REBLOZYL 25 MG POWDER FOR SOLUTION FOR INJECTION - patient leaflet, side effects, dosage

Package leaflet: Information for the patient

Reblozyl 25 mg powder for solution for injection Reblozyl 75 mg powder for solution for injection

Tf This medicine is subject to additional monitoring. This will allow quick identification of new safetyinformation. You canhelp by reporting any side effects you may get. See the end of section 4 for how to report side effects.

Read all of this leaflet carefully before you are given 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.This includes any possible side effects not listed

in this leaflet. See section 4.

What is in this leaflet

• 1. What Reblozyl is and what it is used for

• 2. What you need to know before you are given Reblozyl

• 3. How Reblozyl is given

• 4. Possible side effects

• 5. How to store Reblozyl

• 6. Contents of the pack and other information

1. what reblozyl is and what it is used for

Reblozyl contains the active substance luspatercept. It is used for:

Myelodysplastic syndromes

Myelodysplastic syndromes (MDS) are a collection of many different blood and bone marrow disorders.

• Red blood cells become abnormal and do not develop properly.
• Patients can get a number of signs and symptoms including a low red blood cell count

(anaemia) and may need red blood cell transfusions. Reblozyl is used in adults with anaemia caused by MDS, who need red blood cell transfusions. It is used in adults who have already had or are not able to have erythropoietin therapies.

Beta-thalassaemia

P-thalassaemia is a blood problem that is passed down through genes.

• It affects the production of haemoglobin.
• Patients can get a number of signs and symptoms including a low red blood cell count

(anaemia) and may need red blood cell transfusions.

Reblozyl is used in adults with P-thalassaemia who need red blood cell transfusions.

How Reblozyl works

Reblozyl improves your body’s ability to make red blood cells. Red blood cells contain haemoglobin, which is a protein that carries oxygen throughout your body. As your body makes more red blood cells, your haemoglobin level increases.

Having Reblozyl reduces the need for red blood cell transfusions.

• Regular blood transfusions can cause abnormally high levels of iron in the blood and in

different organs of the body.This can be harmful over time.

2. what you need to know before you are given reblozyl if you are allergic to luspatercept or any of the other ingredients of this medicine (listed in

section 6)

• if you are pregnant (see section on Pregnancy)

Warnings and precautions

Talk to your doctor before being given this medicine if:

• you are a P-thalassaemia patient and you have had your spleen removed. You may have a higher

risk of getting a blood clot. Your doctor will talk to you about other possible risk factors that may increase your risk – these include:

o hormone replacement therapy or

o a previous blood clot

Your doctor may use preventive measures or medicines to reduce the chances of you getting a blood clot.

• you have ever had high blood pressure – this is because Reblozyl may increase it. Your blood

pressure will be checked before you are given Reblozyl and throughout treatment.

Routine tests

You will have a blood test before each dose of this medicine. This is because your doctor needs to make sure your haemoglobin level is suitable for you to be given treatment.

If you have kidney problems, your doctor may perform additional tests.

Children and adolescents

This medicine is not recommended for use in children and adolescents under 18 years.

Other medicines and Reblozyl

Tell your doctor if you are taking, have recently taken or might take any other medicines.

Pregnancy

• Do not use this medicine during pregnancy and for at least 3 months before getting pregnant.

Reblozyl may cause harm to your unborn baby.

• Your doctor will arrange a pregnancy test before starting treatment.
• If you think you may be pregnant or are planning to have a baby, ask your doctor for advice

before using this medicine.

Breast-feeding

• Do not breast-feed when using this medicine and for 3 months after your last dose. It is not

known if it passes into the mother’s milk.

Contraception

• You should use an effective method of contraception during treatment with Reblozyl and for at least 3 months after your last dose.

Talk to your doctor about contraceptive methods that may be right for you while you are using this medicine.

Fertility

If you are a woman, this medicine may cause fertility problems. This could affect your ability to have

a baby. Talk to your doctor for advice before using it.

Driving and using machines

You may feel tired, dizzy, or faint, while using Reblozyl. If this happens do not drive or use any tools or machines and contact your doctor straight away.

Reblozyl contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’.

3. How Reblozyl is given

Before you are given this medicine, your doctor will have carried out blood tests and decided you need Reblozyl.

Reblozyl will be given by an injection under your skin (subcutaneously).

How much will you be given

The dose is based on how much you weigh – in kilograms. The injections will be given by a doctor, nurse or other healthcare professional.

• The recommended starting dose is 1.0 mg for each kilogram of body weight.
• This dose should be given once every three weeks.
• Your doctor will check your progress and may change your dose if needed.

Your doctor will monitor your blood pressure while you are using Reblozyl.

Myelodysplastic syndromes

The maximum single dose is 1.75 mg for each kilogram of body weight.

