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REBLOZYL Powder for solution for injection (2020)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

1. Name of the medicinal product

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

2. Qualitative and quantitative composition

<u>Reblozyl 25 mg powder for solution for injection:</u> Each vial contains 25 mg of luspatercept. After reconstitution, each mL of solution contains 50 mg luspatercept. <u>Reblozyl 75 mg powder for solution ...

3. Pharmaceutical form

Powder for solution for injection (powder for injection). White to off-white lyophilised powder.

4.1. Therapeutic indications

Reblozyl is indicated for the treatment of adult patients with transfusion-dependent anaemia due to very low, low and intermediate-risk myelodysplastic syndromes (MDS) with ring sideroblasts, who had an ...

4.2. Posology and method of administration

Reblozyl treatment should be initiated by a physician experienced in treatment of haematological diseases. Posology Prior to each Reblozyl administration, the haemoglobin (Hb) level of patients should ...

4.3. Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Pregnancy (see section 4.6).

4.4. Special warnings and precautions for use

Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. Thromboembolic events In β-thalassaemia ...

4.5. Interaction with other medicinal products and other forms of interaction

No formal clinical interaction studies have been performed. Concurrent use of iron-chelating agents had no effect on luspatercept pharmacokinetics.

4.6. Fertility, pregnancy and lactation

Women of childbearing potential / Contraception in females Women of childbearing potential have to use effective contraception during treatment with Reblozyl and for at least 3 months after the last dose. ...

4.7. Effects on ability to drive and use machines

Reblozyl may have a minor influence on the ability to drive and use machines. The ability to react when performing these tasks may be impaired due to risks of fatigue, vertigo, dizziness or syncope (see ...

4.8. Undesirable effects

Summary of the safety profile Myelodysplastic syndromes The most frequently reported adverse drug reactions in patients receiving Reblozyl (at least 15% of patients) were fatigue, diarrhoea, asthenia, ...

4.9. Overdose

Overdose with luspatercept may cause an increase of Hb values above the desired level. In the event of an overdose, treatment with luspatercept should be delayed until Hb is ≤11 g/dL.

5.1. Pharmacodynamic properties

<b>Pharmacotherapeutic group:</b> Antianaemic preparations, other antianaemic preparations <b>ATC code:</b> B03XA06 Mechanism of action Luspatercept, an erythroid maturation agent, is a recombinant fusion ...

5.2. Pharmacokinetic properties

Absorption In healthy volunteers and patients, luspatercept is slowly absorbed following subcutaneous administration, with the C<sub>max</sub> in serum often observed approximately 7 days post-dose across ...

5.3. Preclinical safety data

Single and repeat-dose toxicity Following repeated administration of luspatercept in rats, toxicities included: membranoproliferative glomerulonephritis; congestion, necrosis and/or mineralisation of the ...

6.1. List of excipients

Citric acid monohydrate (E330) Sodium citrate (E331) Polysorbate 80 Sucrose Hydrochloric acid (for pH adjustment) Sodium hydroxide (for pH adjustment)

6.2. Incompatibilities

This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.

6.3. Shelf life

<u>Unopened vial:</u> 3 years. <u>After reconstitution:</u> When stored in the original container, chemical and physical in-use stability of the reconstituted medicinal product has been demonstrated for ...

6.4. Special precautions for storage

Store in a refrigerator (2°C-8°C). Do not freeze. Store in the original carton in order to protect from light. For storage conditions after reconstitution of the medicinal product, see section 6.3.

6.5. Nature and contents of container

<u>Reblozyl 25 mg powder for solution for injection:</u> 3 mL Type I glass vial with a hydrophobic inner coating closed with a bromobutyl rubber stopper and aluminium seal with yellow polypropylene flip-off ...

6.6. Special precautions for disposal and other handling

Reblozyl must be reconstituted gently prior to administration. Aggressive shaking should be avoided. Reconstitution of the product Reblozyl is supplied as a lyophilised powder for reconstitution before ...

8. Marketing authorization number(s)

Celgene Europe B.V., Winthontlaan 6 N, 3526 KV Utrecht, Netherlands

9. Date of first authorization / renewal of the authorization

EU/1/20/1452/001 EU/1/20/1452/002

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