ERIVEDGE

Land: Israel

Sprache: Englisch

Quelle: Ministry of Health

Wirkstoff:

VISMODEGIB

Verfügbar ab:

ROCHE PHARMACEUTICALS (ISRAEL) LTD

Darreichungsform:

CAPSULES

Zusammensetzung:

VISMODEGIB 150 MG

Verabreichungsweg:

PER OS

Verschreibungstyp:

Required

Hergestellt von:

HOFFMANN LA ROCHE, SWITZERLAND

Anwendungsgebiete:

ERIVEDGE® is indicated for the treatment of adults with metastatic basal cell carcinoma, or with locally advanced basal cell carcinoma that has recurred following surgery or who are not candidates for surgery, and who are not candidates for radiation

Berechtigungsdatum:

2018-02-28

Gebrauchsinformation

Important information for men and women
taking Erivedge regarding contraception and
contraceptives
ERIVEDGE PREGNANCY
PREVENTION PROGRAMME
•
Erivedge could cause serious birth defects and death of the unborn or
newborn child.
•
You or your partner must not become pregnant during treatment with
this medicine.
•
You
must
follow
the
contraception
guidelines
presented
in
this
brochure.
Introduction:
This brochure contains a summary of important safety information and
guidelines about taking Erivedge. Read it carefully and keep it in
case you will
want to read it in the future. Use Erivedge in accordance with your
doctor’s
instructions.
Also read the Patient Package Insert attached to the medicine package
for
important information about taking the medicine. If there is anything
that
you don’t understand or if you have additional questions, please ask
the
doctor or pharmacist.
THIS BROCHURE IS NOT A SUBSTITUTE FOR THE PATIENT PACKAGE INSERT
ATTACHED
TO THE PREPARATION. FOR FULL INFORMATION ABOUT THE MEDICINE, SEE THE
PATIENT PACKAGE INSERT ATTACHED TO THE PREPARATION.
TABLE OF CONTENTS:
1.
Introduction
1.1 What is Erivedge and how does it work?
2.
Who may not take Erivedge?
3.
Biological mechanisms and the risk for birth defects
4.
Before you begin taking Erivedge
5.
During and after treatment:
6.
Pregnancy and Erivedge
6.1 If you are a woman of childbearing potential taking Erivedge
6.2 If you are a man taking Erivedge
6.3 If pregnancy is suspected
7.
Side effects of Erivedge
1. INTRODUCTION
•
Erivedge could cause serious birth defects and death of the unborn
or newborn child.
•
You or your partner must not become pregnant during treatment
with this medicine.
•
You must follow the contraception guidelines presented in this
brochure.
Read the explicit instructions given to you by your doctor,
particularly about
the effect of Erivedge on unborn children.
1.1 WHAT IS ERIVEDGE AND HOW DOES IT WORK?
Erivedge is an anti-cancer medicine, containing the active ingredient
vismodegib.
It is used in adults to tre

Fachinformation

1
Erivedge PI version 8
ERIVEDGE
®

Vismodegib
CAPSULES 150 MG
1.
NAME OF THE MEDICINAL PRODUCT
Erivedge 150 mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains 150 mg of vismodegib.
Excipient with known effect:
Each hard capsule contains 71.5 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsule (capsule).
Pink coloured opaque body marked “150 mg” and a grey opaque cap
marked “VISMO” with black
ink. The size of the capsule is ‘Size 1’ (dimensions 19.0 x 6.6
mm).
4.
CLINICAL PARTICULARS
Educational material
In order to assist health care providers and patients to avoid
embryonic and foetal exposure to
Erivedge the Marketing Authorisation Holder will provide educational
materials (Erivedge Pregnancy
Prevention Programme) to reinforce the potential risks associated with
the use of Erivedge:
HCP (HEALTH CARE PROVIDER) INFORMATION CARD
This product is marketed with HCP information card providing important
safety information. Please
ensure you are familiar with this material as it contains important
safety information.
PATIENT INFORMATION CARD AND BROCHURE
This product is marketed with patient safety information materials
(patient information card and
patient brochure ). Please explain to the patient the implications of
this treatment including the need
for compliance. Please also explain the signs of important adverse
reactions and instruct the patient
when to seek medical care.
4.1
THERAPEUTIC INDICATION
Erivedge is indicated for the treatment of adults with metastatic
basal cell carcinoma, or with locally
advanced basal cell carcinoma that has recurred following surgery or
who are not candidates for
surgery, and who are not candidates for radiation.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
2
Erivedge should only be prescribed by or under the supervision of a
specialist physician experienced
in the management of the approved indication.
Posology
The recommended dose is one 150 mg capsule taken once daily.
Mis