Talvey

Package leaflet: Information for the patient

TALVEY 2 mg/mL injection solution, 40 mg/mL injection solution

talquetamab

This medicinal product is under additional monitoring. This will allow for rapid identification of
new safety information. You can help by reporting any side effects you experience while taking
this medicinal product. See the end of section 4 for information on how to report side effects.
Please read this leaflet carefully before taking this medicine as 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 get any side effects, including those not listed in this leaflet, contact your doctor or nurse. See section 4.

Contents of this leaflet

1. What TALVEY is and what it is used for
2. What you need to know before taking TALVEY
3. How to take 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 antitumor medicinal product containing the active substance talquetamab.
Talquetamab is an antibody, a type of protein that recognises and binds to specific targets in the body.
It has been designed to bind to the protein GPRC5D (G protein-coupled receptor class C group 5 member D), present on tumour cells in multiple myeloma, and to cluster of differentiation (CD3), a protein on T cells (a type of white blood cell). T cells are part of the body's immune system and help protect it from infections. They can also destroy tumour cells. When this medicine binds to these cells, it links the tumour cells and T cells together. This enables the T cells to destroy the multiple myeloma tumour cells.
TALVEY is used for the treatment of adults with a bone marrow cancer called multiple myeloma.
It is used in patients who have received at least three prior treatments that either did not work or have stopped working.

2. What you should know before taking TALVEY

Do not take TALVEY

• if you are allergic to talquetamab or to 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, consult your doctor or nurse before being administered TALVEY.
Warnings and precautions
Talk to your doctor or nurse before taking TALVEY.
Severe adverse reactions.
After starting treatment with TALVEY, severe adverse reactions may occur. If you experience any of these, inform your doctor or nurse immediately, as emergency medical treatment may be required.
Inform your doctor or nurse immediately if you develop any of the following conditions:

• signs of a condition known as “cytokine release syndrome” (CRS): CRS is a serious immune reaction with 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 confusion, disorientation, drowsiness, feeling less alert, slowed or impaired thinking, altered thought processes, or decreased level of consciousness, confusion, difficulty speaking or understanding language. Some of these may be signs of a serious immune reaction known as “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, rashes, and nail problems
• feeling hot, fever, chills or shaking, sore throat, or mouth ulcers may be signs of an infection.

TALVEY and vaccines
Talk to your doctor or nurse before taking TALVEY if you have recently received or are due to receive a vaccination. Your immune system (the body's natural defenses) may not respond effectively to vaccinations while you are taking this medicine.
You must not receive live vaccines, a specific type of vaccine, at least four weeks before starting treatment with TALVEY and for at least four weeks after the last dose of TALVEY treatment.
Tests and monitoring
Before administration of TALVEY, your doctor will check your blood count to assess the number of blood cells and to check for signs of infection. Any infections will be treated before TALVEY is administered.
After administration of TALVEY, your doctor will monitor you for any adverse reactions. Your blood count will also be checked regularly, as the number of blood cells and other blood components may decrease.
Children and adolescents
TALVEY must not be given to children or adolescents under 18 years of age, as the effects of the medicine in this age group are unknown, and it is not known how this medicine might affect them.
Other medicines and TALVEY
Inform your doctor or nurse if you are taking, have recently taken, or might take any other medicines, including medicines not requiring a prescription and herbal preparations.
Pregnancy, contraception, and breastfeeding
Pregnancy and contraception
TALVEY may 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 ruled out.
If you are pregnant, suspect you may be pregnant, or are planning a pregnancy, consult your doctor or nurse before being administered this medicine.
If you become pregnant during treatment with this medicine, inform your doctor or nurse immediately.
If you are of childbearing potential, 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 take the medicine during pregnancy, live vaccinations of the newborns must be postponed until the infant is at least four weeks old.
Breastfeeding
It is not known whether TALVEY passes into breast milk. A risk to newborns/infants cannot be ruled out.
Consult your doctor before being administered this medicine. You and your doctor will decide whether the benefit of breastfeeding outweighs the risk to the infant. If you and your doctor decide to stop taking the medicine, you must not breastfeed for 3 months after stopping treatment.
Fertility
There are no data on the effect of talquetamab on fertility. No animal studies have been conducted to evaluate the effects of talquetamab on male or female fertility.
Driving and using machines
Some people may experience fatigue, dizziness, or confusion during treatment with TALVEY. Do not drive, operate tools, or machinery for at least 48 hours after the first dose of TALVEY treatment, or as directed by your doctor.
TALVEY contains sodium
TALVEY contains less than 1 mmol (23 mg) of sodium per dose, i.e., essentially “sodium-free”.

