BLENREP 100 mg POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

Introduction

Package Leaflet: Information for the Patient

Blenrep70mg powder for concentrate for solution for infusion

Blenrep 100mg powder for concentrate for solution for infusion

belantamab mafodotin

This medicine is subject to additional monitoring, which will allow for quick identification of new safety information. You can help by reporting any side effects you may get. The last section of this leaflet includes information on how to report side effects.

Read all of this leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or nurse.
• If you get any side effects, talk to your doctor or nurse, even if they are not listed in this leaflet. See section 4.

Contents of the pack

1. What is Blenrep and what is it used for
2. What you need to know before you are given Blenrep
3. How Blenrep is given
4. Possible side effects
5. Storage of Blenrep
6. Contents of the pack and other information

1. What is Blenrep and what is it used for

Blenrep contains the active substance belantamab mafodotin. It is used in combination with other cancer medicines to treat adults who have a type of bone marrow cancer called multiple myeloma.

Belantamab mafodotin consists of a monoclonal antibodyconnected to a cytotoxic agent (a type of cancer medicine). The monoclonal antibody is a protein designed to find the multiple myeloma cells in your body and bind to them. Once bound to the cancer cells, the cytotoxic agent is released inside the cells and kills them.

Blenrep will be given to you together with other cancer medicines used to treat multiple myeloma:

• bortezomib and dexamethasone, or

• pomalidomide and dexamethasone.

It is important that you read the package leaflets of these other medicines. If you have any questions about these medicines, ask your doctor.

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

Do not receive BLENREP

• if you are allergic to belantamab mafodotin or any of the other ingredients of this medicine (listed in section 6).

• Talk to your doctorif you think this applies to you.

Warnings and precautions

Tell your doctor or nurse before you start receiving Blenrep if you have:

Eye problems

This medicine may cause changes to the surface of your eye which can result in changes to your vision, blurred vision and dry eyes.

You should have an eye examination by an eye care professional before each of the first 4 doses of this medicine. Your doctor may ask for more eye examinations for you while you are being treated with Blenrep. Even if your vision seems to be fine, it is important that you have your eyes checked during treatment with this medicine as some changes can occur without symptoms and can only be detected by an eye examination.

• Do not wear contact lenseswhile you are receiving treatment unless your eye care professional tells you to.

Your doctor will ask you to use eye drops called preservative-free artificial tears at least 4 times a day during treatment to keep your eyes moist and lubricated. You should use them as instructed.

Tell your doctor if you notice any changes in your vision. Your doctor may reduce the dose or change the time between doses. Your doctor may also ask you to visit an eye care professional.

• Contact your doctorif you have blurred vision or other eye problems.

Bleeding and abnormal bruising

Blenrep may decrease the number of a type of blood cell called platelets which help blood to clot.

Symptoms of a low platelet count (thrombocytopenia) include:

• unusual bruising under the skin,
• bleeding for longer than normal after a blood test or cut to the skin,
• nosebleeds or bleeding from the gums or more serious bleeding.

Your doctor will ask you to have a blood test before starting treatment and regularly during treatment with Blenrep to check that your platelet levels are normal.

• Contact your doctorif you develop bleeding or unusual bruising, or any symptoms that worry you.

Infusion-related reactions

Blenrep is given by infusion into a vein. Some people who receive infusions develop infusion-related reactions. These reactions can occur during the infusion or in the 24 hours following the infusion. In rare cases, you may have a severe allergic reaction that can include swelling of the face, lips, mouth, tongue or throat, difficulty swallowing or breathing or any itchy rash (hives).

• For more information on the signs of an infusion-related reaction, see section 4.
• Seek medical help immediatelyif you think you may be having an allergic reaction.

If you have previously had a reaction to an infusion with this medicine, or any other medicine:

• Tell your doctor or nursebefore you receive another infusion.

Lung inflammation

Some people who received Blenrep developed severe and potentially life-threatening lung inflammation (pneumonitis).

Possible symptoms of lung inflammation include:

• shortness of breath,
• chest pain,
• appearance of cough or worsening of this.

If you develop symptoms of pneumonitis, your doctor may decide to space out your doses or stop treatment with Blenrep.

• Tell your doctorif you develop any lung problems or respiratory symptoms that worry you.

