Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - reblozyl

Document Subject

Generated Narrative: MedicinalProductDefinition mp430493049f22429aa3d2e8bb859f1d18

identifier: http://ema.europa.eu/identifier/EU/1/20/1452/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Reblozyl 25 mg powder for solution for injection

type: Full name

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part: nan

type: Invented name part

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part: nan

type: Scientific name part

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type: Strength part

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type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-430493049f22429aa3d2e8bb859f1d18

identifier: http://ema.europa.eu/identifier/EU/1/20/1452/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - reblozyl

Attesters

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

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 -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 to treat anaemia in adults with -thalassaemia who may or may not need regular 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.

For MDS and -thalassaemia patients in need of regular blood transfusions
Having Reblozyl can avoid or reduce the need for red blood cell transfusions.

• Red blood cell transfusions can cause abnormally high levels of iron in the blood and in different organs of the body. This can be harmful over time.

For -thalassaemia patients not in need of regular blood transfusions
Having Reblozyl can improve your aneamia by increasing your haemoglobin level.

Do not use 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)
• if you require treatment for the control of mass producing blood cells outside the bone marrow (extramedullary haemopoiesis masses, EMH masses)

Warnings and precautions Talk to your doctor before being given this medicine if:

• you are a -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: * hormone replacement therapy or * a previous blood clot
  Your doctor may use preventive measures or medicines to reduce the chances of you getting a blood clot.
• you have severe back pain that does not go away, numbness or weakness or loss of voluntary movement in legs, hands or arms, loss of bowel and bladder control (incontinence). They may be symptoms of EMH masses and compression of spinal cord.
• 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. You will be given Reblozyl only if your blood pressure is under control.
• you have a condition that affects the strength and health of your bones (osteopenia and osteoporosis). You may have a risk of breaking your bones more easily.

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 and will give you a patient card.
• 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 .

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

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

Serious side effects Tell your doctor straight away if you notice the following:

• 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.
• painful swelling and tightness in the leg or arm (blood clots)
• severe back pain that does not go away, numbness or weakness or loss of voluntary movement in legs, hands or arms, loss of bowel and bladder control (incontinence). They may be symptoms of extramedullary haemopoiesis masses (EMH masses) and compression of spinal cord.
• 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
• cough
• difficulty in breathing or shortness of breath
• high blood pressure without symptoms or associated with headache
• urinary tract infection
• upper respiratory tract infection
• flu or flu like symptoms
• dizziness, headache
• diarrhoea, feeling sick (nausea)
• belly pain
• back, joint or bone pain
• feeling tired or weak
• difficulty to sleep or to stay asleep
• changes in blood test results (increase in liver enzymes, increase in blood creatinine). These may be signs of liver and kidney problems.

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

• fainting, spinning feeling
• broken bones caused by trauma
• bleeding from the nose
• intense headache on one side of the head
• redness, burning and pain at the site of injection (injection site reactions) or swelling, itchy skin (injection site erythema)
• high level of uric acid in the blood (shown in tests)
• foamy urine. This may be a sign of too much protein in your urine (proteinuria and albuminuria).

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 via the national reporting system listed in 44TAppendix V44T. By reporting side effects you can help provide more information on the safety of this medicine.

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.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What Reblozyl contains

• 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 Blanchardstown Corporate Park 2 Dublin 15, D15 TIreland

Manufacturer Celgene Distribution B.V. Orteliuslaan 13528 BD Utrecht Netherlands

This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: