TECVAYLI

Package leaflet: Information for the patient

TECVAYLI 10 mg/mL injection solution, 90 mg/mL injection solution

teclistamab

This medicinal product is under additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you experience while taking this medicine. See the end of section 4 for information on how to report side effects.
Please read this leaflet carefully before you are given this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or nurse.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor or nurse. See section 4.

Contents of this leaflet

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

1. What TECVAYLI is and what it is used for

TECVAYLI is an oncological medicine containing the active substance "teclistamab", used for the treatment of adult patients with a type of bone marrow cancer called multiple myeloma.
It is used in patients who have received at least three prior therapies that either no longer work or have stopped working.

How TECVAYLI works
TECVAYLI is an antibody, a type of protein, designed to recognize and bind to specific targets in the body. TECVAYLI targets B-cell maturation antigen (BCMA), present on the tumor cells of multiple myeloma, and cluster of differentiation 3 (CD3), present on T cells of the immune system.
The medicine works by binding to these cells and bringing them together, enabling the immune system to recognize and attack the multiple myeloma cells.

2. What you should know before being given TECVAYLI

Do not use TECVAYLI if you are allergic to teclistamab or to any of the other ingredients of
this medicine (listed in section 6).
If you think you might be allergic, please consult your doctor or nurse before receiving
TECVAYLI.

Warnings and precautions
Talk to your doctor or nurse before receiving TECVAYLI if:

• you have had a stroke or seizures within the past 6 months.
• you have ever had or currently have hepatitis B infection. This is because TECVAYLI could reactivate the hepatitis B virus. Your doctor will check for signs of this infection before, during, and for some time after treatment with TECVAYLI. Inform your doctor or
  nurse if you experience worsening fatigue or develop yellowing of the skin or the whites of the eyes.

At any time during or after treatment, immediately inform your doctor or nurse if:

• you notice any new symptoms of progressive multifocal leukoencephalopathy (PML) or worsening of existing symptoms. PML is a serious and potentially fatal brain infection. Symptoms may include, but are not limited to, blurred vision, loss of vision or double vision, difficulty speaking, weakness in an arm or leg, changes in the way you walk or problems with balance, persistent numbness, decreased or loss of sensation, memory loss, or confusion.

TECVAYLI and vaccines
Talk to your doctor or nurse before receiving TECVAYLI if you have recently been vaccinated or are scheduled to receive a vaccine.
You must not receive live vaccines within four weeks before and four weeks after the last dose of TECVAYLI.

Tests and monitoring
Before you are given TECVAYLI, your doctor will check your blood count to look for signs of infection; any infection must be treated before you receive TECVAYLI. Your doctor will also check whether you are pregnant or breastfeeding.
During treatment with TECVAYLI, your doctor will monitor you for any side effects and will regularly check your blood count, as the number of blood cells and other blood components may decrease.

Be alert for serious side effects.
Immediately inform your doctor or nurse 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 heartbeat, dizziness, and difficulty breathing.
• effects on the nervous system. Symptoms include confusion, reduced alertness, drowsiness, or difficulty writing and/or speaking. Some of these may be signs of a serious immune reaction known as “immune effector cell-associated neurotoxicity syndrome” (ICANS).
• signs and symptoms of an infection.

Contact your doctor or nurse if you notice any of the symptoms described above.

Children and adolescents
Do not administer TECVAYLI to children or young people under 18 years of age, as the effects of this medicine in this age group are unknown.

Other medicines and TECVAYLI
Inform your doctor or nurse if you are taking, have recently taken, or might take any other medicines, including non-prescription medicines and herbal preparations.

Pregnancy and breastfeeding
It is not known whether TECVAYLI affects the fetus or is excreted in human breast milk.

Pregnancy – information for women
Inform your doctor or nurse before receiving TECVAYLI if you are pregnant, suspect you may be pregnant, or are planning a pregnancy.
If you become pregnant while being treated with this medicine, inform your doctor or nurse immediately.

