IXEMPRA FOR INJECTION 45 MG

Maa: Singapore

Kieli: englanti

Lähde: HSA (Health Sciences Authority)

Aktiivinen ainesosa:

Ixabepilone

Saatavilla:

LOTUS INTERNATIONAL PTE. LTD.

ATC-koodi:

L01DC04

Annos:

45 mg/vial

Lääkemuoto:

INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

Koostumus:

Ixabepilone 45 mg/vial

Antoreitti:

INTRAVENOUS

Prescription tyyppi:

Prescription Only

Valmistaja:

Baxter Oncology GmbH

Valtuutuksen tilan:

ACTIVE

Valtuutus päivämäärä:

2009-02-18

Pakkausseloste

 
Ixa SG_proposed insert_clean_08Feb2010.doc 
1

IXEMPRA (IXABEPILONE) FOR INJECTION 

1 DESCRIPTION 
IXEMPRA (ixabepilone) is a member of a novel class of antineoplastic
agents, the epothilones 
and their analogs. The natural epothilones are isolated from the
myxobacterium_ Sorangium _
_cellulosum._ Ixabepilone is a semisynthetic analog of epothilone B,
a 16-membered polyketide 
macrolide, with a chemically modified lactam substitution for the
existing lactone. This 
modification to the naturally occurring epothilone B improves its
metabolic stability, protein 
binding, and antitumor activity. 
IXEMPRA (ixabepilone) for Injection is for intravenous administration
as a sterile, lyophilized 
white
 powder in 15-mg and 45-mg single-use vials. Diluent for IXEMPRA
is supplied with the 
active drug product for use in constitution of the lyophile. The
diluent is a 50/50 (v/v) solution of 
purified polyoxyethylated castor oil and dehydrated alcohol. 
2 THERAPEUTIC 
INDICATIONS 
IXEMPRA is indicated for the treatment of locally advanced or
metastatic breast cancer after 
failure of cytotoxic chemotherapy, in combination with capecitabine
in patients failing prior 
therapy with a taxane and an anthracycline or for whom further
anthracycline therapy is not 
indicated. 
3 POSOLOGY 
AND 
METHOD OF ADMINISTRATION 
IXEMPRA must be administered under the supervision of a health care
professional qualified in 
the use of anticancer chemotherapy. 
Premedication: 
To minimize the occurrence of a hypersensitivity reaction, all
patients must be appropriately 
premedicated approximately 1 hour before the infusion of IXEMPRA
with both: 
•  an H
1
 antagonist (e.g., diphenhydramine 50 mg orally or equivalent)
and 
•  an H
2
 antagonist (e.g., ranitidine 150-300 mg orally or equivalent) 
Additional premedication with corticosteroids (e.g. dexamethasone
20 mg intravenously, 30  
minutes before infusion or orally, 60 minutes before infusion) is
only required

Valmisteyhteenveto

Ixa SG_proposed insert_clean_08Feb2010.doc
1
IXEMPRA (IXABEPILONE) FOR INJECTION
1
DESCRIPTION
IXEMPRA (ixabepilone) is a member of a novel class of antineoplastic
agents, the epothilones
and their analogs. The natural epothilones are isolated from the
myxobacterium
_ Sorangium _
_cellulosum._
Ixabepilone is a semisynthetic analog of epothilone B, a 16-membered
polyketide
macrolide,
with
a
chemically
modified
lactam
substitution
for
the
existing
lactone.
This
modification to the naturally occurring epothilone B improves its
metabolic stability, protein
binding, and antitumor activity.
IXEMPRA (ixabepilone) for Injection is for intravenous administration
as a sterile, lyophilized
white
powder in 15-mg and 45-mg single-use vials.
Diluent for IXEMPRA is supplied with the
active drug product for use in constitution of the lyophile. The
diluent is a 50/50 (v/v) solution of
purified polyoxyethylated castor oil and dehydrated alcohol.
2
THERAPEUTIC INDICATIONS
IXEMPRA is indicated for the treatment of locally advanced or
metastatic breast cancer after
failure of cytotoxic chemotherapy, in combination with capecitabine in
patients failing prior
therapy with a taxane and an anthracycline or for whom further
anthracycline therapy is not
indicated.
3
POSOLOGY AND METHOD OF ADMINISTRATION
IXEMPRA must be administered under the supervision of a health care
professional qualified in
the use of anticancer chemotherapy.
Premedication:
To minimize the occurrence of a hypersensitivity reaction, all
patients must be appropriately
premedicated approximately 1 hour before the infusion of IXEMPRA with
both:
•
an H
1
antagonist (e.g., diphenhydramine 50 mg orally or equivalent) and
•
an H
2
antagonist (e.g., ranitidine 150-300 mg orally or equivalent)
Additional premedication with corticosteroids (e.g. dexamethasone 20
mg intravenously, 30
minutes before infusion or orally, 60 minutes before infusion) is only
required for patients who
have previously experienced a hypersensitivity reaction to IXEMPRA.
Ixa SG_proposed insert_clean_0