ELREXFIO 40 mg /Ml Injectable Solution

Зміст інструкції

1. ELREXFIO 40 mg/mL injectable solution
   1. What is ELREXFIO and what is it used for
   2. What you need to know before you receive ELREXFIO
   3. How ELREXFIO is administered
   4. Possible side effects
   5. How to store ELREXFIO
   6. Package Contents and Other Information

ELREXFIO 40 mg/mL injectable solution

elranatamab

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 receive 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 experience any side effects, including those not listed in this leaflet, tell your doctor or nurse. See section 4.

Contents of this leaflet

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

1. What is ELREXFIO and what is it used for

ELREXFIO is an antitumoural medicine that contains the active substance elranatamab. It is used for the
treatment of adults affected by a type of bone marrow cancer called multiple myeloma.
It is used as monotherapy for patients whose cancer has returned (relapsed) and who have no longer
responded to previous treatments (refractory), who have received at least three other types of treatment and whose
cancer has worsened after receiving the last treatment.

How ELREXFIO works
ELREXFIO is an antibody, a type of protein designed to recognise and bind to specific targets
in your body. ELREXFIO targets the B-cell maturation antigen (BCMA), which
is found on myeloma multiple cancer cells, as well as cluster of differentiation 3 (CD3), which
is found on T lymphocytes, a particular type of white blood cells in the immune system. This
medicine works by binding to these targets and, in doing so, brings together cancer cells and T cells.
This helps the immune system to destroy the myeloma multiple cancer cells.

2. What you need to know before you receive ELREXFIO

ELREXFIO must not be administered
If you are allergic to elranatamab or any of the other ingredients of this medicine (listed in
section 6).
If you are not sure if you are allergic, ask your doctor or nurse before receiving ELREXFIO.

Warnings and precautions
Before receiving ELREXFIO, tell your doctor or nurse about all of your medical conditions,
even if you have had recent infections.

Pay attention to serious side effects.
Tell your doctor or nurse immediately if any of the following occur:

• Signs of a condition known as “cytokine release syndrome” (CRS). CRS is a serious immune reaction with symptoms such as fever, difficulty breathing, chills, headache, low blood pressure, rapid heartbeat, dizziness and increased levels of liver enzymes in the blood.
• Effects on the nervous system. Symptoms include feeling confused, less alert or having difficulty speaking or writing. Some of these may be signs of a serious immune reaction called “immune effector cell-associated neurotoxicity syndrome” (ICANS).
• Signs and symptoms of an infection such as fever, chills, fatigue or difficulty breathing.

Tell your doctor or nurse if you notice any of the above signs.

ELREXFIO and vaccines
Ask your doctor or nurse before receiving ELREXFIO if you have recently received a
vaccination or are about to receive a vaccination.
You should not receive vaccinations with live virus vaccines within four weeks before
the first dose of ELREXFIO and during treatment with ELREXFIO and at least four weeks
after it has been stopped.

Tests and checks
Before receiving ELREXFIO, your doctor will perform blood tests to rule out the presence
of signs of infection. If you have any infection, it will be treated before starting therapy with
ELREXFIO. Your doctor will also check if you are pregnant or breastfeeding.

During treatment with ELREXFIO, your doctor will monitor you to rule out the presence of
side effects. Your doctor will monitor you for signs and symptoms of CRS and
ICANS within 48 hours of each of the first two doses of Elrexfio. Your doctor will also perform
blood tests regularly, as the number of cells and other components of the blood
may decrease.

Children and adolescents
ELREXFIO is not indicated for children or adolescents under 18 years of age, as the effect of the medicine in this age group is not known.

Other medicines and ELREXFIO
Tell your doctor or nurse if you are taking, have recently taken or might take
any other medicines (e.g., cyclosporine, phenytoin, sirolimus and warfarin), including medicines
you can buy without a prescription and herbal medicines.

