Elrexfio

Package leaflet: Information for the user

ELREXFIO 40 mg/mL injection solution

elranatamab

This medicinal product is subject to 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 medicine. See the end of section 4 for information on how to report side effects.
Please read this leaflet carefully before receiving this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor or nurse.
• If you experience any side effects, including those not listed in this leaflet, consult 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 receiving 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 ELREXFIO is and what it is used for

ELREXFIO is an antitumour medicinal product that contains the active substance elranatamab. It is used for the treatment of adults with a type of bone marrow cancer called multiple myeloma.
It is used as monotherapy in patients whose cancer has returned (relapsed) and who no longer respond to prior treatments (refractory), who have received at least three prior lines of therapy, and whose disease has progressed after the most recent treatment.
How ELREXFIO works
ELREXFIO is a monoclonal antibody, a type of protein designed to recognise and bind to specific targets in the body. ELREXFIO targets B-cell maturation antigen (BCMA), present on multiple myeloma tumour cells, as well as cluster of differentiation 3 (CD3), found on T cells, a particular type of white blood cell in the immune system. This medicine works by binding to these targets, thereby bringing myeloma tumour cells and T cells together. This helps the immune system to destroy multiple myeloma tumour cells.

2. What you should know before receiving ELREXFIO

ELREXFIO must not be administered
If you are allergic to elranatamab or to any of the other ingredients of this medicine (listed in
section 6).
If you are unsure whether you are allergic, consult your doctor or nurse before receiving ELREXFIO.
Warnings and precautions
Before receiving ELREXFIO, inform your doctor or nurse about all your medical conditions,
including if you have had recent infections.
Be alert for serious side effects.
Immediately inform your doctor or nurse if any of the following occur:

• Signs of a condition known as “cytokine release syndrome” (CRS). CRS is a severe 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 confusion, decreased alertness, or 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 infection such as fever, chills, fatigue, or difficulty breathing.

Inform your doctor or nurse if you notice any of the above signs.
ELREXFIO and vaccines
Talk to your doctor or nurse before receiving ELREXFIO if you have recently received a
vaccination or are scheduled to receive one.
You must not receive vaccinations containing live viruses within four weeks before the first dose of ELREXFIO, during treatment with ELREXFIO, and for at least four weeks after stopping treatment.
Tests and monitoring
Before receiving ELREXFIO, your doctor will perform blood tests to rule out signs of infection. If you have any infection, it will be treated before starting therapy with ELREXFIO. Your doctor will also check whether you are pregnant or breastfeeding.
During treatment with ELREXFIO, your doctor will monitor you for possible side effects. Your doctor will monitor you for signs and symptoms of CRS and ICANS within 48 hours after each of the first two doses of ELREXFIO. Your doctor will also perform regular blood tests, as the number of blood cells and other blood components 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 unknown.
Other medicines and ELREXFIO
Inform 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 available without a prescription and herbal medicines.
Pregnancy and breastfeeding
It is not known whether ELREXFIO has effects on the unborn child or whether it is excreted in breast milk.
Pregnancy – information for women
ELREXFIO is not recommended during pregnancy.
If you are pregnant, suspect you may be pregnant, or are planning a pregnancy, inform your doctor or nurse before receiving ELREXFIO.
If you are a woman of childbearing potential, your doctor must perform a pregnancy test before starting treatment.
If you become pregnant during treatment with this medicine, inform your doctor or nurse immediately.
Contraceptive measures
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, operate tools, or use machinery until at least 48 hours after each of the two initial step-up doses and until symptoms improve or as directed by your healthcare provider.
ELREXFIO contains sodium
ELREXFIO contains less than 1 mmol (23 mg) of sodium per dose, i.e., 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 an initial step-up dose of 12 mg on Day 1 of Week 1.
• You will then receive a second step-up dose of 32 mg on Day 4 of Week 1.
• From Week 2 to Week 24 (Day 1), you will receive the full dose of 76 mg once weekly, until you continue to benefit from ELREXFIO.
• From Week 25 to Week 48 (Day 1), your doctor may adjust your treatment from once weekly to once every two weeks, as long as the tumor responds to treatment with ELREXFIO.
• From Week 49 (Day 1) onwards, your doctor may adjust your treatment from once every two weeks to once every four weeks, as long as the tumor continues to respond to treatment with ELREXFIO.

