Talvey 40 mg/ml solution for injection

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Talvey 2 mg/ml injection solution

Talvey 40 mg/ml injection solution

talquetamab

This medicinal product is subject to additional monitoring, which will allow quicker detection of new safety information. You can help by reporting any side effects you may experience. Section 4, towards the end, includes information on how to report these side effects.

Read the entire leaflet carefully before you start receiving this medicine, as it contains important information for you.

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

Contents of the leaflet

1. What Talvey is and what it is used for

2. What you need to know before receiving Talvey

3. How to receive Talvey

4. Possible side effects

5. How to store Talvey

6. Contents of the pack and other information

1. What Talvey is and what it is used for

Talvey is an anticancer medicine that contains the active substance "talquetamab". Talquetamab is an antibody, a type of protein that recognises specific targets in your body and binds to them. It has been designed to bind to the protein GPRC5D (G protein-coupled receptor class C group 5 member D), which is found on cancer cells in multiple myeloma, and to cluster of differentiation 3 (CD3), a protein on so-called "T lymphocytes" (a type of white blood cells). T lymphocytes are part of the body's natural defences and help protect it from infections.

They can also destroy cancer cells. When this medicine binds to these cells, it links the cancer cells and the T cells. This stimulates the T cells to destroy the multiple myeloma cancer cells.

Talvey is used to treat adults with multiple myeloma, a cancer of the bone marrow.

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

2. What you need to know before starting to receive Talvey

Do not receive Talvey

• if you are allergic to teclistamab or any of the other ingredients of this medicine (listed in section 6).

Do not use Talvey if the above applies to you. If you are unsure, speak with your doctor or nurse before receiving Talvey.

Warnings and precautions

Talk to your doctor or nurse before starting to receive Talvey.

Serious adverse effects

There are serious side effects that may occur after starting Talvey. You must tell your doctor or nurse immediately if this happens, as it may require immediate medical attention.

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

• signs of a condition known as "cytokine release syndrome" (CRS). CRS is a serious immune reaction causing symptoms such as fever, low blood pressure, chills, difficulty breathing, fatigue, headache, rapid heartbeat, and increased levels of liver enzymes in the blood.
• effects on the nervous system. Symptoms include feeling confused, disoriented, drowsy, lack of attention, slowed or impaired thinking, altered thought processes, decreased level of consciousness, confusion, difficulty speaking, and difficulty understanding speech. Some of these may be signs of a serious immune reaction called "immune effector cell-associated neurotoxicity syndrome" (ICANS).
• mouth problems such as loss of taste, dry mouth, difficulty swallowing, and inflammation of the lining of the mouth.
• skin problems such as rashes, redness, and nail problems.
• feeling hot, fever, chills, sore throat, or mouth ulcers may be signs of an infection.

Talvey and vaccines

Talk to your doctor or nurse before receiving Talvey if you have recently been vaccinated or are planning to be vaccinated. Your immune system (the body's natural defenses) may not respond as well to vaccination while taking this medicine.

You must not receive live vaccines, a specific type of vaccine, from at least 4 weeks before starting Talvey treatment until at least 4 weeks after your last dose.

Tests and monitoring

Before receiving Talvey, your doctor will perform a blood test to check levels of different blood cells and to detect signs of infection. Any infections will be treated before you start receiving this medicine.

After receiving Talvey, your doctor will monitor you for adverse effects. They will also periodically check your blood counts, as the number of blood cells and other blood components may decrease while using this medicine.

Children and adolescents

Talvey should not be used in children or adolescents under 18 years of age, as the medicine has not been studied in this age group and it is unknown how this medicine may affect them.

Other medicines and Talvey

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

Pregnancy, contraception, and breastfeeding

Pregnancy and contraception

Talvey has the potential to be passed from the mother to the developing fetus. The effects of Talvey on the developing fetus are unknown, and a risk to newborns/infants cannot be excluded.

If you are pregnant, think you may be pregnant, or plan to become pregnant, consult your doctor or nurse before using this medicine.

