YONDELIS 1MG FOR INJECTION

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

TRABECTEDIN

Boleh didapati daripada:

ZUELLIG PHARMA SDN BHD

INN (Nama Antarabangsa):

TRABECTEDIN

Unit dalam pakej:

1Units Units

Dikeluarkan oleh:

BAXTER ONCOLOGY GMBH

Ciri produk

1
PRODUCT NAME
YONDELIS

1 mg for Injection
DOSAGE FORMS AND STRENGTHS
Powder for concentrate for solution for infusion.
YONDELIS

drug product is provided as a sterile lyophilized white to off-white
powder.
Each vial contains 1 mg of trabectedin.
1 mL of reconstituted solution contains 0.05 mg of trabectedin (see
_Instructions for Use and _
_Handling and Disposal_
).
INN: Trabectedin; CAS Registry No.: 114899-77-3
Chemical
Name:
(CAS):
(1'
_R_
,6
_R_
,6a
_R_
,7
_R_
,13
_S_
,14
_S_
,16
_R_
)-5-(acetyloxy)-3',4',6,6a,7,13,14,16-
octahydro-6',8,14-trihydroxy-7',9-dimethoxy-4,10,23-trimethyl-spiro[6,16
(epithiopropanoxymethano)-7,13-imino-12
_H_
-1,3-dioxolo[7,8]isoquino[3,2-
_b_
][3]benzazocine-
20,1'(2'
_H_
)-isoquinolin]-19-one.
Molecular Formula: The molecular formula is C
39
H
43
N
3
O
11
S.
Molecular Weight: The molecular weight of trabectedin is 761.84 g/mol.
Solubility: Trabectedin is hydrophobic, and has a low solubility in
water. Trabectedin solubility
is enhanced in acidic media.
For excipients, see
_List of Excipients._
CLINICAL INFORMATION
INDICATIONS
YONDELIS

is indicated for the treatment of adult patients with advanced soft
tissue sarcoma
(STS), after failure of anthracyclines and ifosfamide, or who are
unsuited to receive these agents.
Efficacy data are based mainly on liposarcoma and leiomyosarcoma
patients.
YONDELIS

in combination with pegylated liposomal doxorubicin hydrochloride
(PLD) is
indicated for the treatment of patients with relapsed
platinum-sensitive ovarian cancer.
DOSAGE AND ADMINISTRATION
YONDELIS

must be administered under the supervision of a physician experienced
in the use
of chemotherapy. Its use should be confined to qualified oncologists
or other health professionals
specialized in the administration of cytotoxic agents.
_POSOLOGY _
For the treatment of soft tissue sarcoma (STS), the recommended
starting dose is 1.5 mg/m
2
body surface area, administered as an intravenous infusion over 24
hours with a three-week
interval between cycles.
2
For the treatment of