Pregnancy and breastfeeding
It is not known whether ELREXFIO has effects on the unborn child or is excreted in breast milk.
Pregnancy - information for women
ELREXFIO is not recommended during pregnancy.
If you are pregnant or suspect you are pregnant or are planning to become pregnant, tell your doctor or
nurse before receiving ELREXFIO.
If you are a woman of childbearing potential, your doctor should perform a pregnancy test before starting
treatment.
If you become pregnant during treatment with this medicine, tell your doctor or
nurse immediately.
Contraception
If you are a woman of childbearing potential, you must use effective contraception during treatment and for
6 months after stopping treatment with ELREXFIO.
Breastfeeding
You must not breastfeed during treatment and for 6 months after stopping
treatment with ELREXFIO.

Driving and using machines
During treatment with ELREXFIO, some people may feel tired, dizzy or
confused. Do not drive vehicles, use tools or operate machinery for at least 48 hours after each
of the 2 incremental doses and until the symptoms improve or as directed by the healthcare
provider.

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

3. How ELREXFIO is administered

Dose administered
You will receive ELREXFIO under the supervision of a healthcare professional experienced in the treatment of
cancer. The recommended dose of ELREXFIO solution for subcutaneous injection is 76 mg, but the
first two doses will be lower.
ELREXFIO is administered as follows:

• You will receive a first incremental dose of 12 mg on Day 1 of Week 1.
• You will then receive a second incremental dose of 32 mg on Day 4 of Week 1.
• From Week 2 to Week 24 (Day 1), you will receive a full dose of 76 mg once a week, as long as you continue to benefit from ELREXFIO.
• From Week 25 to Week 48 (Day 1), your doctor may change your treatment from once a week to once every two weeks, as long as the cancer responds to treatment with ELREXFIO.
• From Week 49 (Day 1) onwards, your doctor may change the treatment from once every two weeks to once every four weeks, as long as the cancer continues to respond to treatment with ELREXFIO.

You must remain near a healthcare facility for 48 hours after each of the first two
incremental doses in case of adverse reactions. Your doctor will monitor you to rule out
adverse reactions for 48 hours after each of the first two doses.

How the medicine is administered
ELREXFIO will always be administered to you by your doctor or nurse via an injection under the
skin (subcutaneous). It is administered in the abdominal area or thigh.
A reaction may occur at the injection site, which may include
skin redness, pain, swelling, bruising, rash, itching, or bleeding. These are generally mild effects that resolve on their own without the need for any additional treatment
.

Other medicines administered during treatment with ELREXFIO
You will be given medicines one hour before each of the first three doses of ELREXFIO.
These reduce the possibility of adverse reactions, such as cytokine release syndrome (see section 4). These medicines may include:

• medicines to reduce the risk of fever (such as paracetamol);
• medicines to reduce the risk of inflammation (corticosteroids);
• medicines to reduce the risk of an allergic reaction (antihistamines such as diphenhydramine).

These medicines may also be given for subsequent doses of ELREXFIO based on
any symptoms you experience after taking ELREXFIO.
You may also receive additional medicines based on any symptoms you experience or your
medical history.

If you receive more ELREXFIO than you should
This medicine will be administered by your doctor or nurse. In the unlikely event that
you are given an excessive amount (overdose), your doctor will monitor you to rule out
adverse reactions.

If you miss your appointment to receive ELREXFIO
To ensure that the treatment works, it is very important to attend all appointments. 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 everyone will experience them.

Serious side effects
Seek immediate medical attention if you experience any of the following serious side effects, which may be severe and life-threatening.

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

• cytokine release syndrome, a severe immune reaction that can cause fever, difficulty breathing, chills, dizziness or mild confusion, rapid heartbeat, increased liver enzymes in the blood;
• low levels of neutrophils (a type of white blood cells that fight infections; neutropenia);
• low levels of antibodies called “immunoglobulins” in the blood (hypogammaglobulinemia), which can increase the likelihood of contracting infections;
• infection, which may include fever, chills, fatigue, or shortness of breath.

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

• immune effector cell-associated neurotoxicity syndrome (ICANS), a severe immune reaction that can cause effects on the nervous system. Some of the symptoms are: o feeling confused; o feeling less alert; o difficulty speaking or writing.

