TECVAYLI 90 mg/mL Injectable Solution

Introduction

Package Leaflet: Information for the Patient

TECVAYLI 10 mg/ml Solution for Injection

TECVAYLI 90 mg/ml Solution for Injection

teclistamab

This medicine is subject to additional monitoring, which will allow for quicker 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 receiving this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or nurse.
• If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What is TECVAYLI and what is it used for

TECVAYLI is a cancer medicine that contains the active substance teclistamab and is used to treat adult patients with a type of bone marrow cancer called multiple myeloma.

It is used in patients who have received at least three other classes of treatment that either did not work or have stopped working.

How TECVAYLI works

TECVAYLI is an antibody, a type of protein that has been designed to recognize specific targets in your body and bind to them. TECVAYLI targets the B-cell maturation antigen (BCMA), which is found on the cancer cells of multiple myeloma, and CD3, which is found on the so-called T-cells of your immune system. This medicine works by binding to these cells and grouping them together, so that your immune system can destroy the multiple myeloma cancer cells.

2. What you need to know before you use TECVAYLI

Do not use TECVAYLIif you are allergic to teclistamab or any of the other ingredients of this medicine (listed in section 6).

If you are not sure if you are allergic, talk to your doctor or nurse before using TECVAYLI.

Warnings and precautions

Talk to your doctor or nurse before starting TECVAYLI if you have had a stroke or seizures in the last 6 months.

TECVAYLI and vaccines

If you have been vaccinated recently or are going to be vaccinated, talk to your doctor or nurse before using TECVAYLI.

You should not receive live vaccines from 4 weeks before to 4 weeks after being treated with TECVAYLI.

Tests and checks

Before starting TECVAYLI,your doctor will check your blood tests for signs of infection. If you have any infection, it will be treated before starting TECVAYLI. Your doctor will also check if you are pregnant or breastfeeding.

During treatment with TECVAYLI, your doctor will monitor you for side effects. Your doctor will regularly check your blood tests, as the number of blood cells and other blood components may decrease.

Be aware of possible serious side effects.

Tell your doctor or nurse immediately if you experience any of the following:

• Signs of a condition known as "cytokine release syndrome" (CRS). Cytokine release syndrome is a serious immune reaction with symptoms such as fever, chills, nausea, headache, rapid heart rate, feeling dizzy, and difficulty breathing.
• Effects on the nervous system. Symptoms include feeling confused, feeling less alert, sleepy or having difficulty writing and/or speaking. Some of these may be signs of a serious immune reaction called "immune effector cell-associated neurotoxicity syndrome" (ICANS).
• Signs and symptoms of an infection.

If you notice any of the above signs, tell your doctor or nurse.

Children and adolescents

Do not give TECVAYLI to children or adolescents under 18 years of age, as it is not known how this medicine affects them.

Other medicines and TECVAYLI

Tell your doctor or nurse if you are taking, have recently taken, or might take any other medicines. This includes medicines that you can buy without a prescription and herbal medicines.

Pregnancy and breastfeeding

It is not known if TECVAYLI affects the unborn baby or if it passes into breast milk.

Pregnancy - information for women

If you are pregnant, think you may be pregnant, or plan to become pregnant, talk to your doctor or nurse before using TECVAYLI.

If you become pregnant while being treated with this medicine, tell your doctor or nurse immediately.

Pregnancy - information for men

If your partner becomes pregnant while you are being treated with this medicine, tell your doctor immediately.

Contraception

If you or your partner can become pregnant, you must use an effective method of contraception during treatment and for 3 months after stopping treatment with TECVAYLI.

Breastfeeding

You and your doctor will decide if the benefit of breastfeeding is greater than the risk to your baby. If you and your doctor decide that you should stop using this medicine, you should not breastfeed for 3 months after stopping treatment.

Driving and using machines

Some people may feel tired, dizzy, or confused when using TECVAYLI. Do not drive, use tools, or operate heavy machinery for at least 48 hours after receiving your third dose of TECVAYLI, or as directed by your doctor.

TECVAYLI contains sodium

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

3. How to use TECVAYLI

Dose

Your doctor will determine your dose of TECVAYLI. The dose will depend on your body weight. The first two doses will be lower.

TECVAYLI is given as follows:

• You will be given 0.06 mg per kilogram of body weight for your first dose.
• You will be given 0.3 mg per kilogram of body weight as your second dose 2-7 days later.
• Then you will receive a "maintenance dose" of 1.5 mg per kilogram of body weight 2-7 days after the second dose.
• After that, you will continue to receive a "maintenance dose" once a week while you are benefiting from TECVAYLI.

Your doctor will monitor you for side effects after each of the first three doses. They will do this for 2 days after each dose.

