HYCAMTIN FOR INJECTION 4 mgvial

Country: Singapura

Bahasa: Inggeris

Sumber: HSA (Health Sciences Authority)

Bahan aktif:

TOPOTECAN HCl EQV TOPOTECAN

Boleh didapati daripada:

NOVARTIS (SINGAPORE) PTE LTD

Kod ATC:

L01XX17

Dos:

4 mg/vial

Borang farmaseutikal:

INJECTION, POWDER, FOR SOLUTION

Komposisi:

TOPOTECAN HCl EQV TOPOTECAN 4 mg/vial

Laluan pentadbiran:

INTRAVENOUS

Jenis preskripsi:

Prescription Only

Dikeluarkan oleh:

GlaxoSmithKline Manufacturing S.p.A.

Status kebenaran:

ACTIVE

Tarikh kebenaran:

1997-07-23

Risalah maklumat

1 of 21 
HYCAMTIN
TOPOTECAN HYDROCHLORIDE 
TM

QUALITATIVE AND QUANTITATIVE COMPOSITION 
Topotecan hydrochloride 
A sterile, lyophilised powder in
single-dose vials for intravenous ( i.v.) infusion 
following reconstitution and further dilution. 
Powder for solution for infusion, 4 mg. 
Each 4 mg vial contains 4 mg topotecan as topotecan
hydrochloride. 
PHARMACEUTICAL FORM 
Powder for i.v. infusion. 
CLINICAL PARTICULARS 
INDICATIONS 
HYCAMTIN is indicated for the treatment of: 
•  metastatic carcinoma of the ovary after failure
of initial or subsequent chemotherapy. 
• 
small cell lung cancer sensitive disease
after failure of first-line chemotherapy. In clinical 
studies submitted to support approval,
sensitive disease was defined as disease 
responding to
chemotherapy but subsequently progressing at least 60 days (in
the Phase 
III study) or at least 90 days (in the Phase II studies) after
chemotherapy (_See Clinical _
_Studies Section_).

HYCAMTIN in combination with cisplatin is indicated for
the treatment of patients with 
histologically confirmed Stage IV-B, recurrent, or
persistent carcinoma of the cervix, which 
is not amenable to curative treatment with surgery and/or
radiation therapy (_See Clinical _
_Studies Section_).

For efficacy data see Clinical Studies. 
DOSAGE AND ADMINISTRATION 
HYCAMTIN must be reconstituted and further diluted
before use (_see Instructions for _
_Use/Handling_). 
Prior to administration of the first course of HYCAMTIN,
patients must have a baseline 
neutrophil count of more than or equal to 1.5 x 10
9
/L and a platelet count of more than or 
equal to 100 x 10
9

/L and a haemoglobin level of more than or equal to 9g/dL. 

2 of 21 
POPULATIONS 
ADULTS 
OVARIAN AND SMALL CELL LUNG CARCINOMA 
INITIAL DOSE 
The recommended dose of HYCAMTIN  is 1.5 mg/m
2
SUBSEQUE

Ciri produk

CONFIDENTIAL
1
HYCAMTIN
TM
TOPOTECAN HYDROCHLORIDE
TRADENAME(S)
HYCAMTIN™
DESCRIPTION AND COMPOSITION
CHEMICAL STRUCTURE
Topotecan
hydrochloride:
_S_
)-10-[(dimethylamino)
methyl]-4-ethyl-4,9-dihydroxy-1
_H_
-
pyrano[3',4':6,7]indolizino[1,2-
_b_
]-quinoline-3, 14-(4
_H_
,12
_H_
)-dione monohydrochloride.
PHARMACEUTICAL FORM(S)
CAPSULES:
Hard capsules for oral administration, 0.25 mg and 1 mg.
Topotecan hard capsule, 0.25 mg: Opaque white to yellowish white,
imprinted with
HYCAMTIN 0.25 mg. Each hard capsule contains topotecan hydrochloride
equivalent to
0.25 mg topotecan free base.
Topotecan hard capsule, 1 mg: Opaque pink, imprinted with HYCAMTIN 1
mg. Each
hard capsule contains topotecan hydrochloride equivalent to 1 mg
topotecan free base.
EXCIPIENTS
CAPSULES
Hydrogenated vegetable oil
Glyceryl monostearate
Gelatin
Titanium dioxide
Black printing ink containing black iron oxide, shellac, anhydrous
alcohol, propylene glycol,
isopropyl alcohol, butanol, concentrated ammonia solution and
potassium hydroxide.
1 mg capsules also contain red iron oxide.
INDICATIONS
CONFIDENTIAL
2

Indicated as monotherapy for the treatment of adult patients with
relapsed small
cell lung cancer (SCLC) for whom re-treatment with the first-line
regimen is not
considered appropriate.
For efficacy data see
_Clinical Studies_
_ _
DOSAGE REGIMEN AND ADMINISTRATION
Prior to administration of the first course of HYCAMTIN, patients must
have a baseline
neutrophil count of more than or equal to 1.5 x 10
9
/L, a platelet count of more than or
equal
to 100 x 10
9
/L and a haemoglobin level of more than or equal to 9 g/dL (after
transfusion if
necessary).
Hycamtin capsule(s) must be swallowed whole, and must not be chewed,
crushed or divided.
Hycamtin capsules may be taken with or without food
_(see Clinical Pharmacology.)_
CONFIDENTIAL
3 INITIAL DOSE
The recommended dose of oral HYCAMTIN is 2.3 mg/m
2
daily for 5 consecutive days
every 21 days.
SUBSEQUENT DOSES
For patients who experience Grade 3 or 4 diarrhoea, the oral HYCAMTIN
dose shou