Inform your doctor immediately if you notice any of the serious side effects listed above.

Other side effects
Other side effects are listed below. Inform your doctor or nurse if you experience any of these side effects.

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

• low levels of red blood cells (anemia);
• feeling tired or weak;
• infection of the nose and throat (upper respiratory tract infection);
• reactions at or near the injection site, including skin redness, itching, swelling, pain, bruising, rash, or bleeding;
• diarrhoea;
• lung infection (pneumonia);
• low levels of platelets in the blood (cells that help blood to clot; thrombocytopenia);
• low levels of a type of lymphocytes, a type of white blood cells (lymphopenia);
• fever (pyrexia);
• decreased appetite;
• rash;
• dry skin;
• joint pain (arthralgia);
• low levels of potassium in the blood (hypokalaemia);
• feeling sick (nausea);
• headache;
• difficulty breathing (dyspnoea);
• blood poisoning (sepsis);
• low number of white blood cells (leukopenia);
• increased level of liver enzymes in the blood (increased transaminases);
• damage to a nerve in the legs and/or arms that can cause tingling, numbness, pain, or loss of sensation (peripheral neuropathy);
• infection of the parts of the body that collect and expel urine (urinary tract infection).

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

• low level of phosphates in the blood (hypophosphataemia);
• low number of neutrophils in the blood, associated with fever (febrile neutropenia).

Reporting of side effects
If you get any side effects, even 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 ELREXFIO

ELREXFIO will be stored at the hospital or clinic by the doctor.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date that is reported on the package 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.
The chemical and physical stability in use after opening of the vial, including storage in prepared syringes,
has been demonstrated for 7 days at a temperature between 2 °C and 8 °C and for 24 hours up to
30 °C.
From a microbiological point of view, the product must be used immediately. If not used
immediately, the storage times and conditions in use before use are the responsibility of the
user and should not normally exceed 24 hours at a temperature between 2 °C and
8 °C, unless the preparation has been carried out under controlled and validated aseptic conditions.
Do not use this medicine if you notice a change in color or other visible signs of deterioration.

6. Package Contents and Other Information

What ELREXFIO contains

• The active ingredient is elranatamab. ELREXFIO is available in two different packages: o One vial of 1.1 mL contains 44 mg of elranatamab (40 mg/mL). o One vial of 1.9 mL contains 76 mg of elranatamab (40 mg/mL). The other ingredients are disodium edetate, L-histidine, L-histidine hydrochloride monohydrate, polysorbate 80, sucrose, water for injections (see “ELREXFIO contains sodium” in section 2).

Description of the appearance of ELREXFIO and package contents
ELREXFIO 40 mg/mL injectable solution (injection) is a liquid from colorless to light brown.
ELREXFIO is supplied in two dosages. Each carton containing 1 glass vial.

Marketing Authorisation Holder
Pfizer Europe MA EEIG
Boulevard de la Plaine 17
1050 Brussels
Belgium

Manufacturer
Pfizer Service Company BV
Hoge Wei 10
B-1930, Zaventem
Belgium
For further information on this medicine, contact the local representative of the marketing authorisation holder:

Latvija
Pfizer Luxembourg SARL filiāle Latvijā
Tel: +371 670 35 775

Belgique/België/Belgien
Luxembourg/Luxemburg
Pfizer NV/SA
Tél/Tel: +32 (0)2 554 62 11