You should stay near a medical center after the first three doses in case you experience side effects.

How the medicine is given

TECVAYLI will be given to you by a doctor or nurse as an injection under your skin (subcutaneous injection). It is given in the stomach area (abdomen) or in the thigh.

Other medicines given during treatment with TECVAYLI

You will be given medicines 1-3 hours before each of the first three doses of TECVAYLI, which help reduce the chance of side effects, such as cytokine release syndrome. These may include:

• medicines to reduce the risk of an allergic reaction (antihistamines)
• medicines to reduce the risk of inflammation (corticosteroids)
• medicines to reduce the risk of fever (such as paracetamol)

You may also be given these medicines for later doses of TECVAYLI depending on the symptoms you have.

You may also be given additional medicines depending on the symptoms you have or your medical history.

If you are given too much TECVAYLI

This medicine will be given to you by a doctor or nurse and it is unlikely that you will be given too much. If you are given too much (an overdose), your doctor will check you for side effects.

If you miss an appointment for a TECVAYLI injection

It is very important to attend all your appointments. If you miss an appointment, make another one as soon as possible.

If you have any other questions about the use of this medicine, ask your doctor or nurse.

4. Possible side effects

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

Serious side effects

Seek medical attention immediately if you experience any of the following serious side effects, which can be serious and even life-threatening.

Very common (may affect more than 1 in 10 people):

• serious immune reaction ("cytokine release syndrome") that can cause fever, chills, nausea, headache, rapid heart rate, feeling dizzy, and difficulty breathing
• low level of antibodies called "immunoglobulins" in the blood (hypogammaglobulinemia), which can make infections more likely
• low level of a type of white blood cell (neutropenia)
• infection, which can include fever, chills, shivering, cough, difficulty breathing, rapid breathing, and rapid heart rate

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

• Effects on the nervous system. These can be signs of a serious immune reaction called "immune effector cell-associated neurotoxicity syndrome" (ICANS). Some of the symptoms are:

• feeling confused
• feeling less alert
• difficulty writing
• difficulty speaking
• sleepiness
• loss of ability to perform skilled movements and gestures (despite having the physical ability and desire to perform them)

Tell your doctor immediately if you experience any of the above serious side effects.

Other side effects

The following are other side effects. If you experience any of these side effects, tell your doctor or nurse.

Very common (may affect more than 1 in 10 people):

• lung infection (pneumonia)
• COVID-19 infection caused by a virus called coronavirus (SARS-CoV-2)
• infection of the nose, sinuses, or throat (upper respiratory tract infection)
• low level of red blood cells in the blood (anemia)
• low level of "platelets" in the blood (cells that help blood clot; thrombocytopenia)
• low white blood cell count (leukopenia)
• low level of a type of white blood cell (lymphopenia)
• low level of "phosphate", "magnesium", or "potassium" in the blood (hypophosphatemia, hypomagnesemia, hypokalemia)
• high level of "calcium" (hypercalcemia)
• high level of "alkaline phosphatase" in the blood
• loss of appetite
• feeling sick (nausea), diarrhea, constipation, vomiting
• headache
• nerve damage that can cause tingling, numbness, pain, or loss of sensation
• high blood pressure (hypertension)
• bleeding that can be serious (hemorrhage)
• cough
• shortness of breath (dyspnea)
• fever
• feeling extremely tired
• muscle pain or discomfort
• swelling of hands, ankles, or feet (edema)
• skin reactions at the injection site or near it, including redness, itching, swelling, pain, bruising, rash, bleeding

Common (may affect up to 1 in 10 people)

• serious infection throughout the body (sepsis)
• skin infection that causes redness (cellulitis)
• low level of a type of white blood cell in the blood with fever (febrile neutropenia)
• low level of "fibrinogen", a type of protein in the blood, making it harder for blood to clot
• brain function changes (encephalopathy)
• low level of "calcium" or "sodium" in the blood (hypocalcemia or hyponatremia)
• high level of "potassium" in the blood (hyperkalemia)
• low level of "albumin" in the blood (hypoalbuminemia)
• low level of oxygen in the blood (hypoxia)
• high level of "gamma-glutamyltransferase" in the blood
• high level of liver enzymes "transaminases" in the blood
• high level of "creatinine" in the blood
• high level of "amylase" in the blood (hyperamylasemia)
• high level of "lipase" in the blood (hyperlipasemia)
• blood tests may show that it takes longer for blood to clot (increased INR and prolonged aPTT)

Reporting of side effects

If you experience any side effects, talk to your doctor or nurse, even if it is possible side effects 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 TECVAYLI

TECVAYLI will be stored by your doctor in the hospital or medical center.

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 carton and on the label of the vial after "EXP". The expiry date is the last day of the month shown.

