TALVEY 2 мг/мл Инъекционный раствор

Содержание инструкции

1. TALVEY 2 mg/mL injectable solution, 40 mg/mL injectable solution
   1. What is TALVEY and what is it used for
   2. What you need to know before you take TALVEY
   3. How to take TALVEY
   4. Possible side effects
   5. How to store TALVEY
   6. Contents of the pack and other information

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

talquetamab

Medicinal product subject to additional monitoring. This will allow the rapid identification of
new safety information. You can contribute by reporting any adverse effects
experienced during the use of this medicine. See the end of section 4 for
information on how to report adverse effects.

Read this leaflet carefully before you start to take 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, see your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of this leaflet

• 1. What TALVEY is and what it is used for
• 2. What you need to know before you take 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 is TALVEY and what is it used for

TALVEY is an antitumoural medicine that contains 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 GPRC5D protein (G protein-coupled receptor family C group 5 member D), present on myeloma multiple tumour cells, and to the
cluster of differentiation (CD3), a protein of 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 hooks the tumour cells and T cells together. This allows the T cells to destroy the
myeloma multiple tumour cells.
TALVEY is used for the treatment of adults with a bone marrow cancer called myeloma
multiple.
It is used in patients who have received at least three previous treatments that have not
worked or have stopped working.

2. What you need to know before you take 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 not sure, ask your doctor or nurse
before you are given TALVEY.

Warnings and precautions
Talk to your doctor or nurse before taking TALVEY.
Serious side effects.
Serious side effects can occur after starting treatment with TALVEY. If any
of these effects occur, you must inform your doctor or nurse immediately, as urgent
medical care may be needed.

Tell your doctor or nurse immediately if you experience 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 unfocused, slowness or difficulty thinking, altered thinking or decreased level of consciousness, confusion, difficulty speaking and understanding language. Some of these may be signs of a serious immune reaction known as “immune effector cell-associated neurotoxicity syndrome” (ICANS)
• problems with the mouth, such as loss of taste, dry mouth, difficulty swallowing and inflammation of the lining of the mouth
• skin problems, redness and nail problems
• feeling of heat, fever, chills or shaking, sore throat or mouth sores may be signs of an infection.

TALVEY and vaccines
Talk to your doctor or nurse before taking TALVEY if you have recently received a
vaccination or are about to receive a vaccination. The immune system (the body’s natural
defenses) may not respond effectively to vaccinations while you are taking
this medicine.
You should 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 treatment
with TALVEY.
Tests and checks

BeforeTALVEY is given, your doctor will check your blood count to
check the number of blood cells and to check for signs of infection. Infections
will be treated before TALVEY is given.

AfterTALVEY is given, your doctor will monitor for any side
effects. Your blood count will also be checked regularly, as the number of blood
cells and other components of the blood may decrease.

Children and adolescents
TALVEY should not be given to children or adolescents under 18 years of age, because the
effects of the medicine in this age group are not known, and it is not known how this medicine may
affect them.

Other medicines and TALVEY
Tell your doctor or nurse if you are taking, have recently taken or might take
any other medicines, including medicines you buy without a prescription and herbal remedies.

Pregnancy, contraception and breastfeeding
Pregnancy and contraception
TALVEY can be passed from the mother to the developing baby. The effects of TALVEY on the developing baby
are not known and a risk to newborns/infants cannot be excluded.
If you are pregnant, suspect you are pregnant or are planning to become pregnant, ask your doctor
or nurse for advice before you are given this medicine.
If you become pregnant during treatment with this medicine, tell your doctor or nurse immediately.
If you are of childbearing potential, you must use effective contraception during treatment and for 3 months
after stopping treatment with TALVEY. Your doctor will check if you are pregnant before
starting treatment.
If your partner becomes pregnant while you are taking this medicine, tell your doctor immediately.
If you take the medicine during pregnancy, vaccinations of newborns with live vaccines should
be postponed until the baby is four weeks old.
Breastfeeding
It is not known whether TALVEY passes into breast milk. A risk to newborns/infants cannot be excluded.
Talk to your doctor before you are given this medicine. You and your doctor will decide
whether the benefit of breastfeeding is greater than the risk to the baby. If you and your doctor
decide to stop taking the medicine, you should not breastfeed for 3 months after stopping
treatment.
Fertility
There are no data on the effect of talquetamab on fertility. No studies have been conducted in
animals to evaluate the effects of talquetamab on male and female fertility.

