Elrexfio 40 mg/ml solucion inyectable

Summary of Product Characteristics: Information for the User

ELREXFIO 40 mg/ml injectable solution

elranatamab

This medicine is subject to additional monitoring, which will facilitate the detection of new information about its safety. You can contribute by reporting any adverse effects you may experience. The final part of section 4 includes information on how to report these adverse effects.

Read this leaflet carefully before you receive 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, consult your doctor or nurse.
• If you experience any adverse effects, consult your doctor or nurse, even if they are not listed in this leaflet. See section 4.

ELREXFIO is a cancer medication that contains the active ingredient elranatamab. It is used to treat adults with a type of bone marrow cancer called multiple myeloma.

It is used in patients whose cancer has relapsed and has stopped responding to previous treatments (refractory), who have received at least three other classes of treatment and whose condition has worsened since receiving the last treatment.

How ELREXFIO works

ELREXFIO is a monoclonal antibody, a type of protein designed to recognize and bind to specific targets in the body. ELREXFIO targets the B cell maturation antigen (BCMA), which is found in the cancer cells of multiple myeloma, and cluster of differentiation 3 (CD3), which is found in T lymphocytes, a particular type of white blood cell of the immune system. This medication acts by binding to these targets and, by doing so, linking cancer cells and lymphocytes. This helps the immune system to destroy the cancer cells of multiple myeloma.

ELREXFIO should not be administered

If you are allergic to elranatamab or any of the other components of this medication (listed in section 6).

If you are unsure if you are allergic, speak with your doctor or nurse before ELREXFIO is administered to you.

Warnings and precautions

Inform your doctor or nurse about all your diseases before ELREXFIO is administered, including if you have had any recent infections.

Be aware of severe adverse effects.

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

• 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 heart rate, dizziness, and elevated liver enzyme levels in the blood.
• Effects on the nervous system. Symptoms include feeling confused, feeling less alert, or having difficulty speaking or writing. Some of these may be signs of a severe immune reaction called “immune effector cell-associated neurotoxicity syndrome” (ICANS).
• Signs and symptoms of an infection such as fever, chills, fatigue, or difficulty breathing.

Inform your doctor or nurse if you observe any of the above-described signs.

ELREXFIO and vaccines

Consult your doctor or nurse before ELREXFIO is administered if you have recently been vaccinated or are to be vaccinated.

You should not receive live-virus vaccines in the four weeks before the first dose of ELREXFIO, while receiving ELREXFIO, and at least four weeks after stopping ELREXFIO treatment.

Tests and controls

Before ELREXFIO is administered, your doctor will check your blood counts to detect signs of infection. If you have any infection, it will be treated before starting ELREXFIO treatment. Your doctor will also check if you are pregnant or breastfeeding.

During ELREXFIO treatment, your doctor will monitor you for adverse effects. Your doctor will monitor signs and symptoms of CRS and ICANS during the 48 hours after each of the first two doses of ELREXFIO. Your doctor will also regularly check your blood counts, as the number of blood cells and other blood components may decrease.

Children and adolescents

ELREXFIO is not indicated in children or adolescents under 18 years of age, as its effect on them is unknown.

Other medications and ELREXFIO

Inform your doctor or nurse if you are taking, have recently taken, or may need to take any other medication (e.g., ciclosporin, phenytoin, sirolimus, and warfarin). This includes over-the-counter medications and herbal remedies.

Pregnancy and breastfeeding

The effect of ELREXFIO on the fetus or its passage into breast milk is unknown.

Pregnancy information for women

ELREXFIO is not recommended during pregnancy.

Inform your doctor or nurse before receiving ELREXFIO if you are pregnant, think you may be pregnant, or intend to become pregnant.

If you can become pregnant, your doctor must perform a pregnancy test before starting treatment.

If you become pregnant during treatment with this medication, inform your doctor or nurse immediately.