Beta-thalassaemia

The maximum single dose is 1.25 mg for each kilogram of body weight.

If you miss a dose

If you miss an injection of Reblozyl, or an appointment is delayed, you will receive a Reblozyl injection as soon as possible. Then, your dose will continue as prescribed – with at least 3 weeks between doses.

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

4. possible side effects

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

Serious side effects

• difficulty in walking or speaking, dizziness, loss of balance and coordination, numbness or

paralysis in the face, leg or arm (often on one side of your body), blurred vision. They may all be symptoms of a stroke.

• blood clots
• swelling of the area around the eyes, the face, lips, mouth, tongue or throat
• allergic reactions
• rashes

Other side effects include:

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

• chest infection
• difficulty in breathing or shortness of breath
• urinary tract infection
• dizziness, headache
• diarrhoea, feeling sick (nausea)
• back, joint or bone pain
• feeling tired or weak

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

• flu symptoms
• fainting, spinning feeling
• high blood pressure associated with no symptoms or with headache
• redness, burning and pain at the site of injection (injection site reactions)
• high level of uric acid in the blood (shown in tests)

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme. Website: or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

5. how to store reblozyl

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 the vial after EXP. The expiry date refers to the last day of that month.

Unopened vials: Store in a refrigerator (2°C – 8°C). Do not freeze. Store in the original carton in order to protect from light.

After first opening and reconstitution, Reblozyl should be used immediately. If not used immediately, when held in the original carton the reconstituted medicinal product may be stored for up to 8 hours at room temperature (< 25°C) or for up to 24 hours at 2°C – 8°C.

Do not freeze the reconstituted solution.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

6. contents of the pack and other information- the active substance is luspatercept. each vial contains 25 mg or 75 mg of luspatercept. after

reconstitution, each mL of solution contains 50 mg luspatercept.

• – The other excipients are citric acid monohydrate (E330), sodium citrate (E331), polysorbate 80,

sucrose, hydrochloric acid (for pH adjustment) and sodium hydroxide (for pH adjustment).

What Reblozyl looks like and contents of the pack

Reblozyl is a white to off-white powder for solution for injection. Reblozyl is supplied in glass vials containing 25 mg or 75 mg of luspatercept.

Each pack contains 1 vial.

Marketing Authorisation Holder

Bristol-Myers Squibb Pharma EEIG

Plaza 254

Blanchardstown Corporate Park 2

Dublin 15, D15 T867

Ireland

Manufacturer

Celgene Distribution B.V.

Orteliuslaan 1000

3528 BD Utrecht

Netherlands

This leaflet was last revised in September 2021

Other sources of information

The following information is intended for healthcare professionals only:

Traceability

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

Incompatibilities

This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.

Storage of the product

Unopened vial

Store in a refrigerator (2°C – 8°C). Do not freeze. Store in the original carton in order to protect from light.

Reconstituted solution

When stored in the original carton, chemical and physical in-use stability of the reconstituted medicinal product has been demonstrated for up to 8 hours at room temperature (< 25°C) or for up to 24 hours at 2°C – 8°C.

From a microbiological point of view, the medicinal 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 not be longer than 24 hours at 2°C – 8°C.

Do not freeze the reconstituted solution.

Dose calculation

The total dose, according to the patient’s weight (kg) can be calculated as follow:

Total dose (mg) = Dose (mg) x patient’s weight (kg) every three weeks.

Reconstitution instructions

Reblozyl is supplied as a lyophilised powder to be reconstituted with water for injections (WFI). A syringe with appropriate graduations must be used for reconstitution to ensure accurate dosage. See Table 1.

Table 1. Reblozyl reconstitution table

• 1. Remove the coloured cap from the vial and wipe the top with an alcohol wipe.

• 2. Add WFI into the vial by means of a syringe with appropriate graduations with a needle directing the flow onto the lyophilised powder. Allow to stand for one minute.

• 3. Discard the needle and syringe used for reconstitution. Do not use them for subcutaneous injection.

• 4. Gently swirl the vial in a circular motion for 30 seconds. Stop swirling and let the vial sit in an upright position for 30 seconds.

• 5. Inspect the vial for undissolved powder in the solution. If undissolved powder is observed, repeat step 4 until the powder is completely dissolved.

• 6. Invert the vial and gently swirl in an inverted position for 30 seconds. Bring the vial back to the upright position and let it sit for 30 seconds.

• 7. Repeat step 6 seven more times to ensure complete reconstitution of material on the sides of the vial.

• 8. Visually inspect the reconstituted solution prior to administration. When properly mixed, Reblozyl reconstituted solution is a colourless to slightly yellow, clear to slightly opalescent solution which is free of visible foreign particulate matter. Do not use if undissolved product or foreign particulate matter is observed.

• 9. If the reconstituted solution is not used immediately, see Storage of the product section above.