Store in a refrigerator (between 2°C and 8°C). Do not freeze.

Store in the original package to protect from light.

Medicines should not be disposed of via wastewater or household waste. Your healthcare professional will dispose of any unused medicines. This will help protect the environment.

6. Container Content and Additional Information

Composition of TECVAYLI

• The active ingredient is teclistamab. TECVAYLI is presented in two different concentrations:

• 10 mg/ml – a 3 ml vial contains 30 mg of teclistamab
• 90 mg/ml – a 1.7 ml vial contains 153 mg of teclistamab

• The other components are disodium dihydrate EDTA, glacial acetic acid, polysorbate 20, sodium acetate trihydrate, sucrose, water for injectable preparations (see "TECVAYLI contains sodium" in section 2).

Appearance of TECVAYLI and Container Content

TECVAYLI is a colorless to light yellow liquid injectable solution.

TECVAYLI is presented in a cardboard container containing 1 glass vial.

Marketing Authorization Holder

Janssen-Cilag International NV

Turnhoutseweg 30

B-2340 Beerse

Belgium

Manufacturer

Janssen Biologics B.V.

Einsteinweg 101

2333 CB Leiden

Netherlands

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

Date of Last Revision of this Leaflet:

This medicine has been authorized with a "conditional approval". This type of approval means that more information on this medicine is expected.

The European Medicines Agency will review the new information on this medicine at least once a 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 website: http://www.ema.europa.eu.

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

This information is intended only for healthcare professionals:

It is very important to strictly follow the preparation and administration instructions provided in this section to minimize possible dosing errors with the TECVAYLI 10 mg/ml and TECVAYLI 90 mg/ml vials.

TECVAYLI should be administered only by subcutaneous injection. Do not administer TECVAYLI intravenously.

TECVAYLI must be administered by a healthcare professional with adequately trained medical personnel and with appropriate medical equipment for the management of serious reactions, including cytokine release syndrome.

The TECVAYLI 10 mg/ml and TECVAYLI 90 mg/ml vials are for single use.

Vials of TECVAYLI of different concentrations should not be combined to obtain the maintenance dose.

To prepare and administer TECVAYLI, aseptic technique must be used.

Disposal of unused medicine and all materials that have come into contact with it will be carried out in accordance with local regulations.

Preparation of TECVAYLI

• Verify the prescribed dose of each TECVAYLI injection. To minimize errors, use the following tables to prepare the TECVAYLI injection.

• Use Table 1 to determine the total dose, injection volume, and number of vials required based on the patient's current body weight for dose escalation 1 using the TECVAYLI 10 mg/ml vial.

Table 1: TECVAYLI Injection Volumes (10 mg/ml) for Dose Escalation 1 (0.06 mg/kg)

• Use Table 2 to determine the total dose, injection volume, and number of vials required based on the patient's current body weight for dose escalation 2 using the TECVAYLI 10 mg/ml vial.

Table 2: TECVAYLI Injection Volumes (10 mg/ml) for Dose Escalation 2 (0.3 mg/kg)

• Use Table 3 to determine the total dose, injection volume, and number of vials required based on the patient's current body weight for the maintenance dose using the TECVAYLI 90 mg/ml vial.

Table 3: TECVAYLI Injection Volumes (90 mg/ml) for Maintenance Dose (1.5 mg/kg)

• Remove the TECVAYLI vial of the corresponding concentration from refrigerated storage (2°C - 8°C) and equilibrate to room temperature (15°C - 30°C), if necessary, for at least 15 minutes. Do not heat TECVAYLI in any other way.
• Once equilibrated, gently rotate the vial for approximately 10 seconds to mix. Do not shake.
• Withdraw the required injection volume of TECVAYLI from the vial(s) into a syringe of appropriate size using a transfer needle.

• Each injection volume should not exceed 2.0 ml. Divide doses that require more than 2.0 ml equally into multiple syringes.

• TECVAYLI is compatible with stainless steel needles and syringe materials made of polypropylene and polycarbonate.
• Replace the transfer needle with a needle of appropriate size for injection.
• Inspect TECVAYLI visually for particles and discoloration before administration. Do not use if the solution is discolored, cloudy, or if there are foreign particles.

• The TECVAYLI injectable solution is colorless to light yellow.

Administration of TECVAYLI

• Inject the required volume of TECVAYLI into the subcutaneous tissue of the abdomen (preferred injection site). Alternatively, TECVAYLI can be injected into the subcutaneous tissue of the thigh. If multiple injections are required, the TECVAYLI injection sites should be separated by at least 2 cm.
• Do not inject into tattoos, scars, or areas where the skin is red, bruised, sensitive, hard, or not intact.

Traceability

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