If you have or have had a hepatitis B infection

Talk to your doctorif you may have or have had a hepatitis B infection. This medicine may cause a reactivation of the infection. Your doctor may check you for signs of infection before and during treatment.

• Tell your doctorif you notice any of the following signs or symptoms: worsening tiredness, yellowing of the skin or the white of the eyes, and dark urine. If you have symptoms of hepatitis B infection, your doctor may decide to space out your doses or stop treatment with Blenrep.

Children and adolescents

This medicine is not intended for use in children or adolescents under 18 years of age.

Other medicines and Blenrep

• Tell your doctorif you are using, have recently used or might use any other medicines.

Pregnancy, breast-feeding and fertility

Pregnancy

It is not known if Blenrep affects the unborn baby. This medicine should not be used during pregnancy.

If you are pregnant, think you may be pregnant or are planning to have a baby:

• Tell your doctorbefore using this medicine.

If you are a woman who can become pregnant

• Your doctor will ask you to have a pregnancy test before starting treatment with Blenrep.
• You must use effective contraceptionduring treatment and for 4 months after the last dose of Blenrep.

If you are a man who can father a child

• You must use effective contraceptionduring treatment and for 6 months after the last dose of Blenrep.

Breast-feeding

It is not known if Blenrep passes into breast milk. You must not breast-feed during treatment and for 3 months after the last dose of this medicine.

Talk to your doctor if you are breast-feeding or plan to breast-feed.

Fertility

It is recommended that men and women who are going to be treated with this medicine and who want to have children seek advice on fertility.

Driving and using machines

Blenrep may cause vision problems that can affect your ability to drive or use machines.

• Do not drive or use machinesunless you are sure that your vision is not affected. Talk to your doctor if you are not sure.

Blenrep contains polysorbate and sodium

This medicine contains 0.28 mg of polysorbate 80 (E433) in each 70 mg vial and 0.4 mg of polysorbate 80 (E433) in each 100 mg vial, which is equivalent to 0.2 mg/ml in each vial. Polysorbates may cause allergic reactions. Tell your doctor if you have any known allergy.

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

3. How Blenrep is given

Your doctor will decide the correct dose of Blenrep for you. The dose is calculated based on your body weight.

Blenrep is given in combination with other medicines used to treat multiple myeloma.

• When given with bortezomib and dexamethasone, the recommended starting dose of Blenrep is 2.5 mg per kilogram of body weight, every 3 weeks.
• When given with pomalidomide and dexamethasone, the recommended starting dose of Blenrep is 2.5 mg per kilogram of body weight for the first dose, and then 1.9 mg per kilogram of body weight, every 4 weeks.

Your doctor or nurse will give you this medicine by infusion into a vein over 30 minutes.

Your doctor will discuss with you how many treatments you need. Treatment will continue until your disease gets worse or you develop unacceptable side effects. Your doctor will discuss the duration of treatment with you.

Before infusion, you should apply lubricating and moisturizing eye drops (preservative-free artificial tears). You should continue to use the eye drops at least 4 times a day while you are receiving treatment with Blenrep.

• Read the informationon ‘Eye problems’ in section 2 of this leaflet.

If you receive more Blenrep than you should

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

If you miss a dose of Blenrep

It is very important that you attend all your appointments to make sure your treatment works. If you do not attend an appointment, ask for another as soon as possible.

• Talk to your doctor or hospital as soon as possible to arrange a new appointment.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects

Some side effects can be serious. Seek medical help immediately if you experience any of the following serious side effects:

Very common: may affect more than 1 in 10 people

• COVID-19. Symptoms may include:
• • fever
  • chills
  • cough
  • sore throat
  • runny or stuffy nose
  • loss of taste or smell.
• lung infection (pneumonia). Symptoms may include:
• • shortness of breath
  • chest pain
  • appearance of cough or worsening of this.
• bruising and abnormal bleeding due to a low number of platelets in the blood (thrombocytopenia).
• Read the informationon “Bruising and abnormal bleeding” in section 2 of this leaflet.
• low number of white blood cells in the blood (neutropenia), which can increase the risk of infections. Symptoms may include:
• • fever
  • chills
  • feeling tired.
• fever (pyrexia). Symptoms may include:
• • chills
  • flushing.