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

If you can become pregnant, you must use an effective method of contraception during treatment and for 3 months after stopping treatment with Talvey. Your doctor will check whether you are pregnant before starting treatment.

If your partner becomes pregnant while you are taking this medicine, inform your doctor immediately.

If you have received this medicine during pregnancy, your newborn baby should not receive any live vaccines until they are at least four weeks old.

Breastfeeding

It is unknown whether Talvey can pass into breast milk. There may be a risk to breastfed newborns or infants. Consult your doctor before starting this medicine. You and your doctor will decide whether the benefits of breastfeeding outweigh the risks to your baby. If you and your doctor decide to stop taking this medicine, you must not breastfeed for 3 months after stopping treatment.

Fertility

There is no data on the effect of teclistamab on fertility. The effects of teclistamab on male and female fertility have not been evaluated in animal studies.

Driving and use of machines

Some people may feel tired, dizzy, or confused when using Talvey. Do not drive, use tools, or operate machinery from the time you receive your first dose until at least 48 hours after receiving your first dose of Talvey, or as advised by your doctor.

Talvey contains sodium

Talvey contains less than 1 mmol of sodium (23 mg) per dose; essentially, "sodium-free".

3. How to receive Talvey

Dose administered

Talvey will be administered under the supervision of a physician experienced in the treatment of patients with multiple myeloma. Your doctor will determine how much Talvey you will receive. The dose of Talvey will depend on your body weight.

Talvey is administered once a week or once every 2 weeks, depending on the dose, as outlined below:

0.4 mg/kg once a week:

• For the first dose, you will receive 0.01 mg per kilogram of body weight.
• For the second dose, which will be administered 2–4 days later, you will receive 0.06 mg per kilogram of body weight.
• For the third dose, you will receive a "treatment dose" of 0.4 mg per kilogram of body weight 2–4 days after the second dose.
• After the third dose, you will then receive a "treatment dose" once a week thereafter.
• Treatment will continue for as long as you benefit from taking Talvey.

Your doctor will monitor you for adverse reactions after each of your first three doses.

This monitoring will last for 2 days after each dose. You must remain close to a medical care facility after each of the first three doses in case you experience adverse reactions.

If you experience adverse reactions after either of your first two doses, your doctor may decide to wait up to 7 days before administering the next dose.

0.8 mg/kg once every 2 weeks:

• For the first dose, you will receive 0.01 mg per kilogram of body weight.
• For the second dose, which will be administered 2–4 days later, you will receive 0.06 mg per kilogram of body weight.
• For the third dose, which will be administered 2–4 days later, you will receive 0.4 mg per kilogram of body weight.
• For the fourth dose, you will then receive a "treatment dose" of 0.8 mg per kilogram of body weight 2–4 days after the third dose.
• After the fourth dose, you will then receive a "treatment dose" once every 2 weeks thereafter.
• Treatment will continue for as long as you benefit from taking Talvey.

Your doctor will monitor you for adverse reactions after each of the first four doses. This monitoring will last for 2 days after each dose. You must remain close to a healthcare facility after receiving each of the first four doses in case you experience adverse reactions.

If you experience adverse reactions after any of your first three doses, your doctor may decide to wait up to 7 days before administering the next dose.

The decision to use 0.4 mg/kg once a week or 0.8 mg/kg every 2 weeks should be made in consultation with your doctor.

How the medicine is administered

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

Other medicines administered during treatment with Talvey

Before the first three doses (if you are receiving 0.4 mg/kg body weight) or the first four doses (if you are receiving 0.8 mg/kg body weight) of Talvey, you will be given medications to help reduce the likelihood of adverse reactions. These may include:

• Medications to reduce allergic reactions (antihistamines)
• Medications to reduce inflammation (corticosteroids)
• Medications to reduce fever (such as paracetamol)

You may also be given these medications when receiving later doses of Talvey, depending on the symptoms you experience.

You may also be given additional medications depending on your symptoms or medical history.

If you are given more Talvey than you should

This medicine will be administered by your doctor or nurse. In the event that you are given an excessive amount (an overdose), your doctor will examine you to determine whether you are experiencing adverse reactions.

