INLYTA TABLETS 1MG

국가: 싱가포르

언어: 영어

출처: HSA (Health Sciences Authority)

유효 성분:

Axitinib

제공처:

PFIZER PRIVATE LIMITED

ATC 코드:

L01XE17

복용량:

1.000mg

약제 형태:

TABLET, FILM COATED

구성:

Axitinib 1.000mg

관리 경로:

ORAL

처방전 유형:

Prescription Only

Manufactured by:

Pfizer Manufacturing Deutschland GmbH

승인 상태:

ACTIVE

승인 날짜:

2013-03-11

환자 정보 전단

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

제품 특성 요약

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,