Erivedge

Maa: Euroopan unioni

Kieli: englanti

Lähde: EMA (European Medicines Agency)

Aktiivinen ainesosa:

vismodegib

Saatavilla:

Roche Registration GmbH

ATC-koodi:

L01XX43

INN (Kansainvälinen yleisnimi):

vismodegib

Terapeuttinen ryhmä:

Antineoplastic agents

Terapeuttinen alue:

Carcinoma, Basal Cell

Käyttöaiheet:

Erivedge is indicated for the treatment of adult patients with:- symptomatic metastatic basal cell carcinoma- locally advanced basal cell carcinoma inappropriate for surgery or radiotherapy

Tuoteyhteenveto:

Revision: 15

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2013-07-12

Pakkausseloste

28
B. PACKAGE LEAFLET
29
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ERIVEDGE 150 MG HARD CAPSULES
vismodegib
Erivedge may cause severe birth defects. It may lead to the death of a
_ _
baby before it is born or shortly
after being born. You must not become pregnant while taking this
medicine. You must follow the
contraception advice described in this leaflet.
_ _
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. Do not pass it on to
others. It may harm them,
even if their signs of illness are 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 Erivedge is and what it is used for
2.
What you need to know before you take Erivedge
3.
How to take Erivedge
4.
Possible side effects
5.
How to store Erivedge
6.
Contents of the pack and other information
1.
WHAT ERIVEDGE IS AND WHAT IT IS USED FOR
WHAT ERIVEDGE IS
Erivedge is an anti-cancer medicine that contains the active substance
vismodegib.
WHAT ERIVEDGE IS USED FOR
Erivedge is used to treat adults with a type of skin cancer called
advanced basal cell carcinoma. It is
used when the cancer:
•
has spread to other parts of the body (called “metastatic” basal
cell carcinoma)
•
has spread to areas nearby (called “locally advanced” basal cell
carcinoma) and your doctor
decides that treatment with surgery or radiation is inappropriate
HOW ERIVEDGE WORKS
Basal cell carcinoma develops when DNA in normal skin cells becomes
damaged and the body cannot
repair the damage. This damage can change how certain proteins in
these cells work and the damaged
cells become cancerous and begin to grow and divide. Erivedge is an
anti-cancer medicine that works
by controlling one of the key prot

Valmisteyhteenveto

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
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
4.1
THERAPEUTIC INDICATION
Erivedge is indicated for the treatment of adult patients with:
symptomatic metastatic basal cell carcinoma
locally advanced basal cell carcinoma inappropriate for surgery or
radiotherapy (see section 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
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.
_Missed doses _
If a dose is missed, patients should be instructed not to take the
missed dose but to resume with the
next scheduled dose.
Duration of treatment
In clinical studies, treatment with Erivedge was continued until
disease progression or until
unacceptable toxicity. Treatment interruptions of up to 4 weeks were
allowed based on individual
tolerability.
Benefit of continued treatment should be regularly assessed, with the
optimal duration of therapy
varying for each individual patient.
_Special populations _
_Elderly _
No dose adjustment is required in patients ≥ 65years of age (see
section 5.2). Of a total number of
138 patients in 4 clinical studies of Erivedge in advanced basal cell
carcinoma, approximately 40 % of
3
patients were ≥ 65 years old and no overall differences in safety
and efficacy were observed between
these patients and younger patients.
_Renal impairment _
Mild and moderate renal impairment is not expected to impact the
eliminati