България
Пфайзер Люксембург САРЛ, Клон България
Тел.: +359 2 970 4333

Lietuva
Pfizer Luxembourg SARL filialas Lietuvoje
Tel: +370 52 51 4000

Česká republika
Pfizer, spol. s r.o.
Tel: +420 283 004 111

Magyarország
Pfizer Kft.
Tel: +36-1-488-37-00

Danmark
Pfizer ApS
Tlf.: +45 44 20 11 00

Malta
Vivian Corporation Ltd.
Tel: +356 21344610

Nederland
Pfizer bv
Tel: +31 (0)800 63 34 636

Deutschland
PFIZER PHARMA GmbH
Tel: +49 (0)30 550055 51000

Eesti
Pfizer Luxembourg SARL Eesti filiaal
Tel: +372 666 7500

Norge
Pfizer AS
Tlf: +47 67 52 61 00

Ελλάδα
Pfizer Ελλάς A.E.
Τηλ: +30 210 6785 800

Österreich
Pfizer Corporation Austria Ges.m.b.H.
Tel: +43 (0)1 521 15-0

España
Pfizer, S.L.
Tel: +34 91 490 99 00

Polska
Pfizer Polska Sp. z o.o.
Tel: +48 22 335 61 00

France
Pfizer
Tél: +33 (0)1 58 07 34 40

Portugal
Laboratórios Pfizer, Lda.
Tel: +351 21 423 5500

Hrvatska
Pfizer Croatia d.o.o.
Tel: +385 1 3908 777

România
Pfizer Romania S.R.L.
Tel: +40 (0) 21 207 28 00

Ireland
Pfizer Healthcare Ireland Unlimited Company
Tel: 1800 633 363 (toll free)
+44 (0)1304 616161

Slovenija
Pfizer Luxembourg SARL
Pfizer, podružnica za svetovanje s področja
farmacevtske dejavnosti, Ljubljana
Tel: +386 (0)1 52 11 400

Ísland
Icepharma hf.
Sími: +354 540 8000

Slovenská republika
Pfizer Luxembourg SARL, organizačná zložka
Tel: +421 2 3355 5500

Italia
Pfizer S.r.l.
Tel: +39 06 33 18 21

Suomi/Finland
Pfizer Oy
Puh/Tel: +358 (0)9 430 040

Κύπρος
Pfizer Ελλάς Α.Ε. (Cyprus Branch)
Τηλ: +357 22 817690

Sverige
Pfizer AB
Tel: +46 (0)8 550-520 00
An authorisation “subject to conditions” has been granted for this medicine. This means that
further data on this medicine must be provided.
The European Medicines Agency will review at least annually the new information on this

Other sources of information
More detailed information on this medicine is available on the website of the European Medicines
Agency, https://www.ema.europa.eu.
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The following information is intended only for healthcare professionals:
ELREXFIO 40 mg/mL injectable solution is supplied as a ready-to-use solution that does not require
dilution before administration. Do not shake.
ELREXFIO is a solution from transparent to slightly opalescent and from colorless to light brown.
The solution should not be administered if its colour has changed or if visible particles are present.
Aseptic technique must be used to prepare and administer ELREXFIO.
Instructions for preparation
The vials of ELREXFIO 40 mg/mL injection solution are for single use only.
ELREXFIO must be prepared according to the instructions below (see Table 1) depending on the
required dose. It is recommended to use a single-dose vial of 44 mg/1.1 mL (40 mg/mL) for each of the
incremental doses.

Table 1.Instructions for preparing ELREXFIO
After opening, the vial and the dosing syringe must be used immediately.
If not used immediately, the storage times and conditions in use, before use, are the responsibility of the
user and generally should not exceed 24 hours at a temperature between 2 °C and 8 °C, unless the
preparation was carried out under controlled and validated aseptic conditions.
After opening, including storage in syringes prepared in an aseptic environment, ELREXFIO is
stable for 7 days at a temperature between 2 °C and 8 °C and for 24 hours up to 30 °C.
Instructions for administration
ELREXFIO is only indicated for subcutaneous injection and must be administered by a healthcare
professional.
The required dose of ELREXFIO must be injected into the subcutaneous tissue of the abdomen (preferred
injection site). Alternatively, ELREXFIO can be injected into the subcutaneous tissue of the
thigh.
ELREXFIO for subcutaneous injection should not be injected into areas where the skin is reddened,
bruised, painful, hardened or in areas where there are scars.
Traceability
In order to improve the traceability of biological medicines, the name and batch number of the
medicine administered must be clearly recorded.
Disposal
The vial and any remaining contents must be disposed of after a single use. Unused medicine and waste
derived from such medicine must be disposed of in accordance with local regulations.