Driving and using machines
Some people may experience fatigue, dizziness or confusion during treatment
with TALVEY. Do not drive, use tools or machines for at least 48 hours after the first dose of
treatment with TALVEY or as directed by your doctor.

TALVEY contains sodium
TALVEY contains less than 1 mmol (23 mg) of sodium per dose, that is to say essentially “sodium-free”.

3. How to take TALVEY

Dose administered
TALVEY will be administered under the supervision of a doctor experienced in the treatment of patients
with multiple myeloma. The dose of TALVEY will be calculated by the doctor who will decide the amount
to administer. The dose of TALVEY depends 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

• As the first dose, you will receive 0.01 mg per each kilogram of body weight.
• As the second dose, which will be administered 2 to 4 days after the first dose, you will receive 0.06 mg per kilogram of body weight.
• As the third dose, you will receive a treatment dose of 0.4 mg per kilogram of body weight 2 to 4 days after the second dose.
• 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.

The doctor will monitor you for any side effects after the first three doses. These checks
will be repeated for 2 days after each dose. You should remain close to a healthcare facility after
each of the first three doses, should you develop side effects.
If side effects occur after one of the first two doses, the doctor may decide to postpone
resumption of treatment with the next dose by up to 7 days.
0.8 mg/kg once every 2 weeks

• As the first dose, you will receive 0.01 mg per each kilogram of body weight.
• As the second dose, which will be administered 2 to 4 days after the first dose, you will receive 0.06 mg per kilogram of body weight.
• As the third dose, which will be administered 2 to 4 days after the second dose, you will receive 0.4 mg per kilogram of body weight.
• As the fourth dose, you will receive a treatment dose of 0.8 mg per kilogram of body weight 2 to 4 days after the third dose.
• 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.

The doctor will monitor you for any side effects after the first four doses. These
checks will be repeated for 2 days after each dose. You should remain close to a healthcare
facility after each of the first four doses, should you develop side effects.
If side effects occur after one of the first three doses, the doctor may decide to postpone
resumption of 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 two weeks
must be made in agreement with the doctor.

How the medicine is administered
TALVEY will be administered by a doctor or nurse by an injection under the skin
(a “subcutaneous” injection). The injection will be given in the area of the stomach (abdomen) or in the thigh.

Medicines administered during treatment with TALVEY
Before the first three doses (if you receive 0.4 mg/kg of body weight) or the first four doses (if
you receive 0.8 mg/kg of body weight) of TALVEY, you will be given medicines that help
to reduce the possibility of side 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, based on
any symptoms you develop.
You may also receive other medicines, based on any symptoms you develop or your medical history.

If you take more TALVEY than you should
This medicine will be administered by a doctor or nurse. In the event that you
are given an excessive amount (overdose), the doctor will monitor you for
any side 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 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 immediate medical attention if you develop any of the following serious side effects
which may be severe and potentially life-threatening.

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

• immune effector cell-associated neurotoxicity syndrome (ICANS), a severe immune reaction that can affect the nervous system. Some of the symptoms are: o feeling of confusion o decreased ability to pay attention or concentrate o feeling disoriented o feeling sleepy o lack of energy o slowness and difficulty thinking
• cytokine release syndrome (CRS), a severe immune reaction that can cause symptoms such as: o fever o low blood pressure o chills o low oxygen levels in the blood o headache o fast heartbeat o increased levels of liver enzymes in the blood
• low levels of neutrophils (neutropenia), a type of white blood cells that help fight infections
• low levels of platelets in the blood (thrombocytopenia), which help the blood to clot.