3. How to take TALVEY

Dose administered
TALVEY will be administered to you under the supervision of a physician experienced in the treatment of patients with multiple myeloma. Your doctor will calculate the dose of TALVEY and decide the amount to be administered. The dose of TALVEY is based on body weight.
TALVEY is administered once a week or once every 2 weeks, depending on the dose, as follows:
0.4 mg/kg once a week

• For your first dose, you will receive 0.01 mg per kilogram of body weight.
• For your second dose, administered 2 to 4 days after the first dose, you will receive 0.06 mg per kilogram of body weight.
• For your third dose, administered 2 to 4 days after the second dose, you will receive a treatment dose of 0.4 mg per kilogram of body weight.
• After the third dose, you will continue to receive a treatment dose once a week.
• Treatment will continue as long as you benefit from taking TALVEY.

Your doctor will monitor you for any adverse effects after the first three doses. These checks will be repeated for 2 days after each dose. You must remain close to a healthcare facility after each of the first three doses in case you develop adverse effects.
If adverse effects occur after one of the first two doses, your doctor may decide to delay resuming treatment with the next dose by up to 7 days.
0.8 mg/kg once every 2 weeks

• For your first dose, you will receive 0.01 mg per kilogram of body weight.
• For your second dose, administered 2 to 4 days after the first dose, you will receive 0.06 mg per kilogram of body weight.
• For your third dose, administered 2 to 4 days after the second dose, you will receive 0.4 mg per kilogram of body weight.
• For your fourth dose, administered 2 to 4 days after the third dose, you will receive a treatment dose of 0.8 mg per kilogram of body weight.
• After the fourth dose, you will continue to receive a treatment dose once every 2 weeks.
• Treatment will continue as long as you benefit from taking TALVEY.

Your doctor will monitor you for any adverse effects after the first four doses. These checks will be repeated for 2 days after each dose. You must remain close to a healthcare facility after each of the first four doses in case you develop adverse effects.
If adverse effects occur after one of the first three doses, your doctor may decide to delay resuming treatment with the next dose by up to 7 days.
The decision to use 0.4 mg/kg once a week or 0.8 mg/kg every 2 weeks must be made in agreement with your doctor.
How the medicine is administered
TALVEY will be administered to you by a doctor or nurse via an injection under the skin (subcutaneous injection). The injection will be given in the abdominal area (abdomen) or in the thigh.
Medicines administered during treatment with TALVEY
Before the first three doses (if receiving 0.4 mg/kg body weight) or the first four doses (if receiving 0.8 mg/kg body weight) of TALVEY, you will be given medicines to help reduce the risk of adverse effects. These medicines may include:

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

These medicines may also be administered before subsequent doses of TALVEY, depending on any symptoms you may develop.
You may also receive other medicines, depending on any symptoms you develop or your medical history.
If you take more TALVEY than you should
This medicine will be administered to you by a doctor or nurse. In the event that you receive an excessive amount (overdose), your doctor will monitor you for any adverse effects.
If you miss an appointment for TALVEY administration
It is very important to attend all appointments for the treatment to work. 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 may 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 can affect the nervous system. Some of the symptoms are: confusion or decreased ability to pay attention or concentrate, disorientation, drowsiness, low energy, slowness, and difficulty thinking
• Cytokine release syndrome (CRS), a serious immune reaction that may cause symptoms such as: fever, low blood pressure, chills, low oxygen levels in the blood, headache, rapid heartbeat, increased liver enzymes in the blood
• Low neutrophil levels (neutropenia), a type of white blood cell that helps fight infections
• Low platelet levels in the blood (thrombocytopenia), which may impair blood clotting

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

Other side effects
The following are other side effects. Inform your doctor or nurse if you experience any of these.