You must remain near a healthcare facility for 48 hours after each of the first two step-up doses in case any adverse reactions occur. Your doctor will monitor you for adverse reactions during the 48 hours following each of the first two doses.
How the medicine is administered
ELREXFIO will always be administered by your doctor or nurse as an injection under the skin (subcutaneously). It is given in the stomach area or the thigh.
You may experience a reaction at the injection site, which can include redness of the skin, pain, swelling, bruising, rash, itching, or bleeding. These are generally mild effects that resolve on their own without the need for 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 likelihood 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 administered for subsequent doses of ELREXFIO, depending on any symptoms you experience after receiving ELREXFIO.
You may also receive additional medicines based on any symptoms you develop 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 receive an excessive amount (overdose), your doctor will monitor you for adverse reactions.
If you miss your appointment to receive ELREXFIO
To ensure that your treatment works, it is very important to attend all your appointments. If you miss an appointment, schedule another one as soon as possible.
If you have any doubts about the use of this medicine, consult 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 experience any of the following serious side effects, which may be severe and potentially fatal.
Very common (may affect more than 1 in 10 people):

• cytokine release syndrome, a severe immune reaction that may 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 may increase the risk of developing 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 serious immune reaction that may affect the nervous system. Some of the symptoms include:
  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 (anaemia);
• 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 unwell (nausea);
• headache;
• difficulty breathing (dyspnoea);
• blood poisoning (sepsis);
• low number of white blood cells (leucopenia);
• increased levels of liver enzymes in the blood (increased transaminases);
• nerve damage in the legs and/or arms causing 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, including any not listed in this leaflet, talk to your doctor or nurse. You can also report side effects directly via 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 by the physician at the hospital or clinic.
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 vial label 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 medicine from light.
Chemical and physical in-use stability after opening the vial, including storage in prepared syringes, has been demonstrated for 7 days at a temperature of 2 °C to 8 °C and for 24 hours up to 30 °C.
From a microbiological standpoint, the product should be used immediately. If not used immediately, the storage times and conditions prior to use are the responsibility of the user and normally should not exceed 24 hours at a temperature between 2 °C and 8 °C, unless preparation occurs under controlled and validated aseptic conditions.
Do not use this medicine if you notice any change in colour or other visible signs of deterioration.

6. Package contents and other information

What ELREXFIO contains

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

Description of the appearance of ELREXFIO and contents of the pack
ELREXFIO 40 mg/mL solution for injection is a liquid ranging from colourless to light brown.
ELREXFIO is available in two strengths. Each carton contains one 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 about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

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

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

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

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

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

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

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

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

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

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

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

Ísland
Icepharma hf.
Sími: +354 540 8000

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

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

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

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

Luxembourg/Luxemburg
Pfizer Luxembourg SARL
Tel: +352 271 430

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

Malta
Vivian Corporation Ltd.
Tel: +356 21344610

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

Norge
Pfizer AS
Tlf: +47 67 52 61 00

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

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

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

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

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

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

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

Sverige
Pfizer AB
Tel: +46 (0)8 550-520 00

This medicinal product has been granted a marketing authorisation “under conditional approval”. This means that additional data on this medicinal product are required.
The European Medicines Agency will review new information on this medicinal product at least annually, and this package leaflet will be updated if necessary.

Further 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.

The following information is intended for healthcare professionals only:
ELREXFIO 40 mg/mL solution for injection is supplied as a ready-to-use solution and does not require dilution prior to administration. Do not shake.
ELREXFIO is a solution ranging from transparent to slightly opalescent and from colourless to light brown.
The solution must not be administered if discoloured or if visible particles are present.
An aseptic technique must be used when preparing and administering ELREXFIO.

Instructions for preparation
ELREXFIO 40 mg/mL single-dose vials for injection 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 preparation of ELREXFIO

After opening, the vial and the dosing syringe must be used immediately.
If not used immediately, the in-use storage times and conditions prior to use are the responsibility of
the user and should normally not 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.
After opening, including storage in syringes prepared under aseptic conditions, ELREXFIO is stable
for 7 days at a temperature between 2 °C and 8 °C and for 24 hours at temperatures up to 30 °C.
Instructions for administration
ELREXFIO is intended for subcutaneous injection only and must be administered by a healthcare
professional.
The required dose of ELREXFIO should be injected into the subcutaneous tissue of the abdomen (the
preferred injection site). Alternatively, ELREXFIO may be injected into the subcutaneous tissue of the
thigh.
ELREXFIO for subcutaneous injection must not be injected into areas where the skin is red, bruised,
tender, hard, or in areas with scars.
Traceability
In order to improve traceability of biological medicinal products, the name and batch number of the
administered product should be clearly recorded.
Disposal
The vial and any remaining contents must be discarded after single use. Unused medicine and waste
materials derived from this medicine must be disposed of in accordance with local regulations.