If you miss your Talvey administration appointment

It is very important to attend all your appointments for the treatment to be effective. If you miss an appointment, schedule another one as soon as possible.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

Serious adverse effects

Seek immediate medical attention if you experience any of the following serious adverse effects, which could be severe and even fatal.

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

• Immune effector cell-associated neurotoxicity syndrome (ICANS), a serious immune reaction that may affect your nervous system. Some of the symptoms are:

  • feeling confused
  • feeling less alert or aware
  • disorientation
  • somnolence
  • low energy
  • slowness and difficulty thinking

• Cytokine release syndrome (CRS), a serious immune reaction. CRS may cause symptoms such as:

  • fever
  • low blood pressure
  • chills
  • low oxygen levels in the blood
  • headache
  • rapid heartbeat
  • increased liver enzyme levels in the blood

• low levels of neutrophils (neutropenia), a type of white blood cell that helps fight infections

• reduced number of "platelets" in the blood (thrombocytopenia), which help blood to clot

Immediately inform your doctor if you experience any of the serious adverse effects listed above.

Other adverse effects

The following is a list of other adverse effects. If you experience any of these, inform your doctor or nurse.

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

• nail problems
• muscle and bone pain (musculoskeletal pain)
• reduced number of red blood cells (anemia)
• feeling tired
• chills
• weight loss
• abnormally dry skin or mucous membranes such as mouth and eyes (xerosis)
• reduced number of lymphocytes (lymphopenia), a type of white blood cell
• problems producing or controlling movement (motor dysfunction)
• dizziness
• nerve damage that may cause tingling, numbness, pain, or loss of pain sensation (sensory neuropathy)
• damage or disease affecting brain function (encephalopathy)
• diarrhea
• nausea
• constipation
• stomach pain
• vomiting
• nasal, sinus, or throat infection (upper respiratory tract infection)
• itching (pruritus)
• decreased appetite
• pain
• reduced number of white blood cells (leucopenia)
• low levels of "potassium" in the blood (hypokalemia)
• low levels of "phosphate" in the blood (hypophosphatemia)
• low levels of "magnesium" in the blood (hypomagnesemia)
• low levels of immunoglobulins, a type of antibody in the blood (hypogammaglobulinemia), which may increase the risk of infections
• swelling caused by fluid accumulation in the body (edema)
• irritation or pain at the injection site
• increased liver enzymes in the blood
• COVID-19 infection
• blood tests may show that blood takes longer to clot (decreased fibrinogen, elevated INR, prolonged aPTT)
• bacterial infection
• mouth pain
• fungal infection
• fever (pyrexia)
• headache
• difficulty breathing (dyspnea)
• cough
• mouth and swallowing problems, such as changes in taste (dysgeusia), dry mouth, difficulty swallowing (dysphagia), and inflammation of the lining of the mouth (stomatitis)
• skin problems, including rash

Common (may affect up to 1 in 10 people)

• hair loss
• bleeding, which may be severe (hemorrhage)
• lung infection (pneumonia)
• viral infection
• blood infection (sepsis)
• low count of a type of white blood cell (neutrophils), with fever

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or nurse, even if they are adverse effects not listed in this leaflet. You may also report them directly through the national reporting system detailed in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Talvey

Talvey will be stored by your doctor at the hospital or medical center. Therefore, the following information is intended primarily for healthcare professionals.

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

Do not use this medicine after the expiry date stated on the carton and on the label of the vial following "EXP". The expiry date refers to the last day of the month indicated.

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

Keep in the original carton to protect from light.

Before using this medicine, check that the solution does not contain particles or discoloration. The solution should be colourless to pale yellow. Do not use this medicine if it appears cloudy, discoloured, or contains visible particles.

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

6. Contents of the container and other information

Composition of Talvey

• The active substance is talquetamab. Talvey is available in two different concentrations:

• 2 mg/ml – a 1.5 ml vial contains 3 mg of talquetamab

• 40 mg/ml – a 1 ml vial contains 40 mg of talquetamab

• The other components are disodium edetate dihydrate (E385), glacial acetic acid (E260), polysorbate 20 (E432), sodium acetate trihydrate (E262), sucrose (E473), water for injections (see "Talvey contains sodium" in section 2).

