Tepkinly 48 mg solucion inyectable

Prospect: information for the patient

Tepkinly 48 mg injectable solution

epcoritamab

This medicine is subject to additional monitoring, which will expedite the detection of new information about its safety. You may contribute by reporting any adverse effects you may experience. The final part of section 4 includes information on how to report these adverse effects.

Read this prospectus carefully before starting to use this medicine, because it contains important information for you.

• Keep this prospectus, as you may need to read it again.
• Your doctor will give you a patient information leaflet. Read it carefully and follow the instructions it contains. Always carry this patient information leaflet with you.
• Always show the patient information leaflet to your doctor or nurse or if you visit the hospital.
• If you have any doubts, consult your doctor, pharmacist or nurse.
• If you experience adverse effects, consult your doctor, pharmacist or nurse, even if they are possible adverse effects that do not appear in this prospectus. See section 4.

What is Tepkinly

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

How Tepkinly works

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

No use Tepkinly

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

Consult your doctor or nurse before Tepkinly is administered to you if you are unsure.

Warnings and Precautions

Consult your doctor, pharmacist, or nurse before starting to use Tepkinly if

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

If any of the above applies to you (or you are unsure), consult your doctor or nurse before Tepkinly is administered to you.

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

• Cytokine Release Syndrome:A potentially life-threatening disease that causes fever, vomiting, difficulty breathing/lack of breath, chills, rapid heart rate, headache, and dizziness or mild disorientation, associated with medications that stimulate T cells.

− Before each subcutaneous injection, you may be administered medications to help reduce the possible effects of cytokine release syndrome.

• ICANS (Immune Effector Cell-Associated Neurotoxicity Syndrome):The 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 a fever of 38°C or higher, chills, cough, or pain when urinating that may vary depending on the location of the infection in the body.
• Tumor Lysis Syndrome:Some people may present with 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 perform blood tests to check if you have this situation. Before each subcutaneous injection, you must be well-hydrated and may be administered other medications that can help reduce elevated uric acid levels and reduce the possible effects of tumor lysis syndrome.
• Tumor Flare:As your cancer is destroyed, it may react and appear to worsen - this is called "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 Medications and Tepkinly

Inform your doctor or pharmacist if you are taking or using, have taken or used recently, or may need to take or use any other medication. This includes medications obtained without a prescription and herbal medications.

Pregnancy

If you are pregnant, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication. Do not use Tepkinly during pregnancy as it may affect the fetus. Your doctor may ask you to take a pregnancy test before starting treatment.

Contraception

If you are a woman who may 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 must speak with your doctor immediately.

Talk to your doctor or nurse about suitable contraceptive methods.

Breastfeeding

You should not breastfeed 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 may affect your baby.

Fertility

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

Driving and Operating Machinery

Due to possible ICANS symptoms, you should exercise caution when driving, riding a bike, or using heavy or potentially hazardous machinery. If you currently have such symptoms, avoid these activities and contact your doctor, nurse, or pharmacist. See section 4 for more information on adverse effects.

Tepkinly contains sodium

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

Tepkinly contains sorbitol

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

Tepkinly contains polysorbate

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

A doctor with experience in cancer treatment will oversee your treatment. Follow the treatment schedule explained by your doctor.

Tepkinly will be administered by a doctor or nurse as a subcutaneous injection. Tepkinly will be administered in 28-day cycles, according to a dosing schedule provided by your doctor.

Tepkinly will be administered according to the following schedule

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

These medications 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 administered 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 severe reactions such as SLC, ICANS, and fever are most likely to occur.

If you have follicular lymphoma (FL)

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

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

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

If you forget to use Tepkinly

If you forget or miss a medical appointment, ask for another one immediately. It is very important not to miss any doses for the treatment to be fully effective.

If you interrupt Tepkinly treatment

Do not interrupt Tepkinly treatment unless you have discussed it with your doctor. This is because interrupting treatment may make your condition worse.

