinking, memory and orientation leading to confusion. These symptoms may start several months after treatment has ended and they usually develop slowly and gradually over weeks or months. It is important that your relatives or caregivers are also aware of these symptoms, since they may notice symptoms that you are not aware of.

• TLS (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 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’.

Children and adolescents

Tepkinly should not be given to children and adolescents under 18 years, as there is no information about 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, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. You should not have Tepkinly during pregnancy, as it may affect your unborn baby.

Contraception

If you are a woman of child-bearing potential, 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 tell your doctor immediately.

Talk to your doctor or nurse about suitable methods of contraception.

Pregnancy

Do not use Tepkinly during pregnancy and if you are of childbearing potential and not using contraception. Pregnancy must be ruled out before treatment. This is because Tepkinly may affect your unborn baby. Tell your doctor immediately if you become pregnant or think you may be pregnant during treatment with Tepkinly.

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 could therefore affect your baby.

Fertility

The effect of Tepkinly on male and female fertility is unknown.

Driving and using machines

Tepkinly may affect your ability to drive, cycle or use tools and machines. If you feel any symptom that makes you feel unwell, do not drive, cycle or use tools or machines until you feel better. 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 28.8 mg sorbitol in each vial, which is 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. Polysorbates may cause allergic reactions. Tell your doctor if you have any known allergies.

3. How Tepkinly will be given

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 and it will be given 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.

If you are given Tepkinly on its own (monotherapy)

You will be given Tepkinly according to the following schedule

Cycle Tepkinly dosing Schedule

Cycle 1 to 3 Weekly

Cycles 4 to 9 Every two weeks

Cycles 10 and beyond Every four weeks

You will be given Tepkinly on its own for as long as your doctor thinks you are benefitting from the treatment.

If you are given Tepkinly in combination with lenalidomide and rituximab

You will be given Tepkinly according to the following schedule:

Cycle Tepkinly dosing Schedule

Cycle 1 to 3 Weekly

Cycles 4 to 12 Every four weeks

In addition to Tepkinly you will be given:

• 20 mg of lenalidomide orally daily on Days 1-21 during your

  treatment (Cycle 1 to 12)

• rituximab dose of 375 mg per square meter of body surface.

  This is given as an infusion into a vein weekly during Cycle 1 and every four weeks during Cycle 2 to 5.

After a maximum of five cycles of combination therapy, treatment with rituximab is stopped. After a maximum of twelve cycles, treatment with Tepkinly and lenalidomide is also stopped.

You may be given other medicines before Tepkinly. This is to help prevent reactions associated with cytokine release syndrome.

These other medicines may include

• Corticosteroids – such as dexamethasone, prednisolone or

  equivalent

• An antihistamine – such as diphenhydramine
• Paracetamol

During the first month (Cycle 1) when you are given Tepkinly:

• It is important that you are well hydrated. For that reason, your

  doctor may tell you to drink plenty of water the day before and the day after you are given Tepkinly. On the day you receive Tepkinly, your doctor may give you fluids through a needle placed in your vein (intravenously).

• If you take medicine for high blood pressure, your doctor

  may ask you to stop taking it for a short time while you are on Tepkinly.

If you have diffuse large B-cell lymphoma (DLBCL) The first full dose (48 mg) of Tepkinly will be given to you on Cycle 1 Day 15.

If you have follicular lymphoma (FL)

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

Your doctor will monitor how your treatment is working.

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.

4. Possible side effects

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 of ICANS 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

Tumour flare

(Common: may affect up to 1 in 10 people)

Symptoms can include

• tender swollen lymph nodes
• chest pain
• cough or difficulty breathing
• pain at the site of the tumour

Febrile neutropenia

(Common: may affect up to 1 in 10 people):

Symptoms can include

• fever due to infection (when you have low levels of white blood cells (shown in blood tests done by your doctor))

Haemophagocytic lymphohistiocytosis (HLH) (Uncommon: may affect up to 1 in 100 people)

• a condition where the immune system makes too many of otherwise normal infection-fighting cells called histiocytes and lymphocytes

Symptoms can include

• fever
• skin rash
• swollen lymph glands
• breathing problems
• easy bruising

Package leaflet: Information for the patient UK511863P98-A3.0

Tepkinly^® 4 mg/0.8 ml concentrate for solution for injection

(epcoritamab)

This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.

The following information is intended for healthcare professionals only:

Read this entire section carefully before preparation of epcoritamab. Certain doses (the priming (0.16 mg) and intermediate dose (0.8 mg)) of epcoritamab require dilution prior to administration. Follow all preparation instructions as below, as improper preparation may lead to improper dose. Epcoritamab can be diluted using two different methods which are either the vial method or the syringe method.