Pregnancy – information for men
If your partner becomes pregnant while you are taking this medicine, inform your doctor immediately.

Contraception – information for women of childbearing potential
If you are of childbearing potential, you must use effective contraception during treatment and for 5 months after stopping treatment with TECVAYLI.

Contraception – information for men
If your partner is of childbearing potential, you must use an effective contraceptive method during treatment and for 3 months after stopping treatment with TECVAYLI.

Breastfeeding
You and your doctor will decide whether the benefit of breastfeeding outweighs the risk to the infant. If you and your doctor decide to discontinue the medicine, you must not breastfeed for 5 months after stopping treatment.

Driving and use of machinery
Some people may experience fatigue, dizziness, or confusion during treatment with TECVAYLI. Do not drive or operate tools or heavy machinery, and avoid performing hazardous activities for at least 48 hours after receiving the third dose of TECVAYLI or as directed by your doctor.

TECVAYLI contains sodium
TECVAYLI contains less than 1 mmol (23 mg) of sodium per dose, i.e., essentially “sodium-free”.

3. How TECVAYLI is administered

Dose administered
Your doctor will calculate the dose of TECVAYLI. The dose of TECVAYLI depends on body weight.
The first two doses will be lower.
TECVAYLI is administered as follows:

• you will receive 0.06 mg per kilogram of body weight as the first dose
• you will receive 0.3 mg per kilogram of body weight as the second dose, 2 to 7 days later
• then you will receive a “maintenance dose” of 1.5 mg per kilogram of body weight, 2 to 7 days after the second dose
• you will then continue to receive the “maintenance dose” once a week for as long as you benefit from treatment with TECVAYLI.

If after 6 months you continue to benefit from treatment with TECVAYLI, your doctor may decide
to administer the “maintenance dose” every two weeks.
Your doctor will monitor you for any adverse reactions after the first three doses, and these checks
will be repeated for two days after each dose.
Therefore, you must remain close to a healthcare facility for the first three doses in case you develop
adverse reactions.

How the medicine is administered
TECVAYLI will be administered by a doctor or nurse via an injection under the skin (subcutaneous injection) in the stomach area (abdomen) or in the thigh.

Other medicines administered during treatment with TECVAYLI
From 1 to 3 hours before each of the first three doses of TECVAYLI, you will be given medicines to help reduce the risk of adverse reactions, such as cytokine release syndrome. These medicines may include:

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

These drugs may also be administered before subsequent doses of TECVAYLI, depending on any symptoms you may develop.
You may also receive other medicines depending on any symptoms you experience or your medical history.

If you are given an overdose of TECVAYLI
This medicine will be administered by a doctor or nurse, and it is unlikely that you will receive more than required. In the event that an excessive amount (an overdose) is administered, your doctor will monitor you for the development of adverse reactions.

If you miss an appointment to receive TECVAYLI
It is very important to attend all appointments. If you miss an appointment, schedule another one as soon as possible.
If you have any doubts about how to use this medicine, consult your doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Serious side effects
Seek immediate medical help if you develop any of the following serious side effects, which can be severe and even fatal.
Very common (may affect more than 1 in 10 people):

• severe immune reaction (“cytokine release syndrome”) which may cause fever, chills, nausea, headache, rapid heartbeat, dizziness, and difficulty breathing
• low levels of antibodies called “immunoglobulins” in the blood (hypogammaglobulinemia), which may make you more vulnerable to infections
• low levels of a type of white blood cells (neutropenia)
• infection, which may include fever, chills, shaking, cough, shortness of breath or rapid breathing, and rapid pulse

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

• effects on the nervous system. These may be signs of a serious immune reaction called “immune effector cell-associated neurotoxicity syndrome” (ICANS). Some of the symptoms are: confusion or reduced alertness, difficulty writing, difficulty speaking, drowsiness, or loss of ability to perform movements and gestures (despite having the physical ability and desire to do so)