If you have any other questions about using this medication, ask your doctor, pharmacist, or nurse.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Severe side effects

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

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

The symptoms may include

• fever
• vomiting
• dizziness or mild drowsiness
• chills
• rapid heartbeat
• difficulty or problems breathing/lack 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, may be subtle at first. Some of those symptoms may be signs of a severe immune reaction called "Immune Effector Cell-Associated Neurotoxicity Syndrome" (ICANS). The 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)

The symptoms may include

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

Other side effects

Inform your doctor or nurse immediately if you notice any of the following side effects or if they worsen.

Very common: may affect more than 1 in 10 people

• Viral infection
• Pneumonia (lung infection)
• Upper respiratory tract infections (respiratory tract infections)
• Decreased appetite
• Pain in bones, joints, ligaments, and muscles
• Abdominal pain
• Headache
• Nausea
• Diarrhea
• Rash
• Fatigue
• Reaction at the injection site
• 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 fatigue, paleness, and shortness of breath (anemia)
• Low levels of platelets, which can cause bleeding and bruising (thrombocytopenia)
• Low levels of a type of white blood cell called lymphocytes, which can affect the body's ability to fight infections (lymphopenia)

Common: may affect up to 1 in 10 people

• Fever due to an infection when having low levels of white blood cells (neutropenic fever)
• Painful lymph node inflammation, 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 reaction to an infection (sepsis)
• Rapid breakdown of tumor cells in the blood resulting in changes in blood chemistry and damage to organs, including the kidneys, heart, and liver (tumor lysis syndrome)
• Irregular heartbeat
• Fluid accumulation 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 side effects

If you experience side effects, consult your doctor, pharmacist, or nurse, even if they are possible side effects that do not appear in this prospectus. You can also report them directly through thenational reporting system included in theAppendix V. By reporting side effects, you can contribute to providing more information about the safety of this medicine.

The doctor, nurse, or pharmacist will conserve Tepkinly in the hospital or medical center. To conserve Tepkinly correctly

• Keep this medication out of the sight and reach of children
• Do not use this medication after the expiration date that appears on the vial label and packaging after EXP. The expiration date is the last day of the month indicated.
• Store and transport refrigerated (between 2 °C and 8 °C).
• Do not freeze.
• Store the vial in the outer packaging to protect it from light.
• If not used immediately, the prepared solution can be stored at between 2 °C and 8 °C for a maximum of 24 hours from the time of preparation.
• Within these 24 hours, the prepared solution can be stored for a maximum of 12 hours at room temperature (20 °C-25 °C) 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 the unused medication in accordance with local regulations. This will help protect the environment.

Composition of Tepkinly

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

Appearance of Tepkinly and contents of the pack

Tepkinly is an injectable solution. It is a colourless to slightly yellow solution supplied in a glass vial.

Each pack 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 further information about this medicinal product, please contact the local representative of the marketing authorisation holder:

Last update of this leaflet

This medicinal product has been authorised under a conditional approval. This type of approval means that it is expected to obtain more information about this medicinal product.

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

Other sources of information

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

The leaflet and patient information leaflet for this medicinal product are available in recent and approved languages at the following URL:www.tepkinly.eu

QR code to include

To listen to or request a copy of this leaflet in , or , please contact the local representative of the marketing authorisation holder.

This leaflet is available in all languages of the European Union/European Economic Area on the website of the European Medicines Agency.

This information is intended for healthcare professionals only:

Epcoritamab is prepared and administered as a subcutaneous injection.

Each vial of epcoritamab is for single use only.

Each vial contains a surplus that allows the extraction of the indicated amount.

Epcoritamab must 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.No filtration of the solution is necessary.

Epcoritamab must be visually inspected for particles and colour changes before administration. The concentrate must be a colourless to slightly yellow solution. Do not use if the solution shows colour 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 of 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.
• Minimise exposure to natural light.
• Allow the Tepkinly solution to reach room temperature before administering it.
• Dispose of the Tepkinly solution that has not been used after the admitted storage time.

Traceability

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