ELREXFIO 40 mg/mL INJECTABLE SOLUTION

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 any of the other ingredients of this medicine (listed in section 6).

If you are not sure if you are allergic, talk to your doctor or nurse before you are given ELREXFIO.

Warnings and precautions

Tell your doctor or nurse about all your illnesses before you are given ELREXFIO, including if you have had any recent infections.

Be aware of serious side effects.

Tell 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 serious immune reaction with symptoms such as fever, difficulty breathing, chills, headache, low blood pressure, fast heart rate, feeling dizzy and increased 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 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 you are given ELREXFIO if you have been vaccinated recently or are going to be vaccinated.

You must not receive live vaccines in the 4 weeks before the first dose of ELREXFIO or while you are being treated with ELREXFIO, and for at least 4 weeks after stopping treatment with ELREXFIO.

Tests and checks

Before you are given ELREXFIO, your doctor will check your blood counts to detect signs of infection. If you have any infection, it will be treated before you start treatment with ELREXFIO. Your doctor will also check if 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 components of the blood may decrease.

Children and adolescents

ELREXFIO is not indicated in children or adolescents under 18 years of age, as it is not known how they will be affected by the medicine.

Other medicines and ELREXFIO

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

Pregnancy and breastfeeding

It is not known if ELREXFIO affects the unborn baby or if it passes into breast milk.

Information on pregnancy for women

ELREXFIO is not recommended during pregnancy.

Tell your doctor or nurse before you are given ELREXFIO if you are pregnant, think you may be pregnant or are planning to have a baby.

If you can become pregnant, your doctor must do a pregnancy test before you start treatment.

If you become pregnant during treatment with this medicine, tell your doctor or nurse immediately.

Contraception

If you can 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 until at least 48 hours after each of your first two doses, 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 given

How it is given

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 given as follows:

• You will receive a first dose of 12 mg on day 1 of week 1.
• You will then receive a second 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 a week, while you are benefiting from treatment with ELREXFIO.
• From week 25 to week 48 (day 1), your doctor may change the treatment from once a week to every two weeks, while your disease has responded to treatment with ELREXFIO.
• From week 49 (day 1) onwards, your doctor may change the treatment from every two weeks to every four weeks, while your disease continues to respond to treatment with ELREXFIO.

You must stay near a medical centre for 48 hours after each of the first two doses in case you have side effects. Your doctor will monitor you for side effects during the 48 hours following each of the first two doses.

How the medicine is given

ELREXFIO will always be given to you by your doctor or nurse as an injection under the skin (subcutaneously). It is given in the stomach area (abdomen) or in the thigh.

You may have a reaction at the injection site, which includes redness of the skin, pain, swelling, bruising, rash, itching or bleeding. These effects are usually mild and go away on their own without needing any additional treatment.

Other medicines given during treatment with ELREXFIO

You will be given medicines one hour before each of the first three doses of ELREXFIO. These help reduce the chance of side effects, 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).

You may also be given these medicines for later doses of ELREXFIO depending on the symptoms you have after receiving ELREXFIO.

You may also be given additional medicines depending on any symptoms you have or your medical history.

If you are given too much ELREXFIO

This medicine will be given to you by your doctor or nurse. In the unlikely event that you are given too much (an overdose), your doctor will check you for side effects.

If you miss a dose of ELREXFIO

It is very important that you attend all your appointments to make sure the treatment works. If you miss an appointment, schedule another one as soon as possible.

If you have any other 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

Get medical help immediately if you have any of the following serious side effects, which can be intense and even life-threatening.

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

• Cytokine release syndrome, a serious immune reaction that can cause fever, difficulty breathing, chills, dizziness or lightheadedness, fast heart rate, increased liver enzyme levels in the blood.
• Low levels of neutrophils (a type of white blood cell that fights infection; neutropenia).
• Low levels of antibodies called “immunoglobulins” in the blood (hypogammaglobulinemia), which can increase the chance of getting infections.
• Infection, which can include fever, chills, fatigue or difficulty breathing.

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

• Immune effector cell-associated neurotoxicity syndrome (ICANS), a serious immune reaction that can cause effects on your nervous system. Some of the symptoms are:

• Feeling confused
• Feeling less alert
• Difficulty speaking or writing

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

Other side effects

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

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

• Low red blood cell count (anaemia)
• Feeling tired or weak
• Infection of the nose and throat (upper respiratory tract infection).
• Reactions at the injection site or near it, such as redness of the skin, itching, swelling, pain, bruising, rash or bleeding
• Diarrhoea
• Lung infection (pneumonia)
• 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)
• Lack of appetite
• Rash
• Dry skin
• Joint pain (arthralgia)
• Low potassium levels in the blood (hypokalaemia)
• Feeling sick (nausea)
• Headache
• Difficulty breathing (dyspnoea)
• Severe infection throughout the body (sepsis)
• Low white blood cell count (leucopenia)
• Increased liver enzyme levels in the blood (increased transaminases)
• Nerve damage in the legs and/or arms that can cause tingling, numbness, pain or loss of pain sensation (peripheral neuropathy)
• Urinary tract infection

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

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

Reporting of side effects

If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of ELREXFIO

Your doctor will store ELREXFIO in the hospital or medical centre.

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

Do not use this medicine after the expiry date which is stated on the carton and label after “EXP”. The expiry date is the last day of the month shown.

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

Store in the original package to protect from light.

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

From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user and would normally not be longer than 24 hours between 2°C and 8°C, unless the preparation has been made in controlled and validated aseptic conditions.

Do not use this medicine if you notice any change in the colour or any other visible signs of deterioration.

6. Package Contents and Additional Information

Composition of ELREXFIO

• The active substance is elranatamab. ELREXFIO is supplied in two different package 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, L-histidine hydrochloride monohydrate, polysorbate 80, sucrose, and water for injectable preparations (see "ELREXFIO contains sodium" in section 2).

Appearance of ELREXFIO and Package Contents

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

ELREXFIO is supplied in two doses. 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

Hoge Wei 10

B-1930, Zaventem

Belgium

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

Date of Last Revision of this Leaflet:

This medicinal product has been authorized with a "conditional approval". This type of approval means that more information on this medicinal product is expected.

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.

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This 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 clear to slightly opalescent and colorless to pale brown solution. The solution should not be administered if it shows changes in color or contains particles.

An 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 only.

ELREXFIO should be prepared following 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 escalation doses.

Table 1. Preparation Instructions for ELREXFIO

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

If not used immediately, the in-use storage times and conditions before use are the responsibility of the user and should not normally exceed 24 hours between 2°C and 8°C, unless the preparation has been made in controlled and validated aseptic conditions. After opening, including storage in prepared syringes in an aseptic environment, ELREXFIO is stable for 7 days between 2°C and 8°C, and for 24 hours up to 30°C.

Administration Instructions

ELREXFIO is for subcutaneous injection only 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 reddened, bruised, painful, hard, or where there are scars.

Traceability

In order to improve the 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 should be discarded after a single use. The disposal of unused medicinal products and all materials that have come into contact with them should be carried out in accordance with local regulations.