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

• Nail problems
• Muscle and bone pain (musculoskeletal pain)
• Low red blood cell levels (anaemia)
• Feeling tired
• Chills
• Weight loss
• Dry skin or mucous membranes, such as dry mouth and dry eyes (xerosis)
• Low lymphocyte levels (lymphopenia), a type of white blood cell
• Problems with movement control or production (motor dysfunction)
• Dizziness
• Nerve damage that may cause tingling, numbness, pain, or loss of pain sensation (sensory neuropathy)
• Damage or diseases affecting brain function (encephalopathy)
• Diarrhoea
• Nausea
• Constipation
• Stomach ache
• Vomiting
• Infection of the nose, sinuses, or throat (upper respiratory tract infection)
• Itching
• Loss of appetite
• Pain
• Low white blood cell levels (leucopenia)
• Low potassium levels in the blood (hypokalaemia)
• Low phosphate levels in the blood (hypophosphataemia)
• Low magnesium levels in the blood (hypomagnesaemia)
• Low levels of immunoglobulins, a type of antibody in the blood (hypogammaglobulinaemia), which may increase susceptibility to infections
• Swelling due to fluid accumulation in the body (oedema)
• Irritation or pain at the injection site
• Increased liver enzyme levels in the blood
• COVID-19
• Prolonged blood clotting time shown in blood tests (increased fibrinogen, increased INR, prolonged PTT)
• Bacterial infections
• Mouth pain
• Fungal infection
• Fever (pyrexia)
• Headache
• Shortness of breath (dyspnoea)
• Cough
• Mouth and swallowing problems, such as altered taste (dysgeusia), dry mouth, difficulty swallowing (dysphagia), and inflammation of the oral mucosa (stomatitis)
• Skin problems, such as rash

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

• Hair loss
• Bleeding, which may be severe (haemorrhage)
• Lung infection (pneumonia)
• Viral infection
• Blood infection (sepsis)
• Low levels of a type of white blood cell (neutrophils), with fever
• Redness, swelling, tingling or burning sensation with skin cracking on the palms of the hands and/or soles of the feet (hand-foot syndrome)

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

• Inability to coordinate muscle movements

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, tell 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 TALVEY

Talvey will be stored at the hospital or clinic by the physician. The information below is intended primarily for healthcare professionals.
This medicinal product should be kept out of the sight and reach of children.
Do not use this medicinal product after the expiry date 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 medicinal product from light.
Before using the medicinal product, check whether the solution contains particles or changes in colour. The solution should be colourless to pale yellow. Do not use this medicinal product if you notice that it is cloudy, has changed colour, or contains visible particles.
Medicinal products must not be disposed of via wastewater or household waste. Ask your healthcare professional how to dispose of medicines no longer used. This will help protect the environment.

6. Package contents and other information

What TALVEY contains

• The active substance is talquetamab. TALVEY is available in two different concentrations: either 2 mg/mL – a 1.5 mL vial contains 3 mg of talquetamab, or 40 mg/mL – a 1 mL vial contains 40 mg of talquetamab.
• The other ingredients are disodium EDTA 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).

Description of the appearance of TALVEY and contents of the pack
TALVEY is an injectable solution (injectable) and is a colourless to pale yellow liquid.
TALVEY 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 ehf. 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
UAB “JOHNSON & JOHNSON” filiāle Latvijā
Tel: +371 678 93561
[email protected]

This medicinal product has been granted a marketing authorisation “under conditional approval”. 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 website of the European Medicines Agency: https://www.ema.europa.eu.
This leaflet is available in all languages of the European Union/European Economic Area on the website of the European Medicines Agency.

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The following 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 for the preparation and administration of TALVEY.

Preparation of TALVEY

• Follow the reference tables below for the preparation of TALVEY:

  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 the 0.01 mg/kg dose using the TALVEY 2 mg/mL vial.
  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 the 0.06 mg/kg dose using the TALVEY 2 mg/mL vial.
  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 0.4 mg/kg dose using the TALVEY 40 mg/mL vial.
  o Use Table 4 to determine the total dose, injection volume, and number of vials required based on the patient’s actual body weight for the 0.8 mg/kg dose using the TALVEY 40 mg/mL vial.

• Check that TALVEY injectable solution is from colourless to pale yellow. Do not use the solution if it appears discoloured, cloudy, or contains foreign particles.
• Remove the vial of the appropriate concentration of TALVEY 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 TALVEY by any other method.
• Once room temperature has been reached, gently rotate the vial for approximately 10 seconds to mix. Do not shake.
• Draw the required injection volume of TALVEY from the vial(s) into a syringe of appropriate size 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 parts in separate syringes.
• TALVEY is compatible with stainless steel injection needles and syringes made of polypropylene or polycarbonate.
• Replace the transfer needle with an injection needle of appropriate size.

Administration of TALVEY

• TALVEY must be administered exclusively by subcutaneous injection.
• TALVEY must be administered by a healthcare professional in a healthcare setting equipped with appropriately trained medical personnel and appropriate medical equipment to manage severe reactions, including cytokine release syndrome (CRS).
• 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 of other areas (e.g., thigh). If multiple injections are required, TALVEY injection sites must be at least 2 cm apart.
• Do not inject into areas with tattoos or scars, or where the skin is red, bruised, painful, hard, or not intact.
• Any unused medicinal product and waste material derived from this medicinal product must be disposed of in accordance with local regulations.