Appearance of Talvey and contents of the pack

Talvey is a liquid, injectable solution ranging from colourless to pale yellow.

Talvey is supplied in a cardboard 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
The Netherlands

Janssen Pharmaceutica NV
Turnhoutseweg 30
B-2340 Beerse
Belgium

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

Date of the most recent review of this leaflet:

This medicinal product has been authorised under a "conditional approval". This type of approval means that further information on this medicinal product is expected.

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

Other sources of information

Detailed information on this medicinal product is available on the European Medicines Agency website: https://www.ema.europa.eu/

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

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This information is intended for healthcare professionals only:

TALVEY vials are supplied as a ready-to-use injectable solution that does not require dilution prior to administration.

Talvey vials of different concentrations must not be combined to achieve the treatment dose.

An aseptic technique must be used when preparing and administering Talvey.

Preparation of Talvey

• Refer to the reference tables below for the preparation of Talvey.

• Use Table 1 to determine the total dose, injection volume, and number of vials required based on the patient's current body weight for the 0.01 mg/kg dose using the Talvey 2 mg/ml vial.

Table 1: 0.01 mg/kg dose: injection volumes with the Talvey 2 mg/ml vial

ª The total dose (mg) is calculated based on the rounded injection volume (ml).

• Use Table 2 to determine the total dose, injection volume, and number of vials required according to the patient's current body weight for the 0.06 mg/kg dose using the Talvey 2 mg/ml vial.

Table 2: 0.06 mg/kg dose: injection volumes with the Talvey 2 mg/ml vial

ª The total dose (mg) is calculated based on the rounded injection volume (ml).

• Use Table 3 to determine the total dose, injection volume, and number of vials required according to the patient's current body weight for the 0.4 mg/kg dose using the Talvey 40 mg/ml vial.

Table 3: 0.4 mg/kg dose: injection volumes with the Talvey 40 mg/ml vial

ª The total dose (mg) is calculated based on the rounded injection volume (ml).

• Use Table 4 to determine the total dose, injection volume, and number of vials required according to the patient's current body weight for a dose of 0.8 mg/kg using the Talvey 40 mg/ml vial.

Table 4: Dose of 0.8 mg/kg: Injection volumes with the Talvey 40 mg/ml vial

ª The total dose (mg) is calculated based on the rounded injection volume (ml).

• Check that the Talvey injectable solution is colorless to pale yellow. Do not use if the solution is discolored, cloudy, or contains foreign particles.

• Remove the Talvey vial of the appropriate concentration from refrigerated storage (2 °C to 8 °C) and allow it to equilibrate to room temperature (15 °C to 30 °C) for at least 15 minutes. Do not heat the Talvey vial by any other method.

• Once equilibrated, gently swirl the vial for approximately 10 seconds to mix. Do not shake.

• Withdraw the required injection volume of Talvey from the vial(s) into a syringe of suitable size using a transfer needle.

• Each injection volume must not exceed 2.0 ml. For doses requiring more than 2.0 ml, divide the dose equally into multiple syringes.

• Talvey is compatible with stainless steel injection needles and syringes made of polypropylene or polycarbonate material.

• Replace the transfer needle with an appropriately sized needle for injection.

Administration of Talvey

• Talvey must be administered by subcutaneous injection.
• Talvey should be administered by a healthcare professional with appropriately trained medical personnel and appropriate medical equipment available to manage severe reactions, including SCLS.
• Inject the required volume of Talvey into the subcutaneous tissue of the abdomen (preferred injection site). Alternatively, Talvey may be injected into the subcutaneous tissue at other sites (e.g., the thigh). If multiple injections are required, Talvey injection sites should be separated by at least 2 cm.
• Do not inject into tattoos or scars or in areas where the skin is red, bruised, tender, hard, or not intact.
• Disposal of unused medicinal product and all materials that have come into contact with it must be carried out in accordance with local regulations.