Epcoritamab is prepared and administered as a subcutaneous injection.

Each vial of epcoritamab is intended for single use only.

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

Epcoritamab must be diluted and administered by a healthcare professional using aseptic technique.

Filtration of the diluted solution is not required. However, if the diluted solution is filtered, do not use filters made of nylon.

Epcoritamab should be inspected visually for particulate matter and discolouration prior to administration. The solution for injection

should be a colourless to slightly yellow solution. Do not use if the solution is discoloured, or cloudy, or if particles are present.

The following table outlines the materials needed for preparation of the 0.16 mg and 0.8 mg doses of Tepkinly using sterile vials.

Materials needed to prepare Tepkinly 0.16 mg dose and Tepkinly 0.8 mg dose

Priming dose (0.16 mg) Intermediate dose (0.8 mg)

4 mg/0.8 ml Tepkinly vial with

light blue cap 4 mg/0.8 ml Tepkinly vial with

light blue cap

0.9% sodium chloride injection 0.9% sodium chloride injection

Two empty sterile vials (10 or

20 ml vial size) One empty sterile vial (10 or 20

ml vial size)

Recommended syringe sizes Recommended syringe sizes

• Two 1 ml syringes
• One 3 ml syringe
• One 5 ml syringe

• One 10 ml syringe

  • Two 1 ml syringes

  • One 5 ml syringe

    Preparation of diluted epcoritamab using the empty sterile vial method

    0.16 mg priming dose preparation instructions - 2 dilutions required – empty sterile vial method

    Use an appropriately sized syringe, vial and needle for each transfer step.

    1. 1) Prepare Tepkinly vial
    2. a)

       Retrieve one 4 mg/0.8 ml Tepkinly vial with the light blue cap

       from the refrigerator.

    3. b)

       Allow the vial to come to room temperature for no more than

       1 hour.

    4. c) Gently swirl the Tepkinly vial.

DO NOT invert, vortex or vigorously shake the vial.

1. 2) Perform first dilution
2. a) Label an appropriately sized empty vial as “dilution A”.
3. b) Transfer 0.8 ml of Tepkinly into the dilution A vial.
4. c)

   Transfer 4.2 ml of sodium chloride 9 mg/ml (0.9%) sterile

   solution into the dilution A vial. The initial diluted solution contains 0.8 mg/ml of epcoritamab.

5. d) Gently swirl the dilution A vial for 30 – 45 seconds.
6. 3) Perform second dilution
7. a)

   Label an appropriately sized empty vial as “dilution B”.

   1. b)

      Transfer 2.0 ml of solution from the dilution A vial into the

      dilution B vial. The dilution A vial is no longer needed and should be discarded.

   2. c)

      Transfer 8.0 ml of sodium chloride 9 mg/ml (0.9%) sterile

      solution into the dilution B vial to make a final concentration of 0.16 mg/ml.

   3. d) Gently swirl the dilution B vial for 30 – 45 seconds.
   4. 4) Withdraw dose

Withdraw 1.0 ml of the diluted epcoritamab from the dilution B vial into a syringe. The dilution B vial is no longer needed and should be discarded.

1. 5) Label syringe

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

1. 6)

   Discard the vial containing unused Tepkinly in accordance

   with local requirements.

0.8 mg intermediate dose preparation instructions - 1 dilution required – empty sterile vial method

Use an appropriately sized syringe, vial and needle for each transfer step.

1. 1) Prepare Tepkinly vial
2. a)

   Retrieve one 4 mg/0.8 ml Tepkinly vial with the light blue cap

   from the refrigerator.

   1. b)

      Allow the vial to come to room temperature for no more than

      1 hour.

   2. c) Gently swirl the Tepkinly vial.

DO NOT invert, vortex or vigorously shake the vial.

1. 2) Perform dilution
2. a) Label an appropriately sized empty vial as “dilution A”.
3. b) Transfer 0.8 ml of Tepkinly into the dilution A vial.
4. c) Transfer 4.2 ml of sodium chloride 9 mg/ml (0.9%) sterile solution into the dilution A vial to make a final concentration of 0.8 mg/ml.
5. d) Gently swirl the dilution A vial for 30 to 45 seconds.
6. 3) Withdraw dose

Withdraw 1.0 ml of the diluted epcoritamab from the dilution A vial into a syringe. The dilution A vial is no longer needed and should be discarded.

