Azacitidine Celgene

Maa: Euroopan unioni

Kieli: englanti

Lähde: EMA (European Medicines Agency)

Aktiivinen ainesosa:

azacitidine

Saatavilla:

Celgene Europe BV

ATC-koodi:

L01BC07

INN (Kansainvälinen yleisnimi):

azacitidine

Terapeuttinen ryhmä:

Antineoplastic agents

Terapeuttinen alue:

Myelodysplastic Syndromes; Leukemia, Myelomonocytic, Chronic; Leukemia, Myeloid, Acute

Käyttöaiheet:

Azacitidine Celgene is indicated for the treatment of adult patients who are not eligible for haematopoietic stem cell transplantation (HSCT) with:intermediate 2 and high-risk myelodysplastic syndromes (MDS) according to the International Prognostic Scoring System (IPSS),chronic myelomonocytic leukaemia (CMML) with 10 29 % marrow blasts without myeloproliferative disorder,acute myeloid leukaemia (AML) with 20 30 % blasts and multi-lineage dysplasia, according to World Health Organisation (WHO) classification,AML with >30% marrow blasts according to the WHO classification.

Tuoteyhteenveto:

Revision: 2

Valtuutuksen tilan:

Withdrawn

Valtuutus päivämäärä:

2019-08-02

Pakkausseloste

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
1.
NAME OF THE MEDICINAL PRODUCT
Azacitidine Celgene 25 mg/mL powder for suspension for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 100 mg azacitidine. After reconstitution, each mL
of suspension contains 25 mg
azacitidine.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for suspension for injection.
White lyophilised powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Azacitidine Celgene is indicated for the treatment of adult patients
who are not eligible for
haematopoietic stem cell transplantation (HSCT) with:
•
intermediate-2 and high-risk myelodysplastic syndromes (MDS) according
to the International
Prognostic Scoring System (IPSS),
•
chronic myelomonocytic leukaemia (CMML) with 10-29% marrow blasts
without
myeloproliferative disorder,
•
acute myeloid leukaemia (AML) with 20-30% blasts and multi-lineage
dysplasia, according to
World Health Organisation (WHO) classification,
•
AML with > 30% marrow blasts according to the WHO classification.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Azacitidine Celgene treatment should be initiated and monitored under
the supervision of a physician
experienced in the use of chemotherapeutic agents. Patients should be
premedicated with anti-emetics
for nausea and vomiting.
Posology
The recommended starting dose for the first treatment cycle, for all
patients regardless of baseline
haematology laboratory values, is 75 mg/m
2
of body surface area, injected subcutaneously, daily for
7 days, followed by a rest period of 21 days (28-day treatment cycle).
It is recommended that patients be treated for a minimum of 6 cycles.
Treatment should be continued
as long as the patient continues to benefit or until disease
progression.
_ _
Patients should be monitored for haematologic response/toxicity and
renal toxicities (see section 4.4);
a delay in starting the next cycle or a dose reduction as described
below may be necessary

Valmisteyhteenveto

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
1.
NAME OF THE MEDICINAL PRODUCT
Azacitidine Celgene 25 mg/mL powder for suspension for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 100 mg azacitidine. After reconstitution, each mL
of suspension contains 25 mg
azacitidine.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for suspension for injection.
White lyophilised powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Azacitidine Celgene is indicated for the treatment of adult patients
who are not eligible for
haematopoietic stem cell transplantation (HSCT) with:
•
intermediate-2 and high-risk myelodysplastic syndromes (MDS) according
to the International
Prognostic Scoring System (IPSS),
•
chronic myelomonocytic leukaemia (CMML) with 10-29% marrow blasts
without
myeloproliferative disorder,
•
acute myeloid leukaemia (AML) with 20-30% blasts and multi-lineage
dysplasia, according to
World Health Organisation (WHO) classification,
•
AML with > 30% marrow blasts according to the WHO classification.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Azacitidine Celgene treatment should be initiated and monitored under
the supervision of a physician
experienced in the use of chemotherapeutic agents. Patients should be
premedicated with anti-emetics
for nausea and vomiting.
Posology
The recommended starting dose for the first treatment cycle, for all
patients regardless of baseline
haematology laboratory values, is 75 mg/m
2
of body surface area, injected subcutaneously, daily for
7 days, followed by a rest period of 21 days (28-day treatment cycle).
It is recommended that patients be treated for a minimum of 6 cycles.
Treatment should be continued
as long as the patient continues to benefit or until disease
progression.
_ _
Patients should be monitored for haematologic response/toxicity and
renal toxicities (see section 4.4);
a delay in starting the next cycle or a dose reduction as described
below may be necessary