Contraception

If you can become pregnant, you must use an effective contraceptive method during treatment and for 6 months after stopping ELREXFIO treatment.

Breastfeeding

You should not breastfeed during treatment and for 6 months after stopping ELREXFIO treatment.

Driving and operating machinery

Some people may feel tired, dizzy, or confused while receiving ELREXFIO. Do not drive, use tools, or operate machinery at least 48 hours after each of your 2 dose escalations, until your symptoms improve or as advised by your healthcare professional.

ELREXFIO contains sodium

ELREXFIO contains less than 1 mmol of sodium (23 mg) per dose; it is essentially “sodium-free”.

How it is administered

You will receive ELREXFIO under the supervision of a healthcare professional with experience in cancer treatment. The recommended dose of ELREXFIO is 76 mg, but the first two doses will be lower.

ELREXFIO is administered as follows:

• You will receive a first dose escalation of 12 mg on day 1 of week 1.
• Subsequently, you will receive a second dose escalation of 32 mg on day 4 of week 1.
• From week 2 to week 24 (day 1), you will receive a full treatment dose of 76 mg once a week, as long as you continue to benefit from ELREXFIO treatment.
• From week 25 onwards, your doctor may change the treatment from once a week to every two weeks, as long as your disease has responded to ELREXFIO treatment.

You must remain near a healthcare facility for 48 hours after each of the first two dose escalations in case you experience adverse effects. Your doctor will monitor you for adverse effects during the 48 hours following each of the first two doses.

How the medication is administered

ELREXFIO will be administered to you by your doctor or nurse in the form of a subcutaneous injection under the skin. It is administered in the abdominal area or in the thigh.

You may experience a reaction at the injection site, which includes skin redness, pain, swelling, bruising, itching, or bleeding. These effects are usually mild and resolve on their own without the need for additional treatment.

Other medications administered during ELREXFIO treatment

You will be administered medications one hour before each of the first three doses of ELREXFIO. These help reduce the risk of adverse effects, such as cytokine release syndrome (see section 4). These medications may include:

• Medications to reduce the risk of fever (such as paracetamol).
• Medications to reduce the risk of inflammation (corticosteroids).
• Medications to reduce the risk of allergic reactions (antihistamines such as diphenhydramine).

These medications may also be administered to you for subsequent doses of ELREXFIO, depending on the symptoms you experience after receiving ELREXFIO.

You may also be administered additional medications based on any symptoms you experience or your medical history.

If you are administered more ELREXFIO than you should

This medication will be administered to you by your doctor or nurse. In the unlikely event that you are administered an excessive amount (an overdose), your doctor will examine you to detect any adverse effects.

If you do not attend your appointment for ELREXFIO administration

It is very important that you attend all your appointments to ensure that the treatment is effective. If you miss an appointment, reschedule as soon as possible.

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Severe side effects

Seek immediate medical help if you experience any of the following severe side effects, which could be intense and even 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 drowsiness, tachycardia, elevated liver enzymes in the blood.
• Low neutrophil counts (a type of white blood cell that fights infections; neutropenia).
• Low levels of antibodies called "immunoglobulins" in the blood (hypogammaglobulinemia), which may increase the likelihood of developing infections.
• Infection, which may include fever, chills, fatigue, or difficulty breathing.

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 your nervous system. Some symptoms are:

• Feeling of confusion
• Feeling less alert
• Difficulty speaking or writing

Inform your doctor immediately if you observe any of the severe side effects mentioned above.

