INLYTA TABLETS 5MG

Riik: Singapur

keel: inglise

Allikas: HSA (Health Sciences Authority)

Toimeaine:

Axitinib

Saadav alates:

PFIZER PRIVATE LIMITED

ATC kood:

L01XE17

Annus:

5.000mg

Ravimvorm:

TABLET, FILM COATED

Koostis:

Axitinib 5.000mg

Manustamisviis:

ORAL

Retsepti tüüp:

Prescription Only

Valmistatud:

Pfizer Manufacturing Deutschland GmbH

Volitamisolek:

ACTIVE

Loa andmise kuupäev:

2013-03-11

Infovoldik

INLYTA
TABLE OF CONTENT
_Please click on either of the following links to access the required
information: _
PRESCRIBING INFORMATION
PATIENT INFORMATION LEAFLET
1. NAME OF THE MEDICINAL PRODUCT
INLYTA
®
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 1 mg or 5 mg axitinib.
3. PHARMACEUTICAL FORM
Film-coated tablet
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
INLYTA
®
is indicated for the treatment of advanced renal cell carcinoma (RCC)
after failure
of one prior systemic therapy.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_POSOLOGY_
_ _
The recommended starting oral dose of INLYTA
®
is 5 mg twice daily. Administer INLYTA
®
doses approximately 12 hours apart with or without food (see Section
5.2 PHARMACOKINETIC
PROPERTIES
). INLYTA
®
should be swallowed whole with a glass of water.
_ _
If the patient vomits or misses a dose, an additional dose should not
be taken. The next
prescribed dose should be taken at the usual time.
_DOSE ADJUSTMENTS_
_ _
Dose increase or reduction is recommended based on individual safety
and tolerability.
Over the course of treatment, patients who tolerate INLYTA
®
for at least two consecutive
weeks with no adverse reactions >Grade 2 (according to the Common
Toxicity Criteria for
Adverse Events [CTCAE]), are normotensive, and are not receiving
anti-hypertensive
medication, may have their dose increased. When a dose increase from 5
mg twice daily is
recommended, the INLYTA
®
dose may be increased to 7 mg twice daily, and further to
10 mg twice daily using the same criteria.
Over the course of treatment, management of some adverse drug
reactions may require
temporary interruption or permanent discontinuation and/or dose
reduction of INLYTA
®
therapy (see Section
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
). If dose reduction from
5 mg twice daily is required, the recommended dose is 3 mg twice
daily. If additional dose
reduction is required, the recommended dose is 2 mg twice daily.
Dose adjustment is not required on the basis of patient age, rac

Toote omadused

INLYTA
TABLE OF CONTENT
_Please click on either of the following links to access the required
information: _
PRESCRIBING INFORMATION
PATIENT INFORMATION LEAFLET
1. NAME OF THE MEDICINAL PRODUCT
INLYTA
®
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 1 mg or 5 mg axitinib.
3. PHARMACEUTICAL FORM
Film-coated tablet
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
INLYTA
®
is indicated for the treatment of advanced renal cell carcinoma (RCC)
after failure
of one prior systemic therapy.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_POSOLOGY _
The recommended starting oral dose of INLYTA
®
is 5 mg twice daily. Administer INLYTA
®
doses approximately 12 hours apart with or without food (see Section
5.2 PHARMACOKINETIC
PROPERTIES
). INLYTA
®
should be swallowed whole with a glass of water.
If the patient vomits or misses a dose, an additional dose should not
be taken. The next
prescribed dose should be taken at the usual time.
_DOSE ADJUSTMENTS _
Dose increase or reduction is recommended based on individual safety
and tolerability.
Over the course of treatment, patients who tolerate INLYTA
®
for at least two consecutive
weeks with no adverse reactions >Grade 2 (according to the Common
Toxicity Criteria for
Adverse Events [CTCAE]), are normotensive, and are not receiving
anti-hypertensive
medication, may have their dose increased. When a dose increase from 5
mg twice daily is
recommended, the INLYTA
®
dose may be increased to 7 mg twice daily, and further to
10 mg twice daily using the same criteria.
Over the course of treatment, management of some adverse drug
reactions may require
temporary interruption or permanent discontinuation and/or dose
reduction of INLYTA
®
therapy (see Section
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
). If dose reduction from
5 mg twice daily is required, the recommended dose is 3 mg twice
daily. If additional dose
reduction is required, the recommended dose is 2 mg twice daily.
Dose adjustment is not required on the basis of patient age, race,
gender,