REBLOZYL 25 MG

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

LUSPATERCEPT

Available from:

BRISTOL, MYERS SQUIBB (ISRAEL) LIMITED, ISRAEL

ATC code:

B03XA06

Pharmaceutical form:

POWDER FOR SOLUTION FOR INJECTION

Composition:

LUSPATERCEPT 25 MG

Administration route:

S.C

Prescription type:

Required

Manufactured by:

CELGENE CORPORATION, USA

Therapeutic area:

LUSPATERCEPT

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 unsatisfactory response to or are ineligible for erythropoietin-based therapy.Reblozyl is indicated in adults for the treatment of anaemia associated with transfusion dependent and non-transfusion-dependent beta-thalassaemia

Authorization date:

2022-01-30

Patient Information leaflet

Patient leaflet in accordance with the Pharmacists’
Regulations (Preparations) - 1986
This medicine is dispensed with a doctor’s prescription only
Reblozyl
®
25 mg
Reblozyl
®
75 mg
Powder for solution for injection
Active ingredient and its quantity:
Reblozyl
®
25 mg: Each vial contains 25 mg luspatercept
Reblozyl
®
75 mg: Each vial contains 75 mg luspatercept
After reconstitution, each mL of solution contains 50 mg luspatercept
Inactive ingredients - see section 6 under ‘Additional
information’ and the section
‘Important information about some of this medicine’s
ingredients’ in section 2.
Read the entire leaflet carefully before you start using this
medicine. This
leaflet contains concise information about this medicine. If you have
any further
questions, ask your doctor or pharmacist.
This medicine has been prescribed to treat you. Do not pass it on to
others. It may
harm them, even if it seems to you that their medical condition is
similar to yours.
In addition to the leaflet, Reblozyl has a Patient Card (for women of
childbearing
potential). This card contains important safety information that you
should know
before starting and during the treatment with Reblozyl and which you
should
follow. Carefully read the Patient Card (for women of childbearing
potential) and
patient leaflet before starting treatment with this medicine. Keep the
card for
further reference if needed.
1. What is this medicine intended for?
- 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 unsatisfactory response to or
are
ineligible
for
erythropoietin-based
therapy.
-
Reblozyl is indicated for the treatment of adult patients with
transfusion-dependent
anaemia associated with beta-thalassaemia.
Therapeutic group: anti-anaemic medicines
Myelodysplastic syndromes (MDS)
Myelodysplastic syndromes (MDS) are a collection of many different
blood and
bone marrow disorders.
Red b

Summary of Product characteristics

1
Reblozyl_NPI_July2023
1.
NAME OF THE MEDICINAL PRODUCT
Reblozyl 25 mg
Reblozyl 75 mg
Powder for solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Reblozyl 25 mg powder for solution for injection
Each vial contains 25 mg of luspatercept. After reconstitution, each
mL of solution contains 50 mg
luspatercept.
Reblozyl 75 mg powder for solution for injection
Each vial contains 75 mg of luspatercept. After reconstitution, each
mL of solution contains 50 mg
luspatercept.
Luspatercept is produced in Chinese Hamster Ovary (CHO) cells by
recombinant DNA technology.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for solution for injection.
White to off-white lyophilised powder.
4.
CLINICAL PARTICULARS
Patient Safety Information Card
The marketing of Reblozyl is subject to risk management plan (RMP)
including a ‘Patient Card (for
Women of Childbearing Potenial)’, emphasizes important safety
information that the patient should
be aware of before and during treatment.
Please explain to the patient the need to review the card before
starting treatment.
Prescriber’s Checklist
This product is marketed with a prescriber’s checklist providing
important safety information.
Please ensure you are familiar with this material as it contains
important safety information.
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 unsatisfactory response to or are ineligible for
erythropoietin-based therapy (see section 5.1).
Reblozyl is indicated for the treatment of adult patients with
transfusion-dependent anaemia associated
with beta-thalassaemia (see section 5.1).
2
Reblozyl_NPI_July2023
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) leve