Tecvayli 10 mg/ml solucion inyectable

Prospect: information for the patient

TECVAYLI 10 mg/ml injectable solution

TECVAYLI 90 mg/ml injectable solution

teclistamab

This medicine is subject to additional monitoring, which will expedite the detection of new information about its safety. You can 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 prospect carefully before starting to receive this medicine, because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or nurse.
• If you experience adverse effects, consult your doctor or nurse, even if they are not listed in this prospect. See section 4.

TECVAYLI is a cancer medication that contains the active ingredient "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 a monoclonal antibody, a type of protein that has been designed to recognize specific targets in the body and bind to them. TECVAYLI targets the B cell maturation antigen (BCMA), which is found in the cancer cells of multiple myeloma, and the CD3 group, which is found in the body's T cells. This medication works by binding to these cells and grouping them, allowing the body's immune system to destroy the cancer cells of multiple myeloma.

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

If you are unsure whether you are allergic, speak with your doctor or nurse before using TECVAYLI.

Warnings and precautions

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

TECVAYLI and vaccines

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

Do not receive live vaccines from 4 weeks before and until 4 weeks after being treated with TECVAYLI.

Tests and check-ups

Before starting to use TECVAYLI,your doctor will review your blood tests for signs of infection. If you have any infection, you 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 your side effects. Your doctor will check your blood tests periodically, as your blood cell count and other blood components may decrease.

Be aware of possible severe side effects.

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

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

If you observe any of the above symptoms, inform your doctor or nurse.

Children and adolescents

Do not administer TECVAYLI to children or adolescents under 18 years of age, as its effects on them are unknown.

Other medications and TECVAYLI

Inform your doctor or nurse if you are taking, have recently taken, or may need to take any other medication. This includes medications that can be obtained without a prescription and herbal remedies.

Pregnancy and breastfeeding

The effects of TECVAYLI on the future baby or passage into breast milk are unknown.

Pregnancy - information for women

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

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

Pregnancy - information for men

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

Contraceptives

If you or your partner can become pregnant, 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 if the benefits of breastfeeding outweigh the risks for your baby. If you and your doctor decide to stop using this medication, do not breastfeed for 3 months after stopping treatment.

Driving and operating machinery

Some people may feel tired, dizzy, or confused when using TECVAYLI. Do not drive, use tools, or operate heavy machinery, or perform activities that may pose a risk to you for at least 48 hours after receiving your third dose of TECVAYLI, or as instructed by your doctor.

TECVAYLI contains sodium

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

Amount Administered

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 administered as follows:

• You will be administered 0.06 mg per kilogram of body weight for your first dose.
• You will be administered 0.3 mg per kilogram of body weight as your second dose 2-7 days later.
• Subsequently, you will receive a "maintenance dose" of 1.5 mg per kilogram of body weight 2-7 days after the second dose.
• Then, you will continue to receive a "maintenance dose" once a week as long as you benefit from the use of TECVAYLI.

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

You should remain near a healthcare facility after the first three doses in case you experience adverse effects.

How the Medication is Administered

TECVAYLI will be administered to you by a doctor or nurse in the form of an injection under your skin (subcutaneous injection). It is administered in the abdominal area or in the thigh.

Other Medications Administered During TECVAYLI Treatment

You will be administered medications 1-3 hours before each of the first three doses of TECVAYLI, which help reduce the likelihood of adverse effects, such as cytokine release syndrome. These may include:

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

It is possible that you will also be administered these medications for subsequent doses of TECVAYLI based on your symptoms.

You may also be administered additional medications based on your symptoms or medical history.

If You Are Administered More TECVAYLI Than You Should

This medication will be administered to you by your doctor or nurse, and it is unlikely that you will be administered an excessive amount. In the event that you are administered an excessive amount (an overdose), your doctor will examine you to see if you experience adverse effects.

If You Miss Your Appointment for TECVAYLI Administration

It is very important to attend all your appointments. If you do not attend an appointment, reschedule as soon as possible.

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

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

Severe side effects

Seek immediate medical attention if you experience any of the following severe side effects, which could be serious or even life-threatening.

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

• Severe immune reaction («cytokine release syndrome») that may cause fever, chills, nausea, headache, tachycardia, dizziness, and difficulty breathing
• Low levels of antibodies called «immunoglobulins» in the blood (hypogammaglobulinemia), which may make infections more likely
• Low levels of a type of white blood cell (neutropenia)
• Infection, which may include fever, chills, shivering, cough, difficulty breathing, rapid breathing, and rapid pulse

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

Inform your doctor immediately if you experience any of the above-mentioned severe side effects.