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

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

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

• nail problems
• muscle and bone pain (musculoskeletal pain)
• low levels of red blood cells (anemia)
• feeling tired
• chills
• weight loss
• very dry skin or mucous membranes, such as mouth and eyes (xerosis)
• low levels of lymphocytes (lymphopenia), a type of white blood cells
• problem in producing or controlling movement (motor dysfunction)
• dizziness
• nerve damage that can cause tingling, numbness, pain or loss of sensation to pain (sensory neuropathy)
• brain damage or disease that alters brain function (encephalopathy)
• diarrhea
• nausea
• constipation
• stomach pain
• vomiting
• infection of the nose, sinuses or throat (upper respiratory tract infection)
• itching
• decreased appetite
• pain
• low levels of white blood cells (leukopenia)
• low levels of potassium in the blood (hypokalaemia)
• low levels of phosphate in the blood (hypophosphataemia)
• low levels of magnesium in the blood (hypomagnesaemia)
• low levels of immunoglobulins, a type of antibodies in the blood (hypogammaglobulinaemia), which can make you more vulnerable to infections
• swelling caused by fluid buildup in the body (edema)
• irritation or pain at the injection site
• increased levels of liver enzymes in the blood
• COVID-19
• longer blood clotting time resulting from blood tests (increased fibrinogen, increased INR and prolonged PTT)
• bacterial infections
• mouth pain
• fungal infection
• fever (pyrexia)
• headache
• shortness of breath (dyspnea)
• cough
• problems with the mouth and swallowing, such as altered taste (dysgeusia), dry mouth, difficulty swallowing (dysphagia) and inflammation of the mouth lining (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 number of a type of white blood cells (neutrophils), with fever
• redness, swelling, tingling or burning with cracking skin 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 get any side effects, talk to your doctor or nurse. This includes any side effects not listed
in this leaflet. 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 doctor. The information below is
intended primarily for healthcare professionals.
This medicine must be kept 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 refers to the last day of that month.
Store in a refrigerator (2 °C – 8 °C). Do not freeze.
Store in the original package to protect the medicine from light.
Before using the medicine, check if the solution contains particles or colour changes. The
solution should be from colourless to light yellow. Do not use this medicine if you notice that the medicine
is cloudy, has changed colour or contains visible particles.
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. Contents of the pack and other information

What TALVEY contains

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

Description of TALVEY and contents of the pack
TALVEY is an injectable solution (injectable) and is a liquid from colourless to pale yellow.
TALVEY is supplied in a carton 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
Netherlands
Janssen Pharmaceutica NV
Turnhoutseweg 30
B-2340 Beerse
Belgium
For further information on this medicine, contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien
Janssen-Cilag NV
Tel/Tél : +32 14 64 94 11
[email protected]

Lietuva
UAB “JOHNSON & JOHNSON”
Tel: +370 5 278 68 88
[email protected]

България
„Джонсън & Джонсън България” ЕООД
Тел.: +359 2 489 94 00
[email protected]

Luxembourg/Luxemburg
Janssen-Cilag NV
Tél/Tel: +32 14 64 94 11
[email protected]

Česká republika
Janssen-Cilag s.r.o.
Tel: +420 227 012 227

Magyarország
Janssen-Cilag Kft.
Tel.: +36 1 884 2858
[email protected]

Danmark
Janssen-Cilag A/S
Tlf.: +45 4594 8282
[email protected]

Malta
AM MANGION LTD
Tel: +356 2397 6000

Deutschland
Janssen-Cilag GmbH
Tel: 0800 086 9247 / +49 2137 955 6955
[email protected]

Nederland
Janssen-Cilag B.V.
Tel: +31 76 711 1111
[email protected]

Eesti
UAB “JOHNSON & JOHNSON” Eesti filiaal
Tel: +372 617 7410
[email protected]