Common: may affect up to 1 in 10 people

• Lung infection due to COVID-19 (pneumonia). Symptoms may include:

• shortness of breath or difficulty breathing
• cough
• chest pain
• fever
• extreme tiredness (fatigue)
• confusion.

• Infusion-related reactions

• Some people may have reactions similar to allergic reactions when they receive an infusion. These occur usually within minutes or hours but can develop up to 24 hours after treatment. Symptoms may include:
• • flushing
  • chills
  • fever
  • difficulty breathing
  • rapid heartbeat
  • decrease in blood pressure.
  • Seek medical help immediatelyif you think you may be having a reaction.

Uncommon: may affect up to 1 in 100 people

• blood vessel disease in the liver (portosinusoidal vascular disease). This can cause:
• • abnormal liver blood tests and long-term problems such as increased pressure in the blood vessels of the abdomen (portal hypertension)
  • swelling of the blood vessels (varices) of the tube that goes from the mouth to the stomach (esophagus)
  • or accumulation of fluid in the abdomen, which can cause abdominal pain, weight gain or abdominal swelling (ascites).

Other side effects

The following side effects have been reported when Blenrep is given in combination with bortezomib and dexamethasone and with Blenrep given in combination with pomalidomide and dexamethasone. Tell your doctor or nurse if you notice any of the following side effects:

Very common: may affect more than 1 in 10 people

• eye problems, including:
• • blurred vision
  • changes to the surface of the eye
  • dry eyes
  • sensitivity to light (photophobia)
  • feeling of something in the eye (foreign body sensation in the eyes)
  • eye irritation
  • eye pain
  • decreased vision
  • clouding of the lens in the eye (cataract).

• Read the informationon ‘Eye problems’ in section 2 of this leaflet.

• cold or cold-like symptoms, such as cough, runny or stuffy nose, or sore throat (upper respiratory tract infection)
• low number of red blood cells that carry oxygen in the blood (anemia), causing weakness and fatigue
• low number of white blood cells in the blood that help fight infections (lymphopenia)
• difficulty sleeping or poor quality sleep (insomnia)
• nerve damage (neuropathy)
• cough
• diarrhea
• nausea
• constipation
• abnormal levels of liver enzymes in the blood (alanine aminotransferase, aspartate aminotransferase, and gamma-glutamyltransferase)
• joint pain
• back pain
• fatigue (fatigue).

Common: may affect up to 1 in 10 people

• other eye problems, including:
• • increased tear production (lacrimation)
  • double vision (diplopia)
  • itchy eyes (ocular pruritus)
  • eye discomfort
  • ulcers on the surface of the eye (in the cornea), possibly with infection (corneal ulcer)
  • vision problems.
• infection of the parts of the body that collect and get rid of urine (urinary tract infection)
• inflammation of the airways in the lungs (bronchitis)
• low number of white blood cells that help fight infections (leukopenia)
• low number of white blood cells with fever (febrile neutropenia)
• low number of antibodies called “immunoglobulins” in the blood that help fight infections (hypogammaglobulinemia)
• decreased appetite
• difficulty breathing (dyspnea)
• vomiting
• rash
• abnormal levels of creatine phosphokinase in the blood
• foamy or bubbly urine that indicates high levels of protein in the urine (albuminuria)
• weakness (asthenia).

Uncommon: may affect up to 1 in 100 people

• reactivation of hepatitis B infection if you have had hepatitis B in the past

• Read the informationon ‘If you have or have had a hepatitis B infection’ in section 2 of this leaflet.

• difficulty breathing, chest pain, and cough, due to inflammation of the lungs (pneumonitis)

• Read the informationon ‘Lung inflammation’ in section 2 of this leaflet.

Other side effects reported(frequency not known):

• decreased sensitivity (hypoesthesia) of the cornea (the transparent layer on the front of the eye that covers the pupil and iris).

Reporting of side effects

If you experience any side effects, talk to your doctor or nurse, even if they are not listed in this leaflet. You can also report side effects directly via 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 Blenrep

Your doctor, pharmacist, or nurse is responsible for storing this medicine and disposing of any unused product properly. The following information is intended for healthcare professionals.

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiration date shown on the label and on the carton after EXP. The expiration date is the last day of the month indicated.

Store in a refrigerator (2°C – 8°C).

The reconstituted solution can be stored for up to 4 hours at room temperature (20°C – 25°C) or in a refrigerator (2°C – 8°C) for up to 4 hours. Do not freeze.