Other side effects

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

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

• Pulmonary infection (pneumonia)
• COVID-19 infection caused by a virus called SARS-CoV-2
• Upper respiratory tract infection (infection of the nose, sinuses, or throat)
• Low levels of red blood cells in the blood (anemia)
• Low levels of «platelets» in the blood (cells that help blood clotting; thrombocytopenia)
• Low number of white blood cells in the blood (leucopenia)
• Low levels of a type of white blood cell in the blood (lymphopenia)
• Low levels of «phosphate», «magnesium», or «potassium» in the blood (hypophosphatemia, hypomagnesemia, or hypokalemia)
• High levels of «calcium» (hypercalcemia)
• High levels of «alkaline phosphatase» in the blood
• Loss of appetite
• Nausea, diarrhea, constipation, vomiting
• Headache
• Nerve damage that may cause tingling, numbness, pain, or loss of sensation
• High blood pressure (hypertension)
• Bleeding that may be severe (hemorrhage)
• Cough
• Shortness of breath (dyspnea)
• Fever
• Intense fatigue
• Muscle pain or discomfort
• Swelling of hands, ankles, or feet (edema)
• Reactions at the injection site or nearby, including redness of the skin, itching, swelling, pain, bruising, rash, or bleeding

Common (may affect up to 1 in 10 people)

• Severe infection throughout the body (sepsis)
• Skin infection that causes redness (cellulitis)
• Low levels of a type of white blood cell in the blood with fever (neutropenic fever)
• Low levels of «fibrinogen», a type of protein in the blood, making it harder for blood to clot
• Cerebral dysfunction (encephalopathy)
• Low levels of «calcium» or «sodium» in the blood (hypocalcemia or hyponatremia)
• High levels of «potassium» in the blood (hyperkalemia)
• Low levels of «albumin» in the blood (hypoalbuminemia)
• Low levels of oxygen in the blood (hypoxia)
• High levels of «gamma-glutamyltransferase» in the blood
• High levels of liver enzymes «transaminases» in the blood
• High levels of «creatinine» in the blood
• High levels of «amylase» in the blood (hyperamylasemia)
• High levels of «lipase» in the blood (hyperlipasemia)
• Blood tests may show that it takes longer for blood to clot (increased RIN and prolonged TTP)

Reporting side effects

If you experience any type of side effect, consult your doctor or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the national notification system included in theAppendix V. By reporting side effects, you can contribute to providing more information about the safety of this medicine.

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

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box and on the vial label after "CAD". The expiration date is the last day of the month indicated.

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

Store in the original packaging to protect it from light.

Medicines should not be thrown down the drain or in the trash. Your healthcare professional will dispose of unused medications. This will help protect the environment.

TECVAYLI Composition

• The active ingredient is teclistamab. TECVAYLI is available 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 edetate, glacial acetic acid, polysorbate 20, sodium acetate trihydrate, sucrose, and water for injection (see "TECVAYLI contains sodium" in section 2).

Appearance of TECVAYLI and contents of the pack

TECVAYLI is a clear, colorless to yellowish liquid injectable solution.

TECVAYLI is presented in a carton pack 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

For further information about this medicinal product, please contact the local representative of the marketing authorization holder:

Last update of the summary of product characteristics:

This medicinal product has been authorised under a «conditional approval». This type of approval means that it is expected that more information will be obtained about this medicinal product.

The European Medicines Agency will review the new information about this medicinal product at least once a year and this summary of product characteristics 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.

This information is intended for healthcare professionals:

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

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

TECVAYLI should be administered by a healthcare professional with adequately trained medical staff and appropriate medical equipment for managing severe reactions, including cytokine release syndrome.

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

Do not combine vials of TECVAYLI of different concentrations to obtain the maintenance dose.

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

Disposal of unused medicinal product and all materials that have been in contact with it should 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: Injection volumes of TECVAYLI (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: Injection volumes of TECVAYLI (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: Injection volumes of TECVAYLI (90 mg/ml) for maintenance dose (1.5 mg/kg)

• Remove the TECVAYLI vial from the refrigerated storage (2°C - 8°C) and equilibrate it 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 roll the vial for approximately 10 seconds to mix it. Do not agitate.
• Withdraw the required injection volume of TECVAYLI from the (the) vial(s) using a suitable syringe and a transfer needle.

• Each injection volume should not exceed 2.0 ml. Divide doses that require more than 2.0 ml of TECVAYLI into several syringes.

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

• TECVAYLI injectable solution is clear, colorless to yellowish.

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 at least 2 cm apart.
• Do not inject into tattoos, scars, or areas where the skin is red, bruised, sensitive, hard, or not intact.

Traceability

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