Tyverb 250mg tablets

国: イギリス

言語: 英語

ソース: MHRA (Medicines & Healthcare Products Regulatory Agency)

有効成分:

Lapatinib ditosylate monohydrate

から入手可能:

Novartis Pharmaceuticals UK Ltd

ATCコード:

L01XE07

INN（国際名）:

Lapatinib ditosylate monohydrate

投薬量:

250mg

医薬品形態:

Tablet

投与経路:

Oral

クラス:

No Controlled Drug Status

処方タイプ:

Valid as a prescribable product

製品概要:

BNF: 08010500; GTIN: 5000123112487 5000123113682 5000123113965

情報リーフレット

PACKAGE LEAFLET: INFORMATION FOR THE USER
TYVERB
® 250 MG FILM-COATED TABLETS
lapatinib
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you only. Don’t pass it on to
others. It may harm them, even
if their signs of illness seem the same as yours.

If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Tyverb is and what it is used for
2.
What you need to know before you take Tyverb
3.
How to take Tyverb
4.
Possible side effects
5.
How to store Tyverb
6.
Contents of the pack and other information
1.
WHAT TYVERB IS AND WHAT IT IS USED FOR
TYVERB IS USED TO TREAT CERTAIN TYPES OF BREAST CANCER
_(HER2-overexpressing)_
which have spread
beyond the original tumour or to other organs (
_advanced_
or
_metastatic_
breast cancer). It may slow or stop
cancer cells from growing, or may kill them.
Tyverb is prescribed to be taken in combination with another
anti-cancer medicine.
Tyverb is prescribed in
COMBINATION WITH CAPECITABINE
, for patients who have had treatment for
advanced or metastatic breast cancer before. This previous treatment
for metastatic breast cancer must
have included trastuzumab.
Tyverb is prescribed in
COMBINATION WITH TRASTUZUMAB
, for patients who have hormone receptor-
negative metastatic breast cancer and have had other treatment for
advanced or metastatic breast cancer
before.
Tyverb is prescribed in
COMBINATION WITH AN AROMATASE INHIBITOR
, for patients with hormone sensitive
metastatic breast cancer (breast cancer that is more likely to grow in
the presence of hormones), who are
not currently intended for chemotherapy.
Information about these medicines is described in separate patient
information leaflets.
ASK YOUR DOCTOR
to give yo

製品の特徴

OBJECT 1
TYVERB
Summary of Product Characteristics Updated 11-Jun-2018 | Novartis
Pharmaceuticals UK Ltd
1. Name of the medicinal product
Tyverb
®
250 mg film-coated tablets
2. Qualitative and quantitative composition
Each film-coated tablet contains lapatinib ditosylate monohydrate,
equivalent to 250 mg lapatinib.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet (tablet).
Oval, biconvex, yellow film-coated tablets, with “GS XJG” debossed
on one side.
4. Clinical particulars
4.1 Therapeutic indications
Tyverb is indicated for the treatment of adult patients with breast
cancer, whose tumours overexpress
HER2 (ErbB2);
• combination with capecitabine for patients with advanced or
metastatic disease with progression
following prior therapy, which must have included anthracyclines and
taxanes and therapy with
trastuzumab in the metastatic setting (see section 5.1).
• in combination with trastuzumab for patients with hormone
receptor-negative metastatic disease that has
progressed on prior trastuzumab therapy(ies) in combination with
chemotherapy (see section 5.1).
• in combination with an aromatase inhibitor for postmenopausal
women with hormone receptor positive
metastatic disease, not currently intended for chemotherapy. The
patients in the registration study were
not previously treated with trastuzumab or an aromatase inhibitor (see
sections 4.4. and 5.1). No data are
available on the efficacy of this combination relative to trastuzumab
in combination with an aromatase
inhibitor in this patient population.
4.2 Posology and method of administration
Tyverb treatment should only be initiated by a physician experienced
in the administration of anti-cancer
medicinal products.
HER2 (ErbB2) overexpressing tumours are defined by IHC3+, or IHC2+
with gene amplification or gene
amplification alone. HER2 status should be determined using accurate
and validated methods.
Posology
_Tyverb / capecitabine combination posology _
The recommended dose of Tyverb is 1250 mg (i.e. fi