1. 4) Label syringe

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

1. 5)

   Discard the vial and any unused portion of Tepkinly in accordance with local requirements.

   • Other side effects

Tepkinly used on its own for patients with DLBCL and FL:

Very common: may affect more than 1 in 10 people

• viral infection
• pneumonia (lung infection)
• upper respiratory tract infections (infection of the airways)
• decreased hunger
• pain in bones, joints, ligaments and muscles
• pain in the belly area
• headache
• nausea
• diarrhoea
• rash
• tiredness
• injection site reactions
• fever
• swelling

Shown in blood tests

• low levels of some white blood cells that fight infection

  (neutropenia)

• low number of red blood cells, which can cause tiredness,

  pale skin, and shortness of breath (anaemia)

• low platelet count, which may make you more likely to bruise or

  bleed (thrombocytopenia)

• decrease in a type of white blood cell called a lymphocyte, that

  may affect the body’s ability to fight infection (lymphopenia)

• low levels of immunoglobulins, which may lead to infections

Common: may affect up to 1 in 10 people

• fever due to infection when you have low levels of white blood

  cells (febrile neutropenia)

• 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)

• 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)

• irregular heartbeat

• extra fluid around the lungs that can make it difficult to breathe

  (pleural effusion)

• vomiting
• itching (pruritus)

Shown in blood tests

• low level of potassium, which can cause weakness, muscle

  cramps, tingling and heart rhythm changes

• low level of phosphates in the blood, 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

Tepkinly used together with lenalidomide and rituximab for patients with FL:

Very common: may affect more than 1 in 10 people

• upper respiratory tract infections (infection of the airways)
• COVID-19
• lung infection (pneumonia)

• hypogammaglobulinemia is a condition in which the body does

  not produce enough antibodies to fight infections

• difficulties sleeping
• effects on your nervous system (neurological changes)
• headache
• diarrhea
• constipation
• nausea
• rash
• feeling tired (fatigue)
• injection site reactions

• fever

  Shown in blood tests

  • low levels of some white blood cells (neutropenia)

  • low number of red blood cells, which can cause tiredness

    (anemia)

  • low platelet count, which may make you more likely to bruise or

    bleed (thrombocytopenia)

  • low levels, as measured in blood tests, of lymphocytes (a type

    of white blood cell; lymphopenia), that may affect the body’s ability to fight infection

  • low level of potassium in blood

  • increased blood level of liver proteins, which may show

    problems with the liver

Common: may affect up to 1 in 10 people

• a viral infection that may cause symptoms such as fever, pain,

  redness, and/or difficulty breathing (cytomegalovirus infection)

• viral infection of the mouth or genitals (herpes virus infection)

• fever due to infection when you have low levels of white blood

  cells (febrile neutropenia)

• an inflammation of the mucous membranes, which are the

  moist lining of the digestive, respiratory and genitourinary systems

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 Yellow Card Scheme (website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store). By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Tepkinly

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).
• Keep the vial in the outer carton in order to protect from light.
• Do not freeze.
• Do not shake.

• 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 epcoritamab solution can be

  stored for 12 hours at room temperature 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.

If the medicine becomes discolored or shows any other signs of deterioration, you should seek the advice of your pharmacist who will tell you what to do.

6. Contents of the pack and other information

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.

Manufacturer:

AbbVie S.r.l.

S.R. 148 Pontina, km 52 SNC

04011 Campoverde di Aprilia (LT)

ITALY

Procured from within the EU and repackaged for the PL Holder: Abacus Medicine Ltd., Abbey House, 282 Farnborough Road, Farnborough, GU14 7NA, United Kingdom

PL 45763/1864

POM

Tepkinly^® is a registered trademark

of AbbVie Biotechnology Ltd

For any information about this medicine, please contact the local representative of the Product Licence Holder:

Abacus Medicine Ltd.

tel: +44(0)2036301244

email: MedInfo@abacusmedicine.co.uk

or

drugsafetyuk@abacusmedicine.co.uk

This leaflet was last revised on 26.08.2026.

This medicine has been given ‘conditional approval’. This means that there is more evidence to come about this medicine. The Medicines and Healthcare products Regulatory Agency will review new information on this medicine at least every year and this leaflet will be updated as necessary.

Blind or partially sighted? Is this leaflet hard to see or read?

Call 02036301310 or write to info@abacusmedicine.com to obtain the leaflet in a format suitable for you.

• Preparation of diluted epcoritamab using the sterile syringe method

0.16 mg priming dose preparation instructions – 2 dilutions required – sterile syringe method

Use an appropriately sized syringe and needle for each transfer step.