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

• a serious and potentially fatal brain infection called progressive multifocal leukoencephalopathy (PML). Some of the symptoms are: blurred vision, loss of vision, double vision, difficulty speaking, weakness in an arm or leg, changes in the way you walk, balance problems, persistent numbness, decreased or loss of sensation, memory loss, or confusion

Tell your doctor straight away if you notice any of the serious side effects listed above.
Other side effects
The following are other side effects. Tell your doctor or nurse if you get any of these side effects.
Very common (may affect more than 1 in 10 people):

• lung infection (pneumonia)
• COVID-19 caused by a virus called coronavirus (SARS-CoV-2)
• urinary tract infection
• infection of the nose, sinuses, or throat (upper respiratory tract infection)
• low levels of red blood cells (anaemia)
• low levels of platelets (cells involved in blood clotting; thrombocytopenia)
• low number of white blood cells (leucopenia)
• low levels of a type of white blood cells (lymphopenia)
• low levels of phosphate, magnesium, or potassium in the blood (hypophosphataemia, hypomagnesaemia, or hypokalaemia)
• increased levels of calcium (hypercalcaemia)
• increased levels of alkaline phosphatase in the blood
• decreased appetite
• nausea, diarrhoea, constipation, vomiting, stomach ache (abdominal pain)
• headache
• nerve damage which may cause tingling, numbness, pain, or loss of pain sensation
• muscle spasms
• high blood pressure (hypertension)
• bleeding, which may be severe (haemorrhage)
• low blood pressure (hypotension)
• cough
• shortness of breath (dyspnoea)
• fever
• feeling extremely tired
• muscle pain or tenderness
• swelling of hands, ankles, or feet (oedema)
• skin reactions at or near the injection site, including redness, itching, swelling, pain, bruising, rash, bleeding

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

• severe infection throughout the body (sepsis)
• skin infection causing redness (cellulitis)
• low number of a type of white blood cells with fever (febrile neutropenia)
• low levels of fibrinogen, a type of protein in the blood, making it difficult for blood clots to form
• change in brain function (encephalopathy)
• low level of calcium or sodium in the blood (hypocalcaemia or hyponatraemia)
• high level of potassium in the blood (hyperkalaemia)
• low level of albumin in the blood (hypoalbuminaemia)
• low blood sugar levels (hypoglycaemia)
• low oxygen level in the blood (hypoxia)
• increased levels of gamma-glutamyl transferase in the blood
• increased levels of liver transaminase enzymes in the blood
• increased levels of creatinine in the blood
• increased levels of amylase in the blood (hyperamylasaemia)
• increased levels of lipase in the blood (hyperlipasaemia)
• blood tests may show a longer blood clotting time (increased international normalized ratio and prolonged activated partial thromboplastin time)

Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor or nurse. You can also report side effects directly through the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store TECVAYLI

TECVAYLI will be stored at the hospital or clinic by the physician.
This medicine should be kept out of the sight and reach of children.
This medicine must not be used after the expiry date which is stated on the carton and on the label
of the vial after “Exp”. The expiry date refers to the last day of that month.
Store in a refrigerator (2°C – 8°C). Do not freeze.
Keep in the original packaging to protect the medicine from light.
Medicines should not be disposed of via wastewater or household waste. Ask your healthcare
professional how to dispose of medicines you no longer use. This will help protect the
environment.

6. Package contents and other information

What TECVAYLI contains

• The active substance is teclistamab. TECVAYLI is available in two different concentrations: either 10 mg/mL – one 3 mL vial contains 30 mg of teclistamab, or 90 mg/mL – one 1.7 mL vial contains 153 mg of teclistamab.
• The other ingredients are disodium edetate dihydrate, glacial acetic acid, polysorbate 20, sodium acetate trihydrate, sucrose, and water for injections (see “TECVAYLI contains sodium” in section 2).

