YONDELIS 1 MG

Land: Israel

Språk: engelska

Källa: Ministry of Health

Aktiva substanser:

TRABECTEDIN

Tillgänglig från:

MEGAPHARM LTD

ATC-kod:

L01CX01

Läkemedelsform:

POWDER FOR CONCENTRATE FOR SOLUTION FOR INJECTION

Sammansättning:

TRABECTEDIN 1 MG/VIAL

Administreringssätt:

I.V

Receptbelagda typ:

Required

Tillverkad av:

JANSSEN PHARMACEUTICA N.V.,BELGIUM

Terapeutisk grupp:

TRABECTEDIN

Terapiområde:

TRABECTEDIN

Terapeutiska indikationer:

Yondelis is indicated for the treatment of patients with advanced soft tissue sarcoma, after failure of anthracyclines and ifosfamide, or who are unsuited to receive these agents. Efficacy data are based mainly on liposarcoma and leiomyosarcoma patients.

Tillstånd datum:

2015-02-28

Bipacksedel

ל ןולעב )תוחיטב עדימ ( הרמחה לע העדוה
ל ןולעב )תוחיטב עדימ ( הרמחה לע העדוה
ל ןולעב )תוחיטב עדימ ( הרמחה לע העדוה
ןכרצ
ןכרצ
ןכרצ
ךיראת :
17.1.16
תילגנאב רישכת םש
:
1mg
Yondelis
םושיר רפסמ
:
142 85 31830 00
םושירה לעב םש :
C Health care
-
J
ל ןולעב )תוחיטב עדימ ( הרמחה לע העדוה
ל ןולעב )תוחיטב עדימ ( הרמחה לע העדוה
ל ןולעב )תוחיטב עדימ ( הרמחה לע העדוה
אפור
אפור
אפור
םי/שקובמה םי/יונישה לע םיטרפ
ןולעב קרפ
יחכונ טסקט
שדח טסקט
POSOLOGY AND
METHOD OF
ADMINISTRATION
DURATION OF TREATMENT
In clinical trials, there were no pre-defined limits to the number
of cycles administered. Treatment continued whilst clinical
benefit was noted. Yondelis has been administered for 6 or
more cycles in 29.5% of patients. The monotherapy regimen
has been used for up to 38 cycles. No cumulative toxicities
have been observed in patients treated with multiple cycles.
WARNINGS AND
PRECAUTIONS
Neutropenia, thrombocytopenia and leucopenia
Grades 3 or 4 neutropenia and thrombocytopenia
associated with Yondelis therapy have been very
Neutropenia, and thrombocytopenia and leucopenia
Grades 3 or 4 neutropenia and thrombocytopenia associated
with Yondelis therapy have been very commonly reported.
commonly reported.
Neutrophil nadirs occurred at a
median of 15 days and recovered within a week. A full
blood cell count including differential and platelet count
must be performed at baseline, weekly for the first two
cycles and then once between cycles (see _Dosage and _
_Administration_). Patients who develop fever should
promptly seek medical attention. If this occurs, active
supportive therapy should be started immediately.
Neutrophil nadirs occurred at a median of 15 days and
recovered within a week.
A full blood cell count including
differential and platelet count must be pe

Produktens egenskaper

Page 1 of 15
YONDELIS 1MG
1.
NAME OF THE MEDICINAL PRODUCT
Yondelis 1 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial of powder contains 1 mg of trabectedin.
1 ml of reconstituted solution contains 0.05 mg of trabectedin (see
Section 6.6)
Excipients:
Each vial contains 8 mg of potassium and 0.4 g of sucrose.
For a full list of excipients and allergens, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for concentrate for solution for infusion.
Yondelis 1mg drug product is provided as a sterile lyophilized White
to off-white powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Yondelis 1mg is indicated for the treatment of patients with advanced
soft tissue sarcoma,
after
failure of anthracyclines and ifosfamide, or who are unsuited to
receive these agents.
Efficacy
data are based mainly on liposarcoma and leiomyosarcoma patients.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Yondelis 1mg must be administered under the supervision of a physician
experienced in the
use of
chemotherapy. Its use should be confined to personnel specialized in
the
administration of
cytotoxic agents.
Posology
For the treatment of soft tissue sarcoma, 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.
All
patients
must
be
premedicated
with
corticosteroids
such as
dexamethasone
20
mg
intravenously
30
minutes
before
each
Yondelis
1mg
infusion;
not
only
as
anti-emetic
prophylaxis,
but also because it appears to provide hepatoprotective effects.
Additional anti-
emetics may
be administered as needed (see Interactions).
The following criteria are required to allow treatment with Yondelis
1mg:
-
Absolute neutrophil count (ANC) ≥ 1,500/mm
3
-
Platelet count ≥ 100,000/mm
3
-
Haemoglobin ≥ 9 g/dl
-
Bilirubin ≤ upper limit of normal (ULN)
-
Alkaline phosphatase of non-osseous origin ≤ 2.5 x ULN (consider
hepatic
isoenzymes 5-nucleotidase or GGT, to distinguish if the elevation
could be osseous in
origin).
-
Albumin ≥ 25