Elrexfio 40 mg/ml solution for injection

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

ELREXFIO 40 mg/ml solution for injection

elranatamab

This medicinal product is subject to additional monitoring, which will allow for rapid identification of new safety information. You can help by reporting any adverse reactions you may experience. Information on how to report adverse reactions is included at the end of section 4.

Read the entire leaflet carefully before you are given this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or nurse.
• If you experience any adverse reactions, consult your doctor or nurse, even if they are not listed in this leaflet. See section 4.

Leaflet contents

1. What ELREXFIO is and what it is used for
2. What you need to know before you are given ELREXFIO
3. How ELREXFIO is administered
4. Possible adverse reactions
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 a cancer medicine that contains the active substance 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 returned (relapsed) and is no longer responding to previous treatments (refractory), who have received at least three prior lines of therapy, and whose disease has progressed since their last treatment.

How ELREXFIO works

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

2. What you need to know before you are given ELREXFIO

ELREXFIO must not be given to you if

You are allergic to elranatamab or to any of the other ingredients of this medicine (listed in section 6).

If you are not sure whether you are allergic, speak with your doctor or nurse before you are given ELREXFIO.

Warnings and precautions

Tell your doctor or nurse about all your medical conditions before you are given ELREXFIO, including if you have recently had an infection.

Be alert for serious side effects.

Immediately tell your doctor or nurse if you experience any of the following symptoms:

• 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, being 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 signs listed above.

ELREXFIO and vaccines

Talk to your doctor or nurse before you are given ELREXFIO if you have recently been vaccinated or are planning to be vaccinated.

You must not receive vaccines made with live organisms within four weeks before the first dose of ELREXFIO, during treatment with ELREXFIO, or for at least four weeks after stopping treatment with ELREXFIO.

Tests and monitoring

Before you are given ELREXFIO, your doctor will check your blood counts to look for signs of infection. If you have an infection, it will be treated before you start treatment with ELREXFIO. Your doctor will also check whether you are pregnant or breastfeeding.

During treatment with ELREXFIO, your doctor will monitor you for side effects. Your doctor will monitor for signs and symptoms of CRS and ICANS during the 48 hours following 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 recommended for use in children or adolescents under 18 years of age, as it is unknown how the medicine will affect them.

Other medicines and ELREXFIO

Tell your doctor or nurse if you are taking, have recently taken, or might need to take any other medicines (e.g., cyclosporine, phenytoin, sirolimus, and warfarin). This includes medicines obtained without a prescription and herbal medicines.

Pregnancy and breastfeeding

It is unknown whether ELREXFIO affects the fetus or passes into breast milk.

Information about pregnancy for women

ELREXFIO is not recommended during pregnancy.

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

If you are able to become pregnant, your doctor should perform a pregnancy test before starting treatment.

If you become pregnant while being treated with this medicine, inform your doctor or nurse immediately.

Contraception

If you are able to become pregnant, you must use an effective method of 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

Some people may feel tired, dizzy, or confused while receiving ELREXFIO. Do not drive, use tools, or operate machinery for at least 48 hours after each of your two step-up doses, or 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; this is essentially “sodium-free”.

3. How ELREXFIO is administered

How it is administered

You will receive ELREXFIO under the supervision of a healthcare professional experienced 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 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 a full treatment dose of 76 mg once weekly, as long as you continue to benefit from ELREXFIO treatment.
• From week 25 to week 48 (day 1), your doctor may change your treatment schedule from once weekly to once every two weeks, as long as your disease has responded to ELREXFIO treatment.
• Starting from week 49 (day 1), your doctor may change your treatment schedule from once every two weeks to once every four weeks, as long as your disease continues to respond to ELREXFIO treatment.

You must remain close to a healthcare facility for 48 hours after each of the first two step-up doses 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 medicine is administered

ELREXFIO will always be administered by your doctor or nurse as a subcutaneous injection (under the skin). It is given in the stomach area (abdomen) or in the thigh.

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

Other medicines administered during ELREXFIO treatment

You will be given medications one hour before each of the first three doses of ELREXFIO. These help reduce the likelihood of experiencing adverse effects, such as cytokine release syndrome (see section 4). These medications 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 allergic reaction (antihistamines such as diphenhydramine).

You may also be given these medications before subsequent doses of ELREXFIO, depending on the symptoms you experience after receiving ELREXFIO.

Additional medications may also be administered based on any symptoms you may have or your medical history.

If you are given 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 (an overdose), your doctor will examine you for any adverse effects.

If you miss your ELREXFIO administration appointment

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

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Serious adverse effects

Seek immediate medical help if you experience any of the following serious adverse effects, which could be severe and even fatal.