1. 1) Prepare Tepkinly vial
2. a)

   Retrieve one 4 mg/0.8 ml Tepkinly vial with the light blue cap

   from the refrigerator.

3. b)

   Allow the vial to come to room temperature for no more than

   1 hour.

4. c) Gently swirl the Tepkinly vial.

DO NOT vortex or vigorously shake the vial.

1. 2) Perform first dilution
2. a) Label an appropriately sized syringe as “dilution A”.
3. b)

   Withdraw 4.2 ml of sodium chloride 9 mg/ml (0.9%) sterile

   solution into the dilution A syringe. Include approximately 0.2 ml air in the syringe.

4. c)

   In a new syringe labelled as “syringe 1”, withdraw 0.8 ml of

   epcoritamab.

5. d)

   Connect the two syringes and push the 0.8 ml of epcoritamab

   into the dilution A syringe. The initially diluted solution contains 0.8 mg/ml of epcoritamab.

6. e)

   Gently mix by inverting the connected syringes 180 degrees

   5 times.

7. f)

   Disconnect the syringes and discard syringe 1.

   1. 3) Perform second dilution
   2. a) Label an appropriately sized syringe as “dilution B”.
   3. b)

      Withdraw 8 ml of sodium chloride 9 mg/ml (0.9%) sterile

      solution into the dilution B syringe. Include approximately 0.2 ml air in the syringe.

   4. c) Label another appropriately sized syringe as “syringe 2”.
   5. d)

      Connect syringe 2 to the dilution A syringe and transfer 2 ml

      of solution into syringe 2. The dilution A syringe is no longer needed and should be discarded.

   6. e)

      Connect syringe 2 to the dilution B syringe and push the

      2 ml of solution into the dilution B syringe to make a final concentration of 0.16 mg/ml.

   7. f)

      Gently mix by inverting the connected syringes 180 degrees

      5 times.

   8. g) Disconnect the syringes and discard syringe 2.
   9. 4) Withdraw dose

Connect and transfer 1 ml of the diluted epcoritamab from the dilution B syringe into a new syringe. The dilution B syringe is no longer needed and should be discarded.

1. 5) Label syringe

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

1. 6)

   Discard the vial and any unused portion of Tepkinly in

   accordance with local requirements.

   0.8 mg intermediate dose preparation instructions -1 dilution required– sterile syringe method

   Use an appropriately sized syringe and needle for each transfer step.

   1. 1) Prepare Tepkinly vial
   2. a) Retrieve one 4 mg/0.8 ml Tepkinly vial with the light blue cap from the refrigerator.
   3. b)

      Allow the vial to come to room temperature for no more than

      1 hour.

   4. c) Gently swirl the Tepkinly vial.

DO NOT vortex or vigorously shake the vial.

1. 2) Perform dilution
2. a) Label an appropriately sized syringe as “dilution A”.
3. b) Withdraw 4.2 ml of sodium chloride 9 mg/ml (0.9%) sterile solution into the dilution A syringe. Include approximately 0.2 ml air in the syringe.
4. c) In a new syringe labelled as “syringe 1”, withdraw 0.8 ml of epcoritamab.
5. d) Connect the two syringes and push the 0.8 ml of epcoritamab into the dilution A syringe to make a final concentration of 0.8 mg/ml.
6. e)

   Gently mix by inverting the connected syringes 180 degrees

   5 times.

7. f)

   Disconnect the syringes and discard syringe 1.

   1. 3) Withdraw dose

Connect a new syringe to the dilution A syringe and transfer 1 ml of the diluted epcoritamab into the new syringe. The dilution A syringe is no longer needed and should be discarded.

1. 4) Label syringe

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

1. 5) Discard the vial and any unused portion of Tepkinly in accordance with local requirements.

3 mg second intermediate dose preparation instructions (No dilution required)

Epcoritamab 3 mg dose is required for FL patients only.

1. 1) Prepare Tepkinly vial
2. a) Retrieve one 4 mg/0.8 ml Tepkinly vial with the light blue cap from the refrigerator.
3. b)

   Allow the vial to come to room temperature for no more than

   1 hour.

4. c) Gently swirl the Tepkinly vial.

DO NOT vortex, or vigorously shake the vial.

1. 2) Withdraw dose

Withdraw 0.6 ml of epcoritamab into a syringe.

1. 3) Label syringe

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

1. 4) Discard the vial and any unused portion of Tepkinly in accordance with local requirements.

Traceability

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