Description of the appearance of TECVAYLI and contents of the pack
TECVAYLI is an injectable solution (injectable) and is a colourless to pale yellow liquid.
TECVAYLI is supplied in a cardboard pack containing 1 glass vial.

Marketing Authorisation Holder
Janssen-Cilag International NV
Turnhoutseweg 30
B-2340 Beerse
Belgium

Manufacturer
Janssen Biologics B.V.
Einsteinweg 101
2333 CB Leiden
The Netherlands

Janssen Pharmaceutica NV
Turnhoutseweg 30
B-2340 Beerse
Belgium

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
Janssen-Cilag NV UAB “JOHNSON & JOHNSON”
Tel/Tél: +32 14 64 94 11 Tel: +370 5 278 68 88
[email protected] [email protected]

България Luxembourg/Luxemburg
„Джонсън & Джонсън България” ЕООД Janssen-Cilag NV
Тел.: +359 2 489 94 00 Tél/Tel: +32 14 64 94 11
[email protected] [email protected]

Česká republika Magyarország
Janssen-Cilag s.r.o. Janssen-Cilag Kft.
Tel: +420 227 012 227 Tel.: +36 1 884 2858
[email protected]

Danmark Malta
Janssen-Cilag A/S AM MANGION LTD
Tlf.: +45 4594 8282 Tel: +356 2397 6000
[email protected]

Deutschland Nederland
Janssen-Cilag GmbH Janssen-Cilag B.V.
Tel: 0800 086 9247 / +49 2137 955 6955 Tel: +31 76 711 1111
[email protected] [email protected]

Eesti Norge
UAB “JOHNSON & JOHNSON” Eesti filiaal Janssen-Cilag AS
Tel: +372 617 7410 Tlf: +47 24 12 65 00
[email protected] [email protected]

Ελλάδα Österreich
Janssen-Cilag Φαρμακευτική Μονοπρόσωπη Janssen-Cilag Pharma GmbH
Α.Ε.Β.Ε. Tel: +43 1 610 300
Tηλ: +30 210 80 90 000

España Polska
Janssen-Cilag, S.A. Janssen-Cilag Polska Sp. z o.o.
Tel: +34 91 722 81 00 Tel.: +48 22 237 60 00
[email protected]

France Portugal
Janssen-Cilag Janssen-Cilag Farmacêutica, Lda.
Tél: 0 800 25 50 75 / +33 1 55 00 40 03 Tel: +351 214 368 600
[email protected]

Hrvatska România
Johnson & Johnson S.E. d.o.o. Johnson & Johnson România SRL
Tel: +385 1 6610 700 Tel: +40 21 207 1800
[email protected]

Ireland Slovenija
Janssen Sciences Ireland UC Johnson & Johnson d.o.o.
Tel: 1 800 709 122 Tel: +386 1 401 18 00
[email protected] [email protected]

Ísland Slovenská republika
Janssen-Cilag AB Johnson & Johnson, s.r.o.
c/o Vistor hf. Tel: +421 232 408 400
Sími: +354 535 7000
[email protected]

Italia Suomi/Finland
Janssen-Cilag SpA Janssen-Cilag Oy
Tel: 800 688 777/+39 02 2510 1 Puh/Tel: +358 207 531 300
[email protected] [email protected]

Κύπρος Sverige
Βαρνάβας Χατζηπαναγής Λτδ Janssen-Cilag AB
Τηλ: +357 22 207 700 Tfn: +46 8 626 50 00
[email protected]

Latvija United Kingdom (Northern Ireland)
UAB “JOHNSON & JOHNSON” filiāle Latvijā Janssen Sciences Ireland UC
Tel: +371 678 93561 Tel: +44 1 494 567 444
[email protected] [email protected]

This medicinal product has been granted a conditional marketing authorisation. This means that further data on this medicinal product are required.
The European Medicines Agency will review new information on this medicinal product at least annually and this patient information leaflet will be updated as necessary.