Other side effects

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

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

• Low red blood cell count (anemia)
• Feeling tired or weak
• Upper respiratory tract infection (infection of the nose and throat).
• Reactions at the injection site or nearby, such as skin redness, itching, swelling, pain, bruising, rash, or bleeding
• Diarrhea
• Pneumonia (lung infection)
• Low platelet count (cells that help blood clot; thrombocytopenia)
• Low levels of a type of lymphocyte, a type of white blood cell (lymphopenia)
• Fever (pyrexia)
• Decreased appetite
• Skin rash
• Dry skin
• Joint pain (arthralgia)
• Low potassium levels in the blood (hypokalemia)
• Unpleasantness (nausea)
• Headache
• Difficulty breathing (dyspnea)
• Severe infection throughout the body (sepsis)
• Low white blood cell count (leucopenia)
• Elevated liver enzyme levels in the blood (elevated transaminases)
• Nerve damage in the legs and/or arms that can cause tingling, numbness, pain, or loss of sensation (peripheral neuropathy)
• Urinary tract infection (infection of the areas of the body that store and expel urine)

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

• Low phosphate levels in the blood (hypophosphatemia)
• Low neutrophil counts in the blood, accompanied by fever (febrile neutropenia).

Reporting side effects

If you experience side effects, consult your doctor or nurse, even if they are possible side effects that do not appear in this prospectus. You can also report them directly through thenational notification system included in theAppendix V. By reporting side effects, you can contribute to providing more information about the safety of this medicine.

Your doctor will keep ELREXFIO in the hospital or medical center.

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging and on the label after “EXP”. The expiration date is the last day of the month indicated.

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

Store in the original packaging to protect it from light.

The prepared syringe can be stored for 24 hours at a temperature of up to 30 °C.

Do not use this medication if you observe changes in color or other visible signs of deterioration.

Composition of ELREXFIO

• The active substance is elranatamab. ELREXFIO is supplied in two different packaging sizes:

• A vial of 1.1 ml contains 44 mg of elranatamab (40 mg/ml).
• A vial of 1.9 ml contains 76 mg of elranatamab (40 mg/ml).

The other components are disodium edetate, L-histidine, hydrochloride of L-histidine monohydrate, polisorbate 80, sucrose, water for injection (see "ELREXFIO contains sodium" in section 2).

Appearance of ELREXFIO and contents of the pack

ELREXFIO 40 mg/ml injectable solution (injectable) is a colourless to pale brown solution.

ELREXFIO is supplied in two doses. Each carton contains 1 glass vial.

Marketing authorisation holder

Pfizer Europe MA EEIG

Boulevard de la Plaine 17

1050 Bruxelles

Belgium

Responsible for manufacturing

Pfizer Service Company BV

Hoge Wei 10

B-1930, Zaventem

Belgium

You can request more information about this medicine by contacting the local representative of the marketing authorisation holder:

Last update of this leaflet:

This medicine has been authorised under a 'conditional approval'. This type of approval means that more information is expected to be obtained about this medicine.

The European Medicines Agency will review the new information about this medicine at least once a year and this leaflet will be updated as necessary.

Other sources of information

More detailed information about this medicine is available on the website of the European Medicines Agency:https://www.ema.europa.eu.

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This information is intended solely 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 agitate.

ELREXFIO is a colourless to pale brown solution. The solution should not be administered if it presents colour changes or contains particles.

Aseptic technique should be used to prepare and administer ELREXFIO.

Preparation instructions

The vials of ELREXFIO 40 mg/ml injectable solution are for single use.

ELREXFIO should be prepared according to the instructions below (see Table 1) depending on the required dose. It is recommended to use a single-use vial of 44 mg/1.1 ml (40 mg/ml) for each of the dose escalations.

Table 1. Preparation instructions for ELREXFIO

Once pierced, the vial and the dosing syringe should be used immediately. If the prepared dosing syringe is not used immediately, it should be stored between 2°C and 30°C for a maximum of 24 hours.

Administration instructions

ELREXFIO is only for subcutaneous injection and should be administered by a healthcare professional.

The required dose of ELREXFIO should 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 red, purple, painful, hard or into areas where there are scars.

Traceability

In order to improve the traceability of biological medicines, the name and batch number of the administered medicine should be clearly recorded.

Disposal

The vial and any remaining contents should be disposed of after single use. The disposal of unused medicine and all materials that have come into contact with it should be carried out in accordance with local regulations.