Norge
Janssen-Cilag AS
Tlf: +47 24 12 65 00
[email protected]

Ελλάδα
Janssen-Cilag Φαρμακευτική Μονοπρόσωπη
Α.Ε.Β.Ε.
Tηλ: +30 210 80 90 000

Österreich
Janssen-Cilag Pharma GmbH
Tel: +43 1 610 300

España
Janssen-Cilag, S.A.
Tel: +34 91 722 81 00
[email protected]

Polska
Janssen-Cilag Polska Sp. z o.o.
Tel.: +48 22 237 60 00

France
Janssen-Cilag
Tél: 0 800 25 50 75 / +33 1 55 00 40 03
[email protected]

Portugal
Janssen-Cilag Farmacêutica, Lda.
Tel: +351 214 368 600

Hrvatska
Johnson & Johnson S.E. d.o.o.
Tel: +385 1 6610 700
[email protected]

România
Johnson & Johnson România SRL
Tel: +40 21 207 1800

Ireland
Janssen Sciences Ireland UC
Tel: 1 800 709 122
[email protected]

Slovenija
Johnson & Johnson d.o.o.
Tel: +386 1 401 18 00
[email protected]

Ísland
Janssen-Cilag AB
c/o Vistor ehf.
Sími: +354 535 7000
[email protected]

Slovenská republika
Johnson & Johnson, s.r.o.
Tel: +421 232 408 400

Italia
Janssen-Cilag SpA
Tel: 800 688 777/+39 02 2510 1
[email protected]

Suomi/Finland
Janssen-Cilag Oy
Puh/Tel: +358 207 531 300
[email protected]

Κύπρος
Βαρνάβας Χατζηπαναγής Λτδ
Τηλ: +357 22 207 700

Sverige
Janssen-Cilag AB
Tfn: +46 8 626 50 00
[email protected]

Latvija
UAB “JOHNSON & JOHNSON” filiāle Latvijā
Tel: +371 678 93561
[email protected]
A marketing authorisation under exceptional circumstances has been granted for this medicinal product. This means that further data on this medicinal product are being collected.
The European Medicines Agency will review the new information at least annually on this

Other sources of information
Detailed information on this medicine is available on the European Medicines Agency website: https://www.ema.europa.eu.
This leaflet is available in all European Union/European Economic Area languages on the
European Medicines Agency website.
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The following information is intended only for healthcare professionals:
Vials of TALVEY are supplied as a ready-to-use injectable solution that does not require
dilution before administration.
Vials of TALVEY of different concentrations must not be combined to obtain the treatment
dose.
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 a dose of
0.01 mg/kg using the 2 mg/mL TALVEY 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 a dose of
0.06 mg/kg using the 2 mg/mL TALVEY 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 a dose of
0.4 mg/kg using the 40 mg/mL TALVEY 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 a dose of
0.8 mg/kg using the 40 mg/mL TALVEY vial.

• Check that TALVEY injectable solution is from colourless to pale yellow. Do not use the solution if it appears discoloured, cloudy or if it 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 in any other way.
• Once room temperature is reached, gently rotate the vial for about 10 seconds to mix. Do not shake.
• Withdraw the required volume for the TALVEY injection from the vial(s) into an appropriately sized syringe using a transfer needle. o 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 polypropylene or polycarbonate syringes.
• Replace the transfer needle with an appropriately sized injection needle.

Administration of TALVEY

• TALVEY must only be administered by subcutaneous injection.
• TALVEY must be administered by a healthcare professional, in a facility equipped with adequately 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 can be injected into the subcutaneous tissue of other areas (e.g., the thigh). If multiple injections are necessary, the injection sites of TALVEY must be at least 2 cm apart.
• Do not inject into areas with tattoos or scars or where the skin is reddened, bruised, painful, hardened or not intact.
• Unused medicine and waste materials from this medicine must be disposed of in accordance with local regulations.