Other sources of information
More detailed information on this medicinal product is available on the European Medicines Agency website: https://www.ema.europa.eu.
This leaflet is available in all languages of the European Union/European Economic Area on the European Medicines Agency website.

The following information is intended for healthcare professionals only:
It is very important to strictly follow the instructions for preparation and administration provided in this section in order to minimise potential dosing errors with the TECVAYLI 10 mg/mL and TECVAYLI 90 mg/mL vials.
TECVAYLI must be administered only by subcutaneous injection. Do not administer TECVAYLI intravenously.
TECVAYLI must be administered by a healthcare professional and/or appropriately trained medical personnel with appropriate medical equipment available to manage severe reactions, including cytokine release syndrome.
The TECVAYLI 10 mg/mL and TECVAYLI 90 mg/mL vials are for single use only.
TECVAYLI vials of different concentrations must not be combined to achieve the maintenance dose.
Aseptic technique must be used when preparing and administering TECVAYLI.
Unused medicinal product and waste material must be disposed of in accordance with local regulations.

Preparation of TECVAYLI

• Verify the prescribed dose for each TECVAYLI injection. To minimise errors, use the following tables to prepare the TECVAYLI injection.
  o Use Table 1 to determine the total dose, injection volume, and number of vials required based on the patient’s actual body weight for step-up dose 1 using the TECVAYLI 10 mg/mL vial.

Table 1. Injection volumes of TECVAYLI (10 mg/mL) for step-up dose 1 (0.06 mg/kg)

o Use Table 2 to determine the total dose, injection volume, and number of
vials required based on the patient's actual body weight for incremental dose 2
using the TECVAYLI 10 mg/mL vial.
Table 2. Injection volumes of TECVAYLI (10 mg/mL) for incremental dose 2 (0.3 mg/kg)

o Use Table 3 to determine the total dose, injection volume, and number of vials required based on the patient's actual body weight for the maintenance dose using the TECVAYLI 90 mg/mL vial.
Table 3. Injection volumes of TECVAYLI (90 mg/mL) for the maintenance dose (1.5 mg/kg)
Body weight Total dose Injection volume Number of vials
(kg) (mg) (mL) (1 vial = 1.7 mL)
35-39 56 0.62 1
40-44 63 0.70 1
45-49 70 0.78 1
50-59 82 0.91 1
60-69 99 1.1 1
70-79 108 1.2 1
80-89 126 1.4 1
90-99 144 1.6 1
100-109 153 1.7 1
110-119 171 1.9 2
120-129 189 2.1 2
130-139 198 2.2 2
140-149 216 2.4 2
150-160 234 2.6 2
Maintenance dose
(1.5 mg/kg)

• Remove the appropriately concentrated TECVAYLI vial from the refrigerator (2 °C–8 °C) and allow it to reach room temperature (15 °C–30 °C) for at least 15 minutes. Do not heat TECVAYLI by any other method.
• Once at room temperature, gently rotate the vial for approximately 10 seconds to mix. Do not shake.
• Draw up the required injection volume of TECVAYLI from the vial(s) into a suitably sized syringe using a transfer needle.
• The volume of each injection must not exceed 2.0 mL. Divide doses requiring more than 2.0 mL into equal portions using separate syringes.
• TECVAYLI is compatible with stainless steel needles and syringes made of polypropylene and polycarbonate.
• Replace the transfer needle with an appropriate injection needle.
• Visually inspect TECVAYLI for particulate matter and discoloration prior to administration. Do not use the solution if it appears discolored, cloudy, or contains foreign particles.
• TECVAYLI is an injectable solution that ranges from colorless to pale yellow.

Administration of TECVAYLI

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

Traceability
To improve the traceability of biological medicinal products, the name and batch number of the administered medicinal product should be clearly documented.