Erivedge 150mg capsules

Pajjiż: Ingilterra

Lingwa: Ingliż

Sors: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredjent attiv:

Vismodegib

Disponibbli minn:

Roche Products Ltd

Kodiċi ATC:

L01XX43

INN (Isem Internazzjonali):

Vismodegib

Dożaġġ:

150mg

Għamla farmaċewtika:

Capsule

Rotta amministrattiva:

Oral

Klassi:

No Controlled Drug Status

Tip ta 'preskrizzjoni:

Valid as a prescribable product

Sommarju tal-prodott:

BNF: 08010500; GTIN: 5000471007190

Fuljett ta 'informazzjoni

1
uk-ie-mt-pil-erivedge-clean-180315-150mg-caps
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.
This medicine is subject to additional monitoring. This will allow
quick identification of new
safety information. You can help by reporting any side effects you may
get. See the end of section 4
for how to report side effects.
_ _
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 and 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
da

Karatteristiċi tal-prodott

OBJECT 1
ERIVEDGE 150 MG HARD CAPSULES
Summary of Product Characteristics Updated 26-Mar-2018 | Roche
Products Limited
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions. See
section 4.8 for how to report adverse reactions.
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 per capsule.
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 indications
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 trials, 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 13