The diluted solution can be stored in a refrigerator (2°C – 8°C) before administration for up to 24 hours. Do not freeze. If refrigerated, allow the diluted solution to reach room temperature before administration. The diluted solution for infusion can be kept at room temperature (20°C – 25°C) for a maximum of 6 hours.

Medicines should not be disposed of via wastewater or household waste. Your healthcare professional will dispose of unused medicines. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Blenrep

The active substance is belantamab mafodotin. One vial of powder contains 70 mg or 100 mg of belantamab mafodotin, respectively. After reconstitution, the solution contains 50 mg of belantamab mafodotin per ml.

The other ingredients are sodium citrate dihydrate, citric acid monohydrate (E330), trehalose dihydrate, disodium edetate, and polysorbate 80 (E433) (see section 2 "Blenrep contains polysorbate and sodium").

Appearance and Package Contents of the Product

Blenrep 70 mg powder for concentrate for solution for infusion (powder for concentrate) and Blenrep 100 mg powder for concentrate for solution for infusion (powder for concentrate) are presented as a white to yellowish powder in a glass vial with a rubber stopper and a removable plastic cap. Each package contains one vial.

Marketing Authorization Holder

GlaxoSmithKline Trading Services Limited

12 Riverwalk

Citywest Business Campus

Dublin 24

Ireland

D24 YK11

Manufacturer

GlaxoSmithKline Manufacturing SpA

Strada Provinciale Asolana, 90

San Polo di Torrile, Parma 43056

Italy

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:09/2025

Other Sources of Information

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

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This information is intended for healthcare professionals only:

Step-by-Step Instructions for Use, Handling, Reconstitution, and Administration.

The trade name and batch number of the administered product must be clearly recorded in the patient's medical history.

Caution should be exercised when handling and preparing Blenrep. Follow the procedures for the correct handling and disposal of cytotoxic anticancer medicines.

Preparation of the Solution for Infusion

Blenrep is a cytotoxic anticancer medicine. Proper handling procedures should be followed. Use an aseptic technique for the reconstitution and dilution of the dosing solution.

Calculate the dose (mg), the total volume (ml) of solution required, and the number of vials needed based on the patient's actual body weight (kg).

Reconstitution

1. Remove the Blenrep vials from the refrigerator and let them stand for approximately 10 minutes to reach room temperature.
2. Reconstitute each 70 mg vial of Blenrep with 1.4 ml of sterile water for injection to obtain a concentration of 50 mg/ml. Gently swirl the vial to aid dissolution. Do not shake.

Reconstitute each 100 mg vial of Blenrep with 2 ml of sterile water for injection to obtain a concentration of 50 mg/ml. Gently swirl the vial to aid dissolution. Do not shake.

1. Visually inspect the reconstituted solution for particles and discoloration. The reconstituted solution should be a clear to opalescent, colorless to yellowish-brown liquid. Discard the reconstituted solution if any foreign particles are observed that are not translucent to white protein particles.

Dilution Instructions for Intravenous Use

1. Withdraw the required volume for the calculated dose from each vial.
2. Add the necessary amount of Blenrep to the infusion bag containing 250 ml of sodium chloride 9 mg/ml (0.9%) injection solution. Mix the diluted solution by gentle inversion. The final concentration of the diluted solution should be between 0.2 mg/ml and 2 mg/ml. Do not shake.
3. Discard any unused reconstituted Blenrep solution remaining in the vial.

If the diluted solution is not used immediately, it can be stored in a refrigerator (2°C to 8°C) for up to 24 hours before administration. If refrigerated, allow the diluted solution to reach room temperature before administration. The diluted solution can be kept at room temperature (20°C to 25°C) for a maximum of 6 hours (including infusion time).

Administration Instructions

1. Administer the diluted solution only by intravenous infusion over approximately 30 minutes using a polyvinyl chloride or polyolefin infusion bag. If the administration time exceeds 30 minutes, do not exceed the permitted duration of use of 6 hours, including both preparation and administration of the dose.
2. No filtration of the diluted solution is required. However, if the diluted solution is filtered, a 0.2 μm or 0.22 μm polyethersulfone (PES) filter is recommended.

Disposal

Disposal of unused medicine and all materials that have come into contact with it should be carried out in accordance with local regulations.