Reblozyl 25 mg, 75 mg powder for solution for injection
luspatercept
What Reblozyl is and what it is used for
Reblozyl contains the active substance luspatercept. It is used for:
Myelodysplastic syndrome
Myelodysplastic syndrome (MDS) is a collective name for several different bloods and bone marrow disorders.
- Red blood cells become abnormal and do not develop properly.
- Patients may have several signs and symptoms, including a low number of red blood cells ( anemia ), and may need red blood cell transfusions. Reblozyl is used in adults who need transfusions of red blood cells due to MDS. It is used in adults who have already received or are unable to receive erythropoietin treatments.
Beta- thalassemia
β- thalassemia is a blood disease that is transmitted through genes.
- The disease affects the production of hemoglobin.
- Patients may have several signs and symptoms such as a low number of red blood cells ( anemia ) and may need transfusions of red blood cells.
Reblozyl is used in adults with β‑ thalassemia who need transfusions of red blood cells.
How Reblozyl works
Reblozyl improves the body’s ability to produce red blood cells. Red blood cells contain hemoglobin, which is a protein that transports oxygen throughout the body. As the body produces more red blood cells, hemoglobin levels increase.
Reblozyl treatment reduces the need for transfusions of red blood cells.
- Regular blood transfusions can cause abnormally high concentrations of iron in the blood and various organs of the body. This can be harmful over time.
What you need to know before you use Reblozyl
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 the section on pregnancy)
Warnings and cautions
Talk to your doctor before using this medicine if:
- you have β‑ thalassemia and you have had your spleen removed. You may be at 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 clotYour doctor may take preventative measures or use medicines to reduce the risk of you getting a blood clot.
- you have ever had high blood pressure – this as Reblozyl can increase blood pressure. Your blood pressure will be checked before you receive Reblozyl and during treatment.
Routine tests
You will be given a blood test before each dose of this medicine. This is because your doctor needs to make sure your hemoglobin value is appropriate for you to receive treatment.
If you have kidney problems, your doctor may perform additional tests.
Children and young people
This medicine is not recommended for use in children and adolescents under 18 years of age.
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 or for at least 3 months before you become pregnant. Reblozyl can harm 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 taking this medicine.
Breast-feeding
- Do not breastfeed while taking this medicine or for 3 months after your last dose. It is unknown if this medicine passes into breast milk.
Contraceptive
- 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 which contraceptives may be suitable for you during treatment with this medicine
Fertility
If you are a woman, this medicine may cause fertility problems. It can affect your ability to have children. Ask your doctor for advice before using this medicine
Driving and using machines
You may feel tired, dizzy, or faint when you use Reblozyl. If this happens, consult your doctor immediately and avoid driving or using tools or machines.
Reblozyl contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per dose, ie essentially ‘sodium-free’.
How to use Reblozyl
Before you are given this medicine, your doctor will have taken blood samples and determined that you need Reblozyl.
Reblozyl is given by injection under the skin ( subcutaneously ).
How much will you be given
Dose one 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.
- The dose should be given once every three weeks.
- Your doctor will monitor your progress and may change your dose as needed.
Your doctor will monitor your blood pressure while you are using Reblozyl.
Myelodysplastic syndrome
The maximum single dose is 1.75 mg for each kilogram of body weight.
Beta- thalassemia
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 a visit is postponed, you will receive an injection of Reblozyl 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 product, ask your doctor or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects are
Tell your doctor immediately if you notice any of the following:
- gait or speech difficulties, dizziness, loss of balance and coordination, numbness or paralysis of the face, legs, or arm (often on one side of the body), and blurred vision. These can all be symptoms of a stroke.
- blood clots
- swelling in the area around the eyes, face, lips, mouth, tongue, or throat
- allergic reactions
- rash
Other side effects include:
Very common side effects ( may affect more than 1 in 10 people):
- lower respiratory tract infection
- difficulty breathing or shortness of breath
- urinary tract infection
- dizziness, headache
- diarrhea, nausea
- back, joint or skeletal pain
- feel tired or weak
Common side effects ( may affect up to 1 in 10 people):
- flu symptoms
- fainting, feeling that everything is spinning
- high blood pressure without any symptoms or with headache
- redness, burning, and pain at the injection site (injection site reactions)
- high level of uric acid in the blood (shown by tests)
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 vial after EXP. The expiration date is the last day of the specified month.
Unopened vials: Store in a refrigerator (2 -C-8 ºC). Do not freeze. Store in the original package. Sensitive to light.
After opening and reconstituting Reblozyl, the solution for injection should be used immediately. If not used immediately, the reconstituted product may be stored in its original package for up to 8 hours at room temperature (≤ 25 ° C) or for up to 24 hours at 2 ° C-8 ° C.
The prepared solution must not be frozen.
Any unused product or waste material should be disposed of by local requirements.
Contents of the pack and other information
Content declaration
- The active substance is luspatercept. Each vial contains 25 mg or 75 mg of luspatercept. After reconstitution, each ml of solution contains 50 mg of luspatercept.
- 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 the medicine looks like and the 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 BV
Orteliuslaan 1000
3528 BD Utrecht
Netherlands