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

• Cytokine release syndrome, a serious immune reaction that may cause fever, difficulty breathing, chills, dizziness or feeling faint, rapid heartbeat, increased liver enzymes in the blood.
• Low levels of neutrophils (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 more than 1 in 100 people):

• Immune effector cell-associated neurotoxicity syndrome (ICANS), a serious immune reaction that may affect your nervous system. Some symptoms include:
  • Feeling confused
  • Feeling less alert
  • Difficulty speaking or writing

Uncommon (may affect more than 1 in 1,000 people):

• Progressive multifocal leukoencephalopathy (PML), a serious and potentially fatal brain infection. Some symptoms include:
  • Blurred vision, double vision, or loss of vision
  • Difficulty speaking
  • Weakness in one arm or one leg
  • Changes in the way you walk or problems with balance
  • Persistent numbness
  • Reduced sensation or loss of sensation
  • Memory loss or confusion

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

Other adverse effects

The following is a list of other adverse effects. Inform your doctor or nurse if you experience any of these.

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

• Low number 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, such as skin redness, itching, swelling, pain, bruising, rash, or bleeding
• Diarrhea
• Lung infection (pneumonia)
• Low levels of platelets (cells that help blood to clot; thrombocytopenia)
• Low levels of a type of lymphocyte, a kind of white blood cell (lymphopenia)
• Fever (pyrexia)
• Decreased appetite
• Skin rash
• Dry skin
• Joint pain (arthralgia)
• Low potassium levels in the blood (hypokalemia)
• Feeling unwell (nausea)
• Headache
• Difficulty breathing (dyspnea)
• Serious infection throughout the body (sepsis)
• Low levels of white blood cells (leukopenia)
• Increased levels of liver enzymes in the blood (increased transaminases)
• Nerve damage in the legs and/or arms that may cause tingling, numbness, pain, or loss of pain sensation (peripheral neuropathy)
• Infection in parts of the body that store and expel urine (urinary tract infection)

Common (may affect more than 1 in 100 people):

• Low level of phosphate in the blood (hypophosphatemia)
• Low levels of neutrophils in the blood accompanied by fever (febrile neutropenia)

Reporting of adverse effects

If you experience any adverse effects, consult your doctor or nurse, even if they are possible adverse effects not listed in this leaflet. You may also report them directly through the national reporting system detailed in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of ELREXFIO

Your doctor will store ELREXFIO at the hospital or medical center.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the container and label after “EXP”. The expiry date refers to the last day of the month indicated.

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

Keep in the original packaging to protect from light.

Chemical and physical in-use stability has been demonstrated after opening the vial, including storage in prepared syringes, for 7 days between 2 °C and 8 °C, and for 24 hours at up to 30 °C.

From a microbiological standpoint, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and should generally not exceed 24 hours 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 any change in colour or other visible signs of deterioration.

6. Contents of the container and other information

Composition of ELREXFIO

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

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

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

The other components are disodium edetate, L-histidine, monohydrate L-histidine hydrochloride, polysorbate 80, sucrose, and water for injections (see “ELREXFIO contains sodium” in section 2).

Appearance of ELREXFIO and contents of the container

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

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

Marketing Authorization Holder

Pfizer Europe MA EEIG

Boulevard de la Plaine 17

1050 Bruxelles

Belgium

Manufacturer

Pfizer Service Company BV

Hermeslaan 11

1932 Zaventem

Belgium

For more information about this medicine, please contact the local representative of the Marketing Authorization Holder:

Date of the most recent review of this leaflet:

This medicinal product has been authorised under a "conditional approval". This type of approval means that further information is expected for this medicinal product.

The European Medicines Agency will review the new information on this medicinal product at least once a year, and this leaflet will be updated as necessary.

Other sources of information

Detailed information on this medicinal product is available on the European Medicines Agency website: https://www.ema.europa.eu.

This information is intended for healthcare professionals only:

ELREXFIO 40 mg/ml solution for injection is supplied as a ready-to-use solution that does not require dilution prior to administration. Do not shake.

ELREXFIO is a clear to slightly opalescent, colourless to pale brown solution. The solution must not be administered if it shows changes in colour or contains particles.

An aseptic technique must be used to prepare and administer ELREXFIO.

Preparation instructions

ELREXFIO 40 mg/ml solution for injection vials are for single use only.

ELREXFIO must be prepared according to the instructions described 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 step-up doses.

Table 1. Preparation instructions for ELREXFIO

After opening, the vial and the dosing syringe must be used immediately.

If not used immediately, the storage times in use and the conditions prior to use are the responsibility of the user and should normally not exceed 24 hours 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 between 2 °C and 8 °C, and for 24 hours at up to 30 °C.

Administration instructions

ELREXFIO is 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 (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 into areas with scars.

Traceability

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

Disposal

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