Votrient Tablet 400 mg

Krajina: Singapur

Jazyk: angličtina

Zdroj: HSA (Health Sciences Authority)

Aktívna zložka:

Pazopanib hydrochloride 433.4 mg eqv pazopanib

Dostupné z:

NOVARTIS (SINGAPORE) PTE LTD

ATC kód:

L01XE11

Dávkovanie:

400 mg

Forma lieku:

TABLET, FILM COATED

Zloženie:

Pazopanib hydrochloride 433.4 mg eqv pazopanib 400 mg

Spôsob podávania:

ORAL

Typ predpisu:

Prescription Only

Výrobca:

Glaxo Operations UK Ltd (trading as Glaxo Wellcome Operations)

Stav Autorizácia:

ACTIVE

Dátum Autorizácia:

2011-09-23

Príbalový leták

 
VOTRIENT
TM 
PAZOPANIB HYDROCHLORIDE 
QUALITATIVE AND QUANTITATIVE COMPOSITION 
_200 MG TABLET _
The 200 mg tablets contain 217 mg of pazopanib hydrochloride,
equivalent to 200 mg of 
pazopanib free base. 
Modified capsule-shaped, pink; with GS JT debossed on one side. 
_400 MG TABLET _
The 400 mg tablets contain 433 mg of pazopanib hydrochloride,
equivalent to 400 mg of 
pazopanib free base. 
Modified capsule-shaped, white; with GS UHL debossed on one side. 
PHARMACEUTICAL FORM 
Film-coated tablets. 
CLINICAL INFORMATION 
INDICATIONS 
Renal cell carcinoma (RCC) 
VOTRIENT is indicated for the first line treatment of advanced
renal cell carcinoma 
(RCC) and for patients who have received
prior cytokine therapy for advanced disease. 
Soft tissue sarcoma (STS) 
VOTRIENT is indicated for the treatment of adult patients with
selective subtypes of Soft 
Tissue Sarcoma (STS) who have received prior chemotherapy for
metastatic disease or 
who have progressed within 12 months after (neo) adjuvant
therapy. 
Efficacy and safety has only been established in certain STS
histological tumour subtypes 
(_see Clinical Studies_). 
DOSAGE AND ADMINISTRATION 
The recommended dose of VOTRIENT is
800 mg orally once daily. 

VOTRIENT should be taken without food (at
least one hour before or two hours after a 
meal) (_see Pharmacokinetics_).
_ _

VOTRIENT should be taken whole with water and must not be broken
or crushed (_see _
_Pharmacokinetics_). 

If a dose is missed, it should not be taken if it is less than
12 hours until the next dose. 

Dose modifications 

Initial dose reduction should be from 800 mg to 400 mg daily.
Subsequent dose 
modification, either an increase or decrease in dose, should be in
200 mg increments in a 
stepwise fashion based on individual tolerability in order to
manage adverse reactions. 
The dose of VOTRIENT should not exceed 800 mg. 
_ _
_C

Súhrn charakteristických

Votrient Jun 2021.SIN
Page 1 of 25 VOTRIENT
Antineoplastic agents – Protein kinase inhibitor
DESCRIPTION AND COMPOSITION
PHARMACEUTICAL FORMS(S)
Film-coated tablet
200mg Tablet: Modified capsule-shaped, pink; with GS JT debossed on
one side.
400mg Tablet: Modified capsule-shaped, white; with GS UHL debossed on
one side.
ACTIVE SUBSTANCE(S)
Each 200 mg tablet contains 216.7 mg of pazopanib hydrochloride, which
is equivalent to 200 mg of
pazopanib as free base.
Each 400 mg tablet contains 433.4 mg of pazopanib hydrochloride, which
is equivalent to 400 mg of
pazopanib as free base.
EXCIPIENTS
Tablet core
Magnesium stearate; microcrystalline cellulose; povidone (K30); sodium
starch glycollate
Tablet coating
200 mg (Opadry Pink): Hypromellose; Iron Oxide Red (E172); Macrogol /
PEG 400; Polysorbate 80;
Titanium dioxide (E171)
400 mg (Opadry White): Hypromellose; Macrogol / PEG 400; Polysorbate
80; Titanium dioxide
(E171)
CLINICAL INFORMATION
INDICATIONS
Renal cell carcinoma (RCC)
VOTRIENT is indicated for the first line treatment of advanced renal
cell carcinoma
(RCC) and for patients who have received prior cytokine therapy for
advanced disease.
Soft tissue sarcoma (STS)
VOTRIENT is indicated for the treatment of adult patients with
selective subtypes of Soft Tissue
Sarcoma
(STS)
who
have
received
prior
chemotherapy
for
metastatic
disease
or
who
have
progressed within 12 months after (neo) adjuvant therapy.
Efficacy and safety has only been established in certain STS
histological tumour subtypes
(
_see Clinical Studies_
).
Votrient Jun 2021.SIN
Page 2 of 25
DOSAGE REGIMEN AND ADMINISTRATION
DOSAGE REGIMEN
GENERAL TARGET POPULATION
The recommended dose of VOTRIENT is 800 mg orally once daily. (see
Method of administration)
DOSE MODIFICATIONS
Initial dose reduction should be from 800 mg to 400 mg daily.
Subsequent dose modification,
either an increase or decrease in dose, should be in 200 mg increments
in a stepwise fashion based
on individual tolerability in order to manage adverse reactions. The
daily dose of VOTRIE